Source: http://www.google.com/patents/US8129364?dq=5636223
Timestamp: 2014-03-15 03:02:22
Document Index: 633884599

Matched Legal Cases: ['Application No. 2', 'Application No. 2006', 'Application No. 2006', 'Application No. 2006', 'Application No. 2006', 'Application No. 2005']

Patent US8129364 - Formulations and methods for treating rhinosinusitis - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThe invention involves methods and formulations for treating or preventing rhinosinusitis, including fungus-induced rhinosinusitis in mammals. In one embodiment, the formulation of the present invention comprises a steroidal anti-inflammatory agent having a specific particle size distribution profile....http://www.google.com/patents/US8129364?utm_source=gb-gplus-sharePatent US8129364 - Formulations and methods for treating rhinosinusitisAdvanced Patent SearchPublication numberUS8129364 B2Publication typeGrantApplication numberUS 11/250,925Publication dateMar 6, 2012Filing dateOct 14, 2005Priority dateApr 16, 2003Also published asCA2522294A1, EP1613282A1, US8309061, US20040209852, US20050180925, US20060051300, US20080058296, US20120237559, WO2004091576A1Publication number11250925, 250925, US 8129364 B2, US 8129364B2, US-B2-8129364, US8129364 B2, US8129364B2InventorsImtiaz ChaudryOriginal AssigneeDey Pharma, L.P.Export CitationBiBTeX, EndNote, RefManPatent Citations (74), Non-Patent Citations (33), Classifications (31), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetFormulations and methods for treating rhinosinusitisUS 8129364 B2Abstract The invention involves methods and formulations for treating or preventing rhinosinusitis, including fungus-induced rhinosinusitis in mammals. In one embodiment, the formulation of the present invention comprises a steroidal anti-inflammatory agent having a specific particle size distribution profile. The formulation may also comprise an antifungal agent, antibiotic or antiviral agent.
What is claimed is: 1. A formulation for the treatment of fungus-induced rhinosinusitis in a mammal, said formulation comprising an aqueous suspension comprising:
13. The formulation of claim 1, wherein said formulation is sterile and has a relatively long period of stability such that after storage for 12 months at a temperature between 15 to 30� C., greater than 90% of the mometasone originally present in the formulation still remains in the formulation.
22. The nasal spray formulation of claim 16, wherein said formulation is sterile and has a relatively long period of stability such that after storage for 12 months at a temperature between 15 to 30� C., greater than 90% of the beclomethasone originally present in the formulation still remains in the formulation.
35. The method of claim 29, wherein said formulation is sterile and has a relatively long period of stability such that after storage for 12 months at a temperature between 15 to 30� C., greater than 90% of the beclomethasone originally present in the formulation still remains in the formulation.
CROSS REFERENCE TO RELATED APPLICATIONS The present application is a continuation of PCT/EP2004/003316, filed Mar. 29, 2004, which is a continuation of U.S. application Ser. No. 10/657,550, filed Sept. 4, 2003, which is a continuation-in-part of U.S. application Ser. No. 10/414,682 and U.S. application Ser. No. 10/414,756, both of which were filed Apr. 16, 2003 now U.S. Pat. No. 7,811,606 and are incorporated herein by reference in their entirety.
FIELD OF THE INVENTION The present invention relates to formulations and methods for treating rhinosinusitis in mammals (e.g., humans), including but not limited to fungus induced rhinosinusitis. The formulations of the present invention comprise a steroidal agent, such as fluticasone or beclomethasone, wherein the steroidal agent has a specific particle size distribution profile. The formulations may also comprise an antibiotic, antifungal agent or an antiviral agent, or any combination thereof. While the formulations of the present invention may take any form, preferably they are provided as a sterile, aqueous suspension or solution which can be administered intranasally to the nasal-paranasal mucosa via spray pump. Also, the steroidal agent may be administered alone or in conjunction with an antifungal agent, antibiotic or antiviral agent.
BACKGROUND OF THE INVENTION Rhinosinusitis is generally described as an inflammation of the nasal cavity and/or paranasal sinuses and involves the nasal mucosa. Chronic rhinosinusitis (CRS) is diagnosed when signs or symptoms of inflammation persist for 8-12 weeks or longer. It is estimated that one out of every seven Americans suffers from chronic rhinosinusitis (CRS). Symptoms of CRS include nasal obstruction, loss of sense of smell, nasal or postnasal discharge, nasal congestion, and facial pain/pressure (typically over the affected sinus area).
SUMMARY OF INVENTION The present invention relates generally to formulations and methods for treating rhinosinusitis in mammals (e.g., humans), including, but not limited to fungus-induced rhinosinusitis. In one embodiment, the formulations of the present invention comprise a steroid, alone or in combination with an antifungal agent or antibiotic. It is believed that treating the patient with an antifungal agent will sufficiently reduce the level of fungal organisms in the patient's mucus such that the one ore more of the symptoms of rhinosinusitis are prevented from developing, or are lessened, or are prevented from worsening.
DETAILED DISCUSSION OF THE INVENTION The present invention is directed to formulations for the treatment of one or more symptoms of rhinosinusitis in an individual. Rhinosinusitis occurs in the nasal-paranasal region. Symptoms of rhinosinusitis include, without limitation, facial pain, pressure, and/or fullness; loss of smell; nasal obstruction or blockage; nasal or postnasal discharge; rhinorrhea; hyposimia/ansomnia; fever; headaches; halitosis; fatigue; dental pain; cough; and ear pain, pressure, and/or fullness. Upon examination, the presence of thick mucus or the visual identification of nasal or paranasal obstruction with mucus or polyps often indicates a rhinosinusitis condition.
Amphotericin β
0.5-150 mg
7.5-15 mg
10 mg Q12H
30 mg Q12H
Mucomist Mucosil
2.5-45
Anticolinergic
mcg Q12H
382-616
475-750
Vanceril Beclovent
mg Q24H
Fortaz, Ceptaz
12.5-150
Aerobid Nasalide
mcg Q24H
12.5-300
mg Q6-8H
Prostaphin
Neo-Synephine
Tetrahydrozolidine
Ticarcillin + Clavulanatc
Asthmacor
75-325
0.075-03
Cephlasporin (Gen
Ticarcillin + Clavulanaic
In one alternative embodiment, the formulations of the present invention are stable. As used herein, the stability of formulations provided herein refers to the length of time at a given temperature that greater than 80%, 85%, 90% or 95% of the initial amount of the active ingredients is present in the formulation. For example, the formulations provided herein may be stored between about 15� C. and about 30� C., and remain stable for at least 1, 2, 12, 18, 24 or 36 months. Also, the formulations may be suitable for administration to a subject in need thereof after storage for more than 1, 2, 12, 18, 24 or 36 months at 250. Also, in another alternative embodiment, using Arrhenius Kinetics, more than 80%, or more than 85%, or more than 90%, or more than 95% of the initial amount of active ingredients remains after storage of the formulations for more than 1, 2, 12, 18, 24 or 36 months between about 15� C. and about 30� C.
The preparation of the steroidal inflammatory of the present invention, e.g., fluticasone propionate and beclomethasone dipropionate, having a specific particle size distribution profile may be obtained by any conventional means known in the art, or by minor modification of such means. For example, suspensions of drug particles can rapidly undergo particulate size reduction when subjected to �jet milling� (high pressure particle in liquid milling) techniques. Other known methods for reducing particle size into the micrometer range include mechanical milling, the application of ultrasonic energy and other techniques.
In one alternative embodiment, the present invention is directed to a pharmaceutical composition that may be useful in treating rhinosinusitis caused by Alpha Hemolytic Sreptococci, Beta Hemolytic Streptococci, Branhamella Catarrhalis, Diptheroids, Heaemophilis influenza (beta-lactamase positive and negative), Moraxella species, Psuedomonas aeroguinosa, Pseudomas maltophilia, Serratia marcesns, Staphylococcus aureus, Streptococcus pheumonia, Aspergillosis, Mucor and Candida albicans, Flusarium, Curvularia, crytococcus, coccidiodes, and histoplasma. Mode of Administration
EXAMPLES Examples 1-5 herein are prophetic examples provided to illustrate, but not to limit, the formulations and methods of the present invention. They are presented with the understanding that changes can be and may need to be made to a specific composition in order to obtain or optimize the formulation. Such modifications to the following prophetic examples, if needed, are normal and understandable to those of ordinary skill in the art, and shall not be used to limit the invention.
Example 1 Amphotericin B
2.0-100.0
mg.ml
80 0.1-1.0
Example 2 Fluconazole
Example 3 Amphotericin B
Example 4 Fluconazole
Example 5 Fluconazole
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"Management of allergic rhinitis", Nursing Times, 2003, 99(23), abstract.* Cited by examinerClassifications U.S. Classification514/177, 424/46, 424/489International ClassificationA61K9/12, A61K31/57, A61K31/56, A61K9/14, A61K31/573, A61K31/7048, A61L2/00, A61K31/496, A61K9/10, A61P11/02, A61K9/00Cooperative ClassificationA61L2/0035, A61K9/0043, A61K31/496, A61K31/56, A61L2/07, A61K31/7048, A61K31/573, A61K9/10, A61K31/57European ClassificationA61K9/00M14, A61K31/573, A61L2/00P2R2, A61L2/07, A61K31/7048, A61K31/57, A61K31/496, A61K31/56Legal EventsDateCodeEventDescriptionDec 10, 2012ASAssignmentEffective date: 20121210Owner name: MYLAN BERTEK PHARMACEUTICALS INC., TEXASOwner name: MYLAN PHARMACEUTICALS, INC., WEST VIRGINIAEffective date: 20121210Owner name: SOMERSET PHARMACEUTICALS, INC., NEW JERSEYFree format text: PATENT RELEASE;ASSIGNOR:BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT;REEL/FRAME:029440/0967Owner name: MYLAN TECHNOLOGIES, INC., VERMONTOwner name: MYLAN INC., PENNSYLVANIAOwner name: MYLAN INSTITUTIONAL INC. 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