Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits
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 of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein said composition contains 0.5%±0.1% of said salt which, 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, and wherein said composition does not comprise phosphatidylcholine.
2. A composition consisting of a salt of deoxycholic acid and a pharmaceutically acceptable excipient, wherein said composition contains 1%±0.1% of said salt which, 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, and wherein said composition does not comprise phosphatidylcholine.
3. The composition of claims 1 or 2 , wherein said excipient is a solvent, a buffer, a preservative, a lyophilization aid, or any combination thereof.
4. The composition of claim 3 , wherein said excipient is a solvent.
5. The composition of claim 4 , wherein said solvent is sterile water.
6. The composition of claim 3 , wherein said excipient is a preservative.
7. The composition of claim 6 , wherein said preservative is benzyl alcohol.
8. The composition of claim 7 , wherein said preservative is 0.9% benzyl alcohol.
9. The composition of claims 1 or 2 , wherein said composition has a pH of about 8.3.
10. A composition consisting of:
a sterile aqueous solution buffered to a pH of about 8.3;
0.5%±0.1% w/v of sodium deoxycholate;
about 0.9% w/v benzyl alcohol; and
about 1% w/v of sodium chloride,
wherein the composition is stable against precipitation, and wherein said composition does not comprise phosphatidylcholine.
11. A composition consisting of:
an aqueous solution buffered to a pH of about 8.3;
1%±0.1% w/v of sodium deoxycholate;
about 0.9% w/v benzyl alcohol; and
about 1% w/v of sodium chloride,
wherein the composition is stable against precipitation, and wherein said composition does not comprise phosphatidylcholine.
12. The composition of claim 1 or 2 , wherein said salt is an alkali metal salt.
13. The composition of claim 12 , wherein said alkali metal salt is sodium.
14. A composition consisting of:
a sterile aqueous solution buffered to a pH of about 8.3;
0.5%±0.1% w/v of sodium deoxycholate;
about 10 mM sodium phosphate;
about 0.9% w/v benzyl alcohol; and
about 75 mM of sodium chloride,
wherein the composition is stable against precipitation, and wherein said composition does not comprise phosphatidylcholine.
15. A composition consisting of:
a sterile aqueous solution buffered to a pH of about 8.3;
1%±0.1% w/v of sodium deoxycholate;
about 10 mM sodium phosphate; and
about 0.86% w/v of sodium chloride,
wherein the composition is stable against precipitation, and wherein said composition does not comprise phosphatidylcholine.