Compositions comprising 5-cholesten-3, 25-diol, 3-sulfate (25HC3S) or pharmaceutically acceptable salt thereof and at least one cyclic oligosaccharide
Compositions comprising 5-cholesten-3,25-diol, 3-sulfate (25HC3S) or pharmaceutically acceptable salt thereof and at least one cyclic oligosaccharide, e.g., a cyclodextrin (CD), are provided. The compositions may be used to prevent and/or treat a variety of diseases and conditions, including organ failure (e.g. acute liver failure), high cholesterol/high lipids, and various inflammatory diseases and conditions.
1. A method of treating alcoholic hepatitis in a subject in need thereof, comprising intravenously administering an effective amount of an aqueous pharmaceutical composition comprising:
5-cholesten-3,25-diol, 3-sulfate (25HC3 S) or pharmaceutically acceptable salt thereof,
at least one buffer, and
at least one cyclic oligosaccharide comprising at least one of hydroxypropyl β-cyclodextrin and sulfobutyl ether β-cyclodextrin.
2. The method of claim 1 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof comprises a pharmaceutically acceptable salt of 25HC3 S.
3. The method of claim 1 , wherein the at least one cyclic oligosaccharide is present in the aqueous pharmaceutical composition at a concentration ranging from 0.1% (w/w) to 90% (w/w).
4. The method of claim 1 , wherein the aqueous pharmaceutical composition has an osmolality ranging from 270 mmol/kg to 340 mmol/kg.
5. The method of claim 1 , wherein the 25HC3S or pharmaceutically acceptable salt thereof is administered at a dose ranging from 0.001 mg/kg to 100 mg/kg.
6. The method of claim 1 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof is administered at a dose ranging from 0.001 mg/kg to 10 mg/kg.
7. The method of claim 1 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof is administered at a dose ranging from 0.1 mg/kg to 10 mg/kg.
8. The method of claim 2 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof is administered at a dose ranging from 0.001 mg/kg to 10 mg/kg.
9. The method of claim 3 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof is administered at a dose ranging from 0.001 mg/kg to 10 mg/kg.
10. The method of claim 1 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof comprises a sodium salt of 25HC3S.
11. The method of claim 1 , wherein the at least one cyclic oligosaccharide comprises hydroxypropyl β-cyclodextrin.
12. The method of claim 1 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof is present in the aqueous pharmaceutical composition at a concentration ranging from 0.01% (w/w) to 3% (w/w).
13. The method of claim 8 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof is present in the aqueous pharmaceutical composition at a concentration ranging from 0.01% (w/w) to 3% (w/w).
14. The method of claim 1 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof is present in the aqueous pharmaceutical composition at a concentration ranging from 0.1 mg/mL to 50 mg/mL.
15. The method of claim 8 , wherein the 25HC3 S or pharmaceutically acceptable salt thereof is present in the aqueous pharmaceutical composition at a concentration ranging from 0.1 mg/mL to 50 mg/mL.
16. The method of claim 1 , wherein the at least one cyclic oligosaccharide is present in the aqueous pharmaceutical composition at a concentration ranging from 0.1% (w/w) to 40% (w/w).
17. The method of claim 8 , wherein the at least one cyclic oligosaccharide is present in the aqueous pharmaceutical composition at a concentration ranging from 0.1% (w/w) to 40% (w/w).
18. The method of claim 1 , wherein the at least one buffer is present in the aqueous pharmaceutical composition at a concentration ranging from 0.1 mM to 50 mM.
19. The method of claim 8 , wherein the at least one buffer is present in the aqueous pharmaceutical composition at a concentration ranging from 0.1 mM to 50 mM.
20. The method of claim 1 , wherein
the 25HC3 S or pharmaceutically acceptable salt thereof comprises a sodium salt of 25HC3 S,
the at least one cyclic oligosaccharide comprises hydroxypropyl β-cyclodextrin,
the 25HC3 S or pharmaceutically acceptable salt thereof is present in the aqueous pharmaceutical composition at a concentration ranging from 0.01% (w/w) to 3% (w/w),
the at least one cyclic oligosaccharide is present in the aqueous pharmaceutical composition at a concentration ranging from 0.1% (w/w) to 40% (w/w), and
the at least one buffer is present in the aqueous pharmaceutical composition at a concentration ranging from 0.1 mM to 50 mM.