PHARMACEUTICAL TABLET

• Main Authors: NANGIA AVINASH, KOSITPRAPA UNCHALEE, GOLDFARB ROBERT I, CARDINAL JOHN
• Format: Patent
• Language: English; Korean
• Published: 29.12.2010
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

A method of preparing a pharmaceutical dosage form having a first and second active drug, comprising (a) forming a controlled release core comprising metformin or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient; (b) coating a coating solution on said controlled release core to form an immediate release coating, said coating solution comprising: (i) pioglitazone or a pharmaceutically acceptable salt thereof; (ii) water; (iii) an organic solvent; (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 or the salt thereof is 1:9 to 1:11; wherein said dosage form releases not less than 75% of the pioglitazone or the salt thereof from the dosage form within 0.5 hour 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°C.