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|Title:||Controlled release corticosteroid compositions and methods for the treatment of otic disorders|
|Abstract:||Disclosed herein are compositions and methods for the treatment of otic disorders with steroid, NSAID, and/or adenosine triphosphatase ("ATPase") modulator agents. In these methods, the steroidal, NSAID, and/or ATPase compositions and formulations are administered locally to an individual afflicted with an otic disorder, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).|
|Inventor(s):||Lichter; Jay (Rancho Santa Fe, CA), Vollrath; Benedikt (San Diego, CA), Trammel; Andrew M. (Olathe, KS), Duron; Sergio G. (San Diego, CA), Piu; Fabrice (San Diego, CA), Dellamary; Luis A. (San Marcos, CA), Ye; Qiang (San Diego, CA), Lebel; Carl (Malibu, CA), Scaife; Michael Christopher (Los Altos, CA), Harris; Jeffrey P. (La Jolla, CA)|
|Assignee:||Otonomy, Inc. (San Diego, CA) The Regents of the University of California (Oakland, CA)|
|Filing Date:||Jul 25, 2011|
|Claims:||1. A method of alleviating or ameliorating the symptoms of otic disorders selected from Meniere's disease, Autoimmune ear disease (AIED), otitis media, acoustic trauma induced sensorineural hearing loss, drug induced sensorineural hearing loss, sensorineural hearing loss due to infection, idiopathic sensorineural hearing loss, vertigo, and tinnitus, in an individual in need thereof comprising intratympanic administration of a pharmaceutical composition on or near the round window membrane of the ear of the individual in need thereof, the composition comprising an auris acceptable thermoreversible aqueous gel comprising a polymer of polyoxypropylene and polyoxyethylene; and between about 1-70 mg/mL of a multiparticulate anti-inflammatory corticosteroid; such that sustained release of the anti-inflammatory corticosteroid across the round window membrane into the cochlea occurs for a period of at least 5 days after a single administration. |
2. A method according to claim 1, wherein the anti-inflammatory corticosteroid is dexamethasone, dexamethasone ester, or pharmaceutically acceptable salt thereof.
3. A method according to claim 1, wherein the anti-inflammatory corticosteroid is methylprednisolone, or pharmaceutically acceptable salt thereof.
4. A method according to claim 1, wherein the anti-inflammatory corticosteroid is prednisolone, or pharmaceutically acceptable salt thereof.
5. A method according to claim 1, wherein the composition has a pH between about 6.6 and about 8.0.
6. A method according to claim 1, further comprising a delivery system for the delivery of the composition to or near to the round window.
7. A method according to claim 6, wherein the delivery system comprises a needle for delivery of the composition.
8. A method according to claim 7, wherein the needle is part of a syringe and needle apparatus, a hypodermic needle, a micro-otoscope.
9. A method according to claim 1, wherein the polymer of polyoxypropylene and polyoxyethylene is present in an amount sufficient to allow injection of the formulation through the tympanic membrane by a 18-31 gauge needle.