CA2495275A1 - Aerosol formulation for inhalation comprising an anticholinergic agent - Google Patents

Aerosol formulation for inhalation comprising an anticholinergic agent Download PDF

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Publication number
CA2495275A1
CA2495275A1 CA002495275A CA2495275A CA2495275A1 CA 2495275 A1 CA2495275 A1 CA 2495275A1 CA 002495275 A CA002495275 A CA 002495275A CA 2495275 A CA2495275 A CA 2495275A CA 2495275 A1 CA2495275 A1 CA 2495275A1
Authority
CA
Canada
Prior art keywords
acid
pharmaceutical preparation
preparation according
aqueous pharmaceutical
inhalation
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
CA002495275A
Other languages
French (fr)
Other versions
CA2495275C (en
Inventor
Friedrich Schmidt
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=31979448&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2495275(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from DE10237232A external-priority patent/DE10237232A1/en
Application filed by Individual filed Critical Individual
Publication of CA2495275A1 publication Critical patent/CA2495275A1/en
Application granted granted Critical
Publication of CA2495275C publication Critical patent/CA2495275C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61K31/435Heterocyclic 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
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention relates to an aqueous aerosol formulation for inhalation that is devoid of a propellant, for anticholinergic agents of formula 1:

(see formula 1) in which X- represents an anion.

Claims (14)

1 ) Aqueous pharmaceutical preparation for inhalation containing as sole active substance a compound of formula 1 wherein X - is an anion selected from the group consisting of chloride, bromide, iodide, sulphate, phosphate, methanesulphonate, nitrate, maleate, acetate, citrate, fumarate, tartrate, oxalate, succinate, benzoate and p-toluenesulphonate, at least one pharmacologically acceptable acid and optionally other pharmacologically acceptable excipients and/or complexing agents.
2) Aqueous pharmaceutical preparation according to claim 1, containing at least one compound of formula 1 wherein X - is selected from the group consisting of chloride, bromide, 4-toluenesulphonate and methanesulphonate.
3) Aqueous pharmaceutical preparation according to claim 1 or 2, wherein the pharmacologically acceptable acid is selected from the inorganic acids hydrochloric acid, hydrobromic acid, nitric acid, sulphuric acid and phosphoric acid or from the organic acids ascorbic acid, citric acid, malic acid, tartaric acid, maleic acid, succinic acid, fumaric acid, acetic acid, formic acid and propionic acid.
4) Aqueous pharmaceutical preparation according to one of claims 1 to 3, characterised by a pH of 2.5 to 6.5.
5) Aqueous pharmaceutical preparation according to one of claims 1 to 4, characterised in that they contain benzalkonium chloride as excipient.
6) Aqueous pharmaceutical preparation according to claim 5, characterised in that the content of benzalkonium chloride is from 1 to 50 mg per 100 ml of solution.
7) Aqueous pharmaceutical preparation according to one of claims 1 to 6, characterised in that the content of 1' is about 4 to 2000 mg per 100 ml of solution.
8) Aqueous pharmaceutical preparation according to one of claims 1 to 7, characterised in that they contain a complexing agent as an additional component.
9) Aqueous pharmaceutical preparation according to one of claims 1 to 8, characterised in that the content of complexing agent is 5 to 20 mg per 100 ml of solution.
10) Use of an aqueous pharmaceutical preparation according to one of claims 1 to 9 for preparing a medicament for treating respiratory complaints.
11) Process for the application by inhalation of an aqueous pharmaceutical preparation according to one of claims 1 to 9 by oral or nasal route.
12) Use of a pharmaceutical preparation according to one of claims 1 to 9 for nebulising in an inhaler according to WO 91/14468 or an inhaler as illustrated in Figures 6a and 6b of WO 97/12687.
13) Inhalation kit consisting of an aqueous pharmaceutical preparation according to one of claims 1 to 9 and an inhaler suitable for nebulising this pharmaceutical preparation.
14) Inhalation kit according to claim 13, wherein the inhaler is the Respimat®.
CA2495275A 2002-08-14 2003-07-25 Aerosol formulation for inhalation comprising an anticholinergic agent Expired - Fee Related CA2495275C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE10237232A DE10237232A1 (en) 2002-08-14 2002-08-14 Aqueous solution for inhalation, useful for treating respiratory disease, contains anticholinergic tricyclo-oxa-aza-nonane derivative and requires no propellant
DE10237232.2 2002-08-14
DE10240257.4 2002-08-31
DE10240257 2002-08-31
PCT/EP2003/008221 WO2004022052A1 (en) 2002-08-14 2003-07-25 Aerosol formulation for inhalation containing an anticholinergic agent

Publications (2)

Publication Number Publication Date
CA2495275A1 true CA2495275A1 (en) 2004-03-18
CA2495275C CA2495275C (en) 2012-04-17

Family

ID=31979448

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2495275A Expired - Fee Related CA2495275C (en) 2002-08-14 2003-07-25 Aerosol formulation for inhalation comprising an anticholinergic agent

Country Status (31)

Country Link
EP (2) EP1530464B1 (en)
JP (1) JP4602767B2 (en)
KR (1) KR101060972B1 (en)
CN (1) CN1674887A (en)
AT (1) ATE400265T1 (en)
AU (1) AU2003298473B9 (en)
BR (1) BR0313457A (en)
CA (1) CA2495275C (en)
CY (1) CY1108776T1 (en)
DE (1) DE50310117D1 (en)
DK (1) DK1530464T3 (en)
EA (1) EA009936B1 (en)
EC (1) ECSP055600A (en)
ES (1) ES2305479T3 (en)
HR (1) HRP20050132A2 (en)
IL (1) IL166814A (en)
MX (1) MXPA05001595A (en)
MY (1) MY142579A (en)
NO (1) NO20051287D0 (en)
NZ (1) NZ538743A (en)
PE (1) PE20040372A1 (en)
PL (1) PL375511A1 (en)
PT (1) PT1530464E (en)
RS (1) RS51396B (en)
SA (1) SA03240265B1 (en)
SI (1) SI1530464T1 (en)
TW (1) TWI317279B (en)
UA (1) UA81775C2 (en)
UY (1) UY27938A1 (en)
WO (1) WO2004022052A1 (en)
ZA (1) ZA200410325B (en)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102004038885A1 (en) * 2004-08-10 2006-02-23 Boehringer Ingelheim Pharma Gmbh & Co. Kg Aerosol formulation for inhalation containing an anticholinergic
DE102005001297A1 (en) * 2005-01-12 2006-07-20 Boehringer Ingelheim Pharma Gmbh & Co. Kg Aerosol formulation for inhalation containing an anticholinergic
DE102005055963A1 (en) * 2005-11-24 2007-07-19 Boehringer Ingelheim Pharma Gmbh & Co. Kg Aerosol formulation for inhalation containing an anticholinergic
DE102005055957A1 (en) * 2005-11-24 2007-07-12 Boehringer Ingelheim Pharma Gmbh & Co. Kg Aerosol formulation for inhalation containing an anticholinergic
DE102005055958A1 (en) * 2005-11-24 2007-07-19 Boehringer Ingelheim Pharma Gmbh & Co. Kg Aerosol formulation for inhalation containing an anticholinergic
DE102005055960A1 (en) * 2005-11-24 2007-07-19 Boehringer Ingelheim Pharma Gmbh & Co. Kg Aerosol formulation for inhalation containing an anticholinergic
EP2077132A1 (en) 2008-01-02 2009-07-08 Boehringer Ingelheim Pharma GmbH & Co. KG Dispensing device, storage device and method for dispensing a formulation
JP5670421B2 (en) 2009-03-31 2015-02-18 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング Component surface coating method
EP2432531B1 (en) 2009-05-18 2019-03-06 Boehringer Ingelheim International GmbH Adapter, inhalation device and nebulizer
US10016568B2 (en) 2009-11-25 2018-07-10 Boehringer Ingelheim International Gmbh Nebulizer
EP2504051B1 (en) 2009-11-25 2019-09-04 Boehringer Ingelheim International GmbH Nebulizer
JP5715640B2 (en) 2009-11-25 2015-05-13 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング Nebulizer
US9943654B2 (en) 2010-06-24 2018-04-17 Boehringer Ingelheim International Gmbh Nebulizer
EP2694220B1 (en) 2011-04-01 2020-05-06 Boehringer Ingelheim International GmbH Medical device comprising a container
US9827384B2 (en) 2011-05-23 2017-11-28 Boehringer Ingelheim International Gmbh Nebulizer
WO2013152894A1 (en) 2012-04-13 2013-10-17 Boehringer Ingelheim International Gmbh Atomiser with coding means
EP3030298B1 (en) 2013-08-09 2017-10-11 Boehringer Ingelheim International GmbH Nebulizer
ES2836977T3 (en) 2013-08-09 2021-06-28 Boehringer Ingelheim Int Nebulizer
US9877486B2 (en) 2014-01-31 2018-01-30 AgBiome, Inc. Methods of growing plants using modified biological control agents
KR102566936B1 (en) 2014-01-31 2023-08-14 아그바이오메, 인크. Modified biological control agents and their uses
PL3139984T3 (en) 2014-05-07 2021-11-08 Boehringer Ingelheim International Gmbh Nebulizer
CN106232166B (en) 2014-05-07 2020-04-14 勃林格殷格翰国际有限公司 Sprayer with a spray tube
CN106255554B (en) 2014-05-07 2021-05-04 勃林格殷格翰国际有限公司 Container, sprayer and use

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG45171A1 (en) * 1990-03-21 1998-01-16 Boehringer Ingelheim Int Atomising devices and methods
DE19653969A1 (en) * 1996-12-20 1998-06-25 Boehringer Ingelheim Kg New aqueous pharmaceutical preparation for the production of propellant-free aerosols
ME00220B (en) * 2000-05-22 2010-10-10 Chiesi Farm Spa Stable pharmaceutical solution formulations for pressurised metered dose inhalers
DE10050994A1 (en) * 2000-10-14 2002-04-18 Boehringer Ingelheim Pharma New diphenylalkanoic acid azabicyclooctane ester quaternary salts useful as anticholinergic agents, especially in treatment of asthma and chronic obstructive pulmonary disease
DE10063957A1 (en) * 2000-12-20 2002-06-27 Boehringer Ingelheim Pharma New drug compositions based on anticholinergics and dopamine agonists
DE10200943A1 (en) * 2002-01-12 2003-07-24 Boehringer Ingelheim Pharma Process for the preparation of scopine esters

Also Published As

Publication number Publication date
AU2003298473A1 (en) 2004-03-29
JP4602767B2 (en) 2010-12-22
SI1530464T1 (en) 2008-12-31
EA200500292A1 (en) 2005-10-27
SA03240265B1 (en) 2009-11-10
ZA200410325B (en) 2006-10-25
PL375511A1 (en) 2005-11-28
IL166814A0 (en) 2006-01-15
DK1530464T3 (en) 2008-09-08
CN1674887A (en) 2005-09-28
MXPA05001595A (en) 2005-04-25
NO20051287L (en) 2005-03-11
UA81775C2 (en) 2008-02-11
CY1108776T1 (en) 2014-04-09
PE20040372A1 (en) 2004-08-03
RS51396B (en) 2011-02-28
KR101060972B1 (en) 2011-09-01
WO2004022052A1 (en) 2004-03-18
AU2003298473B9 (en) 2011-06-09
UY27938A1 (en) 2004-03-31
RS20050074A (en) 2007-09-21
AU2003298473B2 (en) 2009-04-23
MY142579A (en) 2010-12-15
NZ538743A (en) 2006-05-26
EA009936B1 (en) 2008-04-28
CA2495275C (en) 2012-04-17
TW200406213A (en) 2004-05-01
EP1530464B1 (en) 2008-07-09
DE50310117D1 (en) 2008-08-21
IL166814A (en) 2010-11-30
ATE400265T1 (en) 2008-07-15
ES2305479T3 (en) 2008-11-01
NO20051287D0 (en) 2005-03-11
JP2006506345A (en) 2006-02-23
PT1530464E (en) 2008-08-28
EP1530464A1 (en) 2005-05-18
EP1908468A1 (en) 2008-04-09
ECSP055600A (en) 2005-04-18
BR0313457A (en) 2005-06-21
HRP20050132A2 (en) 2006-05-31
TWI317279B (en) 2009-11-21
KR20050049478A (en) 2005-05-25

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Effective date: 20140725