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Details for Patent: 8,309,125

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Details for Patent: 8,309,125

Title:Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Abstract: A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.
Inventor(s): Kositprapa; Unchalee (Davie, FL), Nangia; Avinash (Weston, FL), Cardinal; John (Tamarac, FL), Goldfarb; Robert I. (Golden Beach, FL)
Assignee: Watson Pharmaceuticals, Inc. (Corona, CA)
Filing Date:Jul 14, 2010
Application Number:12/835,945
Claims:1. A method for preparing a sustained release oral tablet comprising: a) forming a controlled release metformin hydrochloride tablet comprising 500 mg to 1000 mg of metformin; b) preparing an immediate release coating solution comprising: i) pioglitazone hydrochloride; ii) water; iii) an organic solvent selected from the group consisting of acetone, isopropyl alcohol, methanol or ethanol; iv) a binder; v) optionally a surfactant; vi) optionally a pore forming agent wherein the ratio of water to organic solvent is 50:50 to 2:98 and the ratio of binder to pioglitazone hydrochloride is 1:9 to 1:11; c) applying the immediate release coating solution to the controlled release metformin hydrochloride tablet so that when tested in a United States Pharmacopeia (USP) Type 2 apparatus at 75 rpm in 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) and at 37.degree. C., not less than 75% of the pioglitazone hydrochloride is released from the sustained release tablet in 30 minutes.

2. The method of claim 1 wherein not less than 95% of the pioglitazone hydrochloride is released from the sustained release tablet in 30 minutes.

3. The method of claim 1 wherein the sustained release tablet is prepared without a gelling polymer.

4. The method of claim 1 wherein the controlled release metformin hydrochloride tablet is formed by: A) mixing the metformin hydrochloride with at least one pharmaceutically acceptable excipient; B) compressing the mixture of step (A) into a tablet; and C) coating the tablet of step (B) with a membrane.

5. A tablet prepared by the method of claim 1.

6. A method for preparing a sustained release oral tablet comprising: i) forming a controlled release metformin hydrochloride tablet comprising 500 mg to 1000 mg of metformin and without a gelling polymer comprising the steps of: a) mixing the metformin hydrochloride with at least one pharmaceutically acceptable excipient; b) compressing the mixture of step (a) into a tablet; and c) coating the tablet of step (b) with a membrane; ii) preparing an immediate release coating solution comprising: a) pioglitazone hydrochloride; b) water; c) an organic solvent selected from the group consisting of acetone, isopropyl alcohol, methanol or ethanol; d) a binder; e) optionally a surfactant; f) optionally a pore forming agent wherein the ratio of water to organic solvent is 50:50 to 2:98 and the ratio of binder to pioglitazone hydrochloride is 1:9 to 1:11; iii) applying the immediate release coating solution to the membrane of the controlled release metformin hydrochloride tablet so that when tested in a United States Pharmacopeia (USP) Type 2 apparatus at 75 rpm in 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) and at 37.degree. C., not less than 95% of the pioglitazone hydrochloride is released from the sustained release tablet in 30 minutes.

7. A tablet prepared by the method of claim 6.
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