CONTROLLED RELEASE COMPOSITIONS FOR MODULATING FREE-RADICAL INDUCED DAMAGE AND METHODS OF USE THEREOF

摘要

Disclosed herein are compositions and methods for the treatment of otic diseases or conditions with free-radical modulating agent compositions and formulations administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).

主权项

1. A pharmaceutical composition or device comprising an amount of a free-radical modulator that is therapeutically effective for treating an otic disease or condition associated with free-radical induced damage, the composition or device comprising substantially low degradation products of the free-radical modulating agent, the pharmaceutical composition or device further comprising two or more characteristics selected from:
(i) between about 0.1% to about 10% by weight of the free-radical modulating agent, or pharmaceutically acceptable prodrug or salt thereof; (ii) between about 14% to about 21% by weight of a polyoxyethylene-polyoxypropylene triblock copolymer of general formula E106 P70 E106; (iii) sterile water, q.s., buffered to provide a pH between about 5.5 and about 8.0; (iv) multiparticulate free-radical modulating agent; (v) a gelation temperature between about 19° C. to about 42° C.; (vi) less than about 50 colony forming units (cfu) of microbiological agents per gram of formulation; (vii) less than about 5 endotoxin units (EU) per kg of body weight of a subject; (viii) a mean dissolution time of about 30 hours for the free-radical modulating agent; and (ix) an apparent viscosity of about 100,000 cP to about 500,000 cP.