Claims for Patent: 9,943,530

Summary for Patent: 9,943,530

Title:	Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
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:	14/548,275
Patent Claims:	1. A method of maintaining serum 25-hydroxyvitamin D at a level of at least 30 ng/mL in a patient comprising orally administering to the patient a sustained release 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 method of claim 1, wherein the administration is once a day. 3. The method of claim 1, comprising administering 1 to 100 mcg per day 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. 4. The method of claim 3, comprising administering 30 mcg of 25-hydroxyvitamin D.sub.3 to the patient per day. 5. The method of claim 1, comprising administering 30 mcg of 25-hydroxyvitamin D.sub.3 daily for at least 3 weeks. 6. The method of claim 1, wherein the sustained release formulation comprises an amount 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 in a range of 1 mcg to 50 mcg. 7. The method of claim 6, wherein the sustained release formulation comprises 30 mcg of 25-hydroxyvitamin D.sub.3. 8. The method of claim 1, wherein the sustained release formulation comprises 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 dispersed within a matrix comprising a release-controlling constituent. 9. The method of claim 1, wherein the sustained release formulation comprises a lipid matrix comprising a glyceride. 10. The method of claim 1, wherein the sustained release formulation comprises 25-hydroxyvitamin D.sub.3 dispersed within a matrix comprising a wax and an oil. 11. The method of claim 1, wherein the sustained release formulation further comprises a glyceride. 12. The method of claim 1, wherein the sustained release formulation is a soft capsule. 13. The method of claim 1, wherein the sustained release formulation comprises 25-hydroxyvitamin D.sub.3 dispersed in a matrix comprising a wax and an oil, and a soft capsule shell. 14. A method of mitigating a surge in Vitamin D metabolism comprising administering an effective amount of a sustained release 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 to a patient in need of treatment thereof wherein CYP24-mediated catabolism to produce 24, 25-dihydroxyvitamin D is reduced compared to treatment with an equal dose of an immediate release composition. 15. The method of claim 14, wherein the administration reduces the risk of hypercalciuria, hypercalcemia, and/or hyperphosphatemia compared to the immediate release composition. 16. The method of claim 14, wherein the administration repletes blood or intracellular 25-hydroxyvitamin D levels more efficiently compared to the immediate release composition. 17. The method of claim 14, wherein the administration avoids supraphysiologic concentrations of 25-hydroxyvitamin D.sub.3 in the blood, cells, and/or lumen. 18. The method of claim 14, comprising orally administering 1 mcg to 100 mcg of 25-hydroxyvitamin D.sub.3 to the patient per day. 19. The method of claim 14, wherein the sustained release formulation comprises 25-hydroxyvitamin D.sub.3 dispersed in a matrix comprising a wax and an oil, and a soft capsule shell. 20. A method of reducing excessive intracellular 24-hydroxylation of 25-hydroxyvitamin D.sub.3 comprising administering an effective amount of a sustained release dosage form of 25-hydroxyvitamin D.sub.3 to a patient in need of treatment thereof, wherein the intracellular 24-hydroxylation of 25-hydroxyvitamin D.sub.3 is reduced relative to treatment with an equal dose of an immediate release composition of 25-hydroxyvitamin D.sub.3. 21. The method of claim 1, wherein the sustained 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 is effected over a period of at least four hours. 22. The method of claim 21, wherein the sustained 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 is effected over a period of at least eight hours. 23. The method of claim 1, wherein the sustained release formulation comprises an amount 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 in a range of 1 mcg to 50 mcg dispersed in a matrix comprising a wax and an oil. 24. The method of claim 1, wherein the sustained release formulation comprises an amount 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 in a range of 1 mcg to 50 mcg dispersed in a matrix comprising a wax and an oil, and disposed in a soft capsule shell.