ES2577294T3 - Procedimiento para la síntesis de clopidogrel y nuevas formas de sales farmacéuticamente aceptables del mismo - Google Patents

Procedimiento para la síntesis de clopidogrel y nuevas formas de sales farmacéuticamente aceptables del mismo Download PDF

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Publication number
ES2577294T3
ES2577294T3 ES07820533.3T ES07820533T ES2577294T3 ES 2577294 T3 ES2577294 T3 ES 2577294T3 ES 07820533 T ES07820533 T ES 07820533T ES 2577294 T3 ES2577294 T3 ES 2577294T3
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ES
Spain
Prior art keywords
clopidogrel
procedure
synthesis
pharmaceutically acceptable
acceptable salts
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.)
Active
Application number
ES07820533.3T
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English (en)
Inventor
Igor Simonic
Primoz Benkic
Rok Zupet
Matej Smrkolj
Mitja Stukelj
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KRKA dd
Original Assignee
KRKA Tovarna Zdravil dd
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Application filed by KRKA Tovarna Zdravil dd filed Critical KRKA Tovarna Zdravil dd
Application granted granted Critical
Publication of ES2577294T3 publication Critical patent/ES2577294T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D495/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms
    • C07D495/02—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms in which the condensed system contains two hetero rings
    • C07D495/04—Ortho-condensed systems
    • 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
    • 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

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

Abstract

Procedimiento para la preparación de hidrogenosulfato de clopidogrel de la forma polimórfica I que está caracterizado por que presenta un tamaño de partícula medio superior a 20 mm que comprende: i) añadir una disolución de ácido sulfúrico en un disolvente orgánico a T2 a una disolución de clopidogrel en un disolvente orgánico a T1, ii) agitar la suspensión tras completar la adición a T3 durante un tiempo determinado, iii) calentar la suspensión hasta T4 bajo control con una velocidad de calentamiento determinada y agitar a esta temperatura durante un tiempo determinado, iv) aislar el producto precipitado, en el que T1 a T3 son unas temperaturas que pueden ser iguales o diferentes y son seleccionadas desde -20 a 40ºC, y T4 es una temperatura desde 15 a 40ºC.

Description

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Claims (1)

  1. imagen1
ES07820533.3T 2006-09-22 2007-09-24 Procedimiento para la síntesis de clopidogrel y nuevas formas de sales farmacéuticamente aceptables del mismo Active ES2577294T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SI200600220A SI22383A (sl) 2006-09-22 2006-09-22 Nov postopek sinteze klopidogrela in nove oblike njegovih farmacevtsko sprejemljivih soli
SI200600220 2006-09-22
PCT/EP2007/060127 WO2008034912A2 (en) 2006-09-22 2007-09-24 Process for the synthesis of clopidogrel and new forms of pharmaceutically acceptable salts thereof

Publications (1)

Publication Number Publication Date
ES2577294T3 true ES2577294T3 (es) 2016-07-14

Family

ID=39092310

Family Applications (1)

Application Number Title Priority Date Filing Date
ES07820533.3T Active ES2577294T3 (es) 2006-09-22 2007-09-24 Procedimiento para la síntesis de clopidogrel y nuevas formas de sales farmacéuticamente aceptables del mismo

Country Status (9)

Country Link
EP (1) EP2078025B1 (es)
ES (1) ES2577294T3 (es)
HR (1) HRP20160809T1 (es)
HU (1) HUE029319T2 (es)
NO (1) NO20091334L (es)
PL (1) PL2078025T3 (es)
SI (2) SI22383A (es)
WO (1) WO2008034912A2 (es)
ZA (1) ZA200902575B (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2107061A1 (en) 2008-04-02 2009-10-07 Krka Tovarna Zdravil, D.D., Novo Mesto Process for the preparation of optically enriched clopidogrel
WO2011051976A2 (en) * 2009-10-30 2011-05-05 Matrix Laboratories Ltd An improved process for the preparation of clopidogrel bisulfate form i
WO2012007019A1 (en) * 2010-07-13 2012-01-19 Pharmathen S.A. Process for the preparation of clopidogrel and salts thereof
CN102120745B (zh) * 2011-01-31 2013-04-10 天津红日药业股份有限公司 一种盐酸氯吡格雷的晶型ⅰ及其制备方法和用途
WO2016011783A1 (zh) * 2014-12-31 2016-01-28 天津大学 一种制备球形硫酸氢氯吡格雷i晶型的方法
CN111606923B (zh) * 2020-06-24 2021-08-24 武汉理工大学 一种外消旋氯吡格雷的合成方法
CN118791459A (zh) * 2024-06-17 2024-10-18 山东信立泰药业有限公司 苯磺酸-2-噻吩乙酯的制备方法

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2623810B2 (fr) * 1987-02-17 1992-01-24 Sanofi Sa Sels de l'alpha-(tetrahydro-4,5,6,7 thieno(3,2-c) pyridyl-5) (chloro-2 phenyl) -acetate de methyle dextrogyre et compositions pharmaceutiques en contenant
FR2779726B1 (fr) * 1998-06-15 2001-05-18 Sanofi Sa Forme polymorphe de l'hydrogenosulfate de clopidogrel
EP1353928B1 (en) * 2001-01-24 2006-12-27 Cadila Healthcare Ltd. Process for preparing clopidogrel
CA2470479A1 (en) * 2001-12-18 2003-06-26 Teva Pharmaceutical Industries Ltd. Polymorphs of clopidogrel hydrogensulfate
IL166593A0 (en) * 2002-08-02 2006-01-15 Racemization and enantiomer separation of clopidogrel
GB2393181A (en) * 2002-09-19 2004-03-24 Cipla Ltd Amorphous clopidogrel
WO2004108665A2 (en) * 2003-04-24 2004-12-16 Sun Pharmaceutical Industries Limited A process for preparation of clopidogrel
US20050059696A1 (en) * 2003-05-08 2005-03-17 Dr. Reddy's Laboratories Limited Process for the recovery of S -(+)-methyl- (2-chlorophenyl)- (6,7-dihydro- 4H-thieno [3,2-c] pyrid-5-yl) acetate hydrogen sulfate (clopidogrel bisulfate) from its (R) and mixture of (R) and (S)- isomers
BR0318449A (pt) * 2003-08-04 2006-08-01 Wockhardt Ltd processo para fabricação de (+)-(s)-clopidogrel bissulfato forma-i
DE10337773A1 (de) * 2003-08-13 2005-03-24 Krka Tovarna Zdravil, D.D. Kristallisation von festen Formen von Clopidogrel-Additionssalzen
PL1740593T3 (pl) * 2004-04-19 2016-09-30 Sposoby wytwarzania wodorosiarczanu klopidogrelu w formie polimorficznej I
CZ295920B6 (cs) * 2004-10-18 2005-11-16 Zentiva, A. S Způsob výroby klopidogrelu
US7772398B2 (en) * 2005-03-11 2010-08-10 Dr. Reddy's Laboratories, Inc. Process for making crystalline form I of clopidogrel hydrogen sulphate
KR100678287B1 (ko) * 2005-06-23 2007-02-02 한미약품 주식회사 클로피도그렐의 제조방법 및 이에 사용되는 중간체
KR20070094230A (ko) * 2006-03-17 2007-09-20 한미약품 주식회사 클로피도그렐 캄파술폰산염 또는 이의 결정다형을 함유하는약학 조성물

Also Published As

Publication number Publication date
ZA200902575B (en) 2010-03-31
SI2078025T1 (sl) 2016-08-31
WO2008034912A2 (en) 2008-03-27
SI22383A (sl) 2008-04-30
EP2078025B1 (en) 2016-04-13
HRP20160809T1 (hr) 2016-09-23
PL2078025T3 (pl) 2016-09-30
HUE029319T2 (en) 2017-02-28
WO2008034912A3 (en) 2008-08-07
NO20091334L (no) 2009-04-22
EP2078025A2 (en) 2009-07-15

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