Aerosolisable formulation

Abstract

An aerosolizable formulation comprising (i) water in an amount of at least 20 wt.% based on the aerosolizable formulation; (ii) nicotine; and (iii) an acid which is at least partially water soluble; wherein at least 5 wt% of the nicotine present in the formulation is in protonated form; and wherein the formulation has a pH of from 4 to 6. A process for forming an aerosol comprising the aerosolizable formulation, the aerosolizable formulation contained in a container, an electronic aerosol provision system having an aerosolizer for aerosolizing the aerosolizable formulation for inhalation by a user, a process for improving sensory properties of an aerosolized nicotine formulation, and a process for improving the storage stability of an aerosolized nicotine formulation.

1 . An aerosolizable formulation comprising:
 (i) water in an amount of at least 20 wt.% based on the aerosolizable formulation;   (ii) nicotine; and   (iii) an acid which is at least partially water soluble;   wherein at least 5 wt% of the nicotine present in the formulation is in a protonated form; and   wherein the aerosolizable formulation has a pH of from 4 to 6.   
     
     
         2 . An aerosolizable formulation according to  claim 1 , wherein water is present in an amount of at least 40 wt.% based on the aerosolizable formulation. 
     
     
         3 . An aerosolizable formulation according to  claim 1 , wherein water is present in an amount of at least 60 wt.% based on the aerosolizable formulation. 
     
     
         4 . An aerosolizable formulation according to  claim 1 , wherein water is present in an amount of at least 80 wt.% based on the aerosolizable formulation. 
     
     
         5 . An aerosolizable formulation according to  claim 1 , wherein water is present in an amount of at least 90 wt.% based on the aerosolizable formulation. 
     
     
         6 . An aerosolizable formulation according to  claim 1 , wherein the nicotine is present in an amount of no greater than 0.2 wt.% based on the aerosolizable formulation. 
     
     
         7 . An aerosolizable formulation according to  claim 1 , wherein the nicotine is present in an amount of from 0.01 to 0.1 wt.% based on the aerosolizable formulation. 
     
     
         8 . An aerosolizable formulation according to  claim 1 , wherein the acid has a solubility in water of at least 100 g/100 mL at 20° C. 
     
     
         9 . An aerosolizable formulation according to  claim 1 , wherein at least 20 wt% of the nicotine present in the formulation is in the protonated form. 
     
     
         10 . An aerosolizable formulation according to  claim 1 , wherein at least 30 wt% of the nicotine present in the formulation is in the protonated form. 
     
     
         11 . An aerosolizable formulation according to  claim 1 , wherein a molar ratio of the acid to the nicotine is from 3:1 to 1:3. 
     
     
         12 . An aerosolizable formulation according to  claim 1 , wherein a molar ratio of the acid to the nicotine is from 2:1 to 1:2. 
     
     
         13 . An aerosolizable formulation according to  claim 1 , wherein a molar ratio of the acid to the nicotine is from 1.2:1 to 1:1.2. 
     
     
         14 . An aerosolizable formulation according to  claim 1 , wherein the acid is a carboxylic acid. 
     
     
         15 . An aerosolizable formulation according to  claim 1 , wherein the acid is selected from the group consisting of citric acid, maleic acid, lactic acid, levulinic acid, benzoic acid, sorbic acid, acetic acid and mixtures thereof. 
     
     
         16 . An aerosolizable formulation according to  claim 1 , wherein the acid comprises citric acid. 
     
     
         17 . An aerosolizable formulation according to  claim 1 , further comprising one or more flavors. 
     
     
         18 . An aerosolizable formulation according to  claim 17 , wherein the one or more flavors are selected from the group consisting of (4-(para-)methoxyphenyl)-2-butanone, vanillin, γ-undecalactone, menthone, 5-propenyl guaethol, menthol, para-mentha-8-thiol-3-one and mixtures thereof. 
     
     
         19 . An aerosolizable formulation according to  claim 17 , wherein the one or more flavors comprises menthol. 
     
     
         20 . An aerosolizable formulation according to  claim 17 , wherein the one or more flavors are present in a total amount of from 0.01 to 1w t.% based on the aerosolizable formulation. 
     
     
         21 . An aerosolizable formulation according to  claim 1 , consisting essentially of
 (i) water;   (ii) nicotine;   (iii) the acid; and   (iv) optionally one or more flavors.   
     
     
         22 . A process for forming an aerosol, the process comprising:
 aerosolizing an aerosolizable formulation comprising:
 (i) water in an amount of at least 20 wt.% based on the aerosolizable formulation; 
 (ii) nicotine; and 
 (iii) an acid which is at least partially water soluble; 
   wherein at least 5 wt% of the nicotine present in the formulation is in a protonated form; and   wherein the aerosolizable formulation has a pH of from 4 to 6.   
     
     
         23 . (canceled) 
     
     
         24 . A process according to  claim 22 , wherein the aerosolizable formulation is aerosolized to form the aerosol at a temperature below 50° C. 
     
     
         25 . A process according to  claim 22 , wherein aerosolizing the aerosolizable formulation comprises applying ultrasonic energy to the aerosolizable formulation. 
     
     
         26 . A contained aerosolizable formulation comprising: 
 (a) a container; and   (b) an aerosolizable formulation, comprising:
 (i) water in an amount of at least 20 wt.% based on the aerosolizable formulation; 
 (ii) nicotine; and 
 (iii) an acid which is at least partially water soluble; 
   wherein at least 5 wt% of the nicotine present in the formulation is in a protonated form; and   wherein the formulation has a pH of from 4 to 6.   
     
     
         27 . (canceled) 
     
     
         28 . A contained aerosolizable formulation according to  claim 26 , wherein the container is configured for engagement with an electronic aerosol provision system. 
     
     
         29 . An electronic aerosol provision system comprising:
 (a) an aerosolizer for aerosolizing an aerosolizable formulation for inhalation by a user of the electronic aerosol provision system;   (b) a power supply comprising a cell or battery for supplying power to the aerosolizer   (c) an aerosolizable formulation, comprising:
 (i) water in an amount of at least 20 wt.% based on the aerosolizable formulation; 
 (ii) nicotine; and 
 (iii) an acid which is at least partially water soluble; 
   wherein at least 5 wt% of the nicotine present in the formulation is in a protonated form; and   wherein the formulation has a pH of from 4 to 6.   
     
     
         30 . (canceled) 
     
     
         31 . A process for improving the sensory properties of an aerosolized nicotine formulation, the process comprising the steps of:
 (a) providing an aerosolizable material comprising (i) water in an amount of at least 20 wt.% based on the aerosolizable material and (ii) nicotine; and   (b) incorporating into the aerosolizable material an acid which is at least partially water soluble;   wherein at least 5 wt% of the nicotine present in the formulation is in a protonated form; and   wherein the formulation has a pH of from 4 to 6.   
     
     
         32 . A process for improving the storage stability of an aerosolized nicotine formulation, the process comprising the steps of:
 (a) providing an aerosolizable material comprising (i) water in an amount of at least 20 wt.% based on the aerosolizable material and (ii) nicotine; and   (b) incorporating into the aerosolizable material an acid which is at least partially water soluble;   wherein at least 5 wt% of the nicotine present in the formulation is in a protonated form; and   wherein the formulation has a pH of from 4 to 6.   
     
     
         33 - 34 . (canceled)