DK1618111T3 - Salte af clopidogrel samt fremgangsmåde til fremstilling - Google Patents
Salte af clopidogrel samt fremgangsmåde til fremstilling Download PDFInfo
- Publication number
- DK1618111T3 DK1618111T3 DK04770646.0T DK04770646T DK1618111T3 DK 1618111 T3 DK1618111 T3 DK 1618111T3 DK 04770646 T DK04770646 T DK 04770646T DK 1618111 T3 DK1618111 T3 DK 1618111T3
- Authority
- DK
- Denmark
- Prior art keywords
- clopidogrel
- butyl
- besylate
- salts
- crystalline
- Prior art date
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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Claims (6)
1. Krystallinsk clopidogrelbesylat med et pulver-røntgendiffraktionsmønster som vist i fig. 2 og med et smeltepunkt i området 124 - 132 °C.
2. Krystallinsk clopidogrelbesylat ifølge krav 1, indeholdende 0,1 - 0,3 vægt-% vand.
3. Fremgangsmåde til fremstilling af krystallinsk clopidogrelbesylat ifølge ethvert af de foregående krav, omfattende følgende trin: i) opløsning af clopidogrelbase i/bringe clopidogrelbase i kontakt med egnede opløsningsmidler, ii) behandling af produktet i trin (i) med benzensulfonsyre, iii) fjernelse af opløsningsmidlerne for at tilvejebringe saltet.
4. Fremgangsmåde ifølge krav 3, kendetegnet ved, at egnede opløsningsmidler er valgt blandt vand, n-heptan, cyclohexan, petroleumæter, ætere hvori hver al-kylradikal af æteren uafhængigt er valgt fra gruppen bestående af metyl, etyl, propyl, isopropyl, butyl, 1-butyl, 2-butyl og t-butyl, eller blandinger deraf.
5. Farmaceutisk sammensætning omfattende clopidogrelbesylat i krystallinsk form ifølge ethvert af krav 1 eller 2 samt et farmaceutisk acceptabelt bindemiddel.
6. Anvendelse af saltene af clopidogrel ifølge ethvert af krav 1 eller 2 til fremstilling af mediciner til behandling af sygdomme tilknyttet blodpladeansamling.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN413MU2003 | 2003-04-25 | ||
| PCT/IN2004/000112 WO2004106344A2 (en) | 2003-04-25 | 2004-04-22 | Salts of clopidogrel and process for preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK1618111T3 true DK1618111T3 (da) | 2015-02-16 |
Family
ID=33485475
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK04770646.0T DK1618111T3 (da) | 2003-04-25 | 2004-04-22 | Salte af clopidogrel samt fremgangsmåde til fremstilling |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US7732608B2 (da) |
| EP (4) | EP2113506A3 (da) |
| KR (1) | KR20060013376A (da) |
| CY (1) | CY1116554T1 (da) |
| DE (1) | DE04770646T1 (da) |
| DK (1) | DK1618111T3 (da) |
| ES (1) | ES2531088T3 (da) |
| HR (1) | HRP20150056T1 (da) |
| NO (1) | NO333586B1 (da) |
| PL (1) | PL1618111T3 (da) |
| PT (1) | PT1618111E (da) |
| SI (1) | SI1618111T1 (da) |
| WO (1) | WO2004106344A2 (da) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10305984A1 (de) * | 2003-02-13 | 2004-09-02 | Helm Ag | Salze organischer Säuren mit Clopidogrel und deren Verwendung zur Herstellung phamazeutischer Formulierungen |
| EP1603920A1 (en) * | 2003-03-12 | 2005-12-14 | Cadila Healthcare Ltd. | Polymorph and amorphous form of (s)-(+)-clopidogrel bisulfate |
| WO2004106344A2 (en) | 2003-04-25 | 2004-12-09 | Cadila Healthcare Limited | Salts of clopidogrel and process for preparation |
| EP1680430B1 (en) * | 2003-11-03 | 2010-01-20 | Cadila Healthcare Ltd. | Processes for preparing form i of (s)-(+)- clopidogrel bisulfate |
| JP2007523203A (ja) * | 2004-02-24 | 2007-08-16 | ジークフリート・ジェネリクス・インターナショナル・アクチェンゲゼルシャフト | クロピドグレルの薬理学的に許容できる塩 |
| BRPI0510008A (pt) * | 2004-04-20 | 2007-09-18 | Sanofi Aventis | sal de clopidogrel e formas polimórficas deste |
| WO2006074066A1 (en) * | 2004-12-30 | 2006-07-13 | Nektar Therapeutics | Non-crystalline formulation comprising clopidogrel |
| WO2007052300A2 (en) | 2005-09-05 | 2007-05-10 | Cadila Healthcare Limited | Processes for the preparation of different forms of (s)-(+)-clopidogrel besylate |
| ATE498626T1 (de) * | 2006-09-25 | 2011-03-15 | Adamed Sp Zoo | Neues clopidogrel-salz und seine kristallinen formen |
| KR101378596B1 (ko) | 2006-12-27 | 2014-03-26 | 경동제약 주식회사 | 결정성 클로피도그렐 · 황산염 형태 ｉ의 제조방법 |
| US7935697B2 (en) | 2006-12-28 | 2011-05-03 | Kinex Pharmaceuticals, Llc | Compositions for modulating a kinase cascade and methods of use thereof |
| KR100805675B1 (ko) | 2007-03-07 | 2008-02-21 | 한림제약(주) | 클로피도그렐 베실레이트를 포함하는 약학 조성물 및 그의제조방법 |
| EP2062909A1 (en) * | 2007-11-21 | 2009-05-27 | SOLVAY (Société Anonyme) | Peptide production and purification process |
| KR100920932B1 (ko) * | 2007-12-05 | 2009-10-20 | 한림제약(주) | 결정형의 클로피도그렐 벤젠술폰산염의 제조방법 |
| EP2107061A1 (en) | 2008-04-02 | 2009-10-07 | Krka Tovarna Zdravil, D.D., Novo Mesto | Process for the preparation of optically enriched clopidogrel |
| WO2012123958A1 (en) | 2011-02-14 | 2012-09-20 | Cadila Healthcare Limited | Highly pure salts of clopidogrel free of genotoxic impurities |
| CN102199161B (zh) * | 2011-03-30 | 2013-07-03 | 天津红日药业股份有限公司 | 一种苯磺酸氯吡格雷晶型ⅰ及其制备方法和用途 |
| CN102285996A (zh) * | 2011-03-30 | 2011-12-21 | 天津红日药业股份有限公司 | 一种苯磺酸氯吡格雷晶型ⅱ及其制备方法和用途 |
| CN104193762B (zh) * | 2014-08-04 | 2017-02-15 | 浙江车头制药股份有限公司 | 一种制备苯磺酸氯吡格雷晶型ⅲ的方法 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2530247B1 (fr) | 1982-07-13 | 1986-05-16 | Sanofi Sa | Nouveaux derives de la thieno (3, 2-c) pyridine, leur procede de preparation et leur application therapeutique |
| GB8608335D0 (en) | 1986-04-04 | 1986-05-08 | Pfizer Ltd | Pharmaceutically acceptable salts |
| 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 |
| US6509348B1 (en) | 1998-11-03 | 2003-01-21 | Bristol-Myers Squibb Company | Combination of an ADP-receptor blocking antiplatelet drug and a thromboxane A2 receptor antagonist and a method for inhibiting thrombus formation employing such combination |
| DE19857137A1 (de) | 1998-12-11 | 2000-06-15 | Bayer Ag | Integriertes Verfahren zur Herstellung von Epoxiden aus Olefinen |
| IN191030B (da) | 2001-01-24 | 2003-09-13 | Cadila Healthcare Ltd | |
| US6767913B2 (en) | 2001-12-18 | 2004-07-27 | Teva Pharmaceutical Industries Ltd. | 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 |
| IL166593A0 (en) | 2002-08-02 | 2006-01-15 | Racemization and enantiomer separation of clopidogrel | |
| EP1606231A1 (en) | 2003-02-03 | 2005-12-21 | Nadkarni, Sunil Sadanand | Process for preparation of clopidogrel, its salts and pharmaceutical compositions |
| DE10305984A1 (de) | 2003-02-13 | 2004-09-02 | Helm Ag | Salze organischer Säuren mit Clopidogrel und deren Verwendung zur Herstellung phamazeutischer Formulierungen |
| EP1603920A1 (en) | 2003-03-12 | 2005-12-14 | Cadila Healthcare Ltd. | Polymorph and amorphous form of (s)-(+)-clopidogrel bisulfate |
| WO2004106344A2 (en) | 2003-04-25 | 2004-12-09 | Cadila Healthcare Limited | Salts of clopidogrel and process for preparation |
| EP1680430B1 (en) | 2003-11-03 | 2010-01-20 | Cadila Healthcare Ltd. | Processes for preparing form i of (s)-(+)- clopidogrel bisulfate |
| EP1900358A1 (en) | 2006-09-16 | 2008-03-19 | Cimex Pharma AG | Pharmaceutical formulations comprising clopidogrel |
-
2004
- 2004-04-22 WO PCT/IN2004/000112 patent/WO2004106344A2/en active Application Filing
- 2004-04-22 SI SI200432209T patent/SI1618111T1/sl unknown
- 2004-04-22 US US10/554,367 patent/US7732608B2/en not_active Expired - Fee Related
- 2004-04-22 DK DK04770646.0T patent/DK1618111T3/da active
- 2004-04-22 DE DE4770646T patent/DE04770646T1/de active Pending
- 2004-04-22 PL PL04770646T patent/PL1618111T3/pl unknown
- 2004-04-22 EP EP09010218A patent/EP2113506A3/en not_active Withdrawn
- 2004-04-22 EP EP14192561.0A patent/EP2865681A3/en not_active Withdrawn
- 2004-04-22 ES ES04770646T patent/ES2531088T3/es not_active Expired - Lifetime
- 2004-04-22 KR KR1020057020142A patent/KR20060013376A/ko not_active Application Discontinuation
- 2004-04-22 EP EP04770646.0A patent/EP1618111B1/en not_active Expired - Lifetime
- 2004-04-22 EP EP08001523A patent/EP1927595B1/en not_active Expired - Lifetime
- 2004-04-22 PT PT47706460T patent/PT1618111E/pt unknown
-
2005
- 2005-10-17 NO NO20054763A patent/NO333586B1/no not_active IP Right Cessation
-
2010
- 2010-04-14 US US12/760,523 patent/US8053579B2/en not_active Expired - Fee Related
-
2015
- 2015-01-16 HR HRP20150056TT patent/HRP20150056T1/hr unknown
- 2015-02-17 CY CY20151100161T patent/CY1116554T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| NO20054763L (no) | 2006-01-16 |
| DE04770646T1 (de) | 2011-12-08 |
| EP2113506A2 (en) | 2009-11-04 |
| NO333586B1 (no) | 2013-07-15 |
| US8053579B2 (en) | 2011-11-08 |
| HRP20150056T1 (hr) | 2015-04-24 |
| US7732608B2 (en) | 2010-06-08 |
| SI1618111T1 (sl) | 2015-05-29 |
| PT1618111E (pt) | 2015-02-05 |
| EP1927595A2 (en) | 2008-06-04 |
| WO2004106344A2 (en) | 2004-12-09 |
| US20060264636A1 (en) | 2006-11-23 |
| US20100197923A1 (en) | 2010-08-05 |
| EP2113506A3 (en) | 2010-02-24 |
| PL1618111T3 (pl) | 2015-06-30 |
| ES2531088T3 (es) | 2015-03-10 |
| EP1618111B1 (en) | 2014-12-24 |
| EP2865681A3 (en) | 2015-08-19 |
| EP1618111A2 (en) | 2006-01-25 |
| EP2865681A2 (en) | 2015-04-29 |
| NO20054763D0 (no) | 2005-10-17 |
| CY1116554T1 (el) | 2017-03-15 |
| EP1927595A3 (en) | 2008-09-24 |
| WO2004106344A3 (en) | 2005-03-24 |
| EP1927595B1 (en) | 2013-03-06 |
| KR20060013376A (ko) | 2006-02-09 |
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