CA2522053C - Polymorphic form of montelukast sodium - Google Patents

Polymorphic form of montelukast sodium Download PDF

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Publication number
CA2522053C
CA2522053C CA2522053A CA2522053A CA2522053C CA 2522053 C CA2522053 C CA 2522053C CA 2522053 A CA2522053 A CA 2522053A CA 2522053 A CA2522053 A CA 2522053A CA 2522053 C CA2522053 C CA 2522053C
Authority
CA
Canada
Prior art keywords
montelukast sodium
acetonitrile
monosolvate
treatment
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.)
Expired - Fee Related
Application number
CA2522053A
Other languages
English (en)
French (fr)
Other versions
CA2522053A1 (en
Inventor
Jun-Hong Chou
Michael B. Gentzler
James N. Michaels
Michael Guojie Wu
Cynthia Bazin
Sophie-Dorothee Clas
Chad Dalton
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 Canada Inc
Merck Sharp and Dohme LLC
Original Assignee
Merck Frosst Canada 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 Merck Frosst Canada Ltd filed Critical Merck Frosst Canada Ltd
Publication of CA2522053A1 publication Critical patent/CA2522053A1/en
Application granted granted Critical
Publication of CA2522053C publication Critical patent/CA2522053C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
  • Rheumatology (AREA)
  • Immunology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Quinoline Compounds (AREA)
CA2522053A 2003-04-15 2004-04-12 Polymorphic form of montelukast sodium Expired - Fee Related CA2522053C (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
CA2522053A1 CA2522053A1 (en) 2004-10-28
CA2522053C true CA2522053C (en) 2010-06-29

Family

ID=33300016

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2522053A Expired - Fee Related CA2522053C (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
WO2005074935A1 (en) * 2004-01-30 2005-08-18 Teva Pharmaceutical Industries Ltd. Montelukast free acid polymorphs
EP1709002A2 (en) * 2004-01-30 2006-10-11 Teva Pharmaceutical Industries Ltd. Montelukast sodium polymorphs
EP1646612B1 (en) 2004-04-21 2009-07-01 Teva Pharmaceutical Industries Ltd Processes for preparing montelukast sodium
EP1831171A4 (en) * 2004-11-19 2010-09-15 Matrix Lab Ltd PROCESS FOR THE PREPARATION OF NEW MONTELUKAST SODIUM AMORPHOUS
JP2008510840A (ja) 2005-07-05 2008-04-10 テバ ファーマシューティカル インダストリーズ リミティド モンテルカストの精製
US8178680B2 (en) * 2005-12-13 2012-05-15 Msn Laboratories Limited Process for the preparation of Montelukast and its pharmaceutically acceptable salts
US8115004B2 (en) * 2006-11-20 2012-02-14 Msn Laboratories Limited Process for pure montelukast sodium through pure intermediates as well as 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
JP2017503814A (ja) 2014-01-22 2017-02-02 タケダ ゲー・エム・ベー・ハーＴａｋｅｄａ ＧｍｂＨ 部分的コントロール状態の重症喘息またはコントロール不良状態の重症喘息のｐｄｅ４インヒビターを用いた（およびロイコトリエン調節薬と組み合わせて用いた）治療
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
EP3846792A4 (en) 2018-09-06 2022-10-12 Innopharmascreen Inc. METHODS AND COMPOSITIONS FOR TREATING ASTHMA OR PARKINSON'S DISEASE

Family Cites Families (8)

* 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
TW448160B (en) * 1993-12-28 2001-08-01 Merck & Co Inc Novel dicyclohexylamine salt and process for the preparation of 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
EP1119372A1 (en) * 1998-10-09 2001-08-01 Schering Corporation Composition and method for treating allergic diseases
AU2002256967A1 (en) * 2000-10-30 2002-09-12 Schering Corporation Treating or reducing the risk of cardiovascular disease
AU2003209043A1 (en) * 2002-02-07 2003-09-02 Dr. Reddy's Laboratories Ltd. Novel anhydrous amorphous forms of montelukast sodium salt

Also Published As

Publication number Publication date
JP2006523699A (ja) 2006-10-19
US20060194838A1 (en) 2006-08-31
US7560559B2 (en) 2009-07-14
CN1852713B (zh) 2010-12-01
WO2004091618A1 (en) 2004-10-28
AU2004229507A1 (en) 2004-10-28
EP1633357A1 (en) 2006-03-15
JP2010132668A (ja) 2010-06-17
AU2004229507B2 (en) 2008-12-18
CN1852713A (zh) 2006-10-25
EP1633357A4 (en) 2010-02-10
CA2522053A1 (en) 2004-10-28

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Effective date: 20130412