Claims for Patent: 10,213,442

Summary for Patent: 10,213,442

Title:	Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3
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. (Miami Beach, FL), Crawford; Keith H. (Lone Tree, CO), Messner; Eric J. (Lake Forest, IL)
Assignee:	OPKO RENAL, LLC (Miami, FL)
Application Number:	15/722,757
Patent Claims:	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.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.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.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.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.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3 is released by diffusion. 20. The sustained release oral dosage formulation of claim 18, 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 released by disintegration of the matrix. 21. The sustained release oral dosage formulation of claim 18, 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 released by a combination of diffusion and disintegration of the matrix. 22. 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 dispersed within a matrix which is solid at body temperature. 23. A controlled release oral formulation comprising 25-hydroxyvitamin D.sub.3 and a pharmaceutical-grade matrix excipient. 24. A controlled release formulation comprising 25-hydroxyvitamin D.sub.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.sub.3 and a controlled release excipient. 31. A pharmaceutical composition comprising 25-hydroxyvitamin D.sub.3 and a controlled release delivery system.