Aerosol inhalation device

Abstract

Actuators for an aerosol inhalation device containing a housing adapted to receive an aerosol canister containing a pressurized medicament formulation, a mouthpiece portion through which the user inhales, a nozzle block and an orifice and a tubular element extending in the mouthpiece portion from the orifice aperture in a longitudinal axis substantially aligned with a longitudinal axis of the mouthpiece portion provide a significant reduction in the non-respirable, coarse fraction of the emitted aerosol medicament via inertial impaction and retention in the actuator than in the oro-pharynx, with consequent less associated side effects and oral candidiasis in the patient. In addition the presence of the tubular element has minimal, negligible impact on the fine particle dose and on the particle size distribution (PSD) of the delivered particles having aerodynamic diameter lower than 9 μm.

1 . An actuator for an aerosol inhalation device, comprising:
 a housing adapted to receive an aerosol canister containing a pressurized medicament formulation, provided with a metering valve having a hollow valve stem;   a mouthpiece portion terminating in a mouthpiece opening through which the user inhales;   a nozzle block defining a valve stem receptacle, an expansion chamber or sump, and an orifice, with an aperture, to propel an aerosol formulation toward said mouthpiece opening; and,   a tubular element extending in said mouthpiece portion from said orifice aperture in a longitudinal axis substantially aligned with a longitudinal axis of said actuator mouthpiece portion and substantially coinciding with the longitudinal axis of said orifice.   
     
     
         2 . An actuator according to  claim 1 , wherein said tubular element is configured such that one of its terminal openings may be close fit to said nozzle block external surface, around said orifice aperture, so as to be in a continuous flow path with said orifice and to enclose said orifice aperture within a recess. 
     
     
         3 . An actuator according to  claim 1 , wherein said tubular element is secured to said nozzle block external surface, around said orifice aperture to be in a continuous flow path with said orifice, using a suitable joining procedure selected from the group consisting of welding, soldering, and a chemical bonding process. 
     
     
         4 . An actuator according to  claim 1 , wherein said tubular element is formed on a lateral part of a shaped hollow cylindrical object suitable to be tightly fitted to the outside of said nozzle block, covering its lateral surfaces so as said tubular element is in a continuous flow path with said orifice. 
     
     
         5 . An actuator according to  claim 1 , wherein said tubular element, said nozzle block, said housing for said aerosol canister, and said mouthpiece portion form a single piece molded actuator. 
     
     
         6 . An actuator according to  claim 1 , wherein at least one of said nozzle block and said tubular element are formed of the same or different materials selected from the group consisting of a metal material and a plastic polymeric material. 
     
     
         7 . An actuator according to  claim 1 , wherein at least one of said nozzle block and said tubular element are formed of the same or different materials selected from the group consisting of aluminium, an aluminium alloy, stainless steel, polypropylene, polyethylene, polytetrafluoroethylene, acrylonitrile-butadiene-styrene, polymethyl methacrylate, polycarbonate, polyamide, and polyethylene terephthalate. 
     
     
         8 . An actuator according to  claim 4 , wherein at least one of said nozzle block, said tubular element, and said shaped hollow cylindrical object are formed of the same or different materials selected from the group consisting of a metal material and a plastic polymeric material. 
     
     
         9 . An actuator according to  claim 4 , wherein at least one of said nozzle block, said tubular element, and said shaped hollow cylindrical object are formed of the same or different materials selected from the group consisting of aluminium, an aluminium alloy, stainless steel, polypropylene, polyethylene, polytetrafluoroethylene, acrylonitrile-butadiene-styrene, polymethyl methacrylate, polycarbonate, polyamide, and polyethylene terephthalate. 
     
     
         10 . An actuator according to  claim 6 , wherein said plastic polymeric material is coated with an antistatic agent by means of a molding or a coating process. 
     
     
         11 . An actuator according to  claim 8 , wherein said plastic polymeric material is coated with an antistatic agent by means of a molding or a coating process. 
     
     
         12 . An actuator according to  claim 1 , wherein said tubular element has an internal diameter in the range of from 2 to 15 mm and a length in the range of from 2 to 20 mm. 
     
     
         13 . An actuator according to  claim 12 , wherein said tubular element has an internal diameter in the range of from 3 to 12 mm and a length in the range of from 3 to 15 mm. 
     
     
         14 . An actuator according to  claim 13 , wherein said tubular element has an internal diameter in the range of from 5 to 7 mm and a length in the range of from 8 to 12 mm. 
     
     
         15 . An actuator according to  claim 1 , wherein said tubular element extends in said mouthpiece portion from said orifice aperture along a longitudinal axis aligned with a longitudinal axis of said actuator mouthpiece portion and coinciding with the longitudinal axis of said orifice. 
     
     
         16 . A shaped hollow cylindrical object suitable to be tightly fitted to the outside of the nozzle block of an actuator for pMDI inhalers, covering its lateral surfaces and comprising in its lateral side a tubular element which is in a continuous flow path with said nozzle block orifice. 
     
     
         17 . An inhaler, comprising
 an actuator according to  claim 1 ; and   a canister having a metering valve and containing a pressurized medicament formulation.   
     
     
         18 . A metered-dose inhaler actuator, comprising
 a housing having a mouthpiece portion, having an opening, and a canister receiving portion configured to receive a canister;   a nozzle block disposed within said housing and defining a valve stem receptacle configured to receive a valve stem of a canister;   an orifice, having an aperture, in fluid communication with said valve stem receptacle to propel an aerosol formulation towards said mouthpiece opening; and   a tubular element extending in said mouthpiece portion from said orifice aperture in a longitudinal axis substantially aligned with a longitudinal axis of said actuator mouthpiece portion and substantially coinciding with the longitudinal axis of said orifice.   
     
     
         19 . A metered-dose inhaler according to  claim 18 , wherein said tubular element extends in said mouthpiece portion from said orifice aperture along a longitudinal axis aligned with a longitudinal axis of said actuator mouthpiece portion and coinciding with the longitudinal axis of said orifice. 
     
     
         20 . A kit of parts, comprising
 an actuator for an aerosol inhalation device;   a shaped hollow cylindrical object according to  claim 11 ; and   an aerosol canister containing a pressurized medicament formulation.   
     
     
         21 . A method for the reduction of the non-respirable dose and consequent potential oro-pharyngeal deposition of the dispensed aerosol formulation on actuation of a metered-dose inhaler, said method comprising equipping said metered-dose inhaler with an actuator according to  claim 1 .