Pressurised metered dose inhalers (MDI)

Abstract

The invention relates to the use of pressurised metered dose inhalers (MDIs) having part or all of their internal surfaces consisting of stainless steel, anodised aluminium or lined with an inert organic coating; and to compositions to be delivered with said MDIs.

1 - 10 . (canceled)  
     
     
         11 . A medicinal aerosol steroid solution formulation product with enhanced chemical stability, including: 
 an aerosol container equipped with a dispensing valve and containing a medicinal aerosol formulation having a corticosteroid drug dissolved therein;    said corticosteroid being selected from the group consisting of budesonide, triamcinolone acetonide, and rofleponide; and    wherein said container is provided with a non-metal interior surface so as to reduce chemical degradation of the corticosteroid.    
     
     
         12 . The product of  claim 11 , wherein said container is made of aluminum having an inert interior coating.  
     
     
         13 . The product of  claim 12 , wherein the interior coating is an epoxy-phenolic lacquer.  
     
     
         14 . The product of  claim 11 , wherein said dispensing valve is a metered dose valve.  
     
     
         15 . The product of  claim 11 , wherein said medicinal aerosol formulation includes a hydrogen-containing propellant.  
     
     
         16 . The product of  claim 15 , wherein the hydrogen-containing propellant is a hydrofluorocarbon.  
     
     
         17 . The product of  claim 16 , wherein the hydrofluorocarbon propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, and mixtures thereof.  
     
     
         18 . The product of  claim 11 , wherein said medicinal aerosol formulation includes ethanol.  
     
     
         19 . The product of  claim 11 , wherein the corticosteroid is selected from the group consisting of budesonide and triamcinolone acetonide.  
     
     
         20 . The product of  claim 11 , wherein the corticosteroid is budesonide.  
     
     
         21 . The product of  claim 11 , wherein the corticosteroid is triamcinolone acetonide.  
     
     
         22 . A method of reducing the chemical degradation of a medicinal corticosteroid dissolved in a formulation contained in a metal container, said corticosteroid being selected from the group consisting of budesonide, triamcinolone acetonide, and rofleponide, comprising the step of providing a coating of inert material on the interior surface of the metal container so as to reduce reaction of the corticosteroid with the container.  
     
     
         23 . A process for making a chemically stable steroid solution aerosol product by filling into a container an aerosol formulation comprising a dissolved corticosteroid, said corticosteroid being selected from the group consisting of budesonide, triamcinolone acetonide, and rofleponide, and said container having an inert non-metal interior surface so as to avoid chemical degradation of the corticosteroid due to interaction with the container.  
     
     
         24 . A medicinal aerosol steroid solution formulation metered dose inhaler product with enhanced chemical stability, including: 
 an aerosol container equipped with a metered dose dispensing valve and containing a medicinal aerosol formulation including a hydrofluoroalkane propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, and mixtures thereof, and having a corticosteroid drug dissolved therein, wherein the corticosteroid is selected from the group consisting of budesonide, triamcinolone acetonide, and rofleponide.