Details for Patent: 9,186,364

Title:	Formulations of deoxycholic acid and salts thereof
Abstract:	The present application is directed to an aqueous pharmaceutical formulation comprising less than about 5% w/v sodium deoxycholate maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate. Also disclosed herein, are methods for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising less than about 5% w/v of sodium deoxycholate, said method comprising maintaining pH of the solution of from at least about 8.0 to about 8.5.
Inventor(s):	Hodge; Robert Emil (McPherson, KS), Webster; Jeffrey Douglas (Thousand Oaks, CA)
Assignee:	KYTHERA BIOPHARMACEUTICALS, INC. (Westlake Village, CA)
Filing Date:	Jan 03, 2013
Application Number:	13/733,729
Claims:	1. A method for substantially inhibiting precipitation of sodium deoxycholate in an aqueous solution consisting of less than 5% w/v of sodium deoxycholate and optionally at least one of pharmaceutically acceptable excipient and/or carrier, said method comprising maintaining pH of the solution from about 8.0 to about 8.5 thereby substantially inhibiting precipitation of the sodium deoxycholate. 2. The method of claim 1, wherein the precipitation of sodium deoxycholate is substantially inhibited for a period of at least six months. 3. The method of claim 1, wherein one of the at least one of pharmaceutically acceptable excipient and/or carrier is about 1% benzyl alcohol. 4. The method of claim 1, wherein one of the at least one of pharmaceutically acceptable excipient and/or carrier is about 1% sodium chloride. 5. The method of claim 1, wherein the aqueous solution has a pH of about 8.3. 6. The method of claim 5, wherein the aqueous solution has a pH of 8.3. 7. The method of claim 1, wherein the sodium deoxycholate in solution has a relative standard deviation for homogeneity of less than about 5%. 8. The method of claim 1, wherein the aqueous solution comprises a sodium deoxycholate concentration from about 0.05% w/v to about 5% w/v. 9. A method for substantially inhibiting precipitation of sodium deoxycholate in an aqueous solution consisting of about 0.5% to about 1.5% w/v of sodium deoxycholate and optionally at least one of pharmaceutically acceptable excipient and/or carrier, said method comprising maintaining pH of the solution from about 8.0 to about 8.5 thereby substantially inhibiting precipitation of the sodium deoxycholate.