US2004062720A1PendingUtilityA1

Pharmaceutical aerosol composition

61
Assignee: CHIESI FARMA SPAPriority: Jun 13, 1997Filed: Jul 3, 2003Published: Apr 1, 2004
Est. expiryJun 13, 2017(expired)· nominal 20-yr term from priority
Inventors:David LewisDavis GandertonBrian MeakinPaolo VenturaGaetano BrambillaRaffaella Garzia
A61K 9/008
61
PatentIndex Score
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Claims

Abstract

Pharmaceutical compositions which contain a corticosteroid, a propellant, a cosolvent, and an antioxidant are useful for the treatment of bronchial disorders by administration via a pressurized metered dose inhaler.

Claims

exact text as granted — not AI-modified
1 . A composition for use in an aerosol inhaler, the composition comprising an active material, a propellant containing a hydrofluoroalkane (HFA), a cosolvent and further comprising a low volatility component to increase the mass median aerodynamic diameter (MMAD) of the aerosol particles on actuation of the inhaler.  
     
     
         2 . A composition according to  claim 1 , wherein the low volatility component has a vapour pressure at 25° C. not more than 0.1 kPa.  
     
     
         3 . A composition according to  claim 2 , wherein the low volatility component has a vapour pressure at 25° C. not more than 0.05 kPa.  
     
     
         4 . A composition according to any preceding claim, wherein the cosolvent has a vapour pressure at 25° C. not less than 3 kPa.  
     
     
         5 . A composition according to any preceding claim, wherein the cosolvent has a vapour pressure at 25° C. not less than 5 kPa.  
     
     
         6 . A composition according to any preceding claim, wherein the cosolvent is an alcohol.  
     
     
         7 . A composition according to any preceding claim, wherein the low volatility component includes a glycol.  
     
     
         8 . A composition according to any preceding claim, wherein the low volatility component includes oleic acid.  
     
     
         9 . A composition according to any preceding claim, wherein the propellant includes one or more HFAs selected from the group comprising HFA 134a and HFA 227.  
     
     
         10 . A composition according to any preceding claim, wherein the composition includes not more than 20% by weight of the low volatility component.  
     
     
         11 . A composition according to any preceding claim, wherein the composition includes at least 0.2% by weight of the low volatility component.  
     
     
         12 . A composition according to any preceding claim, the composition being such that, on actuation of the aerosol inhaler in use, the MMAD of the aerosol particles is not less than 2 μm.  
     
     
         13 . A composition according to any preceding claim, wherein the composition is in the form of a solution.  
     
     
         14 . Use of a low volatility component in a composition for an aerosol inhaler, the composition comprising an active material, a propellant containing hydrofluoro alkane (HFA) and a cosolvent, to increase the mass median aerodynamic diameter (MMAD) of the aerosol particles on actuation of the inhaler.  
     
     
         15 . Use of a low volatility component according to  claim 14  to give a MMAD of the aerosol particles of not less than 2 μm.  
     
     
         16 . Use of a low volatility component according to  claim 14  or  claim 15 , wherein the low volatility component has a vapour pressure at 25° C. not more than 0.1 kPa.  
     
     
         17 . Use of a low volatility component according to any of  claims 14  to  16 , the composition being as claimed in any of  claims 1  to  13 .  
     
     
         18 . An aerosol inhaler containing a composition, the composition being as claimed in any of  claims 1  to  13 .  
     
     
         19 . Method of filling an aerosol inhaler with a composition, the method comprising filling the following components into the inhaler 
 (a) one or more active materials,    (b) one or more low volatility components,    (c) one or more cosolvents    followed by the addition of a propellant containing a hydrofluoroalkane (HFA).    
     
     
         20 . A method according to  claim 19 , the composition being as claimed in any of  claims 1  to  13 .  
     
     
         21 . Aerosol particles emitted from an aerosol inhaler containing a composition, the composition comprising an active component, a propellant containing a hydrofluoro≡alkane (HFA), a cosolvent and a low volatility component, wherein the mass median aerodynamic diameter (MMAD) of the aerosol particles is not less than 2 μm.  
     
     
         22 . Aerosol particles according to  claim 21 , wherein the MMAD of the particles is not less than 2.5 μm.  
     
     
         23 . Aerosol particles according to  claim 21  or  claim 22 , wherein the composition is according to any of  claims 1  to  13 .

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