CA2464660C - Solution d'inhalation a base d'albuterol, et systeme, kit et methode permettant de soulager les symptomes de l'asthme pediatrique - Google Patents
Solution d'inhalation a base d'albuterol, et systeme, kit et methode permettant de soulager les symptomes de l'asthme pediatrique Download PDFInfo
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- CA2464660C CA2464660C CA2464660A CA2464660A CA2464660C CA 2464660 C CA2464660 C CA 2464660C CA 2464660 A CA2464660 A CA 2464660A CA 2464660 A CA2464660 A CA 2464660A CA 2464660 C CA2464660 C CA 2464660C
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- Prior art keywords
- solution
- inhalation solution
- albuterol
- asthma
- inhalation
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- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 title claims abstract description 139
- 229940041682 inhalant solution Drugs 0.000 title claims abstract description 118
- 238000000034 method Methods 0.000 title claims abstract description 32
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- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims abstract description 17
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- 229940057282 albuterol sulfate Drugs 0.000 claims description 31
- BNPSSFBOAGDEEL-UHFFFAOYSA-N albuterol sulfate Chemical compound OS(O)(=O)=O.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 BNPSSFBOAGDEEL-UHFFFAOYSA-N 0.000 claims description 25
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Classifications
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
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- 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]
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- 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
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- 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
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- Pulmonology (AREA)
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Abstract
Solution d'inhalation à base d'albutérol, et système, kit et méthode permettant de soulager le bronchospasme chez les enfants souffrant d'asthme. Dans un mode de réalisation, la solution selon la présente invention est une dose unitaire stérile, prémélangée et prémesurée d'albutérol pour des patients asthmatiques ayant de 2 à 12 ans. Cette solution peut être exempte de produits chimiques anti-microbiens tels que le chlorure de benzalconium. Dans un autre mode de réalisation, la solution selon la présente invention contient environ 0,63 mg ou environ 1,25 mg d'albutérol.
Applications Claiming Priority (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US34820301P | 2001-10-26 | 2001-10-26 | |
| US60/348,203 | 2001-10-26 | ||
| US10/034,829 US6702997B2 (en) | 2001-10-26 | 2001-12-27 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
| US10/034,829 | 2001-12-27 | ||
| AU32975/02 | 2002-04-05 | ||
| AU32975/02A AU3297502A (en) | 2001-10-26 | 2002-04-05 | An albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
| JP2002-145456 | 2002-04-11 | ||
| JP2002145456A JP2003212764A (ja) | 2001-10-26 | 2002-04-11 | 小児喘息の症状を緩和するためのアルブテロール吸入溶液、システム、キット及び方法 |
| PCT/US2002/033352 WO2003037317A1 (fr) | 2001-10-26 | 2002-10-18 | Solution d'inhalation a base d'albuterol, et systeme, kit et methode permettant de soulager les symptomes de l'asthme pediatrique |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2464660A1 CA2464660A1 (fr) | 2003-05-08 |
| CA2464660C true CA2464660C (fr) | 2011-12-20 |
Family
ID=27422969
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2464660A Expired - Fee Related CA2464660C (fr) | 2001-10-26 | 2002-10-18 | Solution d'inhalation a base d'albuterol, et systeme, kit et methode permettant de soulager les symptomes de l'asthme pediatrique |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP1441709A1 (fr) |
| JP (1) | JP2006513129A (fr) |
| CA (1) | CA2464660C (fr) |
| MX (1) | MXPA04003928A (fr) |
| NZ (1) | NZ550304A (fr) |
| WO (1) | WO2003037317A1 (fr) |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS62292719A (ja) * | 1986-06-12 | 1987-12-19 | Kaken Pharmaceut Co Ltd | 外用澄明水溶性製剤 |
| GB8825892D0 (en) * | 1988-11-04 | 1988-12-07 | Fisons Plc | Pharmaceutical composition |
| EP0673240B1 (fr) * | 1992-12-09 | 1999-03-24 | Boehringer Ingelheim Pharmaceuticals Inc. | Formulations de solutions medicinales aerosol stabilisees |
| WO1995021820A1 (fr) * | 1994-02-10 | 1995-08-17 | Yamanouchi Pharmaceutical Co., Ltd. | Nouveau derive du carbamate et composition correspondante |
| EP0840733B1 (fr) * | 1995-07-11 | 2001-10-24 | Merck & Co., Inc. | Sel de bisulfate de triazolymethyle-indole ethylamine |
| DE19653969A1 (de) * | 1996-12-20 | 1998-06-25 | Boehringer Ingelheim Kg | Neue wässrige Arzneimittelzubereitung zur Erzeugung treibgasfreier Aerosole |
| US6126919A (en) * | 1997-02-07 | 2000-10-03 | 3M Innovative Properties Company | Biocompatible compounds for pharmaceutical drug delivery systems |
| DE69804998T2 (de) * | 1997-10-09 | 2002-12-12 | Schering Corp., Kenilworth | Mometasonfuroat-suspensionen zum zerstäuben |
| US20030183224A1 (en) * | 2000-03-01 | 2003-10-02 | Hailey Mark Andrew | Metered dose inhaler |
| US6451289B2 (en) * | 2000-03-24 | 2002-09-17 | Sepracor Inc. | Albuterol formulations |
-
2002
- 2002-10-18 NZ NZ550304A patent/NZ550304A/en not_active IP Right Cessation
- 2002-10-18 EP EP02784157A patent/EP1441709A1/fr not_active Ceased
- 2002-10-18 CA CA2464660A patent/CA2464660C/fr not_active Expired - Fee Related
- 2002-10-18 MX MXPA04003928A patent/MXPA04003928A/es active IP Right Grant
- 2002-10-18 JP JP2003539661A patent/JP2006513129A/ja active Pending
- 2002-10-18 WO PCT/US2002/033352 patent/WO2003037317A1/fr not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| NZ550304A (en) | 2008-05-30 |
| EP1441709A1 (fr) | 2004-08-04 |
| CA2464660A1 (fr) | 2003-05-08 |
| MXPA04003928A (es) | 2005-03-31 |
| JP2006513129A (ja) | 2006-04-20 |
| WO2003037317A1 (fr) | 2003-05-08 |
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| Date | Code | Title | Description |
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| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20201019 |