Steroid solution aerosol products with enhanced chemical stability

Abstract

A medicinal aerosol steroid solution formulation product with enhanced chemical stability. The steroid is a 20-ketosteroid having an OH group at the C-17 or C-21 position and the aerosol container has a non-metal interior surface which has been found to reduce chemical degradation of such steroids.

1 - 28 . (canceled)  
   
   
       29 . Pressurized metered dose inhalers containing a solution of an active ingredient in a hydrofluorocarbon propellant, a co-solvent and optionally a low-volatility component characterized in that part or all of the internal surfaces of said inhalers consist of stainless steel, anodized aluminum or are lined with an inert organic coating.  
   
   
       30 . Pressurized metered dose inhalers according to  claim 29 , wherein the active ingredients are selected from β2 agonists, steroids or anti-cholinergic agents and their combinations.  
   
   
       31 . Pressurized metered dose inhalers according to  claim 30 , wherein the active ingredient is ipratropium bromide, oxitropium bromide, tiotropium bromide, flunisolide, triamcinolone acetonide, fluticasone propionate, mometasone furoate, budesonide, ciclesonide, rofleponide and epimers thereof.  
   
   
       32 . Pressurized metered dose inhalers according to any of claims from  29  to  31 , containing a low-volatility component selected from glycerol, polyethylene glycol and isopropyl myristate.  
   
   
       33 . Pressurized metered dose inhalers according to any of claims from  29  to  32 , wherein the co-solvent is ethanol.  
   
   
       34 . Pressurized metered dose inhalers according to any of claims from  29  to  33 , wherein the propellant is selected from HFA 227, HFA 134a and their mixtures.  
   
   
       35 . Pressurized metered dose inhalers according to any of  claims 29  to  34  wherein the inert organic coating is perfluoroalkoxyalkane, epoxy-phenol resin or fluorinated-ethylenepropylene polyether sulfone.  
   
   
       36 . Pressurized metered dose inhalers according to any of  claims 29  to  35  wherein part or all of the internal surfaces are coated with an epoxy phenol resin.  
   
   
       37 . Pressurized metered dose inhalers according to  claims 29  to  34  wherein part or all of the internal surfaces consist of anodized aluminum.  
   
   
       38 . Stabilized aerosol solution formulation consisting of an active ingredient in a hydrofluorocarbon propellant, a co-solvent and optionally a low-volatility component for use in a pressurized metered dose inhaler as claimed in any of  claims 29  to  37 .  
   
   
       39 . Aerosol solution formulation of dexbudesonide in a hydrofluorocarbon propellant and ethanol as a co-solvent, further comprising a low volatility compound selected from glycerol, ispropylmyristate and polyethylene glycol.