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1. 发明申请

US20150111929A1 PROCESS FOR PREPARING CRYSTALLINE SORAFENIB TOSYLATE 审中-公开
标题翻译：制备水溶性磺酰苯甲酸酯的方法
公开(公告)号：US20150111929A1
公开(公告)日：2015-04-23
申请号：US14381226
申请日：2012-12-31
申请人： SHILPA MEDICARE LIMITED
发明人： Prashant Purohit , Sriram Rampalli , Mohanrao Seshagiri Vijaya Murali , Lavkumar Upalla
IPC分类号： C07D213/81
CPC分类号： C07D213/81 , A61K31/44
摘要： The present invention provides an industrially suitable process for the preparation of substantially pure 4-{4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]phenoxy}-N-methylpyridine-2-carboxamide or Sorafenib and its tosylate salt, with a suitable impurity profile and without requirement of any additional purification steps. The present invention also provides Sorafenib base (II) as stable crystalline Form-SSB.The present invention further relates to a process for the preparation of crystalline Sorafenib tosylate Form-I which is free from contamination of any other polymorphic form of Sorafenib tosylate, for e.g. Form II or Form III, and does not involve any seeding requirement for crystallization step.
摘要翻译：本发明提供工业上合适的制备基本上纯的4- {4 - [（{[4-氯-3-（三氟甲基） - 苯基]氨基}羰基）氨基]苯氧基} -N-甲基吡啶-2-甲酸的方法，甲酰胺或索拉非尼及其甲苯磺酸盐，具有合适的杂质分布，并且不需要任何额外的纯化步骤。本发明还提供了索拉非尼碱（II）作为稳定的晶型SSB。本发明还涉及一种制备结晶索拉非尼甲苯磺酸盐形式I的方法，其不含任何其它多晶型索拉非尼甲苯磺酸盐的污染物，例如， II型或III型，不涉及结晶步骤的任何接种要求。

2. 发明授权

US09790185B2 Process for the preparation of regorafenib and its crystalline forms 有权
公开(公告)号：US09790185B2
公开(公告)日：2017-10-17
申请号：US15324683
申请日：2015-07-06
申请人： SHILPA MEDICARE LIMITED
发明人： Sriram Rampalli , Lav Kumar Upalla , Krishna Kumar Ramachandrula , Prashant Purohit , Chaturvedi Akshay Kant
IPC分类号： C07D213/81
CPC分类号： C07D213/81
摘要： The present invention relates to a process for the preparation of 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide or Regorafenib (I). The present invention further relates to a process for the purification of 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide or Regorafenib (I) to provide highly pure material.The present invention further relates to a process for the preparation stable crystalline material of 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methyl pyridine-2-carboxamide or Regorafenib (I) useful in the preparation of pharmaceutical compositions for the treatment of cancer.

3. 发明授权

US09145406B2 Process for preparing dasatinib monohydrate 有权
标题翻译：制备达沙替尼一水合物的方法
公开(公告)号：US09145406B2
公开(公告)日：2015-09-29
申请号：US14382557
申请日：2013-04-16
申请人： SHILPA MEDICARE LIMITED
发明人： Prashant Purohit , Sriram Rampalli , Mohanrao Seshagiri Vijaya Murali , Lavkumar Upalla , Pradeep Pothana
IPC分类号： C07D417/12
CPC分类号： C07D417/12
摘要： The present invention relates to an improved process for preparation of Dasatinib monohydrate Formula A, comprising the steps of: a) reacting the compound of Formula I with 1-(2-Hydroxyethyl)piperazine (Formula II) in the presence of acetonitrile solvent, an organic base and a phase transfer catalyst; b) heating the reaction mixture at 50-80° C.; c) adding water to the reaction mass obtained in step b); d) cooling the reaction mixture to a temperature below 35° C.; e) filtering and drying the material obtained in step d); f) optionally purifying the product obtained from step e); g) isolating the crystalline Dasatinib monohydrate.
摘要翻译：本发明涉及一种制备达沙替尼一水合物式A的改进方法，其包括以下步骤：a）在乙腈溶剂存在下使式I化合物与1-（2-羟乙基）哌嗪（式II）反应，有机碱和相转移催化剂; b）在50-80℃加热反应混合物; c）向步骤b）中获得的反应物质中加入水; d）将反应混合物冷却至低于35℃的温度; e）过滤并干燥步骤d）中获得的材料; f）任选地纯化从步骤e）获得的产物; g）分离结晶达沙替尼一水合物。

4. 发明授权

US11111250B2 Polymorphs of Ribociclib mono succinate 有权
公开(公告)号：US11111250B2
公开(公告)日：2021-09-07
申请号：US16955823
申请日：2018-12-20
申请人： SHILPA MEDICARE LIMITED
发明人： Sriram Rampalli , Lav Kumar Upalla , Suryanarayan Cherukuvada , Chanti Babu Patneedi , Gopala Krishna Dasari , Vijaya Murali Mohan Rao Seshagiri
IPC分类号： C07D487/04
摘要： The present invention relates to novel crystalline and amorphous polymorphic forms of Ribociclib(1) mono succinate. (I) Said crystalline forms may be useful in the improved preparation of oral dosage forms for the treatment of cancer.

5. 发明授权

US10435409B2 Process for the preparation of ibrutinib 有权
公开(公告)号：US10435409B2
公开(公告)日：2019-10-08
申请号：US16073809
申请日：2017-02-02
申请人： SHILPA MEDICARE LIMITED
发明人： Sriram Rampalli , Lav Kumar Upalla , Chanti Babu Patneedi , Gopala Krishna Dasari , Akshay Kant Chaturvedi
IPC分类号： C07D487/04 , C07D211/32
摘要： The present invention relates to a process for the preparation of 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one or Ibrutinib of Formula (I). The present invention further relates to a process for the preparation highly pure 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one or Ibrutinib(I).

6. 发明申请

US20150057446A1 PROCESS FOR PREPARING DASATINIB MONOHYDRATE 审中-公开
标题翻译：用于制备单酯的方法
公开(公告)号：US20150057446A1
公开(公告)日：2015-02-26
申请号：US14382557
申请日：2013-04-16
申请人： SHILPA MEDICARE LIMITED
发明人： Prashant Purohit , Sriram Rampalli , Mohanrao Seshagiri Vijaya Murali , Lavkumar Upalla , Pradeep Pothana
IPC分类号： C07D417/12
CPC分类号： C07D417/12
摘要： The present invention provides an improved process for preparing N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazole carboxamide monohydrate or Dasatinib monohydrate (Formula A).
摘要翻译：本发明提供了制备N-（2-氯-6-甲基苯基）-2 - [[6- [4-（2-羟基乙基）-1-哌嗪基] -2-甲基-4-嘧啶基]氨基的改进方法 ] -5-噻唑甲酰胺一水合物或达沙替尼一水合物（式A）。

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