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Claims for Patent: 8,778,373

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Claims for Patent: 8,778,373

Title:Methods for controlled release oral dosage of a vitamin D compound
Abstract: A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Inventor(s): Bishop; Charles W. (Mount Horeb, WI), Tabash; Samir P. (Whitby, CA), Agudoawu; Sammy Asiamah (Mississauga, CA), White; Jay A. (Newmarket, CA), Crawford; Keith H. (Highlands Ranch, CO), Messner; Eric J. (Lake Forest, IL), Petkovich; P. Martin (Kingston, CA)
Assignee: Opko IP Holdings II, Inc. (Grand Cayman, KY) Opko Renal, LLC (Miami, FL)
Application Number:13/746,982
Patent Claims: 1. A method of administering an amount of a vitamin D compound to a patient by controlled release such that (a) the ratio of the maximum serum concentration within 24 hours after administration of the vitamin D compound to the concentration 24 hours after administration (Cmax.sub.24hr/C.sub.24hr) is reduced as compared to an equivalent amount of the vitamin D compound administered by bolus IV injection and/or an immediate-release, oral dosage form and/or (b) the time for the plasma concentration of the vitamin D compound to reach its maximum in a dose interval following administration (Tmax) is increased as compared to Tmax for an equivalent amount of the vitamin D compound administered by bolus IV injection and/or an equivalent immediate-release, oral dosage form, wherein the vitamin D compound comprises 25-hydroxyvitamin D.sub.3.

2. The method according to claim 1, wherein (a) the ratio of the maximum serum concentration within 24 hours after administration of the vitamin D compound to the concentration 24 hours after administration (Cmax.sub.24hr/C.sub.24hr) is reduced as compared to an equivalent amount of the vitamin D compound administered by bolus IV injection and/or an immediate-release, oral dosage form.

3. The method according to claim 1, comprising administering 25-hydroxyvitamin D.sub.3 to a human patient in an amount in a range of 1 to 100 .mu.g per day for an extended period of time.

4. The method of claim 3, wherein the extended period of time is at least one month.

5. The method according to claim 2, wherein the human patient is vitamin D deficient.

6. The method according to claim 2, wherein the human patient is vitamin D replete.

7. The method according to claim 2, wherein the human patient has secondary hyperparathyroidism associated with vitamin D deficiency.

8. The method according to claim 7, comprising administering 25-hydroxyvitamin D.sub.3 to the human patient to lower elevated PTH in a human patient by raising the patient's serum concentration of 25(OH)D to at least 30 ng/mL.

9. The method of claim 2, wherein the reduction in the ratio of the maximum serum concentration within 24 hours after administration of the vitamin D compound to the concentration 24 hours after administration (Cmax.sub.24hr/C.sub.24hr) is by a factor of at least 20%.

10. The method of claim 1, wherein (b) the time for the plasma concentration of the vitamin D compound to reach its maximum in a dose interval following administration (Tmax) is increased as compared to Tmax for an equivalent amount of the vitamin D compound administered by bolus IV injection and/or an equivalent immediate-release, oral dosage form.

11. The method according to claim 10, comprising administering 25-hydroxyvitamin D.sub.3 to a human patient in an amount in a range of 1 to 100 .mu.g per day for an extended period of time.

12. The method of claim 11, wherein the extended period of time is at least one month.

13. The method according to claim 10, wherein the human patient is vitamin D deficient.

14. The method according to claim 10, wherein the human patient is vitamin D replete.

15. The method according to claim 10, wherein the human patient has secondary hyperparathyroidism associated with vitamin D deficiency.

16. The method according to claim 15, comprising administering 25-hydroxyvitamin D.sub.3 to the human patient to lower elevated PTH in a human patient by raising the patient's serum concentration of 25(OH)D to at least 30 ng/mL.

17. The method according to claim 10, wherein the increase in the time for the plasma concentration of the vitamin D compound to reach its maximum in a dose interval following administration (Tmax) is by a factor of at least 25%.

18. The method of claim 1, comprising administering 25-hydroxyvitamin D.sub.3 to a human patient to prevent the patient's serum concentration of 25(OH)D from falling below 30 ng/mL.

19. The method according to claim 2, comprising administering 25-hydroxyvitamin D.sub.3 to a human patient in an amount in a range of 1 to 100 .mu.g per day for an extended period of time.

20. The method of claim 19, wherein the extended period of time is at least one month.
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