Otonomy, Inc.

Dompe' Farmaceutici S.p.a.

Alk-AbellÓ, Inc.

Robert Savel

Scott H Coleman

Wei-Cheng Liaw

Jerry Wroblewski

Fabrice Piu

Hong Qi

Zhanpeng Zhang

Scott Coleman

Martha Pastuszka

Natalia Tsivkovskaia

Bonnie Jacques

Disclosed herein are triglyceride based formulations, compositions, and methods for the treatment of otic diseases and conditions. Such triglyceride based formulations and compositions are derived from long-chain triglycerides and allow for the delivery of a variety of therapeutic agents to the outer, middle, and/or inner ear.

Triglyceride otic formulations and uses thereof

Disclosed herein are otic product kits for administration of a sterilized formulation. In some embodiments, the otic product kit comprises: an aseptic container containing the sterilized formulation; a syringe; and an administration needle connectable to the syringe, wherein the sterilized formulation comprising: from about 5.5 wt % to about 6.5 wt % multiparticulate ciprofloxacin; from about 15 wt % to about 17 wt % poloxamer 407; and water. Also disclosed herein are methods of preparing and administrating the sterilized formulation. In some embodiments, the method comprising (1) transferring the sterilized otic formulation from an aseptic container to a syringe through a preparation needle; (2) replacing the preparation needle with an administration needle; and (3) injecting the sterilized otic formulation from the syringe through the administration needle into the ear of a patient.

Ciprofloxacin otic composition and kits and method for using same

Disclosed herein are triglyceride based formulations, compositions, and methods for the treatment of otic diseases and conditions. Such triglyceride based formulations and compositions are derived from medium chain triglycerides and allow for the delivery of a variety of therapeutic agents to the outer, middle, and/or inner ear.

Disclosed herein are methods of making sterilized ciprofloxacin compositions. In some embodiments, the method includes the steps of: (a) forming an aqueous suspension comprising ciprofloxacin particles; (b) heating the aqueous suspension comprising ciprofloxacin particles at a temperature range of from about 100&#xb0; C. to about 120&#xb0; C.; and (c) allowing the aqueous suspension comprising ciprofloxacin particles to cool down. Also described herein are otic formulations containing ciprofloxacin formed by the disclosed methods, and therapeutic use of such otic formulation for providing sustained release of ciprofloxacin into the ear for treating various otic disorders and conditions.

Sterilization of ciprofloxacin composition

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San Diego, CA, United States of America

Robert Savel