CA2479640A1 - Hfa suspension formulations containing an anticholinergic - Google Patents
Hfa suspension formulations containing an anticholinergic Download PDFInfo
- Publication number
- CA2479640A1 CA2479640A1 CA002479640A CA2479640A CA2479640A1 CA 2479640 A1 CA2479640 A1 CA 2479640A1 CA 002479640 A CA002479640 A CA 002479640A CA 2479640 A CA2479640 A CA 2479640A CA 2479640 A1 CA2479640 A1 CA 2479640A1
- Authority
- CA
- Canada
- Prior art keywords
- acid
- contain
- glyceryl
- suspensions according
- group
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- Dispersion Chemistry (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Otolaryngology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
The invention relates to a propellant gas formulation containing suspensions of a crystalline monohydrate of (1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.)- 7- [(hydroxydi-2-thienylacetyl)oxy]-9.9-dimethyl-3-oxa-9- azoniatricyclo[3.3.1.02,4]nonane-bromide.
Claims (9)
1) Suspensions of crystalline tiotropium bromide monohydrate in the propellant gases HFA 227 and/or HFA 134a, optionally in admixture with one or more other propellant gases selected from the group consisting of propane, butane, pentane, dimethylether, CHClF2, CH2F2, CF3CH3, isobutane, isopentane and neopentane.
2) Suspensions according to claim 1, characterised in that they contain between 0.001 and 0.8% tiotropium.
3) Suspensions according to claim 1 or 2, characterised in that they contain as other ingredients surface-active agents (surfactants), adjuvants, antioxidants and/or flavourings.
4) Suspensions according to claim 3, characterised in that they contain as surface-active agents (surfactants) one or more compounds selected from the group consisting of Polysorbate 20, Polysorbate 80, Myvacet 9-45, Myvacet 9-08, isopropylmyristate, oleic acid, propyleneglycol, polyethyleneglycol, Brij, ethyl oleate, glyceryl trioleate, glyceryl monolaurate, glyceryl monooleate, glyceryl monosterate, glyceryl monoricinoleate, cetylalcohol, sterylalcohol, cetylpyridinium chloride, block polymers, natural oil, ethanol and isopropanol .
5) Suspensions according to claim 3, characterised in that they contain as adjuvants one or more compounds selected from the group consisting of alanine, albumin, ascorbic acid, aspartame, betaine, cysteine, phosphoric acid, nitric acid, hydrochloric acid, sulphuric acid and citric acid.
6) Suspensions according to claim 3, characterised in that they contain as antioxidants one or more compounds selected from the group consisting of ascorbic acid, citric acid, sodium edetate, editic acid, tocopherols, butylhydroxytoluene, butylhydroxyanisol and ascorbyl palmitate.
7) Suspensions according to claim 1 or 2, characterised in that they contain no other ingredients apart from the active substance and the propellant gas or gases.
8) Use of a suspension according to one of claims 1 to 7 for preparing a pharmaceutical composition, preferably for preparing a pharmaceutical composition for the treatment by inhalation or nasal route of diseases in which anticholinergics may confer a therapeutic benefit.
9) Use according to claim 8, characterised in that the diseases are respiratory complaints, preferably asthma or COPD.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE10214263A DE10214263A1 (en) | 2002-03-28 | 2002-03-28 | HFA suspension formulations containing an anticholinergic |
| DE10214263.7 | 2002-03-28 | ||
| PCT/EP2003/002898 WO2003082252A1 (en) | 2002-03-28 | 2003-03-20 | Hfa-suspension formulations containing an anticholinergic |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2479640A1 true CA2479640A1 (en) | 2003-10-09 |
| CA2479640C CA2479640C (en) | 2010-09-28 |
Family
ID=28050989
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2479640A Expired - Fee Related CA2479640C (en) | 2002-03-28 | 2003-03-20 | Hfa suspension formulations containing an anticholinergic |
Country Status (27)
| Country | Link |
|---|---|
| EP (2) | EP1492513B1 (en) |
| JP (1) | JP4480401B2 (en) |
| KR (1) | KR101066801B1 (en) |
| CN (1) | CN1329023C (en) |
| AT (1) | ATE339953T1 (en) |
| AU (1) | AU2003209743B2 (en) |
| BR (1) | BR0308764A (en) |
| CA (1) | CA2479640C (en) |
| CY (1) | CY1105543T1 (en) |
| DE (2) | DE10214263A1 (en) |
| DK (1) | DK1492513T3 (en) |
| EA (1) | EA007239B1 (en) |
| EC (1) | ECSP045321A (en) |
| ES (1) | ES2273020T3 (en) |
| HK (1) | HK1079091A1 (en) |
| HR (1) | HRP20040889B1 (en) |
| IL (2) | IL163697A0 (en) |
| ME (1) | ME00247B (en) |
| MX (1) | MXPA04009337A (en) |
| NO (1) | NO20044005L (en) |
| NZ (1) | NZ536043A (en) |
| PL (1) | PL371296A1 (en) |
| PT (1) | PT1492513E (en) |
| RS (1) | RS52178B (en) |
| UA (1) | UA78557C2 (en) |
| WO (1) | WO2003082252A1 (en) |
| ZA (1) | ZA200405638B (en) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2391563T5 (en) † | 2004-07-02 | 2022-10-26 | Boehringer Ingelheim Int | Aerosol suspension formulations with TG 227 ea as propellant |
| TWI396541B (en) * | 2005-10-10 | 2013-05-21 | Boehringer Ingelheim Int | Novel combinations of medicaments for the treatment of respiratory diseases |
| GB201200504D0 (en) * | 2011-12-19 | 2012-02-22 | Teva Branded Pharmaceutical Prod R & D Inc | An inhaler |
| GB201200525D0 (en) | 2011-12-19 | 2012-02-29 | Teva Branded Pharmaceutical Prod R & D Inc | An inhalable medicament |
| EP2705838A1 (en) * | 2012-09-06 | 2014-03-12 | Xspray Microparticles Ab | Tiotropium preparations |
| KR20150096371A (en) * | 2012-10-23 | 2015-08-24 | 시플라 리미티드 | Pharmaceutical composition |
| US10034866B2 (en) | 2014-06-19 | 2018-07-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Inhalable medicament comprising tiotropium |
| CN107056629B (en) * | 2017-04-27 | 2019-04-30 | 河北科技大学 | A kind of preparation method of anhydrous halogenation choline and its derivative monocrystalline |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5610163A (en) * | 1989-09-16 | 1997-03-11 | Boehringer Ingelheim Gmbh | Esters of thienyl carboxylic acids and amino alcohols and their quaternization products |
| GB2326334A (en) * | 1997-06-13 | 1998-12-23 | Chiesi Farma Spa | Pharmaceutical aerosol compositions |
| DK1102579T3 (en) * | 1998-08-04 | 2003-07-14 | Jago Res Ag | Medical aerosol formulations |
| DZ2947A1 (en) * | 1998-11-25 | 2004-03-15 | Chiesi Farma Spa | Pressure metered dose inhaler. |
| DE19921693A1 (en) * | 1999-05-12 | 2000-11-16 | Boehringer Ingelheim Pharma | Pharmaceutical composition for treating respiratory disorders, e.g. asthma, comprises combination of anticholinergic and beta-mimetic agents having synergistic bronchospasmolytic activity and reduced side-effects |
| IT1317846B1 (en) * | 2000-02-22 | 2003-07-15 | Chiesi Farma Spa | FORMULATIONS CONTAINING AN ANTICOLINERGIC DRUG FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE BRONCOPNEUMOPATHY. |
| GB0009605D0 (en) * | 2000-04-18 | 2000-06-07 | Glaxo Group Ltd | Medicaments |
| IL155335A0 (en) * | 2000-10-12 | 2003-11-23 | Boehringer Ingelheim Pharma | Crystalline monohydrate, method for producing the same and the use thereof in the production of a medicament |
| JP2004512359A (en) * | 2000-10-31 | 2004-04-22 | ベーリンガー インゲルハイム ファルマ 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 | Novel pharmaceutical compositions based on anticholinergics and corticosteroids |
| DE10056104A1 (en) * | 2000-11-13 | 2002-05-23 | Boehringer Ingelheim Pharma | Drug compositions useful for treatment of respiratory diseases, especially asthma and chronic obstructive pulmonary disease comprises tiotropium salts and salmeterol salts |
-
2002
- 2002-03-28 DE DE10214263A patent/DE10214263A1/en not_active Withdrawn
-
2003
- 2003-03-20 EP EP03745193A patent/EP1492513B1/en not_active Expired - Lifetime
- 2003-03-20 JP JP2003579790A patent/JP4480401B2/en not_active Expired - Lifetime
- 2003-03-20 KR KR1020047015356A patent/KR101066801B1/en active IP Right Grant
- 2003-03-20 EP EP06115508.1A patent/EP1695701B1/en not_active Expired - Lifetime
- 2003-03-20 PT PT03745193T patent/PT1492513E/en unknown
- 2003-03-20 DE DE50305118T patent/DE50305118D1/en not_active Expired - Lifetime
- 2003-03-20 ME MEP-2008-474A patent/ME00247B/en unknown
- 2003-03-20 MX MXPA04009337A patent/MXPA04009337A/en active IP Right Grant
- 2003-03-20 CN CNB038072491A patent/CN1329023C/en not_active Expired - Lifetime
- 2003-03-20 CA CA2479640A patent/CA2479640C/en not_active Expired - Fee Related
- 2003-03-20 ES ES03745193T patent/ES2273020T3/en not_active Expired - Lifetime
- 2003-03-20 BR BR0308764-6A patent/BR0308764A/en active Pending
- 2003-03-20 AU AU2003209743A patent/AU2003209743B2/en not_active Ceased
- 2003-03-20 RS YU85904A patent/RS52178B/en unknown
- 2003-03-20 IL IL16369703A patent/IL163697A0/en active IP Right Grant
- 2003-03-20 UA UA20041008770A patent/UA78557C2/en unknown
- 2003-03-20 NZ NZ536043A patent/NZ536043A/en not_active IP Right Cessation
- 2003-03-20 DK DK03745193T patent/DK1492513T3/en active
- 2003-03-20 PL PL03371296A patent/PL371296A1/en unknown
- 2003-03-20 AT AT03745193T patent/ATE339953T1/en active
- 2003-03-20 WO PCT/EP2003/002898 patent/WO2003082252A1/en active IP Right Grant
- 2003-03-20 EA EA200401190A patent/EA007239B1/en not_active IP Right Cessation
-
2004
- 2004-07-15 ZA ZA2004/05638A patent/ZA200405638B/en unknown
- 2004-08-24 IL IL163697A patent/IL163697A/en unknown
- 2004-09-23 NO NO20044005A patent/NO20044005L/en not_active Application Discontinuation
- 2004-09-27 HR HRP20040889AA patent/HRP20040889B1/en not_active IP Right Cessation
- 2004-09-28 EC EC2004005321A patent/ECSP045321A/en unknown
-
2005
- 2005-12-02 HK HK05111031A patent/HK1079091A1/en not_active IP Right Cessation
-
2006
- 2006-09-26 CY CY20061101380T patent/CY1105543T1/en unknown
Also Published As
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20220301 |
|
| MKLA | Lapsed |
Effective date: 20200831 |