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|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 (Thousand Oaks, CA), Webster; Jeffrey Douglas (Thousand Oaks, CA)|
|Assignee:||Kythera Biopharmaceuticals, Inc. (Calabasas, CA)|
1. An aqueous pharmaceutical formulation consisting of from about 0.5% w/v to about 1.5% w/v deoxycholate and at least one pharmaceutically acceptable excipient and/or
carrier wherein the formulation has a pH of about 8.3.
2. The aqueous pharmaceutical formulation of claim 1, wherein the aqueous formulation is suitable for subcutaneous injection.
3. The aqueous pharmaceutical formulation of claim 1, wherein said at least one pharmaceutically acceptable excipient and/or carrier is selected from the group consisting of water, a buffer, and a preservative.
4. The aqueous pharmaceutical formulation of claim 2, wherein said at least one pharmaceutically acceptable excipient and/or carrier is selected from the group consisting of water, a buffer, and a preservative.
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