Auris Formulations for Treating Otic Diseases and Conditions

摘要

Disclosed herein are compositions and methods for the treatment of otic disorders with immunomodulating agents and auris pressure modulators. In these methods, the auris compositions and formulations are administered locally to an individual afflicted with an otic disorder, through direct application of the immunomodulating and/or auris pressure modulating compositions and formulations onto the auris media and/or auris interna target areas, or via perfusion into the auris media and/or auris interna structures.

主权项

1. A pharmaceutical formulation for use in the treatment of an otic disease or condition formulated to provide a therapeutically effective amount of an immunomodulating agent, the formulation comprising:
between about 0.2% to about 6% by weight of an immunomodulating agent, or pharmaceutically acceptable prodrug or salt thereof; between about 16% to about 21% by weight of a polyoxyethylene-polyoxypropylene triblock copolymer of general formula E106 P70 E106; sterile water, q.s., buffered to provide a perilymph-suitable pH between about 6.0 and about 7.6; and substantially low degradation products of the immunomodulating agent;wherein the pharmaceutical formulation has a perilymph-suitable osmolarity between about 250 and 320 mOsm/L,less than about 50 colony forming units (cfu) of microbiological agents per gram of formulation, and less than about 5 endotoxin units (EU) per kg of body weight of a subject.