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PROCESS FOR PREPARATION OF IMATINIB METHANESULFONATE CAPSULES
专利权人:
发明人:
申请号:
EP16460037.1
公开号:
EP3257499A1
申请日:
2016.06.17
申请国别(地区):
EP
年份:
2017
代理人:
摘要:
The process for preparation of hard gelatin capsules of imatinib methanesulfonate having a decreased volume consists in that the imatinib methanesulfonate granulate designated for the filling the capsules is deprived of a fraction of the particles size below 0.250 mm, extragranular ingredients are added and thus obtained blend is used to fill the hard gelatin capsules. The object of the invention is also the medicinal product in the form of hard gelatin capsules comprising imatinib methanesulfonate in an amount corresponding to the 100 mg imatinib dose in capsule size number 4 and the 400 mg imatinib dose in capsule size number 0el. The capsules are characterized by more advantageous dissolution profiles and better bioavailability in comparison with capsules manufactured from non-separated granulate.
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