Inhalable compositions comprising caffeine, methods of use and an apparatus for using the same

Abstract

Described herein are compositions, methods and an apparatus relating to the pulmonary delivery of an inhalable composition comprising caffeine, or a salt thereof, and a solvent selected from the group consisting of propylene glycol, glycerol, ethanol and a combination thereof.

What is claimed is: 
     
         1 . An inhalable composition, comprising caffeine, or a salt thereof, and a solvent selected from the group consisting of propylene glycol, glycerol, ethanol and a combination thereof. 
     
     
         2 . The inhalable composition of  claim 1 , wherein the composition comprises propylene glycol and glycerol, and the composition has a ratio of propylene glycol to glycerol of about 2:1 to about 1:2. 
     
     
         3 . The inhalable composition of  claim 1 , wherein the composition is a vapor comprising liquid droplets. 
     
     
         4 . The inhalable composition of  claim 3 , wherein the liquid droplets have an average diameter of about 1 micron to about 10 microns. 
     
     
         5 . The inhalable composition of  claim 1 , wherein the composition further comprises an additive selected from the group consisting of yerba mate leaf extract, huperizine, taurine, inositol, niacinamide, phenylalanine, citicoline, or a salt of any thereof, and a combination thereof. 
     
     
         6 . The inhalable composition of  claim 5 , wherein the composition comprises:
 about 1 wt. % to about 10 wt % caffeine HCl,   about 1 wt. % to about 10 wt % yerba mate leaf extract,   about 1×10 −10  wt. % to about 1×10 −5  wt % huperizine,   about 1 wt. % to about 30 wt % taurine,   about 1 wt. % to about 30 wt % inositol,   about 0.1 wt. % to about 3 wt % niacinamide,   about 1 wt. % to about 30 wt % phenylalanine,   about 1 wt. % to about 30 wt % citicoline,   about 1 wt. % to about 30 wt % propylene glycol, and   about 1 wt. % to about 30 wt % glycerol.   
     
     
         7 . The inhalable composition of  claim 6 , wherein the composition comprises:
 about 3.8 wt % caffeine HCl,   about 2.5 wt % yerba mate leaf extract,   about 1×10 −8  wt % huperizine,   about 9.5 wt % taurine,   about 9.5 wt % inositol,   about 0.6 wt % niacinamide,   about 9.5 wt % phenylalanine,   about 7.6 wt % citicoline,   about 9.5 wt % propylene glycol, and   about 9.5 wt % glycerol.   
     
     
         8 . The inhalable composition of  claim 6 , wherein the composition further comprises about 1 wt % to about 30 wt % of a flavorant. 
     
     
         9 . The inhalable composition of  claim 8 , wherein the flavorant is selected from the group consisting of citric acid, lemon extract, lime extract, orange extract, cinnamon, peppermint, spearmint and a combination thereof. 
     
     
         10 . The inhalable composition of  claim 1 , wherein the composition does not comprise methanol or ethanol. 
     
     
         11 . The inhalable composition of  claim 1 , wherein the composition has a viscosity of about 0.01 Pa·s to about 0.1 Pa·s at 20° C. 
     
     
         12 . An apparatus for the pulmonary administration of an inhalable composition to a subject, wherein:
 the apparatus is a personal electronic vaporizer;   the inhalable composition comprises caffeine, or a salt thereof, and a water-miscible solvent selected from the group consisting of propylene glycol, glycerol, ethanol and a combination thereof; and   the apparatus comprises a means to store the inhalable composition as a liquid, a means to heat and transform the liquid into a vapor and a means to administer at least 0.0001 mg caffeine, or a salt thereof, from the vapor to the subject per inhalation by the subject from the apparatus.   
     
     
         13 . The apparatus of  claim 12 , wherein the apparatus comprises the inhalable composition. 
     
     
         14 . The apparatus of  claim 13 , wherein the composition further comprises an additive selected from the group consisting of yerba mate leaf extract, huperizine, taurine, inositol, niacinamide, phenylalanine, citicoline, or a salt of any thereof, and a combination thereof. 
     
     
         15 . The apparatus of  claim 12 , wherein the transformed vapor comprises liquid droplets having an average diameter of about 1 micron to about 10 microns. 
     
     
         16 . The apparatus of  claim 12 , wherein the means to administer at least 0.0001 mg caffeine, or a salt thereof, administers about 0.0002 mg to about 50 mg of caffeine, or a salt thereof, from the vapor to the subject per inhalation by the subject from the apparatus. 
     
     
         17 . A method for administering an inhalable composition to a subject in need thereof, the method comprising providing the subject with:
 the inhalable composition comprising caffeine, or a salt thereof, and a solvent selected from the group consisting of propylene glycol, glycerol, ethanol and a combination thereof; and   an apparatus for the pulmonary administration of the inhalable composition;   wherein, the method results in a pulmonary administration of at least 0.0001 mg of caffeine from the inhalable composition to the subject.   
     
     
         18 . The method of  claim 17 , wherein the composition is inhaled from the apparatus as a vapor comprising liquid droplets. 
     
     
         19 . The method of  claim 18 , wherein the vapor is formed at a temperature of about 250° F. to about 450° F. 
     
     
         20 . The method of  claim 17 , wherein the composition further comprises an additive selected from the group consisting of yerba mate leaf extract, huperizine, taurine, inositol, niacinamide, phenylalanine, citicoline, or a salt of any thereof, and a combination thereof. 
     
     
         21 . The method of  claim 20 , wherein the composition comprises:
 about 3.8 wt % caffeine HCl,   about 2.5 wt % yerba mate leaf extract,   about 1×10 −8  wt % huperizine,   about 9.5 wt % taurine,   about 9.5 wt % inositol,   about 0.6 wt % niacinamide,   about 9.5 wt % phenylalanine,   about 7.6 wt % citicoline,   about 9.5 wt % propylene glycol, and   about 9.5 wt % glycerol.   
     
     
         22 . The method of  claim 17 , wherein about 0.0002 mg to about 25 mg of caffeine or a salt thereof is inhaled by the subject per inhalation. 
     
     
         23 . The method of  claim 22 , wherein about 0.0005 mg to about 10 mg of caffeine or a salt thereof is inhaled by the subject per inhalation. 
     
     
         24 . The method of  claim 22 , wherein about 10 mg to about 20 mg of caffeine or a salt thereof is inhaled by the subject per inhalation. 
     
     
         25 . The method of  claim 22 , wherein about 20 mg to about 40 mg of caffeine or a salt thereof is inhaled by the subject per inhalation. 
     
     
         26 . The method of  claim 17 , wherein the apparatus is a personal electronic vaporizer.