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Prasugrel controlled release formulations
专利权人:
发明人:
申请号:
EP10154259.5
公开号:
EP2275087B8
申请日:
2010.02.22
申请国别(地区):
EP
年份:
2012
代理人:
摘要:
The present invention relates to a pharmaceutical product for oral administration with controlled release properties regarding pH and release rate. The product comprises prasugrel base in a matrix type pharmaceutical composition which has a dosage form of powder, granules, tablets or, capsules.The present invention relates also to a pharmaceutical product, which is obtained by(a) mixing and heating a blend comprising prasugrel base particles, one or more waxy compounds having a melting temperature in the range of 40 to 70 °C, and pharmaceutically acceptable excipients selected from the group consisting of diluents, such as lactose or microcrystalline cellulose, and glidants, such as silicon dioxide, at a temperature of from the melting point of said waxy compounds to below the decomposition temperature of prasugrel,(b) forming a melt granulate or a melt extrudate, cooling to room temperature, and(c) processing the melt granulate or melt extrudate into prasugrel comprising granular pharmaceutical composition, and optionally(d) mixing the formed granules with other common additives such as a diluent, a disintegrant, a lubricant, a binder, a colorant, a coating agent, etc, in order to form the desired solid dosage form.
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