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WO2010100476A3 - Procédé amélioré - Google Patents

Procédé amélioré Download PDF

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Publication number
WO2010100476A3
WO2010100476A3 PCT/GB2010/050352 GB2010050352W WO2010100476A3 WO 2010100476 A3 WO2010100476 A3 WO 2010100476A3 GB 2010050352 W GB2010050352 W GB 2010050352W WO 2010100476 A3 WO2010100476 A3 WO 2010100476A3
Authority
WO
WIPO (PCT)
Prior art keywords
lenalidomide
crystalline form
isoindol
dione
piperidine
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/GB2010/050352
Other languages
English (en)
Other versions
WO2010100476A2 (fr
Inventor
Vinayak Govind Gore
Vinay Kumar Shukla
Sheryas Bhandari
Suresh Hasbe
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.)
Generics UK Ltd
Mylan Pharmaceuticals Pvt Ltd
Original Assignee
Generics UK Ltd
Mylan India Pvt 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 to EP10707950.1A priority Critical patent/EP2403845B1/fr
Priority to JP2011552515A priority patent/JP5727944B2/ja
Priority to CN2010800195527A priority patent/CN102414196A/zh
Priority to HRP20140686AT priority patent/HRP20140686T1/hr
Priority to NZ595492A priority patent/NZ595492A/xx
Priority to CA2753241A priority patent/CA2753241C/fr
Priority to PL10707950T priority patent/PL2403845T3/pl
Priority to DK10707950.1T priority patent/DK2403845T3/da
Priority to US13/254,249 priority patent/US8946265B2/en
Application filed by Generics UK Ltd, Mylan India Pvt Ltd filed Critical Generics UK Ltd
Priority to ES10707950.1T priority patent/ES2487215T3/es
Priority to AU2010220204A priority patent/AU2010220204B2/en
Priority to SI201030679T priority patent/SI2403845T1/sl
Publication of WO2010100476A2 publication Critical patent/WO2010100476A2/fr
Publication of WO2010100476A3 publication Critical patent/WO2010100476A3/fr
Anticipated expiration legal-status Critical
Priority to SM201400100T priority patent/SMT201400100B/xx
Ceased legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/04—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings directly linked by a ring-member-to-ring-member bond
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Health & Medical Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Glass Compositions (AREA)
  • Optical Communication System (AREA)
  • Lighting Device Outwards From Vehicle And Optical Signal (AREA)

Abstract

La présente invention porte sur des procédés améliorés pour préparer la 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-pipéridine-2,6-dione (I) (lénalidomide) et son intermédiaire 3-(1-oxo-4-nitro-1,3-dihydro-isoindol-2-yl)-pipéridine-2,6-dione. La présente invention porte en outre sur des procédés améliorés de préparation de la forme cristalline A de lénalidomide, sur l'utilisation de ladite forme cristalline A en tant que principe pharmaceutique actif ou en tant qu'intermédiaire dans la préparation d'autres formes cristallines ou amorphes de lénalidomide, sur des compositions comprenant la forme cristalline A de lénalidomide et sur leur utilisation pour le traitement d'une maladie.
PCT/GB2010/050352 2009-03-02 2010-03-01 Procédé amélioré Ceased WO2010100476A2 (fr)

Priority Applications (13)

Application Number Priority Date Filing Date Title
US13/254,249 US8946265B2 (en) 2009-03-02 2010-03-01 Process for the preparation of lenalidomide
CN2010800195527A CN102414196A (zh) 2009-03-02 2010-03-01 改进的方法
HRP20140686AT HRP20140686T1 (hr) 2009-03-02 2010-03-01 Poboljšani postupak
NZ595492A NZ595492A (en) 2009-03-02 2010-03-01 Improved Process for the Preparation of Lenalidomide
CA2753241A CA2753241C (fr) 2009-03-02 2010-03-01 Procede de preparation de lenalidomide
PL10707950T PL2403845T3 (pl) 2009-03-02 2010-03-01 Ulepszony sposób
DK10707950.1T DK2403845T3 (da) 2009-03-02 2010-03-01 Forbedret proces.
EP10707950.1A EP2403845B1 (fr) 2009-03-02 2010-03-01 Procédé amélioré
ES10707950.1T ES2487215T3 (es) 2009-03-02 2010-03-01 Proceso mejorado
JP2011552515A JP5727944B2 (ja) 2009-03-02 2010-03-01 改良プロセス
AU2010220204A AU2010220204B2 (en) 2009-03-02 2010-03-01 Improved process
SI201030679T SI2403845T1 (sl) 2009-03-02 2010-03-01 Izboljšani postopek
SM201400100T SMT201400100B (it) 2009-03-02 2014-07-28 Processo migliorato

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN383KO2009 2009-03-02
IN383/KOL/2009 2009-03-02
IN463KO2009 2009-03-16
IN463/KOL/2009 2009-03-16

Publications (2)

Publication Number Publication Date
WO2010100476A2 WO2010100476A2 (fr) 2010-09-10
WO2010100476A3 true WO2010100476A3 (fr) 2011-06-16

Family

ID=54290149

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2010/050352 Ceased WO2010100476A2 (fr) 2009-03-02 2010-03-01 Procédé amélioré

Country Status (16)

Country Link
US (1) US8946265B2 (fr)
EP (1) EP2403845B1 (fr)
JP (1) JP5727944B2 (fr)
CN (1) CN102414196A (fr)
AU (1) AU2010220204B2 (fr)
CA (1) CA2753241C (fr)
CY (1) CY1115376T1 (fr)
DK (1) DK2403845T3 (fr)
ES (1) ES2487215T3 (fr)
HR (1) HRP20140686T1 (fr)
NZ (1) NZ595492A (fr)
PL (1) PL2403845T3 (fr)
PT (1) PT2403845E (fr)
SI (1) SI2403845T1 (fr)
SM (1) SMT201400100B (fr)
WO (1) WO2010100476A2 (fr)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA83504C2 (en) 2003-09-04 2008-07-25 Селджин Корпорейшн Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
TWI475014B (zh) * 2009-09-17 2015-03-01 Scinopharm Taiwan Ltd 固體形態的３－（４－胺基－１－側氧基－１，３－二氫－異吲哚－２－基）－哌啶－２，６－二酮及其製造方法
WO2011064574A1 (fr) 2009-11-24 2011-06-03 Generics [Uk] Limited Procédés de hplc permettant la détection de la lénalidomide
WO2011111053A1 (fr) * 2010-03-08 2011-09-15 Natco Pharma Limited Forme i de lénalidomide anhydre
EP2799071B1 (fr) 2010-06-16 2018-10-17 Inflammatory Response Research, Inc. Lévocétirizine et montélukast pour le traitement de la grippe et le rhume
WO2013005229A1 (fr) * 2011-07-05 2013-01-10 Hetero Research Foundation Procédé de préparation de lénalidomide
WO2013012485A2 (fr) * 2011-07-19 2013-01-24 Amplio Pharma, Llc Nouvelles formes cristallines de 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)pipéridine-2,6-dione
CN102838586A (zh) * 2012-09-20 2012-12-26 重庆泰濠制药有限公司 一种制备来那度胺的方法
KR20150135339A (ko) 2013-03-13 2015-12-02 인플래머토리 리스폰스 리서치, 아이엔씨. 레보세티리진 및 몬테루카스트의 외상성 손상의 치료 용도
JP2016512262A (ja) 2013-03-13 2016-04-25 インフラマトリー・レスポンス・リサーチ・インコーポレイテッド 血管炎の処置におけるレボセチリジン及びモンテルカストの使用
ES2745041T3 (es) * 2013-03-13 2020-02-27 Inflammatory Response Res Inc Uso de levocetirizina y montelukast en el tratamiento de trastornos autoinmunitarios
WO2014160686A1 (fr) * 2013-03-26 2014-10-02 Celgene Corporation Formes solides comprenant de la 3-(4-amino-1-oxo-1,3-dihydro-iso-indol-2-yl)-pipéridine-2,6-dione et un coagent de formation, compositions et procédés d'utilisation correspondants
CN103601717A (zh) * 2013-10-09 2014-02-26 湖南华腾制药有限公司 一种来那度胺的新型制备方法
LV14985B (lv) 2013-10-14 2015-06-20 Latvijas Organiskās Sintēzes Institūts Lenalidomīda iegūšanas process
EP3137450A2 (fr) * 2014-04-26 2017-03-08 Shilpa Medicare Limited Procédé de préparation de lénalidomide cristallin
US10392364B2 (en) 2014-08-11 2019-08-27 Avra Laboratories Pvt. Ltd. Process for synthesis of lenalidomide
KR102516638B1 (ko) * 2014-08-19 2023-04-03 신톤 비.브이. 레날리도마이드의 결정형 a의 제조 방법
WO2016044095A1 (fr) 2014-09-15 2016-03-24 Inflammatory Response Research, Inc. Lévocétirizine et montélukast dans le traitement de troubles médiés par une inflammation
EA036205B1 (ru) * 2015-12-22 2020-10-14 Синтон Б.В. Фармацевтическая композиция, содержащая аморфный леналидомид и антиоксидант
US10899793B2 (en) 2016-05-27 2021-01-26 Regents Of The University Of Minnesota Melanocortin ligands and methods of use thereof
US11124541B2 (en) 2016-10-18 2021-09-21 Regents Of The University Of Minnesota Chimeric melanocortin ligands and methods of use thereof
JP2020535192A (ja) * 2017-09-27 2020-12-03 バイオコン・リミテッド レナリドミドの結晶形
WO2019138424A1 (fr) * 2018-01-11 2019-07-18 Natco Pharma Limited Compositions pharmaceutiques stables comprenant du lénalidomide
US11332499B2 (en) 2018-08-16 2022-05-17 Regents Of The University Of Minnesota Cyclic peptides and methods of use thereof
CN111196800B (zh) * 2018-11-19 2022-10-11 欣凯医药化工中间体（上海）有限公司 一种制备来那度胺的方法
WO2022144924A1 (fr) * 2021-01-04 2022-07-07 Avra Laboratories Pvt. Ltd. Procédé amélioré de synthèse de lénalidomide

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6335349B1 (en) * 1996-07-24 2002-01-01 Celgene Corporation Substituted 2(2,6-dioxopiperidin-3-yl)isoindolines
WO2006028964A1 (fr) * 2004-09-03 2006-03-16 Celgene Corporation Procedes de preparation de 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines substituees

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5635517B1 (en) 1996-07-24 1999-06-29 Celgene Corp Method of reducing TNFalpha levels with amino substituted 2-(2,6-dioxopiperidin-3-YL)-1-oxo-and 1,3-dioxoisoindolines
UA83504C2 (en) 2003-09-04 2008-07-25 Селджин Корпорейшн Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
WO2008128225A1 (fr) 2007-04-16 2008-10-23 Momenta Pharmaceuticals, Inc. Procédés de chromatographie multidimensionnelle permettant de séparer des n-glycanes
WO2009077784A2 (fr) 2007-12-14 2009-06-25 Generics [Uk] Limited Nouveau procédé de clhp
WO2009114601A2 (fr) 2008-03-11 2009-09-17 Dr. Reddy's Laboratories Ltd. Préparation de lénalidomide
WO2010061209A1 (fr) 2008-11-03 2010-06-03 Generics [Uk] Limited Forme cristalline du lénalidomide et procédé pour sa préparation
WO2011064574A1 (fr) 2009-11-24 2011-06-03 Generics [Uk] Limited Procédés de hplc permettant la détection de la lénalidomide

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6335349B1 (en) * 1996-07-24 2002-01-01 Celgene Corporation Substituted 2(2,6-dioxopiperidin-3-yl)isoindolines
WO2006028964A1 (fr) * 2004-09-03 2006-03-16 Celgene Corporation Procedes de preparation de 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines substituees

Also Published As

Publication number Publication date
JP2012519207A (ja) 2012-08-23
CA2753241C (fr) 2015-06-16
DK2403845T3 (da) 2014-08-04
PT2403845E (pt) 2014-08-04
US20120071509A1 (en) 2012-03-22
SMT201400100B (it) 2014-11-10
AU2010220204A1 (en) 2011-10-20
US8946265B2 (en) 2015-02-03
HRP20140686T1 (hr) 2014-09-26
CY1115376T1 (el) 2017-01-04
PL2403845T3 (pl) 2014-09-30
AU2010220204B2 (en) 2015-10-08
CN102414196A (zh) 2012-04-11
SI2403845T1 (sl) 2014-09-30
EP2403845A2 (fr) 2012-01-11
WO2010100476A2 (fr) 2010-09-10
ES2487215T3 (es) 2014-08-20
CA2753241A1 (fr) 2010-09-10
JP5727944B2 (ja) 2015-06-03
EP2403845B1 (fr) 2014-04-30
NZ595492A (en) 2013-07-26

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