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Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
专利权人:
发明人:
申请号:
EP13001210.7
公开号:
EP2604266A1
申请日:
2003.09.19
申请国别(地区):
EP
年份:
2013
代理人:
摘要:
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 agentwherein 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 1:11wherein 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.
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