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 composition consisting essentially of about 0.4% w/v to less than 2% w/v of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein said composition, when dissolved in water, is maintained at a pH of about 8.1 to about 8.5 and, when so maintained, said composition does not form a precipitate.
2. The composition of claim 1 , wherein said excipient is a solvent, a buffer, a preservative, a lyophilization aid, or any combination thereof.
3. The composition of claim 2 , wherein said excipient is a solvent.
4. The composition of claim 3 , wherein said solvent is sterile water.
5. The composition of claim 2 , wherein said excipient is a preservative.
6. The composition of claim 5 , wherein said preservative is benzyl alcohol.
7. The composition of claim 6 , wherein said preservative is 0.9% benzyl alcohol.
8. The composition of claim 1 , wherein said composition has a pH of about 8.3.
9. The composition of claim 1 , wherein said salt is an alkali metal salt.
10. The composition of claim 9 , wherein said alkali metal salt is sodium.
11. The composition of claim 2 , wherein said excipient comprises a buffer.
12. The composition of claim 11 , wherein said buffer comprises a phosphate buffer.
13. The composition of claim 11 , wherein said buffer comprises 10 mM phosphate buffer.
14. The composition of claim 11 , wherein said buffer comprises dibasic sodium phosphate buffer.