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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 from about 8.0 to about 8.5.
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 or 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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