CA2426074A1 - Inhalable formulation of a solution containing a tiotropium salt - Google Patents

Inhalable formulation of a solution containing a tiotropium salt Download PDF

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Publication number
CA2426074A1
CA2426074A1 CA002426074A CA2426074A CA2426074A1 CA 2426074 A1 CA2426074 A1 CA 2426074A1 CA 002426074 A CA002426074 A CA 002426074A CA 2426074 A CA2426074 A CA 2426074A CA 2426074 A1 CA2426074 A1 CA 2426074A1
Authority
CA
Canada
Prior art keywords
solution containing
inhalable formulation
tiotropium salt
propellant
water
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.)
Granted
Application number
CA002426074A
Other languages
French (fr)
Other versions
CA2426074C (en
Inventor
Barbara Niklaus-Humke
Christel Schmelzer
Petra Barth
Karin Drechsel
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
Individual
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 Individual filed Critical Individual
Publication of CA2426074A1 publication Critical patent/CA2426074A1/en
Application granted granted Critical
Publication of CA2426074C publication Critical patent/CA2426074C/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
    • A61K31/46—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
    • 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
    • A61K31/435—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
    • A61K31/47—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
    • A61K31/535—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
    • A61K31/537—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 spiro-condensed or forming part of bridged ring systems
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (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)
  • Cosmetics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to a propellant-free inhalable formulation of tiotropium bromide or tiotropium bromide monohydrate dissolved in water or in a mixture of water and ethanol and propellant-free inhalable aerosols resulting therefrom.
CA002426074A 2000-10-31 2001-10-24 Inhalable formulation of a solution containing a tiotropium salt Expired - Fee Related CA2426074C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10054036.8 2000-10-31
DE10054036 2000-10-31
PCT/EP2001/012292 WO2002036104A2 (en) 2000-10-31 2001-10-24 Inhalative solution formulation containing a tiotropium salt

Publications (2)

Publication Number Publication Date
CA2426074A1 true CA2426074A1 (en) 2002-05-10
CA2426074C CA2426074C (en) 2008-12-23

Family

ID=7661723

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002426074A Expired - Fee Related CA2426074C (en) 2000-10-31 2001-10-24 Inhalable formulation of a solution containing a tiotropium salt

Country Status (39)

Country Link
EP (2) EP1837021A3 (en)
JP (1) JP4344135B2 (en)
KR (1) KR100853107B1 (en)
CN (2) CN101292964A (en)
AR (1) AR038764A1 (en)
AT (1) ATE373473T1 (en)
AU (2) AU2002221738B2 (en)
BG (1) BG66315B1 (en)
BR (1) BRPI0115076B8 (en)
CA (1) CA2426074C (en)
CY (1) CY1107825T1 (en)
CZ (1) CZ300794B6 (en)
DE (2) DE50113037D1 (en)
DK (1) DK1333819T3 (en)
EA (1) EA007604B1 (en)
EC (1) ECSP034541A (en)
EE (1) EE05314B1 (en)
ES (1) ES2294045T3 (en)
HK (1) HK1060524A1 (en)
HR (1) HRP20030338B1 (en)
HU (1) HU229411B1 (en)
IL (2) IL155538A0 (en)
ME (1) ME00244B (en)
MX (1) MXPA03003742A (en)
MY (1) MY138940A (en)
NO (1) NO332519B1 (en)
NZ (1) NZ526023A (en)
PE (1) PE20030092A1 (en)
PL (1) PL203316B1 (en)
PT (1) PT1333819E (en)
RS (1) RS50859B (en)
SA (1) SA01220482B1 (en)
SI (1) SI1333819T1 (en)
SK (1) SK286027B6 (en)
TW (1) TWI293885B (en)
UA (1) UA78690C2 (en)
UY (1) UY26989A1 (en)
WO (1) WO2002036104A2 (en)
ZA (1) ZA200302922B (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2004285683B2 (en) * 2003-11-03 2011-04-21 Boehringer Ingelheim International Gmbh Method for producing tiotropium salts, tiotropium salts and pharmaceutical formulations, containing the same

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10216036A1 (en) * 2002-04-11 2003-10-23 Boehringer Ingelheim Pharma Aerosol formulation for inhalation containing a tiotropium salt
CN1292748C (en) * 2003-03-05 2007-01-03 南昌弘益科技有限公司 Timepidium bromide inhalant powders and their preparing process
WO2005042528A1 (en) * 2003-11-03 2005-05-12 Boehringer Ingelheim International Gmbh Novel tiotropium salts, methods for the production thereof, and pharmaceutical formulations containing the same
NZ563596A (en) 2005-05-02 2011-01-28 Boehringer Ingelheim Int Crystalline form of tiotropium bromide anhydrate
EP2044967A1 (en) * 2007-10-01 2009-04-08 Boehringer Ingelheim Pharma GmbH & Co. KG Atomiser
CN104306361A (en) * 2014-09-24 2015-01-28 万特制药(海南)有限公司 Tiotropium bromide-containing inhalable solution
CN111374963A (en) * 2018-12-31 2020-07-07 天津药业研究院有限公司 Tiotropium solution for inhalation

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3931041C2 (en) * 1989-09-16 2000-04-06 Boehringer Ingelheim Kg Esters of thienyl carboxylic acids with amino alcohols, their quaternization products, processes for their preparation and medicaments containing them
SG45171A1 (en) * 1990-03-21 1998-01-16 Boehringer Ingelheim Int Atomising devices and methods
DE19536902A1 (en) * 1995-10-04 1997-04-10 Boehringer Ingelheim Int Miniature fluid pressure generating device
DE19653969A1 (en) * 1996-12-20 1998-06-25 Boehringer Ingelheim Kg New aqueous pharmaceutical preparation for the production of propellant-free aerosols
DE19847968A1 (en) * 1998-10-17 2000-04-20 Boehringer Ingelheim Pharma Separate storage of an active material and a solvent comprises a closure cap and a container, with a chamber attached to the unit.

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2004285683B2 (en) * 2003-11-03 2011-04-21 Boehringer Ingelheim International Gmbh Method for producing tiotropium salts, tiotropium salts and pharmaceutical formulations, containing the same
AU2004285683C1 (en) * 2003-11-03 2011-09-08 Boehringer Ingelheim International Gmbh Method for producing tiotropium salts, tiotropium salts and pharmaceutical formulations, containing the same

Also Published As

Publication number Publication date
EA200300482A1 (en) 2003-12-25
MXPA03003742A (en) 2004-10-15
ECSP034541A (en) 2003-05-26
JP4344135B2 (en) 2009-10-14
BG107727A (en) 2004-11-30
NZ526023A (en) 2005-05-27
EE200300203A (en) 2003-10-15
AU2002221738B2 (en) 2007-01-11
NO20031911L (en) 2003-04-29
EP1333819A2 (en) 2003-08-13
MY138940A (en) 2009-08-28
TWI293885B (en) 2008-03-01
IL155538A0 (en) 2003-11-23
UY26989A1 (en) 2002-06-20
HUP0301378A3 (en) 2005-12-28
PT1333819E (en) 2007-10-29
CN101292964A (en) 2008-10-29
WO2002036104A2 (en) 2002-05-10
DE10152521A1 (en) 2002-07-11
CZ20031486A3 (en) 2003-08-13
PL360405A1 (en) 2004-09-06
MEP40408A (en) 2011-02-10
AR038764A1 (en) 2005-01-26
ME00244B (en) 2011-05-10
AU2173802A (en) 2002-05-15
SI1333819T1 (en) 2007-12-31
BRPI0115076B8 (en) 2021-05-25
SK5272003A3 (en) 2003-10-07
BR0115076A (en) 2003-07-29
CA2426074C (en) 2008-12-23
DK1333819T3 (en) 2007-12-03
ES2294045T3 (en) 2008-04-01
HU229411B1 (en) 2013-12-30
DE50113037D1 (en) 2007-10-31
YU33003A (en) 2006-05-25
CN100396285C (en) 2008-06-25
PL203316B1 (en) 2009-09-30
RS50859B (en) 2010-08-31
IL155538A (en) 2008-11-26
HUP0301378A2 (en) 2003-10-28
SK286027B6 (en) 2008-01-07
EP1333819B1 (en) 2007-09-19
CY1107825T1 (en) 2013-06-19
EA007604B1 (en) 2006-12-29
CZ300794B6 (en) 2009-08-12
BRPI0115076B1 (en) 2016-07-26
HRP20030338B1 (en) 2011-09-30
JP2004512357A (en) 2004-04-22
KR100853107B1 (en) 2008-08-21
HK1060524A1 (en) 2004-08-13
EP1837021A3 (en) 2008-03-19
ATE373473T1 (en) 2007-10-15
NO332519B1 (en) 2012-10-08
EP1837021A2 (en) 2007-09-26
HRP20030338A2 (en) 2005-04-30
SA01220482B1 (en) 2007-07-31
KR20030060926A (en) 2003-07-16
CN1473038A (en) 2004-02-04
NO20031911D0 (en) 2003-04-29
UA78690C2 (en) 2007-04-25
EE05314B1 (en) 2010-08-16
BG66315B1 (en) 2013-04-30
ZA200302922B (en) 2004-04-22
PE20030092A1 (en) 2003-03-24
WO2002036104A3 (en) 2002-08-01

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MKLA Lapsed

Effective date: 20201026