Compositions for treatment of ear disorders and methods of use thereof

摘要

The present invention relates to compositions and methods useful for the treatment of ear disorders, administered to a treated ear in the form of a foam or a mousse. Administering a medicament in such forms will increase the residence time of the medicament in the ear canal, provide relatively uniform distribution of the composition, and can increase the penetration of the active pharmaceutical ingredient in the affected area, may release active substances slowly, enhance treatment effectiveness, increase compliance and is more convenient to use than currently available ear medications. The administration in the form of a foam or a mousse may preferably be provided as a metered dose, of a volume suitable to fill the ear canal.

主权项

1. A method for the treatment of otitis externa, comprising administering into the ear canal of a subject in need of such treatment a pharmaceutical composition comprising an active agent capable of treating otitis externa, the pharmaceutical composition further comprising a foam forming agent, a hydrophilic carrier, and a propellant gas, said pharmaceutical composition being devoid of C1-C4 aliphatic alcohols and being formulated so as to form, upon ejection of said pharmaceutical composition from a dispensing device that includes a pressurized container and a pipe that extends from the pressurized container and allows access of the foam or mousse into the ear canal, an aqueous foam or mousse that provides prolonged contact of the active agent with the ear canal compared to the contact of said active agent with the ear canal when applied in the form of ear drops, wherein the pharmaceutical composition comprising the active agent is administered on a dosage schedule that is less frequent than would be required for administering said active agent in the form of ear drops.