CA2768553C - Anhydrate of tiotropium bromide - Google Patents

Anhydrate of tiotropium bromide Download PDF

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Publication number
CA2768553C
CA2768553C CA2768553A CA2768553A CA2768553C CA 2768553 C CA2768553 C CA 2768553C CA 2768553 A CA2768553 A CA 2768553A CA 2768553 A CA2768553 A CA 2768553A CA 2768553 C CA2768553 C CA 2768553C
Authority
CA
Canada
Prior art keywords
tiotropium bromide
anhydrous tiotropium
anhydrous
present
process according
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
CA2768553A
Other languages
English (en)
French (fr)
Other versions
CA2768553A1 (en
Inventor
Vinayak Govind Gore
Bindu Manojkumar
Dattatraya Shinde
Dattatrey Kokane
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
Original Assignee
Generics UK 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 Generics UK Ltd filed Critical Generics UK Ltd
Priority to CA2931876A priority Critical patent/CA2931876A1/en
Publication of CA2768553A1 publication Critical patent/CA2768553A1/en
Application granted granted Critical
Publication of CA2768553C publication Critical patent/CA2768553C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D491/00—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00
    • C07D491/12—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00 in which the condensed system contains three hetero rings
    • C07D491/18—Bridged systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • 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
    • A61P11/06—Antiasthmatics
    • 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
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D451/00—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof
    • C07D451/02—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof
    • C07D451/04—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof with hetero atoms directly attached in position 3 of the 8-azabicyclo [3.2.1] octane or in position 7 of the 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring system
    • C07D451/06—Oxygen atoms
    • C07D451/10—Oxygen atoms acylated by aliphatic or araliphatic carboxylic acids, e.g. atropine, scopolamine

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA2768553A 2009-08-07 2010-08-06 Anhydrate of tiotropium bromide Expired - Fee Related CA2768553C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2931876A CA2931876A1 (en) 2009-08-07 2010-08-06 Anhydrate of tiotropium bromide

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN1048KO2009 2009-08-07
IN1048/KOL/2009 2009-08-07
PCT/GB2010/051310 WO2011015882A2 (en) 2009-08-07 2010-08-06 Novel anhydrate

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2931876A Division CA2931876A1 (en) 2009-08-07 2010-08-06 Anhydrate of tiotropium bromide

Publications (2)

Publication Number Publication Date
CA2768553A1 CA2768553A1 (en) 2011-02-10
CA2768553C true CA2768553C (en) 2016-08-02

Family

ID=42830336

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2768553A Expired - Fee Related CA2768553C (en) 2009-08-07 2010-08-06 Anhydrate of tiotropium bromide
CA2931876A Abandoned CA2931876A1 (en) 2009-08-07 2010-08-06 Anhydrate of tiotropium bromide

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2931876A Abandoned CA2931876A1 (en) 2009-08-07 2010-08-06 Anhydrate of tiotropium bromide

Country Status (9)

Country Link
US (2) US8697719B2 (enExample)
EP (1) EP2462140A2 (enExample)
JP (2) JP5822831B2 (enExample)
CN (1) CN102639531B (enExample)
AU (1) AU2010280497B2 (enExample)
CA (2) CA2768553C (enExample)
IN (1) IN2012DN00968A (enExample)
NZ (2) NZ597920A (enExample)
WO (1) WO2011015882A2 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1869035E (pt) 2005-12-19 2013-01-10 Sicor Inc Novas formas de brometo de tiotrópio e processos para sua preparação
US9108962B2 (en) 2005-12-19 2015-08-18 Sicor, Inc. Forms of tiotropium bromide and processes for preparation thereof
CA2768553C (en) 2009-08-07 2016-08-02 Generics [Uk] Limited Anhydrate of tiotropium bromide
TR201111589A2 (tr) * 2011-03-03 2012-09-21 Bi̇lgi̇ç Mahmut Tiotropyum bromür susuz kristal formu.
PT106142B (pt) 2012-02-10 2014-07-18 Hovione Farmaci Ncia S A Processo para a preparação de brometo de tiotrópio
EP2897955B1 (en) * 2012-09-11 2019-11-06 Bilgic, Mahmut New tiotropium bromide crystalline form
CN104341413A (zh) * 2013-07-29 2015-02-11 天津金耀集团有限公司 一种无水噻托溴铵的新晶型
HUE045868T2 (hu) * 2013-11-22 2020-01-28 Teva Branded Pharmaceutical Products R&D Inc Inhalálható gyógykészítmény
EP2913332A1 (en) 2014-02-27 2015-09-02 Euticals S.P.A. Crystalline form of tiotropium bromide with lactose
US10555903B2 (en) * 2016-10-14 2020-02-11 Glenmark Specialty S.A. Nebulizable compositions of tiotropium and formoterol

Family Cites Families (32)

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DE3931041C2 (de) 1989-09-16 2000-04-06 Boehringer Ingelheim Kg Ester von Thienylcarbonsäuren mit Aminoalkoholen, ihre Quaternierungsprodukte, Verfahren zu ihrer Herstellung und diese enthaltende Arzneimittel
US5610163A (en) 1989-09-16 1997-03-11 Boehringer Ingelheim Gmbh Esters of thienyl carboxylic acids and amino alcohols and their quaternization products
US6908928B2 (en) 2000-10-12 2005-06-21 Bi Pharma Kg. Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions
AU2002214996B2 (en) 2000-10-12 2007-03-15 Boehringer Ingelheim Pharma Gmbh & Co. Kg Crystalline monohydrate, method for producing the same and the use thereof in the production of a medicament
DE10064816A1 (de) 2000-12-22 2002-06-27 Boehringer Ingelheim Pharma Verfahren zur Herstellung eines Anticholinergikums
US6506900B1 (en) 2001-01-31 2003-01-14 Boehringer Ingelheim Pharma Ag Process for preparing a scopine ester intermediate
AUPR315301A0 (en) 2001-02-19 2001-03-15 Silverbrook Research Pty. Ltd. An Apparatus (ART102)
US6608055B2 (en) 2001-06-22 2003-08-19 Boehringer Ingelheim Pharma Kg Crystalline anticholinergic, processes for preparing it and its use for preparing a pharmaceutical composition
US6610849B2 (en) 2001-06-28 2003-08-26 Boehringer Ingelheim Pharma Kg Process for the manufacture of tropenol
DE10200943A1 (de) 2002-01-12 2003-07-24 Boehringer Ingelheim Pharma Verfahren zur Herstellung von Scopinestern
US6747153B2 (en) 2002-05-31 2004-06-08 Boehringer Ingelheim Pharma Gmbh & Co. Kg Industrial process for preparing tropenol
ES2329133T3 (es) 2003-05-28 2009-11-23 Theravance, Inc. Compuestos azabicicloalcanicos como antagonistas de receptores de muscarinicos.
US7968717B2 (en) 2003-11-03 2011-06-28 Boehringer Ingelhein International Gmbh Crystalline anhydrate with anticholinergic efficacy
WO2005042527A1 (de) * 2003-11-03 2005-05-12 Boehringer Ingelheim International Gmbh Neues kristallines anhydrat mit anticholinerger wirksamkeit
CN1271073C (zh) * 2004-10-26 2006-08-23 江苏正大天晴药业股份有限公司 结晶性抗胆碱能药噻托溴铵晶体
WO2006076222A2 (en) 2005-01-10 2006-07-20 Glaxo Group Limited Pharmaceutical formulations
EP1879888A2 (en) * 2005-05-02 2008-01-23 Boehringer Ingelheim International GmbH Crystalline forms of tiotropium bromide
KR20080012932A (ko) * 2005-05-02 2008-02-12 베링거 인겔하임 인터내셔날 게엠베하 티오트로퓸 브로마이드의 신규한 결정형
DE102005035112A1 (de) 2005-07-27 2007-02-15 Boehringer Ingelheim Pharma Gmbh & Co. Kg Neues Verfahren zur Herstellung von Tiotropiumsalzen unter Anwendung von in organischen Lösungsmitteln löslichen N-Methylscopiniumsalzen
PT1869035E (pt) * 2005-12-19 2013-01-10 Sicor Inc Novas formas de brometo de tiotrópio e processos para sua preparação
JP2008530251A (ja) * 2005-12-19 2008-08-07 シコール インコーポレイティド 純粋且つ安定な臭化チオトロピウム
US20070167480A1 (en) * 2005-12-19 2007-07-19 Sicor Inc. Pure and stable tiotropium bromide
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US20080051582A1 (en) 2006-07-10 2008-02-28 Sicor Inc. Process for the preparation of tiotropium bromide
WO2008089852A1 (de) 2007-01-26 2008-07-31 Boehringer Ingelheim Pharma Gmbh & Co.Kg Neues verfahren zur herstellung von tiotropiumsalzen
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WO2011015884A1 (en) 2009-08-07 2011-02-10 Generics [Uk] Limited Process to prepare scopine esters
WO2011015883A1 (en) 2009-08-07 2011-02-10 Generics [Uk] Limited Dichloromethane solvate of tiotropium bromide and its use
CA2768553C (en) 2009-08-07 2016-08-02 Generics [Uk] Limited Anhydrate of tiotropium bromide
WO2011095800A2 (en) 2010-02-02 2011-08-11 Generics [Uk] Limited Analytical methods

Also Published As

Publication number Publication date
US20140249175A1 (en) 2014-09-04
WO2011015882A2 (en) 2011-02-10
AU2010280497A8 (en) 2012-03-08
CN102639531B (zh) 2016-01-20
US9181268B2 (en) 2015-11-10
CA2768553A1 (en) 2011-02-10
JP5822831B2 (ja) 2015-11-24
NZ624602A (en) 2015-11-27
NZ597920A (en) 2014-05-30
EP2462140A2 (en) 2012-06-13
JP2015214574A (ja) 2015-12-03
CN102639531A (zh) 2012-08-15
US20150051241A9 (en) 2015-02-19
AU2010280497B2 (en) 2015-10-22
JP2013501041A (ja) 2013-01-10
AU2010280497A1 (en) 2012-02-23
IN2012DN00968A (enExample) 2015-04-10
WO2011015882A3 (en) 2011-09-01
CA2931876A1 (en) 2011-02-10
US8697719B2 (en) 2014-04-15
US20120149725A1 (en) 2012-06-14

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