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Claims for Patent: 8,653,058

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Claims 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 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.
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