AU2004229507B2 - Polymorphic form of montelukast sodium - Google Patents

Polymorphic form of montelukast sodium Download PDF

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Publication number
AU2004229507B2
AU2004229507B2 AU2004229507A AU2004229507A AU2004229507B2 AU 2004229507 B2 AU2004229507 B2 AU 2004229507B2 AU 2004229507 A AU2004229507 A AU 2004229507A AU 2004229507 A AU2004229507 A AU 2004229507A AU 2004229507 B2 AU2004229507 B2 AU 2004229507B2
Authority
AU
Australia
Prior art keywords
montelukast sodium
acetonitrile
treatment
monosolvate
montelukast
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
AU2004229507A
Other languages
English (en)
Other versions
AU2004229507A1 (en
Inventor
Cynthia Bazin
Jun-Hong Chou
Sophie-Dorothee Clas
Chad Dalton
Michael B. Gentzler
James N. Michaels
Michael Guojie Wu
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.)
Merck Frosst Canada and Co
Merck Sharp & Dohme LLC
Original Assignee
Merck Frosst Canada and Co
Merck Sharp and Dohme Ltd
Merck Sharp & Dohme LLC
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 Merck Frosst Canada and Co, Merck Sharp and Dohme Ltd, Merck Sharp & Dohme LLC filed Critical Merck Frosst Canada and Co
Publication of AU2004229507A1 publication Critical patent/AU2004229507A1/en
Application granted granted Critical
Publication of AU2004229507B2 publication Critical patent/AU2004229507B2/en
Assigned to MERCK SHARP & DOHME CORP., MERCK FROSST CANADA & CO. reassignment MERCK SHARP & DOHME CORP. Request to Amend Deed and Register Assignors: MERCK & CO., INC., MERCK FROSST CANADA & CO.
Assigned to MERCK SHARP & DOHME CORP., MERCK FROSST CANADA & CO. reassignment MERCK SHARP & DOHME CORP. Request to Amend Deed and Register Assignors: MERCK & CO., INC., MERCK FROSST CANADA & CO.
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom 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
    • C07D215/18—Halogen atoms or nitro radicals

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Immunology (AREA)
  • Otolaryngology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Quinoline Compounds (AREA)
AU2004229507A 2003-04-15 2004-04-12 Polymorphic form of montelukast sodium Ceased AU2004229507B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US46294103P 2003-04-15 2003-04-15
US60/462,941 2003-04-15
PCT/US2004/011211 WO2004091618A1 (en) 2003-04-15 2004-04-12 Polymorphic form of montelukast sodium

Publications (2)

Publication Number Publication Date
AU2004229507A1 AU2004229507A1 (en) 2004-10-28
AU2004229507B2 true AU2004229507B2 (en) 2008-12-18

Family

ID=33300016

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2004229507A Ceased AU2004229507B2 (en) 2003-04-15 2004-04-12 Polymorphic form of montelukast sodium

Country Status (7)

Country Link
US (1) US7560559B2 (enExample)
EP (1) EP1633357A4 (enExample)
JP (2) JP2006523699A (enExample)
CN (1) CN1852713B (enExample)
AU (1) AU2004229507B2 (enExample)
CA (1) CA2522053C (enExample)
WO (1) WO2004091618A1 (enExample)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MXPA06008584A (es) * 2004-01-30 2007-04-16 Teva Pharma Polimorfos de acido libre de montelukast.
US20050187244A1 (en) * 2004-01-30 2005-08-25 Entire Interest. Montelukast sodium polymorphs
MXPA06012220A (es) 2004-04-21 2007-07-18 Teva Pharma Procesos para preparar sodio de montelukast.
WO2006054317A1 (en) * 2004-11-19 2006-05-26 Matrix Laboratories Ltd Process for the preparation of novel amorphous montelukast sodium
US7812168B2 (en) 2005-07-05 2010-10-12 Teva Pharmaceutical Industries Ltd. Purification of montelukast
US8178680B2 (en) * 2005-12-13 2012-05-15 Msn Laboratories Limited Process for the preparation of Montelukast and its pharmaceutically acceptable salts
WO2008062478A2 (en) * 2006-11-20 2008-05-29 Manne Satyanarayana Reddy Improved process for pure montelukast sodium through pure intermediates as well as novel amine salts
WO2010064257A1 (en) * 2008-12-01 2010-06-10 Innogent Laboratories Private Limited Novel intermediates for producing [r-(e)]-1-[[[1-[3-[2-(7- chloro -quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy- methylethyl) phenyl]propyl]thio] methyl] cyclopropaneacetic acid, monosodium salt and process thereof
EP2287154A1 (en) 2009-07-14 2011-02-23 KRKA, D.D., Novo Mesto Efficient synthesis for the preparation of montelukast
WO2011033470A1 (en) 2009-09-16 2011-03-24 Ranbaxy Laboratories Limited Crystalline form of montelukast sodium
US20110195042A1 (en) * 2010-02-10 2011-08-11 Thomas Edward Huetter Compositions, Methods and Kits Useful for Treating a Respiratory Symptom
WO2011121091A1 (en) 2010-03-31 2011-10-06 Krka, D.D., Novo Mesto Efficient synthesis for the preparation of montelukast and novel crystalline form of intermediates therein
KR100990046B1 (ko) 2010-07-30 2010-10-26 동국제약 주식회사 신규한 몬테루카스트 4-할로 벤질아민염 및 이를 이용한 몬테루카스트 나트륨염의 제조방법
US8471030B2 (en) 2010-12-06 2013-06-25 Orochem Technologies Inc. Purification of montelukast using simulated moving bed
WO2014012954A1 (en) 2012-07-18 2014-01-23 Takeda Gmbh Treatment of partly controlled or uncontrolled severe asthma
CN104055741B (zh) * 2013-03-18 2017-02-15 青岛大学 一种孟鲁司特钠片剂及其制备方法
CN104649968B (zh) * 2013-11-25 2017-03-15 天津汉瑞药业有限公司 一种孟鲁司特钠倍半水合物化合物
WO2015110394A1 (en) 2014-01-22 2015-07-30 Takeda Gmbh Treatment of partly controlled or uncontrolled severe asthma with a pde4 inhibitor (and in combination with a leukotriene modifier)
CN107049940A (zh) * 2017-03-10 2017-08-18 重庆西南医院 一种促进孟鲁司特钠经直肠吸收的促进剂及其使用方法
CN107162969A (zh) * 2017-07-05 2017-09-15 成都亿知科技有限公司 孟鲁司特钠晶体及其制备方法和药物组合物
AU2019334202A1 (en) 2018-09-06 2021-03-25 Innopharmascreen, Inc. Methods and compositions for treatment of asthma or parkinson's disease

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5614632A (en) * 1993-12-28 1997-03-25 Merck & Co., Inc. Process for the preparation of leukotriene anatgonists

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5565473A (en) * 1990-10-12 1996-10-15 Merck Frosst Canada, Inc. Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists
US5523477A (en) * 1995-01-23 1996-06-04 Merck & Co., Inc. Process for the preparation of 1-(thiomethyl)-cyclopropaneacetic acid
US5869673A (en) * 1997-02-28 1999-02-09 Merck & Co., Inc. Process for 3-(2-(7-chloro-2-quinolinyl)ethenyl) - benzaldehyde
US5952347A (en) * 1997-03-13 1999-09-14 Merck & Co., Inc. Quinoline leukotriene antagonists
JP2002527406A (ja) * 1998-10-09 2002-08-27 シェーリング コーポレイション アレルギー性疾患を処置するための組成物および方法
WO2002067938A2 (en) * 2000-10-30 2002-09-06 Schering Corporation Treating or reducing the risk of cardiovascular disease
WO2003066598A1 (en) * 2002-02-07 2003-08-14 Dr. Reddy's Laboratories Ltd. Novel anhydrous amorphous forms of montelukast sodium salt

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5614632A (en) * 1993-12-28 1997-03-25 Merck & Co., Inc. Process for the preparation of leukotriene anatgonists

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
D2: ISRAEL E et al J. Allergy Clin. Immunol, 2002, vol. 110, pp 847-854 *
D3: KITCHEN CJ et al J. Pharm. Biomed. Anal. 2003, vol. 31, pp647-654 *

Also Published As

Publication number Publication date
EP1633357A4 (en) 2010-02-10
WO2004091618A1 (en) 2004-10-28
CA2522053C (en) 2010-06-29
US7560559B2 (en) 2009-07-14
US20060194838A1 (en) 2006-08-31
CA2522053A1 (en) 2004-10-28
JP2010132668A (ja) 2010-06-17
CN1852713B (zh) 2010-12-01
EP1633357A1 (en) 2006-03-15
AU2004229507A1 (en) 2004-10-28
CN1852713A (zh) 2006-10-25
JP2006523699A (ja) 2006-10-19

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE CO-PATENTEE NAME FROM MERCK & CO., INC. TO MERCK SHARP & DOHME CORP.

MK14 Patent ceased section 143(a) (annual fees not paid) or expired