You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for Patent: 8,309,125


✉ Email this page to a colleague

« Back to Dashboard


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.

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.