Simulated cigarette

Abstract

A simulated cigarette comprising a housing having a generally cigarette-like shape and size; a reservoir within the housing configured to receive and contain a dose of inhalable formulation; a means for controlling the flow from the reservoir; an outlet passage from the means for controlling the flow from the reservoir to an outlet in the housing from which outlet a user inhales the formulation, wherein a deliverable daily dose of inhalable formulation is delivered by pulmonary administration using one or more of said simulated cigarette, wherein said deliverable daily dose comprises less than 60 mg of nicotine or a pharmaceutically acceptable salt thereof.

1 . A simulated cigarette comprising a housing having a generally cigarette-like shape and size; a reservoir within the housing configured to receive and contain a dose of inhalable formulation; a means for controlling the flow from the reservoir; an outlet passage from the means for controlling the flow from the reservoir to an outlet in the housing from which outlet a user inhales the formulation, wherein a deliverable daily dose of inhalable formulation is delivered by pulmonary administration using one or more of said simulated cigarette, wherein said deliverable daily dose comprises less than 60 mg of nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The simulated cigarette of  claim 1 , wherein said deliverable daily dose is 40 mg or less of nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         3 . The simulated cigarette of  claim 1 , wherein said deliverable daily dose is 20 mg or less of nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         4 . The simulated cigarette of  claim 1 , wherein said deliverable daily dose is 18 mg or less of nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         5 . The simulated cigarette of  claim 1 , wherein said deliverable daily dose of inhalable formulation is a maximum daily dose. 
     
     
         6 . The simulated cigarette of  claim 1 , wherein the reservoir receives said dose of inhalable formulation from a refill pack. 
     
     
         7 . The simulated cigarette of  claim 6 , wherein the refill pack contains from about 2 mg to about 20 mg nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         8 . The simulated cigarette of  claim 6 , wherein the refill pack contains from about 17 mg to about 18 mg nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         9 . The simulated cigarette of  claim 6 , wherein the refill pack contains from about 11 mg to about 12 mg nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         10 . The simulated cigarette of  claim 6 , wherein the refill pack contains from about 5 mg to about 6 mg nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         11 . The simulated cigarette of  claim 6 , wherein the daily dose of inhalable formulation is provided in two refill packs. 
     
     
         12 . The simulated cigarette of  claim 10 , wherein the daily dose of inhalable formulation is provided in five refill packs. 
     
     
         13 . The simulated cigarette of  claim 6 , wherein the refill pack comprises approximately 15-30 doses. 
     
     
         14 . The simulated cigarette of  claim 6 , wherein the refill pack comprises approximately 20 doses. 
     
     
         15 . The simulated cigarette of  claim 1 , wherein the dose comprises approximately 0.1-1 mg nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         16 . The simulated cigarette of  claim 1 , wherein the second and subsequent doses comprise approximately 0.2-0.7 mg nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         17 . The simulated cigarette of  claim 1 , wherein the second and subsequent doses comprise approximately 0.66-0.69 mg nicotine or a pharmaceutically acceptable salt thereof, or approximately 0.43-0.45 mg nicotine or a pharmaceutically acceptable salt thereof, or approximately 0.21-0.23 nicotine or a pharmaceutically acceptable salt thereof. 
     
     
         18 . The simulated cigarette of  claim 1 , wherein the first dose comprises less than approximately 1 mg nicotine or a pharmaceutically acceptable salt thereof, preferably less than approximately 0.43 mg, more preferably approximately 0.02-0.3 mg. 
     
     
         19 . The simulated cigarette of  claim 1 , wherein each dose is consumed at a rate of approximately one inhalation every 15 seconds for up to 4 minutes. 
     
     
         20 . The simulated cigarette of  claim 1 , wherein the outlet is a breath-actuated valve. 
     
     
         21 . The simulated cigarette of  claim 1 , further comprising a heating element to selectably volatilize at least some components of the formulation, and a power source arranged to selectively supply electrical power to the heater when the user inhales from the inhaler, the power source being arranged to heat the heater to a temperature that will volatilize some but not all of the components of the composition. 
     
     
         22 . The simulated cigarette of  claim 21 , wherein the heater is arranged to heat the formulation to between 40 and 180° C. 
     
     
         23 . The simulated cigarette of  claim 22 , wherein the heater is arranged to heat the formulation to between 40 and 100° C. 
     
     
         24 . The simulated cigarette of  claim 21 , wherein the composition comprises ethanol and the heater is arranged to heat the formulation to volatilize the majority of the ethanol. 
     
     
         25 . The simulated cigarette of  claim 21 , wherein the formulation includes propylene glycol and the heater is arranged to heat the formulation not to volatilise the majority of the propylene glycol. 
     
     
         26 . The simulated cigarette of  claim 21 , wherein the heater is arranged to heat the formulation after it has left the reservoir. 
     
     
         27 . The simulated cigarette of  claim 21 , further comprising at least one airflow path arranged to draw air in through the side of the cigarette as a user inhales from an inhaling end, and impinge on the composition leaving the heater at the inhaling end. 
     
     
         28 . The simulated cigarette of  claim 27 , wherein there is more than one path and wherein the paths are arranged to generate swirl around the main axis of the inhaler. 
     
     
         29 . The simulated cigarette of  claim 27 , wherein there is more than one path and wherein the airflow paths are arranged to pass through a constriction in the vicinity of the outlet end of the inhaler thereby generating a venture effect and promoting suction of the composition out of the inhaler. 
     
     
         30 . The simulated cigarette of  claim 1 , wherein the reservoir is pressurized. 
     
     
         31 . The simulated cigarette of  claim 1 , wherein the composition includes a propellant. 
     
     
         32 . The simulated cigarette of  claim 31 , wherein the propellant is HFA.