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METHOD FOR PRODUCING CINACALCET COMPOSITIONS FOR DIRECT TABLETING
专利权人:
发明人:
申请号:
EP12700675.7
公开号:
EP2804588B1
申请日:
2012.01.17
申请国别(地区):
EP
年份:
2017
代理人:
摘要:
The present invention relates generally to a novel method for producing pharmaceutical compositions of cinacalcet or pharmaceutically acceptable salts thereof in substantially dry powder form,which is very suitable for direct compression and for providing improved features of dissolution and compressibility. The method includes providing a core composition mixture including cinacalcet with a particle size distribution -d(90) of less than 150 µm and a diluent wherein the core composition has an overall particle size profile of less than 355 µmand separately selecting other fillers having bulk density of from 350 to 650 g/l, and mixing said excipients with the core composition. The method may further comprise the step of direct compression of the resulting powder into oral tablets.
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