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Claims for Patent: 8,426,391

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Claims 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.
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