Claims for Patent: 8,426,391

Summary for Patent: 8,426,391

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. (Mt. Horeb, WI), Crawford; Keith H. (Fitchburg, WI), Messner; Eric J. (Lake Forest, IL)
Assignee:	Proventiv Therapeutics, LLC (Bannockburn, IL)
Application Number:	12/278,053
Patent Claims:	1. A method of treating 25-hydroxyvitamin D insufficiency or deficiency 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, 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. 3. The method of claim 1, comprising administering an effective amount of the formulation to increase the patient's serum total 25-hydroxyvitamin D level to at least 30 ng/mL. 4. The method of claim 1, wherein the administration provides a lower maximum (C.sub.max) blood level of 25-hydroxyvitamin D compared to an equal dose of an immediate release formulation. 5. The method of claim 4, wherein the administration avoids a transient supraphysiologic surge of blood 25-hydroxyvitamin D. 6. The method of claim 1, wherein the administration avoids transient increases in blood levels of 25-hydroxyvitamin D of greater than 3 ng/mL following a unit dose. 7. The method of claim 1, wherein the administration increases the bioavailability 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, compared to an equal dose of an immediate release formulation. 8. The method of claim 1, wherein the 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. 9. The method of claim 1, wherein the 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. 10. The method of claim 8, wherein the matrix comprises a wax matrix. 11. The method of claim 1, wherein the administration is once a day. 12. The method of claim 1, wherein the administration is of 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 100 mcg per day. 13. The method of claim 12, wherein the administration is of 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 5 mcg to 50 mcg per day. 14. A method of treating 25-hydroxyvitamin D insufficiency or deficiency in a patient comprising gradually administering to the patient a 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 avoid a transient supraphysiologic surge of blood 25-hydroxyvitamin D.