AU2016240289B2 - Process for the preparation of aclidinium bromide - Google Patents

Process for the preparation of aclidinium bromide Download PDF

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Publication number
AU2016240289B2
AU2016240289B2 AU2016240289A AU2016240289A AU2016240289B2 AU 2016240289 B2 AU2016240289 B2 AU 2016240289B2 AU 2016240289 A AU2016240289 A AU 2016240289A AU 2016240289 A AU2016240289 A AU 2016240289A AU 2016240289 B2 AU2016240289 B2 AU 2016240289B2
Authority
AU
Australia
Prior art keywords
process according
bromide
mixture
solvent
solvents
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
AU2016240289A
Other languages
English (en)
Other versions
AU2016240289A1 (en
Inventor
Constanca Cacela
Ana Carina Constantino
Zita Mendes
Bruno SANTOS
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.)
Hovione Scientia Ltd
Original Assignee
Hovione Scientia 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 Hovione Scientia Ltd filed Critical Hovione Scientia Ltd
Publication of AU2016240289A1 publication Critical patent/AU2016240289A1/en
Application granted granted Critical
Publication of AU2016240289B2 publication Critical patent/AU2016240289B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D453/00—Heterocyclic compounds containing quinuclidine or iso-quinuclidine ring systems, e.g. quinine alkaloids
    • C07D453/02—Heterocyclic compounds containing quinuclidine or iso-quinuclidine ring systems, e.g. quinine alkaloids containing not further condensed quinuclidine ring systems
    • 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
    • A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D9/00—Crystallisation
    • B01D9/0018—Evaporation of components of the mixture to be separated
    • B01D9/0027—Evaporation of components of the mixture to be separated by means of conveying fluid, e.g. spray-crystallisation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D9/00—Crystallisation
    • B01D9/005—Selection of auxiliary, e.g. for control of crystallisation nuclei, of crystal growth, of adherence to walls; Arrangements for introduction thereof
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Non-Silver Salt Photosensitive Materials And Non-Silver Salt Photography (AREA)
  • Catalysts (AREA)
AU2016240289A 2015-03-30 2016-03-30 Process for the preparation of aclidinium bromide Ceased AU2016240289B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PT10837015A PT108370B (pt) 2015-03-30 2015-03-30 Processo de preparação de brometo de aclidínio
PT108370 2015-03-30
PCT/GB2016/050888 WO2016156836A1 (en) 2015-03-30 2016-03-30 Process for the preparation of aclidinium bromide

Publications (2)

Publication Number Publication Date
AU2016240289A1 AU2016240289A1 (en) 2017-10-19
AU2016240289B2 true AU2016240289B2 (en) 2020-08-27

Family

ID=55806548

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016240289A Ceased AU2016240289B2 (en) 2015-03-30 2016-03-30 Process for the preparation of aclidinium bromide

Country Status (9)

Country Link
US (2) US10087177B2 (enExample)
EP (1) EP3277679A1 (enExample)
JP (4) JP2018510189A (enExample)
CN (1) CN108112252B (enExample)
AU (1) AU2016240289B2 (enExample)
CA (2) CA2980665A1 (enExample)
IL (1) IL254712A0 (enExample)
PT (1) PT108370B (enExample)
WO (1) WO2016156836A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT108370B (pt) 2015-03-30 2018-10-25 Hovione Farm S A Processo de preparação de brometo de aclidínio
CN108586450B (zh) * 2017-12-15 2021-02-19 上海方予健康医药科技有限公司 一种胆碱m受体抗结剂的重结晶纯化方法
PT115583B (pt) * 2019-06-17 2022-05-02 Hovione Farm S A Processo contínuo para a preparação de medicamentos anticolinérgicos
CN114890997A (zh) * 2022-04-20 2022-08-12 江苏联环药业股份有限公司 一种抗胆碱能药物噻格溴铵的制备工艺

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005014044A1 (en) * 2003-07-29 2005-02-17 Boehringer Ingelheim International Gmbh Medicaments for inhalation comprising betamimetics and an anticholinergic
WO2008009397A1 (en) * 2006-07-21 2008-01-24 Laboratorios Almirall, S.A. Process for manufacturing 3(r)-(2-hydroxy-2,2-dithien-2-ylacetoxy)-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide
WO2014027045A1 (en) * 2012-08-15 2014-02-20 Glaxo Group Limited Chemical process
WO2015062560A1 (en) * 2013-10-29 2015-05-07 Zentiva, K.S. An industrially applicable process for preparing high purity aclidinium bromide
WO2015071824A1 (en) * 2013-11-13 2015-05-21 Glenmark Pharmaceuticals Limited; Glenmark Generics Limited Process for the preparation of aclidinium bromide

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2165768B1 (es) * 1999-07-14 2003-04-01 Almirall Prodesfarma Sa Nuevos derivados de quinuclidina y composiciones farmaceuticas que los contienen.
SK9742002A3 (en) * 2000-01-07 2003-02-04 Transform Pharmaceuticals Inc High-throughput formation, identification, and analysis of diverse solid-forms
US6482847B2 (en) * 2000-10-03 2002-11-19 Hoffmann-La Roche Inc. Amorphous form of cell cycle inhibitor having improved solubility and bioavailability
AR044134A1 (es) * 2003-05-02 2005-08-24 Novartis Ag Derivados de quinuclidina, metodo de preparacion y composiciones farmaceuticas.
RS55940B1 (sr) * 2005-12-28 2017-09-29 Vertex Pharma Čvrsti oblici n-[2,4-bis(1,1-dimetiletil)-5-hidroksifenil]-1,4-dihidro-4-oksohinolin-3-karboksamida
PT108370B (pt) 2015-03-30 2018-10-25 Hovione Farm S A Processo de preparação de brometo de aclidínio

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005014044A1 (en) * 2003-07-29 2005-02-17 Boehringer Ingelheim International Gmbh Medicaments for inhalation comprising betamimetics and an anticholinergic
WO2008009397A1 (en) * 2006-07-21 2008-01-24 Laboratorios Almirall, S.A. Process for manufacturing 3(r)-(2-hydroxy-2,2-dithien-2-ylacetoxy)-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide
WO2014027045A1 (en) * 2012-08-15 2014-02-20 Glaxo Group Limited Chemical process
WO2015062560A1 (en) * 2013-10-29 2015-05-07 Zentiva, K.S. An industrially applicable process for preparing high purity aclidinium bromide
WO2015071824A1 (en) * 2013-11-13 2015-05-21 Glenmark Pharmaceuticals Limited; Glenmark Generics Limited Process for the preparation of aclidinium bromide

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
MARÍA PRAT ET AL, "Discovery of Novel Quaternary Ammonium Derivatives of (3 R )-Quinuclidinol Esters as Potent and Long-Acting Muscarinic Antagonists . . .", JOURNAL OF MEDICINAL CHEMISTRY, (2009-08-27), vol. 52, no. 16, pages 5076 - 5092 *

Also Published As

Publication number Publication date
CA2980665A1 (en) 2016-10-06
US20180362523A1 (en) 2018-12-20
JP2022160667A (ja) 2022-10-19
PT108370A (pt) 2016-09-30
JP2018510189A (ja) 2018-04-12
US10087177B2 (en) 2018-10-02
CN108112252B (zh) 2020-11-24
US10590124B2 (en) 2020-03-17
IL254712A0 (en) 2017-11-30
EP3277679A1 (en) 2018-02-07
US20180105517A1 (en) 2018-04-19
WO2016156836A1 (en) 2016-10-06
JP7124035B2 (ja) 2022-08-23
AU2016240289A1 (en) 2017-10-19
PT108370B (pt) 2018-10-25
CN108112252A (zh) 2018-06-01
JP2021020965A (ja) 2021-02-18
CA3165243A1 (en) 2016-10-06
JP2020143160A (ja) 2020-09-10

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Legal Events

Date Code Title Description
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ MENDES, ZITA; CACELA, CONSTANCA; CONSTANTINO, ANA CARINA AND SANTOS, BRUNO

FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired