Claims for Patent: 8,653,058

Summary for Patent: 8,653,058

Title:	Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits
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 (Thousand Oaks, CA), Webster; Jeffrey Douglas (Thousand Oaks, CA), Moriarty; Robert M. (Michiana Shores, IN)
Assignee:	Kythera Biopharmaceuticals, Inc. (Calabasas, CA)
Application Number:	13/207,337
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,653,058
Patent Claims:	1. A composition consisting of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein said composition contains 0.5%.+-.0.1% of said salt which, when dissolved in water, is maintained at a pH of about 8.1 to about 8.5 and, when so maintained, said composition does not form a precipitate, and wherein said composition does not comprise phosphatidylcholine. 2. A composition consisting of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein said composition contains 1%.+-.0.1% of said salt which, when dissolved in water, is maintained at a pH of about 8.1 to about 8.5 and, when so maintained, said composition does not form a precipitate, and wherein said composition does not comprise phosphatidylcholine. 3. The composition of claims 1 or 2, wherein said excipient is a solvent, a buffer, a preservative, a lyophilization aid, or any combination thereof. 4. The composition of claim 3, wherein said excipient is a solvent. 5. The composition of claim 4, wherein said solvent is sterile water. 6. The composition of claim 3, wherein said excipient is a preservative. 7. The composition of claim 6, wherein said preservative is benzyl alcohol. 8. The composition of claim 7, wherein said preservative is 0.9% benzyl alcohol. 9. The composition of claims 1 or 2, wherein said composition has a pH of about 8.3. 10. A composition consisting of: a sterile aqueous solution buffered to a pH of about 8.3; 0.5%.+-.0.1% w/v of sodium deoxycholate; about 0.9% w/v benzyl alcohol; and about 1% w/v of sodium chloride, wherein the composition is stable against precipitation, and wherein said composition does not comprise phosphatidylcholine. 11. A composition consisting of: an aqueous solution buffered to a pH of about 8.3; 1%.+-.0.1% w/v of sodium deoxycholate; about 0.9% w/v benzyl alcohol; and about 1% w/v of sodium chloride, wherein the composition is stable against precipitation, and wherein said composition does not comprise phosphatidylcholine. 12. The composition of claim 1 or 2, wherein said salt is an alkali metal salt. 13. The composition of claim 12, wherein said alkali metal salt is sodium. 14. A composition consisting of: a sterile aqueous solution buffered to a pH of about 8.3; 0.5%.+-.0.1% w/v of sodium deoxycholate; about 10 mM sodium phosphate; about 0.9% w/v benzyl alcohol; and about 75 mM of sodium chloride, wherein the composition is stable against precipitation, and wherein said composition does not comprise phosphatidylcholine. 15. A composition consisting of: a sterile aqueous solution buffered to a pH of about 8.3; 1%.+-.0.1% w/v of sodium deoxycholate; about 10 mM sodium phosphate; and about 0.86% w/v of sodium chloride, wherein the composition is stable against precipitation, and wherein said composition does not comprise phosphatidylcholine.

Details for Patent 8,653,058

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-22