Formulations of deoxycholic acid and salts thereof
The present application is directed to an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid, wherein the composition is maintained at a pH from about 8.1 to about 8.5 such that the composition is stabilized against precipitation. Also disclosed herein, are methods for stabilizing an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid against precipitation, said method comprising maintaining pH of the solution from about 8.1 to about 8.5.
1. A method for stabilizing an aqueous composition of a salt of deoxycholic acid against precipitation during storage, which method comprises:
a) forming an aqueous solution of the salt of deoxycholic acid;
b) adjusting the pH of the aqueous solution to a pH of from about 8.1 to about 8.5 thereby stabilizing said composition against precipitation during storage; and
c) and forming the aqueous composition consisting of the salt of deoxycholic acid at a concentration ranging from about 0.4% w/v to less than 2% w/v and at least one pharmaceutically acceptable excipient and/or carrier.
2. The method of claim 1 , wherein said salt is the sodium salt of deoxycholic acid.
3. The method of claim 1 , wherein the pH of the aqueous solution is maintained at about 8.3.
4. The method of claim 3 , wherein said salt is the sodium salt of deoxycholic acid.
5. The method of claim 1 , wherein the pH is maintained at from about 8.1 to about 8.5.
6. The method of claim 5 , wherein the pH is maintained with a sufficient amount of buffer.