Compositions comprising salbutamol sulphate

Abstract

A pharmaceutical composition is described that is suitable for delivery from a pressurised container. The composition is preferably free of polar excipients and comprises: (a) a propellant component that consists essentially of 1,1-difluoroethane (R-152a); (b) a surfactant component that comprises at least one surfactant compound other than oleic acid; and (c) a drug component that consists of salbutamol sulphate. The pharmaceutical composition can be delivered using a metered dose inhaler (MDI).

I/We claim: 
     
         1 . A pharmaceutical composition comprising:
 (a) a propellant component, at least 90 weight % of which is 1,1-difluoroethane (R-152a),   (b) a surfactant component consisting essentially of at least one surfactant compound selected from the group consisting of ethyl oleate, polyvinylpyrrolidone, sorbitan monooleate, sorbitan trioleate, isopropyl myristate, polyethylene glycols and lecithin; and   (c) a drug component consisting of solid drug particles, said drug particles consisting essentially of salbutamol sulphate,   wherein the 1,1-difluoroethane propellant and surfactant component provide a propellant/surfactant mixture in which the solid drug particles of salbutamol sulphate are suspended,   wherein the salbutamol sulphate and surfactant component are present as distinct chemical compounds at the time they are blended with the propellant to form the pharmaceutical composition; and   wherein the pharmaceutical composition is free of polar excipients.   
     
     
         2 . The pharmaceutical composition of  claim 1  which consists essentially of components (a), (b) and (c). 
     
     
         3 . A pharmaceutical composition for delivery from a pressurised container, said composition consisting essentially of:
 (a) a propellant component at least 90 weight % of which is 1,1-difluoroethane (R-152a),   (b) a surfactant component consisting essentially of at least one surfactant compound selected from the group consisting of ethyl oleate, polyvinylpyrrolidone, sorbitan monooleate, sorbitan trioleate, isopropyl myristate, polyethylene glycols and lecithin; and   (c) a drug component consisting of solid drug particles of salbutamol sulphate,   wherein the 1,1-difluoroethane propellant and surfactant component provide a propellant/surfactant mixture in which the solid drug particles of salbutamol sulphate are suspended, and   wherein the salbutamol sulphate and surfactant component are present as distinct chemical compounds at the time they are blended with the propellant to form the pharmaceutical composition.   
     
     
         4 . The pharmaceutical composition of  claim 1  which consists entirely of components (a), (b) and (c). 
     
     
         5 . The pharmaceutical composition of  claim 3  which consists entirely of components (a), (b) and (c). 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein at least 95 weight % of the propellant component is 1,1-difluoroethane (R-152a). 
     
     
         7 . The pharmaceutical composition of  claim 3 , wherein at least 95 weight % of the propellant component is 1,1-difluoroethane (R-152a). 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein at least 99 weight % of the propellant component is 1,1-difluoroethane (R-152a). 
     
     
         9 . The pharmaceutical composition of  claim 3 , wherein at least 99 weight % of the propellant component is 1,1-difluoroethane (R-152a). 
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein the propellant component consists entirely of 1,1-difluoroethane (R-152a). 
     
     
         11 . The pharmaceutical composition of  claim 3 , wherein the propellant component consists entirely of 1,1-difluoroethane (R-152a). 
     
     
         12 . A metered dose inhaler (MDX) fitted with a sealed and pressurized container that contains a pharmaceutical composition as claimed in  claim 1 . 
     
     
         13 . A metered dose inhaler (MDI) fitted with a sealed and pressurized container that contains a pharmaceutical composition as claimed in  claim 3 .