Ciprofloxacin otic composition and kits and method for using same

Abstract

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.

1 . A 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, wherein the multiparticulate ciprofloxacin has a D90 of from 5 μm to 40 μm, and wherein the sterilized formulation is injectable through a 20-24 gauge needle. 
     
     
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         15 . The sterilized formulation of  claim 1 , wherein the multiparticulate ciprofloxacin has a D90 of from about 10 μm to about 35 μm. 
     
     
         16 . The sterilized formulation of  claim 1 , wherein the sterilized formulation provides sustained release of a therapeutically effective amount of ciprofloxacin into the ear for a period of at least 5 days after a single administration. 
     
     
         17 . The sterilized formulation of  claim 1 , where the sterilized formulation has a pH of from about 7.0 to about 8.0. 
     
     
         18 . The sterilized formulation of  claim 1 , where the sterilized formulation has an osmolarity of from about 270 mOsm/L to about 320 mOsm/L. 
     
     
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         21 . The sterilized formulation of  claim 1 , wherein the formulation comprises from about 15 wt % to about 16 wt % poloxamer 407. 
     
     
         22 . The sterilized formulation of  claim 1 , wherein the formulation comprises about 6% multiparticulate ciprofloxacin.