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 pharmaceutical composition comprising:
5-cholesten-3,25-diol, 3-sulfate (25HC3S) or salt thereof, wherein the 25HC3S or salt thereof is present in the pharmaceutical composition at a concentration ranging from 0.1 mg/mL to 50 mg/mL; and
an aqueous vehicle comprising 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 pharmaceutical composition of claim 1 , wherein the 25HC3S or salt thereof comprises a salt of 25HC3S.
3. The pharmaceutical composition of claim 1 , wherein the at least one cyclic oligosaccharide is present in the pharmaceutical composition at a concentration ranging from 0.1% (w/w) to 90% (w/w).
4. The pharmaceutical composition of claim 2 , wherein the at least one cyclic oligosaccharide is present in the pharmaceutical composition at a concentration ranging from 0.1% (w/w) to 90% (w/w).
5. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition has an osmolality ranging from 270 mmol/kg to 340 mmol/kg.
6. The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition has an osmolality ranging from 270 mmol/kg to 340 mmol/kg.
7. The pharmaceutical composition of claim 3 , wherein the pharmaceutical composition has an osmolality ranging from 270 mmol/kg to 340 mmol/kg.
8. The pharmaceutical composition of claim 4 , wherein the pharmaceutical composition has an osmolality ranging from 270 mmol/kg to 340 mmol/kg.
9. The pharmaceutical composition of claim 1 , wherein the 25HC3S or salt thereof comprises a sodium salt of 25HC3S.
10. The pharmaceutical composition of claim 3 , wherein the 25HC3S or salt thereof comprises a sodium salt of 25HC3S.
11. The pharmaceutical composition of claim 5 , wherein the 25HC3S or salt thereof comprises a sodium salt of 25HC3S.
12. The pharmaceutical composition of claim 1 , wherein the at least one cyclic oligosaccharide comprises hydroxypropyl β-cyclodextrin.
13. The pharmaceutical composition of claim 2 , wherein the at least one cyclic oligosaccharide comprises hydroxypropyl β-cyclodextrin.
14. The pharmaceutical composition of claim 3 , wherein the at least one cyclic oligosaccharide comprises hydroxypropyl β-cyclodextrin.
15. The pharmaceutical composition of claim 9 , wherein the at least one cyclic oligosaccharide comprises hydroxypropyl β-cyclodextrin.
16. The pharmaceutical composition of claim 1 , wherein the at least one cyclic oligosaccharide is present in the pharmaceutical composition at a concentration ranging from 0.1% (w/w) to 40% (w/w).
17. The pharmaceutical composition of claim 1 , wherein the at least one buffer is present in the pharmaceutical composition at a concentration ranging from 0.1 mM to 50 mM.
18. The pharmaceutical composition of claim 1 , wherein
the 25HC3S or salt thereof comprises a sodium salt of 25HC3S,
the at least one cyclic oligosaccharide comprises hydroxypropyl β-cyclodextrin,
the at least one cyclic oligosaccharide is present in the 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 pharmaceutical composition at a concentration ranging from 0.1 mM to 50 mM.
19. The pharmaceutical composition of claim 1 , wherein:
a volume of the pharmaceutical composition ranges from 0.5 mL to 5 mL; and
the at least one cyclic oligosaccharide is present in the composition at a concentration ranging from 1% (w/w) to 40% (w/w).
20. The pharmaceutical composition of claim 1 , wherein:
a volume of the pharmaceutical composition ranges from 50 mL to 1000 mL; and
the at least one cyclic oligosaccharide is present in the composition at a concentration ranging from 0.1% (w/w) to 4% (w/w).