CA2427583A1 - 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
CA2427583A1
CA2427583A1 CA002427583A CA2427583A CA2427583A1 CA 2427583 A1 CA2427583 A1 CA 2427583A1 CA 002427583 A CA002427583 A CA 002427583A CA 2427583 A CA2427583 A CA 2427583A CA 2427583 A1 CA2427583 A1 CA 2427583A1
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
CA002427583A
Other languages
French (fr)
Other versions
CA2427583C (en
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
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=7661727&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2427583(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2427583A1 publication Critical patent/CA2427583A1/en
Application granted granted Critical
Publication of CA2427583C publication Critical patent/CA2427583C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic 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
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/53831,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/439Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/468-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, ***e
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4738Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators

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.
CA002427583A 2000-10-31 2001-10-24 Inhalable formulation of a solution containing a tiotropium salt Expired - Fee Related CA2427583C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10054042.2 2000-10-31
DE10054042 2000-10-31
PCT/EP2001/012296 WO2002036591A2 (en) 2000-10-31 2001-10-24 Inhalative solution formulation containing a tiotropium salt

Publications (2)

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

Family

ID=7661727

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002427583A Expired - Fee Related CA2427583C (en) 2000-10-31 2001-10-24 Inhalable formulation of a solution containing a tiotropium salt

Country Status (33)

Country Link
EP (1) EP1335729A2 (en)
JP (1) JP4559703B2 (en)
KR (1) KR100983208B1 (en)
CN (1) CN1237970C (en)
AR (1) AR038765A1 (en)
AU (2) AU2174102A (en)
BG (1) BG66425B1 (en)
BR (1) BR0115016A (en)
CA (1) CA2427583C (en)
CZ (1) CZ305033B6 (en)
DE (1) DE10152369A1 (en)
EA (1) EA009068B1 (en)
EC (1) ECSP034570A (en)
EE (1) EE05343B1 (en)
HK (1) HK1060569A1 (en)
HR (1) HRP20030337A2 (en)
HU (1) HUP0301377A3 (en)
IL (2) IL155676A0 (en)
ME (1) ME00242B (en)
MX (1) MXPA03003750A (en)
MY (1) MY132777A (en)
NO (1) NO332524B1 (en)
NZ (1) NZ526024A (en)
PE (1) PE20020518A1 (en)
PL (1) PL361001A1 (en)
SA (1) SA01220503B1 (en)
SK (1) SK288031B6 (en)
TW (1) TWI296934B (en)
UA (1) UA76435C2 (en)
UY (1) UY26991A1 (en)
WO (1) WO2002036591A2 (en)
YU (1) YU33103A (en)
ZA (1) ZA200303045B (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MXPA02010565A (en) 2000-04-28 2004-05-17 Kosan Biosciences Inc Production of polyketides.
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
WO2005034871A2 (en) * 2003-10-09 2005-04-21 Inverseon, Inc. Methods for treating diseases and conditions with inverse agonists
SE0303269L (en) * 2003-12-03 2005-06-04 Microdrug Ag Medical product
JP4991693B2 (en) * 2005-03-16 2012-08-01 メダ ファーマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト Combinations of anticholinergics and leukotriene receptor antagonists for the treatment of respiratory diseases
WO2007140285A2 (en) * 2006-05-26 2007-12-06 Dey, L.P. Nebulizable compositions of quaternary ammonium muscarinic receptor antagonists
CN100446770C (en) * 2007-01-10 2008-12-31 上海现代药物制剂工程研究中心有限公司 Water aerosol containing beclomethasone dipropionate
TR200907237A2 (en) * 2009-09-23 2011-04-21 Bi̇lgi̇ç Mahmut Tiotropium dry powder combination
CN116196298A (en) * 2018-07-26 2023-06-02 四川海思科制药有限公司 Aerosol pharmaceutical composition containing glycopyrronium salt and preparation method and application thereof
CN111936124A (en) * 2018-07-26 2020-11-13 四川海思科制药有限公司 Aerosol pharmaceutical composition containing glycopyrronium salt and indacaterol salt, and preparation method and application thereof

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 (en) * 1992-02-06 1993-08-12 Ig Spruehtechnik Gmbh ASTHMA OR PULMONAL AEROSOL PREPARATIONS WITH LECITHIN
UA62917C2 (en) * 1995-06-27 2004-01-15 Berinher Inhelheim Kg Medicinal composition for generating propellant-free aerosols
US5824669A (en) * 1996-03-22 1998-10-20 Nitromed, Inc. Nitrosated and nitrosylated compounds and compositions and their use for treating respiratory disorders
EP0954318A1 (en) * 1996-06-04 1999-11-10 The Procter & Gamble Company A nasal spray containing an intranasal steroid and an antihistamine
DE19653969A1 (en) * 1996-12-20 1998-06-25 Boehringer Ingelheim Kg New aqueous pharmaceutical preparation for the production of propellant-free aerosols
JPH10298107A (en) * 1997-04-25 1998-11-10 Taisho Pharmaceut Co Ltd Pharmaceutical composition
US6475467B1 (en) * 1998-08-04 2002-11-05 Jago Research Ag Medicinal aerosol formulations
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.

Also Published As

Publication number Publication date
KR100983208B1 (en) 2010-09-20
IL155676A0 (en) 2003-11-23
SA01220503B1 (en) 2007-03-10
PL361001A1 (en) 2004-09-20
TWI296934B (en) 2008-05-21
EA200300483A1 (en) 2003-12-25
JP4559703B2 (en) 2010-10-13
BG107726A (en) 2004-11-30
EP1335729A2 (en) 2003-08-20
MY132777A (en) 2007-10-31
EE200300202A (en) 2003-10-15
HUP0301377A2 (en) 2003-10-28
HK1060569A1 (en) 2004-08-13
NO20031914D0 (en) 2003-04-29
ZA200303045B (en) 2004-04-22
EA009068B1 (en) 2007-10-26
HUP0301377A3 (en) 2005-12-28
ME00242B (en) 2011-05-10
NZ526024A (en) 2005-10-28
KR20040010552A (en) 2004-01-31
DE10152369A1 (en) 2002-05-08
CZ305033B6 (en) 2015-04-08
UY26991A1 (en) 2002-06-20
AU2002221741B2 (en) 2007-04-05
AR038765A1 (en) 2005-01-26
CN1237970C (en) 2006-01-25
UA76435C2 (en) 2006-08-15
ECSP034570A (en) 2003-06-25
MEP40708A (en) 2011-02-10
SK5262003A3 (en) 2003-10-07
WO2002036591A2 (en) 2002-05-10
SK288031B6 (en) 2012-12-03
CN1473044A (en) 2004-02-04
BR0115016A (en) 2005-05-03
EE05343B1 (en) 2010-10-15
JP2004523482A (en) 2004-08-05
CA2427583C (en) 2008-02-12
PE20020518A1 (en) 2002-07-12
BG66425B1 (en) 2014-04-30
YU33103A (en) 2006-05-25
NO332524B1 (en) 2012-10-08
IL155676A (en) 2012-05-31
CZ20031487A3 (en) 2003-09-17
HRP20030337A2 (en) 2005-04-30
NO20031914L (en) 2003-06-23
WO2002036591A3 (en) 2002-07-25
MXPA03003750A (en) 2004-10-15
AU2174102A (en) 2002-05-15

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Effective date: 20201026