Formulations of deoxycholic acid and salts thereof

Abstract

The present application is directed to an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid, wherein the composition is maintained at a pH from about 8.1 to about 8.5 such that the composition is stabilized against precipitation. Also disclosed herein, are methods for stabilizing an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid against precipitation, said method comprising maintaining pH of the solution from about 8.1 to about 8.5.

1 - 17 . (canceled) 
     
     
         18 . A method to lyse a fat cell, the method comprising administering to said fat cell a composition consisting essentially of about 0.4% w/v to less than 2% w/v of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein the composition, when dissolved in water, is maintained at a pH of about 8.1 to about 8.5, and, when so maintained, the composition does not form a precipitate. 
     
     
         19 . The method of  claim 18 , wherein said excipient is a solvent, a buffer, a preservative, a lyophilization aid, or any combination thereof. 
     
     
         20 . The method of  claim 19 , wherein said excipient is a solvent. 
     
     
         21 . The method of  claim 20 , wherein said solvent is sterile water. 
     
     
         22 . The method of  claim 19 , wherein said excipient is a preservative. 
     
     
         23 . The method of  claim 22 , wherein said preservative is benzyl alcohol. 
     
     
         24 . The method of  claim 23 , wherein said preservative is 0.9% benzyl alcohol. 
     
     
         25 . The method of  claim 18 , wherein said composition has a pH of about 8.3. 
     
     
         26 . The method of  claim 18 , wherein said salt is an alkali metal salt. 
     
     
         27 . The method of  claim 26 , wherein said alkali metal salt is sodium. 
     
     
         28 . The method of  claim 19 , wherein said excipient comprises a buffer. 
     
     
         29 . The method of  claim 28 , wherein said buffer comprises a phosphate buffer. 
     
     
         30 . The method of  claim 28 , wherein said buffer comprises 10 mM phosphate buffer. 
     
     
         31 . The method of  claim 28 , wherein said buffer comprises dibasic sodium phosphate buffer.