Otonomy, Inc.

Medinox, Inc.

Alk-abelló, Inc.

Wei-Cheng Liaw

Scott H Coleman

Robert Savel

Jerry Wroblewski

Ching-San Lai

Vassil P Vassilev

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 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

The present invention provides methods for producing pharmaceutical-grade particulate dithiocarbamates from secondary amines by vigorously contacting at least one secondary amine and a pharmaceutically acceptable diluent that is a solvent for the carbon disulfide, but not for the secondary amine in an inert gas atmosphere, cooling the mixture so as to precipitate the dithiocarbamate therefrom, and separating the precipitated dithiocarbamate from the cooled mixture. The preferred solvent contains absolute ethanol. In alternative embodiments, the invention further provides methods for purifying a dithiocarbamate to obtain a pharmaceutical-grade dithiocarbamate particulate from a dithiocarbamate feed and methods for producing a sterile pharmaceutical-grade dithiocarbamate from a dithiocarbamate feed.

Method for preparation of pharmaceutical-grade dithiocarbamate

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San Diego, CA, United States of America

Wei-Cheng Liaw