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WO2011110876A8 - Novel salts for the manufacture of pharmaceutical compositions - Google Patents

Novel salts for the manufacture of pharmaceutical compositions Download PDF

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Publication number
WO2011110876A8
WO2011110876A8 PCT/HU2011/000014 HU2011000014W WO2011110876A8 WO 2011110876 A8 WO2011110876 A8 WO 2011110876A8 HU 2011000014 W HU2011000014 W HU 2011000014W WO 2011110876 A8 WO2011110876 A8 WO 2011110876A8
Authority
WO
WIPO (PCT)
Prior art keywords
manufacture
pharmaceutical compositions
novel salts
salts
novel
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/HU2011/000014
Other languages
French (fr)
Other versions
WO2011110876A1 (en
Inventor
Imre KIRÁLY
Péter Trinka
Balázs VOLK
László Pongó
József Barkóczy
Péter SLÉGEL
Magdolna OBRECZÁN
András DANCSÓ
Mónika MEZŐVÁRI
Tibor SZABÓ
György RUZSICS
László SZLÁVIK
Gyula LUKÁCS
András BOZA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Egis Pharmaceuticals PLC
Original Assignee
Egis Pharmaceuticals PLC
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 Egis Pharmaceuticals PLC filed Critical Egis Pharmaceuticals PLC
Priority to CN2011800153251A priority Critical patent/CN102858762A/en
Priority to EA201290726A priority patent/EA022496B1/en
Publication of WO2011110876A1 publication Critical patent/WO2011110876A1/en
Publication of WO2011110876A8 publication Critical patent/WO2011110876A8/en
Anticipated expiration legal-status Critical
Priority to ZA2012/06254A priority patent/ZA201206254B/en
Ceased legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D401/00—Heterocyclic 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
    • C07D401/02—Heterocyclic 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
    • C07D401/12—Heterocyclic 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to novel polymorphous salts of dabigatran etexilate of the formula 11 and process for the preparation thereof.
PCT/HU2011/000014 2010-02-02 2011-02-02 Novel salts for the manufacture of pharmaceutical compositions Ceased WO2011110876A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN2011800153251A CN102858762A (en) 2010-02-02 2011-02-02 Novel salts for the preparation of pharmaceutical compositions
EA201290726A EA022496B1 (en) 2010-02-02 2011-02-02 Polymorphous form of dabigatran etexilate hydrochloride
ZA2012/06254A ZA201206254B (en) 2010-02-02 2012-08-20 Novel salts for the manufacture of pharmaceutical compositions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
HUP1000069 2010-02-02
HU1000069A HUP1000069A2 (en) 2010-02-02 2010-02-02 New salts for the preparation of pharmaceutical composition

Publications (2)

Publication Number Publication Date
WO2011110876A1 WO2011110876A1 (en) 2011-09-15
WO2011110876A8 true WO2011110876A8 (en) 2012-07-05

Family

ID=89989543

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/HU2011/000014 Ceased WO2011110876A1 (en) 2010-02-02 2011-02-02 Novel salts for the manufacture of pharmaceutical compositions

Country Status (5)

Country Link
CN (1) CN102858762A (en)
EA (1) EA022496B1 (en)
HU (1) HUP1000069A2 (en)
WO (1) WO2011110876A1 (en)
ZA (1) ZA201206254B (en)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030181488A1 (en) 2002-03-07 2003-09-25 Boehringer Ingelheim Pharma Gmbh & Co. Kg Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionic acid ethyl ester and the salts thereof
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
EP2649060B1 (en) 2010-12-06 2017-04-05 MSN Laboratories Limited Process for the preparation of benzimidazole derivatives and its salts
CN102558153A (en) * 2012-02-08 2012-07-11 北京阜康仁生物制药科技有限公司 Novel pharmaceutical salt of dabigatran etexilate and preparation method thereof
EP2631234A1 (en) 2012-02-23 2013-08-28 Esteve Química, S.A. Solid forms of dabigatran etexilate mesylate and processes for their preparation
WO2013144971A1 (en) * 2012-03-27 2013-10-03 Cadila Healthcare Limited New solid forms of dabigatran etexilate bisulfate and mesylate and processes to prepare them
CN102633777B (en) * 2012-03-31 2014-04-16 天津药物研究院 Dabigatran etexilate 2-ketoglutarate as well as preparation method and application thereof
EP2834224B1 (en) 2012-04-02 2018-06-06 MSN Laboratories Limited Process for the preparation of benzimidazole derivatives and salts thereof
CN103539779B (en) * 2012-07-13 2016-12-21 四川海思科制药有限公司 A kind of hydroxyl-substituted sulfonate of dabigatran etcxilate and its production and use
US9365544B2 (en) * 2012-07-16 2016-06-14 Interquim, S.A. Process for the preparation of intermediates for the synthesis of Dabigatran Etexilate, and crystalline forms of said intermediates
IN2015DN02616A (en) 2012-09-28 2015-09-18 Ranbaxy Lab Ltd
CA2886094A1 (en) 2012-09-28 2014-04-03 Ranbaxy Laboratories Limited Process for the preparation of dabigatran etexilate or pharmaceutically acceptable salt thereof
CN103864756B (en) * 2012-12-11 2018-06-15 四川海思科制药有限公司 Fourth disulfonic acid dabigatran etcxilate and its preparation method and application
WO2014178017A1 (en) 2013-04-30 2014-11-06 Ranbaxy Laboratories Limited Dabigatran etexilate impurity, process of its preparation, and its use as a reference standard
EP2835370A1 (en) 2013-08-08 2015-02-11 Medichem, S.A. New crystals of dabigatran etexilate mesylate
CN104418840A (en) * 2013-09-05 2015-03-18 天津汉瑞药业有限公司 Dabigatran etexilate mesylate anhydrous compound
WO2015071841A1 (en) 2013-11-12 2015-05-21 Druggability Technologies Holdings Limited Complexes of dabigatran and its derivatives, process for the preparation thereof and pharmaceutical compositions containing them
CN104892574A (en) * 2014-03-04 2015-09-09 浙江海正药业股份有限公司 Dabigatran etexilate mesylate crystal forms, preparation methods and uses thereof
CN108947966A (en) * 2014-04-04 2018-12-07 江苏天士力帝益药业有限公司 Dabigatran etcxilate mesylate novel crystal forms and preparation method thereof
US20170165247A1 (en) * 2014-07-18 2017-06-15 Olon S.P.A. Crystalline compounds of dabigatran etexilate
CN105348260A (en) * 2014-08-19 2016-02-24 天津药物研究院 Dabigatran etexilate hydrobromide, preparation method and applications thereof
CN106554370A (en) * 2015-09-25 2017-04-05 陕西合成药业股份有限公司 Dabigatran derivant containing phosphate ester and its production and use
CN116621815A (en) * 2023-07-21 2023-08-22 成都苑东生物制药股份有限公司 Industrial preparation method of dabigatran etexilate mesylate

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE121699A1 (en) 1997-02-18 1999-12-08 Boehringer Ingelheim Pharma BICYCLE HETERO CYCLES DISSTITUTED AS INHIBITORS OF THROMBIN
DE10337697A1 (en) * 2003-08-16 2005-03-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg Tablet containing 3 - [(2 - {[4- (hexyloxycarbonylamino-iminomethyl) -phenyl-amino] -methyl} -1-methyl-1H-benzimidazole-5-carbonyl) -pyridin-2-yl-amino] - propionic acid ethyl ester or its salts
DE10339862A1 (en) 2003-08-29 2005-03-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg New crystalline forms of ethyl 3-(N-(2-(4-(hexyloxycarbonylamidino)phenylaminomethyl)-1-methyl-1H-benzimidazole-5-carbonyl)-N-(2-pyridyl)amino)propionate methanesulfonate used for post-operative prophylaxis of deep vein thrombosis
DE102005020002A1 (en) 2005-04-27 2006-11-02 Boehringer Ingelheim Pharma Gmbh & Co. Kg Physiologically acceptable salts of 3 - [(2 - {[4- (hexyloxycarbonylamino-imino-methyl) -phenyl-amino] -methyl} -1-methyl-1H-benzimidazole-5-carbonyl) -pyridin-2-yl-amino] - propionate
DE102005025728A1 (en) 2005-06-04 2006-12-07 Boehringer Ingelheim Pharma Gmbh & Co. Kg Polymorphs of 3 - [(2 - {[4- (hexyloxycarbonylamino-imino-methyl) -phenyl-amino] -methyl} -1-methyl-1H-benzimidazole-5-carbonyl) -pyridin-2-yl-amino] -propionic acid ethyl ester
DE102005061623A1 (en) * 2005-12-21 2007-06-28 Boehringer Ingelheim Pharma Gmbh & Co. Kg Improved process for the preparation of 4- (benzimidazolylmethylamino) -benzamidines and their salts
AR061996A1 (en) * 2006-07-17 2008-08-10 Boehringer Ingelheim Int INDICATIONS FOR DIRECT THROMBIN INHIBITORS IN THE CARDIOVASCULAR FIELD
JP2010505906A (en) * 2006-10-10 2010-02-25 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 3-[(2-{[4- (Hexyloxycarbonylamino-imino-methyl) -phenylamino] -methyl} -1-methyl-1H-benzimidazol-5-carbonyl) -pyridin-2-yl-amino] -Physiologically acceptable salt of propionic acid ethyl ester
DE102006054005A1 (en) 2006-11-16 2008-05-21 Boehringer Ingelheim Pharma Gmbh & Co. Kg New polymorphs of 3 - [(2 - {[4- (hexyloxycarbonylamino-imino-methyl) -phenyl-amino] -methyl} -1-methyl-1H-benzimidazole-5-carbonyl) -pyridin-2-yl-amino] -propionic acid ethyl
CN100556642C (en) * 2007-06-06 2009-11-04 中国科学院化学研究所 Control method of degradation performance of aliphatic polybutylene adipate material

Also Published As

Publication number Publication date
ZA201206254B (en) 2013-10-30
WO2011110876A1 (en) 2011-09-15
EA201290726A1 (en) 2013-07-30
HU1000069D0 (en) 2010-04-28
HUP1000069A2 (en) 2012-05-02
EA022496B1 (en) 2016-01-29
CN102858762A (en) 2013-01-02

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