CA2427583C - Formulation d'une solution d'inhalation contenant un sel de tiotropium - Google Patents

Formulation d'une solution d'inhalation contenant un sel de tiotropium Download PDF

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Publication number
CA2427583C
CA2427583C CA002427583A CA2427583A CA2427583C CA 2427583 C CA2427583 C CA 2427583C CA 002427583 A CA002427583 A CA 002427583A CA 2427583 A CA2427583 A CA 2427583A CA 2427583 C CA2427583 C CA 2427583C
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CA
Canada
Prior art keywords
pharmaceutical preparation
preparation according
tiotropium
acid
salt
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
CA002427583A
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English (en)
Other versions
CA2427583A1 (fr
Inventor
Karin Drechsel
Barbara Niklaus-Humke
Christel Schmelzer
Petra Barth
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.)
Boehringer Ingelheim Pharma GmbH and Co KG
Original Assignee
Boehringer Ingelheim Pharma GmbH and Co KG
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
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Application filed by Boehringer Ingelheim Pharma GmbH and Co KG filed Critical Boehringer Ingelheim Pharma GmbH and Co KG
Publication of CA2427583A1 publication Critical patent/CA2427583A1/fr
Application granted granted Critical
Publication of CA2427583C publication Critical patent/CA2427583C/fr
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • 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
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic 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
    • 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
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

La présente invention concerne une formulation d'inhalation sans gaz propulseur d'un bromure de tiotropium ou d'un monohydrate de bromure de tiotropium dissous dans l'eau ou dans un mélange d'eau et d'éthanol, ainsi que des aérosols inhalables sans gaz propulseur obtenus à partir de cette formulation.
CA002427583A 2000-10-31 2001-10-24 Formulation d'une solution d'inhalation contenant un sel de tiotropium Expired - Fee Related CA2427583C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10054042 2000-10-31
DE10054042.2 2000-10-31
PCT/EP2001/012296 WO2002036591A2 (fr) 2000-10-31 2001-10-24 Formulation d'une solution d'inhalation contenant un sel de tiotropium

Publications (2)

Publication Number Publication Date
CA2427583A1 CA2427583A1 (fr) 2002-05-10
CA2427583C true CA2427583C (fr) 2008-02-12

Family

ID=7661727

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002427583A Expired - Fee Related CA2427583C (fr) 2000-10-31 2001-10-24 Formulation d'une solution d'inhalation contenant un sel de tiotropium

Country Status (32)

Country Link
EP (1) EP1335729A2 (fr)
JP (1) JP4559703B2 (fr)
KR (1) KR100983208B1 (fr)
CN (1) CN1237970C (fr)
AR (1) AR038765A1 (fr)
AU (2) AU2174102A (fr)
BG (1) BG66425B1 (fr)
BR (1) BR0115016A (fr)
CA (1) CA2427583C (fr)
CZ (1) CZ305033B6 (fr)
DE (1) DE10152369A1 (fr)
EA (1) EA009068B1 (fr)
EC (1) ECSP034570A (fr)
EE (1) EE05343B1 (fr)
HR (1) HRP20030337A2 (fr)
HU (1) HUP0301377A3 (fr)
IL (2) IL155676A0 (fr)
ME (1) ME00242B (fr)
MX (1) MXPA03003750A (fr)
MY (1) MY132777A (fr)
NO (1) NO332524B1 (fr)
NZ (1) NZ526024A (fr)
PE (1) PE20020518A1 (fr)
PL (1) PL361001A1 (fr)
SA (1) SA01220503B1 (fr)
SK (1) SK288031B6 (fr)
TW (1) TWI296934B (fr)
UA (1) UA76435C2 (fr)
UY (1) UY26991A1 (fr)
WO (1) WO2002036591A2 (fr)
YU (1) YU33103A (fr)
ZA (1) ZA200303045B (fr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE60114865T2 (de) 2000-04-28 2006-07-27 Kosan Biosciences, Inc., Hayward Heterologe herstellung von polyketiden
US20030235538A1 (en) 2002-04-09 2003-12-25 Boehringer Ingelheim Pharma Gmbh & Co. Kg Method for the administration of an anticholinergic by inhalation
GB2389530B (en) 2002-06-14 2007-01-10 Cipla Ltd Pharmaceutical compositions
US9539221B2 (en) * 2003-10-09 2017-01-10 Egb Advisors, Llc Method of treating airway diseases with β-adrenergic inverse agonists
SE0303269L (sv) * 2003-12-03 2005-06-04 Microdrug Ag Medicinsk produkt
MX2007011273A (es) * 2005-03-16 2007-11-08 Meda Pharma Gmbh & Co Kg La combinacion de anticolinergicos y antagonistas del receptor de leucotrieno para el tratamiento de enfermedades respiratorias.
AU2007267523B2 (en) * 2006-05-26 2012-02-09 Dey, L.P. Nebulizable compositions of quaternary ammonium muscarinic receptor antagonists
CN100446770C (zh) * 2007-01-10 2008-12-31 上海现代药物制剂工程研究中心有限公司 丙酸培氯米松水雾剂
TR200907237A2 (tr) * 2009-09-23 2011-04-21 B�Lg�� Mahmut Tiotropyum kuru toz kombinasyonu
CN111936124A (zh) * 2018-07-26 2020-11-13 四川海思科制药有限公司 一种含格隆铵盐及茚达特罗盐的气雾剂药物组合物及其制备方法与应用
CN116196298A (zh) * 2018-07-26 2023-06-02 四川海思科制药有限公司 一种含格隆铵盐的气雾剂药物组合物及其制备方法与应用

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0504112A3 (en) * 1991-03-14 1993-04-21 Ciba-Geigy Ag Pharmaceutical aerosol formulations
DE4203306A1 (de) * 1992-02-06 1993-08-12 Ig Spruehtechnik Gmbh Asthma oder pulmonal-aerosolzubereitungen mit lecithin
PT835098E (pt) * 1995-06-27 2002-12-31 Boehringer Ingelheim Pharma Nova composicao farmaceutica estavel para a producao de aerossois sem gas propulsante
US5824669A (en) * 1996-03-22 1998-10-20 Nitromed, Inc. Nitrosated and nitrosylated compounds and compositions and their use for treating respiratory disorders
JPH11511758A (ja) * 1996-06-04 1999-10-12 ザ、プロクター、エンド、ギャンブル、カンパニー 鼻腔用ステロイドと抗ヒスタミン剤を含む鼻腔内噴霧薬
DE19653969A1 (de) * 1996-12-20 1998-06-25 Boehringer Ingelheim Kg Neue wässrige Arzneimittelzubereitung zur Erzeugung treibgasfreier Aerosole
JPH10298107A (ja) * 1997-04-25 1998-11-10 Taisho Pharmaceut Co Ltd 医薬組成物
EP1102579B1 (fr) * 1998-08-04 2003-03-19 Jago Research Ag Formulations d'aerosol a usage medical
DE19847968A1 (de) * 1998-10-17 2000-04-20 Boehringer Ingelheim Pharma Verschlußkappe und Behälter als Zweikammer-Kartusche für Vernebler zur Erzeugung von Aerosolen

Also Published As

Publication number Publication date
SK288031B6 (sk) 2012-12-03
HUP0301377A3 (en) 2005-12-28
NZ526024A (en) 2005-10-28
EP1335729A2 (fr) 2003-08-20
EA200300483A1 (ru) 2003-12-25
CN1473044A (zh) 2004-02-04
CZ20031487A3 (cs) 2003-09-17
MXPA03003750A (es) 2004-10-15
HUP0301377A2 (hu) 2003-10-28
NO20031914L (no) 2003-06-23
EE05343B1 (et) 2010-10-15
HK1060569A1 (en) 2004-08-13
CZ305033B6 (cs) 2015-04-08
ME00242B (fr) 2011-05-10
MEP40708A (en) 2011-02-10
WO2002036591A2 (fr) 2002-05-10
NO332524B1 (no) 2012-10-08
UY26991A1 (es) 2002-06-20
KR20040010552A (ko) 2004-01-31
CN1237970C (zh) 2006-01-25
BG107726A (bg) 2004-11-30
MY132777A (en) 2007-10-31
KR100983208B1 (ko) 2010-09-20
YU33103A (sh) 2006-05-25
TWI296934B (en) 2008-05-21
ECSP034570A (es) 2003-06-25
IL155676A0 (en) 2003-11-23
IL155676A (en) 2012-05-31
AU2174102A (en) 2002-05-15
SK5262003A3 (en) 2003-10-07
BR0115016A (pt) 2005-05-03
WO2002036591A3 (fr) 2002-07-25
AR038765A1 (es) 2005-01-26
BG66425B1 (bg) 2014-04-30
NO20031914D0 (no) 2003-04-29
JP2004523482A (ja) 2004-08-05
ZA200303045B (en) 2004-04-22
UA76435C2 (en) 2006-08-15
JP4559703B2 (ja) 2010-10-13
EA009068B1 (ru) 2007-10-26
DE10152369A1 (de) 2002-05-08
PE20020518A1 (es) 2002-07-12
HRP20030337A2 (en) 2005-04-30
EE200300202A (et) 2003-10-15
PL361001A1 (en) 2004-09-20
AU2002221741B2 (en) 2007-04-05
CA2427583A1 (fr) 2002-05-10
SA01220503B1 (ar) 2007-03-10

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Effective date: 20201026