EA201290074A1 - Способы кристаллизации ривароксабана - Google Patents

Способы кристаллизации ривароксабана

Info

Publication number
EA201290074A1
EA201290074A1 EA201290074A EA201290074A EA201290074A1 EA 201290074 A1 EA201290074 A1 EA 201290074A1 EA 201290074 A EA201290074 A EA 201290074A EA 201290074 A EA201290074 A EA 201290074A EA 201290074 A1 EA201290074 A1 EA 201290074A1
Authority
EA
Eurasian Patent Office
Prior art keywords
rivaroxaban
crystallization methods
crystallization
solvate
methods
Prior art date
Application number
EA201290074A
Other languages
English (en)
Other versions
EA031064B1 (ru
EA031064B2 (ru
Inventor
Сильво Зупанциц
Аница Пецавар
Original Assignee
КРКА, д.д., НОВО МЕСТО
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 КРКА, д.д., НОВО МЕСТО filed Critical КРКА, д.д., НОВО МЕСТО
Publication of EA201290074A1 publication Critical patent/EA201290074A1/ru
Publication of EA031064B1 publication Critical patent/EA031064B1/ru
Publication of EA031064B2 publication Critical patent/EA031064B2/ru

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D413/00Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D413/14Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing three or more hetero rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42Oxazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)

Abstract

Настоящее изобретение относится к ривароксабану, в частности к способу получения ривароксабана, или его фармацевтически приемлемой соли, или сольвата и его кристаллизации для получения продукта, обладающего желаемыми качественными свойствами.
EA201290074A 2009-07-31 2010-07-30 Способы кристаллизации ривароксабана EA031064B2 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SI200900218 2009-07-31
PCT/EP2010/004688 WO2011012321A1 (en) 2009-07-31 2010-07-30 Processes for crystallization of rivaroxaban

Publications (3)

Publication Number Publication Date
EA201290074A1 true EA201290074A1 (ru) 2012-07-30
EA031064B1 EA031064B1 (ru) 2018-11-30
EA031064B2 EA031064B2 (ru) 2020-07-01

Family

ID=42831508

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201290074A EA031064B2 (ru) 2009-07-31 2010-07-30 Способы кристаллизации ривароксабана

Country Status (7)

Country Link
EP (1) EP2459555B1 (ru)
EA (1) EA031064B2 (ru)
ES (1) ES2905760T3 (ru)
HU (1) HUE057769T2 (ru)
PL (1) PL2459555T3 (ru)
SI (1) SI2459555T1 (ru)
WO (1) WO2011012321A1 (ru)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2705028B1 (en) * 2011-05-06 2019-08-21 Egis Gyógyszergyár Zrt. Process for the preparation of a rivaroxaban and intermediates formed in said process
CN102827154B (zh) * 2011-06-14 2015-04-22 上海科胜药物研发有限公司 一种合成利伐沙班中间体4-{4-[(5s)-5-(氨基甲基)-2-氧代-1,3-恶唑烷-3-基]苯基}吗啉-3-酮的方法
CN103012388B (zh) * 2011-09-20 2016-01-20 联化科技(上海)有限公司 一种利伐沙班及其中间体的制备方法,以及中间体化合物
EP2573084A1 (en) * 2011-09-22 2013-03-27 Enantia, S.L. Novel crystalline forms of rivaroxaban and processes for their preparation
BR112014027248B1 (pt) 2012-05-02 2021-01-26 Symed Labs Limited processo em um único recipiente para preparar rivaroxaban
WO2014020458A1 (en) * 2012-08-01 2014-02-06 Alembic Pharmaceuticals Limited Improved process for preparation of rivaroxaban
HUE037188T2 (hu) 2012-12-21 2018-08-28 Farma Grs D O O Eljárás rivaroxaban elõállítására
WO2014102822A2 (en) 2012-12-26 2014-07-03 Wanbury Ltd. Aldehyde derivative of substitute oxazolidinones
PT2895176T (pt) 2012-12-26 2017-01-27 Wanbury Ltd Intermediário de rivaroxabano e a sua preparação
IN2013MU01113A (ru) 2013-03-25 2015-06-19 Glenmark Generics Ltd
CN104109158A (zh) * 2013-04-16 2014-10-22 上海医药工业研究院 一种纯化利伐沙班的方法
CN104650058A (zh) * 2013-11-23 2015-05-27 天津市汉康医药生物技术有限公司 利伐沙班一水合物化合物
IN2014MU00072A (ru) 2014-01-08 2015-08-21 Wockhardt Ltd
IN2014CH00290A (ru) * 2014-01-23 2015-08-14 Symed Labs Ltd
WO2015198259A1 (en) 2014-06-26 2015-12-30 Erregierre S.P.A. Process for the synthesis of rivaroxaban and intermediate for the production thereof
CN104211693B (zh) * 2014-08-07 2017-02-22 成都百裕制药股份有限公司 一种利伐沙班晶型及其制备方法与用途
CN105503849B (zh) * 2014-09-26 2019-10-08 重庆华邦胜凯制药有限公司 一种制备小粒度利伐沙班原料药的方法
EA034656B1 (ru) * 2014-10-22 2020-03-03 Закляды Фармацеутычне Польфарма С.А Способ получения полиморфа ривароксабана
CN107778303B (zh) * 2016-08-27 2020-03-24 鲁南制药集团股份有限公司 利伐沙班的精制方法
CN108344832B (zh) * 2017-12-28 2021-03-09 江苏悦兴医药技术有限公司 一种主成分与其杂质完全分离的检测方法
CN109142601B (zh) * 2018-10-25 2021-03-12 重庆华邦胜凯制药有限公司 一种分离利伐沙班中间体及其杂质的方法
CN111518092B (zh) * 2019-02-01 2022-12-20 鲁南制药集团股份有限公司 利伐沙班乙酸溶剂合物及其制备方法
CN115745984A (zh) * 2019-04-02 2023-03-07 北京四环制药有限公司 一种制备易于粉碎的利伐沙班及其制备方法
CN111721858B (zh) * 2020-06-03 2022-07-01 杭州华东医药集团新药研究院有限公司 一种测定利伐沙班中基因毒性杂质的方法
GR1010231B (el) * 2021-03-24 2022-05-10 Φαρματεν Α.Β.Ε.Ε., Φαρμακευτικο σκευασμα που περιλαμβανει ριβαροξαμπανη και μεθοδος παρασκευης αυτου
EP4201933A1 (en) 2021-12-23 2023-06-28 Zaklady Farmaceutyczne Polpharma S.A. Crystallisation process for rivaroxaban

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19962924A1 (de) 1999-12-24 2001-07-05 Bayer Ag Substituierte Oxazolidinone und ihre Verwendung
DE10129725A1 (de) 2001-06-20 2003-01-02 Bayer Ag Kombinationstherapie substituierter Oxazolidinone
DE10300111A1 (de) * 2003-01-07 2004-07-15 Bayer Healthcare Ag Verfahren zur Herstellung von 5-Chlor-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophencarboxamid
DE102004002044A1 (de) 2004-01-15 2005-08-04 Bayer Healthcare Ag Herstellverfahren
NZ567092A (en) 2005-10-04 2011-05-27 Bayer Schering Pharma Ag Novel polymorphous form and the amorphous form of 5-chloro-N-({ (5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidine-5-yl}-methyl)-2-thiophene carboxamide
CN101896185A (zh) * 2007-12-11 2010-11-24 拜耳先灵制药股份公司 治疗和/或预防心力衰竭的噁唑烷酮
US20100168111A1 (en) 2008-12-31 2010-07-01 Apotex Pharmachem Inc. Polymorphic form of 5 chloro n {[(5s) 2 oxo 3 [4 (3 oxomorpholin 4 yl)phenyl]oxa-zolidin 5 yl]-methyl}thiophene 2 carboxamide
WO2014020458A1 (en) 2012-08-01 2014-02-06 Alembic Pharmaceuticals Limited Improved process for preparation of rivaroxaban

Also Published As

Publication number Publication date
EA031064B1 (ru) 2018-11-30
EA031064B2 (ru) 2020-07-01
EP2459555B1 (en) 2021-11-03
EP2459555A1 (en) 2012-06-06
SI2459555T1 (sl) 2022-03-31
HUE057769T2 (hu) 2022-06-28
ES2905760T3 (es) 2022-04-12
WO2011012321A1 (en) 2011-02-03
PL2459555T3 (pl) 2022-03-28

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Designated state(s): AM AZ KZ KG MD TJ TM

LC4A Partial administrative revocation of a eurasian patent (b2)