You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

Claims for Patent: 8,207,149


✉ Email this page to a colleague

« Back to Dashboard


Summary 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.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.