Composition comprising an antibiotic and a corticosteroid

Abstract

This invention relates to compositions (e.g., otic compositions) comprising an antibiotic (generally a quinolone or naphthyridinone), corticosteroid, and organic acid (generally a fatty acid). This invention also relates to treatment methods using such a composition, uses of such a composition to make medicaments, and therapeutic kits comprising such a composition.

1 . A pharmaceutical composition, wherein:
 the composition comprises:
 a corticosteroid, 
 an antibiotic, and 
 a fatty acid; 
   the antibiotic comprises:
 a fluoroquinolone, a salt of the fluoroquinolone, or a solvate of the fluoroquinolone or its salt, or 
 a fluoronaphthyridinone, a salt of the fluoronaphthyridinone, or a solvate of the fluoronaphthyridinone or its salt; 
   the fatty acid:
 comprises from about 3 to about 18 carbon atoms, and has a melting point of no greater than about 60° C. 
   
     
     
         2 . A composition according to  claim 1 , wherein the composition is in the form of a suspension. 
     
     
         3 . A composition according to  claim 1 , wherein the corticosteroid comprises mometasone, mometasone furoate, or a solvate of mometasone or mometasone furoate. 
     
     
         4 . A composition according to  claim 3 , wherein the corticosteroid comprises mometasone furoate monohydrate. 
     
     
         5 . A composition according to  claim 1 , wherein the antibiotic comprises a 6-fluoroquinolin-4(1H)-one, a salt of the 6-fluoroquinolin-4(1H)-one, or a solvate of the 6-fluoroquinolin-4(1H)-one or its salt. 
     
     
         6 . A composition according to  claim 5 , wherein the 6-fluoroquinolin-4(1H)-one comprises a 6-fluoroquinolin-4(1H)-one selected from the group consisting of amifloxacin, balofloxacin, ciprofloxacin, clinafloxacin, fleroxacin, garenoxacin, gatifloxacin, grepafloxacin, lomefloxacin, moxifloxacin, norfloxacin, pefloxacin, pradofloxacin, sitafloxacin, sparfloxacin, temafloxacin, danofloxacin, difloxacin, enrofloxacin, sarafloxacin, flumequine, ibafloxacin, levofloxacin, nadifloxacin, ofloxacin, pazufloxacin, prulifloxacin, rufloxacin, and marbofloxacin. 
     
     
         7 . A composition according to  claim 5 , wherein the 6-fluoroquinolin-4(1H)-one comprises orbifloxacin. 
     
     
         8 . A composition according to  claim 1 , wherein the composition further comprises an antifungal agent. 
     
     
         9 . A composition according to  claim 8 , wherein the antifungal agent comprises a triazole, a salt of triazole, or a solvate of the triazole or its salt. 
     
     
         10 . A composition according to  claim 9 , wherein the triazole comprises a triazole selected from the group consisting of fluconazole, itraconazole, saperconazole, terconazole, and voriconazole. 
     
     
         11 . A composition according to  claim 9 , wherein the triazole comprises posaconazole. 
     
     
         12 . A composition according to  claim 1 , wherein the fatty acid comprises lauric acid. 
     
     
         13 . A composition according to  claim 1 , wherein the fatty acid comprises oleic acid. 
     
     
         14 . A composition according to  claim 1 , wherein the composition further comprises mineral oil. 
     
     
         15 . A method for treating an infection in an animal, wherein the method comprises administering a composition according to any one of  claims 1  to  14  to the animal. 
     
     
         16 . A method according to  claim 15 , wherein the infection comprises an otic infection in a dog. 
     
     
         17 . A therapeutic kit, wherein the kit comprises:
 a composition according to any one of  claims 1  to  14 , and   an additional component selected from the group consisting of:
 a diagnostic tool, 
 an otic cleaning solution, 
 an apparatus for cleaning an ear, 
 instructions for administering the composition to an animal, and 
 a device for administering the composition to an animal.