Controlled release metformin compositions
A method for treating a patient using an antidiabetic drug, said method comprising administering to the patient a high dose of the antidiabetic drug wherein said antidiabetic drug exhibits one or more dose proportional pharmacokinetic parameters is described.
1 . A method for treating a patient using an antidiabetic drug, said method comprising administering to the patient a high dose of the antidiabetic drug wherein said antidiabetic drug exhibits one or more dose proportional pharmacokinetic parameters.
2 . The method of claim 1 wherein said antidiabetic drug is selected from the group consisting of biguanides, hormone analogues, sulfonylureas, and thiozolidinediones or salts, derivatives, prodrugs or metabolites thereof.
3 . The method of claim 1 wherein said antidiabetic drug is a biguanide.
4 . The method of claim 3 wherein said biguanide is metformin.
5 . The method of claim 1 wherein said antidiabetic drug is administered once a day.
6 . The method of claim 1 wherein said antidiabetic drug is administered to lower blood sugar.
7 . The method of claim 1 wherein said antidiabetic drug is administered to a patient in need of treatment of non-insulin-dependent diabetes mellitus (NIDDM).
8 . The method of claim 1 wherein the dose proportional pharmacokinetic parameter is selected from the group consisting of AUC and Cmax.
9 . The method of claim 3 wherein said biguanide is administered at a dose of greater than about 500 mg.
10 . The method of claim 3 wherein said biguanide is administered at a dose of greater than about 750 mg.
11 . The method of claim 3 wherein said biguanide is administered at a dose of greater than about 850 mg.
12 . The method of claim 3 wherein said biguanide is administered at a dose of greater than about 1000 mg.
13 . The method of claim 3 wherein said biguanide is administered at a dose of greater than about 1500 mg.
14 . The method of claim 3 wherein said biguanide is administered at a dose of greater than about 2000 mg.
15 . The method of claim 3 wherein said biguanide is administered at a dose of greater than about 2500 mg.
16 . The method of claim 4 wherein administration of metformin exhibits the pharmacokinetic parameters selected from the group consisting of
(a) Cmax of about 1 to about 3.1 μg/ml; and
(b) AUC of about 9 to about 29 μg·h/ml;
after administration of about 500 mg to about 2500 mg of metformin.
17 . The method of claim 16 wherein administration of metformin exhibits the pharmacokinetic parameters selected from the group consisting of
(a) Cmax of about 1 to about 2 μg/ml; and
(b) AUC of about 9 to about 15 μg·h/ml;
after administration of about 1000 mg of metformin.
18 . The method of claim 16 wherein administration of metformin exhibits the pharmacokinetic parameters selected from the group consisting of
(a) Cmax of about 1.2 to about 2.4 μg/ml; and
(b) AUC of about 12 to about 21 μg·h/ml;
after administration of about 1500 mg of metformin.
19 . The method of claim 16 wherein administration of metformin exhibits the pharmacokinetic parameters selected from the group consisting of
(a) Cmax of about 1.5 to about 2.7 μg/ml; and
(b) AUC of about 17 to about 25 μg·h/ml;
after administration of about 2000 mg of metformin.
20 . The method of claim 16 wherein administration of metformin exhibits the pharmacokinetic parameters selected from the group consisting of
(a) Cmax of about 1.9 to about 3.1 μg/ml; and
(b) AUC of about 20 to about 29 μg·h/ml;
after administration of about 2500 mg of metformin.
21 . The method of claim 1 wherein said high dose of the antidiabetic drug is released in a controlled manner.