Patent ID: 8916203

Claim:
A method of preparing a reconstituted lyophilized pharmaceutical composition suitable for parenteral administration, comprising: providing a formulation comprising polymeric nanoparticles, wherein the polymeric nanoparticles comprise a therapeutic agent and a polymer selected from the group consisting of poly(lactic) acid-block-poly(ethylene)glycol copolymer and poly(lactic)-co-poly(glycolic) acid-block-poly(ethylene)glycol copolymer; adding hydroxypropyl β-cyclodextrin and a sugar selected from the group consisting of trehalose and sucrose to the formulation such that the formulation has 7 to 12 weight percent of the hydroxypropyl β-cyclodextrin and 4 to 6 weight percent of the sugar; lyophilizing the formulation to form a lyophilized formulation; and reconstituting the lyophilized formulation in an aqueous medium to form the reconstituted lyophilized pharmaceutical composition, wherein the reconstituted lyophilized pharmaceutical composition has a concentration of 10-100 mg/mL of the polymeric nanoparticles.