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Last Updated: April 18, 2024

Details for Patent: 9,050,349


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Title:Synthetic bile acid compositions and methods
Abstract: Bile acids and related compositions and methods of synthesis and use. More specifically, deoxycholic acid and related compositions, said compositions being free of all moieties of animal origin and free of pyrogenic moieties.
Inventor(s): Moriarty; Robert M. (Michiana Shores, IN), David; Nathaniel E. (Los Angeles, CA), Mahmood; Nadir Ahmeduddin (Calabasas, CA)
Assignee: KYTHERA BIOPHARMACEUTICALS, INC. (Westlake Village, CA)
Filing Date:Jun 10, 2013
Application Number:13/914,510
Claims:1. A syringe or syringe-loadable container comprising a composition comprising a deoxycholate salt and at least one pharmaceutically acceptable excipient and/or carrier, wherein the deoxycholate has a .sup.14C content of less than 1 ppt.

2. The syringe or syringe-loadable container of claim 1, wherein said deoxycholate salt is sodium deoxycholate.

3. The syringe or syringe-loadable container of claim 2, wherein said sodium deoxycholate is present at a concentration of about 0.5% (w/v), about 1% (w/v), about 2% (w/v), or about 5% (w/v) in said composition.

4. The syringe or syringe-loadable container of claim 1, wherein said pharmaceutically acceptable excipient is selected from the group consisting of: water, a buffer, benzyl alcohol, and combinations thereof.

5. The syringe or syringe-loadable container of claim 1, wherein said pharmaceutically acceptable excipients consist of a buffer and benzyl alcohol.

6. The syringe or syringe-loadable container of claim 1, wherein the deoxycholate has a .sup.14C content of less than 0.9 ppt.

7. A syringe or syringe-loadable container comprising an aqueous pharmaceutical composition comprising a deoxycholate salt and at least one pharmaceutically acceptable excipient and/or carrier, wherein the deoxycholate has a .sup.14C content of less than 1 ppt.

8. The syringe or syringe-loadable container of claim 7, wherein said deoxycholate salt is sodium deoxycholate.

9. The syringe or syringe-loadable container of claim 8, wherein said sodium deoxycholate is present at a concentration of about 0.5% (w/v), about 1% (w/v), about 2% (w/v), or about 5% (w/v) in said composition.

10. The syringe or syringe-loadable container of claim 7, wherein said pharmaceutically acceptable excipient is selected from the group consisting of: water, a buffer, benzyl alcohol, and combinations thereof.

11. The syringe or syringe-loadable container of claim 7, wherein said pharmaceutically acceptable excipients consist of a buffer and benzyl alcohol.

12. The syringe or syringe-loadable container of claim 7, wherein the deoxycholate has a .sup.14C content of less than 0.9 ppt.

13. A syringe or syringe-loadable container comprising an aqueous pharmaceutical composition comprising a deoxycholate salt, phosphatidyl choline and at least one pharmaceutically acceptable excipient and/or carrier, wherein the deoxycholate has a .sup.14C content of less than 1 ppt.

14. The syringe or syringe-loadable container of claim 13, wherein said deoxycholate salt is sodium deoxycholate.

15. The syringe or syringe-loadable container of claim 14, wherein said sodium deoxycholate is present at a concentration of about 0.5% (w/v), about 1% (w/v), about 2% (w/v), or about 5% (w/v) in said composition.

16. The syringe or syringe-loadable container of claim 13, wherein said pharmaceutically acceptable excipient is selected from the group consisting of: water, a buffer, benzyl alcohol, and combinations thereof.

17. The syringe or syringe-loadable container of claim 13, wherein said pharmaceutically acceptable excipients consist of a buffer and benzyl alcohol.

18. The syringe or syringe-loadable container of claim 13, wherein the deoxycholate has a .sup.14C content of less than 0.9 ppt.

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