Nicotine composition

Abstract

The present invention describes a composition, such as a tobacco free or low tobacco nicotine containing composition, comprising: a. From about 0.2 wt % to about 2 wt % nicotine in free base form; b. a native cellulose material in an amount from about 35 wt % to about 60 wt %; c. water in an amount at least 35 wt %; d. one or more pH control salts in an amount from about 0.5 wt % to about 3 wt %; e. a release control agent comprising agar agar in an amount from about 0.1 wt % to about 2 wt % f. optional additional ingredients, preferably in an amount up to about 12 wt %. The composition may be provided in pouches for oral delivery to a user.

1 . A composition comprising:
 a. From about 0.2 wt % to about 5 wt % nicotine in free base form;   b. a native cellulose material in an amount from about 35 wt % to about 60 wt %;   c. water in an amount at least 35 wt %;   d. one or more pH control salts in an amount from about 0.5 wt % to about 3 wt %;   e. a release control agent comprising agar agar and/or derivatives of agar agar in an amount from about 0.1wt % to about 2 wt %   f. optional additional ingredients, preferably in an amount up to about 12 wt %.   
     
     
         2 . A composition according to  claim 1 , further comprising additional ingredients, preferably in an amount from about 1 wt % to about 10 wt % or more preferably in an amount from about 1 wt % to about 8 wt %. 
     
     
         3 . A composition according to  claim 1 or claim 2  wherein the additional ingredients comprise one or more additives selected from flavourings, flavour enhancers, sweeteners and preservatives. 
     
     
         4 . A composition according to  claim 2 or 3  wherein the additional ingredients comprise sweeteners, preferably in an amount from about 1 wt % to about 3 wt %. 
     
     
         5 . A composition according to  claim 4 , wherein the sweeteners comprise compounds selected from sugars (such as sucrose, fructose, glucose, dextrose, maltose, lactose, galactose), sugar alcohols (such as xylitol, maltitol, sorbitol, erythritol) and/or sugar substitutes (such as aspartame, saccharin, sucralose, allulose, acesulfame K, cyclamate or steviol glycosides). 
     
     
         6 . A composition according to  claim 4 or claim 5  comprising a sugar alcohol in an amount less than 3 wt %, preferably less than 2 wt %, such as between 1 wt % and 2 wt %. 
     
     
         7 . A composition according to any of  claims 4 to 6  comprising a sugar substitute in an amount less than 1 wt %, preferably less than 0.5 wt %, such as between 0.05 wt % and 0.3 wt %. 
     
     
         8 . A composition according to  claim 6 or claim 7  wherein the or a sugar alcohol comprises xylitol and/or the or a sugar substitute comprises acesulfame K. 
     
     
         9 . A composition according to any of  claims 2 to 8  further comprising one or more preservatives selected from calcium chloride, salts of sorbic acid (such as potassium sorbate), salts of benzoic acid (such as sodium benzoate), nitrate salts, nitrite salts, sulfate salts, sulfite salts and proponiate salts. 
     
     
         10 . A composition according to  claim 9 , wherein potassium sorbate is present in an amount less than about 1 wt %, preferably between 0.1 wt % and 0.5 wt %, such as between about 0.25 wt % and about 0.35 wt %. 
     
     
         11 . A composition according to any of  claims 1 to 9 , wherein the pH control salts comprise buffering salts such as a combination of ammonium chloride and sodium bicarbonate. 
     
     
         12 . A composition according to  claim 11 , where ammonium chloride is present in an amount between 0.05 wt % and 1 wt %, preferably between 0.1 wt % and 0.5 wt %, for example between 0.15 wt % and 0.25 wt %. 
     
     
         13 . A composition according to  any preceding claim , where sodium bicarbonate is present in an amount between less than 1 wt %, preferably between 0.1 wt % and 0.5 wt %, for example between 0.2 wt % and 0.3 wt %. 
     
     
         14 . A composition according to  any preceding claim  comprising greater than 40 wt % water, for example between 40 wt % and 50 wt % water, preferably between about 44 wt % and about 48 wt % water. 
     
     
         15 . A composition according to  any preceding claim  wherein the filler material comprises powdered cellulose and/or microcrystalline cellulose (MCC). 
     
     
         16 . A composition according to  any preceding claim , wherein the release control agent comprises agar agar in an amount less than about 1 wt %, preferably less than 0.7 wt %. 
     
     
         17 . A composition according to  claim 16 , wherein the release control agent comprises agar agar in an amount from about 0.2 wt % to about 0.7 wt %, preferably in an amount from about 0.2 wt % to about 0.5 wt %. 
     
     
         18 . A composition according to  any preceding claim , wherein the ratio of agar agar to nicotine is less than about 1.3:1. 
     
     
         19 . A composition according to  any preceding claim , wherein the ratio of agar agar to nicotine is from about 0.1:1 to about 1.2:1, preferably from about 0.1:1 to about 1:1, more preferably from about 0.1:1 to about 0.8:1. 
     
     
         20 . A composition according to  any preceding claims  further comprising tobacco leaf in an amount less than 5 wt %, preferably about 1 wt % to 3 wt %. 
     
     
         21 . A composition according to  any preceding claim  where the pH as measured by Coresta Method No. 69, 2017, is from 6 to 9, preferably from 7 to 9 and more preferably from 7 to 8.5. 
     
     
         22 . A composition according to any of  claims 3 to 21  wherein the flavour enhancers are selected from the group comprising sodium chloride, glutamate salts, glycine salts, inosinic acid salts and 5′-ribonucleotide salts. 
     
     
         23 . A composition according to  claim 22  comprising sodium chloride in an amount less than 8 wt %, preferably between 1 wt % and 7 wt %. 
     
     
         24 . A composition according to any of  claims 3 to 23  comprising flavouring compounds in an amount less than about 5 wt % of the total composition, for example less than 3 wt % of the composition or between 0.5 wt % and 3 wt % of the composition. 
     
     
         25 . A composition according to  any preceding claim , wherein the the quantity of nicotine is between 0.2 wt % and 3 wt %, or between 0.2 wt % and 2 wt %. 
     
     
         26 . A composition according to  any preceding claim  consisting essentially of the claimed components. 
     
     
         27 . A water or saliva permeable pouch containing a composition according to  any preceding claim . 
     
     
         28 . A package containing a plurality of pouches according to  claim 27 . 
     
     
         29 . A process for forming a nicotine containing composition according to any of  claims 1 to 26  comprising:
 a. combining in a mixer native cellulose material in an amount 40 wt % to 60 wt % of the intended composition with agar agar (and/or derivatives of agar agar) powder in an amount 0.2 wt % to 2 wt % of the intended composition, thereby to form a precursor composition; 
 b. adding water to the precursor composition and mixing at a temperature greater than 50° C.; 
 c. adding to the precursor composition nicotine in free base form, in an amount 0.2wt % to about 2wt % of the intended final composition, while the temperature is greater than 50° C.; 
 d. allowing the mixture to cool. 
 
     
     
         30 . A process according to  claim 29 , wherein additional water is added between steps (c) and (d). 
     
     
         31 . A process according to  claim 29 or 30 , wherein in steps (b) and (c), the mixing of the precursor is at a temperature greater than about 60° C., preferably above about 70° C., preferably above 80° C. 
     
     
         32 . A process according to any of  claims 29 to 31 , wherein in step (b) the water is provided to the precursor at a temperature above about 70° C., preferably above about 80° C. 
     
     
         33 . A process according to  claim 32 , wherein in step (b) the water is provided to the precursor is in the form of steam or vapour. 
     
     
         34 . A process according to any of  claims 30 to 33 , wherein additional water added between steps (c) and (d) is at a temperature greater than about 70° C., preferably above about 80° C. 
     
     
         35 . A process according to any of  claims 34 , wherein additional water added between steps (c) and (d) is in the form of steam or vapour. 
     
     
         36 . A process according to any of  claims 29 to 35 , wherein the precursor mixture is heated while in the mixer, for example during step (b) and/or (c) and or during or after any addition of water following step (c). 
     
     
         37 . A process according to any of  claims 29 to 36 , wherein further water is added to the composition after step (d). 
     
     
         38 . A process according to any of  claims 29 to 37 , wherein any of the following components are added to the precursor mixture prior to step (b):
 a. one or more pH control salts in an amount from about 0.5 wt % to about 3 wt % of the intended composition;   b. additional ingredients, preferably in an amount up to about 12 wt % of the intended composition.   
     
     
         39 . A process according to any of  claims 29 to 38  where the intended composition is a composition according to any of  claims 1 to 26 . 
     
     
         40 . Use as a nicotine release control agent of agar agar in a composition comprising:
 a. From about 0.2 wt % to about 5 wt % nicotine in free base form;   b. a native cellulose material in an amount from about 35 wt % to about 60 wt %;   c. water in an amount at least 35 wt %;   d. one or more pH control salts in an amount from about 0.5 wt % to about 3 wt %;   e. a release control agent comprising agar agar and/or derivatives of agar agar in an amount from about 0.1 wt % to about 2 wt % f. optional additional ingredients, preferably in an amount up to about 12 wt %.   
     
     
         41 . Use as a nicotine stabilising agent of agar agar in a composition comprising:
 a. From about 0.2 wt % to about 5 wt % nicotine in free base form;   b. a native cellulose material in an amount from about 35 wt % to about 60 wt %;   c. water in an amount at least 35 wt %;   d. one or more pH control salts in an amount from about 0.5 wt % to about 3 wt %;   e. a release control agent comprising agar agar and/or derivatives of agar agar in an amount from about 0.1 wt % to about 2 wt %   f. optional additional ingredients, preferably in an amount up to about 12 wt %.   
     
     
         42 . A use according to  claim 38 or claim 39 , wherein the composition further comprises additional ingredients, preferably in an amount from about 1 wt % to about 10 wt % or more preferably in an amount from about 1 wt % to about 8 wt %. 
     
     
         43 . A use according to  claims 40 to 42  wherein the additional ingredients in the composition comprise one or more additives selected from flavourings, flavour enhancers, sweeteners and preservatives. 
     
     
         44 . A use according to  claim 42 or 43  wherein the additional ingredients comprise sweeteners, preferably in an amount from about 1 wt % to about 3 wt %. 
     
     
         45 . A use according to  claim 44 , wherein the sweeteners comprise compounds selected from sugars (such as sucrose, fructose, glucose, dextrose, maltose, lactose, galactose), sugar alcohols (such as xylitol, maltitol, sorbitol, erythritol) and/or sugar substitutes (such as aspartame, saccharin, sucralose, allulose, acesulfame K, cyclamate or steviol glycosides). 
     
     
         46 . A use according to  claim 44 or claim 45  comprising a sugar alcohol in an amount less than 3 wt %, preferably less than 2 wt %, such as between 1 wt % and 2 wt %. 
     
     
         47 . A composition according to any of  claims 46  comprising a sugar substitute in an amount less than 1 wt %, preferably less than 0.5 wt %, such as between 0.05 wt % and 0.3 wt %. 
     
     
         48 . A according to  claim 46 or claim 47  wherein the or a sugar alcohol comprises xylitol and/or the or a sugar substitute comprises acesulfame K. 
     
     
         49 . A use according to any of  claims 42 to 48  further comprising one or more preservatives selected from calcium chloride, salts of sorbic acid (such as potassium sorbate), salts of benzoic acid (such as sodium benzoate), nitrate salts, nitrite salts, sulfate salts, sulfite salts and proponiate salts. 
     
     
         50 . A use according to  claim 49 , wherein potassium sorbate is present in an amount less than about 1 wt %, preferably between 0.1 wt % and 0.5 wt %, such as between about 0.25wt % and about 0.35 wt %. 
     
     
         51 . A use according to any of  claims 40 to 49 , wherein the pH control salts comprise buffering salts such as a combination of ammonium chloride and sodium bicarbonate. 
     
     
         52 . A use according to  claim 51 , where ammonium chloride is present in an amount between 0.05 wt % and 1 wt %, preferably between 0.1 wt % and 0.5 wt %, for example between 0.15 wt % and 0.25 wt %. 
     
     
         53 . A use according to any of  claims 40 to 52 , where sodium bicarbonate is present in an amount between less than 1 wt %, preferably between 0.1 wt % and 0.5 wt %, for example between 0.2 wt % and 0.3 wt %. 
     
     
         54 . A use according to any of  claims 40 to 53 , comprising greater than 40 wt % water, for example between 40 wt % and 50 wt % water, preferably between about 44 wt % and about 48 wt % water. 
     
     
         55 . A use according to any of  claims 40 to 54  wherein the filler material comprises powdered cellulose and/or microcrystalline cellulose (MCC). 
     
     
         56 . A use according to any of  claims 40 to 55 , wherein the release control agent comprises agar agar in an amount less than about 1 wt %, preferably less than 0.7 wt %. 
     
     
         57 . A use according to  claim 56 , wherein the release control agent comprises agar agar in an amount from about 0.2 wt % to about 0.7 wt %, preferably in an amount from about 0.2 wt % to about 0.5 wt %. 
     
     
         58 . A use according to any of  claims 40 to 57 , wherein the ratio of agar agar to nicotine is less than about 1.3:1. 
     
     
         59 . A use according to any of  claims 40 to 58 , wherein the ratio of agar agar to nicotine is from about 0.1:1 to about 1.2:1, preferably from about 0.1:1 to about 1:1, more preferably from about 0.1:1 to about 0.8:1. 
     
     
         60 . A use according to any of  claims 40 to 59  further comprising tobacco leaf in an amount less than 5 wt %, preferably about 1 wt % to 3 wt %. 
     
     
         61 . A use according to any of  claims 40 to 60  where the pH as measured by Coresta Method No.69, 2017, is from 6 to 9, preferably from 7 to 9 and more preferably from 7 to 8.5. 
     
     
         62 . A use according to any of  claims 43 to 61  wherein the flavour enhancers are selected from the group comprising sodium chloride, glutamate salts, glycine salts, inosinic acid salts and 5′-ribonucleotide salts. 
     
     
         63 . A use according to  claim 62  comprising sodium chloride in an amount less than 8 wt %, preferably between 1 wt % and 7 wt %. 
     
     
         64 . A use according to any of  claims 43 to 63  comprising flavouring compounds in an amount less than about 5 wt % of the total composition, for example less than 3 wt % of the composition or between 0.5 wt % and 3 wt % of the composition. 
     
     
         65 . A use according to any of  claims 40 to 64 , wherein the quantity of nicotine is between 0.2 wt % and 3 wt %, or between 0.2 wt % and 2wt % 
     
     
         66 . A use according to any of  claims 40 to 65 , wherein the composition consists essentially of the claimed components.