Pharmaceutical aerosol composition

Abstract

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, filling of an aerosol container and use of the composition for the administration of active materials by inhalation.

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   .