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Claims for Patent: 8,207,149

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Claims for Patent: 8,207,149

Title:Method for treating secondary hyperparathyroidism in CKD
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): Tabash; Samir P. (Whitby, CA), White; Jay A. (Newmarket, CA), Bishop; Charles W. (Mount Horeb, WI), Agudoawu; Sammy A. (Mississauga, CA), Messner; Eric J. (Lake Forest, IL), Petkovich; P. Martin (Kingston, CA)
Assignee: Cytochroma, Inc. (Markham, CA) Proventiv Therapeutics, LLC (Bannockburn, IL)
Application Number:13/244,945
Patent Claims: 1. A method of treating secondary hyperparathyroidism in Chronic Kidney Disease (CKD) Stage 3 or Stage 4 in a human patient, comprising administering to the patient an effective amount of a controlled release, oral dosage form of 25-hydroxyvitamin D to reduce the subject's serum parathyroid hormone level by at least 30% while safely raising serum total 25-hydroxyvitamin D.

2. The method of claim 1, wherein the subject is vitamin D insufficient or vitamin D deficient.

3. The method of claim 2, wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to increase the subject's serum total 25-hydroxyvitamin D level to at least 30 ng/mL.

4. The method of claim 3, wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to increase the subject's serum total 25-hydroxyvitamin D level to a value in a range of 50 ng/mL to 90 ng/mL.

5. The method of claim 1, wherein the subject's plasma intact parathyroid hormone level is reduced to the target range for the CKD Stage.

6. The method of claim 1, wherein the 25-hydroxyvitamin D is selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D.sub.3, and a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3.

7. The method of claim 6, wherein the 25-hydroxyvitamin D is 25-hydroxyvitamin D.sub.3.

8. The method of claim 1, comprising administering said oral dosage on a schedule of once per day.

9. The method of claim 8, wherein the daily dose is in a range of 1 .mu.g to 1000 .mu.g.

10. The method of claim 1, wherein the daily dose of 25-hydroxyvitamin D is in a range of 1 .mu.g to 1000 .mu.g.

11. The method of claim 1, wherein the amount of 25-hydroxyvitamin D in the controlled release, oral dosage form is in a range of 1 .mu.g to 1000 .mu.g per unit dose.
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