Propellant-free aerosol formulation for inhalation

Abstract

The present invention relates to propellant-free aerosol formulations for inhalation containing ipratropium bromide and salbutamol.

1 . Propellant-free solution formulations for inhalation which contain the active substances salbutamol, optionally in the form of the pharmacologically acceptable acid addition salts thereof, and ipratropium bromide and optionally further excipients, in a solvent selected from among water, ethanol and water-ethanol mixtures, the weight ratio of salbutamol to ipratropium bromide being in the range from 5:1 to 5.5:1 and the solution formulation containing no other active substances, wherein the formulation contains as further constituents disodium EDTA in an amount of 40 to 60 mg per 100 g as a complexing agent. 
     
     
         2 . Propellant-free solution formulation according to  claim 1 , wherein the salbutamol is present in the form of one of the pharmacologically acceptable acid addition salts thereof with an acid selected from among hydrochloric acid, hydrobromic acid, nitric acid, sulphuric acid or phosphoric acid. 
     
     
         3 . Propellant-free solution formulation according to  claim 1 , wherein the solvent is water. 
     
     
         4 . Propellant-free solution formulation according to  claim 1 , wherein the pH of the formulation is in the range from 3.0 and 4.0. 
     
     
         5 . Propellant-free solution formulation according to  claim 4 , wherein the pH is adjusted using inorganic or organic acids. 
     
     
         6 . Propellant-free solution formulation according to  claim 1 , wherein it contains as further constituents one or more preservatives. 
     
     
         7 . (canceled) 
     
     
         8 . Propellant-free solution formulation according to  claim 6 , wherein the preservative is benzalkonium chloride, cetylpyridinium chloride, benzoic acid or a salt of benzoic acid.