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.

Claims

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.

Description

[0073] Embodiments of the present invention will now be described with reference to the following drawings:

[0074] FIG. 1 shows a plot of nicotine release profiles for a composition according to the present invention and comparative examples;

[0075] FIG. 2 shows a plot of nicotine release profiles for a composition according to the present invention and comparative examples;

[0076] FIG. 3 shows photographs of a pouch and composition according to the present invention and comparative examples.

[0077] In a first embodiment of the present invention there is provided a tobacco free (or in some instances low tobacco) nicotine formulation for use in pouches for oral use. The formulation has a high water content and contains nicotine in its free base form. The composition involves a cellulosic filler and also the use of agar agar as a nicotine release agent to promote the release of nicotine from the composition when it is placed (e.g. in a pouch) in the oral cavity of a user.

[0078] In an embodiment, the composition has a general formulation as described below: [0079] a. From about 0.2 wt % to about 5 wt % nicotine in free base form; [0080] b. A native cellulose material, such as microcrystalline cellulose, in an amount from about 35 wt % to about 60 wt %; [0081] c. water in an amount at least 35 wt %; [0082] d. one or more pH control salts, such as a combination of ammonium chloride and sodium bicarbonate in an amount from about 1 wt % to about 6 wt %; [0083] e. a release control agent comprising agar agar or a derivative thereof in an amount from about 0.1 wt % to about 2 wt % [0084] f. optional additional ingredients, such as flavourings, flavour enhancers, sweeteners and preservatives, preferably in an amount up to about 12 wt %.

[0085] All wt % are based on the total weight of the composition.

[0086] The quantity of nicotine in the composition varies by the desired strength of the product. In some embodiments the quantity of nicotine is between 0.2 wt % and 3 wt %, or between 0.2 wt % and 2 wt %.

[0087] The native cellulose useful in the present invention may comprise powdered cellulose and/or microcrystalline cellulose. Examples of powdered cellulose which may be used in te invention include Arbocel (RTM) as supplied by J. Rettenmaier & Shne GmbH; Elcema; KC Flock (RTM) supplied by Nippon Paper Industries Co. Ltd.; Microcel 3E-150 supplied by Roquette Frres; Sanacel (RTM) supplied by CFF GmbH; Sanacel Pharma (RTM) supplied by CFF GmbH; Sancel-W supplied by NB Entrepreneurs Company; or Solka-Floc (RTM) supplied by J. Rettenmaier USA LP.

[0088] Examples of microcrystalline cellulose which may be used in the invention include Avicel (RTM) PH supplied by Dupont Nutrition and Biosciences, Inc.; Cellets supplied by Pharmatrans Sanaq AG; Celphere supplied by Asahi Kasei Corporation; Ceolus KG supplied by Asahi Kasei Corporation; Emcocel supplied by JRS Pharma GmbH; MCC Sanaq supplied by Pharmatrans Sanaq AG; Pharmacel supplied by DFE Pharma GmbH; Tabulose supplied by Roquette Frres; Vivapur supplied by JRS Pharma GmbH.

[0089] While the water content of the composition should be at least 35 wt %, it is preferred that a greater proportion of water is contained in the composition. Greater palatability for the user, including greater softness, tends to be found when the water content of the composition is greater than 40 wt %. Preferred compositions have a water content greater than 42 wt %, for example between 44 wt % and 48 wt % water.

[0090] The composition contains pH control salts to provide optimum pH of the composition while in use in the mouth of a user. It is preferred that the pH of the composition, when measured according to the Coresta Method No.69, 2017, is from 6 to 9, preferably from 7 to 9 and more preferably from 7 to 8.5. This can be achieved by providing pH adjusting agents such as sodium bicarbonate or buffering salts such as a combination of a ammonium chloride and sodium bicarbonate. Typical quantities of pH control salts are between 0.2 wt % and 2 wt %, preferably between 0.2 wt % and 1 wt %. Alternative buffering salts may be selected from e.g. carbonate or sesquicarbonate salts; acetate salts, glycinate, acetate, glycinate, gluconate, borate, glycerophosphate or citrate salts; phosphate salts.

[0091] Flavourings contained within the composition are not limited but preferably include flavonoid compounds to stimulate the olefactory system of the user, typically in an amount of less than about 3 wt % of the total composition. Such compounds are commercially available and are well known to those skilled in the art.

[0092] The flavour of the composition may be improved by the inclusion of sweeteners or flavour enhancers.

[0093] Sweeteners may include sugar based sweeteners such as sucrose, fructose, glucose, dextrose, maltose, lactose, galactose; sugar alcohols such as xylitol, maltitol, sorbitol, erythritol; or other sugar substitutes such as aspartame, saccharin, sucralose, allulose, acesulfame K, cyclamate or steviol glycosides. The sweeteners may be present alone though are preferably used in combination (for example a sugar alcohol and a sugar substitute). A preferred combination is xylitol and acesulfame K. Quantities of the sweetener present in the composition depend on the properties of the sweeteners chosen, as would be understood by a person skilled in the art but typically range between 1 wt % and 3 wt % in total.

[0094] Flavour enhancers may include sodium chloride, salts of glutamic acid (such as sodium glutamate), glycine salts, inosinic acid salts and 5-ribonucleotide salts (such as on or more disodium ribonucleotides). Quantities of the flavour enhancer present in the composition depend on the properties of the flavour enhancer chosen, as would be understood by a person skilled in the art but typically range between 1 wt % and 8 wt % in total.

[0095] Preservatives may include antimicrobial preservatives such as sorbic acid salts (such as sodium or potassium sorbate), benzoic acid salts, nitrate salts, nitrite salts, sulfate salts, sulfite salts and proponiate salts. Salts such as calcium chloride may also be used as preservatives.

[0096] All compositions may contain a small quantity of tobacco, such as between 1 wt % and 5 wt %, especially when contained in a pouch.

[0097] The inventors have surprisingly found that the presence of agar agar in the composition acts as an effective nicotine stabilizer and release control agent. Without wishing to be bound by any particular theory, it is postulated that the nicotine may be partially bound within an agar agar gel which may be formed during manufacture. This appears to provide both a highly stable nicotine composition, which despite the use of free base nicotine and high levels of moisture is able to maintain a long shelf life. Moreover, the nicotine release profile of the composition is fast and consistent, providing excellent product performance.

[0098] This performance is provided despite a relatively small quantity of agar agar being provided in the composition. The agar agar is preferably present in an amount from 0.1wt % to about 1.2 wt %. It is preferably present in a ratio of agar agar to nicotine of 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. This is a significantly lower ratio than would be required for prior art stabilizing agents.

[0099] Any food or pharmaceutical grade agar agar may be utilized in the present invention. Specific examples include Rokoagar (RTM) RGM 600 and RGM 800, as supplied by Industrias Roko, S.A..

[0100] In preferred embodiments, the composition may have a general composition as follows: [0101] a. From about 0.2 wt % to about 3 wt % nicotine in free base form; [0102] b. Microcrystalline cellulose, in an amount from about 35 wt % to about 60 wt %; [0103] c. water in an amount at least 35 wt % and preferably above 40 wt %; [0104] d. buffer salts ammonium chloride in an amount 0.05 wt % and 1 wt % and sodium bicarbonate in an amount from about 0.1 wt % to about 1 wt %; [0105] e. a release control agent comprising agar agar in an amount from about 0.1 wt % to about 2 wt % [0106] f. optional additional ingredients, such as [0107] a. flavourings in an amount from 0.5 wt % to about 3 wt %, [0108] b. flavour enhancers such as sodium chloride in an amount between 2 wt % and 8 wt %, [0109] c. sweeteners such as xylitol in an amount from about between 1 wt % and 2 wt % and/or acesulfame K in an amount from 0.05 wt % to 1 wt %; and [0110] d. preservatives, such as potassium sorbate in an amount from about 0.25 wt % to about 1 wt %. [0111] e. tobacco in a quantity from 0 wt % to 3 wt %.

[0112] In a further embodiment, there is provided a process for the manufacture of tobacco-free or low-tobacco nicotine compositions. The process involves the mixing in a vessel (such as an autoclave) the native cellulose in a portion of from 30 wt % to 60 wt % of the intended final composition and agar agar in a portion of from 0.1 wt % to 2 wt % of the final composition, each in powder or granular form. One or more of the other solid components of the composition, such as pH control salts, flavour enhancers, sweeteners or preservatives may also be added at this stage of the process, though any tobacco intended for inclusion in the final composition should ideally be held until the remainder of the composition is complete.

[0113] At least a portion of the water (preferably at least 10 wt % of the intended final composition) is then added to the composition and the composition is heated. The heating may take place in a number of ways. The mixing vessel may be heated, for example by use of a heating manifold. Alternatively or additionally, the water may be heated prior to its introduction to the mixing vessel or some or all of the water may be added as steam.

[0114] The temperature of the resulting precursor mixture should be at least 50 C., preferably at least 60 C. and more preferably at least 70 C. The precursor is heated such that the agar agar at least partially dissolves in the water. Without wishing to be bound by any theory, it is postulated that the low concentration of agar agar coupled with shear applied during mixing, sufficient dissolution of agar agar may be obtained at such temperatures.

[0115] While the heated precursor mixture is being mixed, the nicotine is added to the precursor in an amount from 0.2 wt % to 2 wt % of the final composition. At this stage, other liquid components of the composition, such as flavourings, may be added.

[0116] Optionally, a second portion of water (preferably at least 10 wt % of the intended final composition) is then added to the composition and the composition is heated, again to at least 50 C., preferably at least 60 C. and more preferably at least 70 C.

[0117] The precursor is then allowed to cool, preferably while mixing is continued. The resulting composition may be set aside. Without wishing to be bound by any particular theory, it is believed that the agar agar forms a gel which at least partially encapsulates the nicotine which is present, stabilizing it and also providing excellent release properties.

[0118] In an optional finishing step, the resulting composition may have further water added to it, preferably with the water at ambient temperature. This step is to afford a greater content to the composition where required. In some embodiments, flavour enhancers, sweeteners or preservatives may be added at this stage, additionally to or in the alternative to their addition earlier in the process.

[0119] The finished composition may optionally be mixed with tobacco in an amount of up to 5 wt % of the final composition. The composition is soft to the touch, produces little dust and does not form clumps. The product is white in colour. In preferred embodiments, it is packed into saliva permeable pouches ready for oral delivery.

EXAMPLES

[0120] A number of compositions were produced according to the method described above.

TABLE-US-00001 Example 1 Comparative Comparative Ingredient w/w (%) Example 1 Example 2 Water 46% 46% 46% MCC 42.13% 24.50% 41.80% Sodium chloride 5.30% 4.00% 6.00% Aromas 3% 1.59% 3.8% Xylitol 1.72% 1.80% 0.50% Nicotine 0.60% 0.60% 0.60% Agar Agar 0.30% 20% Potassium 0.30% 0.30% 0.20% Sorbate Acesulfam K 0.20% 0.15% 0.15% Ammonium 0.20% 0.10% 0.60% chloride Sodium 0.25% 0.26% 0.35% bicarbonate

[0121] 0.7 g portions of each of the finished compositions were packed into a saliva permeable pouch and tested according to the following release test:

[0122] A single person avoids nicotine intake for 10 hours before the experiment starts and avoids food or drink intake 1 hour before the experiment starts. Prior to the procedure, the testing person rinses his or her mouth with water and waits for 10 minutes.

[0123] A pouch is taken and the weight is measured before being placed under the lip of the testing person. The pouch is kept in place, without moving, for 5 minutes. The pouch is then removed and placed in a 50 cm3 distilled water and stirred or shaken for 30 minutes. A sample is taken and analysed for its nicotine content using HPLC.

[0124] The tester then waits at least one hour before repeating the experiment, holding the pouch in place for 10, 20, 30 and 40 minutes on successive repeats.

[0125] The results of the release tests are plotted in FIG. 1. As can be seen, a slight increase in the release rate and total release of nicotine over 40 minutes can be seen with the inclusion of 20 wt % agar agar. However, as can be surprisingly seen, a relatively small proportion of agar agar in the composition (0.3 wt %, with 0.6 wt % nicotine) provides a very significant increase in both release rate and total release over 40 minutes.

[0126] Further compositions, identical to those of Example 1 but which comprised different stabilizers in place of agar agar were prepared and tested according to the same method. The stabilizers used in these examples are shown in the table below:

TABLE-US-00002 Example Stabilizer Comparative Example 3 Sodium Alginate Comparative Example 4 Sodium carboxymethyl cellulose Comparative Example 5 Chitosan Comparative Example 6 Pectin Comparative Example 7 Methyl cellulose Comparative Example 8 Guargum Comparative Example 9 Vegetable oil-glycerol (2:1)

[0127] The results of the release tests are plotted in the graph at FIG. 2, with the plot of Example 1 overlaid. It is clear from the plot that agar agar provides for the greatest overall release of nicotine over a 40 minute period and also provides for a significantly faster release over the first 10 minutes of use. This provides significant advantages for users seeking to cease smoking.

pH TestCorresta Method No. 69, 2017

[0128] A pH electrode is calibrated using at least two pH buffers (4,00 and 7,00 or 7,00 and 10,00) to produce a two-point calibration that will cover the pH range of the products tested. Calibration is performed in conjunction with the measurements of the samples and at 23 C. The calibration slope must be within 95%-105% before the electrode can be used for sample measurements. The electrode must be rinsed, before and after each measurement, with water.

[0129] The samples for testing are allowed to reach room temperature before preparation. Samples are then mixed with water at a concentration of 5 wt % and shaken or stirred for 30 minutes. The pH electrode is then used to determine the pH of the water in the sample mixture.

Comparative Examples 10 to 12

[0130] Comparative examples 10-12 list commercial products which are based on a nicotine salt and featuring low moisture content, i.e., below 10 % wt. These products generally feature long shelf life of at least 12 months. However, miscoloration and lumpiness increase with increasing moisture content. Very dry products may dust during storage and be difficult to handle during packaging. Low moisture products typically feature poor palatability (dry mouthfeel) and show delayed nicotine release. The appearance of samples is presented in FIG. 3.

Comparative Example 10

TABLE-US-00003 Composition Characteristics Nicotine Nicotine content: 16.6 mg/g MCC Moisture content: 5.94% Maltitol Shelf-life: 15 months Sodium bicarbonate Color (storage): White Aromas Lumping: No Glycerol Palatability: Poor Polyvinylpyrrolidone Release: Slow Acesulfame K Dusting: Yes pH: 8.71

Comparative Example 11

TABLE-US-00004 Composition Characteristics Nicotine Nicotine content: 15 mg/g MCC Moisture content: 4.79% Maltitol Shelf-life: 12 months Hydroxypropyl cellulose Color (storage): White Sodium bicarbonate Lumping: No Acesulfame K Palatability: Poor Aromas Release: Slow Dusting: Yes pH: 8.39

Comparative Example 12

TABLE-US-00005 Composition Characteristics Nicotine Nicotine content: 17 mg/g MCC Moisture content: 8.31% Maltitol Shelf-life: 10 months Chewing gum base Color (storage): Creamy white Sodium bicarbonate Lumping: Moderate Glycerol Palatability: Poor Propylene Glycol Release: Slow Aromas Dusting: Yes pH: 9.61

Comparative Examples 13 to 17

[0131] Comparative examples 13-17 list commercial products based on a nicotine free-base and featuring high moisture content, i.e., above 40 % wt. Lumpiness and various degrees of miscoloration are characteristic to nearly all products. Comparative Examples 13 to 16 are variations of the same product from the same manufacturer, that vary mainly with respect to aromas, release modifiers, and sweeteners used. The products in these examples contain calcium chloride. Typically, calcium chloride is used as excipient with water binding properties and as antimicrobial preservative. The appearance of samples is presented in FIG. 3.

Comparative Example 13

TABLE-US-00006 Composition Characteristics Nicotine Nicotine content: 14 mg/g Water Moisture content: 44.89% MCC Shelf-life: 12 months Plant fiber Color (storage): Creamy- Yellowish Glycerol Lumping: Visible Sodium bicarbonate Palatability: Good Calcium Chloride Release: Fast Sodium Chloride Dusting: No Aromas pH: 8.65 Mono/diglycerides of fatty acids Acesulfame K

Comparative Example 14

TABLE-US-00007 Composition Characteristics Nicotine Nicotine content: 14 mg/g Water Moisture content: 44.89% MCC Shelf-life: 12 months Plant fiber Color (storage): Creamy- Yellowish Glycerol Lumping: Visible Sodium bicarbonate Palatability: Good Calcium Chloride Release: Fast Sodium Chloride Dusting: No Aromas pH: 8.7 Mono/diglycerides of fatty acids Acesulfame K

[0132] Comparative Example 15

TABLE-US-00008 Composition Characteristics Nicotine Nicotine content: 14 mg/g Water Moisture content: 44.89% MCC Shelf-life: 10 months Plant fiber Color (storage): Creamy- Yellowish Glycerol Lumping: Visible Sodium bicarbonate Palatability: Good Calcium Chloride Release: Fast Sodium Chloride Dusting: No Aromas pH: 9.12 Mono-/diglycerides of fatty acids Saccharine

[0133] Comparative Example 16

TABLE-US-00009 Composition Characteristics Nicotine Nicotine content: 8 mg/g Water Moisture content: 41.86% MCC Shelf-life: 12 months Plant fiber Color (storage): Creamy- Yellowish Glycerol Lumping: Visible Sodium bicarbonate Palatability: Good Calcium Chloride Release: Fast Sodium Chloride Dusting: No Aromas pH: 8.4

Comparative Example 17

TABLE-US-00010 Composition Characteristics Nicotine Nicotine content: 14 mg/g Water Moisture content: 49.70% MCC Shelf-life: 12 months Xylitol Color (storage): White Glycerol Lumping: No Sodium bicarbonate Palatability: Good Sodium alginate Release: Fast Ammonium chloride Dusting: No Sodium chloride pH: 8.92 Aromas Acesulfame K

Comparative Examples 18 and 19

[0134] Comparative examples 18 and 19 list commercial products based on free-base nicotine and featuring medium moisture content, i.e., below 10-30 % wt. These products feature a shelf life of around 6-12 months. Both products exhibit signs of miscoloration and lumpiness. Comparative Example 16, rich in sugar alcohol, is especially prone to form lumps, which harden over time, thereby significantly decreasing product palatability. The appearance of samples is presented in FIG. 3.

Comparative Example 18

TABLE-US-00011 Composition Characteristics Nicotine Nicotine content: 15 mg/g Water Moisture content: 29.56% Fiber Shelf-life: 12 months Xylitol Color (storage): Yellow- Brownish Erythritol Lumping: Strong Sodium bicarbonate Palatability: Poor Sodium alginate Release: Potassium sorbate Dusting: No Sodium chloride pH: 9.94 Aromas Acesulfame K

[0135] Comparative Example 19

TABLE-US-00012 Composition Characteristics Nicotine Nicotine content: 13 mg/g Water Moisture content: 16.65% Plant fiber Shelf-life: 6 months Xylitol Color (storage): White Glycerol Lumping: Moderate Sodium bicarbonate Palatability: Good Sodium alginate Release: Ammonium chloride Dusting: No Sodium chloride pH: 8.8 Aromas Acesulfame K

Example 2

[0136] Example 2 represent an example of formulation according to the present invention. The product features high moisture content and high nicotine stability during at least 12 months of storage. No signs of miscoloration, lumping or dusting are observed after storage.

Example 2

TABLE-US-00013 Components w/w % Characteristics Nicotine (free-base) 0.8 wt % Nicotine content: 8 mg/g Water 45 wt % Moisture content: 45% MCC 42.2 wt % Shelf-life: 12 months Agar agar 0.3 wt % Color (storage): White Sodium bicarbonate 0.25 wt % Lumping: No Ammonium chloride 0.2 wt % Palatability: Good Sodium chloride 5.3 wt % Release: Fast Aromas 2.75 wt % Dusting: No Xylitol 1.7 wt % pH: 8.5 Potassium Sorbate 0.3 wt % Acesulfame K 0.2 wt %

[0137] The Examples show that compositions of the present invention provide a soft, white product that avoids clumping and is thus palatable to use and easy to pack and manufacture. It also has a substantial shelf life and delivers nicotine quickly and consistently to the user.

[0138] The invention is as defined in the following claims.