WO2006121557A1 - Pregabaline exempte de lactame et son procede de preparation - Google Patents

Pregabaline exempte de lactame et son procede de preparation Download PDF

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Publication number
WO2006121557A1
WO2006121557A1 PCT/US2006/013360 US2006013360W WO2006121557A1 WO 2006121557 A1 WO2006121557 A1 WO 2006121557A1 US 2006013360 W US2006013360 W US 2006013360W WO 2006121557 A1 WO2006121557 A1 WO 2006121557A1
Authority
WO
WIPO (PCT)
Prior art keywords
lactam
pregabalin
amine
eluent
hplc
Prior art date
Application number
PCT/US2006/013360
Other languages
English (en)
Inventor
Lilach Hedvati
Gideon Pilarski
Yuriy Raizi
Sharon Tomer
Ziv Dee Noor
Claude Singer
Original Assignee
Teva Pharmaceutical Industries Ltd.
Teva Pharmaceuticals Usa, Inc.
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 Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals Usa, Inc. filed Critical Teva Pharmaceutical Industries Ltd.
Priority to EP06749676A priority Critical patent/EP1879852A1/fr
Publication of WO2006121557A1 publication Critical patent/WO2006121557A1/fr
Priority to IL185033A priority patent/IL185033A0/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C229/00—Compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C229/02—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
    • C07C229/04—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated
    • C07C229/06—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton
    • C07C229/08—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to hydrogen atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N2030/022—Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027—Liquid chromatography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8818—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving amino acids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/86—Signal analysis
    • G01N30/8675—Evaluation, i.e. decoding of the signal into analytical information

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une prégabaline sensiblement exempte de lactame et un procédé pour obtenir cette prégabaline sensiblement exempte de lactame. Le procédé de l'invention consiste à extraire un mélange acide contenant un complexe de prégabaline présentant un acide minéral fort à l'aide d'un alcool C3-8; et à combiner la phase organique avec une base organique.
PCT/US2006/013360 2005-05-10 2006-04-11 Pregabaline exempte de lactame et son procede de preparation WO2006121557A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP06749676A EP1879852A1 (fr) 2005-05-10 2006-04-11 Pregabaline exempte de lactame et son procede de preparation
IL185033A IL185033A0 (en) 2005-05-10 2007-08-02 Pregabalin free of lactam and a process for preparation thereof

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US67978405P 2005-05-10 2005-05-10
US60/679,784 2005-05-10
US68969905P 2005-06-09 2005-06-09
US60/689,699 2005-06-09
US73300605P 2005-11-02 2005-11-02
US60/733,006 2005-11-02
US73506905P 2005-11-08 2005-11-08
US60/735,069 2005-11-08

Publications (1)

Publication Number Publication Date
WO2006121557A1 true WO2006121557A1 (fr) 2006-11-16

Family

ID=36646087

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/013360 WO2006121557A1 (fr) 2005-05-10 2006-04-11 Pregabaline exempte de lactame et son procede de preparation

Country Status (3)

Country Link
EP (1) EP1879852A1 (fr)
IL (1) IL185033A0 (fr)
WO (1) WO2006121557A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102007019071A1 (de) 2007-04-23 2008-10-30 Ratiopharm Gmbh Stabilisierte pharmazeutische Zusammensetzung enthaltend Pregabalin
WO2009046309A2 (fr) * 2007-10-03 2009-04-09 Teva Pharmaceutical Industries Ltd. Prégabaline-4-éliminée, prégabaline-5-éliminée, leur utilisation en tant que marqueur de référence et standard et procédé de production de prégabaline contenant de faibles taux de ceux-ci
US7586005B2 (en) 2005-09-19 2009-09-08 Teva Pharmaceutical Industries Ltd. Asymmetric synthesis of (S)-(+)-3-(aminomethyl)-5-methylhexanoic acid
US7619112B2 (en) 2005-05-10 2009-11-17 Teva Pharmaceutical Industries Ltd. Optical resolution of 3-carbamoylmethyl-5-methyl hexanoic acid
WO2010115612A3 (fr) * 2009-04-10 2011-02-03 Synthon B.V. Compositions de prégabaline
US8546112B2 (en) 2008-05-21 2013-10-01 Sandoz Ag Process for the stereoselective enzymatic hydrolysis of 5-methyl-3-nitromethyl-hexanoic acid ester
WO2016075082A1 (fr) 2014-11-10 2016-05-19 Sandoz Ag Amination réductrice stéréosélective d'aldéhydes alpha-chiraux au moyen d'ω-transaminases pour la synthèse de précurseurs de la prégabaline et du brivaracétam
WO2023071011A1 (fr) 2021-10-26 2023-05-04 浙江华海药业股份有限公司 Procédé de purification de prégabaline

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996038405A1 (fr) * 1995-06-02 1996-12-05 Warner-Lambert Company Procedes de production d'acide (s)-3-(aminomethyl)-5-methylhexanoique
WO1996040617A1 (fr) * 1995-06-07 1996-12-19 Warner-Lambert Company Procede de preparation d'acide (s)-3-(aminomethyl)-5-methylhexanoique
US6333198B1 (en) * 1998-06-10 2001-12-25 Glaxo Wellcome, Inc. Compound and its use
US20020012679A1 (en) * 1998-08-03 2002-01-31 Societe Laboratoires Des Produits Ethiques - Ethypharm Process for manufacturing coated gabapentin or pregabalin particles

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996038405A1 (fr) * 1995-06-02 1996-12-05 Warner-Lambert Company Procedes de production d'acide (s)-3-(aminomethyl)-5-methylhexanoique
WO1996040617A1 (fr) * 1995-06-07 1996-12-19 Warner-Lambert Company Procede de preparation d'acide (s)-3-(aminomethyl)-5-methylhexanoique
US6333198B1 (en) * 1998-06-10 2001-12-25 Glaxo Wellcome, Inc. Compound and its use
US20020012679A1 (en) * 1998-08-03 2002-01-31 Societe Laboratoires Des Produits Ethiques - Ethypharm Process for manufacturing coated gabapentin or pregabalin particles

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7619112B2 (en) 2005-05-10 2009-11-17 Teva Pharmaceutical Industries Ltd. Optical resolution of 3-carbamoylmethyl-5-methyl hexanoic acid
US7678938B2 (en) 2005-05-10 2010-03-16 Teva Pharmaceutical Industries Ltd. Optical resolution of 3-carbamoylmethyl-5-methyl hexanoic acid
US7586005B2 (en) 2005-09-19 2009-09-08 Teva Pharmaceutical Industries Ltd. Asymmetric synthesis of (S)-(+)-3-(aminomethyl)-5-methylhexanoic acid
US7851651B2 (en) 2005-09-19 2010-12-14 Teva Pharmaceutical Industries Ltd. Asymmetric synthesis of (S)-(+)-3-(aminomethyl)-5-methylhexanoic acid
US7923575B2 (en) 2005-09-19 2011-04-12 Teva Pharmaceutical Industries Limited Asymmetric synthesis of (S)-(+)-3-(aminomethyl)-5-methylhexanoic acid
DE102007019071A1 (de) 2007-04-23 2008-10-30 Ratiopharm Gmbh Stabilisierte pharmazeutische Zusammensetzung enthaltend Pregabalin
WO2009046309A2 (fr) * 2007-10-03 2009-04-09 Teva Pharmaceutical Industries Ltd. Prégabaline-4-éliminée, prégabaline-5-éliminée, leur utilisation en tant que marqueur de référence et standard et procédé de production de prégabaline contenant de faibles taux de ceux-ci
WO2009046309A3 (fr) * 2007-10-03 2009-05-22 Teva Pharma Prégabaline-4-éliminée, prégabaline-5-éliminée, leur utilisation en tant que marqueur de référence et standard et procédé de production de prégabaline contenant de faibles taux de ceux-ci
US8546112B2 (en) 2008-05-21 2013-10-01 Sandoz Ag Process for the stereoselective enzymatic hydrolysis of 5-methyl-3-nitromethyl-hexanoic acid ester
WO2010115612A3 (fr) * 2009-04-10 2011-02-03 Synthon B.V. Compositions de prégabaline
WO2016075082A1 (fr) 2014-11-10 2016-05-19 Sandoz Ag Amination réductrice stéréosélective d'aldéhydes alpha-chiraux au moyen d'ω-transaminases pour la synthèse de précurseurs de la prégabaline et du brivaracétam
WO2023071011A1 (fr) 2021-10-26 2023-05-04 浙江华海药业股份有限公司 Procédé de purification de prégabaline

Also Published As

Publication number Publication date
EP1879852A1 (fr) 2008-01-23
IL185033A0 (en) 2007-12-03

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