Process for manufacturing a metered dose inhaler

Abstract

A metered dose inhaler having all or part of its internal surfaces coated with one or more fluorocarbon polymers, optimally in combination with one or more non-fluorocarbon polymers, for dispensing an inhalation drug formation comprising albuterol or a physiologically acceptable salt thereof and a fluorocarbon propellant, optionally in combination with one or more other pharmacologically active agents or one or more excipients.

We claim:  
     
         1 . A metered dose inhaler having part or all of its internal surfaces coated with one or more fluorocarbon polymers, optionally in combination with one or more non-fluorocarbon polymers, for dispensing an inhalation drug formulation comprising fluticasone propionate or a physiologically acceptable solvate thereof and a fluorocarbon propellant, optionally in combination with one or more other pharmacologically active agents or one or more excipients.  
     
     
         2 . An inhaler according to  claim 1  containing said drug formulation.  
     
     
         3 . An inhaler according to  claim 2 , wherein said drug formulation further comprises a surfactant.  
     
     
         4 . An inhaler according to  claim 2  or  claim 3 , wherein said drug formulation further comprises a polar cosolvent.  
     
     
         5 . An inhaler according to  claim 2  wherein said drug formulation further comprises 0.01 to 5% w/w based upon propellant of a polar cosolvent, which formulation is substantially free of surfactant.  
     
     
         6 . An inhaler according to any one of  claims 2  to  5 , wherein said drug formulation comprises fluticasone propionate or a physiologically acceptable solvate thereof in combination with a bronchodilator or an antiallergic.  
     
     
         7 . An inhaler according to  claim 6 , wherein said drug formulation comprises fluticasone propionate in combination with salmeterol xinafoate.  
     
     
         8 . An inhaler according to  claim 2 , wherein said drug formulation consists essentially of fluticasone propionate or a physiologically acceptable solvate thereof, optionally in combination with one or more other pharmacologically active agents, and a fluorocarbon propellant.  
     
     
         9 . An inhaler according to  claim 8 , wherein said drug formulation consists essentially of fluticasone propionate or a physiologically acceptable solvate thereof in combination with a bronchodilator or an antiallergic.  
     
     
         10 . An inhaler according to  claim 9 , wherein said drug formulation consists essentially of fluticasone propionate or a physiologically acceptable solvate thereof in combination with salmeterol or a physiologically acceptable salt thereof.  
     
     
         11 . An inhaler according to  claim 10 , wherein said drug formulation consists essentially of fluticasone propionate in combination with salmeterol xinafoate.  
     
     
         12 . An inhaler according to  claim 2 , wherein said drug formulation consists of fluticasone propionate or a physiologically acceptable solvate thereof and a fluorocarbon propellant.  
     
     
         13 . An inhaler according to any one of  claims 2  to  12 , wherein the fluorocarbon propellant is 1,1,1,2-tetrafluoroethane, or 1,1,1,2,3,3,3-heptafluoro-n-propane or mixtures thereof.  
     
     
         14 . An inhaler according to  claim 13 , wherein the fluorocarbon propellant is 1,1,1,2-tetrafluoroethane.  
     
     
         15 . An inhaler according to any one of  claims 1  to  14  comprising a can made of metal wherein part or all of the internal metallic surfaces are coated.  
     
     
         16 . An inhaler according to  claim 15  wherein the metal is aluminium or an alloy thereof.  
     
     
         17 . An inhaler according to any one of  claims 1  to  16  wherein said fluorocarbon polymer is a perfluorocarbon polymer.  
     
     
         18 . An inhaler according to  claim 17  wherein said fluorocarbon polymer is selected from PTFE, PFA, FEP and mixtures thereof.  
     
     
         19 . An inhaler according to any one of  claims 1  to  18 , wherein said fluorocarbon polymer is in combination with a non-fluorocarbon polymer selected from polyamideimide and polyethersulphone.  
     
     
         20 . An inhaler according to any one of  claims 1  to  19  comprising a substantially ellipsoidal base.  
     
     
         21 . A metered dose inhaler system comprising a metered dose inhaler according to any one of  claim 1  to  20  fitted into suitable channeling device for oral or nasal inhalation of the drug formulation.  
     
     
         22 . Use of a metered dose inhaler system according to  claim 21  for the treatment of respiratory disorders.