CA2495275A1 - Aerosol formulation for inhalation comprising an anticholinergic agent - Google Patents
Aerosol formulation for inhalation comprising an anticholinergic agent Download PDFInfo
- 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
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
- A61K31/439—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
- 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
-
- 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
-
- 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
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- 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
- A61P43/00—Drugs 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.
(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®.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE10237232.2 | 2002-08-14 | ||
| 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 |
| DE10240257 | 2002-08-31 | ||
| DE10240257.4 | 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) | EP1908468A1 (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)
| 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 |
| DE102005055960A1 (en) * | 2005-11-24 | 2007-07-19 | 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 |
| DE102005055957A1 (en) * | 2005-11-24 | 2007-07-12 | 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 |
| EP2077132A1 (en) | 2008-01-02 | 2009-07-08 | Boehringer Ingelheim Pharma GmbH & Co. KG | Dispensing device, storage device and method for dispensing a formulation |
| EP2662472B1 (en) | 2009-03-31 | 2019-02-27 | Boehringer Ingelheim International Gmbh | Method for coating a surface of a component |
| US9265910B2 (en) | 2009-05-18 | 2016-02-23 | Boehringer Ingelheim International Gmbh | Adapter, inhalation device, and nebulizer |
| US10016568B2 (en) | 2009-11-25 | 2018-07-10 | Boehringer Ingelheim International Gmbh | Nebulizer |
| WO2011064163A1 (en) | 2009-11-25 | 2011-06-03 | Boehringer Ingelheim International Gmbh | Nebulizer |
| EP2504052B1 (en) | 2009-11-25 | 2022-07-27 | Boehringer Ingelheim International GmbH | Nebulizer |
| EP2585151B1 (en) | 2010-06-24 | 2018-04-04 | 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 |
| WO2015018904A1 (en) | 2013-08-09 | 2015-02-12 | Boehringer Ingelheim International Gmbh | Nebulizer |
| PL2835146T3 (en) | 2013-08-09 | 2021-04-06 | Boehringer Ingelheim International Gmbh | Nebulizer |
| DK3099172T3 (en) | 2014-01-31 | 2021-11-22 | Agbiome Inc | MODIFIED BIOLOGICAL PERFORMANCE AND ITS USES |
| US9877486B2 (en) | 2014-01-31 | 2018-01-30 | AgBiome, Inc. | Methods of growing plants using modified biological control agents |
| EA032832B1 (en) | 2014-05-07 | 2019-07-31 | Бёрингер Ингельхайм Интернациональ Гмбх | Nebulizer |
| AU2015257878B2 (en) | 2014-05-07 | 2019-08-08 | Boehringer Ingelheim International Gmbh | Container, nebulizer and use |
| JP6559157B2 (en) | 2014-05-07 | 2019-08-14 | 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 |
Family Cites Families (6)
| 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 |
| AU2000250701B2 (en) * | 2000-05-22 | 2004-07-01 | Chiesi Farmaceutici S.P.A. | 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 |
-
2003
- 2003-07-25 KR KR1020057002504A patent/KR101060972B1/en not_active IP Right Cessation
- 2003-07-25 EP EP07121698A patent/EP1908468A1/en not_active Withdrawn
- 2003-07-25 ES ES03740479T patent/ES2305479T3/en not_active Expired - Lifetime
- 2003-07-25 CN CNA038192004A patent/CN1674887A/en active Pending
- 2003-07-25 AU AU2003298473A patent/AU2003298473B9/en not_active Ceased
- 2003-07-25 MX MXPA05001595A patent/MXPA05001595A/en active IP Right Grant
- 2003-07-25 AT AT03740479T patent/ATE400265T1/en active
- 2003-07-25 WO PCT/EP2003/008221 patent/WO2004022052A1/en active IP Right Grant
- 2003-07-25 JP JP2004533274A patent/JP4602767B2/en not_active Expired - Fee Related
- 2003-07-25 SI SI200331363T patent/SI1530464T1/en unknown
- 2003-07-25 EP EP03740479A patent/EP1530464B1/en not_active Expired - Lifetime
- 2003-07-25 RS YUP-2005/0074A patent/RS51396B/en unknown
- 2003-07-25 DK DK03740479T patent/DK1530464T3/en active
- 2003-07-25 CA CA2495275A patent/CA2495275C/en not_active Expired - Fee Related
- 2003-07-25 DE DE50310117T patent/DE50310117D1/en not_active Expired - Lifetime
- 2003-07-25 NZ NZ538743A patent/NZ538743A/en not_active IP Right Cessation
- 2003-07-25 PT PT03740479T patent/PT1530464E/en unknown
- 2003-07-25 BR BR0313457-1A patent/BR0313457A/en not_active Expired - Fee Related
- 2003-07-25 EA EA200500292A patent/EA009936B1/en not_active IP Right Cessation
- 2003-07-25 UA UAA200502195A patent/UA81775C2/en unknown
- 2003-07-25 PL PL03375511A patent/PL375511A1/en unknown
- 2003-08-12 MY MYPI20033067A patent/MY142579A/en unknown
- 2003-08-12 PE PE2003000803A patent/PE20040372A1/en not_active Application Discontinuation
- 2003-08-13 TW TW092122269A patent/TWI317279B/en not_active IP Right Cessation
- 2003-08-14 UY UY27938A patent/UY27938A1/en not_active Application Discontinuation
- 2003-08-31 SA SA3240265A patent/SA03240265B1/en unknown
-
2004
- 2004-12-22 ZA ZA200410325A patent/ZA200410325B/en unknown
-
2005
- 2005-02-10 IL IL166814A patent/IL166814A/en not_active IP Right Cessation
- 2005-02-11 HR HR20050132A patent/HRP20050132A2/en not_active Application Discontinuation
- 2005-02-14 EC EC2005005600A patent/ECSP055600A/en unknown
- 2005-03-11 NO NO20051287A patent/NO20051287D0/en not_active Application Discontinuation
-
2008
- 2008-10-08 CY CY20081101114T patent/CY1108776T1/en unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20140725 |