Details for Patent: 9,737,549

Title:	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.
Inventor(s):	Hodge; Robert Emil (McPherson, KS), Webster; Jeffrey Douglas (Thousand Oaks, CA), Moriarty; Robert M. (Michiana Shores, IN)
Assignee:	Kythera Biopharmaceuticals, Inc. (Parsippany, NJ)
Filing Date:	Nov 26, 2013
Application Number:	14/091,109
Claims:	1. A method for stabilizing an aqueous composition of a salt of deoxycholic acid against precipitation during storage, which method comprises: a) forming an aqueous solution of the salt of deoxycholic acid; b) adjusting the pH of the aqueous solution to a pH of from about 8.1 to about 8.5 thereby stabilizing said composition against precipitation during storage; and c) and forming the aqueous composition consisting of the salt of deoxycholic acid at a concentration ranging from about 0.4% w/v to less than 2% w/v and at least one pharmaceutically acceptable excipient and/or carrier. 2. The method of claim 1, wherein said salt is the sodium salt of deoxycholic acid. 3. The method of claim 1, wherein the pH of the aqueous solution is maintained at about 8.3. 4. The method of claim 3, wherein said salt is the sodium salt of deoxycholic acid. 5. The method of claim 1, wherein the pH is maintained at from about 8.1 to about 8.5. 6. The method of claim 5, wherein the pH is maintained with a sufficient amount of buffer.