Stabilized hydroxyvitamin D
The invention provides a stabilized 1α-hydroxyvitamin D (“SHVD”) which is particularly well suited for pharmaceutical formulations.
1. A stabilized 1α-hydroxyvitamin D 2 characterized by a purity equal to or greater than 98% by a weight-based HPLC assay, residual solvents of 0.5% or less, a total impurity of 1.5% or less, and no single impurity of greater than 0.5%.
2. A pharmaceutical composition comprising an active component which is the stabilized 1α-hydroxyvitamin D 2 of claim 1 .
3. The composition of claim 2 , which is a soft gelatin, capsule.
4. The composition of claim 2 which is a solution.
5. The composition of claim 4 , wherein the solution is contained in a vial.
6. The composition of claim 2 , in unit dosage form, having a content of active component of 0.5 μg-25 μg.
7. A composition which comprises a solution of an effective amount of the stabilized 1α-hydroxyvitamin D 2 of claim 1 in an oil, the solution contained in a soft gelatin capsule.
8. The composition of claim 7 wherein the oil comprises fractionated coconut oil.
9. The composition of claim 7 , which further comprises an antioxidant.
10. The composition of claim 9 , wherein the antioxidant is selected from the group consisting of butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT) or vitamin E.
11. The composition of claim 10 , wherein the antioxidant is butylated hydroxyanisole (BHA).
12. The composition of claim 10 , wherein the antioxidant is butylated hydroxytoluene (BHT).
13. The composition of claim 10 , wherein the antioxidant is vitamin E.
14. A composition which comprises a solid pharmaceutical preparation of an effective amount of the stabilized 1α-hydroxyvitamin D 2 of claim 1 , wherein the solid pharmaceutical preparation is in the form of a tablet, a capsule, a granule or a powder.
15. The composition of claim 14 , wherein the pharmaceutical preparation is in the form of a tablet.
16. The composition of claim 14 , wherein the pharmaceutical preparation is in the form of a capsule.
17. The composition of claim 14 , wherein the pharmaceutical preparation is in the form of a granule.
18. The composition of claim 14 , wherein the pharmaceutical preparation is in the form of a powder.
19. A pharmaceutical composition consisting essentially of a stabilized 1-αhydroxyvitamin D 2 according to claim 1 and a pharmaceutically acceptable carrier.