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MONOCLINIC CRYSTALLINE FORM OF ASENAPINE MALEATE WITH A SPECIFIC PARTICLE SIZE DISTRIBUTION
专利权人:
发明人:
申请号:
EP12722788.2
公开号:
EP2709615A1
申请日:
2012.05.18
申请国别(地区):
EP
年份:
2014
代理人:
摘要:
A monoclinic crystalline form of asenapine maleate is described, which is characterized in that it is not micronised and has a particle size distribution characterized by a d90 of 40 μm or less. A process for the preparation of a monoclinic crystalline form of asenapine maleate is also described, the process comprising the following steps: a) providing a mixture of monoclinic asenapine maleate and an organic solvent which, under the conditions of the process, acts as an antisolvent b) stirring the mixture at a temperature between 15 and 60° C. and c) collecting the crystals, wherein the organic solvent is selected from alcohols, ketones, ethers, esters, hydrocarbons or mixtures thereof.
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