Controlled-release CNS modulating compositions and methods for the treatment of otic disorders

摘要

Disclosed herein are compositions and methods for the treatment of otic disorders with CNS modulating agent compositions and compositions administered locally to an individual afflicted with an otic disorder, through direct application of these compositions and compositions onto or via perfusion into the targeted auris structure(s).

主权项

1. A method of treating an otic disease or condition comprising administering an intratympanic composition on or near the round window membrane of an individual in need thereof, the intratympanic composition comprising:
between about 0.01% to about 20% by weight of a micronized Central Nervous System (CNS) modulator, or pharmaceutically acceptable salt thereof; and a polyoxyethylene-polyoxypropylene copolymer in an amount sufficient to provide a gelation temperature between about 19° C. to about 42° C., and a gelation viscosity between about 15,000 cP and about 1,000,000 cP; and the intratympanic composition having an osmolarity of less than about 1000 mOsm/L; wherein the intratympanic composition provides a sustained release of a therapeutically effective amount of the CNS modulator across the round window membrane into the cochlea for a period of at least 5 days after a single administration.