Formulations of deoxycholic acid and salts thereof
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.
1. An aqueous pharmaceutical formulation consisting of about 0.05% w/v to about 2% w/v sodium 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 , wherein said at least one pharmaceutically acceptable excipient and/or carrier is selected from the group consisting of water, and a preservative.
4. The aqueous pharmaceutical formulation of claim 1 , wherein the pH is about 8.3.
5. The aqueous pharmaceutical formulation of claim 3 , wherein said preservative is benzyl alcohol.
6. 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 base; a preservative; and a tonicity agent.
7. The aqueous pharmaceutical formulation of claim 6 , wherein said preservative is benzyl alcohol.
8. The aqueous pharmaceutical formulation of claim 6 , wherein said base is sodium hydroxide.
9. The aqueous pharmaceutical formulation of claim 6 , wherein said tonicity agent is sodium chloride.