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. A method for inhibiting precipitation of sodium deoxycholate in an aqueous solution to increase the shelf life of the solution, comprising preparing an aqueous solution of sodium deoxycholate and adjusting the pH of the solution to be sufficient to substantially inhibit precipitation of the sodium deoxycholate, wherein the aqueous solution consists of from about 0.05% w/v to about 2% w/v sodium deoxycholate and at least one pharmaceutically acceptable excipient and/or carrier; and wherein the pH of the solution is adjusted to be between about 8.0 and about 8.5.
2. The method of claim 1 , wherein the pH is adjusted to about 8.3.
3. The method of claim 1 , wherein the sodium deoxycholate is present in an amount from about 0.5% w/v to about 1.5% w/v.
4. The method of claim 1 , wherein the sodium deoxycholate is present in an amount of about 1% w/v.
5. The method of claim 1 , wherein the at least one pharmaceutically acceptable excipient and/or carrier is selected from the group consisting of water, a buffer and a preservative.