Controlled release corticosteroid compositions and methods for the treatment of OTIC disorders
AssigneesOtonomy, Inc., The Regents of the University of California
InventorsJay Lichter, Andrew M. Trammel, Jeffrey P. Harris, Fabrice Piu, Carl Lebel, Qiang Ye, Luis A. Dellamary
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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).
Claims19
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 from about 16% to 21% by weight of polyoxypropylene and polyoxyethylene and from 1 mg/mL to 70 mg/mL 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.
A method for alleviating or ameliorating the symptoms of Meniere's disease in an individual comprising administration of a pharmaceutical composition formulated to provide sustained release of a therapeutically effective amount of dexamethasone, dexamethasone ester, methylprednisolone, or prednisolone, or pharmaceutically acceptable salt thereof, across the round window membrane into the cochlea for a period of at least 5 days after a single administration, the composition comprising:
- between 1 mg/mL to 70 mg/mL of multiparticulate dexamethasone, dexamethasone ester, methylprednisolone, prednisolone, or pharmaceutically acceptable salt thereof;
- between 16% to 21% by weight of a polyoxyethylene-polyoxypropylene triblock copolymer of general formula E106 P70 E106;
- sterile water, q.s., buffered to provide an perilymph-suitable pH between 7.0 and 7.6;
- wherein the pharmaceutical composition has an perilymph-suitable osmolarity between 250 and 320 mOsm/kg, and
- less than 50 colony forming units (cfu) of microbiological agents per gram of formulation.
A method for alleviating or ameliorating the symptoms of sudden sensineural hearing loss in an individual comprising administration of a pharmaceutical composition formulated to provide sustained release of a therapeutically effective amount of dexamethasone, dexamethasone ester, methylprednisolone, or prednisolone, or pharmaceutically acceptable salt thereof, across the round window membrane into the cochlea for a period of at least 5 days after a single administration, the composition comprising:
- between 1 mg/mL to 70 mg/mL of multiparticulate dexamethasone, dexamethasone acetate, methylprednisolone, prednisolone, or pharmaceutically acceptable salt thereof;
- between 16% to 21% by weight of a polyoxyethylene-polyoxypropylene triblock copolymer of general formula E106 P70 E106;
- sterile water, q.s., buffered to provide an perilymph-suitable pH between 7.0 and 7.6;
- wherein the pharmaceutical formulation has an perilymph-suitable osmolarity between 250 and 320 mOsm/kg, and
- less than 50 colony forming units (cfu) of microbiological agents per gram of formulation.
Dependencies are inferred from the claim text.