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Pharmaceutical composition of imatinibe methanesulphonate and a process for its manufacture
专利权人:
发明人:
申请号:
EP12156117.9
公开号:
EP2497464A2
申请日:
2012.02.20
申请国别(地区):
EP
年份:
2012
代理人:
摘要:
Pharmaceutical composition of imatinib methanesulfonate has the form of a solid blend and consists of: a) from 99,7 to 96% by weight of granulate of imatinib methanesulfonate, wherein the granulate contains, based on total weight of the granulate, a1) from 81 to 100% by weight of imatinib methanesulfonate in the crystalline form alpha and a2) from 0 to 19% by weight of one or more pharmaceutical excipients b) from 0,3 to 3% by weight of an external lubricant and c) from 0 to 1% by weight of an extragranular glidant. The composition is manufactured by dry granulation of imatinib methanesulfonate, optionally with excipients, without using any solvents, followed by blending the resulting granulate with the lubricant, and optionally the glidant. The blend thus prepared is used for filling unit dosage forms.
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