Patent Publication Number: US-2023139639-A1

Title: Single-dose, ready-to-use injectable formulations

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. Ser. No. 16/939,713, filed on Jul. 27, 2020, which claims the benefit of U.S. Ser. No. 15/806,321, filed on Nov. 7, 2017, which claims the benefit of U.S. Provisional Application No. 62/418,688, filed Nov. 7, 2016, each of which is incorporated herein by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     Provided herein are single-dose, ready-to-use formulations that contain a compound of Formula (I), including pharmaceutically acceptable salts, polymorphs and amorphous forms thereof. Further provided herein are processes for preparing the same. 
     BACKGROUND 
     The compound of Formula (I) 
     
       
         
         
             
             
         
       
     
     N-(5-(3-(7-(3-fluorophenyl)-3H-imidazo[4,5-c]pyridin-2-yl)-1H-indazol-5-yl)pyridin-3-yl)-3-methylbutanamide, is a Wnt inhibitor. The compound of Formula (I) can be prepared as disclosed in U.S. Pat. No. 8,252,812, incorporated by reference herein in its entirety. The compound of Formula (I), including pharmaceutically acceptable salts and polymorph and amorphous forms thereof can be used in the treatment of disorders characterized by the activation of Wnt pathway signaling (e.g., cancer, abnormal cellular proliferation, angiogenesis, Alzheimer&#39;s disease, lung disease and osteoarthritis), the modulation of cellular events mediated by Wnt pathway signaling, as well as genetic diseases and neurological conditions/disorders/diseases due to mutations or dysregulation of the Wnt pathway and/or of one or more of Wnt signaling components. There exists a need for formulations containing a compound of Formula (I), including pharmaceutically acceptable salts and polymorph and amorphous forms thereof, such as a ready-to-use, single-dose formulation. 
     SUMMARY 
     Provided herein is a process for preparing a single-dose, ready-to-use formulation comprising a compound of Formula (I) 
     
       
         
         
             
             
         
       
     
     or a pharmaceutically acceptable salt or amorphous or polymorph form thereof, the process comprising: 
     (a) providing an aqueous solution comprising water; 
     (b) providing a slurry comprising a compound of Formula (I), or a pharmaceutically acceptable salt or amorphous or polymorph form thereof; 
     (c) mixing the aqueous solution and the slurry to form a suspension; and 
     (d) filling a container with the suspension to prepare a single-dose, ready-to-use formulation. 
     The process provided herein comprises providing an aqueous solution comprising water. In some embodiments of the process provided herein, the aqueous solution comprises a buffer. In some embodiments, the aqueous buffer is a phosphate buffer. In some embodiments, the phosphate buffer is selected from the group consisting of sodium phosphate dibasic, sodium phosphate monobasic, potassium phosphate monobasic, potassium phosphate dibasic, and mixtures thereof. In some embodiments, the phosphate buffer is a mixture of sodium phosphate dibasic heptahydrate and sodium phosphate monobasic monohydrate. In some embodiments, the buffer is phosphate buffered saline. 
     In some embodiments of the process provided herein, the aqueous solution comprises an excipient. In some embodiments, the excipient comprises a surfactant, a viscosity enhancer, or a mixture thereof. In some embodiments, the viscosity enhancer is a water-soluble polymer. In some embodiments, the viscosity enhancer is a cellulose derivative. In some embodiments, the cellulose derivative is sodium carboxymethylcellulose. In some embodiments, the aqueous solution comprises about 0.01 g/kg to about 50 g/kg; about 0.5 g/kg to about 50 g/kg; about 1.0 g/kg to about 50 g/kg; about 1 g/kg to about 25 g/kg; about 1 g/kg to about 10 g/kg; about 1 g/kg to about 7.5 g/kg; about 1 g/kg to about 5.5 g/kg; about 1 g/kg to about 2.5 g/kg; about 2.5 g/kg to about 50 g/kg; about 5 g/kg to about 50 g/kg; about 10 g/kg to about 50 g/kg; about 25 g/kg to about 50 g/kg; about. 0.1 to about 5 g/kg; about 2.5 g/kg to about 7.5 g/kg; about 5 g/kg to about 10 g/kg; or about 10 g/kg to about 20 g/kg of a viscosity enhancer. In some embodiments, the aqueous solution comprises about 5.5 g/kg of a cellulose derivative. 
     In some embodiments of the process provided herein, the surfactant is a polysorbate. In some embodiments, the aqueous solution comprises about 0.01 g/kg to about 5 g/kg; about 0.01 g/kg to about 2.5 g/kg; about 0.01 g/kg to about 1 g/kg; about 0.01 g/kg to about 0.75 g/kg; about 0.01 g/kg to about 0.5 g/kg; about 0.01 g/kg to about 0.25 g/kg; about 0.025 g/kg to about 5 g/kg; about 0.05 g/kg to about 5 g/kg; about 1 g/kg to about 5 g/kg; about 0.1 g/kg to about 5 g/kg; 0.1 g/kg to about 2.5 g/kg; about 0.1 g/kg to about 1 g/kg; about 0.1 g/kg to about 0.75 g/kg; about 0.1 g/kg to about 0.5 g/kg; about 0.1 g/kg to about 0.25 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.25 g/kg to about 2.5 g/kg; about 0.25 g/kg to about 0.75 g/kg; about 0.5 g/kg to about 2.5 g/kg; about 0.5 g/kg to about 1 g/kg; or about 1 g/kg to about 2 g/kg of a surfactant. In some embodiments, the aqueous solution comprises about 0.5 g/kg of a surfactant. In some embodiments, the aqueous solution comprises about 5.55 g/kg of sodium carboxymethylcellulose and about 0.5 g/kg of polysorbate 80. 
     The process provided herein comprises providing a slurry comprising a compound of Formula (I), or a pharmaceutically acceptable salt or amorphous or polymorph form thereof. In some embodiments of the process provided herein, the slurry comprises about 0.001 g/kg to about 5 g/kg; about 0.001 g/kg to about 2.5 g/kg; about 0.001 g/kg to about 1 g/kg; about 0.001 g/kg to about 0.75 g/kg; about 0.001 g/kg to about 0.5 g/kg; about 0.001 g/kg to about 0.25 g/kg; about 0.001 g/kg to about 0.01 g/kg; about 0.01 g/kg to about 5 g/kg; about 0.01 g/kg to about 2.5 g/kg; about 0.01 g/kg to about 1 g/kg; about 0.01 g/kg to about 0.75 g/kg; about 0.01 g/kg to about 0.5 g/kg; about 0.01 g/kg to about 0.25 g/kg; about 0.1 g/kg to about 2.5 g/kg; about 0.1 g/kg to about 1 g/kg; about 0.1 g/kg to about 0.75 g/kg; about 0.1 g/kg to about 0.5 g/kg; about 0.1 g/kg to about 0.25 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.5 g/kg to about 5 g/kg; about 1 g/kg to about 5 g/kg; about 2.5 g/kg to about 5 g/kg; about 0.25 g/kg to about 0.75 g/kg; about 0.5 g/kg to about 1 g/kg; or about 1 g/kg to about 2 g/kg of the compound of Formula (I), or a salt or amorphous or polymorph form thereof. In some embodiments, the slurry comprises about 0.15 g/kg, about 0.35 g/kg, or about 1.15 g/kg of the compound of Formula (I), or a salt or amorphous or polymorph form thereof. In some embodiments, the compound of Formula (I) comprises a polymorph form. In some embodiments, the polymorph is Form 1 and has an X-ray powder diffraction pattern comprising peaks at ° 2θ values of 6.8±0.2, 12.4±0.2, and 18.5±0.2. In some embodiments, the compound of Formula (I) comprises a mixture of a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. 
     In some embodiments of the process provided herein, the slurry comprises an excipient. In some embodiments, the excipient comprises a surfactant. In some embodiments, the surfactant is a polysorbate. In some embodiments, the slurry comprises about 0.01 g/kg to about 5 g/kg; 0.01 g/kg to about 2.5 g/kg; about 0.01 g/kg to about 1 g/kg; about 0.01 g/kg to about 0.75 g/kg; about 0.01 g/kg to about 0.5 g/kg; about 0.01 g/kg to about 0.25 g/kg; about 0.025 g/kg to about 5 g/kg; about 0.05 g/kg to about 5 g/kg; about 1 g/kg to about 5 g/kg; about 0.1 g/kg to about 5 g/kg; 0.1 g/kg to about 2.5 g/kg; about 0.1 g/kg to about 1 g/kg; about 0.1 g/kg to about 0.75 g/kg; about 0.1 g/kg to about 0.5 g/kg; about 0.1 g/kg to about 0.25 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.25 g/kg to about 2.5 g/kg; about 0.25 g/kg to about 0.75 g/kg; about 0.5 g/kg to about 5 g/kg; about 0.5 g/kg to about 2.5 g/kg; about 0.5 g/kg to about 1 g/kg; about 1 g/kg to about 5 g/kg; about 2.5 g/kg to about 5 g/kg; or about 1 g/kg to about 2 g/kg of a surfactant. In some embodiments, the slurry comprises about 0.5 g/kg of a surfactant. 
     In some embodiments of the process provided herein, the slurry comprises about 0.15 g/kg of polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water and about 0.5 g/kg of polysorbate 80. In some embodiments, the slurry comprises no more than 5% by weight of other Forms. For example, not more than 1% or less than 0.1% of another Form, including amorphous. In some embodiments, the slurry comprises about 0.35 g/kg of polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water and about 0.5 g/kg of polysorbate 80. In some embodiments, the slurry comprises about 1.15 g/kg of polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water and about 0.5 g/kg of polysorbate 80. 
     In some embodiments of the process provided herein, the aqueous solution is a filtered mixture. In some embodiments, the filtered mixture comprises water. In some embodiments, the filtered mixture comprises water and an excipient. In some embodiments, the excipient comprises a surfactant, a viscosity enhancer, or a mixture thereof. In some embodiments, the aqueous solution is a sterile filtered mixture. In some embodiments, the aqueous solution is a heat-sterilized mixture. 
     In some embodiments of the process provided herein, the aqueous solution comprises a sterile diluent. 
     In some embodiments of the process provided herein, the aqueous solution is a first sterilized mixture; the slurry is a second sterilized mixture; and the process comprises mixing the first sterilized mixture and the second sterilized mixture. 
     Provided herein is a process comprising mixing the aqueous solution and the slurry to form a suspension. In some embodiments of the process provided herein, the aqueous solution and slurry are mixed to form a suspension comprising about 0.005 mg/mL to about 2.5 mg/mL, about 0.01 mg/mL to about 2.0 mg/mL, about 0.01 mg/mL to about 1 mg/mL, about 0.01 mg/mL to about 0.5 mg/mL, about 0.01 mg/mL to about 0.2 mg/mL, or about 0.015 mg/mL to about 0.115 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. 
     Provided herein is a process comprising filling a container with the suspension to prepare a single-dose, ready-to-use formulation. In some embodiments of the process provided herein, the container comprises a suspension comprising about 0.005 mg/mL to about 2.5 mg/mL, about 0.005 mg/mL to about 2 mg/mL, about 0.001 mg/mL to about 2 mg/mL, about 0.01 mg/mL to about 1.8 mg/mL, about 0.015 mg/mL to about 0.115, about 0.025 mg/mL to about 1.6 mg/mL, about 0.05 mg/mL to about 1.5 mg/mL, about 0.075 mg/mL to about 1.25 mg/mL, about 0.1 mg/mL to about 1 mg/mL, or about 0.25 mg/mL to about 0.75 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. In some embodiments, the container is selected from the group consisting of a vial, a bottle, an ampule, and a syringe. In some embodiments, the vial is a glass vial or a plastic vial made of polyethylene, polypropylene, polyolefins, polyethylene terephthalate, polyethylene terephthalate G, poly(vinyl chloride), and mixtures thereof. In some embodiments, the container has a volume of 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL, 6 mL, 7 mL, 8 mL, 9 mL, or 10 mL. In some embodiments, the container is a 3 mL polypropylene vial. 
     In some embodiments of the process provided herein, the mixing is done aseptically. 
     In some embodiments of the process provided herein, the filling is done aseptically. 
     In some embodiments, the process further comprises terminally sterilizing the filled container containing the suspension. In some embodiments, the container is terminally sterilized when the suspension comprises about 0.05 mg/mL to about 10 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. For example, the suspension comprises about 0.05 mg/mL to about 5 mg/mL, about 0.05 mg/mL to about 2.5 mg/mL, about 0.05 mg/mL to about 1 mg/mL, about 0.05 mg/mL to about 0.5 mg/mL, about 0.05 mg/mL to about 0.1 mg/mL, about 0.1 mg/mL to about 10 mg/mL, about 0.1 mg/mL to about 5 mg/mL, about 0.1 mg/mL to about 2.5 mg/mL, about 0.1 mg/mL to about 1 mg/mL, about 0.1 mg/mL to about 0.5 mg/mL, about 0.1 mg/mL to about 0.25 mg/mL, about 0.25 mg/mL to about 10 mg/mL, about 0.25 mg/mL to about 5 mg/mL, about 0.25 mg/mL to about 2.5 mg/mL, about 0.25 mg/mL to about 1 mg/mL, about 0.25 mg/mL to about 0.5 mg/mL, bout 0.5 mg/mL to about 10 mg/mL, about 0.5 mg/mL to about 5 mg/mL, about 0.5 mg/mL to about 2.5 mg/mL, about 0.5 mg/mL to about 1 mg/mL, about 1 mg/mL to about 10 mg/mL, about 1 mg/mL to about 5 mg/mL, about 1 mg/mL to about 2.5 mg/mL, about 2.5 mg/mL to about 10 mg/mL, about 2.5 mg/mL to about 5 mg/mL, or about 5 mg/mL to about 10 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. 
     Also provided herein is a single-dose, ready-to-use formulation comprising a compound of Formula (I) 
     
       
         
         
             
             
         
       
     
     or a pharmaceutically acceptable salt or amorphous or polymorph form thereof, prepared by a process comprising: 
     (a) providing an aqueous solution comprising water; 
     (b) providing a slurry comprising a compound of Formula (I), or a pharmaceutically acceptable salt or amorphous or polymorph form thereof; 
     (c) mixing the aqueous solution and the slurry to form a suspension; and 
     (d) filling a container with the suspension to prepare a single-dose, ready-to-use formulation. 
     The single-dose, ready-to-use formulation prepared by the process provided herein comprises providing an aqueous solution comprising water. In some embodiments, the aqueous solution comprises a buffer. In some embodiments, the aqueous buffer is a phosphate buffer. In some embodiments, the phosphate buffer is selected from the group consisting of sodium phosphate dibasic, sodium phosphate monobasic, potassium phosphate monobasic, potassium phosphate dibasic, and mixtures thereof. In some embodiments, the phosphate buffer is a mixture of sodium phosphate dibasic heptahydrate and sodium phosphate monobasic monohydrate. In some embodiments, the buffer is phosphate buffered saline. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the aqueous solution comprises an excipient. In some embodiments, the excipient comprises a surfactant, a viscosity enhancer, or a mixture thereof. In some embodiments, the viscosity enhancer is a cellulose derivative. In some embodiments, the cellulose derivative is a water-soluble cellulose derivative. In some embodiments, the cellulose derivative is sodium carboxymethylcellulose. In some embodiments, the aqueous solution comprises about 0.01 g/kg to about 50 g/kg; about 0.5 g/kg to about 50 g/kg; about 1.0 g/kg to about 50 g/kg; about 1 g/kg to about 25 g/kg; about 1 g/kg to about 10 g/kg; about 1 g/kg to about 7.5 g/kg; about 1 g/kg to about 5.5 g/kg; about 1 g/kg to about 2.5 g/kg; about 2.5 g/kg to about 50 g/kg; about 5 g/kg to about 50 g/kg; about 10 g/kg to about 50 g/kg; about 25 g/kg to about 50 g/kg; about 0.1 g/kg to about 5 g/kg; about 2.5 g/kg to about 7.5 g/kg; about 5 g/kg to about 10 g/kg; or about 10 g/kg to about 20 g/kg of a viscosity enhancer. In some embodiments, the aqueous solution comprises about 5.5 g/kg of a cellulose derivative. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the surfactant is a polysorbate. In some embodiments, the aqueous solution comprises about 0.1 g/kg to about 5 g/kg; 0.1 g/kg to about 2.5 g/kg; about 0.1 g/kg to about 1 g/kg; about 0.1 g/kg to about 0.75 g/kg; about 0.1 g/kg to about 0.5 g/kg; about 0.1 g/kg to about 0.25 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.5 g/kg to about 5 g/kg; about 1 g/kg to about 5 g/kg; about 0.1 g/kg to about 5 g/kg; 0.1 g/kg to about 2.5 g/kg; about 0.1 g/kg to about 1 g/kg; about 0.1 g/kg to about 0.75 g/kg; about 0.1 g/kg to about 0.5 g/kg; about 0.1 g/kg to about 0.25 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.25 g/kg to about 2.5 g/kg; about 0.25 g/kg to about 0.75 g/kg; about 0.5 g/kg to about 2.5 g/kg; about 0.5 g/kg to about 1 g/kg; or about 1 g/kg to about 2 g/kg of a surfactant. In some embodiments, the aqueous solution comprises about 0.5 g/kg of a surfactant. In some embodiments, the aqueous solution comprises about 5.55 g/kg of sodium carboxymethylcellulose and about 0.5 g/kg of polysorbate 80. 
     The single-dose, ready-to-use formulation prepared by the process provided herein comprises providing a slurry comprising a compound of Formula (I), or a pharmaceutically acceptable salt or amorphous or polymorph form thereof. In some embodiments of the process provided herein, the slurry comprises about 0.001 g/kg to about 5 g/kg; about 0.001 g/kg to about 2.5 g/kg; about 0.001 g/kg to about 1 g/kg; about 0.001 g/kg to about 0.75 g/kg; about 0.001 g/kg to about 0.5 g/kg; about 0.001 g/kg to about 0.25 g/kg; about 0.001 g/kg to about 0.01 g/kg; about 0.01 g/kg to about 5 g/kg; about 0.01 g/kg to about 2.5 g/kg; about 0.01 g/kg to about 1 g/kg; about 0.01 g/kg to about 0.75 g/kg; about 0.01 g/kg to about 0.5 g/kg; about 0.01 g/kg to about 0.25 g/kg; about 0.1 g/kg to about 2.5 g/kg; about 0.1 g/kg to about 1 g/kg; about 0.1 g/kg to about 0.75 g/kg; about 0.1 g/kg to about 0.5 g/kg; about 0.1 g/kg to about 0.25 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.5 g/kg to about 5 g/kg; about 1 g/kg to about 5 g/kg; about 2.5 g/kg to about 5 g/kg; about 0.25 g/kg to about 0.75 g/kg; about 0.5 g/kg to about 1 g/kg; or about 1 g/kg to about 2 g/kg of the compound of Formula (I), or a salt or amorphous or polymorph form thereof. In some embodiments, the slurry comprises about 0.15 g/kg, about 0.35 g/kg, or about 1.15 g/kg of the compound of Formula (I), or a salt or amorphous or polymorph form thereof. In some embodiments, the compound of Formula (I) comprises a polymorph form. In some embodiments, the polymorph is Form 1 and has an X-ray powder diffraction pattern comprising peaks at ° 2θ values of 6.8±0.2, 12.4±0.2, and 18.5±0.2. In some embodiments, the compound of Formula (I) comprises a mixture of a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the compound comprises no more than 5% by weight of other Forms. For example, not more than 1% or less than 0.1% of another Form, including amorphous. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the slurry comprises an excipient. In some embodiments, the excipient comprises a surfactant. In some embodiments, the surfactant is a polysorbate. In some embodiments, the slurry comprises about 0.01 g/kg to about 5 g/kg; 0.01 g/kg to about 2.5 g/kg; about 0.01 g/kg to about 1 g/kg; about 0.01 g/kg to about 0.75 g/kg; about 0.01 g/kg to about 0.5 g/kg; about 0.01 g/kg to about 0.25 g/kg; about 0.025 g/kg to about 5 g/kg; about 0.05 g/kg to about 5 g/kg; about 1 g/kg to about 5 g/kg; about 0.1 g/kg to about 5 g/kg; 0.1 g/kg to about 2.5 g/kg; about 0.1 g/kg to about 1 g/kg; about 0.1 g/kg to about 0.75 g/kg; about 0.1 g/kg to about 0.5 g/kg; about 0.1 g/kg to about 0.25 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.25 g/kg to about 2.5 g/kg; about 0.25 g/kg to about 0.75 g/kg; about 0.5 g/kg to about 5 g/kg; about 0.5 g/kg to about 2.5 g/kg; about 0.5 g/kg to about 1 g/kg; about 1 g/kg to about 5 g/kg; about 2.5 g/kg to about 5 g/kg; or about 1 g/kg to about 2 g/kg of a surfactant. In some embodiments, the slurry comprises about 0.5 g/kg of a surfactant. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the slurry comprises about 0.15 g/kg of polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water and about 0.5 g/kg of polysorbate 80. In some embodiments, the slurry comprises about 0.35 g/kg of polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water and about 0.5 g/kg of polysorbate 80. In some embodiments, the slurry comprises about 1.15 g/kg of polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water and about 0.5 g/kg of polysorbate 80. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the aqueous solution is a filtered mixture. In some embodiments, the filtered mixture comprises water. In some embodiments, the filtered mixture comprises water and an excipient. In some embodiments, the excipient comprises a surfactant, a viscosity enhancer, or a mixture thereof. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the aqueous solution comprises a sterile diluent. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the aqueous solution is a sterile-filtered mixture or a first bulk sterilized mixture or both; the slurry is a second bulk sterilized mixture; and the process comprises mixing the first bulk sterilized mixture and the second bulk sterilized mixture. 
     Provided herein is a single-dose, ready-to-use formulation prepared by a process comprising mixing the aqueous solution and the slurry to form a suspension. In some embodiments, the aqueous solution and slurry are mixed to form a suspension comprising about 0.005 mg/mL to about 2.5 mg/mL, about 0.001 mg/mL to about 2 mg/mL, about 0.01 mg/mL to about 2.0 mg/mL, about 0.01 mg/mL to about 1 mg/mL, about 0.01 mg/mL to about 0.5 mg/mL, about 0.01 mg/mL to about 0.2 mg/mL, or about 0.015 mg/mL to about 0.115 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. 
     Provided herein is a single-dose, ready-to-use formulation prepared by a process comprising filling a container with the suspension to prepare a single-dose, ready-to-use formulation. In some embodiments, the container comprises a suspension comprising about 0.005 mg/mL to about 2.5 mg/mL, about 0.005 mg/mL to about 2 mg/mL, about 0.01 mg/mL to about 1.8 mg/mL, about 0.015 mg/mL to about 0.115, about 0.025 mg/mL to about 1.6 mg/mL, about 0.05 mg/mL to about 1.5 mg/mL, about 0.075 mg/mL to about 1.25 mg/mL, about 0.1 mg/mL to about 1 mg/mL, or about 0.25 mg/mL to about 0.75 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. In some embodiments, the container is selected from the group consisting of a vial, a bottle, an ampule, and a syringe. In some embodiments, the vial is a glass vial or a plastic vial made of polyethylene, polypropylene, polyolefins, polyethylene terephthalate, polyethylene terephthalate G, poly(vinyl chloride), and mixtures thereof. In some embodiments, the container has a volume of 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL. In some embodiments, the container is a 3 mL polypropylene vial. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the mixing is done aseptically. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the filling is done aseptically. 
     In some embodiments of the single-dose, ready-to-use formulation prepared by the process provided herein, the container containing the suspension is terminally sterilized. In some embodiments, the container is terminally sterilized when the suspension comprises about 0.05 mg/mL to about 10 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. For example, the suspension comprises about 0.05 mg/mL to about 5 mg/mL, about 0.05 mg/mL to about 2.5 mg/mL, about 0.05 mg/mL to about 1 mg/mL, about 0.05 mg/mL to about 0.5 mg/mL, about 0.05 mg/mL to about 0.1 mg/mL, about 0.1 mg/mL to about 10 mg/mL, about 0.1 mg/mL to about 5 mg/mL, about 0.1 mg/mL to about 2.5 mg/mL, about 0.1 mg/mL to about 1 mg/mL, about 0.1 mg/mL to about 0.5 mg/mL, about 0.1 mg/mL to about 0.25 mg/mL, about 0.25 mg/mL to about 10 mg/mL, about 0.25 mg/mL to about 5 mg/mL, about 0.25 mg/mL to about 2.5 mg/mL, about 0.25 mg/mL to about 1 mg/mL, about 0.25 mg/mL to about 0.5 mg/mL, bout 0.5 mg/mL to about 10 mg/mL, about 0.5 mg/mL to about 5 mg/mL, about 0.5 mg/mL to about 2.5 mg/mL, about 0.5 mg/mL to about 1 mg/mL, about 1 mg/mL to about 10 mg/mL, about 1 mg/mL to about 5 mg/mL, about 1 mg/mL to about 2.5 mg/mL, about 2.5 mg/mL to about 10 mg/mL, about 2.5 mg/mL to about 5 mg/mL, or about 5 mg/mL to about 10 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. 
     Also provided herein is a method for treating osteoarthritis in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the single-dose, ready-to-use formulation prepared by the process provided herein that comprises a therapeutically effective amount of a compound of Formula (I), including salt and amorphous and polymorph forms thereof. In some embodiments, administration of the formulation is intra-articular. In some embodiments, the formulation is administered to the subject once. In some embodiments, the formulation is administered more than once with each injection separated by about 3 months to about 60 months. In some embodiments, the formulation is administered once every 2 weeks, every 3 weeks, every 4 weeks, every 6 weeks, every 8 weeks, or every 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, or 60 months. 
     Other features and advantages of the processes, formulations, and uses provided herein will be apparent from the following detailed description and figures, and from the claims. 
    
    
     
       DESCRIPTION OF DRAWINGS 
         FIGS.  1 A- 1 D  are scans of polymorph Form 1 of the compound of Formula (I).  FIG.  1 A  is an x-ray powder diffraction scan of fully dried Form 1.  FIG.  1 B  is a differential scanning calorimetry scan of Form 1.  FIG.  1 C  is a thermal gravimetric analysis scan of Form 1.  FIG.  1 D  is a dynamic vapor sorption scan of Form 1. 
         FIGS.  2 A- 2 H  are scans of polymorph Forms 2, 2*, and 2** of the compound of Formula (I).  FIG.  2 A  is an x-ray powder diffraction scan of fully dried Form 2.  FIG.  2 B  is a differential scanning calorimetry scan of Form 2.  FIG.  2 C  is a thermal gravimetric analysis scan of Form 2.  FIG.  2 D  is an x-ray powder diffraction scan of fully dried Form 2*.  FIG.  2 E  is a differential scanning calorimetry scan of Form 2*.  FIG.  2 F  is a thermal gravimetric analysis scan of Form 2*.  FIG.  2 G  is an x-ray powder diffraction scan of Form 2**.  FIG.  2 H  is a differential scanning calorimetry scan of Form 2**. 
         FIGS.  3 A- 3 C  are scans of polymorph Form 3 of the compound of Formula (I).  FIG.  3 A  is an x-ray powder diffraction scan of fully dried Form 3.  FIG.  3 B  is a differential scanning calorimetry scan of Form 3.  FIG.  3 C  is a thermal gravimetric analysis scan of Form 3. 
         FIGS.  4 A- 4 I  are scans of polymorph Forms 4, 4*, and 4** of the compound of Formula (I).  FIG.  4 A  is an x-ray powder diffraction scan of fully dried Form 4.  FIG.  4 B  is a differential scanning calorimetry scan of Form 4.  FIG.  4 C  is a thermal gravimetric analysis scan of Form 4.  FIG.  4 D  is an x-ray powder diffraction scan of fully dried Form 4*.  FIG.  4 E  is a differential scanning calorimetry scan of Form 4*.  FIG.  4 F  is a thermal gravimetric analysis scan of Form 4*.  FIG.  4 G  is an x-ray powder diffraction scan of Form 4**.  FIG.  4 H  is a differential scanning calorimetry scan of Form 4**.  FIG.  4 I  is a thermal gravimetric analysis scan of Form 4**. 
         FIGS.  5 A- 5 D  are scans of polymorph Forms 5 and 5* of the compound of Formula (I).  FIG.  5 A  is an x-ray powder diffraction scan of fully dried Form 5.  FIG.  5 B  is a differential scanning calorimetry scan of Form 5.  FIG.  5 C  is a thermal gravimetric analysis scan of Form 5.  FIG.  5 D  is an x-ray powder diffraction scan of Form 5*. 
         FIGS.  6 A and  6 B  are scans of polymorph Form 6 of the compound of Formula (I).  FIG.  6 A  is an x-ray powder diffraction scan of Form 6.  FIG.  6 B  is a differential scanning calorimetry scan of Form 6. 
         FIGS.  7 A- 7 C  are scans of polymorph Form 7 of the compound of Formula (I).  FIG.  7 A  is an x-ray powder diffraction scan of fully dried Form 7.  FIG.  7 B  is a differential scanning calorimetry scan of Form 7.  FIG.  7 C  is a thermal gravimetric analysis scan of Form 7. 
         FIGS.  8 A- 8 C  are scans of polymorph Form 8 of the compound of Formula (I).  FIG.  8 A  is an x-ray powder diffraction scan of fully dried Form 8.  FIG.  8 B  is a differential scanning calorimetry scan of Form 8.  FIG.  8 C  is a thermal gravimetric analysis scan of Form 8. 
         FIGS.  9 A- 9 D  are scans of polymorph Form 9 of the compound of Formula (I).  FIG.  9 A  is an x-ray powder diffraction scan of fully dried Form 9.  FIG.  9 B  is a differential scanning calorimetry scan of Form 9.  FIG.  9 C  is a thermal gravimetric analysis scan of Form 9.  FIG.  9 D  is a dynamic vapor sorption scan of Form 9. 
         FIGS.  10 A- 10 E  are scans of polymorph Forms 10 and 10* of the compound of Formula (I).  FIG.  10 A  is an x-ray powder diffraction scan of fully dried Form 10.  FIG.  10 B  is a differential scanning calorimetry scan of Form 10.  FIG.  10 C  is a thermal gravimetric analysis scan of Form 10.  FIG.  10 D  is an x-ray powder diffraction scan of Form 10*.  FIG.  10 E  is a differential scanning calorimetry scan of Form 10*. 
         FIGS.  11 A- 11 F  are scans of polymorph Forms 11 and 11* of the compound of Formula (I).  FIG.  11 A  is an x-ray powder diffraction scan of fully dried Form 11.  FIG.  11 B  is a differential scanning calorimetry scan of Form 11.  FIG.  11 C  is a thermal gravimetric analysis scan of Form 11.  FIG.  11 D  is an x-ray powder diffraction scan of fully dried Form 11*.  FIG.  11 E  is a differential scanning calorimetry scan of Form 11*.  FIG.  11 F  is a thermal gravimetric analysis scan of Form 11*. 
         FIGS.  12 A- 12 C  are scans of Form 12, an example of a non-stoichiometric hydrate of polymorph Form 1 of the compound of Formula (I).  FIG.  12 A  is an x-ray powder diffraction scan of Form 12.  FIG.  12 B  is a differential scanning calorimetry scan of Form 12.  FIG.  12 C  is a thermal gravimetric analysis scan of Form 12. 
         FIGS.  13 A- 13 D  are scans of Form 13, an example of a non-stoichiometric hydrate of polymorph Form 1 of the compound of Formula (I).  FIG.  13 A  is an x-ray powder diffraction scan of Form 13.  FIG.  13 B  is a differential scanning calorimetry scan of Form 13.  FIG.  13 C  is a thermal gravimetric analysis scan of Form 13.  FIG.  13 D  is a dynamic vapor sorption scan of Form 13. 
         FIG.  14    is a flow chart showing an exemplary process described herein. 
         FIGS.  15 A- 15 D  are scans of Form 1 in the presence of increasing relative humidity (RH), an example of a non-stoichiometric or stoichiometric hydrate of polymorph Form 1 of the compound of Formula (I).  FIG.  15 A  is an x-ray powder diffraction scan of Form 1 exposed to 10% RH as the anhydrous Form 1.  FIG.  15 B  is an x-ray powder diffraction scan of Form 1 exposed to 20% RH as a partial hydrate of Form 1.  FIG.  15 C  is an x-ray powder diffraction scan of Form 1 exposed to 30% RH as a hydrate of Form 1 (≈10-12% water uptake).  FIG.  15 D  is an x-ray powder diffraction scan of Form 1 exposed to 90% RH as a full hydrate of Form 1 (≈17-20% water uptake). 
     
    
    
     DETAILED DESCRIPTION 
     1. Definitions 
     Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Methods and materials are described herein for use in the present disclosure; other, suitable methods and materials known in the art can also be used. The materials, methods, and examples are illustrative only and not intended to be limiting. All publications, patent applications, patents, sequences, database entries, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. 
     The term “pharmaceutically acceptable carrier” or “pharmaceutically acceptable excipient” includes any and all solvents, co-solvents, complexing agents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, and the like, which are not biologically or otherwise undesirable. The use of such media and agents for pharmaceutically active substances is well known in the art. Except insofar as any conventional media or agent is incompatible with the active ingredient, its use in the therapeutic formulations is contemplated. Supplementary active ingredients can also be incorporated into the formulations. In addition, various excipients, such as are commonly used in the art, can be included. These and other such compounds are described in the literature, e.g., in the Merck Index, Merck &amp; Company, Rahway, N.J. Considerations for the inclusion of various components in pharmaceutical compositions are described, e.g., in Gilman et al. (Eds.) (2010);  Goodman and Gilman&#39;s: The Pharmacological Basis of Therapeutics,  12th Ed., The McGraw-Hill Companies. 
     As used herein, a “single-dose” refers to a sterile formulation that is packaged in a container for parenteral administration (injection or infusion). A single-dose formulation is designed for use with a single patient as a single injection/infusion. Examples of containers for use with single-dose formulations include vials, ampules, bottles, and syringes. 
     “Ready-to-use,” as used herein, refers to a formulation that does not require constitution or dilution with a prescribed amount of diluent, e.g., water for injection or other suitable diluent, before use by the designated route. For example, a formulation in a vial, of the desired concentration, that only needs to be drawn up into a syringe. 
     The term “polymorph,” as used herein, refers to crystals of the same molecule having different physical properties as a result of the order of the molecules in the crystal lattice. Polymorphs of a single compound have one or more different chemical, physical, mechanical, electrical, thermodynamic, and/or biological properties from each other. Differences in physical properties exhibited by polymorphs can affect pharmaceutical parameters such as storage stability, compressibility, density (important in composition and product manufacturing), dissolution rates (an important factor in determining bio-availability), solubility, melting point, chemical stability, physical stability, powder flowability, water sorption, compaction, and particle morphology. Differences in stability can result from changes in chemical reactivity (e.g. differential oxidation, such that a dosage form discolors more rapidly when comprised of one polymorph than when comprised of another polymorph) or mechanical changes (e.g., crystal changes on storage as a kinetically favored polymorph converts to a thermodynamically more stable polymorph) or both (e.g., one polymorph is more hygroscopic than the other). As a result of solubility/dissolution differences, some transitions affect potency and/or toxicity. In addition, the physical properties of the crystal may be important in processing; for example, one polymorph might be more likely to form solvates or might be difficult to filter and wash free of impurities (i.e., particle shape and size distribution might be different between one polymorph relative to the other). “Polymorph” does not include amorphous forms of the compound. As used herein, “amorphous” refers to a non-crystalline form of a compound which may be a solid state form of the compound or a solubilized form of the compound. For example, “amorphous” refers to a compound without a regularly repeating arrangement of molecules or external face planes. 
     The term “anhydrous,” as used herein, refers to a crystal form of the compound of Formula (I) that has 1% or less by weight water. For example, 0.5% or less, 0.25% or less, or 0.1% or less by weight water. 
     The term “solvate” as used herein refers to a crystalline form of a compound of Formula (I), such as a polymorph form of the compound, where the crystal lattice comprises one or more solvents of crystallization. 
     The term “non-stoichiometric hydrate” refers to a crystalline form of a compound of Formula I that comprises water, but wherein variations in the water content do not cause significant changes to the crystal structure. In some embodiments, a non-stoichiometric hydrate can refer to a crystalline form of a compound of Formula I that has channels or networks throughout the crystal structure into which water molecules can diffuse. During drying of non-stoichiometric hydrates, a considerable proportion of water can be removed without significantly disturbing the crystal network, and the crystals can subsequently rehydrate to give the initial non-stoichiometric hydrated crystalline form. Unlike stoichiometric hydrates, the dehydration and rehydration of non-stoichiometric hydrates is not accompanied by a phase transition, and thus all hydration states of a non-stoichiometric hydrate represent the same crystal form. In some embodiments, a non-stoichiometric hydrate can have up to about 20% by weight water, such as, about 20%, about 19%, about 18%, about 17%, about 16%, about 15%, about 14%, about 13%, about 12%, about 11%, about 10%, about 9%, about 8%, about 7%, about 6%, about 5%, about 4%, about 3%, about 2%, or greater than 1% water by weight. In some embodiments, a non-stoichiometric hydrate can have between 1% and about 20% by weight water, such as between 1% and about 5%, 1% and about 10%, 1% and about 15%, about 2% and about 5%, about 2% and about 10%, about 2% and about 15%, about 2% and about 20%, about 5% and about 10%, about 5% and about 15%, about 5% and about 20%, about 10% and about 15%, about 10% and about 20%, or about 15% and about 20% by weight water. 
     In some embodiments the % water by weight in a crystal form, such as a non-stoichiometric or stoichiometric hydrate, is determined by the Karl Fischer titration method. In some embodiments, the crystal form is dried prior to Karl Fischer titration. 
     “Purity,” when used in reference to a composition including a polymorph of a compound of Formula (I), refers to the percentage of one specific polymorph form relative to another polymorph form or an amorphous form of a compound of Formula (I) in the referenced composition. For example, a composition comprising polymorph Form 1 having a purity of 90% would comprise 90 weight parts Form 1 and 10 weight parts of other polymorph and/or amorphous forms of the compound of Formula (I). 
     As used herein, a compound or composition is “substantially free of” one or more other components if the compound or composition contains no significant amount of such other components. Such components can include starting materials, residual solvents, or any other impurities that can result from the preparation of and/or isolation of the compounds and compositions provided herein. In some embodiments, a polymorph form provided herein is substantially free of other polymorph forms. In some embodiments, a particular polymorph of the compound of Formula (I) is “substantially free” of other polymorphs if the particular polymorph constitutes at least about 95% by weight of the compound of Formula (I) present. In some embodiments, a particular polymorph of the compound of Formula (I) is “substantially free” of other polymorphs if the particular polymorph constitutes at least about 97%, about 98%, about 99%, or about 99.5% by weight of the compound of Formula (I) present. In certain embodiments, a particular polymorph of the compound of Formula (I) is “substantially free” of water if the amount of water constitutes no more than about 2%, about 1%, or about 0.5% by weight of the polymorph. 
     As used herein, a compound is “substantially present” as a given polymorph if at least about 50% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 60% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 70% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 80% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 90% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 95% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 96% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 97% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 98% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 99% by weight of the compound is in the form of that polymorph. In some embodiments, at least about 99.5% by weight of the compound is in the form of that polymorph. 
     “Room temperature” or “RT” refers to the ambient temperature of a typical laboratory, which is typically around 25° C. 
     The term “administration” or “administering” refers to a method of giving a dosage of a compound or pharmaceutical formulation to a vertebrate or invertebrate, including a mammal, a bird, a fish, or an amphibian. The preferred method of administration can vary depending on various factors, e.g., the components of the pharmaceutical formulation, the site of the disease, and the severity of the disease. 
     “Subject,” as used herein, means a human or a non-human mammal, e.g., a dog, a cat, a mouse, a rat, a cow, a sheep, a pig, a goat, a non-human primate or a bird, e.g., a chicken, as well as any other vertebrate or invertebrate. In some embodiments, the subject is a human. 
     As used herein, “therapeutically effective amount” is an amount of the formulation provided herein comprising a compound of Formula (I), or salt or amorphous or polymorph form thereof, which is sufficient to achieve the desired effect and can vary according to the nature and severity of the disease condition, and the potency of the compound. A therapeutic effect is the relief, to some extent, of one or more of the symptoms of the disease, and can include curing a disease. “Curing” means that the symptoms of active disease are eliminated. However, certain long-term or permanent effects of the disease can exist even after a cure is obtained (such as, e.g., extensive tissue damage). 
     “Treat,” “treatment,” or “treating,” as used herein, refers to administering a compound or pharmaceutical formulation as provided herein for therapeutic purposes. The term “therapeutic treatment” refers to administering treatment to a patient already suffering from a disease, thus causing a therapeutically beneficial effect, such as ameliorating existing symptoms, preventing additional symptoms, ameliorating the underlying metabolic causes of symptoms, postponing or preventing the further development of a disorder and/or reducing the severity of symptoms that will or are expected to develop. 
     2. Process for Preparing Single-Dose, Ready-to-Use Formulations 
     Provided herein is a process for preparing a single-dose, ready-to-use formulation comprising a compound of Formula (I) 
     
       
         
         
             
             
         
       
     
     including salts and amorphous and polymorph forms thereof. The process includes: 
     (a) providing an aqueous solution comprising water; 
     (b) providing a slurry comprising a compound of Formula (I), including salts and amorphous and polymorph forms thereof; 
     (c) mixing the aqueous solution and slurry to form a suspension; and 
     (d) aseptically filling a container with the suspension to prepare a single-dose formulation. 
     In the process provided herein, the process comprises providing an aqueous solution comprising water. Suitable types of water include, but are not limited to, deionized water, distilled water, reverse osmosis filtered water, reagent grade water, water for injection (WFI), USP/EP grade water suitable for use in pharmaceuticals, and aqueous buffer solutions. The water is substantially free of contaminants, such as parasites, pathogens, chemical contaminants, and particulate contamination. In some embodiments, the aqueous solution comprises a buffer. In some embodiments, the aqueous solution comprises an excipient. In some embodiments, the aqueous solution comprises a buffer and an excipient. In some embodiments, the excipient comprises a surfactant. In some embodiments, the excipient comprises a viscosity enhancer. In some embodiments, the excipient comprises a surfactant, a viscosity enhancer, or a mixture thereof. For example, the aqueous solution can include a surfactant and a viscosity enhancer in an aqueous buffer. In some embodiments, the viscosity enhancer is a cellulose derivative. In some embodiments, the aqueous solution comprises about 5.55 g/kg of sodium carboxymethylcellulose and about 0.5 g/kg of polysorbate 80 in phosphate buffered saline. 
     In some embodiments of the process provided herein, the aqueous solution includes a viscosity enhancer. The viscosity enhancer can be, for example, a cellulose or cellulose derivative or a synthetic polymer. Examples of viscosity enhancers include, but are not limited to, microcrystalline cellulose (Avicel: Asahi Kasei Corp., etc.), microcrystalline cellulose carmellose sodium (Avicel RC: Asahi Kasei Corp., etc.), methyl cellulose (Metolose SM: Shin-Etsu Chemical Co., Ltd., etc.), ethyl cellulose (Ethocel: Dow Chemical Co., etc.), hydroxypropyl cellulose (Nisso HPC: Nippon Soda Co., Ltd., etc.), low-substituted hydroxypropyl cellulose (L-HPC: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl methyl cellulose 2208 (Metolose 90SH: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl methyl cellulose 2906 (Metolose 65SH: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl methyl cellulose 2910 (Metolose 60SH: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl cellulose phthalate 200731 (HPMCP: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl cellulose phthalate 220824 (HPMCP: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl methyl cellulose acetate succinate (Shin-Etsu AQOAT: Shin-Etsu Chemical Co., Ltd., etc.), carmellose (NS-300: Gotoku Chemical Co., Ltd., etc.), carmellose calcium (ECG-505: Gotoku Chemical Co., Ltd., etc.), carmellose sodium (Cellogen: Daiichi Kogyo Seiyaku Co., Ltd., etc.), croscarmellose sodium (Ac-Di-Sol: Asahi Kasei Corp., etc.), carboxymethyl ethyl cellulose (CMEC: Freund Corp., etc.), cellulose acetate phthalate (CAP: Wako Pure Chemical Industries, Ltd., etc.), hydroxyethyl cellulose (NATROSOL: Aqualon Corp., etc.), polyvinyl alcohol, polyvinylpyrrolidone, or mixtures thereof. In some embodiments, the viscosity enhancer is a cellulose derivative. In some embodiments, the cellulose derivative is a water-soluble cellulose or water-soluble cellulose derivative. In some embodiments, the cellulose derivative is a carboxymethylcellulose, or a pharmaceutically acceptable salt thereof. For example, the aqueous solution comprises sodium carboxymethylcellulose. 
     A viscosity enhancer can be present in the aqueous solution in an amount of about 0.01 g/kg to about 50 g/kg of the aqueous solution. For example, about 0.01 g/kg to about 25 g/kg; about 0.01 g/kg to about 5 g/kg; about 0.1 g/kg to about 50 g/kg; about 0.1 g/kg to about 25 g/kg; about 0.1 g/kg to about 5 g/kg; about 0.5 g/kg to about 50 g/kg; about 0.5 g/kg to about 0.25 g/kg; about 0.5 g/kg to about 10 g/kg; about 0.5 g/kg to about 7.5 g/kg; about 0.5 g/kg to about 5.5 g/kg; about 0.5 g/kg to about 2.5 g/kg; about 1 g/kg to about 50 g/kg; about 1 g/kg to about 25 g/kg; about 1 g/kg to about 10 g/kg; about 1 g/kg to about 7.5 g/kg; about 1 g/kg to about 5.5 g/kg; about 1 g/kg to about 2.5 g/kg; about 2.5 g/kg to about 50 g/kg; about 5 g/kg to about 50 g/kg; about 10 g/kg to about 50 g/kg; about 25 g/kg to about 50 g/kg; about 0.1 g/kg to about 5 g/kg; about 2.5 g/kg to about 7.5 g/kg; about 5 g/kg to about 10 g/kg; and about 10 g/kg to about 20 g/kg of the aqueous solution. In some embodiments, the viscosity enhancer can be present in the aqueous solution at about 5 g/kg of the aqueous solution. In some embodiments, the viscosity enhancer can be present in the aqueous solution at about 5.55 g/kg of the aqueous solution. For example, the aqueous solution comprises about 5.55 g/kg sodium carboxymethylcellulose. In some embodiments, a cellulose derivative is present in the aqueous solution in an amount of about 0.05% to about 5% by weight of the aqueous solution. For example, about 0.05% to about 2.5%; about 0.05% to about 1%; about 0.05% to about 0.75%; about 0.05% to about 0.55%; about 0.05% to about 0.25%; about 0.1% to about 5%; about 0.1% to about 2.5%; about 0.1% to about 1%; about 0.1% to about 0.75%; about 0.1% to about 0.55%; about 0.1% to about 0.25%; about 0.25% to about 5%; about 0.5% to about 5%; about 1% to about 5%; about 2.5% to about 5%; about 0.25% to about 0.75%; about 0.5% to about 1%; and about 1% to about 2% by weight of the aqueous solution. In some embodiments, the viscosity enhancer can be present in the aqueous solution at about 0.55% by weight of the aqueous solution. For example, the aqueous solution comprises about 0.55% sodium carboxymethylcellulose by weight. 
     In some embodiments of the process provided herein, the aqueous solution includes a surfactant. Examples of surfactants include, but are not limited to, polysorbates such as polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, and polysorbate 85; polyoxyethylene hydrogenated castor oils such as polyoxyethylene hydrogenated castor oil 60 and polyoxyl 35 castor oil; sorbitan fatty acid esters; sucrose fatty acid esters; polyoxyethylene polyoxypropylene glycols; polyoxyethylene fatty acid ethers; polyoxyl stearates; phosphatidylcholines; phosphatidylglycerols, including, but not limited to phosphatidylglycerols containing fatty acids, fatty alcohols, or a combination thereof, and carbon chain lengths between 4 and 20 carbons; and other surfactants, including, but not limited to, 1,2-dimyristoyl-sn-glycero-3-(phospho-s-(1-glycerol)), 1,2-dioleoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-(phospho-rac-(1-glycerol)), 1,2-distearoyl-sn-glycero-3-(phospho-rac-(1-glycerol)), 1,2-distearoyl-sn-glycero-3-phosphocholine, deoxycholic acid, dipalmitoylphosphatidylglycerol (dl), distearoylphosphatidylcholine (dl), docusate sodium, egg phospholipids, glyceryl palmitostearate, glyceryl trioleate, hydrogenated soybean lecithin, hydrolyzed soy protein (enzymatic; 2000 mw), hydroxyethylpiperazine ethane sulfonic acid, lecithin, miripirium chloride, n-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phiv, oleic acid, palmitic acid, peg vegetable oil, peg-20 sorbitan isostearate, peg-40 castor oil, phospholipid, poloxamer 188, polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 3350, polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 600, polyoxyethylene fatty acid esters, sodium cholesteryl sulfate, sodium deoxycholate, sodium n-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glyc, sodium oleate, sorbitan monolaurate, sorbitan monopalmitate, stearic acid, tricaprylin, or mixtures thereof. In some embodiments, the surfactant is a polysorbate. For example, the aqueous solution comprises polysorbate 80. 
     A surfactant can be present in the aqueous solution in an amount of about 0.01 g/kg to about 5 g/kg of the aqueous solution. In some embodiments, the concentration of surfactant depends on the critical micelle concentration of the individual surfactant. In some embodiments, the amount of surfactant is enough to be above the critical micelle concentration of the surfactant, enough to coat the surface area of the particles, or both. For example, about 0.01 g/kg to about 2.5 g/kg; about 0.01 g/kg to about 1 g/kg; about 0.01 g/kg to about 0.75 g/kg; about 0.01 g/kg to about 0.5 g/kg; about 0.01 g/kg to about 0.25 g/kg; about 0.025 g/kg to about 5 g/kg; about 0.05 g/kg to about 5 g/kg; about 1 g/kg to about 5 g/kg; about 0.1 g/kg to about 5 g/kg; about 0.1 g/kg to about 2.5 g/kg; about 0.1 g/kg to about 1 g/kg; about 0.1 g/kg to about 0.75 g/kg; about 0.1 g/kg to about 0.5 g/kg; about 0.1 g/kg to about 0.25 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.5 g/kg to about 5 g/kg; about 1 g/kg to about 5 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.25 g/kg to about 2.5 g/kg; about 0.25 g/kg to about 0.75 g/kg; about 0.5 g/kg to about 2.5 g/kg; about 0.5 g/kg to about 1 g/kg; and about 1 g/kg to about 2 g/kg of the aqueous solution. In some embodiments, the surfactant can be present in the aqueous solution at about 0.5 g/kg of the aqueous solution. For example, the aqueous solution comprises about 0.5 g/kg polysorbate 80. In some embodiments, a surfactant can be present in the aqueous solution in an amount of about 0.001% to about 0.5% by weight of the aqueous solution. For example, about 0.001% to about 0.25%; about 0.001% to about 0.1%; about 0.001% to about 0.075%; about 0.001% to about 0.05%; about 0.001% to about 0.025%; about 0.0025% to about 0.5%; about 0.005% to about 0.5%; about 0.1% to about 0.5%; about 0.01% to about 0.5%; about 0.01% to about 0.25%; about 0.01% to about 0.1%; about 0.01% to about 0.075%; about 0.01% to about 0.05%; about 0.01% to about 0.025%; about 0.025% to about 0.5%; about 0.05% to about 0.5%; about 0.1% to about 0.5%; about 0.025% to about 0.5%; about 0.025% to about 2.5%; about 0.025% to about 0.075%; about 0.05% to about 2.5%; about 0.05% to about 0.1%; and about 0.1% to about 0.2% by weight of the aqueous solution. In some embodiments, the surfactant can be present in the aqueous solution at about 0.05% by weight of the aqueous solution. For example, the aqueous solution comprises about 0.05% polysorbate 80 by weight. 
     In the process provided herein, the process comprises providing a slurry comprising a compound of Formula (I), including salts and amorphous and polymorph forms thereof. In some embodiments, the compound of Formula (I) is polymorph Form 1. In some embodiments, the compound of Formula (I) is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the slurry comprises a surfactant. In some embodiments, the slurry comprises water. For example, the slurry can include a compound of Formula (I), including salts and amorphous and polymorph forms thereof and a surfactant in water. 
     The compound of Formula (I), including salts and amorphous and polymorph forms thereof can be present in the slurry in an amount of about 0.001 g/kg to about 5 g/kg of the slurry. For example, about 0.001 g/kg to about 5 g/kg; about 0.001 g/kg to about 2.5 g/kg; about 0.001 g/kg to about 1 g/kg; about 0.001 g/kg to about 0.75 g/kg; about 0.001 g/kg to about 0.5 g/kg; about 0.001 g/kg to about 0.25 g/kg; about 0.001 g/kg to about 0.01 g/kg; about 0.01 g/kg to about 2.5 g/kg; about 0.01 g/kg to about 1 g/kg; about 0.01 g/kg to about 0.75 g/kg; about 0.01 g/kg to about 0.5 g/kg; about 0.01 g/kg to about 0.25 g/kg; about 0.1 g/kg to about 2.5 g/kg; about 0.1 g/kg to about 1 g/kg; about 0.1 g/kg to about 0.75 g/kg; about 0.1 g/kg to about 0.5 g/kg; about 0.1 g/kg to about 0.25 g/kg; about 0.25 g/kg to about 5 g/kg; about 0.5 g/kg to about 5 g/kg; about 1 g/kg to about 5 g/kg; about 2.5 g/kg to about 5 g/kg; about 0.25 g/kg to about 0.75 g/kg; about 0.5 g/kg to about 1 g/kg; and about 1 g/kg to about 2 g/kg of the slurry. In some embodiments, the compound of Formula (I), including salts and amorphous and polymorph forms thereof, can be present in the slurry at about 0.15 g/kg of the slurry. In some embodiments, the compound of Formula (I), including salts and amorphous and polymorph forms thereof, can be present in the slurry at about 0.35 g/kg of the slurry. In some embodiments, the compound of Formula (I), including salts and amorphous and polymorph forms thereof, can be present in the slurry at about 1.15 g/kg of the slurry. In some embodiments, the slurry comprises about 0.15 g/kg polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the slurry comprises about 0.35 g/kg polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the slurry comprises about 1.15 g/kg polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. 
     In some embodiments, the compound of Formula (I), including salts and amorphous and polymorph forms thereof, can be present in the slurry in an amount of about 0.0001% to about 0.5% by weight of the slurry. For example, about 0.0001% to about 0.5%; about 0.0001% to about 0.25%; about 0.0001% to about 0.1%; about 0.0001% to about 0.075%; about 0.0001% to about 0.05%; about 0.0001% to about 0.025%; about 0.0001% to about 0.001%; about 0.001% to about 0.5%; about 0.001% to about 0.25%; about 0.001% to about 0.1%; about 0.001% to about 0.075%; about 0.001% to about 0.05%; about 0.001% to about 0.025%; about 0.01% to about 0.25%; about 0.01% to about 0.1%; about 0.01% to about 0.075%; about 0.01% to about 0.05%; about 0.01% to about 0.025%; about 0.025% to about 0.5%; about 0.05% to about 0.5%; about 0.1% to about 0.5%; about 0.25% to about 0.5%; about 0.025% to about 0.075%; about 0.05% to about 0.1%; and about 0.1% to about 0.2% by weight of the slurry. In some embodiments, the compound of Formula (I), including salts and amorphous and polymorph forms thereof, can be present in the slurry at about 0.015% by weight of the slurry. For example, the slurry comprises about 0.015% by weight of polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the compound of Formula (I), including salts and amorphous and polymorph forms thereof, can be present in the slurry at about 0.035% by weight of the slurry. For example, the slurry comprises about 0.035% by weight of polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the compound of Formula (I), including salts and amorphous and polymorph forms thereof, can be present in the slurry at about 0.115% by weight of the slurry. For example, the slurry comprises about 0.115% by weight of polymorph Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. 
     In some embodiments, the slurry comprises about 0.15 g/kg of a compound of Formula (I), e.g., Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water and about 0.5 g/kg of polysorbate 80 in water. In some embodiments, the compounds has no more than 5% by weight of other Forms. For example, not more than 1% or less than 0.1% of any additional Form, including amorphous. In some embodiments, the slurry comprises about 0.35 g/kg of a compound of Formula (I), e.g., Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water, and about 0.5 g/kg of polysorbate 80 in water. In some embodiments, the slurry comprises about 1.15 g/kg of a compound of Formula (I), e.g., Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water, and about 0.5 g/kg of polysorbate 80 in water. 
     In some embodiments, the slurry comprises water. Suitable types of water include, but are not limited to, deionized water, distilled water, reverse osmosis filtered water, reagent grade water, water for injection (WFI), USP grade water suitable for use in pharmaceuticals, and aqueous buffer solutions. The water is substantially free of contaminants, such as parasites, pathogens, chemical contaminants, and particulate contamination. In some embodiments, the slurry comprises water for injection. 
     In the process provided herein, the process comprises mixing the aqueous solution and slurry to form a suspension. In some embodiments, the aqueous solution is added to the slurry. In some embodiments, the slurry is added to the aqueous solution. In some embodiments, the aqueous solution and the slurry are added to a container substantially at the same time. 
     In some embodiments, the aqueous solution is a filtered mixture. In some embodiments, the filtered mixture comprises water. In some embodiments, the filtered mixture comprises water and an excipient. In some embodiments, the excipient comprises a surfactant, a viscosity enhancer, or a mixture thereof. In some embodiments, the filtered mixture is prepared by filtering the aqueous solution through a 0.2 μm filter. In some embodiments, the filter comprises a membrane comprising cellulose acetate, cellulose nitrate, nylon, a polymer, such as polyethersulfone or polytetrafluorethylene, regenerated cellulose, or glass. In some embodiments, the filter membrane is a polymeric membrane. In some embodiments, the filter membrane is a polyethersulfone (PES) membrane. In some embodiments, a sterile diluent is mixed with the filtered mixture. 
     In some embodiments, the aqueous solution, the slurry, or both, are sterilized. In some embodiments, sterilization is by heat. In some embodiments, sterilization is by bulk steam sterilization. In some embodiments, sterilization is by dry heat sterilization. In some embodiments, sterilization is by irradiation. In some embodiments, sterilization is by filtration. In some embodiments, sterilization is by bulk steam sterilization, dry heat sterilization, irradiation, or combinations thereof. In some embodiments, the aqueous solution is sterilized by filtration or by heat or by a combination of filtration and heat. In some embodiments, the aqueous solution is sterilized to form a first sterilized mixture prior to mixing with the slurry. In some embodiments, the filtered mixture is sterilized prior to mixing with the slurry. In some embodiments, the filtered mixture is aseptically mixed with sterile diluent and sterilized prior to mixing with the slurry. In some embodiments, the slurry is sterilized to form a second sterilized mixture prior to mixing with the aqueous solution. In some embodiments, the slurry is sterilized by heat. In some embodiments, the aqueous solution is sterilized to form a first sterilized mixture and the slurry is sterilized to form a second sterilized mixture prior to mixing. 
     In some embodiments, the aqueous solution and the slurry are mixed aseptically to form a suspension. The mixing can be done with any sterile diluent or solution for injection. For example, any commercially available sterile diluent or solution for injection can be used. In some embodiments, the sterile solution for injection includes, but is not limited to, saline, with or without potassium chloride, e.g., a 0.9% saline solution, dextrose, e.g., a 5% dextrose solution, phosphate buffer, Lactated Ringer&#39;s solution, and combinations thereof. In some embodiments, the sterile solution for injection is a commercially available solution containing hyaluronic acid or hyaluronic acid derivatives. In some embodiments, the sterile diluent is aseptically added in an amount sufficient to result in a suspension comprising 0.015 mg/mL of the compound of Formula (I) including salts and amorphous and polymorph forms thereof. In some embodiments, the sterile diluent is aseptically added in an amount sufficient to result in a suspension comprising 0.035 mg/mL of the compound of Formula (I) including salts and amorphous and polymorph forms thereof. In some embodiments, the sterile diluent is aseptically added in an amount sufficient to result in a suspension comprising 0.115 mg/mL of the compound of Formula (I) including salts and amorphous and polymorph forms thereof. 
     In the process provided herein, the aqueous solution and slurry are mixed to form a suspension. For example, in some embodiments, the compound of Formula (I), including salts and amorphous and polymorph forms thereof, is not completely dissolved in the aqueous phase of the suspension. In the process provided herein, the suspension comprises about 0.005 mg/mL to about 2.5 mg/mL, about 0.01 mg/mL to about 2.0 mg/mL, about 0.01 mg/mL to about 1 mg/mL, about 0.01 mg/mL to about 0.5 mg/mL, about 0.01 mg/mL to about 0.2 mg/mL, or about 0.015 mg/mL to about 0.115 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. In some embodiments, the suspension comprises 0.015 mg/mL of the compound of Formula (I) including salts and amorphous and polymorph forms thereof. In some embodiments, the suspension comprises 0.035 mg/mL of the compound of Formula (I) including salts and amorphous and polymorph forms thereof. In some embodiments, the suspension comprises 0.115 mg/mL of the compound of Formula (I) including salts and amorphous and polymorph forms thereof. 
     In some embodiments of the process provided herein, the aqueous solution, the slurry, the suspension, or combination thereof, are prepared in tanks. For example, the tank can be a tank used for manufacturing. In some embodiments, the tank is a stainless steel tank. In some embodiments, the tanks are jacketed for steam. In some embodiments, the tanks are equipped with one or more mixers, for example, a standard mixer and/or homogenizer, which are used to mix the ingredients added to the tank. In some embodiments, the tank is equipped with a heating and/or cooling device. In some embodiments, the tanks comprise ports for addition, recirculation equipment, transfer equipment, mixers, heating and/or cooling equipment, and combinations thereof. In some embodiments, the tanks have a capacity between about 5 L and about 5000 L. In some embodiments, the tanks have a capacity between about 5 L and about 3000 L; about 5 L and about 2000 L; about 5 L and about 1000 L; about 5 L and about 500 L; about 5 L and about 300 L; about 5 L and about 150 L; about 5 L and about 100 L; about 5 L and about 50 L; about 5 L and about 30 L; about 5 L and about 20 L; about 20 L and about 5000 L; about 20 L and about 3000 L; about 20 L and about 2000 L; about 20 L and about 1000 L; about 20 L and about 500 L; about 20 L and about 300 L; about 20 L and about 150 L; about 20 L and about 100 L; about 20 L and about 50 L; about 20 L and about 30 L; about 30 L and about 5000 L; about 30 L and about 3000 L; about 30 L and about 2000 L; about 30 L and about 1000 L; about 30 L and about 500 L; about 30 L and about 300 L; about 30 L and about 150 L; about 30 L and about 100 L; about 30 L and about 50 L; about 50 L and about 5000 L; about 50 L and about 3000 L; about 50 L and about 2000 L; about 50 L and about 1000 L; about 50 L and about 500 L; about 50 L and about 300 L; about 50 L and about 150 L; about 50 L and about 100 L; about 100 L and about 5000 L; about 100 L and about 3000 L; about 100 L and about 2000 L; about 100 L and about 1000 L; about 100 L and about 500 L; about 100 L and about 300 L; about 100 L and about 150 L; about 150 L and about 5000 L; about 150 L and about 3000 L; about 150 L and about 2000 L; about 150 L and about 1000 L; about 150 L and about 500 L; about 150 L and about 300 L; about 300 L and about 5000 L; about 300 L and about 3000 L; about 300 L and about 2000 L; about 300 L and about 1000 L; about 300 L and about 500 L; about 500 L and about 5000 L; about 500 L and about 3000 L; about 500 L and about 2000 L; about 500 L and about 1000 L; about 1000 L and about 5000 L; about 1000 L and about 3000 L; about 1000 L and about 2000 L; about 2000 L and about 5000 L; about 2000 L and about 3000 L; or about 3000 L and about 5000 L. In some embodiments, the tank has a capacity of about 5000 L, about 3000 L, about 2000 L, about 1000 L, about 500 L, about 300 L, about 150 L, about 100 L, about 50 L, about 30 L, about 20 L, or about 5 L. Other size tanks are known and can be used with the provided process. 
     In some embodiments, the process is performed using a scaled-up manufacturing process. A scaled-up manufacturing process can be used for volumes greater than 1 L or about 1 L or greater than 1 gallon or about 1 gallon, for example, greater than about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 40, 50, 60, 70, 80, 90, 100, 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 800, 900, 1000, 1500, 2000, 2500, 3000, or more liters. 
     In the process provided herein, the process comprises aseptically filling a container with the suspension to prepare a single-dose, ready-to-use formulation. Examples of containers include, but are not limited to, vials, bottles, ampules, and syringes. In some embodiments, the suspension is aseptically filled into a single-use vial (i.e., unused portions of each vial are discarded and not saved for later administration). In some embodiments, the vial is a plastic vial. For example, the vial can be made of polyethylene, polypropylene, polyolefins, polyethylene terephthalate, polyethylene terephthalate G, poly(vinyl chloride), and mixtures thereof. In some embodiments, the vial is a polypropylene vial. In some embodiments, the vial is a glass vial. The container can be any size that can fit the desired amount of the formulation. For example, the container can be a 1 mL, 2 mL, 3 mL, 4 mL, 5 mL, 6 mL, 7 mL, 8 mL, 9 mL, or 10 mL container. In some embodiments, the container is a 3 mL vial. In some embodiments, the container is a 5 mL vial. In some embodiments, the container is a 3 mL polypropylene vial. For example, a polypropylene vial that is made using blow-fill-seal technology. In some embodiments, the vial is designed for easy withdrawal of the formulation with a syringe. In some embodiments, the vial has a Luer slip design. In some embodiments, the vial has a Luer lock design. 
     The resulting single-dose, ready-to-use formulations produced by the process provided herein are filled into containers comprising between about 0.005 mg/mL and about 2.5 mg/mL of the compound of Formula (I), including amorphous and polymorph forms thereof, for example, between about 0.005 mg/mL to about 2 mg/mL, about 0.01 mg/mL to about 1.8 mg/mL, about 0.015 mg/mL to about 0.115, about 0.025 mg/mL to about 1.6 mg/mL, about 0.05 mg/mL to about 1.5 mg/mL, about 0.075 mg/mL to about 1.25 mg/mL, about 0.1 mg/mL to about 1 mg/mL, or about 0.25 mg/mL to about 0.75 mg/mL. In some embodiments, the containers comprise a formulation comprising about 0.015 mg/mL of the compound of Formula (I), including amorphous and polymorph forms thereof. In some embodiments, the containers comprise a formulation comprising about 0.035 mg/mL of the compound of Formula (I), including amorphous and polymorph forms thereof. In some embodiments, the containers comprise a formulation comprising about 0.115 mg/mL of the compound of Formula (I), including amorphous and polymorph forms thereof. In some embodiments, the containers comprise a concentration between about 0.1 mg/mL and 4 mg/mL. In some embodiments, the concentration is 2 mg/mL. 
     In some embodiments, the process further comprises terminally sterilizing the container containing the suspension. For example, the sterilization can be performed at 121.1° C. (250° F.) or at lower temperatures, for example, between about 70-100° C., to achieve an F o  of NLT 2. In some embodiments, the NLT is greater than 10 or greater than 30. In some embodiments, the container is terminally sterilized when the suspension comprises about 0.05 mg/mL to about 10 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. For example, the suspension comprises about 0.05 mg/mL to about 5 mg/mL, about 0.05 mg/mL to about 2.5 mg/mL, about 0.05 mg/mL to about 1 mg/mL, about 0.05 mg/mL to about 0.5 mg/mL, about 0.05 mg/mL to about 0.1 mg/mL, about 0.1 mg/mL to about 10 mg/mL, about 0.1 mg/mL to about 5 mg/mL, about 0.1 mg/mL to about 2.5 mg/mL, about 0.1 mg/mL to about 1 mg/mL, about 0.1 mg/mL to about 0.5 mg/mL, about 0.1 mg/mL to about 0.25 mg/mL, about 0.25 mg/mL to about 10 mg/mL, about 0.25 mg/mL to about 5 mg/mL, about 0.25 mg/mL to about 2.5 mg/mL, about 0.25 mg/mL to about 1 mg/mL, about 0.25 mg/mL to about 0.5 mg/mL, bout 0.5 mg/mL to about 10 mg/mL, about 0.5 mg/mL to about 5 mg/mL, about 0.5 mg/mL to about 2.5 mg/mL, about 0.5 mg/mL to about 1 mg/mL, about 1 mg/mL to about 10 mg/mL, about 1 mg/mL to about 5 mg/mL, about 1 mg/mL to about 2.5 mg/mL, about 2.5 mg/mL to about 10 mg/mL, about 2.5 mg/mL to about 5 mg/mL, or about 5 mg/mL to about 10 mg/mL of the compound of Formula (I) or a salt or amorphous or polymorph form thereof. 
     In some embodiments, the process further comprises labeling the containers. In some embodiments, the process further comprises packaging the containers, for example, into boxes, cartons, or pre-formed blisters. In some embodiments, the process further comprises labeling the boxes, cartons, or preformed blisters. 
     3. Single-Dose, Ready-to-Use Formulations 
     Provided herein are single-dose, ready-to-use pharmaceutical formulations comprising a compound of Formula (I), including pharmaceutically acceptable salts and amorphous and polymorph forms thereof, prepared by the process described herein. In some embodiments, the formulations are prepared as single-dose formulations. Provided herein are pharmaceutical formulations prepared from a polymorph form of a compound of Formula (I). In some embodiments, the polymorph form is Form 1. In some embodiments, the polymorph form is a mixture of Form 1 and Form 9. In some embodiments, the polymorph is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulation comprises a polymorph form of a compound of Formula (I). In some embodiments, the polymorph form is Form 1. In some embodiments, the pharmaceutical formulation comprises a polymorph form of a compound of Formula (I) that is a mixture of forms. In some embodiments, the mixture of forms is a mixture of Forms 1 and 9. In some embodiments, the pharmaceutical formulation comprises a polymorph form of a compound of Formula (I) that is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein contains polymorph Form 1 that has a purity of at least about 90% (not including water or solvents). In some embodiments, the purity is at least about 95%. In some embodiments, the purity is at least about 98%. For example, the purity is at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the formulation comprising Form 1 is substantially free of other forms of the compound of Formula (I), e.g., Form 9. In some embodiments, the formulation contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.05%, 0.01%, or 0.001% by weight of other forms of the compound of Formula (I). In some embodiments, the other forms of the compound of Formula (I) are other anhydrous forms of the compound of Formula (I). In some embodiments, the formulation contains less than about 15% by weight of one or more other compounds of Formula (I). For example, the formulation contains less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.05%, 0.01%, or 0.001% by weight of one or more other forms of the compound of Formula (I). For example, the formulation can contain less than about 15% by weight of Form 2, Form 3, Form 4, Form 5, Form 6, Form 7, Form 8, Form 9, Form 10, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or combinations of two or more thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein contains a non-stoichiometric or stoichiometric hydrate of polymorph Form 1 having between 1% and about 20% by weight water that has a purity of at least about 90%. In some embodiments, the purity is at least about 95%. In some embodiments, the purity is at least about 98%. For example, the purity is at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the formulation comprising the non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water is substantially free of other forms of the compound of Formula (I), e.g., Form 9. In some embodiments, the formulation contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.05%, 0.01%, or 0.001% by weight of other forms of the compound of Formula (I). In some embodiments, the other forms of the compound of Formula (I) are other anhydrous forms of the compound of Formula (I). In some embodiments, the formulation contains less than about 15% by weight of one or more other compounds of Formula (I). For example, the formulation contains less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.05%, 0.01%, or 0.001% by weight of one or more other forms of the compound of Formula (I). For example, the formulation can contain less than about 15% by weight of Form 1, Form 2, Form 3, Form 4, Form 5, Form 6, Form 7, Form 8, Form 9, Form 10, Form 11, or combinations of two or more thereof. 
     In some embodiments, the single-dose, ready-to-use formulation prepared by the process provided herein comprises about 0.001 mg to about 5.0 mg per injection of a compound of Formula (I), including amorphous and polymorph forms thereof. For example, the formulation in some embodiments comprises about 0.001 mg to about 4 mg, about 0.001 mg to about 3 mg, about 0.001 mg to about 2 mg, about 0.001 mg to about 1 mg, about 0.001 mg to about 0.5 mg, 0.001 mg to about 0.4 mg, about 0.001 mg to about 0.3 mg, about 0.001 mg to about 0.25 mg, about 0.001 mg to about 0.2 mg, about 0.001 mg to about 0.15 mg, about 0.001 mg to about 0.1 mg, about 0.001 mg to about 0.075 mg, about 0.001 mg to about 0.055 mg, about 0.001 mg to about 0.05 mg, about 0.001 mg to about 0.035 mg, about 0.001 mg to about 0.025 mg, about 0.001 mg to about 0.01 mg, about 0.001 mg to about 0.005 mg, about 0.005 mg to about 5.0 mg, about 0.0075 mg to about 5.0 mg, about 0.01 mg to about 5.0 mg, about 0.01 mg to about 4.0 mg, about 0.01 mg to about 3.0 mg, about 0.01 mg to about 2.0 mg, about 0.01 mg to about 1.0 mg, about 0.01 mg to about 0.7 mg, about 0.01 mg to about 0.5 mg, about 0.01 mg to about 0.3 mg, about 0.01 mg to about 0.23 mg, about 0.01 mg to about 0.1 mg, about 0.01 mg to about 0.07 mg, about 0.01 mg to about 0.05 mg, about 0.01 mg to about 0.03 mg, about 0.03 mg to about 4.0 mg, about 0.03 mg to about 3.0 mg, about 0.03 mg to about 2.0 mg, about 0.03 mg to about 1.0 mg, about 0.03 mg to about 0.7 mg, about 0.03 mg to about 0.5 mg, about 0.03 mg to about 0.3 mg, about 0.03 mg to about 0.23 mg, about 0.03 mg to about 0.1 mg, about 0.03 mg to about 0.07 mg, about 0.03 mg to about 0.05 mg, about 0.07 mg to about 4.0 mg, about 0.07 mg to about 3.0 mg, about 0.07 mg to about 2.0 mg, about 0.07 mg to about 1.0 mg, about 0.07 mg to about 0.7 mg, about 0.07 mg to about 0.5 mg, about 0.07 mg to about 0.3 mg, about 0.07 mg to about 0.23 mg, about 0.07 mg to about 0.1 mg, about 0.025 mg to about 5.0 mg, about 0.045 mg to about 5.0 mg, about 0.05 mg to about 5.0 mg, about 0.075 mg to about 5.0 mg, about 0.1 mg to about 5.0 mg, about 0.25 mg to about 5.0 mg, about 0.01 mg to about 3.0 mg, about 0.025 mg to about 2.0 mg, about 0.01 mg to about 0.1 mg, and about 0.15 mg to about 0.25 mg of the compound of Formula (I), including amorphous and polymorph forms thereof. In some embodiments, the formulation comprises about 0.001 mg, 0.005 mg, 0.01 mg, 0.03 mg, 0.05 mg, 0.07 mg, 0.1 mg, 0.23 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.2 mg, 1.5 mg, 1.7 mg, 2.0 mg, 2.2 mg, 2.5 mg, 2.7 mg, 3.0 mg, 3.2 mg, 3.5 mg, 3.7 mg, 4.0 mg, 4.2 mg, 4.5 mg, 4.7 mg, or 5.0 mg of the compound of Formula (I), including amorphous and polymorph forms thereof. In some embodiments, the single-dose, ready-to-use formulation comprises 0.03 mg of the compound of Formula (I), including amorphous and polymorph forms thereof. In some embodiments, the single-dose, ready-to-use formulation comprises 0.07 mg of the compound of Formula (I), including amorphous and polymorph forms thereof. In some embodiments, the single-dose, ready-to-use formulation comprises 0.115 mg of the compound of Formula (I), including amorphous and polymorph forms thereof. 
     The single-dose, ready-to-use formulations prepared by the process provided herein comprising a compound of Formula (I), including salts and amorphous and polymorph forms thereof, can comprise a conventional pharmaceutical carrier, excipient, or the like. In some embodiments, the compounds of Formula (I), including salts and amorphous and polymorph forms thereof, are formulated as a suspension. For example, the compound of Formula (I) is not completely dissolved in the pharmaceutically acceptable carrier, i.e., the compound of Formula (I) is suspended in the pharmaceutically acceptable carrier. In some embodiments, the formulation comprises the compound of Formula (I) suspended in a pharmaceutically acceptable carrier. In some embodiments, the formulation comprises a polymorph form of Formula (I) suspended in a pharmaceutically acceptable carrier. In some embodiments, the formulation comprises Form 1 suspended in a pharmaceutically acceptable carrier. In some embodiments, the formulation comprises a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water suspended in a pharmaceutically acceptable carrier. In some embodiments, the pharmaceutical formulation is a solution, i.e., the compound of Formula (I) is completely dissolved in the pharmaceutically acceptable carrier. 
     In some embodiments, the polymorph form is dried prior to mixing with the pharmaceutically acceptable carrier. 
     In some embodiments, the single-dose, ready-to-use pharmaceutically administrable formulations comprising a compound of Formula (I), including amorphous and polymorph forms thereof, can optionally comprise pharmaceutical excipients in a carrier, e.g., water, saline, buffer, aqueous dextrose, mannitol, glycerol, glycols, ethanol or the like, to form a suspension. If desired, the pharmaceutical formulation can also contain minor amounts of nontoxic auxiliary substances such as wetting agents, emulsifying agents, co-solvents, solubilizing agents, pH buffering agents, and the like. 
     In some embodiments, a single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein comprises water. Suitable types of water include, but are not limited to, deionized water, distilled water, reverse osmosis filtered water, reagent grade water, water for injection (WFI), USP/EP grade water suitable for use in pharmaceuticals, and aqueous buffer solutions. The water is substantially free of contaminants, such as parasites, pathogens, chemical contaminants, and particulate contamination. For example, the pharmaceutical formulation can include an aqueous buffer solution. Examples of buffer agents include, but are not limited to, acetic acid, acetic anhydride, adipic acid, alanine, albumin, alcohol, alfadex, ammonia, ammonium acetate, ammonium sulfate, anhydrous citric acid, anhydrous dextrose, anhydrous lactose, anhydrous trisodium citrate, arginine, ascorbic acid, aspartic acid, benzenesulfonic acid, benzoic acid, calcium chloride, calcium gluceptate, calcium hydroxide, calcium, caprylic acid, carbon dioxide, citric acid monohydrate, dibasic potassium phosphate, diethanolamine, disodium citrate sesquihydrate, disodium hydrogen citrate, edetate calcium disodium, edetate disodium, edetate sodium, edetic acid, ethanolamine hydrochloride, ferric chloride, gluceptate sodium, glycine hydrochloride, glycine, guanidine hydrochloride, histidine, hydrochloric acid, isoleucine, lactic acid, lactobionic acid, leucine, lysine acetate, lysine, lysine monohydrate, magnesium chloride, magnesium stearate, maleic acid, metaphosphoric acid, methanesulfonic acid, nitric acid, phosphate ion, phosphoric acid, potassium chloride, potassium hydroxide, potassium phosphate (monobasic), sodium acetate, sodium ascorbate, sodium benzoate, sodium bicarbonate, sodium bisulfate, sodium carbonate, sodium citrate, sodium hydroxide, sodium hypochlorite, sodium phosphate dihydrate, sodium phosphate, sodium phosphate p-32, sodium phosphate dibasic dihydrate, sodium phosphate dibasic dodecahydrate, sodium phosphate dibasic, sodium phosphate dibasic (anhydrous), sodium phosphate dibasic heptahydrate, sodium phosphate monobasic (anhydrous), sodium phosphate monobasic dihydrate, sodium phosphate monobasic monohydrate, sodium phosphate monobasic, sodium sulfate (anhydrous), sodium sulfate, sodium thioglycolate, sodium thiomalate, sodium thiosulfate, succinic acid, sulfuric acid, tartaric acid, tartaric acid (dl), trifluoroacetic acid, tromantadine, and tromethamine. In some embodiments, the pharmaceutical formulation comprises phosphate buffered saline. 
     In some embodiments, a single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein comprises a viscosity enhancer. The viscosity enhancer can be, for example, a cellulose or cellulose derivative or a synthetic polymer. Examples of viscosity enhancers include, but are not limited to, microcrystalline cellulose (Avicel: Asahi Kasei Corp., etc.), microcrystalline cellulose carmellose sodium (Avicel RC: Asahi Kasei Corp., etc.), methyl cellulose (Metolose SM: Shin-Etsu Chemical Co., Ltd., etc.), ethyl cellulose (Ethocel: Dow Chemical Co., etc.), hydroxypropyl cellulose (Nisso HPC: Nippon Soda Co., Ltd., etc.), low-substituted hydroxypropyl cellulose (L-HPC: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl methyl cellulose 2208 (Metolose 90SH: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl methyl cellulose 2906 (Metolose 65SH: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl methyl cellulose 2910 (Metolose 60SH: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl cellulose phthalate 200731 (HPMCP: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl cellulose phthalate 220824 (HPMCP: Shin-Etsu Chemical Co., Ltd., etc.), hydroxypropyl methyl cellulose acetate succinate (Shin-Etsu AQOAT: Shin-Etsu Chemical Co., Ltd., etc.), carmellose (NS-300: Gotoku Chemical Co., Ltd., etc.), carmellose calcium (ECG-505: Gotoku Chemical Co., Ltd., etc.), carmellose sodium (Cellogen: Daiichi Kogyo Seiyaku Co., Ltd., etc.), croscarmellose sodium (Ac-Di-Sol: Asahi Kasei Corp., etc.), carboxymethyl ethyl cellulose (CMEC: Freund Corp., etc.), cellulose acetate phthalate (CAP: Wako Pure Chemical Industries, Ltd., etc.), hydroxyethyl cellulose (NATROSOL: Aqualon Corp., etc.), polyvinyl alcohol, polyvinylpyrrolidone, or mixtures thereof. In some embodiments, the viscosity enhancer is a cellulose derivative. In some embodiments, the cellulose derivative is a water-soluble cellulose or water-soluble cellulose derivative. In some embodiments, a cellulose derivative is a carboxymethylcellulose, or a pharmaceutically acceptable salt thereof. For example, a cellulose derivative is sodium carboxymethylcellulose. A viscosity enhancer can be present in the formulation in an amount of about 0.1% to about 5% by weight of the formulation. For example, about 0.1% to about 2.5%; about 0.1% to about 1%; about 0.1% to about 0.75%; about 0.1% to about 0.5%; about 0.1% to about 0.25%; about 0.25% to about 5%; about 0.5% to about 5%; about 1% to about 5%; about 2.5% to about 5%; about 0.25% to about 0.75%; about 0.5% to about 1%; and about 1% to about 2% by weight of the formulation. In some embodiments, the viscosity enhancer can be present in the formulation at about 0.5% by weight of the formulation. In some embodiments, the viscosity enhancer is a cellulose derivative and is present in the formulation at about 0.5% by weight of the formulation. 
     In some embodiments, a single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein comprises a surfactant. Non-limiting examples of surfactants include polysorbates such as polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, and polysorbate 85; polyoxyethylene hydrogenated castor oils such as polyoxyethylene hydrogenated castor oil 60 and polyoxyl 35 castor oil; sorbitan fatty acid esters; sucrose fatty acid esters; polyoxyethylene polyoxypropylene glycols; polyoxyethylene fatty acid ethers; polyoxyl stearates; phosphatidylcholines; phosphatidylglycerols, including, but not limited to phosphatidylglycerols containing fatty acids, fatty alcohols, or a combination thereof, and carbon chain lengths between 4 and 20 carbons; and other surfactants, including, but not limited to, 1,2-dimyristoyl-sn-glycero-3-(phospho-s-(1-glycerol)), 1,2-dioleoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-(phospho-rac-(1-glycerol)), 1,2-distearoyl-sn-glycero-3-(phospho-rac-(1-glycerol)), 1,2-di stearoyl-sn-glycero-3-phosphocholine, deoxycholic acid, dipalmitoylphosphatidylglycerol (dl), di stearoylphosphatidylcholine (dl), docusate sodium, egg phospholipids, glyceryl palmitostearate, glyceryl trioleate, hydrogenated soybean lecithin, hydrolyzed soy protein (enzymatic; 2000 mw), hydroxyethylpiperazine ethane sulfonic acid, lecithin, miripirium chloride, n-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phiv, oleic acid, palmitic acid, peg vegetable oil, peg-20 sorbitan isostearate, peg-40 castor oil, phospholipid, poloxamer 188, polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 3350, polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 600, polyoxyethylene fatty acid esters, sodium cholesteryl sulfate, sodium deoxycholate, sodium n-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glyc, sodium oleate, sorbitan monolaurate, sorbitan monopalmitate, stearic acid, tricaprylin, or mixtures thereof. In some embodiments, the surfactant is a polysorbate. For example, the pharmaceutical formulation comprises polysorbate 80. A surfactant can be present in the formulation in an amount of about 0.001% to about 0.5% by weight of the formulation. In some embodiments, the concentration of surfactant depends on the critical micelle concentration of the individual surfactant. In some embodiments, the amount of surfactant is enough to be above the critical micelle concentration of the surfactant, enough to coat the surface area of the particles, or both. For example, about 0.001% to about 0.25%; about 0.001% to about 0.1%; about 0.001% to about 0.075%; about 0.001% to about 0.05%; about 0.001% to about 0.025%; about 0.0025% to about 0.5%; about 0.005% to about 0.5%; about 0.1% to about 0.5%; about 0.01% to about 0.5%; about 0.01% to about 0.25%; about 0.01% to about 0.1%; about 0.01% to about 0.075%; about 0.01% to about 0.05%; about 0.01% to about 0.025%; about 0.025% to about 0.5%; about 0.05% to about 0.5%; about 0.1% to about 0.5%; about 0.025% to about 0.5%; about 0.025% to about 2.5%; about 0.025% to about 0.075%; about 0.05% to about 2.5%; about 0.05% to about 0.1%; and about 0.1% to about 0.2% by weight of the formulation. In some embodiments, the surfactant can be present in the formulation at about 0.05% by weight of the formulation. 
     In some embodiments, a single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein comprises a compound of Formula (I), including amorphous and polymorph forms thereof, and a pharmaceutically acceptable carrier. For example, the formulation comprises a compound of Formula (I) and saline, e.g., phosphate buffered saline. In some embodiments, the pharmaceutical formulation comprises a compound of Formula (I), a pharmaceutically acceptable carrier, and one or more excipients. For example, the formulation comprises a compound of Formula (I), a pharmaceutically acceptable carrier, e.g., phosphate buffered saline, and one or more excipients, e.g., a surfactant and a cellulose derivative. In some embodiments, the surfactant is a polysorbate, e.g., polysorbate 80. In some embodiments, the cellulose derivative is sodium carboxymethylcellulose. In some embodiments, the pharmaceutical formulation comprises a compound of Formula (I), e.g., a polymorph form of Formula (I), e.g., Form 1, a pharmaceutically acceptable carrier, e.g., phosphate buffered saline, and one or more excipients, e.g., sodium carboxymethylcellulose and a polysorbate, e.g., polysorbate 80. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein comprises a compound of Formula (I), e.g., a polymorph form of Formula (I), about 0.01% to about 5% by weight of a cellulose derivative, and about 0.01% to about 0.5% by weight of a surfactant in an aqueous buffer. For example, a pharmaceutical formulation provided herein can include a compound of Formula (I), e.g., Form 1 or a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water, about 0.5% by weight sodium carboxymethylcellulose and about 0.05% by weight polysorbate 80 in phosphate buffered saline. 
     In some embodiments, a single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein has a pH of about 6.0 to about 8.0. For example, a pharmaceutical formulation can have a pH of about 7.3 or 7.4. In some embodiments a pharmaceutical formulation provided herein has a pH of about 3.0 to about 5.0. For example, a pharmaceutical formulation can have a pH of about 3.8. 
     The single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein can contain an excipient. The term “excipient” is used herein to describe any ingredient other than the compound(s) provided herein, e.g., compound of Formula (I), including polymorph and amorphous forms thereof. Pharmaceutically acceptable excipients include, but are not limited to, ion exchangers, alumina, aluminum stearate, lecithin, self-emulsifying drug delivery systems (SEDDS) such as d-α-tocopherol polyethylene glycol 1000 succinate, surfactants used in pharmaceutical dosage forms such as Tweens, poloxamers or other similar polymeric delivery matrices, serum proteins, such as human serum albumin, buffer substances such as phosphates, tris, glycine, sorbic acid, potassium sorbate, partial glyceride mixtures of saturated vegetable fatty acids, water, salts or electrolytes, such as protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium-chloride, zinc salts, colloidal silica, magnesium trisilicate, polyvinyl pyrrolidone, cellulose-based substances, polyethylene glycol, sodium carboxymethyl cellulose, polyacrylates, waxes, polyethylene-polyoxypropylene-block polymers, and wool fat, solubilizers, tonicity agents, stabilizers, preservatives, salt formation substances, chelators/chelating agents, viscosity enhancers, contrast agent, anti-foam agents, control release agents, lubricants, adhesives, analgesics, antiheparins, antivirals, colorants, emollients, propellants, and other excipients, including, but not limited to activated charcoal, barium sulfate, bibapcitide, brocrinat, calcobutrol, glutathione, zinc, zinc acetate, zinc carbonate, zinc chloride, and zinc oxide. Cyclodextrins such as α-, β, and γ-cyclodextrin, or chemically modified derivatives such as hydroxyalkylcyclodextrins, including 2- and 3-hydroxypropyl-b-cyclodextrins, or other solubilized derivatives can also be advantageously used to enhance delivery of compounds described herein. Dosage forms or formulations containing a compound as described herein in the range of 0.005% to 100% with the balance made up from non-toxic carrier may be prepared. The contemplated formulations can contain 0.001%-100% active ingredient, in one embodiment 0.1-95%, in another embodiment 75-85%, in a further embodiment 20-80%. Actual methods of preparing such dosage forms are known, or will be apparent, to those skilled in the art; for example, see  Remington: The Science and Practice of Pharmacy,  22 nd  Edition (Pharmaceutical Press, London, U K. 2012). 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a solubilizer. Examples of solubilizers include, but are not limited to, acetyltryptophan (dl), alanine, albumin (aggregated), alcohol, alfadex intracavitary powder, ammonia, anhydrous dextrose, anhydrous lactose, anhydrous trisodium citrate, arginine, ascorbic acid, aspartic acid, benzenesulfonic acid, benzyl alcohol, benzyl benzoate, benzyl chloride, betadex sulfobutyl ether sodium, butanol (mixed isomers), caprylic acid, carboxymethylcellulose, carboxymethylcellulose sodium, castor oil, cholesterol, corn oil, cottonseed oil, creatine, creatinine, croscarmellose sodium, crospovidone, cysteine hydrochloride, cysteine, cysteine (dl), dextran 40, dextran, diacetylated monoglycerides, diethanolamine, dimethyl sulfoxide, ethanolamine hydrochloride, ethyl acetate, ethylene-vinyl acetate copolymer (15% vinyl acetate), gamma cyclodextrin, gelatin, gentisic acid ethanolamide, gentisic acid, gluconolactone, glucuronic acid, glycerin, hetastarch, human albumin microspheres, hyaluronate sodium, hydroxypropyl betadex intramuscular injection, hypromellose, isopropyl alcohol, methylcellulose, methylpyrrolidone, microcrystalline cellulose, N,N-dimethylacetamide, niacinamide, oleic acid, palmitic acid, peanut oil, peg vegetable oil, peg-20 sorbitan isostearate, peg-40 castor oil, phenylethyl alcohol, polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 3350, polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 600, polypropylene glycol, polyvinyl alcohol, poppy seed oil, povidone k12, povidone k17, povidone, proline, propyl gallate, propylene glycol, sesame oil, soybean oil, starch, stearic acid, trimethylsilyl treated dimethiconol/trimethylsiloxysilicate crosspolymer, and yellow wax, and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a tonicity agent. Examples of tonicity agents include, but are not limited to, dextrose monohydrate, dextrose solution, dextrose, dimethyl sulfoxide, fructose, gluconolactone, glucuronic acid, glycerin, glycine hydrochloride, glycine, guanidine hydrochloride, histidine, hydrochloric acid, hypertonic sodium chloride solution, isoleucine, isopropyl alcohol, isotonic sodium chloride solution, lactic acid (dl), lactobionic acid, lactose monohydrate, lactose, leucine, lysine acetate, lysine, lysine monohydrate, magnesium chloride, magnesium stearate, maleic acid, mannitol, meglumine, methionine, methylboronic acid, polypropylene glycol, potassium chloride, potassium hydroxide, potassium phosphate (monobasic), proline, propyl gallate, propylene glycol, saccharin sodium, serine, sodium acetate, sodium ascorbate, sodium benzoate, sodium bicarbonate, sodium bisulfate, sodium carbonate, sodium chloride, sodium citrate, sodium gluconate, sodium hydroxide, sodium hypochlorite, sodium lactate, sodium phosphate dihydrate, sodium phosphate, sodium phosphate p-32, sodium phosphate dibasic dihydrate, sodium phosphate dibasic dodecahydrate, sodium phosphate dibasic, sodium phosphate dibasic (anhydrous), sodium phosphate dibasic heptahydrate, sodium phosphate monobasic (anhydrous), sodium phosphate monobasic dihydrate, sodium phosphate monobasic monohydrate, sodium phosphate monobasic, sodium sulfate (anhydrous), sodium sulfate, sodium thioglycolate, sodium thiomalate, sodium thiosulfate, sorbitol, succinic acid, sucrose, sulfuric acid, tartaric acid, tartaric acid (dl), threonine, trehalose, trifluoroacetic acid, trisodium citrate dihydrate, tromethamine, tryptophan, tyrosine, urea, urethane, and valine and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a stabilizer. Examples of stabilizers include, but are not limited to, acetyltryptophan (dl), alanine, albumin (aggregated), alcohol, alfadex intracavitary powder, ammonia, anhydrous dextrose, anhydrous lactose, anhydrous trisodium citrate, arginine, ascorbic acid, aspartic acid, benzenesulfonic acid, benzyl alcohol, benzyl benzoate, benzyl chloride, betadex sulfobutyl ether sodium, boric acid, butanol (mixed isomers), caprylic acid, carboxymethylcellulose, carboxymethylcellulose sodium, castor oil, cholesterol, creatine, creatinine, croscarmellose sodium, crospovidone, cysteine hydrochloride, cysteine, cysteine (dl), dextran 40, dextran, ethylene-vinyl acetate copolymer (15% vinyl acetate), gelatin, gentisic acid ethanolamide, gentisic acid, hetastarch, human albumin microspheres, hyaluronate sodium, hypromellose, meglumine, methionine, methylboronic acid, methylcellulose, methylpyrrolidone, microcrystalline cellulose, miripirium chloride, n-(carbonyl-methoxypolyethylene glycol 2000)-1,2-di stearoyl-sn-glycero-3-phiv, N,N-dimethylacetamide, niacinamide, phenylalanine, polyvinyl alcohol, povidone K12, povidone K17, povidone, serine, sodium citrate, sodium gluconate, sodium lactate, starch, threonine, trehalose, tricaprylin, trimethylsilyl treated dimethiconol/trimethylsiloxysilicate crosspolymer, trisodium citrate dihydrate, tryptophan, tyrosine, urea, and valine and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a preservative. Examples of preservatives include, but are not limited to, acetone sodium bisulfite, alpha-tocopherol, benzalkonium chloride, benzyl alcohol, benzyl benzoate, benzyl chloride, boric acid, butylated hydroxyanisole, butylated hydroxytoluene, butylparaben, chlorobutanol, chlorobutanol hemihydrate, cresol, diethyl pyrocarbonate, edetate calcium disodium, edetate disodium, edetate sodium, edetic acid, hexylresorcinol, metacresol, methylparaben, miripirium chloride, monothioglycerol, nitrogen, phenol, phenylethyl alcohol, phenylmercuric nitrate, potassium bisulfite, potassium metabisulfite, propylparaben, sodium ascorbate, sodium benzoate, sodium bisulfate, sodium chlorate, sodium dithionite, sodium formaldehyde sulfoxylate, sodium iodide, sodium metabisulfite, sodium sulfite, sodium tartrate, sulfur dioxide, sulfurous acid, and thimerosal and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a salt formation agent. Examples of salt formation agents include, but are not limited to, acetic acid, acetic anhydride, adipic acid, ammonium acetate, ammonium sulfate, anhydrous citric acid, benzoic acid, calcium chloride, calcium gluceptate, calcium hydroxide, calcium, carbon dioxide, citric acid monohydrate, dibasic potassium phosphate, diethanolamine, disodium citrate sesquihydrate, disodium hydrogen citrate, hydrochloric acid, isoleucine, lactic acid (dl), lactobionic acid, magnesium chloride, magnesium stearate, maleic acid, metaphosphoric acid, methanesulfonic acid, nitric acid, phosphate ion, phosphoric acid, sodium hydroxide, sodium hypochlorite, sodium phosphate dihydrate, sodium phosphate, sodium phosphate p-32, sodium phosphate dibasic dihydrate, sodium phosphate dibasic dodecahydrate, sodium phosphate dibasic, sodium phosphate dibasic (anhydrous), sodium phosphate dibasic heptahydrate, sodium phosphate monobasic (anhydrous), sodium phosphate monobasic dihydrate, sodium phosphate monobasic monohydrate, sodium phosphate monobasic, and trifluoroacetic acid and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a chelator or chelating agent. Examples of chelators or chelating agents include, but are not limited to, caldiamide sodium, caloxetate trisodium, calteridol calcium, edetate calcium disodium, edetate disodium, edetate sodium, edetic acid, ferric chloride, gluceptate sodium, methylboronic acid, nioxime, oxidronate disodium, peg-60 hydrogenated castor oil, pentasodium pentetate, pentetate calcium trisodium, pentetic acid, sodium phosphite, sodium pyrophosphate, sodium succinate hexahydrate, sodium trimetaphosphate, succimer, and versetamide and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a viscosity enhancer. Examples of viscosity enhancers include, but are not limited to, carboxymethylcellulose, carboxymethylcellulose sodium, croscarmellose sodium, crospovidone, ethylene-vinyl acetate copolymer (15% vinyl acetate), gelatin, hetastarch, human albumin microspheres, hyaluronate sodium, hypromellose, methylcellulose, methylpyrrolidone, microcrystalline cellulose, polyvinyl alcohol, povidone K12, povidone K17, povidone, starch, and trimethylsilyl treated dimethiconol/trimethylsiloxysilicate crosspolymer and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a contrast agent. Examples of contrast agents include, but are not limited to, diatrizoic acid, perflutren, stannous chloride, stannous fluoride, stannous tartrate, tetrakis(2-methoxyisobutylisocyanide)copper(I) tetrafluoroborate, and tetrofosmin and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain an anti-foam agent. Examples of anti-foam agents include, but are not limited to, dimethicone, polysiloxane, silicone, and simethicone and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a control release agent. Examples of control release agents include, but are not limited to, poly(dl-lactic-co-glycolic acid), (50:50; 12000 mw), polyglactin, and polylactide and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a lubricant. Examples of lubricants include, but are not limited to, silicone and simethicone and combinations thereof. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain an adhesive. An example of an adhesive includes, but is not limited to, Duro-Tak 87-2287. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain an analgesic. An example of an analgesic includes, but is not limited to, disodium sulfosalicylate. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain an anti-heparin agent. An example of an anti-heparin agent includes, but is not limited to, protamine sulfate. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain an antiviral agent. An example of an antiviral agent includes, but is not limited to, tromantadine. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a colorant. An example of a colorant includes, but is not limited to, methylene blue. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain an emollient. An example of an emollient includes, but is not limited to, urethane. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein contain a propellant. An example of a propellant includes, but is not limited to, dichlorodifluoromethane. 
     The formulations prepared by the process provided herein are single-dose, ready-to-use pharmaceutical formulations packaged in a container for parenteral administration (injection or infusion). For example, the pharmaceutical formulation is prepared to contain the therapeutically effective amount of the compound of Formula (I), including amorphous and polymorph forms thereof, and is intended to be used in a single subject for a single fusion or injection. The formulations provided herein are not designed for multiple-dose administration or for multiple use. The formulations provided herein are “ready-to-use,” i.e., formulations that do not require constitution or dilution with a prescribed amount of diluent, e.g., water for injection or other suitable diluent, before use by the designated route. For example, a formulation in a vial, of the desired concentration, that only needs to be drawn up into a syringe. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein comprises a volume of about 0.1 mL to about 10 mL per container (i.e., per injection). For example, about 0.1 mL to about 10 mL, about 0.1 mL to about 5 mL, about 0.1 mL to about 4 mL, about 0.1 mL to about 3 mL, about 0.1 mL to about 2 mL, about 0.1 mL to about 1 mL, about 0.1 mL to about 0.5 mL, about 0.1 mL to about 0.25 mL, about 2 mL to about 10 mL, about 2 mL to about 5 mL, about 2 mL to about 4 mL, about 2 mL to about 3 mL, about 3 mL to about 5 mL, about 3 mL to about 10 mL, about 0.5 mL to about 1 mL, about 0.25 mL to about 2 mL. In some embodiments, the single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein comprises a volume of about 1 mL to about 10 mL per container (i.e., per injection). For example, about 1 mL to about 10 mL, about 1 mL to about 5 mL, about 1 mL to about 4 mL, about 1 mL to about 3 mL, about 1 mL to about 2 mL, about 2 mL to about 10 mL, about 2 mL to about 5 mL, about 2 mL to about 4 mL, about 2 mL to about 3 mL, about 3 mL to about 5 mL, about 3 mL to about 10 mL. In some embodiments, the formulation comprises a volume of about 2 mL per container (i.e., injection). 
     In some embodiments, the unit dosage of the compound of Formula (I), including amorphous and polymorph forms thereof, is about 0.1 μg/kg to about 10 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 0.1 μg/kg to about 5 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 0.2 μg/kg to about 9 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 0.25 μg/kg to about 8 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 0.3 μg/kg to about 7 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 0.4 μg/kg to about 6 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 0.5 μg/kg to about 5 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 0.6 μg/kg to about 5 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 1.0 μg/kg to about 4 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 2.0 μg/kg to about 4 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 3.0 μg/kg to about 5 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 4.0 μg/kg to about 6 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is about 5.0 μg/kg to about 10 μg/kg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.001 mg to 1 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.001 mg to 0.5 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.001 mg to 0.3 mg in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.01 mg to 1 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.01 mg to 0.5 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.01 mg to 0.3 mg in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.03 mg to 0.9 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.03 mg to 0.23 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.05 mg to 0.8 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.07 mg to 0.7 mg of body weight in humans. 
     In some embodiments, the unit dosage of compounds of Formula (I), including amorphous and polymorph forms thereof, is 0.08 mg to 0.7 mg of body weight in humans. In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.1 mg to 0.6 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.12 mg to 0.6 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.14 mg to 0.5 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.16 mg to 0.5 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.18 mg to 0.4 mg of body weight in humans. 
     In some embodiments, the unit dosage of compound of Formula (I), including amorphous and polymorph forms thereof, is 0.2 mg to 0.4 mg of body weight in humans. 
     In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein are stable for at least 3 months. For example, the formulations do not exhibit a change (e.g., greater than 5%) in one or more of polymorph forms (e.g., an increase or decrease of a certain form), appearance, pH, percent impurities, activity (as measured by in vitro assays), or osmolarity over time, e.g., at least 3 months as compared to the original formulation after manufacturing. In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein are stable for at least 6 months. For example, the formulations do not exhibit a significant change (e.g., greater than 5%) in one or more of polymorph form (e.g., an increase or decrease of a certain form), appearance, pH, percent impurities, activity (as measured by in vitro assays), or osmolarity over time, e.g., at least 6 months as compared to the original formulation after manufacturing. In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein are stable for at least 9 months. For example, the formulations do not exhibit a significant change (e.g., greater than 5%) in one or more of polymorph form (e.g., an increase or decrease of a certain form), appearance, pH, percent impurities, activity (as measured by in vitro assays), or osmolarity over time, e.g., at least 9 months as compared to the original formulation after manufacturing. In some embodiments, the single-dose, ready-to-use pharmaceutical formulations prepared by the process provided herein are stable for at least 12 months. For example, the formulations do not exhibit a significant change, as defined by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), in one or more of polymorph form (e.g., an increase or decrease of a certain form), appearance, pH, percent impurities, activity (as measured by in vitro assays), or osmolarity over time, e.g., at least 12 months as compared to the original formulation after manufacturing. 
     In some such embodiments, the single-dose, ready-to-use pharmaceutical formulation prepared by the process provided herein comprises between about 0.005 mg/mL and 2.5 mg/mL of the compound of Formula (I), including amorphous and polymorph forms thereof, for example, between about 0.005 mg/mL to about 2 mg/mL, about 0.01 mg/mL to about 1.8 mg/mL, about 0.025 mg/mL to about 1.6 mg/mL, about 0.05 mg/mL to about 1.5 mg/mL, about 0.075 mg/mL to about 1.25 mg/mL, about 0.1 mg/mL to about 1 mg/mL, or about 0.25 mg/mL to about 0.75 mg/mL. In some such embodiments, the pharmaceutical formulation comprises about 0.015 mg/mL to about 0.115 mg/mL of the compound of Formula (I), including amorphous and polymorph forms thereof. In some such embodiments, the pharmaceutical formulation comprises about 0.015 mg/mL of the compound of Formula (I), including amorphous and polymorph forms thereof. In some such embodiments, the pharmaceutical formulation comprises about 0.035 mg/mL of the compound of Formula (I), including amorphous and polymorph forms thereof. In some such embodiments, the pharmaceutical formulation comprises about 0.115 mg/mL of the compound of Formula (I), including amorphous and polymorph forms thereof. In some embodiments, the injection volume comprises between about 0.1 mg/mL and 4 mg/mL. In some embodiments, the injection volume is 2 mg/mL. 
     The single-dose, ready-to-use formulations prepared by the process provided herein comprising a compound of Formula (I), including amorphous and polymorph forms thereof, can be formulated as a plurality of particles. For example, particles of a compound of Formula (I), including amorphous and polymorph forms thereof, can have a median particle size of less than 20 μm (e.g., less than about 15 μm; less than about 10 μm; less than about 7.5 μm; less than about 5 μm; less than about 2.5 μm; less than about 1 μm; and less than about 0.5 μm). For example, the median particle size can be between about 0.1 μm and 20 μm, such as between about 0.5-20, 0.5-15, 0.5-10, 0.5-7.5, 0.5-5, 0.5-2.5, 0.5-1, 2.5-15, 5-10, 7.5-20, or 1-5 μm. In some embodiments, the particles also comprise a polymer. Examples of suitable polymers include biocompatible and biodegradable polymers like poly(lactic acid), a poly(glycolic acid), a poly(lactic-co-glycolic acid), a poly(lactide-co-glycolide), and mixtures thereof. In some embodiments, the particles comprise poly(lactic-co-glycolic acid) (PLGA). 
     In some embodiments, the compound of Formula (I), including amorphous and polymorph forms thereof, e.g., a polymorph form of Formula (I), e.g., Form 1, has a particle size distribution (D value), e.g., a D50, of between about 1 and about 6 μm, such as between about 1.5 and about 5 μm, or about 2.4 to about 2.55 μm. For example, the D50 can be about 1.5, 1.6, 1.7, 1.8, 1.9, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3, 3.1, 3.2, 3.3, 3.4, 3.5, 4, 4.5, or 5 μm. In some embodiments, the D50 value is about 2.55 μm. In some embodiments, the D50 value is about 2.45 μm. In some embodiments, the D50 value is about 2.1 μm. In some embodiments, the D50 value is about 2 μm. In some embodiments, the D50 value is about 1.6 μm. The D50 can be measured by conventional particle size measuring techniques well known to those skilled in the art. Such techniques include, for example, sedimentation field flow fractionation, photon correlation spectroscopy, light scattering, laser diffraction and disc centrifugation. 
     In some embodiments, the single-dose, ready-to-use formulations prepared by the process provided herein comprising a compound of Formula (I), including amorphous and polymorph forms thereof, are administered parenterally, including intramuscularly, intra-articularly, periarticularly, intraspinally, intradiscal, intrasynovially, and epidurally. In some embodiments, the formulation is administered to a patient with disc degeneration. In some embodiments, the formulation is administered to a patient with osteoarthritis. In some embodiments, the formulation can be a bursa injection, a caudal injection (e.g., a caudal epidural steroid injection (ESI)), a facet injection, a facet synovial injection, a hip joint injection, an intradiscal injection, an occipital nerve injection, a sciatic/piriformis injection, a sacroiliac (SI) joint injection, or combinations thereof. In some embodiments, the formulation can be injected locally, for example, in a patient with osteoarthritis, at the site of osteoarthritis (e.g., knee, hip, shoulder, etc.). Injections can occur at one or more locations surrounding the joint. In some embodiments, the injection is guided using an imaging method such as ultrasound. In some embodiments, administration (e.g., injection) of the formulation is preceded or combined with a local anesthetic. 
     The single-dose, ready-to-use formulations prepared by the process provided herein comprising a compound of Formula (I), including amorphous and polymorph forms thereof, can also be administered in combination (administered together or sequentially) with other known agents. 
     In some embodiments, the single-dose, ready-to-use formulations prepared by the process provided herein comprising a compound of Formula (I), including amorphous and polymorph forms thereof, can be administered in combination with one or more of the following: (a) Nonsteroidal anti-inflammatory drugs (NSAIDs), including, but not limited to, ibuprofen, naproxen, aspirin, acetaminophen, indomethacin (e.g., INDOCIN® and TIVORBEX®), diclofenac by mouth or to the affected area (e.g., VOLTAREN®, ZIPSOR®, PENNSAID®, FLECTOR®, and CATAFLAM®), meloxicam (e.g., MOBIC), celecoxib (e.g., CELEBREX®), piroxicam (e.g., FELDENE®), etodolac (e.g., LODINE®), nabumetone (e.g., RELAFEN®), lumiracoxib, valdecoxib (e.g., BEXTRA), etoricoxib, parecoxib, fenoprofen (e.g., NALFON®), oxaprozin (e.g., DAYPRO®), mefanamic acid (e.g. PONSTEL®), diflunisal (e.g., DOLOBID®), fenoprofen (e.g., NALFON®), flurbirofen (e.g., ANSAID®), ketoprofen (e.g., ORUVAIL®), ketorolac (e.g., TORADOL®), sulindac (e.g., CLINORIL®), meclofenamate, choline salicylate-magnesium salicylate, salsalate (e.g., DISALCID®), and tolmetin (e.g., TOLECTIN®); (b) physical therapy; (c) injections of corticosteroid medications such as, e.g., prednisone, dexamethasone, hydrocortisone, and methylprenisolone; (d) injections of hyaluronic acid derivatives (e.g., HYALGAN®, SYNVISC®, EUFLEXXA®, GEL-ONE®, MONOVISC®, ORTHOVISC®, and SUPARTZ®); (e) injections or topical application of Capsaicin (e.g., CAPSAGELL®); (f) narcotics, such as, e.g., codeine, fentanyl, hydrocodone, hydromorphone, morphine, meperidine, oxycodone, and tramadol (e.g., ULTRAM®, CONZIP®, and RYZOLTL®); (g) antidepressants such as dulozetine (e.g., CYMBALTA®); (h) braces and/or shoe inserts or any device that can immobilize or support the joints to help keep pressure off it (e.g., splints, braces, shoe inserts or other medical devices); (i) realigning bones (osteotomy); (j) joint replacement (arthroplasty); and (k) chronic pain class. 
     In some embodiments, the single-dose, ready-to-use formulations prepared by the process provided herein comprising a compound of Formula (I), including amorphous and polymorph forms thereof, can be used to treat osteoarthritis. In some embodiments, the formulations can be used to treat osteoarthritis in combination with one or more of the following drugs or methods: prednisone, methylprednisolone, SYNVISC® (hylan G-F 20), ABT-981 [ MAbs  (2015) 7(3):605-619], stem cell injection, JNJ-42160443 (fulranumab), platelet rich plasma (PRGF) injection, tanezumab, venlafaxine, PH-797804, PG-530742 (the dihydrated sodium salt PG-116800), Sprifermin (AS902330, rhFGF-18), epicutaneous ketoprofen in transfersome (IDEA-033) [ Annals of the Rheumatic Diseases  (2007) 66(9):1178-1183], FX005 and FX006 (both by Flexion Therapeutics, Inc.), JNJ-39439335 (Mavatrep) [ J. Med. Chem.  (2015) 58(9):3859-3874], polmacoxib (Acelex, CG100649), balicatib (AAE581), GSK3196165, cebranopadol (GRT6005), fasinumab (REGN475), TPX-100 (by OrthoTrophix), PRX167700 (by Proximagen), EP 104IAR (extended release fluticasone propionate composition), LY2951742 and LY545694 (both by Eli Lilly &amp; Co), Adalimumab (Humira®), GW842166 (by GSK), YY1201 (by Yooyoung Pharmaceutical Co., Ltd.), CF101 (IB-MECA) and CF602 (both by Can-Fite BioPharma), PLA-695 (by Pfizer), VX-150 (by Vertex), ADL5859 and ADL5747 (both by Adolor Corporation now Cubist Pharmaceuticals), funapide (INN) (TV-45070, XEN402), AGG-523 (by Pfizer) [ Osteoarthritis Cartilage  (2011) 19(3):315-323], CNTX-4975 (capsaicin for injection by Centrexion Corporation), CR845 (by Cara Therapeutics), ASP7962 (by Astellas Pharma), DA-5202 (by Dong-A ST Co., Ltd.), GZ389988 (by Sanofi-Genzyme), and MEDI 7352 (by AstraZeneca), LNA043 (by Novartis). 
     4. Kits 
     Also provided herein are kits. Typically, a kit includes one or more formulations as described herein, e.g., a single-dose, ready-to-use formulation prepared by the process provided herein comprising a compound of Formula (I), including amorphous and polymorph forms thereof. In certain embodiments, a kit can include one or more delivery systems, e.g., for delivering or administering the formulation as provided herein, and directions for use of the kit (e.g., instructions for treating a patient). In some embodiments, the kit can include a formulation as described herein and a label that indicates that the contents are to be administered to a patient with bone or cartilage diseases or osteoarthritis. The actual dose of the compound of Formula (I) provided herein depends on the specific compound, and on the condition to be treated; the selection of the appropriate dose is well within the knowledge of the skilled artisan. 
     5. Methods for Treating Osteoarthritis 
     Provided are methods for the treatment of osteoarthritis in a subject. The methods comprise administering to the subject a therapeutically effective amount of a single-dose, ready-to-use formulation provided herein comprising a compound of Formula (I), including salt and amorphous or polymorph forms thereof. In some embodiments, the formulation is prepared by the process provided herein. In some embodiments, the methods provided herein include intra-articular administration of a single-dose, ready-to-use pharmaceutical formulation comprising a therapeutically effective amount of a compound of Formula (I), including salt and amorphous and polymorph forms thereof. In some embodiments, the methods provided herein include intra-articular administration of a single-dose, ready-to-use pharmaceutical formulation prepared by a process provided herein. In some embodiments, the polymorph form is Form 1. In some embodiments, the polymorph form is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. 
     In some embodiments, provided herein are methods for treating osteoarthritis in a subject comprising intra-articular administration to the subject a single-dose, ready-to-use pharmaceutical formulation comprising a therapeutically effective amount of a compound of Formula (I). In some embodiments, the compound of Formula (I) in the formulation comprises Form 1. In some embodiments, the compound of Formula (I) in the formulation comprises a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the compound of Formula (I) in the formulation is substantially present as a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and 20% by weight water. 
     In some embodiments of the method provided herein, the single-dose, ready-to-use formulations prepared by the process provided herein comprising a compound of Formula (I), including amorphous and polymorph forms thereof, are administered parenterally, including intramuscularly, intra-articularly, periarticularly, intradiscal, intraspinally, intrasynovially, and epidurally. In some embodiments, the formulation is administered to a patient with disc degeneration. In some embodiments, the formulation is administered to a patient with osteoarthritis. In some embodiments, the formulation can be a bursa injection, a caudal injection (e.g., a caudal epidural steroid injection (ESI)), a facet injection, a facet synovial injection, a hip joint injection, an intradiscal injection, an occipital nerve injection, a sciatic/piriformis injection, a sacroiliac (SI) joint injection, or combinations thereof. In some embodiments, the formulation can be injected locally, for example, in a patient with osteoarthritis, at the site of osteoarthritis (e.g., knee, hip, shoulder, etc.). Injections can occur at one or more locations surrounding the joint. In some embodiments, the formulation is administered intra-articularly. In some embodiments, the injection is guided using an imaging method such as ultrasound. In some embodiments, administration (e.g., injection) of the formulation is preceded or combined with a local anesthetic. 
     In some embodiments of the methods provided herein, the formulation comprising a compound of Formula (I), including salt and amorphous and polymorph forms thereof, is administered once. In some embodiments, the formulation comprising a compound of Formula (I), including salt and amorphous and polymorph forms thereof, is administered more than once. For example, the formulation is administered by injections spaced at least 7 days apart. In some embodiments, the formulation is administered once every two weeks. In some embodiments, the formulation is administered once every three weeks. In some embodiments, the formulation is administered once every four weeks. In some embodiments, the formulation is administered once every six weeks. In some embodiments, the formulation is administered once every eight weeks. In some embodiments, the formulation is administered once every twelve weeks (three months). 
     6. Polymorphs 
     Provided herein are formulations comprising a compound of Formula (I): 
     
       
         
         
             
             
         
       
     
     including pharmaceutically acceptable salts and amorphous and polymorph forms thereof. 
     The compound of Formula (I) provided herein can be prepared using methods known and understood by those of ordinary skill in the art. For example, synthetic methods such as those described in PCT/US2013/031055 can be used, and this application is herein incorporated by reference in its entirety. 
     The formulations provided herein can contain a polymorph form of the compound of Formula (I). The forms include, e.g., solvates, hydrates, non-stoichiometric or stoichiometric hydrates, and non-solvated forms of the compound of Formula (I), including, for example, polymorph Forms 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and 13. 
     One such polymorph is a polymorph known as Form 1. Form 1 is an anhydrous polymorph of the compound of Formula (I). In one embodiment, Form 1 has an X-ray powder diffraction (XRPD or XRD) pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 6.8±0.2, 12.4±0.2, and 18.5±0.2. In some embodiments, Form 1 has an XRPD pattern with at least peaks at ° 2θ values of 6.8±0.2, 12.4±0.2, 16.5±0.2, 18.5±0.2, and 19.2±0.2. In some embodiments, Form 1 has an XRPD pattern with at least peaks at ° 2θ values of 6.8±0.2, 9.3±0.2, 12.4±0.2, 13.9±0.2, 16.5±0.2, 18.5±0.2, 19.2±0.2, and 24.6±0.2. For example, in some embodiments, Form 1 has an XRPD pattern with at least peaks at ° 2θ values of 6.8±0.2, 9.3±0.2, 12.4±0.2, 13.9±0.2, 14.5±0.2, 16.5±0.2, 18.5±0.2, 19.2±0.2, 20.3±0.2, and 24.6±0.2. 
     In some embodiments, the formulations provided herein comprise a composition comprising polymorph Form 1. In some embodiments, the composition can be substantially pure. For example, the composition has a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than about 15% by weight of other forms of the compound of Formula (I). For example, the composition can contain less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than about 15% by weight of the polymorph Form 9. For example, the composition can contain less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of the polymorph of Form 9. In some embodiments, the composition contains less than about 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 2, Form 3, Form 4, Form 5, Form 6, Form 7, Form 8, Form 9, Form 10, and Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water, or a combination of two or more thereof. 
     In some embodiments, provided herein is a formulation comprising polymorph Form 1 that exhibits an endotherm between about 50-100° C. as measured by differential scanning calorimetry (DSC) related to sorbed water. In some embodiments, polymorph Form 1 exhibits a recrystallization event that is observed between about 270-290° C., e.g., around 280° C. In some embodiments, the endotherm and exotherm are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, provided herein is a formulation comprising polymorph Form 1 that recrystallizes into Form 9 with a melting point of around 363° C. In some embodiments, polymorph Form 1 undergoes a total mass loss of about 0.33% before around 100° C., e.g., from about 39° C. to about 100° C., as measured by thermal gravimetric analysis (TGA). 
     In some embodiments, polymorph Form 1 is prepared by a method comprising drying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, to generate polymorph Form 1. In some embodiments, the composition comprises a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, polymorph Form 1 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate polymorph Form 1 as a residual solid. In some embodiments, the reslurrying takes place at room temperature (RT). In some embodiments, the reslurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 1 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof in a solvent or mixture of solvents to generate polymorph Form 1 as a residual solid. In some embodiments, the compound of Formula (I) is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the solvent is methanol. In some embodiments, the solvent is toluene. In some embodiments, the solvent is heptane. In some embodiments, the solvent is dichloromethane (DCM). In some embodiments, the solvent is water. In some embodiments, the solvent is in a mixture with water, for example the solvent can be a mixture of water and acetonitrile, methanol, ethyl acetate (EA), methyl tert-butyl ether (MtBE), isopropyl alcohol (IPAc), methyl acetate (MA), methyl isobutyl ketone (MIBK), DCM, n-butyl acetate, heptane, toluene, or n-butanol. In some embodiments, the water is present in an amount of about 5% by weight. In some embodiments, the reslurrying takes place at room temperature. In some embodiments, the reslurrying takes place at around 50° C. In some embodiments, polymorph Form 1 is prepared by a method further comprising drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     Provided herein are formulations comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, for example, above 30% relative humidity (RH), Form 1 readily sorbs water and shows a distinctive shift in Form 1 peaks from 6.8±0.2 to 6.2±0.2 and 12.6±0.2 to 11±0.2. In some embodiments, a non-stoichiometric or stoichiometric hydrate of Form 1 comprises up to about 20% by weight water. For example, up to about 20%, about 19%, about 18%, about 17%, about 16%, about 15%, about 14%, about 13%, about 12%, about 11%, about 10%, about 9%, about 8%, about 7%, about 6%, about 5%, about 4%, about 3%, about 2%, or greater than 1% water by weight. In some embodiments, a non-stoichiometric or stoichiometric hydrate of Form 1 has between 1 to about 20% water by weight, e.g., between 1% and about 10%, about 5% and about 15%, about 10% and about 20%, 1% and about 5%, about 5% and about 10%, about 10% and about 15%, about 15% and about 20%, or about 17% and about 20% water by weight. 
     In some embodiments, provided herein is a formulation comprising a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I) (e.g., anhydrous forms of the compound of Formula (I)). In some embodiments, the composition contains less than 20% by weight of polymorph Form 9 having X-ray powder diffraction pattern comprising peaks at ° 2θ values of 4.9±0.2, 18.6±0.2, and 21.1±0.2. For example, the composition contains less than 15% by weight of Form 9, such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Form 9. In some embodiments, the composition contains less than 15% of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 3, Form 4, Form 5, Form 6, Form 7, Form 8, Form 9, Form 10, Form 11, or a combination of two or more thereof. 
     Another example of a non-stoichiometric hydrate of polymorph Form 1 is referred to as Form 12. 
     In one embodiment, provided herein is a formulation comprising polymorph Form 12. In some embodiments, Form 12 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ positions 6.4±0.2, 11.0±0.2, and 18.4±0.2. In some embodiments, Form 12 has an XRPD pattern with at least peaks at ° 2θ positions 6.4±0.2, 9.2±0.2, 11.0±0.2, 18.4±0.2, and 19.7±0.2. In some embodiments, Form 12 has an XRPD pattern with at least peaks at ° 2θ positions 6.4±0.2, 9.2±0.2, 11.0±0.2, 15.6±0.2, 18.4±0.2, 19.7±0.2, 24.4±0.2, and 25.2±0.2. For example, in some embodiments, Form 12 has an XRPD pattern with at least peaks at ° 2θ positions 6.4±0.2, 9.2±0.2, 11.0±0.2, 15.6±0.2, 16.1±0.2, 18.4±0.2, 19.7±0.2, 20.8±0.2, 24.4±0.2, and 25.2±0.2. 
     In some embodiments, provided herein is polymorph Form 12 that exhibits an endotherm between about 50-100° C. as measured by DSC. In some embodiments, polymorph Form 12 exhibits an exotherm at around 283° C. In some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, provided herein is polymorph Form 12 that has a melting point of around 364° C. In some embodiments, polymorph Form 12 undergoes a weight loss of about 1.4% before around 100° C., e.g., from about 30° C. to about 100° C., as measured by TGA. 
     One example of a non-stoichiometric hydrate of polymorph Form 1 is referred to as Form 13. 
     In one embodiment, provided herein is a formulation comprising polymorph Form 13. In some embodiments, polymorph Form 13 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 6.8±0.2, 12.4±0.2, and 18.5±0.2. In some embodiments, Form 13 has an XRPD pattern with at least peaks at ° 2θ values of 6.8±0.2, 12.4±0.2, 16.5±0.2, 18.5±0.2, and 19.2±0.2. In some embodiments, Form 13 has an XRPD pattern with at least peaks at ° 2θ values of 6.8±0.2, 9.3±0.2, 12.4±0.2, 13.9±0.2, 16.5±0.2, 18.5±0.2, 19.2±0.2, and 24.6±0.2. For example, in some embodiments, Form 13 has an XRPD pattern with at least peaks at ° 2θ values of 6.8±0.2, 9.3±0.2, 12.4±0.2, 13.9±0.2, 14.5±0.2, 16.5±0.2, 18.5±0.2, 19.2±0.2, 20.3±0.2, and 24.6±0.2. 
     In some embodiments, polymorph Form 13 exhibits an endotherm between about 50-100° C. as measured by DSC. In some embodiments, polymorph Form 13 exhibits an exotherm at between about 265-285° C., e.g., around 278° C. For example, in some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, polymorph Form 13 has a melting point of around 363° C. In some embodiments, polymorph Form 13 undergoes a weight loss of about 1.9% before around 100° C. as measured by TGA. 
     Provided herein are methods of preparing a non-stoichiometric or stoichiometric hydrate of polymorph Form 1. In some embodiments, the method comprises reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate a non-stoichiometric or stoichiometric hydrate of polymorph Form 1 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) is a mixture of a non-stoichiometric or stoichiometric hydrate of polymorph Form 1 and Form 1. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, the method comprises reslurrying a composition comprising a mixture of a non-stoichiometric or stoichiometric hydrate of polymorph Form 1 and Form 1 in a solvent or mixture of solvents to generate a non-stoichiometric or stoichiometric hydrate of polymorph Form 1 as a residual solid. In some embodiments, the solvent is in a mixture with water, for example the solvent can be a mixture of water and acetonitrile, methanol, MtBE, MA, MIBK, DCM, IPAc, n-butyl acetate, heptane, toluene, or n-butanol. In some embodiments, the water is present in an amount of about 5% by weight. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 2. Form 2 is an anhydrous polymorph of the compound of Formula (I). In one embodiment, polymorph Form 2 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 7.0±0.2, 21.5±0.2, and 22.0±0.2. In some embodiments, Form 2 has an XRPD pattern with at least peaks at ° 2θ values of 7.0±0.2, 18.9±0.2, 21.5±0.2, 22.0±0.2, and 24.2±0.2. In some embodiments, Form 2 has an XRPD pattern with at least peaks at ° 2θ values of 7.0±0.2, 14.1±0.2, 18.9±0.2, 19.2±0.2, 21.5±0.2, 22.0±0.2, 24.2±0.2, and 26.4±0.2. For example, in some embodiments, Form 2 has an XRPD pattern with at least peaks at ° 2θ values of 7.0±0.2, 10.4±0.2, 14.1±0.2, 17.6±0.2, 18.9±0.2, 19.2±0.2, 21.5±0.2, 22.0±0.2, 24.2±0.2, and 26.4±0.2. 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 2. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 3, Form 4, Form 5, Form 6, Form 7, Form 8, Form 9, Form 10, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 2 exhibits an endotherm between about 50-100° C. as measured by DSC. In some embodiments, polymorph Form 2 exhibits an endotherm between about 220-230° C. In some embodiments, polymorph Form 2 exhibits an exotherm between about 233-238° C. In some embodiments, polymorph Form 2 exhibits an exotherm between about 290-295° C. In some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, polymorph Form 2 has a melting point of around 363° C. In some embodiments, polymorph Form 2 undergoes a weight loss of about 2.7% before around 116° C., e.g., from about 36° C. to about 116° C., as measured by TGA. 
     In some embodiments, polymorph Form 2 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 2 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) comprises a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 2 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 2 as a residual solid. In some embodiments, the solvent is acetonitrile. In some embodiments, the solvent is ethanol. In some embodiments, the solvent is in a mixture with water, for example the solvent can be a mixture of water and ethanol or water and n-propanol. In some embodiments, the water is present in an amount of about 5% by weight. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 3. Form 3 is an anhydrous polymorph of the compound of Formula (I). In one embodiment, polymorph Form 3 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 7.2±0.2, 22.2±0.2, and 24.4±0.2. In some embodiments, Form 3 has an XRPD pattern with at least peaks at ° 2θ values of 6.3±0.2, 7.2±0.2, 21.6±0.2, 22.2±0.2, and 24.4±0.2. In some embodiments, Form 3 has an XRPD pattern with at least peaks at ° 2θ values of 6.3±0.2, 7.2±0.2, 11.0±0.2, 18.4±0.2, 19.0±0.2, 21.6±0.2, 22.2±0.2, and 24.4±0.2. For example, in some embodiments, Form 3 has an XRPD pattern with at least peaks at ° 2θ values of 6.3±0.2, 7.2±0.2, 11.0±0.2, 14.2±0.2, 17.8±0.2, 18.4±0.2, 19.0±0.2, 21.6±0.2, 22.2±0.2, and 24.4±0.2. 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 3. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 4, Form 5, Form 6, Form 7, Form 8, Form 9, Form 10, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 3 exhibits an exotherm between about 190-220° C., as measured by DSC. In some embodiments, polymorph Form 3 exhibits an exotherm at between about 225-235° C., e.g., around 230° C., as measured by DSC. In some embodiments, polymorph Form 3 exhibits an exotherm at between about 292-300° C., e.g., around 297° C., as measured by DSC. For example, in some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, polymorph Form 3 has a melting point of around 365° C. In some embodiments, polymorph Form 3 undergoes a weight loss of about 1.6% before around 81° C. and a weight loss of about 1.7% between about 81-169° C. as measured by TGA. 
     In some embodiments, polymorph Form 3 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 3 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) comprises a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 3 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 3 as a residual solid. In some embodiments, the solvent is IPAc. In some embodiments, the solvent is n-butyl acetate. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 4. Form 4 is an anhydrous polymorph of the compound of Formula (I). In one embodiment, polymorph Form 4 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 7.0±0.2, 21.8±0.2, and 25.1±0.2. In some embodiments, Form 4 has an XRPD pattern with at least peaks at ° 2θ values of 7.0±0.2, 19.5±0.2, 21.8±0.2, 23.2±0.2, and 25.1±0.2. In some embodiments, Form 4 has an XRPD pattern with at least peaks at ° 2θ values of 7.0±0.2, 17.6±0.2, 18.3±0.2, 19.5±0.2, 21.8±0.2, 23.2±0.2, 25.1±0.2, and 25.8±0.2. For example, in some embodiments, Form 4 has an XRPD pattern with at least peaks at ° 2θ values of 7.0±0.2, 9.6±0.2, 17.6±0.2, 18.3±0.2, 19.5±0.2, 21.8±0.2, 23.2±0.2, 25.1±0.2, 25.8±0.2, and 29.3±0.2. 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 4. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 3, Form 5, Form 6, Form 7, Form 8, Form 9, Form 10, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 4 exhibits an endotherm between about 50-100° C. as measured by DSC. In some embodiments, polymorph Form 4 exhibits an endotherm at between about 180-215° C. In some embodiments, polymorph Form 4 exhibits an endotherm between about 220-230° C. In some embodiments, polymorph Form 4 exhibits an exotherm at between about 230-240° C., e.g., around 235° C. In some embodiments, polymorph Form 4 exhibits an exotherm at between about 300-310° C. For example, in some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, polymorph Form 4 has a melting point of between about 366-369° C., e.g., around 367° C. In some embodiments, polymorph Form 4 undergoes a weight loss of about 8.3% before around 200° C., e.g., from about 42° C. to about 200° C., as measured by TGA. 
     In some embodiments, polymorph Form 4 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 4 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) comprises a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 4 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 4 as a residual solid. In some embodiments, the solvent is EA. In some embodiments, the solvent is MA. In some embodiments, the solvent is MtBE. In some embodiments, the solvent is n-propanol. In some embodiments, the solvent is acetone. In some embodiments, the solvent is in a mixture with water, for example the solvent can be a mixture of water and MA, EA, or acetone. In some embodiments, the water is present in an amount of about 5% by weight. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 5. Form 5 is an anhydrous polymorph of the compound of Formula (I). In one embodiment, polymorph Form 5 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 7.3±0.2, 22.3±0.2, and 24.5±0.2. In some embodiments, Form 5 has an XRPD pattern with at least peaks at ° 2θ values of 6.3±0.2, 7.3±0.2, 21.7±0.2, 22.3±0.2, and 24.5±0.2. In some embodiments, Form 5 has an XRPD pattern with at least peaks at ° 2θ values of 6.3±0.2, 7.3±0.2, 11.0±0.2, 19.1±0.2, 19.5±0.2, 21.7±0.2, 22.3±0.2, and 24.5±0.2. For example, in some embodiments, Form 5 has an XRPD pattern with at least peaks at ° 2θ values of 6.3±0.2, 7.3±0.2, 11.0±0.2, 14.3±0.2, 19.1±0.2, 19.5±0.2, 21.7±0.2, 22.3±0.2, 24.5±0.2, and 26.5±0.2. 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 5. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 3, Form 4, Form 6, Form 7, Form 8, Form 9, Form 10, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 5 exhibits an endotherm between about 50-100° C. as measured by DSC. In some embodiments, polymorph Form 5 exhibits an endotherm at between about 210-235° C., e.g., around 222° C. In some embodiments, polymorph Form 5 exhibits an exotherm at between about 227-240° C., e.g., around 235° C. In some embodiments, polymorph Form 5 exhibits an exotherm at between about 280-300° C., e.g., around 293° C. For example, in some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, polymorph Form 5 has a melting point of around 363° C. In some embodiments, polymorph Form 5 undergoes a weight loss of about 3.1% before around 100° C. and about 1.7% between about 100-250° C. as measured by TGA. 
     In some embodiments, polymorph Form 5 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 5 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) comprises a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 5 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 5 as a residual solid. In some embodiments, the solvent is MtBE. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 6. Form 6 is an anhydrous polymorph of the compound of Formula (I). 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 6. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 3, Form 4, Form 5, Form 7, Form 8, Form 9, Form 10, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 6 exhibits an exotherm between about 245-260° C. as measured by DSC. For example, in some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. In some embodiments, polymorph Form 6 has a melting point of around 364° C. 
     In some embodiments, polymorph Form 6 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 6 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 6 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 6 as a residual solid. In some embodiments, the solvent is IPAc. In some embodiments, the solvent is in a mixture with water, for example the solvent can be a mixture of water and IPAc. In some embodiments, the water is present in an amount of about 5% by weight. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 7. Form 7 is an anhydrous polymorph of the compound of Formula (I). In one embodiment, polymorph Form 7 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 7.1±0.2, 21.6±0.2, and 23.2±0.2. In some embodiments, Form 7 has an XRPD pattern with at least peaks at ° 2θ values of 4.9±0.2, 7.1±0.2, 18.5±0.2, 21.6±0.2, and 23.2±0.2. In some embodiments, Form 7 has an XRPD pattern with at least peaks at ° 2θ values of 4.9±0.2, 7.1±0.2, 10.9±0.2, 18.5±0.2, 19.4±0.2, 21.6±0.2, 23.2±0.2, and 30.3±0.2. For example, in some embodiments, Form 7 has an XRPD pattern with at least peaks at ° 2θ values of 4.9±0.2, 7.1±0.2, 8.8±0.2, 10.9±0.2, 18.5±0.2, 19.4±0.2, 21.6±0.2, 22.1±0.2, 23.2±0.2, and 30.3±0.2. 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 7. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 3, Form 4, Form 5, Form 6, Form 8, Form 9, Form 10, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 7 exhibits an exotherm between about 227-235° C., e.g., around 232° C., as measured by DSC. In some embodiments, polymorph Form 7 exhibits an exotherm between about 299-305° C., e.g., around 303° C. For example, in some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, polymorph Form 7 has a melting point of around 365° C. In some embodiments, polymorph Form 7 undergoes a weight loss of about 12% before around 200° C., e.g., from about 36° C. to about 200° C., as measured by TGA. 
     In some embodiments, polymorph Form 7 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 7 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 7 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 7 as a residual solid. In some embodiments, the solvent is methyl ethyl ketone (MEK). In some embodiments, the solvent is in a mixture with water, for example the solvent can be a mixture of water and MEK. In some embodiments, the water is present in an amount of about 5% by weight. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 8. Form 8 is an anhydrous polymorph of the compound of Formula (I). In one embodiment, polymorph Form 8 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 6.9±0.2, 17.7±0.2, and 21.5±0.2. In some embodiments, Form 8 has an XRPD pattern with at least peaks at ° 2θ values of 6.9±0.2, 11.5±0.2, 17.7±0.2, 21.5±0.2, and 27.6±0.2. In some embodiments, Form 8 has an XRPD pattern with at least peaks at ° 2θ values of 6.9±0.2, 11.5±0.2, 15.3±0.2, 16.9±0.2, 17.7±0.2, 21.5±0.2, 27.6±0.2, and 28.9±0.2. For example, in some embodiments, Form 8 has an XRPD pattern with at least peaks at ° 2θ values of 6.9±0.2, 11.5±0.2, 12.7±0.2, 14.2±0.2, 15.3±0.2, 16.9±0.2, 17.7±0.2, 21.5±0.2, 27.6±0.2, and 28.9±0.2. 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 8. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 3, Form 4, Form 5, Form 6, Form 7, Form 9, Form 10, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 8 exhibits an endotherm between about 41-60° C. as measured by DSC. In some embodiments, polymorph Form 8 exhibits an exotherm at between about 221-235° C., e.g., around 231° C. In some embodiments, polymorph Form 8 exhibits an endotherm between about 279-290° C., e.g., around 285° C. For example, in some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, polymorph Form 8 has a melting point of around 364° C. In some embodiments, polymorph Form 8 undergoes a weight loss of about 4.2% before around 190° C. and about 3.9% between about 190-261° C. as measured by TGA. 
     In some embodiments, polymorph Form 8 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 8 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 8 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 8 as a residual solid. In some embodiments, the solvent is MIBK. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 9. Form 9 is an anhydrous polymorph of the compound of Formula (I). In one embodiment, polymorph Form 9 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 4.9±0.2, 18.6±0.2, and 21.1±0.2. In some embodiments, Form 9 has an XRPD pattern with at least peaks at ° 2θ values of 4.9±0.2, 18.6±0.2, 21.1±0.2, 24.1±0.2, and 25.2±0.2. In some embodiments, Form 9 has an XRPD pattern with at least peaks at ° 2θ values of 4.9±0.2, 15.3±0.2, 16.5±0.2, 18.6±0.2, 21.1±0.2, 22.4±0.2, 24.1±0.2, and 25.2±0.2. For example, in some embodiments, Form 9 has an XRPD pattern with at least peaks at ° 2θ values of 4.9±0.2, 10.1±0.2, 15.3±0.2, 16.5±0.2, 18.6±0.2, 21.1±0.2, 22.4±0.2, 24.1±0.2, 25.2±0.2, and 28.6±0.2. 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 9. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 3, Form 4, Form 5, Form 6, Form 7, Form 8, Form 10, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 9 exhibits a single melting endotherm at around 364° C. as measured by DSC. For example, in some embodiments, the endotherm is observed when using a scan rate of 10° C. per minute. In some embodiments, other polymorph forms provided herein, such as, e.g., Form 1 and Form 2, can convert to Form 9 when heated to just before melting (i.e., around 364° C.). 
     In some embodiments, polymorph Form 9 has a melting point of around 364° C. In some embodiments, polymorph Form 9 undergoes a weight loss of about 0.28% before around 100° C., e.g., from about 30.5° C. to about 100° C., as measured by TGA. 
     In some embodiments, polymorph Form 9 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 9 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 9 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 9 as a residual solid. In some embodiments, the solvent is n-butanol. In some embodiments, the solvent is IPAc. In some embodiments, the solvent is n-butyl acetate. In some embodiments, the solvent is in a mixture with water, for example the solvent can be a mixture of water and ethanol or water and n-propanol. In some embodiments, the water is present in an amount of about 5% by weight. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 10. Polymorph Form 10 is a polymorph of the compound of Formula (I) comprising DMSO. For example, DMSO is on the surface of the polymorph. In one embodiment, polymorph Form 10 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 20.7±0.2, 21.7±0.2, and 24.2±0.2. In some embodiments, Form 10 has an XRPD pattern with at least peaks at ° 2θ values of 18.2±0.2, 19.0±0.2, 20.7±0.2, 21.7±0.2, and 24.2±0.2. In some embodiments, Form 10 has an XRPD pattern with at least peaks at ° 2θ values of 17.8±0.2, 18.2±0.2, 19.0±0.2, 20.7±0.2, 21.7±0.2, 23.4±0.2, 24.2±0.2, and 27.9±0.2. For example, in some embodiments, Form 10 has an XRPD pattern with at least peaks at ° 2θ values of 6.7±0.2, 17.8±0.2, 18.2±0.2, 19.0±0.2, 19.9±0.2, 20.7±0.2, 21.7±0.2, 23.4±0.2, 24.2±0.2, and 27.9±0.2. 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 10. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 3, Form 4, Form 5, Form 6, Form 7, Form 8, Form 9, Form 11, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 10 exhibits an endotherm between about 212-237° C. as measured by DSC. In some embodiments, polymorph Form 10 exhibits an endotherm at between about 234-245° C., e.g., around 237° C. In some embodiments, polymorph Form 10 exhibits an exotherm between about 300-325° C., e.g., around 308° C. For example, in some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, polymorph Form 10 has a melting point of between about 364-372° C., such as, e.g., around 369° C. In some embodiments, polymorph Form 10 undergoes a weight loss of about 0.6% before around 100° C., a weight loss of about 3.8% between about 100-170° C., and a weight loss of about 7.1% between about 170-260° C. as measured by TGA. 
     In some embodiments, polymorph Form 10 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 10 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 10 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 10 as a residual solid. In some embodiments, the solvent is DMSO. In some embodiments, the solvent is in a mixture with water, for example the solvent can be a mixture of water and DMSO. In some embodiments, the water is present in an amount of about 5% by weight. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     Provided herein is a formulation comprising a polymorph known as Form 11. Form 11 is an anhydrous polymorph of the compound of Formula (I). In one embodiment, polymorph Form 11 has an XRPD pattern, obtained with CuKα1-radiation, with at least peaks at ° 2θ values of 6.4±0.2, 18.5±0.2, and 22.4±0.2. In some embodiments, Form 11 has an XRPD pattern with at least peaks at ° 2θ values of 6.4±0.2, 17.8±0.2, 18.5±0.2, 19.9±0.2, and 22.4±0.2. In some embodiments, Form 11 has an XRPD pattern with at least peaks at ° 2θ values of 6.4±0.2, 8.4±0.2, 17.8±0.2, 18.5±0.2, 19.9±0.2, 22.4±0.2, 24.5±0.2, and 26.8±0.2. For example, in some embodiments, Form 11 has an XRPD pattern with at least peaks at ° 2θ values of 6.4±0.2, 8.4±0.2, 17.8±0.2, 18.5±0.2, 19.9±0.2, 20.3±0.2, 22.4±0.2, 22.9±0.2, 24.5±0.2, and 26.8±0.2. 
     In some embodiments, provided herein is a formulation comprising a composition comprising polymorph Form 11. In some embodiments, the composition is substantially pure. For example, the composition can have a purity of at least about 90%. In some embodiments, the composition has a purity of at least about 95%. In some embodiments, the composition has a purity of at least about 98%. For example, the composition can have a purity of at least 98.5%, 98.6%, 98.7%, 98.8%, 98.9%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9%. In some embodiments, the composition is substantially free of other forms of the compound of Formula (I). For example, in some embodiments, the composition is substantially free of other anhydrous forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of other forms of the compound of Formula (I). In some embodiments, the composition contains less than 15% by weight of one or more other forms of the compound of Formula (I), such as less than 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight of one or more other forms of the compound of Formula (I). For example, the composition can contain less than about 15% of Form 1, Form 2, Form 3, Form 4, Form 5, Form 6, Form 7, Form 8, Form 9, Form 10, a non-stoichiometric or stoichiometric hydrate of Form 1, or a combination of two or more thereof. 
     In some embodiments, polymorph Form 11 exhibits an endotherm between about 215-230° C. as measured by DSC. In some embodiments, polymorph Form 11 exhibits an exotherm at between about 230-240° C., e.g., around 235° C. In some embodiments, polymorph Form 11 exhibits an exotherm between about 300-315° C., e.g., around 310° C. For example, in some embodiments, the endotherms and exotherms are observed when using a scan rate of 10° C. per minute. 
     In some embodiments, polymorph Form 11 has a melting point of around 368° C. In some embodiments, polymorph Form 11 undergoes a weight loss of about 0.8% before around 100° C. and a weight loss of about 7.0% between about 100-249° C., as measured by TGA. 
     In some embodiments, polymorph Form 11 is prepared by a method comprising reslurrying a composition comprising the compound of Formula (I), including amorphous and polymorph forms thereof, in a solvent or mixture of solvents to generate Form 11 as a residual solid. In some embodiments, the composition comprising the compound of Formula (I) is a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. In some embodiments, the reslurrying takes place at RT. In some embodiments, the slurrying takes place at around 50° C. In some embodiments, the method further comprises drying the residual solid, for example, under vacuum. In some embodiments, the drying is at a temperature of between about 60° C. and 90° C., such as, e.g., around 75° C. 
     In some embodiments, polymorph Form 11 is prepared by a method comprising reslurrying a composition comprising a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water in a solvent or mixture of solvents to generate polymorph Form 11 as a residual solid. In some embodiments, the solvent is dimethylformamide (DMF). In some embodiments, the solvent is in a mixture with water, for example the solvent can be a mixture of water and DMF. In some embodiments, the water is present in an amount of about 5% by weight. In some embodiments, the reslurrying takes place at RT. In some embodiments, the reslurrying takes place at around 50° C. 
     EXAMPLES 
     Example 1: Preparation of Single-Dose, Ready-to-Use Formulations 
     Single-dose, ready-to-use formulations containing either 0.015 mg/mL, 0.025 mg/mL or 0.115 mg/mL of polymorph Form 1 of the compound of Formula (I) were prepared. The compound of Formula (I) was prepared according to the process provided in US 2013/0267495, incorporated herein by reference in its entirety. The polymorph of Form 1 was prepared as described herein. 
     For a 0.015 mg/mL Formulation: 
     Water, sodium carboxymethylcellulose (CMC) (5.55 g/kg), polysorbate 80 (0.50 g/kg), sodium phosphate monobasic monohydrate (0.268 g/kg), sodium phosphate dibasic heptahydrate (2.44 g/kg), and sodium chloride (9.11 g/kg) were added to a 300 L first tank. The aqueous solution in the first tank was then filtered through a 0.2 μm polyethersulfone (PES) filter into a second tank, where it was bulk sterilized. 0.15 g/kg of polymorph Form 1 of the compound of Formula (I), water for injection, and 0.5 g/kg polysorbate 80 were added to a 30 L third tank to form a slurry containing 15 μg/mL of the compound of Formula (I). The slurry was sterilized by overhead steam pressure, then added to the second tank containing the aqueous solution. The slurry was homogenized at 30 Hz and manufactured using principles of overkill cycle (F 0 ≥30). The mixture was aseptically mixed with sterile diluent to form a suspension with a concentration of 0.015 mg/mL of the compound of Formula (I). The bulk solution temperature was maintained at 250° F. as monitored by bottom TC and overhead pressure was maintained greater than the steam pressure introduced in the tank jacket (˜&gt;5 psi). To maintain overhead pressure during bleeding of the top valve next to the mixer to monitor TC above the tank, steam was introduced via the air filter into the tank to maintain pressure and high temperature. The steam pressure was monitored and bulk sterilization performed. The suspension was then aseptically filled using a Weiler 624 BFS machine into 3 mL polypropylene vials, with a target volume of 2.5 mL and a final concentration of 0.015 mg/mL of the compound of Formula (I). Each vial contained 0.03 mg of Form 1 of the compound of Formula (I) in 2 mL phosphate buffered saline. The vials were labeled and packaged. 
     For a 0.035 mg/mL Formulation: 
     Water, sodium carboxymethylcellulose (CMC) (5.55 g/kg), polysorbate 80 (0.50 g/kg), sodium phosphate monobasic monohydrate (0.268 g/kg), sodium phosphate dibasic heptahydrate (2.44 g/kg), and sodium chloride (9.11 g/kg) were added to a 300 L first tank. The aqueous solution in the first tank was then filtered through a 0.2 μm polyethersulfone (PES) filter into a second tank, where it was bulk sterilized. 0.35 g/kg of polymorph Form 1 of the compound of Formula (I), water for injection, and 0.5 g/kg polysorbate 80 were added to a 30 L third tank to form a slurry containing 35 μg/mL of the compound of Formula (I). The slurry was sterilized by overhead steam pressure, then added to the second tank containing the aqueous solution. The slurry was homogenized at 30 Hz and manufactured using principles of overkill cycle (F 0 ≥30). The mixture was aseptically mixed with sterile diluent to form a suspension with a concentration of 0.035 mg/mL of the compound of Formula (I). The bulk solution temperature was maintained at 250° F. as monitored by bottom TC and overhead pressure was maintained greater than the steam pressure introduced in the tank jacket (˜&gt;5 psi). To maintain overhead pressure during bleeding of the top valve next to the mixer to monitor TC above the tank, steam was introduced via the air filter into the tank to maintain pressure and high temperature. The steam pressure was monitored and bulk sterilization performed. The suspension was then aseptically filled using a Weiler 624 BFS machine into 3 mL polypropylene vials, with a target volume of 2.5 mL and a final concentration of 0.035 mg/mL of the compound of Formula (I). Each vial contained 0.07 mg of Form 1 of the compound of Formula (I) in 2 mL phosphate buffered saline. The vials were labeled and packaged. 
     For a 0.075 mg/mL Formulation: 
     Water, sodium carboxymethylcellulose (CMC) (5.55 g/kg), polysorbate 80 (0.50 g/kg), sodium phosphate monobasic monohydrate (0.268 g/kg), sodium phosphate dibasic heptahydrate (2.44 g/kg), and sodium chloride (9.11 g/kg) were added to a 300 L first tank. The aqueous solution in the first tank was then filtered through a 0.2 μm polyethersulfone (PES) filter into a second tank, where it was bulk sterilized. 0.75 g/kg of polymorph Form 1 of the compound of Formula (I), water for injection, and 0.5 g/kg polysorbate 80 were added to a 30 L third tank to form a slurry containing 75 μg/mL of the compound of Formula (I). The slurry was sterilized by overhead steam pressure, then added to the second tank containing the aqueous solution. The slurry was homogenized at 30 Hz and manufactured using principles of overkill cycle (F 0 ≥30). The mixture was aseptically mixed with sterile diluent to form a suspension with a concentration of 0.075 mg/mL of the compound of Formula (I). The bulk solution temperature was maintained at 250° F. as monitored by bottom TC and overhead pressure was maintained greater than the steam pressure introduced in the tank jacket (˜&gt;5 psi). To maintain overhead pressure during bleeding of the top valve next to the mixer to monitor TC above the tank, steam was introduced via the air filter into the tank to maintain pressure and high temperature. The steam pressure was monitored and bulk sterilization performed. The suspension was then aseptically filled using a Weiler 624 BFS machine into 3 mL polypropylene vials, with a target volume of 2.5 mL and a final concentration of 0.075 mg/mL of the compound of Formula (I). Each vial contained 0.15 mg of Form 1 of the compound of Formula (I) in 2 mL phosphate buffered saline. The vials were labeled and packaged. 
     For a 0.115 mg/mL Formulation: 
     Water, sodium carboxymethylcellulose (CMC) (5.55 g/kg), polysorbate 80 (0.50 g/kg), sodium phosphate monobasic monohydrate (0.268 g/kg), sodium phosphate dibasic heptahydrate (2.44 g/kg), and sodium chloride (9.11 g/kg) were added to a 300 L first tank. The aqueous solution in the first tank was then filtered through a 0.2 μm polyethersulfone (PES) filter into a second tank, where it was bulk sterilized. 0.15 g/kg of polymorph Form 1 of the compound of Formula (I), water for injection, and 0.5 g/kg polysorbate 80 were added to a 30 L third tank to form a slurry containing 115 μg/mL of the compound of Formula (I). The slurry was sterilized by overhead steam pressure, then added to the second tank containing the aqueous solution. The slurry was homogenized at 30 Hz and manufactured using principles of overkill cycle (F 0 ≥30). The mixture was aseptically mixed with sterile diluent to form a suspension with a concentration of 0.115 mg/mL of the compound of Formula (I). The bulk solution temperature was maintained at 250° F. as monitored by bottom TC and overhead pressure was maintained greater than the steam pressure introduced in the tank jacket (˜&gt;5 psi). To maintain overhead pressure during bleeding of the top valve next to the mixer to monitor TC above the tank, steam was introduced via the air filter into the tank to maintain pressure and high temperature. The steam pressure was monitored and bulk sterilization performed. The suspension was then aseptically filled using a Weiler 624 BFS machine into 3 mL polypropylene vials, with a target volume of 2.5 mL and a final concentration of 0.035 mg/mL of the compound of Formula (I). Each vial contained 0.23 mg of Form 1 of the compound of Formula (I) in 2 mL phosphate buffered saline. The vials were labeled and packaged. 
     Example 2: Polymorph Screen 
     A polymorph form of the compound of Formula (I) was used in the ready-to-use formulations described in Example 1, above. A polymorph screen was performed on the compound of Formula (I) to determine solubility, polymorphism, and thermodynamic stability. 
     A. Analysis of the Starting Solid 
     X-ray powder diffraction (XRD), differential scanning calorimetry (DSC), and thermal gravimetric analysis (TGA) scans of the starting solid compound of Formula (I) indicated that the starting solid was a crystalline material and was a mixture of Form 1 and a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water. According to the DSC scan ( FIG.  12 B ), the solid showed a wide endotherm between 50° C.-100° C.; it also showed a sharp exotherm at 284° C.; and the solid eventually melted at 364° C. According to the TGA scan ( FIG.  12 C ), a 1.4% weight loss was observed before 100° C. 
     The solubility of the starting solid was measured by the gravimetric method and indicated that the compound had low solubility at RT and at 50° C. in all solvents tested except DMF and DMSO. Results from the solubility data test at RT and at 50° C. are shown in Table 3. 
     
       
         
           
               
             
               
                 TABLE 3 
               
             
            
               
                   
               
               
                 Solubility data of the starting solid (a non-stoichiometric  
               
               
                 or stoichiometric hydrate of Form 1) 
               
            
           
           
               
               
               
            
               
                   
                 Solubility at RT 
                 Solubility at 50° C. 
               
               
                 Solvents 
                 (mg/mL) 
                 (mg/mL) 
               
               
                   
               
            
           
           
               
               
               
            
               
                 Acetone 
                 1 
                 1 
               
               
                 Acetonitrile 
                 ~0 
                 0 
               
               
                 MeOH 
                 1 
                 1 
               
               
                 Toluene 
                 1 
                 1 
               
               
                 EtOH 
                 2 
                 2 
               
               
                 IPAc 
                 ~0 
                 ~0 
               
               
                 EA 
                 1 
                 1 
               
               
                 MtBE 
                 ~0 
                 ~0 
               
               
                 IPA 
                 2 
                 5 
               
               
                 MEK 
                 1 
                 1 
               
               
                 MA 
                 ~0 
                 ~0 
               
               
                 n-Propanol 
                 1 
                 2 
               
               
                 MIBK 
                 1 
                 1 
               
               
                 n-Butyl acetate 
                 ~0 
                 ~0 
               
               
                 water 
                 1 
                 1 
               
               
                 Heptane 
                 ~0 
                 ~0 
               
               
                 n-Butanol 
                 1 
                 2 
               
               
                 DMSO 
                 n/a 
                 n/a 
               
               
                 DMF 
                 12 
                 16 
               
               
                 DCM 
                 2 
                 2 
               
               
                 Acetic acid 
                 ~0 
                 3 
               
               
                   
               
            
           
         
       
     
     Reslurry experiments in various solvents were performed. Approximately 30-80 mg of the starting solid (a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water) was slurried in 39 different solvents (pure and binary solvents; the ratio of organic solvent/water (V/V) was 95%/5%) at RT and 50° C. for 5 days. Three solvates, one hydrate, and eleven non-solvated forms were identified. A “*” after a particular Form, e.g., Form 2*, indicates that the forms had similar XRD scans with minor differences and were considered to belong to the same class. Generally, the identified forms showed multiple endotherms/exotherms on differential scanning calorimetry (DSC) scans; Form 9 showed a single endotherm. XRD of both wet and dry samples were scanned ( FIG.  12 A  (dry sample)). The data is shown in Tables 4 and 5 below. 
     
       
         
           
               
             
               
                 TABLE 4 
               
             
            
               
                   
               
               
                 Results of slurry experiments at RT 
               
            
           
           
               
               
               
               
            
               
                   
                 Crystalline Form 
                   
                 Crystalline Form 
               
               
                 Solvent 
                 (wet/dry) 
                 Solvent 
                 (wet/dry) 
               
               
                   
               
            
           
           
               
               
               
               
               
               
            
               
                 Acetone 
                 Solvate 1 
                 Form 2 
                 Acetone/water 
                 Solvate 2 
                 Form 4** 
               
               
                 Acetonitrile 
                 Form 2 
                 Form 1  
                 Acetonitrile/ 
                 Form 12 
                 Form 1 
               
               
                 MeOH 
                 Form 13 
                 Form 1 
                 water 
                   
                   
               
               
                 Toluene 
                 Form 1 
                 Form 2* 
                 MeOH/water 
                 Form 12 
                 Form 1 
               
               
                 EtOH 
                 Form 2* 
                 Form 3 
                 Toluene/water 
                 Form 13 
                 Form 1 
               
               
                 IPAc 
                 Form 3 
                 Form 4 
                 EtOH/water 
                 Solvate 3 
                 Form 2 
               
               
                 EA 
                 Form 4* 
                 Form 5 
                 IPAc/water 
                 Form 12 
                 Form 1 
               
               
                 MtBE 
                 Form 5* 
                 Form 6 
                 EA/water 
                 Form 12 
                 Form 1 
               
               
                 IPA 
                 Form 6 
                 Form 7 
                 MtBE/water 
                 Form 12 
                 Form 1 
               
               
                 MEK 
                 Form 7 
                 Form 4 
                 IPA/water 
                 Form 6 
                 Form 6 
               
               
                 MA 
                 Form 4 
                 Form 4* 
                 MEK/water 
                 Form 7 
                 Form 7 
               
               
                 n-Propanol 
                 Form 4* 
                 Form 8 
                 MA/water 
                 Form 13 
                 Form 1 
               
               
                 MIBK 
                 Form 8 
                 Form 3 
                 n-Propanol/ 
                 Form 2** 
                 Form 2** 
               
               
                 n-Butyl 
                 Form 3* 
                 Form 1 
                 water 
                   
                   
               
               
                 acetate 
                   
                   
                 MIBK/water 
                 Form 12 
                 Form 1 
               
               
                 Water 
                 Form 13 
                 Form 1 
                 n-Butyl 
                 Form 13 
                 Form 12 
               
               
                 Heptane 
                 Form 1 
                 Form 9 
                 acetate/water 
                   
                   
               
               
                 n-Butanol 
                 Form 9 
                 Form 10 
                 Heptane/water 
                 Form 13 
                 Form 12 
               
               
                 DMSO 
                 amorphous 
                 Form 11 
                 n-Butanol/water 
                 Form 13 
                 Form 13 
               
               
                 DMF 
                 Form 11 
                 Form 1 
                 DMSO/water 
                 amorphous 
                 Form 10 
               
               
                 DCM 
                 Form 1 
                 Form 2 
                 DMF/water 
                 Form 11 
                 Form 11 
               
               
                   
                   
                   
                 DCM/water 
                 Form 13 
                 Form 1 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 5 
               
             
            
               
                   
               
               
                 Results of slurry experiments at 50° C. 
               
            
           
           
               
               
               
               
            
               
                   
                 Crystalline Form 
                   
                 Crystalline Form 
               
               
                 Solvent 
                 (wet/dry) 
                 Solvent 
                 (wet/dry) 
               
               
                   
               
            
           
           
               
               
               
               
               
               
            
               
                 Acetone 
                 Solvate 2 
                 Form 4** 
                 Acetone/water 
                 Form 4** 
                 Form 4** 
               
               
                 Acetonitrile 
                 Form 2* 
                 Form 2 
                 Acetonitrile/water 
                 Form 13 
                 Form 13 
               
               
                 MeOH 
                 Form 1 
                 Form 1 
                 MeOH/water 
                 Form 13 
                 Form 13 
               
               
                 Toluene 
                 Form 1 
                 Form 1 
                 Toluene/water 
                 Form 13 
                 Form 13 
               
               
                 EtOH 
                 Form 2* 
                 Form 2* 
                 EtOH/water 
                 Form 9 
                 Form 9 
               
               
                 IPAc 
                 Form 9 
                 Form 9 
                 IPAc/water 
                 Form 13 
                 Form 13 
               
               
                 EA 
                 Form 4* 
                 Form 4 
                 EA/water 
                 Form 4* 
                 Form 4* 
               
               
                 MtBE 
                 Form 5* 
                 Form 4 
                 MtBE/water 
                 Form 13 
                 Form 13 
               
               
                 IPA 
                 Form 6 
                 Form 6 
                 IPA/water 
                 Form 6 
                 Form 6 
               
               
                 MEK 
                 Form 7 
                 Form 7 
                 MEK/water 
                 Form 7 
                 Form 7 
               
               
                 MA 
                 Form 4 
                 Form 4 
                 MA/water 
                 Form 12 
                 Form 4 
               
               
                 n-Propanol 
                 Form 4 
                 Form 4** 
                 n-Propanol/water 
                 Form 9 
                 Form 9 
               
               
                 MIBK 
                 Form 8 
                 Form 8 
                 MIBK/water 
                 Form 13 
                 Form 1 
               
               
                 n-Butyl 
                 Form 9 
                 Form 9 
                 n-Butyl 
                 Form 13 
                 Form 1 
               
               
                 acetate 
                   
                   
                 acetate/water 
                   
                   
               
               
                 water 
                 Form 13 
                 Form 13 
                 Heptane/water 
                 Form 13 
                 Form 1 
               
               
                 Heptane 
                 Form 13 
                 Form 13 
                 n-Butanol/water 
                 Form 13 
                 Form 1 
               
               
                 n-Butanol 
                 Form 9 
                 Form 9 
                 DMSO/water 
                 Amorphous 
                 Form 10 
               
               
                 DMSO 
                 Amorphous 
                 Form 10* 
                 DMF/water 
                 Form 11 
                 Form 11 
               
               
                 DMF 
                 Form 11 
                 Form 11* 
                 DCM/water 
                 Form 13 
                 Form 1 
               
               
                 DCM 
                 Form 13 
                 Form 13 
               
               
                   
               
            
           
         
       
     
     The slurry experiments identified 3 solvated forms from wet samples (Solvates 1, 2, and 3); 2 non-stoichiometric hydrates of Form 1 (Forms 12 and 13); and 11 non-solvated forms (Forms 1-11). In some instances, similar XRD scans with minor differences were obtained. These were considered to be part of the same class (e.g., the same form). For example, XRD scans of Form 2 and Form 2* were similar and were considered to belong to the same class. The solvated forms were obtained from wet sample analysis; after drying, the sample indicated a different XRD. 
     Solvate 1 was obtained from acetone at RT, and after drying, a low crystallinity solid was generated. Solvate 2 was obtained from acetone (at RT) and acetone/water (at RT), and after drying, Form 4** was generated. Solvate 3 was obtained from EtOH/water at RT, and after drying, Form 2 was generated. 
     B. Form 1 
     The experiments that generated Form 1 are shown in Table 6, below. Form 1 was generally obtained from drying of Form 13 or Form 12. Form 1 may be considered as a dehydrated hydrate. Reslurry in many binary solvents (with 5% water) generated Form 1. Purity of the residual solid was 98.9%. KF of Form 1 (one sample) solid was 5.8%; residual MeOH of Form 1 solid was 0.01%. A TGA scan of fully dried Form 1 solid was performed ( FIG.  1 C ). A 0.33% weight loss was observed before 100° C. 
     Form 1 showed sharp crystalline peaks on the XRD scan ( FIG.  1 A ). The XRD peaks of Form 1 are shown in Table 7, below. According to the DSC scan ( FIG.  1 B ), the solid showed a wide endotherm between 50-100° C.; it showed a sharp exotherm at 281° C.; and the melting point was 363° C. Form 1 has a primitive orthorhombic crystal structure with the approximate dimensions: a [Å]=29.062, b [Å]=23.945, c [Å]=7.245 and an approximate volume cell of [Å 3 /cell]=5,041.7 and a space group defined as Pbca (61). 
     The Form 1 solid was dried at 75° C. under vacuum overnight, and XRD, DSC, and TGA scans were performed. Comparison of the first and the second XRD scans (after drying at 75° C. under vacuum overnight), showed no change. However, the DSC scans indicated the absence of endotherm. The loss of the early peak on the DSC scan had no effect on the XRD trace, showing that the wide endotherm between 50-100° C. on DSC scan was due to the free solvent. 
     The Form 1 solid was heated in a DSC chamber to 305° C. (past the endotherm/exotherm around 280° C.), and then scanned by XRD. Comparison of the first and the third XRD and DSC scans shows that after heating to 305° C., Form 1 converted to Form 9. It can be concluded that the endotherm/exotherm around 280° C. might be due to melting/crystallization events. 
     Form 1 tended to convert to a non-stoichiometric or stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water (Form 13) at RH above 4050%. The hydrate lost its water below 30% RH. Form 1 converts to Form 13 when exposed to air. 
     The dynamic vapor sorption (DVS) scan of Form 1 solid showed a 17% water absorption at 90% RH ( FIG.  1 D ). The XRD data indicated that the solid used in the DVS test converted to the hydrate form before the start of the DVS test. However, at 0% RH, water was lost, perhaps indicating that the solid was Form 1. 
     
       
         
           
               
             
               
                 TABLE 6 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Form 1 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 1 
                 MeOH 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 MeOH 
                 50° C. 
                 Form 1 
                 Form 1 
               
               
                   
                 Toluene 
                 RT 
                 Form 1 
                 Form 1 
               
               
                   
                 Toluene 
                 50° C. 
                 Form 1 
                 Form 1 
               
               
                   
                 water 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 Heptane 
                 RT 
                 Form 1 
                 Form 1 
               
               
                   
                 DCM 
                 RT 
                 Form 1 
                 Form 1 
               
               
                   
                 Acetonitrile/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 MeOH/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 Toluene/water 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 IPAc/water 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 EA/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 MtBE/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 MA/water 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 MIBK/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 MIBK/water 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
                 DCM/water 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 DCM/water 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
                 n-Butyl acetate/water 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
                 Heptane/water 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
                 n-Butanol/water 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 7 
               
             
            
               
                   
               
               
                 XRD peaks of Form 1 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 5.778 
                 15.2835 
                 57 
                 97 
                 28.3 
                 1765 
                 18.5 
                 0.309 
               
               
                 6.801 
                 12.9871 
                 19 
                 343 
                 100 
                 8306 
                 87.1 
                 0.412 
               
               
                 9.26 
                 9.5427 
                 20 
                 178 
                 51.9 
                 3884 
                 40.7 
                 0.371 
               
               
                 12.421 
                 7.1203 
                 30 
                 231 
                 67.3 
                 4862 
                 51 
                 0.358 
               
               
                 13.919 
                 6.357 
                 35 
                 147 
                 42.9 
                 3668 
                 38.5 
                 0.424 
               
               
                 14.501 
                 6.1033 
                 40 
                 133 
                 38.8 
                 3439 
                 36.1 
                 0.44 
               
               
                 16.5 
                 5.3681 
                 47 
                 196 
                 57.1 
                 4286 
                 44.9 
                 0.372 
               
               
                 17.26 
                 5.1333 
                 53 
                 46 
                 13.4 
                 560 
                 5.9 
                 0.207 
               
               
                 18.52 
                 4.7868 
                 68 
                 342 
                 99.7 
                 9539 
                 100 
                 0.474 
               
               
                 19.161 
                 4.6282 
                 54 
                 215 
                 62.7 
                 4130 
                 43.3 
                 0.327 
               
               
                 20.302 
                 4.3706 
                 49 
                 133 
                 38.8 
                 2823 
                 29.6 
                 0.361 
               
               
                 20.619 
                 4.304 
                 43 
                 80 
                 23.3 
                 2047 
                 21.5 
                 0.435 
               
               
                 23.056 
                 3.8543 
                 41 
                 38 
                 11.1 
                 765 
                 8 
                 0.342 
               
               
                 24.642 
                 3.6098 
                 33 
                 175 
                 51 
                 7235 
                 75.8 
                 0.703 
               
               
                 25.302 
                 3.5171 
                 86 
                 80 
                 23.3 
                 2345 
                 24.6 
                 0.498 
               
               
                 26.1 
                 3.4113 
                 83 
                 69 
                 20.1 
                 1545 
                 16.2 
                 0.381 
               
               
                 27.46 
                 3.2453 
                 52 
                 46 
                 13.4 
                 872 
                 9.1 
                 0.322 
               
               
                 28.739 
                 3.1038 
                 39 
                 84 
                 24.5 
                 2146 
                 22.5 
                 0.434 
               
               
                 30.444 
                 2.9337 
                 34 
                 32 
                 9.3 
                 1080 
                 11.3 
                 0.54 
               
               
                 33.302 
                 2.6882 
                 30 
                 27 
                 7.9 
                 683 
                 7.2 
                 0.405 
               
               
                   
               
            
           
         
       
     
     C. Forms 2, 2*, and 2*** 
     The experiments that generated Forms 2, 2*, and 2** are shown in Table 8, below. XRD scans of Forms 2, 2* and 2** were performed ( FIGS.  2 A,  2 D, and  2 G  show the XRD scans of Forms 2, 2*, and 2**, respectively). The XRD peaks of Forms 2 and 2* are shown in Tables 9 and 10, below, respectively. DSC scans were also performed ( FIGS.  2 B,  2 E , and  2 H show the DSC scans of Forms 2, 2*, and 2**, respectively). According to the DSC scans, Forms 2, 2* and 2** each showed a wide endotherm between 50° C.-100° C., and multiple endotherms and exotherms before melting at 363° C. The wide endotherm before 100° C. may be due to the containment of water/solvent in the solid. Form 2 was obtained from acetonitrile; Form 2* from ethanol; Form 2** from n-propanol/5% water. 
     A TGA scan of Form 2 ( FIG.  2 C ) showed a 2.7% weight loss before 116° C.  FIG.  2 F  shows the TGA scan of Form 2* 
     A PLM photo of Form 2 was taken, indicating that the particle size of this solid was around 50 um. 
     The Form 2 solid was heated in a DSC machine to 90° C. (past the wide endotherm between 50-100° C.); to 270° C. (past the endotherm/exotherm around 240° C.); and finally to 330° C. (past the exotherm around 330° C.). The residual solid was analyzed by XRD. According to the first and second XRD and DSC scans, the form did not change before and after heating to 90° C. The wide endotherm between 50-100° C. might be free solvent or hydrate. According to the first and third XRD and DSC scans, after heating a Form 2 sample to 270° C., the solid converted to low crystalline solids. According to the first and fourth XRD and DSC scans, after heating the sample to 330° C., the solid converted to Form 9. Thus, the exotherm around 290° C. was a re-crystallization event. According to an XRD and DSC overlay, the behavior of Form 2* was similar to Form 2. 
     Residual acetonitrile and EtOH in Form 2 and 2* was not detected. 
     
       
         
           
               
             
               
                 TABLE 8 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Forms 2, 2*, and 2** 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 2 
                 Acetonitrile 
                 RT 
                 Form 2 
                 Form 2 
               
               
                   
                 Acetonitrile 
                 50° C. 
                 Form 2* 
                 Form 2 
               
               
                   
                 EtOH/water 
                 RT 
                 Solvate 3 
                 Form 2 
               
               
                 Form 2* 
                 EtOH 
                 RT 
                 Form 2* 
                 Form 2* 
               
               
                   
                 EtOH 
                 50° C. 
                 Form 2* 
                 Form 2* 
               
               
                   
                 Acetonitrile 
                 50° C. 
                 Form 2* 
                 Form 2 
               
               
                 Form 2** 
                 n- 
                 RT 
                 Form 2** 
                 Form 2** 
               
               
                   
                 Propanol/water 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 9 
               
             
            
               
                   
               
               
                 XRD peaks of Form 2 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 7.021 
                 12.5802 
                 164 
                 2202 
                 54.1 
                 36151 
                 38.2 
                 0.279 
               
               
                 8.298 
                 10.6462 
                 156 
                 194 
                 4.8 
                 2332 
                 2.5 
                 0.204 
               
               
                 10.399 
                 8.5 
                 193 
                 397 
                 9.8 
                 6246 
                 6.6 
                 0.267 
               
               
                 11.258 
                 7.8531 
                 206 
                 151 
                 3.7 
                 1407 
                 1.5 
                 0.158 
               
               
                 12.239 
                 7.2259 
                 181 
                 287 
                 7 
                 5980 
                 6.3 
                 0.354 
               
               
                 14.1 
                 6.2759 
                 186 
                 648 
                 15.9 
                 14147 
                 15 
                 0.371 
               
               
                 14.597 
                 6.0632 
                 195 
                 182 
                 4.5 
                 7983 
                 8.4 
                 0.746 
               
               
                 16.18 
                 5.4734 
                 235 
                 201 
                 4.9 
                 4033 
                 4.3 
                 0.341 
               
               
                 16.561 
                 5.3484 
                 251 
                 280 
                 6.9 
                 8382 
                 8.9 
                 0.509 
               
               
                 17.033 
                 5.2013 
                 288 
                 160 
                 3.9 
                 1810 
                 1.9 
                 0.192 
               
               
                 17.639 
                 5.0238 
                 295 
                 366 
                 9 
                 3542 
                 3.7 
                 0.165 
               
               
                 18.878 
                 4.6968 
                 316 
                 1210 
                 29.7 
                 29303 
                 31 
                 0.412 
               
               
                 19.22 
                 4.614 
                 333 
                 585 
                 14.4 
                 21169 
                 22.4 
                 0.615 
               
               
                 19.863 
                 4.4662 
                 340 
                 95 
                 2.3 
                 437 
                 0.5 
                 0.078 
               
               
                 20.411 
                 4.3474 
                 385 
                 86 
                 2.1 
                 671 
                 0.7 
                 0.133 
               
               
                 21.48 
                 4.1335 
                 532 
                 1944 
                 47.8 
                 61345 
                 64.8 
                 0.536 
               
               
                 22.04 
                 4.0297 
                 647 
                 4071 
                 100 
                 94605 
                 100 
                 0.395 
               
               
                 23.036 
                 3.8576 
                 634 
                 142 
                 3.5 
                 1478 
                 1.6 
                 0.177 
               
               
                 24.24 
                 3.6686 
                 497 
                 1688 
                 41.5 
                 28976 
                 30.6 
                 0.292 
               
               
                 25.561 
                 3.482 
                 422 
                 120 
                 2.9 
                 2545 
                 2.7 
                 0.361 
               
               
                 25.918 
                 3.4349 
                 365 
                 271 
                 6.7 
                 11426 
                 12.1 
                 0.717 
               
               
                 26.379 
                 3.3759 
                 349 
                 497 
                 12.2 
                 15133 
                 16 
                 0.518 
               
               
                 26.739 
                 3.3313 
                 387 
                 181 
                 4.4 
                 2845 
                 3 
                 0.267 
               
               
                 27.979 
                 3.1863 
                 297 
                 235 
                 5.8 
                 4050 
                 4.3 
                 0.293 
               
               
                 29.043 
                 3.072 
                 338 
                 347 
                 8.5 
                 4584 
                 4.8 
                 0.225 
               
               
                 29.661 
                 3.0094 
                 321 
                 310 
                 7.6 
                 7879 
                 8.3 
                 0.432 
               
               
                 30.204 
                 2.9565 
                 355 
                 135 
                 3.3 
                 1501 
                 1.6 
                 0.189 
               
               
                 31.58 
                 2.8308 
                 232 
                 206 
                 5.1 
                 3991 
                 4.2 
                 0.329 
               
               
                 32.602 
                 2.7443 
                 193 
                 63 
                 1.5 
                 1129 
                 1.2 
                 0.305 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 10 
               
             
            
               
                   
               
               
                 XRD peaks of Form 2* 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 4.859 
                 18.1701 
                 127 
                 87 
                 1.2 
                 1714 
                 1.9 
                 0.335 
               
               
                 7.119 
                 12.4067 
                 148 
                 3587 
                 48.4 
                 44853 
                 50.4 
                 0.213 
               
               
                 8.321 
                 10.6166 
                 149 
                 407 
                 5.5 
                 4871 
                 5.5 
                 0.203 
               
               
                 10.439 
                 8.4669 
                 186 
                 1184 
                 16 
                 13629 
                 15.3 
                 0.196 
               
               
                 11.319 
                 7.8109 
                 190 
                 413 
                 5.6 
                 4673 
                 5.3 
                 0.192 
               
               
                 12.3 
                 7.1899 
                 179 
                 1010 
                 13.6 
                 13220 
                 14.9 
                 0.223 
               
               
                 12.803 
                 6.9089 
                 182 
                 140 
                 1.9 
                 1587 
                 1.8 
                 0.193 
               
               
                 14.121 
                 6.2667 
                 179 
                 1966 
                 26.5 
                 27290 
                 30.7 
                 0.236 
               
               
                 14.559 
                 6.0791 
                 199 
                 169 
                 2.3 
                 4381 
                 4.9 
                 0.441 
               
               
                 16.236 
                 5.4546 
                 244 
                 436 
                 5.9 
                 5696 
                 6.4 
                 0.222 
               
               
                 16.62 
                 5.3297 
                 271 
                 674 
                 9.1 
                 7919 
                 8.9 
                 0.2 
               
               
                 17.059 
                 5.1935 
                 313 
                 629 
                 8.5 
                 6279 
                 7.1 
                 0.17 
               
               
                 17.699 
                 5.0071 
                 303 
                 1094 
                 14.7 
                 12619 
                 14.2 
                 0.196 
               
               
                 18.858 
                 4.7018 
                 359 
                 2334 
                 31.5 
                 31734 
                 35.7 
                 0.231 
               
               
                 19.321 
                 4.5903 
                 325 
                 1650 
                 22.2 
                 28313 
                 31.8 
                 0.292 
               
               
                 19.823 
                 4.4751 
                 412 
                 127 
                 1.7 
                 582 
                 0.7 
                 0.078 
               
               
                 20.321 
                 4.3665 
                 327 
                 333 
                 4.5 
                 3361 
                 3.8 
                 0.172 
               
               
                 21.479 
                 4.1336 
                 451 
                 3245 
                 43.8 
                 56365 
                 63.3 
                 0.295 
               
               
                 22.119 
                 4.0154 
                 612 
                 7417 
                 100 
                 89000 
                 100 
                 0.204 
               
               
                 22.782 
                 3.9 
                 536 
                 327 
                 4.4 
                 11890 
                 13.4 
                 0.618 
               
               
                 23.098 
                 3.8475 
                 466 
                 638 
                 8.6 
                 11127 
                 12.5 
                 0.296 
               
               
                 24.3 
                 3.6597 
                 361 
                 4873 
                 65.7 
                 61170 
                 68.7 
                 0.213 
               
               
                 25.599 
                 3.4769 
                 487 
                 475 
                 6.4 
                 7278 
                 8.2 
                 0.26 
               
               
                 25.88 
                 3.4399 
                 541 
                 562 
                 7.6 
                 10968 
                 12.3 
                 0.332 
               
               
                 26.361 
                 3.3782 
                 372 
                 1289 
                 17.4 
                 20859 
                 23.4 
                 0.275 
               
               
                 26.739 
                 3.3312 
                 266 
                 660 
                 8.9 
                 13196 
                 14.8 
                 0.34 
               
               
                 27.938 
                 3.1909 
                 284 
                 560 
                 7.6 
                 9888 
                 11.1 
                 0.3 
               
               
                 28.641 
                 3.1142 
                 319 
                 210 
                 2.8 
                 2324 
                 2.6 
                 0.188 
               
               
                 29.398 
                 3.0357 
                 357 
                 100 
                 1.3 
                 2376 
                 2.7 
                 0.404 
               
               
                 29.779 
                 2.9977 
                 295 
                 708 
                 9.5 
                 13168 
                 14.8 
                 0.316 
               
               
                 30.3 
                 2.9473 
                 283 
                 451 
                 6.1 
                 6600 
                 7.4 
                 0.249 
               
               
                 31.658 
                 2.8239 
                 239 
                 667 
                 9 
                 9228 
                 10.4 
                 0.235 
               
               
                 32.519 
                 2.7511 
                 221 
                 191 
                 2.6 
                 2896 
                 3.3 
                 0.258 
               
               
                 33.903 
                 2.6419 
                 213 
                 72 
                 1 
                 876 
                 1 
                 0.207 
               
               
                 34.82 
                 2.5744 
                 229 
                 110 
                 1.5 
                 3822 
                 4.3 
                 0.591 
               
               
                 35.504 
                 2.5264 
                 230 
                 97 
                 1.3 
                 3876 
                 4.4 
                 0.679 
               
               
                   
               
            
           
         
       
     
     D. Form 3 
     The experiments that generated Form 3 are shown in Table 11, below. XRD and DSC scans of Form 3 were taken ( FIGS.  3 A and  3 B , respectively). Table 12, below, shows the XRD peaks of Form 3. Multiple exotherms and endotherms were observed from the DSC scan of Form 3. 
     A TGA scan of Form 3 was taken ( FIG.  3 C ) and showed a 1.6% weight loss of the solid before 81° C., followed by a 1.7% weight loss between 81° C. and 169° C. 
     Form 3 was obtained from IPAc at RT, while Form 3* was obtained from reslurry in n-butyl acetate. 
     
       
         
           
               
             
               
                 TABLE 11 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Form 3 and Form 3* 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 3 
                 IPAc 
                 RT 
                 Form 3 
                 Form 3 
               
               
                   
                 n-Butyl acetate  
                 RT 
                 Form 3* 
                 Form 3 
               
               
                 Form 3* 
                 n-Butyl acetate  
                 RT 
                 Form 3* 
                 Form 3 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 12 
               
             
            
               
                   
               
               
                 XRD peaks of Form 3 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 5.024 
                 17.5739 
                 231 
                 87 
                 4.4 
                 845 
                 1.9 
                 0.165 
               
               
                 6.34 
                 13.9294 
                 368 
                 1030 
                 52.5 
                 12361 
                 27.5 
                 0.204 
               
               
                 7.219 
                 12.2357 
                 182 
                 1962 
                 100 
                 36491 
                 81.1 
                 0.316 
               
               
                 8.441 
                 10.4665 
                 188 
                 159 
                 8.1 
                 3261 
                 7.2 
                 0.349 
               
               
                 9.237 
                 9.5659 
                 207 
                 320 
                 16.3 
                 3365 
                 7.5 
                 0.179 
               
               
                 10.561 
                 8.37 
                 240 
                 278 
                 14.2 
                 6270 
                 13.9 
                 0.383 
               
               
                 10.998 
                 8.0381 
                 217 
                 849 
                 43.3 
                 17119 
                 38.1 
                 0.343 
               
               
                 11.46 
                 7.715 
                 256 
                 87 
                 4.4 
                 662 
                 1.5 
                 0.129 
               
               
                 12.439 
                 7.11 
                 215 
                 311 
                 15.9 
                 6502 
                 14.5 
                 0.355 
               
               
                 12.865 
                 6.8756 
                 209 
                 92 
                 4.7 
                 1599 
                 3.6 
                 0.295 
               
               
                 14.22 
                 6.2233 
                 231 
                 522 
                 26.6 
                 12265 
                 27.3 
                 0.399 
               
               
                 15.524 
                 5.7034 
                 273 
                 311 
                 15.9 
                 2957 
                 6.6 
                 0.162 
               
               
                 16.021 
                 5.5276 
                 309 
                 218 
                 11.1 
                 2669 
                 5.9 
                 0.208 
               
               
                 16.78 
                 5.2792 
                 368 
                 330 
                 16.8 
                 3780 
                 8.4 
                 0.195 
               
               
                 17.181 
                 5.1567 
                 384 
                 99 
                 5 
                 2614 
                 5.8 
                 0.449 
               
               
                 17.782 
                 4.9837 
                 428 
                 496 
                 25.3 
                 6264 
                 13.9 
                 0.215 
               
               
                 18.381 
                 4.8227 
                 509 
                 551 
                 28.1 
                 5102 
                 11.3 
                 0.157 
               
               
                 19.02 
                 4.6622 
                 447 
                 589 
                 30 
                 20513 
                 45.6 
                 0.592 
               
               
                 19.758 
                 4.4896 
                 487 
                 423 
                 21.6 
                 14362 
                 31.9 
                 0.577 
               
               
                 20.8 
                 4.267 
                 520 
                 214 
                 10.9 
                 1518 
                 3.4 
                 0.121 
               
               
                 21.19 
                 4.1893 
                 408 
                 418 
                 21.3 
                 4581 
                 10.2 
                 0.186 
               
               
                 21.6 
                 4.1107 
                 553 
                 1017 
                 51.8 
                 41986 
                 93.3 
                 0.702 
               
               
                 22.181 
                 4.0044 
                 662 
                 1736 
                 88.5 
                 44981 
                 100 
                 0.44 
               
               
                 23.185 
                 3.8333 
                 508 
                 259 
                 13.2 
                 3327 
                 7.4 
                 0.218 
               
               
                 24.44 
                 3.6392 
                 467 
                 1441 
                 73.4 
                 29510 
                 65.6 
                 0.348 
               
               
                 25.198 
                 3.5313 
                 551 
                 232 
                 11.8 
                 1362 
                 3 
                 0.1 
               
               
                 25.618 
                 3.4745 
                 557 
                 79 
                 4 
                 365 
                 0.8 
                 0.079 
               
               
                 26.103 
                 3.4109 
                 512 
                 180 
                 9.2 
                 7374 
                 16.4 
                 0.696 
               
               
                 26.479 
                 3.3634 
                 475 
                 306 
                 15.6 
                 11652 
                 25.9 
                 0.647 
               
               
                 27.3 
                 3.264 
                 455 
                 133 
                 6.8 
                 1016 
                 2.3 
                 0.13 
               
               
                 28.04 
                 3.1796 
                 378 
                 93 
                 4.7 
                 1485 
                 3.3 
                 0.271 
               
               
                 28.82 
                 3.0953 
                 372 
                 201 
                 10.2 
                 3455 
                 7.7 
                 0.292 
               
               
                 29.258 
                 3.0499 
                 362 
                 76 
                 3.9 
                 2580 
                 5.7 
                 0.577 
               
               
                 29.88 
                 2.9878 
                 334 
                 191 
                 9.7 
                 4011 
                 8.9 
                 0.357 
               
               
                 31.802 
                 2.8115 
                 251 
                 205 
                 10.4 
                 4094 
                 9.1 
                 0.34 
               
               
                 32.62 
                 2.7429 
                 231 
                 87 
                 4.4 
                 1109 
                 2.5 
                 0.217 
               
               
                 32.943 
                 2.7167 
                 215 
                 52 
                 2.7 
                 1107 
                 2.5 
                 0.362 
               
               
                 33.961 
                 2.6375 
                 217 
                 101 
                 5.1 
                 1686 
                 3.7 
                 0.284 
               
               
                   
               
            
           
         
       
     
     E. Form 4 
     The experiments that generated Forms 4, 4*, and 4** are shown in Table 13, below. XRD of Forms 4, 4*, and 4** were taken ( FIGS.  4 A,  4 D, and  4 G , respectively). Tables 14 and 15, below, show the XRD peaks of Form 4 and Form 4*, respectively. DSC scans of Forms 4, 4*, and 4** were also performed ( FIGS.  4 B,  4 E, and  4 H , respectively). According to the DSC scans, Form 4 showed a wide endotherm between 50° C.-100° C., followed by multiple endotherms/exotherms, and then melted at around 367° C. Forms 4* and 4** showed similar DSC patterns as Form 4. 
     TGA scans of Form 4, Form 4*, and Form 4** were taken ( FIGS.  4 C,  4 F, and  4 I , respectively). For Form 4, there was an 8.3% weight loss before 200° C.; for Form 4*, there was a 4.4% weight loss before 102° C., followed by a 0.5% weight loss between 102° C. and 250° C.; and for Form 4**, there were three stages of weight loss, which were 2.8%, 1.9%, and 1.3%, respectively. 
     These solid forms were obtained from methyl acetate, n-propanol, MIBK, MtBE, ethyl acetate, acetone/water, and ethyl acetate/water. 
     
       
         
           
               
             
               
                 TABLE 13 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Forms 4, 4*, and 4** 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 4 
                 EA 
                 RT 
                 Form 4* 
                 Form 4 
               
               
                   
                 EA 
                 50° C. 
                 Form 4* 
                 Form 4 
               
               
                   
                 MA 
                 RT 
                 Form 4 
                 Form 4 
               
               
                   
                 MA 
                 50° C. 
                 Form 4 
                 Form 4 
               
               
                   
                 MA/water 
                 50° C. 
                 Form 12 
                 Form 4 
               
               
                   
                 MtBE 
                 50° C. 
                 Form 5* 
                 Form 4 
               
               
                   
                 n-Propanol 
                 RT 
                 Form 4 
                 Form 4* 
               
               
                 Form 4* 
                 EA 
                 RT 
                 Form 4* 
                 Form 4* 
               
               
                   
                 EA 
                 50° C. 
                 Form 4* 
                 Form 4 
               
               
                   
                 EA/water 
                 50° C. 
                 Form 4* 
                 Form 4* 
               
               
                   
                 n-Propanol 
                 RT 
                 Form 4 
                 Form 4* 
               
               
                 Form 4** 
                 Acetone/water 
                 RT 
                 Solvate 2 
                 Form 4** 
               
               
                   
                 Acetone 
                 50° C. 
                 Solvate 2 
                 Form 4** 
               
               
                   
                 n-Propanol 
                 50° C. 
                 Form 4 
                 Form 4** 
               
               
                   
                 Acetone/water 
                 50° C. 
                 Form 4** 
                 Form 4** 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 14 
               
             
            
               
                   
               
               
                 XRD peaks of Form 4 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 3.433 
                 25.7129 
                 197 
                 48 
                 1 
                 697 
                 0.7 
                 0.247 
               
               
                 7.019 
                 12.5829 
                 222 
                 3897 
                 77.3 
                 66968 
                 69.4 
                 0.292 
               
               
                 8.659 
                 10.203 
                 242 
                 448 
                 8.9 
                 8198 
                 8.5 
                 0.311 
               
               
                 8.98 
                 9.8395 
                 223 
                 219 
                 4.3 
                 7649 
                 7.9 
                 0.594 
               
               
                 9.64 
                 9.1672 
                 251 
                 516 
                 10.2 
                 6969 
                 7.2 
                 0.23 
               
               
                 10.917 
                 8.0978 
                 210 
                 77 
                 1.5 
                 1041 
                 1.1 
                 0.23 
               
               
                 12.339 
                 7.1673 
                 220 
                 465 
                 9.2 
                 9572 
                 9.9 
                 0.35 
               
               
                 13.82 
                 6.4023 
                 268 
                 501 
                 9.9 
                 11493 
                 11.9 
                 0.39 
               
               
                 14.278 
                 6.1981 
                 271 
                 192 
                 3.8 
                 7288 
                 7.6 
                 0.645 
               
               
                 14.923 
                 5.9314 
                 288 
                 172 
                 3.4 
                 1636 
                 1.7 
                 0.162 
               
               
                 16.462 
                 5.3804 
                 310 
                 329 
                 6.5 
                 3066 
                 3.2 
                 0.158 
               
               
                 17.041 
                 5.199 
                 375 
                 105 
                 2.1 
                 942 
                 1 
                 0.153 
               
               
                 17.638 
                 5.0241 
                 435 
                 1073 
                 21.3 
                 13511 
                 14 
                 0.214 
               
               
                 18.281 
                 4.8488 
                 487 
                 772 
                 15.3 
                 9782 
                 10.1 
                 0.215 
               
               
                 19.52 
                 4.5437 
                 504 
                 1590 
                 31.5 
                 31949 
                 33.1 
                 0.342 
               
               
                 21.759 
                 4.081 
                 677 
                 5040 
                 100 
                 96504 
                 100 
                 0.326 
               
               
                 23.22 
                 3.8275 
                 693 
                 1457 
                 28.9 
                 28109 
                 29.1 
                 0.328 
               
               
                 25.12 
                 3.5421 
                 710 
                 3091 
                 61.3 
                 69330 
                 71.8 
                 0.381 
               
               
                 25.76 
                 3.4556 
                 455 
                 827 
                 16.4 
                 22029 
                 22.8 
                 0.453 
               
               
                 27.221 
                 3.2733 
                 419 
                 180 
                 3.6 
                 2915 
                 3 
                 0.275 
               
               
                 28.638 
                 3.1145 
                 409 
                 210 
                 4.2 
                 4338 
                 4.5 
                 0.351 
               
               
                 29.259 
                 3.0498 
                 461 
                 568 
                 11.3 
                 11998 
                 12.4 
                 0.359 
               
               
                 30.137 
                 2.9629 
                 409 
                 149 
                 3 
                 1946 
                 2 
                 0.222 
               
               
                 31.817 
                 2.8102 
                 253 
                 110 
                 2.2 
                 4034 
                 4.2 
                 0.623 
               
               
                 32.319 
                 2.7677 
                 245 
                 137 
                 2.7 
                 3829 
                 4 
                 0.475 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 15 
               
             
            
               
                   
               
               
                 XRD peaks of Form 4* 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 4.981 
                 17.7282 
                 270 
                 684 
                 15.8 
                 12231 
                 12.6 
                 0.304 
               
               
                 7.22 
                 12.2329 
                 244 
                 3416 
                 79 
                 65744 
                 67.8 
                 0.327 
               
               
                 8.459 
                 10.4447 
                 202 
                 335 
                 7.7 
                 4814 
                 5 
                 0.244 
               
               
                 10.56 
                 8.3707 
                 219 
                 629 
                 14.5 
                 10739 
                 11.1 
                 0.29 
               
               
                 11.42 
                 7.7419 
                 240 
                 203 
                 4.7 
                 2908 
                 3 
                 0.244 
               
               
                 12.42 
                 7.1209 
                 221 
                 614 
                 14.2 
                 11445 
                 11.8 
                 0.317 
               
               
                 13.019 
                 6.7947 
                 238 
                 59 
                 1.4 
                 423 
                 0.4 
                 0.122 
               
               
                 14.26 
                 6.2057 
                 227 
                 1052 
                 24.3 
                 20787 
                 21.4 
                 0.336 
               
               
                 16.318 
                 5.4274 
                 409 
                 85 
                 2 
                 665 
                 0.7 
                 0.133 
               
               
                 16.722 
                 5.2973 
                 332 
                 496 
                 11.5 
                 8980 
                 9.3 
                 0.308 
               
               
                 17.199 
                 5.1515 
                 393 
                 226 
                 5.2 
                 3448 
                 3.6 
                 0.259 
               
               
                 17.82 
                 4.9733 
                 402 
                 725 
                 16.8 
                 8502 
                 8.8 
                 0.199 
               
               
                 18.98 
                 4.672 
                 432 
                 1352 
                 31.3 
                 36895 
                 38.1 
                 0.464 
               
               
                 19.44 
                 4.5623 
                 439 
                 990 
                 22.9 
                 28546 
                 29.4 
                 0.49 
               
               
                 20.46 
                 4.3371 
                 444 
                 119 
                 2.8 
                 1163 
                 1.2 
                 0.166 
               
               
                 21.58 
                 4.1144 
                 458 
                 1982 
                 45.8 
                 71568 
                 73.8 
                 0.614 
               
               
                 22.22 
                 3.9974 
                 837 
                 4325 
                 100 
                 96937 
                 100 
                 0.381 
               
               
                 23.16 
                 3.8373 
                 758 
                 114 
                 2.6 
                 1085 
                 1.1 
                 0.162 
               
               
                 24.42 
                 3.6421 
                 522 
                 2466 
                 57 
                 48977 
                 50.5 
                 0.338 
               
               
                 25.679 
                 3.4663 
                 590 
                 252 
                 5.8 
                 5211 
                 5.4 
                 0.352 
               
               
                 26.5 
                 3.3607 
                 470 
                 671 
                 15.5 
                 23177 
                 23.9 
                 0.587 
               
               
                 26.95 
                 3.3056 
                 356 
                 313 
                 7.2 
                 3645 
                 3.8 
                 0.198 
               
               
                 28.118 
                 3.1709 
                 385 
                 255 
                 5.9 
                 5045 
                 5.2 
                 0.336 
               
               
                 29.9 
                 2.9858 
                 360 
                 383 
                 8.9 
                 13112 
                 13.5 
                 0.582 
               
               
                 30.421 
                 2.9359 
                 346 
                 239 
                 5.5 
                 5602 
                 5.8 
                 0.398 
               
               
                 31.779 
                 2.8134 
                 293 
                 336 
                 7.8 
                 5905 
                 6.1 
                 0.299 
               
               
                 32.618 
                 2.743 
                 267 
                 124 
                 2.9 
                 1934 
                 2 
                 0.265 
               
               
                   
               
            
           
         
       
     
     F. Forms 5 and 5* 
     The experiments that generated Forms 5 and 5* are shown in Table 16, below. XRD scans of Forms 5 and 5* were taken ( FIGS.  5 A and  5 D , respectively). The XRD peaks of Form 5 are shown in Table 17, below. A DSC scan of Form 5 was also performed and showed a wide endotherm between 50° C.-100° C., and multiple endotherms and exotherms before melting at 363° C. ( FIG.  5 B ). 
     A TGA scan of Form 5 solid showed a 3.1% weight loss before 100° C., followed by a 1.7% weight loss between 100° C. and 250° C. ( FIG.  5 C ). 
     Forms 5 and 5* were obtained from slurrying Form 12 in MtBE at RT and 50° C. Wet solid showed Form 5*, while dry solid indicated Form 5. 
     
       
         
           
               
             
               
                 TABLE 16 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Forms 5 and 5* 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 5 
                 MtBE 
                 RT 
                 Form 5* 
                 Form 5 
               
               
                 Form 5* 
                 MtBE 
                 RT 
                 Form 5* 
                 Form 5 
               
               
                   
                 MtBE 
                 50° C. 
                 Form 5* 
                 Form 4 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 17 
               
             
            
               
                   
               
               
                 XRD peaks of Form 5 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 5.098 
                 17.3185 
                 260 
                 155 
                 2.4 
                 2464 
                 2.1 
                 0.27 
               
               
                 6.38 
                 13.8428 
                 256 
                 1778 
                 27.7 
                 34733 
                 29.6 
                 0.332 
               
               
                 7.28 
                 12.1332 
                 214 
                 3964 
                 61.6 
                 78158 
                 66.5 
                 0.335 
               
               
                 8.518 
                 10.3715 
                 234 
                 241 
                 3.7 
                 3170 
                 2.7 
                 0.224 
               
               
                 9.24 
                 9.5627 
                 227 
                 472 
                 7.3 
                 6614 
                 5.6 
                 0.238 
               
               
                 10.639 
                 8.3083 
                 266 
                 765 
                 11.9 
                 20508 
                 17.5 
                 0.456 
               
               
                 11.019 
                 8.0226 
                 242 
                 1596 
                 24.8 
                 37620 
                 32 
                 0.401 
               
               
                 11.483 
                 7.6998 
                 398 
                 133 
                 2.1 
                 949 
                 0.8 
                 0.121 
               
               
                 12.44 
                 7.1091 
                 246 
                 584 
                 9.1 
                 11910 
                 10.1 
                 0.347 
               
               
                 12.94 
                 6.8358 
                 249 
                 152 
                 2.4 
                 4189 
                 3.6 
                 0.469 
               
               
                 14.301 
                 6.1883 
                 279 
                 1114 
                 17.3 
                 22226 
                 18.9 
                 0.339 
               
               
                 14.839 
                 5.9648 
                 300 
                 167 
                 2.6 
                 5989 
                 5.1 
                 0.61 
               
               
                 15.581 
                 5.6827 
                 404 
                 376 
                 5.8 
                 4045 
                 3.4 
                 0.183 
               
               
                 16.08 
                 5.5073 
                 452 
                 459 
                 7.1 
                 9013 
                 7.7 
                 0.334 
               
               
                 16.357 
                 5.4146 
                 509 
                 260 
                 4 
                 11967 
                 10.2 
                 0.782 
               
               
                 16.839 
                 5.2606 
                 521 
                 473 
                 7.4 
                 7195 
                 6.1 
                 0.259 
               
               
                 17.254 
                 5.1351 
                 550 
                 258 
                 4 
                 4373 
                 3.7 
                 0.288 
               
               
                 17.839 
                 4.968 
                 562 
                 414 
                 6.4 
                 4207 
                 3.6 
                 0.173 
               
               
                 18.439 
                 4.8078 
                 667 
                 590 
                 9.2 
                 5946 
                 5.1 
                 0.171 
               
               
                 19.059 
                 4.6527 
                 616 
                 1603 
                 24.9 
                 35964 
                 30.6 
                 0.381 
               
               
                 19.5 
                 4.5486 
                 671 
                 1163 
                 18.1 
                 30384 
                 25.9 
                 0.444 
               
               
                 20.882 
                 4.2506 
                 850 
                 305 
                 4.7 
                 2860 
                 2.4 
                 0.159 
               
               
                 21.679 
                 4.0959 
                 935 
                 2272 
                 35.3 
                 66194 
                 56.4 
                 0.495 
               
               
                 22.28 
                 3.9867 
                 1083 
                 6430 
                 100 
                 117449 
                 100 
                 0.311 
               
               
                 23.221 
                 3.8273 
                 856 
                 564 
                 8.8 
                 9429 
                 8 
                 0.284 
               
               
                 24.461 
                 3.6361 
                 697 
                 4250 
                 66.1 
                 74709 
                 63.6 
                 0.299 
               
               
                 25.276 
                 3.5206 
                 726 
                 170 
                 2.6 
                 1349 
                 1.1 
                 0.135 
               
               
                 26.081 
                 3.4137 
                 756 
                 442 
                 6.9 
                 17518 
                 14.9 
                 0.674 
               
               
                 26.52 
                 3.3582 
                 689 
                 1014 
                 15.8 
                 34615 
                 29.5 
                 0.58 
               
               
                 28.139 
                 3.1686 
                 528 
                 306 
                 4.8 
                 4846 
                 4.1 
                 0.269 
               
               
                 28.821 
                 3.0952 
                 533 
                 463 
                 7.2 
                 7067 
                 6 
                 0.259 
               
               
                 29.94 
                 2.9819 
                 499 
                 755 
                 11.7 
                 15565 
                 13.3 
                 0.35 
               
               
                 30.458 
                 2.9324 
                 435 
                 467 
                 7.3 
                 9861 
                 8.4 
                 0.359 
               
               
                 31.86 
                 2.8065 
                 343 
                 648 
                 10.1 
                 13697 
                 11.7 
                 0.359 
               
               
                 32.642 
                 2.741 
                 314 
                 125 
                 1.9 
                 2403 
                 2 
                 0.327 
               
               
                 34.002 
                 2.6344 
                 298 
                 123 
                 1.9 
                 1956 
                 1.7 
                 0.27 
               
               
                   
               
            
           
         
       
     
     G. Form 6 
     The experiments that generated Form 6 are shown in Table 18, below. XRD and DSC scans of Form 6 were taken ( FIGS.  6 A and  6 B , respectively). According to the DSC scan, the solid showed a small exotherm at 250° C. and a sharp melting endotherm at 358° C. 
     Form 6 was obtained by slurrying starting material in IPA and IPA/5% water at RT and 50° C. 
     
       
         
           
               
             
               
                 TABLE 18 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Form 6 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 6 
                 IPA 
                 RT 
                 Form 6 
                 Form 6 
               
               
                   
                 IPA 
                 50° C. 
                 Form 6 
                 Form 6 
               
               
                   
                 IPA/water 
                 RT 
                 Form 6 
                 Form 6 
               
               
                   
                 IPA/water 
                 50° C. 
                 Form 6 
                 Form 6 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     H. Form 7 
     The experiments that generated Form 7 are shown in Table 19, below. XRD and DSC scans of Form 7 were taken ( FIGS.  7 A and  7 B , respectively). The XRD peaks of Form 7 are shown in Table 20, below. According to the DSC scan, the solid showed two exotherms at 227° C. and 299° C., followed by a melting endotherm at 365° C. Form 7 showed low degree of crystallinity on XRD. The double exotherm on the DSC scans may be associated with the low crystallinity observed on the XRD scan. 
     A TGA scan of Form 7 solid showed a 12% weight loss before 200° C. ( FIG.  7 C ). 
     Form 7 was obtained from MEK and MEK/5% water at RT and 50° C. 
     
       
         
           
               
             
               
                 TABLE 19 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Form 7 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 7 
                 MEK 
                 RT 
                 Form 7 
                 Form 7 
               
               
                   
                 MEK 
                 50° C. 
                 Form 7 
                 Form 7 
               
               
                   
                 MEK/water 
                 RT 
                 Form 7 
                 Form 7 
               
               
                   
                 MEK/water 
                 50° C. 
                 Form 7 
                 Form 7 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 20 
               
             
            
               
                   
               
               
                 XRD peaks of Form 7 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 4.94 
                 17.8745 
                 362 
                 1384 
                 23.3 
                 50829 
                 29.2 
                 0.624 
               
               
                 7.06 
                 12.5111 
                 286 
                 3171 
                 53.3 
                 69159 
                 39.8 
                 0.371 
               
               
                 8.759 
                 10.0876 
                 370 
                 628 
                 10.6 
                 9606 
                 5.5 
                 0.26 
               
               
                 9.9 
                 8.9272 
                 429 
                 537 
                 9 
                 11110 
                 6.4 
                 0.352 
               
               
                 10.881 
                 8.1241 
                 546 
                 879 
                 14.8 
                 16425 
                 9.4 
                 0.318 
               
               
                 11.84 
                 7.4681 
                 588 
                 413 
                 6.9 
                 7187 
                 4.1 
                 0.296 
               
               
                 12.997 
                 6.8061 
                 463 
                 135 
                 2.3 
                 1351 
                 0.8 
                 0.17 
               
               
                 14.404 
                 6.1442 
                 604 
                 126 
                 2.1 
                 3331 
                 1.9 
                 0.449 
               
               
                 15.1 
                 5.8626 
                 791 
                 596 
                 10 
                 8819 
                 5.1 
                 0.252 
               
               
                 15.92 
                 5.5622 
                 792 
                 593 
                 10 
                 24460 
                 14.1 
                 0.701 
               
               
                 16.581 
                 5.3421 
                 739 
                 641 
                 10.8 
                 14919 
                 8.6 
                 0.396 
               
               
                 18.5 
                 4.7919 
                 1066 
                 1555 
                 26.1 
                 43174 
                 24.8 
                 0.472 
               
               
                 19.4 
                 4.5717 
                 1087 
                 930 
                 15.6 
                 17521 
                 10.1 
                 0.32 
               
               
                 20.382 
                 4.3535 
                 1178 
                 154 
                 2.6 
                 867 
                 0.5 
                 0.096 
               
               
                 21.56 
                 4.1183 
                 1424 
                 5949 
                 100 
                 173972 
                 100 
                 0.497 
               
               
                 22.098 
                 4.0192 
                 1830 
                 692 
                 11.6 
                 17678 
                 10.2 
                 0.434 
               
               
                 23.22 
                 3.8275 
                 1749 
                 1971 
                 33.1 
                 42151 
                 24.2 
                 0.364 
               
               
                 24.203 
                 3.6743 
                 1776 
                 351 
                 5.9 
                 11935 
                 6.9 
                 0.578 
               
               
                 24.884 
                 3.5751 
                 1658 
                 271 
                 4.6 
                 2378 
                 1.4 
                 0.149 
               
               
                 25.759 
                 3.4556 
                 1416 
                 492 
                 8.3 
                 19894 
                 11.4 
                 0.687 
               
               
                 26.3 
                 3.3858 
                 1335 
                 499 
                 8.4 
                 23631 
                 13.6 
                 0.805 
               
               
                 27.34 
                 3.2594 
                 1192 
                 307 
                 5.2 
                 4494 
                 2.6 
                 0.249 
               
               
                 28.641 
                 3.1142 
                 1004 
                 382 
                 6.4 
                 18030 
                 10.4 
                 0.802 
               
               
                 29.078 
                 3.0684 
                 979 
                 324 
                 5.4 
                 14234 
                 8.2 
                 0.747 
               
               
                 30.28 
                 2.9492 
                 759 
                 711 
                 12 
                 16004 
                 9.2 
                 0.383 
               
               
                 31.985 
                 2.7959 
                 551 
                 111 
                 1.9 
                 4816 
                 2.8 
                 0.738 
               
               
                 33.402 
                 2.6804 
                 509 
                 102 
                 1.7 
                 2060 
                 1.2 
                 0.343 
               
               
                 34.24 
                 2.6167 
                 474 
                 92 
                 1.5 
                 1901 
                 1.1 
                 0.351 
               
               
                   
               
            
           
         
       
     
     I. Form 8 
     The experiments that generated Form 8 are shown in Table 21, below. XRD and DSC scans of Form 8 were taken ( FIGS.  8 A and  8 B , respectively). The XRD peaks of Form 8 are shown in Table 22, below. According to the DSC scan, the solid showed two endotherms at 205° C. and 231° C., followed by an exotherm at 279° C., followed by a melting endotherm at 362° C. Form 8 showed a low degree of crystallinity on the XRD scan. The double exotherm on the DSC scan may confirm the low crystallinity seen on XRD (low crystalline material convert to higher crystallinity solid). 
     A TGA scan of Form 8 showed a 4.2% weight loss before 190° C., followed by a 3.9% weight loss between 190° C. and 261° C. ( FIG.  8 C ). 
     Form 8 was obtained from MIBK at RT and 50° C. MIBK/5% water reslurry does not produce the same form. 
     
       
         
           
               
             
               
                 TABLE 21 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Form 8 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 8 
                 MIBK 
                 RT 
                 Form 8 
                 Form 8 
               
               
                   
                 MIBK 
                 50° C. 
                 Form 8 
                 Form 8 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 22 
               
             
            
               
                   
               
               
                 XRD peaks of Form 8 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 6.88 
                 12.8368 
                 318 
                 2815 
                 80.8 
                 71578 
                 51.7 
                 0.432 
               
               
                 10.699 
                 8.2619 
                 380 
                 70 
                 2 
                 722 
                 0.5 
                 0.175 
               
               
                 11.48 
                 7.7016 
                 344 
                 466 
                 13.4 
                 9513 
                 6.9 
                 0.347 
               
               
                 12.66 
                 6.9866 
                 348 
                 136 
                 3.9 
                 1759 
                 1.3 
                 0.22 
               
               
                 14.16 
                 6.2496 
                 435 
                 166 
                 4.8 
                 3298 
                 2.4 
                 0.338 
               
               
                 15.259 
                 5.8017 
                 483 
                 269 
                 7.7 
                 6267 
                 4.5 
                 0.396 
               
               
                 16.879 
                 5.2484 
                 669 
                 333 
                 9.6 
                 7638 
                 5.5 
                 0.39 
               
               
                 17.681 
                 5.0121 
                 780 
                 1959 
                 56.2 
                 76035 
                 54.9 
                 0.66 
               
               
                 19.618 
                 4.5213 
                 833 
                 134 
                 3.8 
                 2110 
                 1.5 
                 0.268 
               
               
                 21.5 
                 4.1296 
                 1116 
                 3484 
                 100 
                 138450 
                 100 
                 0.676 
               
               
                 24.244 
                 3.6682 
                 899 
                 99 
                 2.8 
                 2643 
                 1.9 
                 0.454 
               
               
                 27.559 
                 3.234 
                 753 
                 366 
                 10.5 
                 11182 
                 8.1 
                 0.519 
               
               
                 28.881 
                 3.0889 
                 636 
                 279 
                 8 
                 8137 
                 5.9 
                 0.496 
               
               
                 30.878 
                 2.8935 
                 403 
                 87 
                 2.5 
                 1890 
                 1.4 
                 0.369 
               
               
                 31.221 
                 2.8624 
                 386 
                 69 
                 2 
                 1898 
                 1.4 
                 0.468 
               
               
                   
               
            
           
         
       
     
     J. Form 9 
     The experiments that generated Form 9 are shown in Table 23, below. XRD and DSC scans of Form 9 were taken ( FIGS.  9 A and  9 B , respectively). The XRD peaks of Form 9 are shown in Table 24, below. According to the DSC scan, the solid showed a single melting endotherm at 364° C. Form 9 has a primitive monoclinic crystal structure with the approximate dimensions: a [Å]=17.135, b [Å]=14.342, c [Å]=10.186; α(deg)=90, β(deg)=95.99, γ(deg)=90 and an approximate volume cell of [Å 3 /cell]=2,489.5 and a space group defined as P2 1 /c (14). 
     A TGA scan of Form 9 showed a 0.28% weight loss before 100° C. ( FIG.  9 C ). 
     Other forms, when heated to just before melting at 364° C., seemed to convert to Form 9. This has been confirmed for Forms 1 and 2. 
     A DVS scan of Form 9 showed a 0.8% water absorption at 90% RH. Form 9 did not change its form before and after the DVS scan ( FIG.  9 D ). 
     
       
         
           
               
             
               
                 TABLE 23 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Form 9 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                   
                 n-Butanol 
                 RT 
                 Form 9 
                 Form 9 
               
               
                 Form 9 
                 IPAc 
                 50° C. 
                 Form 9 
                 Form 9 
               
               
                   
                 n-Butyl acetate  
                 50° C. 
                 Form 9 
                 Form 9 
               
               
                   
                 n-Butanol 
                 50° C. 
                 Form 9 
                 Form 9 
               
               
                   
                 EtOH/water 
                 50° C. 
                 Form 9 
                 Form 9 
               
               
                   
                 n- 
                 50° C. 
                 Form 9 
                 Form 9 
               
               
                   
                 Propanol/water 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 24 
               
             
            
               
                   
               
               
                 XRD peaks of Form 9 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 4.94 
                 17.8746 
                 21 
                 895 
                 100 
                 23398 
                 100 
                 0.444 
               
               
                 6.26 
                 14.1076 
                 21 
                 34 
                 3.8 
                 513 
                 2.2 
                 0.257 
               
               
                 10.099 
                 8.7516 
                 28 
                 66 
                 7.4 
                 1172 
                 5 
                 0.302 
               
               
                 11.883 
                 7.4413 
                 30 
                 46 
                 5.1 
                 828 
                 3.5 
                 0.306 
               
               
                 13.16 
                 6.7221 
                 27 
                 37 
                 4.1 
                 400 
                 1.7 
                 0.184 
               
               
                 15.341 
                 5.771 
                 39 
                 71 
                 7.9 
                 1541 
                 6.6 
                 0.369 
               
               
                 16.518 
                 5.3622 
                 40 
                 93 
                 10.4 
                 1728 
                 7.4 
                 0.316 
               
               
                 18.622 
                 4.7608 
                 46 
                 260 
                 29.1 
                 7069 
                 30.2 
                 0.462 
               
               
                 19.74 
                 4.4938 
                 80 
                 138 
                 15.4 
                 1937 
                 8.3 
                 0.239 
               
               
                 21.101 
                 4.2068 
                 64 
                 342 
                 38.2 
                 8314 
                 35.5 
                 0.413 
               
               
                 22.42 
                 3.9622 
                 56 
                 77 
                 8.6 
                 1721 
                 7.4 
                 0.38 
               
               
                 24.1 
                 3.6897 
                 58 
                 198 
                 22.1 
                 3904 
                 16.7 
                 0.335 
               
               
                 25.2 
                 3.5311 
                 63 
                 157 
                 17.5 
                 3615 
                 15.5 
                 0.391 
               
               
                 26.897 
                 3.312 
                 46 
                 44 
                 4.9 
                 1307 
                 5.6 
                 0.505 
               
               
                 28.577 
                 3.121 
                 35 
                 54 
                 6 
                 1754 
                 7.5 
                 0.552 
               
               
                 29.884 
                 2.9874 
                 32 
                 30 
                 3.4 
                 477 
                 2 
                 0.254 
               
               
                 30.926 
                 2.8891 
                 35 
                 32 
                 3.6 
                 682 
                 2.9 
                 0.341 
               
               
                   
               
            
           
         
       
     
     K. Forms 10 and 10* 
     The experiments that generated Forms 10 and 10* are shown in Table 25, below. XRD scans of Forms 10 and 10* were taken ( FIGS.  10 A and  10 D , respectively). The XRD peaks of Form 10 are shown in Table 26, below. DSC scans of Forms 10 and 10* were also taken and indicated multiple endotherms/exotherms, followed by melting at 367° C. ( FIGS.  10 B and  10 E , respectively). 
     Forms 10 and 10* were produced by drying of amorphous solids (obtained from DMSO and DMSO/water reslurry at RT and 50° C.). Both Form 10 and 10* are associated with DMSO. 
     A TGA scan of Form 10 solid showed a 0.6% weight loss before 100° C., followed by a 3.8% weight loss between 100° C. and 170° C., followed by a 7.1% weight loss between 170° C. and 260° C. ( FIG.  10 C ). 
     
       
         
           
               
             
               
                 TABLE 25 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Forms 10 and 10* 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 10 
                 DMSO 
                 RT 
                 amorphous 
                 Form 10 
               
               
                   
                 DMSO/water 
                 RT 
                 amorphous 
                 Form 10 
               
               
                   
                 DMSO/water 
                 50° C. 
                 amorphous 
                 Form 10 
               
               
                 Form 10* 
                 DMSO 
                 50° C. 
                 amorphous 
                 Form 10* 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 26 
               
             
            
               
                   
               
               
                 XRD peaks of Form 10 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 6.701 
                 13.1792 
                 148 
                 1553 
                 32.1 
                 31364 
                 34.4 
                 0.343 
               
               
                 8.3 
                 10.6444 
                 207 
                 1026 
                 21.2 
                 17914 
                 19.6 
                 0.297 
               
               
                 9.38 
                 9.4203 
                 212 
                 1352 
                 27.9 
                 21528 
                 23.6 
                 0.271 
               
               
                 10.819 
                 8.1705 
                 223 
                 514 
                 10.6 
                 8714 
                 9.6 
                 0.288 
               
               
                 11.919 
                 7.4192 
                 271 
                 635 
                 13.1 
                 9435 
                 10.3 
                 0.253 
               
               
                 12.919 
                 6.8469 
                 266 
                 1160 
                 24 
                 22094 
                 24.2 
                 0.324 
               
               
                 13.718 
                 6.45 
                 242 
                 81 
                 1.7 
                 856 
                 0.9 
                 0.18 
               
               
                 14.84 
                 5.9646 
                 271 
                 244 
                 5 
                 4716 
                 5.2 
                 0.329 
               
               
                 15.536 
                 5.6988 
                 312 
                 147 
                 3 
                 1304 
                 1.4 
                 0.151 
               
               
                 16.58 
                 5.3424 
                 392 
                 1813 
                 37.5 
                 30451 
                 33.4 
                 0.286 
               
               
                 17.821 
                 4.9731 
                 434 
                 2208 
                 45.6 
                 58342 
                 64 
                 0.449 
               
               
                 18.16 
                 4.881 
                 434 
                 2862 
                 59.2 
                 89029 
                 97.6 
                 0.529 
               
               
                 19.001 
                 4.6667 
                 1021 
                 3215 
                 66.5 
                 45840 
                 50.2 
                 0.242 
               
               
                 19.88 
                 4.4623 
                 1163 
                 1454 
                 30.1 
                 19014 
                 20.8 
                 0.222 
               
               
                 20.701 
                 4.2873 
                 1514 
                 4838 
                 100 
                 78140 
                 85.7 
                 0.275 
               
               
                 21.66 
                 4.0994 
                 596 
                 4067 
                 84.1 
                 91229 
                 100 
                 0.381 
               
               
                 23.38 
                 3.8017 
                 596 
                 2251 
                 46.5 
                 64928 
                 71.2 
                 0.49 
               
               
                 24.22 
                 3.6717 
                 663 
                 4578 
                 94.6 
                 84228 
                 92.3 
                 0.313 
               
               
                 26 
                 3.4242 
                 595 
                 430 
                 8.9 
                 11172 
                 12.2 
                 0.442 
               
               
                 27.12 
                 3.2853 
                 639 
                 146 
                 3 
                 1986 
                 2.2 
                 0.231 
               
               
                 27.88 
                 3.1974 
                 642 
                 2073 
                 42.8 
                 48132 
                 52.8 
                 0.395 
               
               
                 28.88 
                 3.089 
                 638 
                 477 
                 9.9 
                 14155 
                 15.5 
                 0.504 
               
               
                 29.867 
                 2.9891 
                 544 
                 205 
                 4.2 
                 4572 
                 5 
                 0.379 
               
               
                 30.32 
                 2.9454 
                 528 
                 568 
                 11.7 
                 11936 
                 13.1 
                 0.357 
               
               
                 31.098 
                 2.8735 
                 517 
                 443 
                 9.2 
                 5841 
                 6.4 
                 0.224 
               
               
                 31.661 
                 2.8236 
                 433 
                 118 
                 2.4 
                 953 
                 1 
                 0.137 
               
               
                 33.379 
                 2.6822 
                 433 
                 311 
                 6.4 
                 9235 
                 10.1 
                 0.505 
               
               
                 34.22 
                 2.6181 
                 444 
                 281 
                 5.8 
                 6059 
                 6.6 
                 0.367 
               
               
                 34.822 
                 2.5743 
                 460 
                 84 
                 1.7 
                 2707 
                 3 
                 0.548 
               
               
                 35.438 
                 2.5309 
                 465 
                 89 
                 1.8 
                 858 
                 0.9 
                 0.164 
               
               
                   
               
            
           
         
       
     
     L. Forms 11 and 11* 
     The experiments that generated Forms 11 and 11* are shown in Table 27, below. XRD scans of Forms 11 and 11* were taken ( FIGS.  11 A and  11 D , respectively). The XRD peaks of Form 11 and Form 11* are shown in Tables 28 and 29, below, respectively. DSC scans of Forms 11 and 11* were also taken ( FIGS.  11 B and  11 E , respectively). According to the DSC scans, the solid showed multiple endotherms/exotherms and eventually melted at 368° C. Amorphous halo was observed in the XRD of both Forms. The double exotherm on the DSC of both forms may be also associated with the amorphous halo observed on XRD scans. 
     TGA scans of Form 11 and 11* were taken ( FIGS.  11 C and  11 F , respectively). Form 11 solids showed a 0.8% weight loss before 100° C., followed by a 7.0% weight loss between 100° C. and 249° C. Form 11* solids showed a 1.0% weight loss before 100° C., and followed by a 7.0% weight loss before 250° C. 
     Forms 11 and 11* were obtained from DMF and DMF/5% water at RT and 50° C. 
     
       
         
           
               
             
               
                 TABLE 27 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Forms 11 and 11* 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 11 
                 DMF 
                 RT 
                 Form 11 
                 Form 11 
               
               
                   
                 DMF 
                 50° C. 
                 Form 11 
                 Form 11* 
               
               
                   
                 DMF/water 
                 RT 
                 Form 11 
                 Form 11 
               
               
                   
                 DMF/water 
                 50° C. 
                 Form 11 
                 Form 11 
               
               
                 Form 11* 
                 DMF 
                 50° C. 
                 Form 11 
                 Form 11* 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 28 
               
             
            
               
                   
               
               
                 XRD peaks of Form 11 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 6.42 
                 13.7554 
                 19 
                 496 
                 81.7 
                 9502 
                 100 
                 0.326 
               
               
                 8.421 
                 10.4908 
                 20 
                 335 
                 55.2 
                 5775 
                 60.8 
                 0.293 
               
               
                 8.86 
                 9.9726 
                 24 
                 166 
                 27.3 
                 4268 
                 44.9 
                 0.437 
               
               
                 10.859 
                 8.1404 
                 21 
                 91 
                 15 
                 1292 
                 13.6 
                 0.241 
               
               
                 12.479 
                 7.0871 
                 44 
                 83 
                 13.7 
                 1004 
                 10.6 
                 0.206 
               
               
                 12.977 
                 6.8165 
                 29 
                 51 
                 8.4 
                 1542 
                 16.2 
                 0.514 
               
               
                 14.519 
                 6.0957 
                 28 
                 91 
                 15 
                 1421 
                 15 
                 0.265 
               
               
                 16.801 
                 5.2727 
                 57 
                 104 
                 17.1 
                 2226 
                 23.4 
                 0.364 
               
               
                 17.801 
                 4.9787 
                 103 
                 358 
                 59 
                 5109 
                 53.8 
                 0.243 
               
               
                 18.519 
                 4.7871 
                 101 
                 607 
                 100 
                 8460 
                 89 
                 0.237 
               
               
                 18.861 
                 4.7011 
                 102 
                 125 
                 20.6 
                 1763 
                 18.6 
                 0.24 
               
               
                 19.922 
                 4.453 
                 85 
                 383 
                 63.1 
                 7376 
                 77.6 
                 0.327 
               
               
                 20.258 
                 4.38 
                 79 
                 180 
                 29.7 
                 5778 
                 60.8 
                 0.546 
               
               
                 20.899 
                 4.247 
                 76 
                 105 
                 17.3 
                 1291 
                 13.6 
                 0.209 
               
               
                 21.738 
                 4.085 
                 86 
                 55 
                 9.1 
                 757 
                 8 
                 0.234 
               
               
                 22.441 
                 3.9585 
                 94 
                 471 
                 77.6 
                 7125 
                 75 
                 0.257 
               
               
                 22.859 
                 3.8871 
                 78 
                 167 
                 27.5 
                 3724 
                 39.2 
                 0.379 
               
               
                 24.458 
                 3.6365 
                 60 
                 298 
                 49.1 
                 4544 
                 47.8 
                 0.259 
               
               
                 26.82 
                 3.3213 
                 45 
                 195 
                 32.1 
                 4777 
                 50.3 
                 0.416 
               
               
                 29 
                 3.0764 
                 43 
                 99 
                 16.3 
                 3112 
                 32.8 
                 0.534 
               
               
                 29.524 
                 3.023 
                 63 
                 37 
                 6.1 
                 190 
                 2 
                 0.087 
               
               
                 31.04 
                 2.8788 
                 38 
                 46 
                 7.6 
                 826 
                 8.7 
                 0.305 
               
               
                 31.825 
                 2.8095 
                 36 
                 56 
                 9.2 
                 737 
                 7.8 
                 0.224 
               
               
                 32.456 
                 2.7563 
                 31 
                 40 
                 6.6 
                 857 
                 9 
                 0.364 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 29 
               
             
            
               
                   
               
               
                 XRD peaks of Form 11* 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 6.441 
                 13.7116 
                 24 
                 424 
                 93.4 
                 8643 
                 100 
                 0.347 
               
               
                 6.944 
                 12.7196 
                 20 
                 84 
                 18.5 
                 2078 
                 24 
                 0.421 
               
               
                 8.518 
                 10.3718 
                 22 
                 227 
                 50 
                 4871 
                 56.4 
                 0.365 
               
               
                 8.86 
                 9.9721 
                 23 
                 147 
                 32.4 
                 3581 
                 41.4 
                 0.414 
               
               
                 10.859 
                 8.141 
                 26 
                 107 
                 23.6 
                 1695 
                 19.6 
                 0.269 
               
               
                 12.519 
                 7.0648 
                 34 
                 90 
                 19.8 
                 2165 
                 25 
                 0.409 
               
               
                 13.021 
                 6.7935 
                 31 
                 54 
                 11.9 
                 1517 
                 17.6 
                 0.478 
               
               
                 14.618 
                 6.0547 
                 32 
                 76 
                 16.7 
                 1605 
                 18.6 
                 0.359 
               
               
                 16.638 
                 5.3238 
                 55 
                 115 
                 25.3 
                 2410 
                 27.9 
                 0.356 
               
               
                 17.838 
                 4.9684 
                 71 
                 368 
                 81.1 
                 6709 
                 77.6 
                 0.31 
               
               
                 18.522 
                 4.7864 
                 130 
                 454 
                 100 
                 7473 
                 86.5 
                 0.28 
               
               
                 19.96 
                 4.4447 
                 109 
                 315 
                 69.4 
                 6433 
                 74.4 
                 0.347 
               
               
                 20.26 
                 4.3795 
                 109 
                 146 
                 32.2 
                 5359 
                 62 
                 0.624 
               
               
                 20.904 
                 4.2461 
                 127 
                 58 
                 12.8 
                 559 
                 6.5 
                 0.164 
               
               
                 21.639 
                 4.1034 
                 142 
                 194 
                 42.7 
                 4690 
                 54.3 
                 0.411 
               
               
                 22.441 
                 3.9586 
                 161 
                 368 
                 81.1 
                 5409 
                 62.6 
                 0.25 
               
               
                 22.94 
                 3.8735 
                 78 
                 150 
                 33 
                 6057 
                 70.1 
                 0.686 
               
               
                 23.398 
                 3.7988 
                 78 
                 116 
                 25.6 
                 2330 
                 27 
                 0.341 
               
               
                 24.44 
                 3.6391 
                 75 
                 305 
                 67.2 
                 5097 
                 59 
                 0.284 
               
               
                 26.819 
                 3.3215 
                 68 
                 206 
                 45.4 
                 4795 
                 55.5 
                 0.396 
               
               
                 29.018 
                 3.0745 
                 56 
                 109 
                 24 
                 4093 
                 47.4 
                 0.638 
               
               
                 29.566 
                 3.0188 
                 82 
                 43 
                 9.5 
                 341 
                 3.9 
                 0.135 
               
               
                 31.022 
                 2.8804 
                 58 
                 55 
                 12.1 
                 509 
                 5.9 
                 0.157 
               
               
                 31.881 
                 2.8047 
                 49 
                 48 
                 10.6 
                 482 
                 5.6 
                 0.171 
               
               
                 32.338 
                 2.7661 
                 42 
                 50 
                 11 
                 1360 
                 15.7 
                 0.462 
               
               
                   
               
            
           
         
       
     
     Additional experiments with Form 1 of a compound of Formula (I) showed that when Form 1 was exposed to moisture ( FIGS.  15 A- 15 D ), Form 1 formed non-stoichiometric or stoichiometric hydrates. The crystal lattice of Form 1 expanded when water was sorbed, giving rise to XRD peaks at ˜5, ˜7 and ˜11 degrees while maintaining the main XRD pattern. The hydrates of Form 1 of a compound of Formula (I) (Form 11) were fully reversible, and lost water when exposed to % RH of less than 20%, turning Form 11 to hydrated forms of Form 1 and to the anhydrous Form 1. 
     M. Form 13 and Form 12 
     The experiments that generated Form 13 and Form 12 are shown in Tables 30 and 32, below, respectively. Forms 12 and 13 are examples of non-stoichiometric hydrates of Form 1 that have between 1% and about 20% by weight water. XRD scans of Form 13 and Form 12 were taken ( FIGS.  13 A and  12 A , respectively). The XRD peaks of Form 13 are shown in Table 31, below. DSC scans of Form 13 and Form 12 were also taken ( FIGS.  13 B and  12 B , respectively). According to the DSC scan, Form 13 solids showed a wide endotherm between 50° C.-100° C., followed by a small exotherm at 278° C.; and a melting endotherm at 363° C. According to the DSC scan, Form 12 solids showed a wide endotherm between 50° C.-100° C., followed by a sharp exotherm at 283° C.; and a melting endotherm at 364° C. 
     The purity of the Form 13 sample was 98.8%; the KF of an undried Form 13 sample was 35.7%. A DVS scan of Form 13 solid showed a 17% water sorption at 90% RH ( FIG.  13 D ). Form 13 converted to Form 1 upon drying. 
     A TGA scan of Form 13 solid showed a 1.9% weight loss before 100° C. ( FIG.  13 C ). 
     Form 13 solid was heated in a DSC chamber to 170° C. (past the endotherm between 50-100° C.), and then scanned by XRD. A comparison of the first and the second XRD and DSC scans, after heating to 170° C., showed that Form 13 converted to Form 1. It can be concluded that the endotherm between 50-100° C. is due to bonded water. 
     Form 13 has a primitive orthorhombic crystal structure with the approximate dimensions: a [Å]=33.759, b [Å]=22.590, c [Å]=7.386 and an approximate volume cell of [Å 3 /cell]=5,632.5 and a space group defined as Pbca(61). 
     Form 13 solid was heated in a DSC chamber to 330° C. (past the endotherm/exotherm around 300° C.), and then scanned by XRD. A comparison of the first and the third XRD and DSC scans, after heating to 170° C., showed that Form 13 converted to Form 9. It can be concluded that the endotherm/exotherm is due to melting/crystallization events. 
     
       
         
           
               
             
               
                 TABLE 30 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Form 13 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 13 
                 MeOH 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 MeOH/water 
                 50° C. 
                 Form 13 
                 Form 13 
               
               
                   
                 water 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 water 
                 50° C. 
                 Form 13 
                 Form 13 
               
               
                   
                 Toluene/water 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 Toluene/water 
                 50° C. 
                 Form 13 
                 Form 13 
               
               
                   
                 MA/water 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 n-Butyl 
                 RT 
                 Form 13 
                 Form 12 
               
               
                   
                 acetate/water 
                   
                   
                   
               
               
                   
                 n-Butyl 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
                 acetate/water 
                   
                   
                   
               
               
                   
                 Heptane 
                 50° C. 
                 Form 13 
                 Form 13 
               
               
                   
                 Heptane/water 
                 RT 
                 Form 13 
                 Form 12 
               
               
                   
                 Heptane/water 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
                 n-Butanol/water 
                 RT 
                 Form 13 
                 Form 13 
               
               
                   
                 n-Butanol/water 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
                 DCM 
                 50° C. 
                 Form 13 
                 Form 13 
               
               
                   
                 DCM/water 
                 RT 
                 Form 13 
                 Form 1 
               
               
                   
                 DCM/water 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
                 Acetonitrile/water 
                 50° C. 
                 Form 13 
                 Form 13 
               
               
                   
                 IPAc/water 
                 50° C. 
                 Form 13 
                 Form 13 
               
               
                   
                 MtBE/water 
                 50° C. 
                 Form 13 
                 Form 13 
               
               
                   
                 MIBK/water 
                 50° C. 
                 Form 13 
                 Form 1 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 31 
               
             
            
               
                   
               
               
                 XRD peaks of Form 13 
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 2-Theta 
                 d(A) 
                 BG 
                 Height 
                 I % 
                 Area 
                 I % 
                 FWHM 
               
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
            
               
                 5.06 
                 17.45 
                 278 
                 309 
                 6.5 
                 3685 
                 4.8 
                 0.203 
               
               
                 6.379 
                 13.8451 
                 223 
                 4743 
                 100 
                 76110 
                 100 
                 0.273 
               
               
                 9.24 
                 9.5632 
                 164 
                 1370 
                 28.9 
                 20018 
                 26.3 
                 0.248 
               
               
                 11 
                 8.0364 
                 173 
                 3445 
                 72.6 
                 51777 
                 68 
                 0.256 
               
               
                 12.899 
                 6.8574 
                 195 
                 173 
                 3.6 
                 3114 
                 4.1 
                 0.306 
               
               
                 13.462 
                 6.572 
                 199 
                 204 
                 4.3 
                 2376 
                 3.1 
                 0.198 
               
               
                 14.159 
                 6.2498 
                 202 
                 390 
                 8.2 
                 5424 
                 7.1 
                 0.236 
               
               
                 15.56 
                 5.6901 
                 262 
                 1335 
                 28.1 
                 19295 
                 25.4 
                 0.246 
               
               
                 16.059 
                 5.5145 
                 302 
                 1002 
                 21.1 
                 17561 
                 23.1 
                 0.298 
               
               
                 16.841 
                 5.26 
                 313 
                 774 
                 16.3 
                 7797 
                 10.2 
                 0.171 
               
               
                 17.46 
                 5.075 
                 322 
                 314 
                 6.6 
                 3863 
                 5.1 
                 0.209 
               
               
                 18.419 
                 4.8128 
                 339 
                 2354 
                 49.6 
                 29374 
                 38.6 
                 0.212 
               
               
                 19.3 
                 4.5951 
                 357 
                 210 
                 4.4 
                 8112 
                 10.7 
                 0.657 
               
               
                 19.741 
                 4.4935 
                 329 
                 1566 
                 33 
                 30236 
                 39.7 
                 0.328 
               
               
                 20.202 
                 4.3919 
                 342 
                 210 
                 4.4 
                 2880 
                 3.8 
                 0.233 
               
               
                 20.84 
                 4.2589 
                 300 
                 1054 
                 22.2 
                 18033 
                 23.7 
                 0.291 
               
               
                 21.201 
                 4.1873 
                 284 
                 964 
                 20.3 
                 15700 
                 20.6 
                 0.277 
               
               
                 22.121 
                 4.015 
                 259 
                 197 
                 4.2 
                 2208 
                 2.9 
                 0.191 
               
               
                 23.2 
                 3.8307 
                 268 
                 482 
                 10.2 
                 7844 
                 10.3 
                 0.277 
               
               
                 24.42 
                 3.642 
                 280 
                 1101 
                 23.2 
                 16244 
                 21.3 
                 0.251 
               
               
                 24.839 
                 3.5816 
                 303 
                 468 
                 9.9 
                 9306 
                 12.2 
                 0.338 
               
               
                 25.219 
                 3.5284 
                 385 
                 1093 
                 23 
                 16646 
                 21.9 
                 0.259 
               
               
                 26.164 
                 3.4032 
                 359 
                 357 
                 7.5 
                 5064 
                 6.7 
                 0.241 
               
               
                 26.499 
                 3.3609 
                 402 
                 317 
                 6.7 
                 7316 
                 9.6 
                 0.392 
               
               
                 26.798 
                 3.324 
                 346 
                 179 
                 3.8 
                 8025 
                 10.5 
                 0.762 
               
               
                 27.339 
                 3.2594 
                 394 
                 720 
                 15.2 
                 13063 
                 17.2 
                 0.308 
               
               
                 27.639 
                 3.2247 
                 341 
                 318 
                 6.7 
                 5673 
                 7.5 
                 0.303 
               
               
                 28.799 
                 3.0974 
                 256 
                 805 
                 17 
                 16756 
                 22 
                 0.354 
               
               
                 29.902 
                 2.9857 
                 262 
                 234 
                 4.9 
                 3508 
                 4.6 
                 0.255 
               
               
                 31.234 
                 2.8613 
                 230 
                 106 
                 2.2 
                 1473 
                 1.9 
                 0.236 
               
               
                 31.96 
                 2.798 
                 226 
                 308 
                 6.5 
                 3908 
                 5.1 
                 0.216 
               
               
                 32.939 
                 2.717 
                 208 
                 117 
                 2.5 
                 1444 
                 1.9 
                 0.21 
               
               
                 33.962 
                 2.6375 
                 199 
                 266 
                 5.6 
                 4617 
                 6.1 
                 0.295 
               
               
                 34.917 
                 2.5675 
                 217 
                 73 
                 1.5 
                 736 
                 1 
                 0.171 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
             
               
                 TABLE 32 
               
             
            
               
                   
               
               
                 Summary of experiments that generated Form 12 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Form 12 
                 Acetonitrile/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 MeOH/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 IPAc/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 EA/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 MtBE/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 MIBK/water 
                 RT 
                 Form 12 
                 Form 1 
               
               
                   
                 n-Butyl 
                 RT 
                 Form 13 
                 Form 12 
               
               
                   
                 acetate/water 
                   
                   
                   
               
               
                   
                 Heptane/water 
                 RT 
                 Form 13 
                 Form 12 
               
               
                   
                 MA/water 
                 50° C. 
                 Form 12 
                 Form 4 
               
               
                   
               
               
                 *Amount of water in binary solvents is 5% 
               
            
           
         
       
     
     N. Solvates 1-3 
     The experiments that generated Solvates 1, 2, and 3 are shown in Table 33, below. Solvates 1 and 2 solids were exposed to air overnight, and then analyzed by XRD. After the analysis, the solids were dried at 50° C. under vacuum, and then analyzed by XRD again. 
     After exposure to air overnight, Solvate 1 converted to low crystallinity; after drying at 50° C., the sample was still low crystallinity solid. After exposure to air overnight, the XRD pattern of Solvate 2 changed a little; after drying at 50° C., the form remained the same as the solid exposed to air overnight. 
     
       
         
           
               
             
               
                 TABLE 33 
               
             
            
               
                   
               
               
                 Summary of experiments that generated solvates 1-3 
               
            
           
           
               
               
               
               
               
            
               
                 Form 
                 Solvent 
                 Temperature 
                 Wet 
                 Dry 
               
               
                   
               
               
                 Solvate 1 
                 Acetone 
                 RT 
                 Solvate 1 
                 Low 
               
               
                   
                   
                   
                   
                 crystallinity 
               
               
                 Solvate 2 
                 Acetone/water 
                 RT 
                 Solvate 2 
                 Form 4** 
               
               
                   
                 Acetone 
                 50° C. 
                 Solvate 2 
                 Form 4** 
               
               
                 Solvate 3 
                 EtOH/water 
                 RT 
                 Solvate 3 
                 Form 2 
               
               
                   
               
               
                 *Amount of water in binary solvent is 5% 
               
            
           
         
       
     
     Example 2: Competitive Slurry Experiments Between Polymorph Forms 
     In order to find out the thermodynamic stability between the different forms, several competitive slurry experiments were carried out. Form 1, Form 2, Form 2*, Form 3, Form 4, Form 4*, Form 4**, Form 5, Form 7, Form 8, Form 9, Form 10, Form 11, Form 11*, and Form 13 (10 mg for each) was mixed and slurried in 2 mL of solvent at both RT and 50° C. The solids were slurried for 3-5 days and then analyzed by XRD. According to the analytical data, Form 2* was the most stable form in a MeOH, EtOH, and acetone system at both RT and 50° C. Form 4 or 4* was most stable in EA at RT and 50° C. Form 13 was most stable in water at RT and 50° C. Table 34 shows the XRD scan results from the competitive slurry experiments. 
     
       
         
           
               
             
               
                 TABLE 34 
               
             
            
               
                   
               
               
                 XRD scan results of competitive slurry experiments 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Form after 3 days; 
                   
               
               
                 Temperature 
                 Solvent 
                 wet/dry 
                 Form after 5 days; wet/dry 
               
               
                   
               
               
                 RT 
                 MeOH 
                 Form 2*/Form 2* 
                 Form 2*/Form 2* 
               
               
                   
                 EtOH 
                 Form 2*/Form 2* 
                 Form 2*/Form 2* 
               
               
                   
                 Acetone 
                 Form 2*/Form 2* 
                 Form 2*/Form 2* 
               
               
                   
                 EA 
                 Form 4/Form 4 
                 Form 4/Form 4 
               
               
                   
                 water 
                 Form 13/Form 13 
                 Form 13/Form 1&amp;Form 13 
               
               
                 50° C. 
                 MeOH 
                 Form 2*/Form 2* 
                 Form 2*/Form 2* 
               
               
                   
                 EtOH 
                 Form 2*/Form 2* 
                 Form 2*/Form 2* 
               
               
                   
                 Acetone 
                 Form 2*/Form 2* 
                 Form 2*/Form 2* 
               
               
                   
                 EA 
                 Form 4/Form 4 
                 Form 4*/Form 4* 
               
               
                   
                 water 
                 Form 13/Form 13 
                 Form 13/Form 13 
               
               
                   
               
            
           
         
       
     
     In order to find out the thermodynamic stability between Form 13 and Form 9, several competitive slurry experiments were carried out. 15 mg of Form 1, Form 9 and Form 13 solid were mixed in 1 mL of toluene, IPAc, and n-butyl acetate, and slurried for 3 days at RT and 50° C. 
     The residual solid was analyzed by XRD. After a three-day slurry, it was difficult to tell which one was more stable between Form 13 and Form 9. The XRD scan results of the experiment is shown in Table 35, below. 
     
       
         
           
               
             
               
                 TABLE 35 
               
             
            
               
                   
               
               
                 XRD scan results competitive slurry experiments 
               
            
           
           
               
               
               
            
               
                 Temperature 
                 Solvent 
                 Form after 3 days; wet/dry 
               
               
                   
               
               
                 RT 
                 Toluene 
                 Form 13/Form 1 
               
               
                   
                 IPAc 
                 Form 9 + Form 13/Form 9 + Form 1 
               
               
                   
                 n-Butyl acetate 
                 Form 9 + Form 13/Form 9 + Form 1 
               
               
                 50° C. 
                 Toluene 
                 Form 9 + Form 13/Form 9 + Form 1 
               
               
                   
                 IPAc 
                 Form 9/Form 9 
               
               
                   
                 n-Butyl acetate 
                 Form 9 + Form 13/Form 9 + Form 1 
               
               
                   
               
            
           
         
       
     
     OTHER EMBODIMENTS 
     It is to be understood that the foregoing description is intended to illustrate and not limit the scope of the disclosure, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims.