发明公开
EP2176241A2 A NOVEL HYDRATED FORM OF ERLOTINIB FREE BASE AND A PROCESS FOR PREPARATION OF ERLOTINIB HYDROCHLORIDE POLYMORPH FORM A SUBSTANTIALLY FREE OF POLYMORPH FORM B
有权
用于产生基本上与埃罗替尼盐酸盐的多晶型B-FREE多态性游离碱厄洛替尼和方法的新的水合形式
- 专利标题： A NOVEL HYDRATED FORM OF ERLOTINIB FREE BASE AND A PROCESS FOR PREPARATION OF ERLOTINIB HYDROCHLORIDE POLYMORPH FORM A SUBSTANTIALLY FREE OF POLYMORPH FORM B
- 专利标题（中）： 用于产生基本上与埃罗替尼盐酸盐的多晶型B-FREE多态性游离碱厄洛替尼和方法的新的水合形式
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申请号： EP07827536.9申请日： 2007-08-17
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公开(公告)号： EP2176241A2公开(公告)日： 2010-04-21
- 发明人: PARTHASARADHI REDDY, Bandi , RATHNAKAR REDDY, Kura , RAJI REDDY, Rapolu , MURALIDHARA REDDY, Dasari , SRINIVASA RAO, Thungathurthy
- 申请人： Hetero Drugs Limited
- 申请人地址： Hetero House 8-3-166/7/1 Erragadda Hyderabad 500 018 Andhrapradesh IN
- 专利权人： Hetero Drugs Limited
- 当前专利权人： Hetero Drugs Limited
- 当前专利权人地址： Hetero House 8-3-166/7/1 Erragadda Hyderabad 500 018 Andhrapradesh IN
- 代理机构： Thomas, Simon
- 国际公布： WO2009024989 20090226
- 主分类号： C07D239/94
- IPC分类号： C07D239/94 ; A61K31/517
摘要：
The present invention provides a novel and stable hydrated form of erlotinib free base, and a process for its preparation thereof. The present invention also provides a process for preparation of erlotinib hydrochloride crystalline polymorph A substantially free of polymorph B. The present invention further relates to erlotinib hydrochloride crystalline particles having mean particle size (D
50 ) ranging from about 4 μm to 15 μm and 90 volume-% of the particles (D
90 ) ranging from about 14 μm to 30 μm, to the methods for the manufacture of said crystalline particles, and to pharmaceutical compositions comprising said crystalline particles.
50 ) ranging from about 4 μm to 15 μm and 90 volume-% of the particles (D
90 ) ranging from about 14 μm to 30 μm, to the methods for the manufacture of said crystalline particles, and to pharmaceutical compositions comprising said crystalline particles.
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