WO2014192030A3 - An improved process for preparation of dabigatran etexilate and pharmaceutically acceptable acid addition salts thereof - Google Patents

An improved process for preparation of dabigatran etexilate and pharmaceutically acceptable acid addition salts thereof Download PDF

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Publication number
WO2014192030A3
WO2014192030A3 PCT/IN2014/000364 IN2014000364W WO2014192030A3 WO 2014192030 A3 WO2014192030 A3 WO 2014192030A3 IN 2014000364 W IN2014000364 W IN 2014000364W WO 2014192030 A3 WO2014192030 A3 WO 2014192030A3
Authority
WO
WIPO (PCT)
Prior art keywords
preparation
pharmaceutically acceptable
dabigatran etexilate
acid addition
acceptable acid
Prior art date
Application number
PCT/IN2014/000364
Other languages
French (fr)
Other versions
WO2014192030A2 (en
Inventor
Ravindra Babu Bollu
Subha Velayudhan NAIR
Prasanta Kumar DALASINGH
Venkata Sunil Kumar Indukuri
Seeta Rama Anjaneyulu GORANTLA
Satyanarayana Chava
Original Assignee
Laurus Labs Private Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Laurus Labs Private Limited filed Critical Laurus Labs Private Limited
Publication of WO2014192030A2 publication Critical patent/WO2014192030A2/en
Publication of WO2014192030A3 publication Critical patent/WO2014192030A3/en

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D401/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/12Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links

Abstract

The present invention provides an improved process for preparation of dabigatran etexilate and pharmaceutically acceptable acid addition salts thereof, particularly mesylate salt. The present invention also provides novel salts of intermediates of Dabigatran etexilate and their polymorphs.
PCT/IN2014/000364 2013-05-29 2014-05-29 An improved process for preparation of dabigatran etexilate and pharmaceutically acceptable acid addition salts thereof WO2014192030A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2339CH2013 2013-05-29
IN2339/CHE/2013 2013-05-29

Publications (2)

Publication Number Publication Date
WO2014192030A2 WO2014192030A2 (en) 2014-12-04
WO2014192030A3 true WO2014192030A3 (en) 2015-02-26

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PCT/IN2014/000364 WO2014192030A2 (en) 2013-05-29 2014-05-29 An improved process for preparation of dabigatran etexilate and pharmaceutically acceptable acid addition salts thereof

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WO (1) WO2014192030A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106397403A (en) * 2016-08-30 2017-02-15 苏州天马精细化学品股份有限公司 Method for purifying dabigatran etexilate mesylate intermediate

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104744438A (en) * 2014-12-17 2015-07-01 烟台东诚药业集团股份有限公司 Method for synthesising and preparing dabigatran benzimidazole intermediate
CN104892576A (en) * 2015-05-27 2015-09-09 上海应用技术学院 Purification method for Dabigatran etexilate analogue intermediate
CN105153118A (en) * 2015-09-24 2015-12-16 青岛黄海制药有限责任公司 Central control method of midbody in dabigatran etexilate mesylate preparation process
CN105418587B (en) * 2015-11-30 2017-12-01 山东新华制药股份有限公司 The process for purification of dabigatran etcxilate free alkali
CN105859686B (en) * 2016-05-24 2021-10-08 浙江华海药业股份有限公司 Refining method of dabigatran etexilate free alkali
CN107686476A (en) * 2017-09-04 2018-02-13 扬子江药业集团广州海瑞药业有限公司 A kind of preparation technology of dabigatran etexilate methanesulfonate
CN108864048A (en) * 2018-07-05 2018-11-23 天方药业有限公司 A kind of preparation method of dabigatran etexilate methanesulfonate
CN111793058A (en) * 2019-04-09 2020-10-20 鲁南制药集团股份有限公司 Improved method for preparing dabigatran etexilate intermediate
WO2022198361A1 (en) * 2021-03-22 2022-09-29 天津睿创康泰生物技术有限公司 Novel crystal form of dabigatran etexilate ethyl ester hydrochloride, preparation method therefor and use thereof
CN114716411B (en) * 2022-04-29 2024-03-15 天方药业有限公司 Method for recovering and preparing dabigatran etexilate mesylate from production mother liquor

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6087380A (en) * 1949-11-24 2000-07-11 Boehringer Ingelheim Pharma Kg Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions
WO2012027543A1 (en) * 2010-08-25 2012-03-01 Teva Pharmaceuticals Usa, Inc. Solid state forms of dabigatran etexilate, dabigatran etexilate mesylate and processes for preparation thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6087380A (en) * 1949-11-24 2000-07-11 Boehringer Ingelheim Pharma Kg Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions
WO2012027543A1 (en) * 2010-08-25 2012-03-01 Teva Pharmaceuticals Usa, Inc. Solid state forms of dabigatran etexilate, dabigatran etexilate mesylate and processes for preparation thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106397403A (en) * 2016-08-30 2017-02-15 苏州天马精细化学品股份有限公司 Method for purifying dabigatran etexilate mesylate intermediate

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Publication number Publication date
WO2014192030A2 (en) 2014-12-04

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