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WO2008129562A3 - Procédé amélioré pour la préparation d'atorvastatine amorphe hémicalcique stable et de ses sels - Google Patents

Procédé amélioré pour la préparation d'atorvastatine amorphe hémicalcique stable et de ses sels Download PDF

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Publication number
WO2008129562A3
WO2008129562A3 PCT/IN2008/000249 IN2008000249W WO2008129562A3 WO 2008129562 A3 WO2008129562 A3 WO 2008129562A3 IN 2008000249 W IN2008000249 W IN 2008000249W WO 2008129562 A3 WO2008129562 A3 WO 2008129562A3
Authority
WO
WIPO (PCT)
Prior art keywords
calcium
preparation
amorphous atorvastatin
stable amorphous
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.)
Ceased
Application number
PCT/IN2008/000249
Other languages
English (en)
Other versions
WO2008129562A2 (fr
Inventor
Sanjay Suri
Tapan Kashyap
Madan Pal Tanwar
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.)
Morepen Laboratories Ltd
Original Assignee
Morepen Laboratories 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
Application filed by Morepen Laboratories Ltd filed Critical Morepen Laboratories Ltd
Publication of WO2008129562A2 publication Critical patent/WO2008129562A2/fr
Anticipated expiration legal-status Critical
Publication of WO2008129562A3 publication Critical patent/WO2008129562A3/fr
Ceased legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D207/00—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D207/30—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D207/34—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pyrrole Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention porte sur la préparation d'un sel de calcium d'atorvastatine amorphe stable, hautement pure (c'est-à-dire satisfaisant les paramètres de qualité ICH par rapport aux substances apparentées). Ce procédé de préparation comprend les opérations suivantes : (a) hydrolyse d'un noyau 1,3-dioxane de (4R-cis)-1,1-diméthyléthyl-6-[2-[2-(4- fluorophényl)-5-(1-méthyléthyl)-3-phényl-4-[(phénylamino)carbonyl]-1lH-pyrrol-1-yl]éthyl]-2,2-diméthyl-1,3-dioxane-4-acétate représenté par la formule (I); (b) hydrolyse in situ du groupe t-butyle pour former la solution de sel de sodium d'atorvastatine; (c) addition d'un seul anti-oxydant ou d'un mélange de deux anti-oxydants ou davantage et éventuellement d'une amine; (d) addition de solution de sel de sodium d'atorvastatine à une solution aqueuse d'acétate de calcium ou de chlorure de calcium; (e) ensemencement facultatif par de l'atorvastatine amorphe calcique; (f) filtration et lavage du gâteau obtenu à l'aide de différents mélanges solvants en présence d'anti-oxydants; (g) dissolution du gâteau précité dans un solvant ou un mélange de deux solvants organiques ou davantage en faisant suivre par une cristallisation du produit à l'aide d'un anti-solvant.
PCT/IN2008/000249 2007-04-20 2008-04-17 Procédé amélioré pour la préparation d'atorvastatine amorphe hémicalcique stable et de ses sels Ceased WO2008129562A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN870DE2007 2007-04-20
IN870/DEL/2007 2007-04-20

Publications (2)

Publication Number Publication Date
WO2008129562A2 WO2008129562A2 (fr) 2008-10-30
WO2008129562A3 true WO2008129562A3 (fr) 2009-12-30

Family

ID=39876065

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2008/000249 Ceased WO2008129562A2 (fr) 2007-04-20 2008-04-17 Procédé amélioré pour la préparation d'atorvastatine amorphe hémicalcique stable et de ses sels

Country Status (1)

Country Link
WO (1) WO2008129562A2 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011131601A1 (fr) 2010-04-19 2011-10-27 Dsm Ip Assets B.V. Production d'atorvastatine à faible teneur en impuretés lactones
US20130041162A1 (en) * 2010-04-19 2013-02-14 Dsm Sinochem Pharmaceuticals Netherlands B.V. Production of atorvastatin low in ether impurities
EP2616454B1 (fr) 2010-09-16 2015-04-15 DSM Sinochem Pharmaceuticals Netherlands B.V. Esters d'acides hexanoïques comme intermédiaires pour la préparation d'atorvastatine
CN109142586B (zh) * 2018-10-09 2021-04-30 河南师范大学 一种液相色谱法测定阿托伐他汀钙中间体ats-9及其杂质b含量的方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050032880A1 (en) * 2003-06-12 2005-02-10 Lorenz Douglas A. Process for forming amorphous atorvastatin
US20050119493A1 (en) * 2001-08-31 2005-06-02 Sanjay Suri Process for the preparation of amorphous atorvastin calcium salt (2:1)
US7151183B2 (en) * 2000-11-30 2006-12-19 Teva Pharmaceutical Industries Ltd. Processes for preparing amorphous atorvastatin hemi-calcium

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7151183B2 (en) * 2000-11-30 2006-12-19 Teva Pharmaceutical Industries Ltd. Processes for preparing amorphous atorvastatin hemi-calcium
US20050119493A1 (en) * 2001-08-31 2005-06-02 Sanjay Suri Process for the preparation of amorphous atorvastin calcium salt (2:1)
US20050032880A1 (en) * 2003-06-12 2005-02-10 Lorenz Douglas A. Process for forming amorphous atorvastatin

Also Published As

Publication number Publication date
WO2008129562A2 (fr) 2008-10-30

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