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Claims for Patent: 8,906,410

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Claims for Patent: 8,906,410

Title:Oral dosage form of 25-hydroxyvitamin D
Abstract: Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3.
Inventor(s): Bishop; Charles W. (Mount Horeb, WI), Crawford; Keith H. (Highlands Ranch, CO), Messner; Eric J. (Lake Forest, IL)
Assignee: Opko Health, Inc. (N/A)
Application Number:13/848,982
Patent Claims: 1. A sustained release oral dosage formulation of 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3.

2. The sustained release oral dosage formulation of claim 1, wherein the formulation further provides delayed release of the 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3 after ingestion of the formulation.

3. The sustained release oral dosage formulation of claim 2, wherein release is substantially delayed until the 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3 reaches the ileum of the intestine.

4. The sustained release oral dosage formulation of claim 2, further comprising an enteric coating.

5. The sustained release oral dosage formulation of claim 1, comprising the 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3 dispersed within a matrix.

6. The sustained release oral dosage formulation of claim 5, wherein the matrix releasably binds the 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3.

7. The sustained release oral dosage formulation of claim 6, wherein the matrix provides for release of the 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3 via diffusion.

8. The sustained release oral dosage formulation of claim 6, wherein the matrix provides for release of the 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3 via disintegration of the matrix.

9. The sustained release oral dosage formulation of claim 6, wherein the dosage form further comprises a permeable framework around the matrix.

10. The sustained release oral dosage formulation of claim 5, wherein the matrix comprises a wax matrix.

11. The sustained release oral dosage formulation of claim 10, wherein the wax matrix comprises a wax and an oil.

12. The sustained release oral dosage formulation of claim 5, further comprising a glyceride.

13. The sustained release oral dosage formulation of claim 5, further comprising a gelatin capsule, the wax matrix being disposed in the gelatin capsule.

14. The sustained release oral dosage formulation of claim 13, wherein the gelatin capsule is a hard gelatin capsule.

15. The sustained release oral dosage formulation of claim 5, wherein the formulation is semi-solid at body temperature.

16. The sustained release oral dosage formulation of claim 13, wherein the gelatin capsule is a soft gelatin capsule.

17. The sustained release oral dosage formulation of claim 1, wherein the 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3 is contained in granules coated with a polymer.

18. The sustained release oral dosage formulation of claim 17, wherein the polymer comprises an insoluble polymer selected from the group consisting of methacrylic acid esters, polyvinyl esters, polyvinyl acetals, polyacrylic acid esters, and butadiene styrene copolymers.

19. The sustained release oral dosage formulation of claim 18, wherein the polymer comprises methacrylic acid esters.

20. The sustained release oral dosage formulation of claim 19, further comprising trimethylammonioethyl methacrylate chlorides.

21. The sustained release oral dosage formulation of claim 1, comprising 1 to 50 mcg per unit dose of the 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3.

22. The sustained release oral dosage formulation of claim 1, wherein the sustained release is effected over a period of at least four hours.

23. The sustained release oral dosage formulation of claim 1, comprising 25-hydroxyvitamin D.sub.3.

24. The sustained release oral dosage formulation of claim 1, wherein the release of 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3 avoids supraphysiologic surges in intralumenal, intracellular, and/or blood levels of 25-hydroxyvitamin D.

25. A sustained release oral dosage formulation of 25-hydroxyvitamin D.sub.3 dispersed within a wax matrix comprising a wax, an oil, and a glyceride, and disposed within a capsule.
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