Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D

1. A sustained release oral dosage formulation of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 in combination with one or more calcium salts, bisphosphonates, calcimimetics, nicotinic acid, iron, phosphate binders, cholecalciferol, ergocalciferol, active Vitamin D sterols, glycemic and hypertension control agents, and antineoplastic agents.

2. The sustained release oral dosage formulation of claim 1 , comprising 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 in combination with one or more calcium salts.

3. The sustained release oral dosage formulation of claim 1 , comprising 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 in combination with one or more bisphosphonates.

4. The sustained release oral dosage formulation of claim 1 , comprising 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 in combination with nicotinic acid.

5. The sustained release oral dosage formulation of claim 1 , comprising 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 in combination with iron.

6. The sustained release oral dosage formulation of claim 1 , comprising 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 in combination with one or more phosphate binders.

7. The sustained release oral dosage formulation of claim 1 , comprising 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 in combination with one or more glycemic control agents.

8. The sustained release oral dosage formulation of claim 1 , comprising 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 in combination with one or more hypertension control agents.

9. The sustained release oral dosage formulation of claim 1 , comprising 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 in combination with one or more antineoplastic agents.

10. A sustained release oral dosage formulation of 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 dispersed within a matrix and encased with a coating material.

11. The sustained release oral dosage formulation of claim 10 , having a melting point which is higher than body temperature but lower than the melting temperature of the coating material.

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

13. The sustained release oral dosage formulation of claim 12 , wherein the lipid comprises one or more glycerides, fatty acids, fatty alcohols, fatty acid esters, or combinations thereof.

14. The sustained release oral dosage formulation of claim 13 , wherein the lipid comprises one or more glycerides.

15. The sustained release oral dosage formulation of claim 13 , wherein the lipid comprises one or more fatty acids.

16. The sustained release oral dosage formulation of claim 13 , wherein the lipid comprises one or more fatty alcohols.

17. The sustained release oral dosage formulation of claim 13 , wherein the lipid comprises one or more fatty acid esters.

18. A sustained release oral dosage formulation of 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 dispersed within a matrix and comprising a permeable overcoating.

19. The sustained release oral dosage formulation of claim 18 , wherein the 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 is released by diffusion.

20. The sustained release oral dosage formulation of claim 18 , wherein the 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 is released by disintegration of the matrix.

21. The sustained release oral dosage formulation of claim 18 , wherein the 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 is released by a combination of diffusion and disintegration of the matrix.

22. A sustained release oral dosage formulation of 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 dispersed within a matrix which is solid at body temperature.

23. A controlled release oral formulation comprising 25-hydroxyvitamin D 3 and a pharmaceutical-grade matrix excipient.

24. A controlled release formulation comprising 25-hydroxyvitamin D 3 dispersed within a matrix wherein the matrix comprises a mixture of rate controlling constituents and excipients.

25. The formulation according to claim 24 , encased with a coating material.

26. The formulation according to claim 24 , wherein the rate controlling constituents are lipophilic.

27. The formulation according to claim 26 , encased with a coating material.

28. The formulation according to claim 24 wherein the rate controlling constituent comprises a poly(meth)acrylate polymer.

29. The formulation according to claim 28 , encased with a coating material.

30. A capsule comprising 25-hydroxyvitamin D 3 and a controlled release excipient.

31. A pharmaceutical composition comprising 25-hydroxyvitamin D 3 and a controlled release delivery system.