- 专利标题： ANHYDRATE-FREE POLYMORPHICALLY PURE MICRONIZED CRYSTALLINE BREXPIPRAZOLE DIHYDRATE FOR USE IN INTRAMUSCULAR INJECTABLE SUSTAINED RELEASE FORMULATIONS
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申请号： EP17702109.4申请日： 2017-01-31
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公开(公告)号： EP3411370A1公开(公告)日： 2018-12-12
- 发明人: BORN, Max , LANGES, Christoph , LENGAUER, Hannes
- 申请人： Hexal AG
- 申请人地址： Industriestrasse 25 83607 Holzkirchen DE
- 专利权人： Hexal AG
- 当前专利权人： Hexal AG
- 当前专利权人地址： Industriestrasse 25 83607 Holzkirchen DE
- 代理机构： Prüfer & Partner mbB Patentanwälte · Rechtsanwälte
- 优先权： EP16153668 20160201
- 国际公布： WO2017134038 20170810
- 主分类号： C07D409/12
- IPC分类号： C07D409/12 ; A61K31/4704 ; A61K31/496 ; A61P25/18 ; A61P25/24 ; A61P25/28
摘要：
The present invention relates to a brexpiprazole dihydrate crystalline form having a particle size distribution of d50 of at most 10 µm and less than 5% w/w of brexpiprazole anhydrate . The present invention also relates to a process for preparing this brexpiprazole dihydrate crystalline form and to pharmaceutical compositions thereof. The present invention also relates to a process for determining the absence of brexpiprazole anhydrate in this brexpiprazole dihydrate crystalline form. This brexpiprazole dihydrate crystalline form is used for the preparation of pharmaceutical compositions having delayed release properties upon intramuscular injection .
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