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Claims for Patent: 6,790,459

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Claims for Patent: 6,790,459

Title: Methods for treating diabetes via administration of controlled release metformin
Abstract:A method for treating patients having non-insulin-dependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing preferably a biguanide drug such as metformin, on a once-a-day basis. The dosage form provides a mean time to maximum plasma concentration (T.sub.max) of the drug which occurs at a 5.5 to 7.5 hours after oral administration on a once-a-day basis to human patients. Preferably, the dose of drug is administered at dinnertime to a patient in the fed state.
Inventor(s): Cheng; Xiu Xiu (Davie, FL), Chen; Chih-Ming (Davie, FL), Jan; Steve (Coral Springs, FL), Chou; Joseph (Manassas, VA)
Assignee: Andrx Labs, LLC (Davie, FL)
Application Number:09/705,625
Patent Claims: 1. A method for lowering blood glucose levels in human patients needing treatment for non-insulin-dependent diabetes mellitus (NIDDM), comprising orally administering to human patients on a once-a-day basis at least one oral controlled release dosage form comprising an effective dose of metformin or a pharmaceutically acceptable salt thereof and an effective amount of a controlled release carrier to control the release of said metformin or pharmaceutically acceptable salt thereof from said dosage form, wherein following oral administration of a single dose, the dosage form provides a mean time to maximum plasma concentration (T.sub.max) of metformin at from 5.5 to 7.5 hours after administration following dinner; and the administration of the at least one metformin dosage form provides a mean AUC.sub.0-24 of 22590.+-.3626 ng.multidot.hr/ml and a mean C.sub.max of 2435.+-.630 ng/ml on the first day of administration and a mean AUC.sub.0-24 of 24136.+-.7996 ng.multidot.hr/ml and a mean C.sub.max of 2288.+-.736 np/ml on the 14th day of administration, for administration of a 2000 mg once-a-day dose of metformin.

2. The method of claim 1, in which the administration of the at least one metformin dosage form provides a mean time to maximum plasma concentration (T.sub.max) of metformin at from 6.0 to 7.0 hours after administration.

3. The method of claim 1, in which the administration of the at least one metformin dosage form occurs at dinner time and provides a mean time to maximum plasma concentration (T.sub.max) of metformin at from 5.5 to 7.0 hours after the administration.

4. The method of claim 1, in which the administration of the at least one metformin dosage form provides a width at 50% of the height of a mean plasma concentration/time curve of metformin from about 4.5 to about 13 hours.

5. The method of claim 1, in which the administration of the at least one metformin dosage form provides a width at 50% of the height of a mean plasma concentration/time curve of metformin from about 5.5 to about 10 hours.

6. The method of claim 1, in which the administration of the at least one metformin dosage form provides a mean maximum plasma concentration (C.sub.max) of metformin which is more than about 7 times the mean plasma level of said metformin at about 24 hours after administration.

7. The method of claim 1, in which the administration of the at least one metformin dosage form provides a mean maximum plasma concentration (C.sub.max) of metformin which is from about 7 times to about 14 times the plasma level of said metformin at about 24 hours after administration.

8. The method of claim 1, in which the administration of the at least one metformin dosage form provides a mean maximum plasma concentration (C.sub.max) of metformin which is from about 8 times to about 12 times the plasma level of said metformin at about 24 hours after administration.

9. The method of claim 1, in which the administration of the at least one metformin dosage form provides a mean AUC.sub.0-24hr from at least 80% of the mean AUC.sub.0-24 provided by administration of an immediate release reference standard twice a day, wherein the daily dose of the reference standard is substantially equal to the once-a-day dose of metformin administered in the controlled release oral dosage form.

10. The method of claim 1, in which the administration of the at least one metformin dosage form provides a mean AUC.sub.0-24hr that is from at least 90% of the mean AUC.sub.0-24 provided by administration of an immediate release reference standard twice a day, wherein the daily dose of the reference standard is substantially equal to the once-a-day dose of metformin administered in the controlled release oral dosage form.

11. The method of claim 1, in which the once-a-day dosage of the metformin is about 2000 mg, which is provided by two controlled release dosage forms containing about 1000 mg.

12. The method of claim 1, in which the administration of the at least one metformin dosage form provides a mean AUC.sub.0-24 of 18277.+-.2961 ng.multidot.hr/ml and a mean C.sub.max of 1929.+-.333 ng/ml, for administration of a 1700 mg once-a-day dose of metformin.

13. The method of claim 1, in which the administration of the at least one metformin dosage form provides a mean t.sub.1/2 from 2.8 to 4.4.

14. The method of claim 1, further comprising administering to said human patients at least one additional pharmaceutically active ingredient for treatment of NIDDM.

15. The method of claim 1, further comprising administering to said human patients an additional pharmaceutically active ingredient for treatment of NIDDM, said additional pharmaceutically active ingredient selected from the group consisting of a sulfonylurea, a glitazone or a second biguanide.

16. The method of claim 1, in which the dose of metformin comprises metformin hydrochloride.

17. The method of claim 16, in which the once-a-day dose of metformin hydrochloride is about 1000 mg to about 2500 mg.

18. The method of claim 16, in which the once-a-day dose of metformin hydrochloride is about 2000 mg to about 2500 mg metformin.

19. The method of claim 1, in which the once-a-day dose of metformin or pharmaceutically acceptable salt thereof is 2000 mg.

20. The method of claim 1, in which the once-a-day dose of metformin or pharmaceutically acceptable salt thereof is 1000 mg.

21. The method of claim 1, in which the once-a-day dose of metformin or pharmaceutically acceptable salt thereof is 500 mg.
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