Metered dose inhaler for fluticasone propionate

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 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.

1 - 22 . (CANCELED)  
     
     
         23 . A process for manufacturing a metered dose inhaler for dispensing an inhalation drug formulation comprising a drug and a fluorocarbon propellant, comprising: 
 providing a metered dose inhaler can having a mouth, a cap for covering the mouth of said can, and a drug metering valve;    applying to at least one internal surface of said can, cap or drug metering valve which comes into contact with said inhalation drug formulation, without prior application of a primer thereto, a fluorocarbon polymer, optionally in combination with one or more non-fluorocarbon polymers, to form a coating on said at least one internal surface of said can, cap or drug metering valve; and    assembling said can, cap and drug metering valve into a completed metered dose inhaler.    
     
     
         24 . The process according to  claim 23 , and further comprising the step of introducing into said metered dose inhaler said drug formulation.  
     
     
         25 . The process according to  claim 24 , wherein said drug formulation is introduced into said can through said valve.  
     
     
         26 . The process according to  claim 23 , wherein said fluorocarbon polymer is applied to said cap.  
     
     
         27 . The process according to  claim 23 , wherein said fluorocarbon polymer is applied to said valve.  
     
     
         28 . The process according to  claim 23 , wherein said fluorocarbon polymer is applied as a coating to an internal surface of said can and said coating is thereafter cured at an elevated temperature.  
     
     
         29 . The process according to  claim 28 , wherein said can is formed of strengthened aluminum or an aluminum alloy.  
     
     
         30 . The process according to  claim 28 , wherein said fluorocarbon polymer is applied to an internal surface of said can at a thickness of 1 μm to 1 mm.  
     
     
         31 . A process for manufacturing a metered dose inhaler for dispensing an inhalation drug formulation comprising a drug and a fluorocarbon propellant, comprising: 
 providing a metered dose inhaler can having a mouth, a cap for covering the mouth of said can, and a drug metering valve;    applying to an internal surface of said can, which comes into contact with said inhalation drug formulation, a fluorocarbon polymer, optionally in combination with one or more non-fluorocarbon polymers, to form a coating on said internal surface of said can; and    assembling said can, cap and drug metering valve into a completed metered dose inhaler, wherein said coating has a thickness of 1 μm to 100 μm.    
     
     
         32 . The process according to  claim 31 , wherein said coating has a thickness of 1 μm to 25 μm.  
     
     
         33 . The process according to  claim 31 , wherein a primer is applied to said can before application of said fluorocarbon coating.  
     
     
         34 . The process according to  claim 31 , wherein said fluorocarbon polymer is applied to said can without prior application of a primer.  
     
     
         35 . The process according to  claim 23 , wherein said fluorocarbon polymer is applied to said can by electrostatic dry powder coating.  
     
     
         36 . The process according to  claim 23 , wherein said fluorocarbon polymer is applied to said can by spraying a preformed metered dose inhaler can inside with said fluorocarbon polymer and then curing at an elevated temperature.  
     
     
         37 . The process according to  claim 36 , wherein curing is conducted at a temperature of 300° C. to 400° C.  
     
     
         38 . The process according to  claim 36 , wherein curing is conducted at a temperature of 350° C. to 380° C.  
     
     
         39 . The process according to  claim 23 , wherein said fluorocarbon polymer is coated on said can by in situ plasma polymerization at the can walls using fluorocarbon monomer.  
     
     
         40 . The process according to  claim 39 , wherein plasma polymerization is conducted at a temperature of 20° C. to 100° C.  
     
     
         41 . A process according to  claim 24 , wherein the fluorocarbon propellant is 1,1,1,2-tetrafluoroethane, or 1,1,1,2,3,3,3-heptafluoro-n-propane or mixtures thereof.  
     
     
         42 . A process according to  claim 24 , wherein the fluorocarbon propellant is 1,1,1,2-tetrafluoroethane.  
     
     
         43 . A process according to  claim 23 , wherein said can is made of metal wherein part or all of the internal metallic surfaces of the can are coated.  
     
     
         44 . A process according to  claim 43 , wherein the metal is aluminium or an alloy thereof.  
     
     
         45 . A process according to  claim 23 , wherein said fluorocarbon polymer is a perfluorocarbon polymer.  
     
     
         46 . A process according to  claim 45 , wherein said fluorocarbon polymer is selected from PTFE, PFA, FEP and mixtures thereof.  
     
     
         47 . A process according to  claim 24 , further comprising fitting said metered dose inhaler into a suitable channeling device for oral or nasal inhalation of the drug formulation.  
     
     
         48 . The process of  claim 23 , wherein said can comprises side walls and a base of a thickness greater than 0.46 mm and said fluorocarbon polymer is applied to said can.  
     
     
         49 . A process for manufacturing a metered dose inhaler having internal metallic surfaces for dispensing an inhalation drug formulation comprising a particulate drug and a fluorocarbon propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoro-n-propane and mixtures thereof, comprising: 
 providing a metered dose inhaler can having a mouth, a cap for covering the mouth of said can, and a drug metering valve, wherein said can comprises side walls and a base having a thickness greater than 0.46 mm;    forming a coating from a polymer composition comprising one or more fluorocarbon polymers on at least one of said internal metallic surfaces which comes into contact with said inhalation drug formulation without prior application of a primer thereto; and    assembling said can, cap and drug metering valve into a completed metered dose inhaler.    
     
     
         50 . The process according to  claim 49 , and further comprising the step of introducing into said metered dose inhaler said drug formulation.  
     
     
         51 . The process according to  claim 49 , wherein said fluorocarbon polymer is applied to said cap.  
     
     
         52 . The process according to  claim 49 , wherein said fluorocarbon polymer is applied to said valve.  
     
     
         53 . The process according to  claim 49 , wherein said fluorocarbon polymer is applied as a coating to an internal surface of said can and said coating is thereafter cured at an elevated temperature.  
     
     
         54 . The process according to  claim 49 , wherein said fluorocarbon polymer is applied to said can by spraying a preformed metered dose inhaler can inside with said fluorocarbon polymer and then curing at an elevated temperature.  
     
     
         55 . The process according to  claim 54 , wherein curing is conducted at a temperature of 300° C. to 400° C.  
     
     
         56 . The process according to  claim 54 , wherein said coating has a thickness of 1 μm to 1 mm.  
     
     
         57 . The process according to  claim 54 , wherein said coating has a thickness of 1 μm to 100 μm.  
     
     
         58 . The process according to  claim 54 , wherein said coating has a thickness of 1 μm to 25 μm.  
     
     
         59 . The process according to  claim 23 , wherein said fluorocarbon polymer is applied as a part of a polymer composition comprising said fluorocarbon polymer and a non-fluorocarbon polymer.  
     
     
         60 . The process according to  claim 28 , wherein said fluorocarbon polymer is applied as a part of a polymer composition comprising said fluorocarbon polymer and a non-fluorocarbon polymer.  
     
     
         61 . The process according to  claim 31 , wherein said fluorocarbon polymer is applied as a part of a polymer composition comprising said fluorocarbon polymer and a non-fluorocarbon polymer.  
     
     
         62 . The process according to  claim 43 , wherein said fluorocarbon polymer is applied as a part of a polymer composition comprising said fluorocarbon polymer and a non-fluorocarbon polymer.  
     
     
         63 . The process according to  claim 49 , wherein said fluorocarbon polymer is applied as a part of a polymer composition comprising said fluorocarbon polymer and a non-fluorocarbon polymer.  
     
     
         64 . The process according to  claim 53 , wherein said fluorocarbon polymer is applied as a part of a polymer composition comprising said fluorocarbon polymer and a non-fluorocarbon polymer.