DE60230327D1 - Polymorphe von clopidogrel-hydrogensulfat - Google Patents

Polymorphe von clopidogrel-hydrogensulfat

Info

Publication number
DE60230327D1
DE60230327D1 DE60230327T DE60230327T DE60230327D1 DE 60230327 D1 DE60230327 D1 DE 60230327D1 DE 60230327 T DE60230327 T DE 60230327T DE 60230327 T DE60230327 T DE 60230327T DE 60230327 D1 DE60230327 D1 DE 60230327D1
Authority
DE
Germany
Prior art keywords
polymorph
hydrogen sulphate
clopidogrel hydrogen
clopidogrel hydrogensulfate
clopidogrel
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.)
Expired - Lifetime
Application number
DE60230327T
Other languages
English (en)
Inventor
Revital Lifshitz-Liron
Eti Kovalevski-Ishai
Shlomit Wizel
Sharon Avhar-Maydan
Rami Lidor-Hadas
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.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries Ltd
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
Priority claimed from US10/074,409 external-priority patent/US6767913B2/en
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Application granted granted Critical
Publication of DE60230327D1 publication Critical patent/DE60230327D1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
DE60230327T 2001-12-18 2002-12-18 Polymorphe von clopidogrel-hydrogensulfat Expired - Lifetime DE60230327D1 (de)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US34244001P 2001-12-18 2001-12-18
US34235101P 2001-12-21 2001-12-21
US34818202P 2002-01-11 2002-01-11
US10/074,409 US6767913B2 (en) 2001-12-18 2002-02-12 Crystal forms iii, iv, v, and novel amorphous form of clopidogrel hydrogensulfate, processes for their preparation, processes for the preparation of form i, compositions containing the new forms and methods of administering the new forms
US35915702P 2002-02-21 2002-02-21
PCT/US2002/040679 WO2003051362A2 (en) 2001-12-18 2002-12-18 Polymorphs of clopidogrel hydrogensulfate

Publications (1)

Publication Number Publication Date
DE60230327D1 true DE60230327D1 (de) 2009-01-22

Family

ID=27536010

Family Applications (1)

Application Number Title Priority Date Filing Date
DE60230327T Expired - Lifetime DE60230327D1 (de) 2001-12-18 2002-12-18 Polymorphe von clopidogrel-hydrogensulfat

Country Status (18)

Country Link
EP (1) EP1467735B1 (de)
JP (2) JP2005514387A (de)
KR (1) KR100839136B1 (de)
CN (1) CN1620293A (de)
AT (1) ATE417051T1 (de)
AU (1) AU2002366383B2 (de)
CA (1) CA2470479A1 (de)
DE (1) DE60230327D1 (de)
ES (1) ES2316650T3 (de)
HR (1) HRP20040647A2 (de)
HU (1) HUP0402485A3 (de)
IL (1) IL162461A0 (de)
IS (1) IS7319A (de)
MX (1) MXPA04006088A (de)
NO (1) NO20043038L (de)
PL (1) PL370802A1 (de)
PT (1) PT1467735E (de)
WO (1) WO2003051362A2 (de)

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CZ297472B6 (cs) * 2002-08-27 2006-12-13 Zentiva, A.S. Zpusob výroby clopidogrelu hydrogensulfátu krystalické formy I
GB2393181A (en) * 2002-09-19 2004-03-24 Cipla Ltd Amorphous clopidogrel
ITMI20022228A1 (it) * 2002-10-21 2004-04-22 Dinamite Dipharma S P A Sali di clopidogrel con acidi alchil-solforici.
AU2003285841A1 (en) * 2002-11-28 2004-06-18 Anpharm Przedsiebiorstwo Farmaceutyczne S.A. A process for the preparation of crystalline form 1 or clopidogrel hydrogen sulfate
US20060100231A1 (en) * 2003-03-10 2006-05-11 Hetero Drugs Limited Amorphous clopidogrel hydrogen sulfate
US7872019B2 (en) 2003-03-12 2011-01-18 Cadila Healthcare Limited Polymorphs and amorphous form of (S)-(+)-clopidogrel bisulfate
WO2005003139A1 (en) * 2003-07-02 2005-01-13 EGIS Gyógyszergyár Rt. Process for the preparation of crystalline polymorph of a platelet aggregation inhibitor drug
HU0302029D0 (en) * 2003-07-02 2003-09-29 Egyt Gyogyszervegyeszeti Gyar Amorphous form of an anticoagulant agent
PL378711A1 (pl) * 2003-07-02 2006-05-15 Egis Gyorgyszergyar Rt. Proces wytwarzania bezpostaciowej formy leku inhibitującego agregację płytek krwi
DE10337773A1 (de) * 2003-08-13 2005-03-24 Krka Tovarna Zdravil, D.D. Kristallisation von festen Formen von Clopidogrel-Additionssalzen
ATE455778T1 (de) 2003-11-03 2010-02-15 Cadila Healthcare Ltd Verfahren zur herstellung form i von (s)-(+)- clopidogrelbisulfat
RU2328501C1 (ru) * 2004-04-09 2008-07-10 Ханми Фарм. Ко., ЛТД Кристаллический клопидогрель нафталинсульфонат или его гидрат, способ его получения и содержащая его фармацевтическая композиция
SI1740593T1 (sl) * 2004-04-19 2016-08-31 Krka, Tovarna Zdravil, D.D., Novo Mesto Postopek za pripravo polimorfne oblike I klopidogrel hidrogen sulfata
MXPA06012128A (es) * 2004-04-20 2007-01-31 Sanofi Aventis Sal de clopidogrel y formas polimorfas de la misma.
ZA200608569B (en) * 2004-04-20 2007-12-27 Sanofi Aventis Polymorphic forms of methyl (+)-(S)-alpha- (2-chlorophenyl)-6, 7-dinydrothieno[3,2-C] pyridine-5(4H) acetate hydrobromide, clopidrogel hydrobromide
WO2005117866A1 (en) * 2004-06-01 2005-12-15 Ivax Pharmaceuticals S.R.O. Amorphous clopidogrel hydrochloride and its antithrombotic use
EP1693375A1 (de) * 2005-02-21 2006-08-23 KRKA, tovarna zdravil, d.d., Novo mesto Verfahren zur Herstellung von Clopidrogel hydrogen sulfat in Form I
KR20070009851A (ko) * 2005-07-14 2007-01-19 씨제이 주식회사 클로피도그렐 황산수소염 함유 약학 조성물
US20090093635A1 (en) * 2006-03-09 2009-04-09 Sandor Garadnay PROCESS FOR MAKING POLYMORPH FROM I OF (S) - (+) -METHYL-ALPHA- (2-CHLOROPHENYL) -6, 7-DYHIDRO-THIENO- [3, 2-c] PYRIDINE-5 (4H) -ACETATE HYDROGEN SULFATE
SI22383A (sl) * 2006-09-22 2008-04-30 Krka, Tovarna Zdravil, D.D., Novo Mesto Nov postopek sinteze klopidogrela in nove oblike njegovih farmacevtsko sprejemljivih soli
HUP0600839A3 (en) * 2006-11-14 2008-09-29 Egis Gyogyszergyar Nyrt Solid pharmaceutical composition containing polymorph i of clopidogrel hydrogensulfate and process for the preparation thereof
KR101464482B1 (ko) * 2007-05-08 2014-11-26 경동제약 주식회사 클로피도그렐 황산수소염을 함유하는 약학적 조성물 및 그제조방법
EP2107061A1 (de) 2008-04-02 2009-10-07 Krka Tovarna Zdravil, D.D., Novo Mesto Herstellungsverfahren für optisch angereichertes Clopidogrel
KR101130445B1 (ko) * 2009-10-29 2012-03-27 동아제약주식회사 클로피도그랠 황산수소염 ⅰ형 제조방법
CN101962387B (zh) * 2010-09-13 2013-01-30 成都雅途生物技术有限公司 一种新结晶形态的氯吡格雷硫酸氢盐及其制备方法
CN102358743A (zh) * 2011-11-05 2012-02-22 江南大学 一种制备无定形氯吡格雷硫酸氢盐的简便方法
CN103006599A (zh) * 2012-12-31 2013-04-03 广州白云山天心制药股份有限公司 含氯化钠药物载体的抗凝血片剂及其制备方法
CN103408567B (zh) * 2013-07-18 2016-12-28 浙江普洛医药科技有限公司 一种制备硫酸氢氯吡格雷晶型ⅰ的方法
CN104610274B (zh) * 2013-11-05 2017-04-19 亚宝药业集团股份有限公司 一种i型氯吡格雷硫酸氢盐的制备方法
US9701636B2 (en) 2013-11-15 2017-07-11 Akebia Therapeutics, Inc. Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
CN104045653A (zh) * 2014-07-15 2014-09-17 苏州天马精细化学品股份有限公司 一种硫酸氢氯吡格雷的纯化方法
KR101710922B1 (ko) 2015-06-03 2017-02-28 경동제약 주식회사 클로피도그렐 황산염 결정형 i형의 제조방법
CN107163060B (zh) * 2017-05-24 2021-03-02 常州制药厂有限公司 一种硫酸氢氯吡格雷晶型ii制备方法
CN107337683B (zh) * 2017-08-16 2019-08-16 中荣凯特（北京）生物科技有限公司 一种噻吩并吡啶类衍生物硫酸氢盐的晶型ⅱ及其制备方法和应用
CN112399969B (zh) * 2018-07-12 2023-10-27 有机合成药品工业株式会社 硫酸氢氯吡格雷的ⅰ型晶体的制备方法
KR102220480B1 (ko) * 2019-02-13 2021-02-25 한국바이오켐제약 주식회사 클로피도그렐황산염의 제조방법 및 이를 포함하는 약학제제

Family Cites Families (7)

* 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
FR2664276B1 (fr) * 1990-07-04 1992-10-23 Sanofi Sa Derive thienyl-2 glycidique, son procede de preparation et son utilisation comme intermediaire de synthese.
US5576328A (en) * 1994-01-31 1996-11-19 Elf Sanofi Method for the secondary prevention of ischemic events
FR2751540B1 (fr) * 1996-07-26 1998-10-16 Sanofi Sa Composition pharmaceutique antithrombotique
FR2769313B1 (fr) * 1997-10-06 2000-04-21 Sanofi Sa Derives d'esters hydroxyacetiques, leur procede de preparation et leur utilisation comme intermediaires de synthese
FR2779726B1 (fr) * 1998-06-15 2001-05-18 Sanofi Sa Forme polymorphe de l'hydrogenosulfate de clopidogrel
AU2002356430A1 (en) * 2002-12-09 2004-06-30 Hetero Drugs Limited A novel polymorph of clopidogrel hydrogen sulfate

Also Published As

Publication number Publication date
IS7319A (is) 2004-06-16
MXPA04006088A (es) 2004-09-27
WO2003051362A3 (en) 2003-08-07
KR20040066917A (ko) 2004-07-27
CN1620293A (zh) 2005-05-25
HUP0402485A3 (en) 2008-10-28
CA2470479A1 (en) 2003-06-26
HUP0402485A2 (hu) 2005-04-28
PL370802A1 (en) 2005-05-30
JP2005514387A (ja) 2005-05-19
PT1467735E (pt) 2009-03-10
EP1467735A4 (de) 2005-11-23
EP1467735A2 (de) 2004-10-20
IL162461A0 (en) 2005-11-20
EP1467735B1 (de) 2008-12-10
KR100839136B1 (ko) 2008-06-20
NO20043038L (no) 2004-09-09
ATE417051T1 (de) 2008-12-15
WO2003051362A2 (en) 2003-06-26
AU2002366383B2 (en) 2007-06-14
ES2316650T3 (es) 2009-04-16
JP2009108107A (ja) 2009-05-21
HRP20040647A2 (en) 2005-04-30
AU2002366383A1 (en) 2003-06-30

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Legal Events

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