BOCK, Dominique Anna,MAIER, Thomas,HAFERKAMP, Sven,PORSTMANN, Frank
申请号：
EP20150705246
公开号：
EP3105203(A1)
申请日:
2015.02.10
申请国别(地区):
欧洲专利局
年份:
2016
代理人:
摘要：
Tapentadol hydrochloride ((1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride) in stable polymorphic crystal form B which is substantially free of polymorphic crystal form A, characterised in that the crystal exhibits a PXRD pattern in which the intensity of the peaks at 2Theta 18.89o, 22,58o and 24.28o (+-0.3o) are each ≤ 1.5%, preferably ≤ 1% relative to the peak at 2Theta 14.55o (+-0.3o), more specifically at 2Theta 18.25o, 18.89o, 22.58o and 24.28o (+-0.3o) are each ≤1.5%, preferably ≤1% relative to the peak 2Theta 14.55o (+-0.3o). Preferably the tapentadol is essentially free of low alkyl carboxylic acids or esters of such acids. Processes of preparing tapentadol hydrochloride substantially in a stable polymorphic pure form B are also provided.
