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Claims for Patent: 6,903,083

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Claims for Patent: 6,903,083

Title: Stabilized hydroxyvitamin D
Abstract:The invention provides a stabilized 1.alpha.-hydroxyvitamin D ("SHVD") which is particularly well suited for pharmaceutical formulations.
Inventor(s): Knutson; Joyce C. (Madison, WI), Mazess; Richard B. (Madison, WI), Bishop; Charles W. (Mount Horeb, WI)
Assignee: Bone Care International, Inc. (Middleton, WI)
Application Number:10/223,986
Patent Claims: 1. A stabilized 1.alpha.-hydroxyvitamin D.sub.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 1.alpha.-hydroxyvitamin D.sub.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 .mu.g-25 .mu.g.

7. A composition which comprises a solution of an effective amount of the stabilized 1.alpha.-hydroxyvitamin D.sub.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 1.alpha.-hydroxyvitamin D.sub.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-.alpha.hydroxyvitamin D.sub.2 according to claim 1 and a pharmaceutically acceptable carrier.
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