WO2023143687A1 - Pouch composition with specific nicotine to solvent ratio - Google Patents

Pouch composition with specific nicotine to solvent ratio Download PDF

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Publication number
WO2023143687A1
WO2023143687A1 PCT/DK2023/050017 DK2023050017W WO2023143687A1 WO 2023143687 A1 WO2023143687 A1 WO 2023143687A1 DK 2023050017 W DK2023050017 W DK 2023050017W WO 2023143687 A1 WO2023143687 A1 WO 2023143687A1
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WO
WIPO (PCT)
Prior art keywords
nicotine
amount
pouch
pouch composition
present
Prior art date
Application number
PCT/DK2023/050017
Other languages
French (fr)
Inventor
Peter BOJE
Original Assignee
Mac Baren Tobacco Company A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mac Baren Tobacco Company A/S filed Critical Mac Baren Tobacco Company A/S
Publication of WO2023143687A1 publication Critical patent/WO2023143687A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24BMANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B13/00Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24FSMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F23/00Cases for tobacco, snuff, or chewing tobacco
    • A24F23/02Tobacco pouches
    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24BMANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10Chemical features of tobacco products or tobacco substitutes
    • A24B15/16Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24BMANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18Treatment of tobacco products or tobacco substitutes
    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24BMANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18Treatment of tobacco products or tobacco substitutes
    • A24B15/28Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances

Definitions

  • This invention relates to a pouch composition, a pouch product comprising said pouch composition in a pouch and methods of manufacturing said pouch composition and pouch product.
  • Nicotine consumption by smoking has traditionally been the main method of nicotine delivery.
  • smoking as a method of nicotine delivery is being challenged by several alternative systems for nicotine deliv- ery.
  • pouch products containing pouch compositions containing nicotine, also known as snus.
  • These pouch products may vary in type and composition depending on e.g. market of sale and local preferences or regulations.
  • the pouch product is used by placing the pouch in the mouth, preferably between gum and upper lip, where it is left for a desired amount of time delivering nicotine. Nicotine is absorbed by the mucous in the mouth.
  • a pouch product and a pouch composition are provided which in use enable optimized transferal of an active ingredient via the mucous mem- brane.
  • a pouch product and a pouch composition are pro- vided which in use result in reduced irritation of gums and/or mucous membrane.
  • a pouch product and a pouch composition are provided which in use have an improved feel for the user.
  • a pouch composition comprising at least one water insoluble fibre, at least one sugar alcohol in a total amount of 0 - 12 wt%, one or more intense sweeteners in a total amount of 0 - 8%, water in an amount of 8 - 50 wt%, nicotine and a nicotine solvent in form of a hygroscopic sweet substance capable of dissolving nicotine, wherein the nicotine and nicotine solvent are present in a ratio of 10:90 - 30:70, such as 20:80.
  • wt% refers to the weight percentage of all ingredients in the pouch composition with full water content but without pouch.
  • the water content may be 8 - 50 wt.%, such as or up to 20, 25, 30, 35, 40, 45, 48 or 50 wt%.
  • the nicotine solvent is Propane- 1,2, 3 -tri ol, Propane- 1, 2-diol and/or Butan- 1,3 -diol as these nicotine solvents may provide sweetness as well as may help balance moisture.
  • the solvents Propane-1, 2, 3-triol, Propane- 1, 2-diol and/or Butan- 1,3 -diol are all known solvents for use in dilution of flavors and other strong ingredients. They are in general tasteless and have a little sweetness from the OH groups. They are fully mixable with water in the range 0 to 100 %, but also mixable with other things like nicotine and many flavors. When the nicotine: solvent ratio is 10:90 - 30:70, such as 20:80, an advanta- geous mix may be achieved.
  • glycerin is defined as Propane-1, 2, 3-triol
  • PG is defined as Propane- 1,2-diol
  • Snus, snuff is defined as none water soluble botanical fibers in a none water soluble saliva permeable bag with ingredients such as nicotine, flavors, pH regulating agents, anticaking agents, preservatives, texturizing agents and sugar alcohols
  • the insoluble fibre is one or more of botanical fibers for exam- ple fibers from wheat, oat, buckwheat, potatoes, bamboo, cellulose, apple, cacao, beets, sugar beets, wood, seaweed, barley, rye, com, tomato and any combination hereof.
  • the one or more fibers may be chosen to provide the right water content ranging from very' dry products to very' moist products.
  • the fibers in their capacity of being a water insoluble in- gredient may continue to provide volume to the pouch product during use as they are not dissolved and released by saliva.
  • the majority of the other ingredients present may- be water soluble, whereby they may be dissolved by saliva and released from the pouch composition through the pouch and provide taste, aroma and/or effect of the active in- gredient to the user.
  • At least one of the one or more water insoluble fibers may fibers that can contain from 150 to 1000 w% of water and are approved for usage in food and/or pharma. Such as or up to 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 650%, 700%, 750%, 800%, 850%, 900%, 950%, 1000%, 200 - 800%, 200 - 600% w% water.
  • the fibers are selected to have a length of 10 - 300pm, such as 20 - 200 pm, such as 25 - 100 pm, such as 30 - 75 pm, such as 25 - 50 pm.
  • a high content of fibers may provide a product with a dry feel to the user.
  • a dry product may for some users have an undesirable feel and may also result in a reduced impact of the active ingredient as the saliva used to transfer ingredients through the mucous mem- brane may be absorbed by the fibers.
  • texturizing agents may be provided in an amount to balance the dryness of the fibers and provide a desired feeling of moisture and softness to the product.
  • the pouch composition may comprise one or more texturizing agents, for example one or more of agar, guar gum, alginate salts and/or arabica gum which may act as a gelling agent when absorbing water or other liquids.
  • the texturizing agent is present in an amount of 0.1 - 5 wt%, e.g. in an amount of or up to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 wt%.
  • a pouch composition is achieved which has a texture with a desired sensation of moisture and firmness for the user.
  • the active ingredient may be chosen to provide a desired effect to the pouch product and pouch composition .
  • nicotine may be present to provide a nicotine deliv- ery product whereby an alternative to products providing nicotine by smoking is achieved.
  • the at least one active ingredient may be present in a concentration of 0.01 - 20% de- pending on type and intended effect.
  • Active ingredients may be nicotine, Caffeine, cannabinoid such as CBD, CBT and other oils extracted from hemp or cannabis, melatonin, vitamin A, vitamin B, vitamin C, vit- amin D, vitamin E, antioxidants, minerals, salt, pre-biotics, pro-biotics, pain killers or antihistamines, Viagra, products for teeth and gum health such as anti-caries agents, acid buffering agents, tooth whiteners, desensitizers, saliva enhancers, herbals such as chamomile, tea such as green tea, thyme, oregano, ginger, turmeric, mint, appetite sup- pressors, cough suppressors, eucalyptus, relaxing agents, energizing agents, caffeine, ginseng, taurine and/or breath fresheners.
  • cannabinoid such as CBD, CBT and other oils extracted from hemp or cannabis
  • melatonin vitamin A, vitamin B, vitamin C, vit- amin D, vitamin E, antioxidants, minerals, salt, pre
  • Nicotine may advantageously be provided in a concentration of 0.1 - 5 wt% equivalent to free base nicotine, depending on the desired strength of the resulting nicotine pouch composition and pouch product in order to achieve a desired nicotine deliver ⁇ ' to the user.
  • the amount of nicotine in the pouch composition is up to or between any of 0.2, 0.5 1, 1.5, 1.6, 2, 2,5, 3, 3,5, 4, 4,5 5 wt%, such as 0.2 - 4 wt%, 0.3 - 3.5% wt%, 0, 4 - 3 wt%.
  • the nicotine may be provided in the form of free base nicotine, synthetic nicotine, nic- otine salt and/or as nicotine bound to a resin.
  • Free base nicotine refers to (S)-3-(l -Methyl -2-pyrroli-dinyl)pyri dine, (-)- 1 -Methyl -2- (3-pyridyl)pyrrolidine CAS number 54-11-5.
  • the wording synthetic nicotine may refer to (S)-3-(l -Methyl -2-pyrroli-dinyl)pyri dine derived from a chemical synthesis or a mixture of (S)-3-(l-Methyl-2-pyrroli-dinyl)pyr- idine and (R)-3-(l-Methyl-2-pyrroli-dinyl)pyridine derived from a chemical synthesis. Also referred to as R,S-nicotine. CAS Number 6912-85-2.
  • nicotine bound to a resin may refer to a plastic resin such as, but not limited to, Amberlite IRP64, Purolite Cl 15HMR or Doshion P551 mixed with free base nico- tine.
  • free nicotine salt may refer to any salt that is obtained from free base nicotine.
  • Such salts could be (but not limited to): nicotine hydrochloride, nicotine dihy- drochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nic- otine sulphate, nicotine zinc chloride monohydrate and nicotine salicylate, and mixtures thereof.
  • nicotine is provided in more than one form.
  • a combination of nicotine may be advantageous in case of polarcrilex (NICOTINE POLACRILEX 20% NP CAS No. 96055-45-7) and free base nicotine, such combinations may for example be 30 % polarcrilex and 70 % free base nicotine.
  • the polarcrilex gives a long slow release of nicotine where the free base gives a quick release for immediate nicotine craving.
  • a combination of nicotine salt and freebase nicotine can also be used to give another experience of how the nicotine is delivered through the oral mucosa.
  • a second active ingredient taken from the group comprising nic- otine, cannabinoids such as CBD, melatonin, turmeric, chamomile, and similar active ingredients that relax your body is also present.
  • cannabinoids such as CBD, melatonin, turmeric, chamomile, and similar active ingredients that relax your body
  • nicotine may advantageously be provided together with active ingredients for teeth and gum health, vitamin supplements, calming effects, oral hygiene, appetite regulating and similar.
  • nicotine may advantageously be provided together with active ingredients for providing an increased feeling of energy such as caffeine and/or other active ingredients such as cannabinoid such as CBD, CBT and other oils extracted from hemp or cannabis, melatonin, vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, antioxidants, minerals, salt, pre-biotics, pro-biotics, pain killers or antihistamines, Vi- agra, products for teeth and gum health such as anti-caries agents, acid buffering agents, tooth whiteners, desensitizers, saliva enhancers, herbals such as chamomile, tea such as green tea, thyme, oregano, ginger, turmeric, mint, appetite suppressors, cough suppres- sors, eucalyptus, relaxing agents, energizing agents, caffeine, ginseng, taurine and/or breath fresheners.
  • active ingredients for providing an increased feeling of energy such as caffeine and/or other active ingredients such as cannabinoid such as CBD, CBT and other oils
  • the concentration of at last one first active ingredient is 0,01 - 5 wt% such as or up to 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 or 5 wt% and/or wherein concentration of a second active ingredient is 0,1 - 5 wt% such as or up to 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 or 5 wt% and/or wherein the ratio between the first active ingredient and the second active ingredient is 0, 1 - 1, such as 1:10, 1 :9, 1 :8, 1 :7, 1 :6, 1 :5, 1 :4, 1 :3, 1 :2, 1 : 1.
  • the one or more sugar alcohol may be one or more of sorbitol, mannitol, xylitol, hy- drogenated starch hydrolyzates, maltitol, isomalt, erythritol, lactitol, polydextrose alone or in combination.
  • These sugarless sweeteners may be provided to add sweetness to the pouch composition, but may also be included as a humectant.
  • a first of the one or more sugar alcohols may be present in an amount of 0 - 12 wt% such as 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11 wt% and optionally a second and/or third sugar alcohol may be present in an amount of 0 -12 wt% such as 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11 wt%.
  • the pouch composition may comprise one or more intense sweet- eners in a concentration of 0.01 - 2 wt%, such as 0.05, 0.1, 0.5, 0.8, 0.9, 1 or 1.5 wt% in combination with or as an alternative to the one or more sugar alcohol.
  • the intense sweeteners may e.g. be Acesulphame potassium (950), Advantame (969), Alitame (956) Aspartame (951), Aspartame-acesulphame salt (962), Cyclamate (952), Monk fruit ex- tract Neotame (961), Saccharin (954), Steviol glycosides (960), Sucralose (955) and/or Thaumatin (957).
  • a combination of two or more sugar alcohols may be used in the pouch composition.
  • xylitol and sorbitol may be used together in order to achieve a combination of nice cooling effect from xylitol and good humectant effect from sor- bitol as well as a specific amount of sweetness may be provided to the pouch composi- tion.
  • the ratio between a first sugar alcohol and a second sugar alcohol may for example be 1:1 - 1 JOO, such as 1 :50, such as 1 :25 whereby an optimum of e.g. sweetness, cooling or humectance from one is combined with added density from another.
  • the sugar alcohols may be added to e.g. act as humectants, to help control density, to help deliver nicotine to the oral mucosa and to have an improved oral hygiene.
  • a texturizing agent may be added to give a nice smooth water full feeling. Together with humectants in the form of sugar alcohols, glycerine and similar, they keep the water content high and a nice moist piece of snuff is always available, also in hot and dry- areas.
  • salt in form of sodiumchlori de, ammoniumchloride, and/or pota- siumchloride is added in an amount of 0,05 - 18 wt%, such as or up to 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 wt%.
  • Salt can help the nicotine experience and enhance both flavors and experience of the nicotine as well as help create saliva which may optimize the nicotine delivery .
  • tobacco is present in an amount of 0 - 5 wt%, such as up to 4%, 3%, 2%, 1%, 0,5%.
  • a product with a combination of an active ingredient, such as nic- otine, with tobacco may provide a product with a reduced amount of tobacco still having a desired nicotine content. This combination may be advantageous in that the user still gets the tobacco taste, but a much lower amount of the none-healthy ingredients in to- bacco beside nicotine.
  • Tobacco may also in some embodiments be added in combination with other active ingredients mentioned herein.
  • Tobacco may be in the form tobacco rustica or tobacco nicotiana and/or a mixture of them. Depending on mixture, it can be very strong w'ith a nicotine content up to 17 % from tobacco rustica or a milder version mixed with none-tobacco products and/or to- bacco nicotiana products. Tobacco may for example be provided as whole or in partic- ulate form with a size between 0.1 - 6 mm, such as or up to 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.55mm.
  • the pouch composition comprises one or more preservatives, one or more pH regulating agents, and/or one or more flavours.
  • a flavor may in some embodiments provide aroma and/or taste.
  • the flavour may be any of but not limited to: coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, hemp, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazel- nut, almonds, pineapple, strawberry', raspberry', tropical fruits, cherries, cinnamon, pep- permint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry', apricot, raspberry', cherry', pineapple, lemongrass, lime, jala- penos, chili (capsaicin), citrus, tobacco flavorvarimixer and/or plum essence.
  • flavours may each be present in an amount of 0 - 15 wt% such as 2 - 12 wt% such as or up to 1, 2, 3, 4, 5, 6, 7 ,8, 9, 10, 11, 12, 13, 14, 15 wt%. Adding up to a total amount of 0 - 15 wt%
  • Preservatives may be selected as one or more of sorbic acid, sodium sorbate, potassium sorbate, calcium sorbate, benzoic acid, sodium benzoate, calcium benzoate, propionic acid, sodium propionate, potassium propionate, calcium propionate.
  • pH regulating agents may be selected as one or more of sodium bicarbonate, sodium carbonate, magnsisum carbonate, magnesium bicarbonate, potassium carbonate, potas- siumbicarbonate, ferrous carbonate.
  • sorbic acid sodium sorbate, potassium sorbate, calcium sorbate, benzoic acid, sodium benzoate, calcium benzoate, propionic acid, sodium propionate, potassium propionate, calcium propionate.
  • pH regulating agents may be selected as one or more of sodium bicarbonate, sodium carbonate, magnsisum carbonate, magnesium bicarbonate, potassium carbonate, potas- siumbicarbonate, ferrous carbonate.
  • sodiumcarbonate to elevate pH to more than 8 if polarcrilex or nicotinesalts are used.
  • the preservative is present in an amount of 0,01 - 2 wt%, such as or up to 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.2, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9 2 wt%
  • the pH regulating agent is present in an amount of 0,2 - 4 wt% such as or up to 0.2, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5 or wt%
  • the flavour is present in an amount of 2 - 12 wt% such as or up to 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 wt%.
  • Water may be any of e.g. tap water, ionexchanged water, reversed osmosis and/or dis- tilled water.
  • the pouch composition may further comprise one or more solvents, such as flavour solvents, such as
  • flavour solvents may comprise ethanol in combination with water in a 0,5 to 80 w%.
  • the pouch composition may also comprise one or more flavor solvents such as Propane- 1,2,3-triol, Propane- 1 ,2-diol and/or Butan- 1,3 -diol.
  • flavor solvents such as Propane- 1,2,3-triol, Propane- 1 ,2-diol and/or Butan- 1,3 -diol.
  • the nicotine solvents may also provide sweetness as well as may help balance moisture by acting as humectants.
  • the flavor solvents can be used to adjust the transporta- tion time of nicotine to the oral mucosa. This adjustment can be done by using the fact the free base nicotine has higher affinity towards none-polar solvents than polar sol- vents. If a part of the pouch such as the center or surface region contains more solvent that is less polar than water, this part will automatically have a higher percentage of nicotine, especially when the pouch is worked in the mouth.
  • the present application also relates to a pouch product comprising a pouch and a pouch composition as described herein.
  • the pouch may in some embodiments be at least partly from a water permeable mem- brane e.g. a non-woven fabric or paper.
  • the pouch comprises at least one chamber for containing the pouch composition.
  • the at least one chamber may have a length of 2 - 50 mm, such as 10 - 40mm, such as or up to 20, 25, 30, 35, 40 mm.
  • the at least one chamber When filled, the at least one chamber may have a width of 5 - 20 mm, such as or up to 7 - 15mm, such as or up to 5, 7, 10, 12, 15, 17, 20mm.
  • the at least one chamber When filled, the at least one chamber may have a thickness of 2 - 12 mm, such as or up to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 mm.
  • the present application also relates to a method for producing a pouch composition as described herein, the method comprising the steps of a) providing a dry mix comprising: i. said at least one water insoluble fibre ii. said at least one sugar alcohol iii. said at least one intense sweetener iv. Said at least one texturizing agent b) Providing a liquid mix comprising nicotine and nicotine solvent present in a ratio of 10:90 - 30:70, such as 20:80. c) Mixing the dry mix and the liquid phase to obtain a pouch composition.
  • the safety hazards of handling nicotine in higher concentrations may be avoided.
  • a ratio of 10:90 - 30:70, such as 20:80 may deliver nicotine in an appro- priate concentration while also providing the nicotine solvent which also provides ben- eficial properties to the pouch composition such as an excellent solvent for nicotine.
  • the solvent also acts as humectants that keeps the pouch moist and is much harder to evaporate than water.
  • liquid ingredients such as water and/or flavour may be added to the liquid mix in step b.
  • Water and/or flavour and/or glycerin may also or alternatively be added as a second or third liquid mix which may be added to the dry mix together with, before and/or after the mixing of the dry mix and the liquid mix comprising nicotine and nicotine solvent present in a ratio of 10:90 - 30:70, such as 20:80.
  • said at least one anti caking agent, said at least one preservative, said at least one pH adjusting agent and/or said at least one salt may be added to the dry mix in step a).
  • the water content of the pouch composition is adjusted to a final water content by adding water to the pouch containing the pouch composition e.g. by spraying, dipping and/or soaking.
  • the pouch product may be manufactured as follows.
  • the pouch composition may be provided by a process in which all dry matter is weighted off and added together to a dry mix.
  • all liquid matter may be added together and preferably mixed to obtain a liquid mix.
  • the liquid matter may be added together in a liquid mix comprising nicotine and nicotine solvent present in a ratio of 10:90 - 30:70, such as 20:80 and in a second or third liquid mix comprising e.g. water and flavor(s).
  • the liquid mix may hereafter be added to the dry mix by spraying during mixing. .After all liquid has been added to the dry mix stirring may be continued until a pouch composi- tion with an even distribution of ingredients is obtained.
  • the pouch composition may be added to storage bags, preferably under inert conditions for storage until further pro- cess steps. Alternatively, the pouch composition may directly be used in following pro- cess step. The pouch composition may then be filled into pouches with at least one chamber for the pouch composition where after the pouch is closed. If desired, further water may be sprayed unto the pouch with pouch material.
  • Each pouch with pouch composition may e.g. weigh 0,425 g before a final water addi- tion step and 0,525 g after water addition.
  • the water content in the pouch composition in the pouch product may thus be higher than in the (intermediate) pouch composition before being filled into the pouch in case the pouch composition comprises an intermediate water content and the final water con- tent is achieved in a final hydration step (water addition step).
  • compositions Fl - F7 are shown. The compositions are intended to illustrate different embodiments of the present invention and are not to be construed as limiting to the invention.
  • Compositions Fl - F7 are either the finished pouch composition in- tended to be filled in to pouches without a water addition step or pouch compositions in a pouch to which a final amount of water has been added, i.e. pouch composition with full water content.
  • Composition Fl is based on wheat fibres and free base nicotine. Texturing agent is Arabica Gum. It is a sweet product for maximum delivery' of flavor and nicotine.
  • Composition F2 is based on MCC (micro crystalline cellulose) fibres and nicotine based on freebase nicotine mixed with an ion exchange resin.
  • Texturing agent is Arabica Gum. It is a sweet product for maximum delivery of flavor and a slow release of nico- tine. The slow release of nicotine provides a beter lifetime for the product because the nicotine does not evaporate, and it gives an overall better nicotine uptake because the nicotine is slowly going to the oral mucosa. This also helps less nicotine to enter the stomach with can create stomach problems for users.
  • Composition F3 is based on sea wheat fibers and free base nicotine in VG.
  • the 20 nicotine in VG makes nicotine safer to handle and it does not so easy get oxidated by- air because it is diluted.
  • Texturizing agent is Guar Gum.
  • Guar Gum is a bit more jelly- like than Arabica Gum and creates a smooth feeling outside the pouch when used orally. It is a sweet product for maximum delivery of flavor and ni cotine.
  • Composition F4 is based on bamboo fibers and free nicotine salt.
  • Texturizing agent is Sodium Alginate in combination with a free nicotine salt. Free nicotine salts are more acidic than free base nicotine, therefor sodium carbonate is added ad pH adjusting agent. Free nicotine salts generally enter the body more through the throat than the upper oral mucosa. This is a different feeling that some users prefer when using snuff.
  • Composition F5 is based on wheat fibers and free base nicotine. Texturing agent is Agar that is known to be especially white. It is a salty product that together with ammo- niumchloride provides maximum nicotine delivery'.
  • Composition F6 is based on wheat fibers and free base nicotine. Texturing agent is Guar Gum that is known to provide a moist feeling outside on the snuff. It is a salty product that together with ammoniumchloride provides maximum nicotine delivery.
  • Composition F7 is based on wheat fibers and free base nicotine. Tobacco is added to give a tobacco flavor and because some countries insist on tobacco in the snuff. Tex- turing agent is Guar Gum that is known to provide a moist feeling outside on the snuff It is a salty product that together with ammoniumchloride provides maximum nicotine delivery.
  • compositions in table II and III are pouch compositions with a low water content i.e. pouch composition intended to be submitted to a hydration step preferably after the pouch composition has been added to a pouch.
  • Table II A salty formulation with 16mg nicotine pr 100g: Table III A sweet formulation with 20mg nicotine pr 100g:

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  • General Chemical & Material Sciences (AREA)
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Abstract

The present relates to a pouch composition comprising at least one water insoluble fibre, at least one sugar alcohol in a total amount of 0 - 22 wt%, one or more intense sweeteners in a total amount of 0 - 8%, water in an amount of 12 - 50 wt%, nicotine and a nicotine solvent in form of a hygroscopic sweet substance capable of dissolving nicotine, wherein the nicotine and nicotine solvent are present in a ratio of 10:90 - 30:70 and a pouch product comprising the pouch composition.

Description

Pouch composition with specific nicotine to solvent ratio
Field of the Invention
This invention relates to a pouch composition, a pouch product comprising said pouch composition in a pouch and methods of manufacturing said pouch composition and pouch product.
Background of the Invention
Nicotine consumption by smoking has traditionally been the main method of nicotine delivery. However, due to the many health related problems, smoking as a method of nicotine delivery is being challenged by several alternative systems for nicotine deliv- ery.
One range of products developed as smoking alternatives are oral delivery products in the form of pouch products containing pouch compositions containing nicotine, also known as snus. These pouch products may vary in type and composition depending on e.g. market of sale and local preferences or regulations.
Most snus pouch products contain relatively many ingredients and due to the increased interest in the products, product specialization and optimization is of great interest.
The pouch product is used by placing the pouch in the mouth, preferably between gum and upper lip, where it is left for a desired amount of time delivering nicotine. Nicotine is absorbed by the mucous in the mouth. Object of the Invention
In a first object of the invention, a pouch product and a pouch composition are provided which in use enable optimized transferal of an active ingredient via the mucous mem- brane.
In a second object of the invention, a pouch product and a pouch composition are pro- vided which in use result in reduced irritation of gums and/or mucous membrane.
In a third object of the invention, a pouch product and a pouch composition are provided which in use have an improved feel for the user.
Description of the Invention
These and other advantages are achieved by a pouch composition comprising at least one water insoluble fibre, at least one sugar alcohol in a total amount of 0 - 12 wt%, one or more intense sweeteners in a total amount of 0 - 8%, water in an amount of 8 - 50 wt%, nicotine and a nicotine solvent in form of a hygroscopic sweet substance capable of dissolving nicotine, wherein the nicotine and nicotine solvent are present in a ratio of 10:90 - 30:70, such as 20:80.
Unless otherwise indicated wt% refers to the weight percentage of all ingredients in the pouch composition with full water content but without pouch.
The water content may be 8 - 50 wt.%, such as or up to 20, 25, 30, 35, 40, 45, 48 or 50 wt%.
Preferably, the nicotine solvent is Propane- 1,2, 3 -tri ol, Propane- 1, 2-diol and/or Butan- 1,3 -diol as these nicotine solvents may provide sweetness as well as may help balance moisture.
The solvents Propane-1, 2, 3-triol, Propane- 1, 2-diol and/or Butan- 1,3 -diol are all known solvents for use in dilution of flavors and other strong ingredients. They are in general tasteless and have a little sweetness from the OH groups. They are fully mixable with water in the range 0 to 100 %, but also mixable with other things like nicotine and many flavors. When the nicotine: solvent ratio is 10:90 - 30:70, such as 20:80, an advanta- geous mix may be achieved.
VG, glycerin is defined as Propane-1, 2, 3-triol, PG is defined as Propane- 1,2-diol
Snus, snuff is defined as none water soluble botanical fibers in a none water soluble saliva permeable bag with ingredients such as nicotine, flavors, pH regulating agents, anticaking agents, preservatives, texturizing agents and sugar alcohols
In various embodiments, the insoluble fibre is one or more of botanical fibers for exam- ple fibers from wheat, oat, buckwheat, potatoes, bamboo, cellulose, apple, cacao, beets, sugar beets, wood, seaweed, barley, rye, com, tomato and any combination hereof. De- pending on the capability to contain moisture and oily liquids, the one or more fibers may be chosen to provide the right water content ranging from very' dry products to very' moist products. Furthermore, the fibers in their capacity of being a water insoluble in- gredient may continue to provide volume to the pouch product during use as they are not dissolved and released by saliva. The majority of the other ingredients present may- be water soluble, whereby they may be dissolved by saliva and released from the pouch composition through the pouch and provide taste, aroma and/or effect of the active in- gredient to the user.
In some embodiments, at least one of the one or more water insoluble fibers may fibers that can contain from 150 to 1000 w% of water and are approved for usage in food and/or pharma. Such as or up to 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 650%, 700%, 750%, 800%, 850%, 900%, 950%, 1000%, 200 - 800%, 200 - 600% w% water.
In some embodiments, the fibers are selected to have a length of 10 - 300pm, such as 20 - 200 pm, such as 25 - 100 pm, such as 30 - 75 pm, such as 25 - 50 pm.
A high content of fibers may provide a product with a dry feel to the user. A dry product may for some users have an undesirable feel and may also result in a reduced impact of the active ingredient as the saliva used to transfer ingredients through the mucous mem- brane may be absorbed by the fibers. However, texturizing agents may be provided in an amount to balance the dryness of the fibers and provide a desired feeling of moisture and softness to the product.
In some embodiments, the pouch composition may comprise one or more texturizing agents, for example one or more of agar, guar gum, alginate salts and/or arabica gum which may act as a gelling agent when absorbing water or other liquids. In some em- bodiments, the texturizing agent is present in an amount of 0.1 - 5 wt%, e.g. in an amount of or up to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 wt%.
By choosing an optimized combination of nicotine solvent, fibers and water together with a texturizing agent a pouch composition is achieved which has a texture with a desired sensation of moisture and firmness for the user.
The active ingredient may be chosen to provide a desired effect to the pouch product and pouch composition . Preferably nicotine may be present to provide a nicotine deliv- ery product whereby an alternative to products providing nicotine by smoking is achieved.
The at least one active ingredient may be present in a concentration of 0.01 - 20% de- pending on type and intended effect.
Other active ingredients may be added alternatively or in combination with nicotine.
Active ingredients may be nicotine, Caffeine, cannabinoid such as CBD, CBT and other oils extracted from hemp or cannabis, melatonin, vitamin A, vitamin B, vitamin C, vit- amin D, vitamin E, antioxidants, minerals, salt, pre-biotics, pro-biotics, pain killers or antihistamines, Viagra, products for teeth and gum health such as anti-caries agents, acid buffering agents, tooth whiteners, desensitizers, saliva enhancers, herbals such as chamomile, tea such as green tea, thyme, oregano, ginger, turmeric, mint, appetite sup- pressors, cough suppressors, eucalyptus, relaxing agents, energizing agents, caffeine, ginseng, taurine and/or breath fresheners.
Nicotine may advantageously be provided in a concentration of 0.1 - 5 wt% equivalent to free base nicotine, depending on the desired strength of the resulting nicotine pouch composition and pouch product in order to achieve a desired nicotine deliver}' to the user. Preferably, the amount of nicotine in the pouch composition is up to or between any of 0.2, 0.5 1, 1.5, 1.6, 2, 2,5, 3, 3,5, 4, 4,5 5 wt%, such as 0.2 - 4 wt%, 0.3 - 3.5% wt%, 0, 4 - 3 wt%.
The nicotine may be provided in the form of free base nicotine, synthetic nicotine, nic- otine salt and/or as nicotine bound to a resin.
Free base nicotine refers to (S)-3-(l -Methyl -2-pyrroli-dinyl)pyri dine, (-)- 1 -Methyl -2- (3-pyridyl)pyrrolidine CAS number 54-11-5.
The wording synthetic nicotine may refer to (S)-3-(l -Methyl -2-pyrroli-dinyl)pyri dine derived from a chemical synthesis or a mixture of (S)-3-(l-Methyl-2-pyrroli-dinyl)pyr- idine and (R)-3-(l-Methyl-2-pyrroli-dinyl)pyridine derived from a chemical synthesis. Also referred to as R,S-nicotine. CAS Number 6912-85-2.
The wording nicotine bound to a resin may refer to a plastic resin such as, but not limited to, Amberlite IRP64, Purolite Cl 15HMR or Doshion P551 mixed with free base nico- tine.
The wording free nicotine salt may refer to any salt that is obtained from free base nicotine. Such salts could be (but not limited to): nicotine hydrochloride, nicotine dihy- drochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nic- otine sulphate, nicotine zinc chloride monohydrate and nicotine salicylate, and mixtures thereof.
In some embodiments, nicotine is provided in more than one form. A combination of nicotine may be advantageous in case of polarcrilex (NICOTINE POLACRILEX 20% NP CAS No. 96055-45-7) and free base nicotine, such combinations may for example be 30 % polarcrilex and 70 % free base nicotine. The polarcrilex gives a long slow release of nicotine where the free base gives a quick release for immediate nicotine craving. A combination of nicotine salt and freebase nicotine can also be used to give another experience of how the nicotine is delivered through the oral mucosa. In some embodiments, a second active ingredient taken from the group comprising nic- otine, cannabinoids such as CBD, melatonin, turmeric, chamomile, and similar active ingredients that relax your body is also present. By choosing a combination of active ingredients special targeted and/or synergistic effects may be achieved.
For example, nicotine may advantageously be provided together with active ingredients for teeth and gum health, vitamin supplements, calming effects, oral hygiene, appetite regulating and similar.
In some embodiments, nicotine may advantageously be provided together with active ingredients for providing an increased feeling of energy such as caffeine and/or other active ingredients such as cannabinoid such as CBD, CBT and other oils extracted from hemp or cannabis, melatonin, vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, antioxidants, minerals, salt, pre-biotics, pro-biotics, pain killers or antihistamines, Vi- agra, products for teeth and gum health such as anti-caries agents, acid buffering agents, tooth whiteners, desensitizers, saliva enhancers, herbals such as chamomile, tea such as green tea, thyme, oregano, ginger, turmeric, mint, appetite suppressors, cough suppres- sors, eucalyptus, relaxing agents, energizing agents, caffeine, ginseng, taurine and/or breath fresheners.
In some embodiments, the concentration of at last one first active ingredient is 0,01 - 5 wt% such as or up to 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 or 5 wt% and/or wherein concentration of a second active ingredient is 0,1 - 5 wt% such as or up to 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 or 5 wt% and/or wherein the ratio between the first active ingredient and the second active ingredient is 0, 1 - 1, such as 1:10, 1 :9, 1 :8, 1 :7, 1 :6, 1 :5, 1 :4, 1 :3, 1 :2, 1 : 1.
The one or more sugar alcohol may be one or more of sorbitol, mannitol, xylitol, hy- drogenated starch hydrolyzates, maltitol, isomalt, erythritol, lactitol, polydextrose alone or in combination. These sugarless sweeteners may be provided to add sweetness to the pouch composition, but may also be included as a humectant.
For example, a first of the one or more sugar alcohols may be present in an amount of 0 - 12 wt% such as 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11 wt% and optionally a second and/or third sugar alcohol may be present in an amount of 0 -12 wt% such as 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11 wt%.
In some embodiments, the pouch composition may comprise one or more intense sweet- eners in a concentration of 0.01 - 2 wt%, such as 0.05, 0.1, 0.5, 0.8, 0.9, 1 or 1.5 wt% in combination with or as an alternative to the one or more sugar alcohol. The intense sweeteners may e.g. be Acesulphame potassium (950), Advantame (969), Alitame (956) Aspartame (951), Aspartame-acesulphame salt (962), Cyclamate (952), Monk fruit ex- tract Neotame (961), Saccharin (954), Steviol glycosides (960), Sucralose (955) and/or Thaumatin (957).
In some cases, a combination of two or more sugar alcohols may be used in the pouch composition. For example xylitol and sorbitol may be used together in order to achieve a combination of nice cooling effect from xylitol and good humectant effect from sor- bitol as well as a specific amount of sweetness may be provided to the pouch composi- tion.
The ratio between a first sugar alcohol and a second sugar alcohol may for example be 1:1 - 1 JOO, such as 1 :50, such as 1 :25 whereby an optimum of e.g. sweetness, cooling or humectance from one is combined with added density from another.
The sugar alcohols may be added to e.g. act as humectants, to help control density, to help deliver nicotine to the oral mucosa and to have an improved oral hygiene.
By balancing fibres, texturizing agents and sugar alcohols, it is possible to control at least feel and moisture of pouch composition and pouch product. The combination of fibers that can bind significant amounts of water may result in a dry product. Therefore, a texturizing agent may be added to give a nice smooth water full feeling. Together with humectants in the form of sugar alcohols, glycerine and similar, they keep the water content high and a nice moist piece of snuff is always available, also in hot and dry- areas.
In some embodiments, salt in form of sodiumchlori de, ammoniumchloride, and/or pota- siumchloride is added in an amount of 0,05 - 18 wt%, such as or up to 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 wt%. Salt can help the nicotine experience and enhance both flavors and experience of the nicotine as well as help create saliva which may optimize the nicotine delivery .
In some embodiments tobacco is present in an amount of 0 - 5 wt%, such as up to 4%, 3%, 2%, 1%, 0,5%. A product with a combination of an active ingredient, such as nic- otine, with tobacco may provide a product with a reduced amount of tobacco still having a desired nicotine content. This combination may be advantageous in that the user still gets the tobacco taste, but a much lower amount of the none-healthy ingredients in to- bacco beside nicotine.
Tobacco may also in some embodiments be added in combination with other active ingredients mentioned herein.
Tobacco may be in the form tobacco rustica or tobacco nicotiana and/or a mixture of them. Depending on mixture, it can be very strong w'ith a nicotine content up to 17 % from tobacco rustica or a milder version mixed with none-tobacco products and/or to- bacco nicotiana products. Tobacco may for example be provided as whole or in partic- ulate form with a size between 0.1 - 6 mm, such as or up to 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.55mm.
In various embodiments, the pouch composition comprises one or more preservatives, one or more pH regulating agents, and/or one or more flavours.
A flavor may in some embodiments provide aroma and/or taste. The flavour may be any of but not limited to: coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, hemp, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazel- nut, almonds, pineapple, strawberry', raspberry', tropical fruits, cherries, cinnamon, pep- permint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry', apricot, raspberry', cherry', pineapple, lemongrass, lime, jala- penos, chili (capsaicin), citrus, tobacco flavorvarimixer and/or plum essence. Also, or alternatively included may be essential oils including peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above. The one or more flavours may each be present in an amount of 0 - 15 wt% such as 2 - 12 wt% such as or up to 1, 2, 3, 4, 5, 6, 7 ,8, 9, 10, 11, 12, 13, 14, 15 wt%. Adding up to a total amount of 0 - 15 wt%
Preservatives may be selected as one or more of sorbic acid, sodium sorbate, potassium sorbate, calcium sorbate, benzoic acid, sodium benzoate, calcium benzoate, propionic acid, sodium propionate, potassium propionate, calcium propionate. Depending on pre- servative content of the product, possibly together with the desired storage conditions, complete protection against fungus and other microbiogical growth may be achieved. pH regulating agents may be selected as one or more of sodium bicarbonate, sodium carbonate, magnsisum carbonate, magnesium bicarbonate, potassium carbonate, potas- siumbicarbonate, ferrous carbonate. Depending on the nicotine type and other ingredi- ents with acidic / caustic properties. E.g. sodiumcarbonate to elevate pH to more than 8 if polarcrilex or nicotinesalts are used. Sodiumbicarbonate to elevate pH to between 8 and 9 when free base nicotine is used, because of its caustic properties. pH Control is important. If pH is too low there will be a poor nicotine delivery through the oral mu- cosa, and if it is too high, the oral mucosa will be damaged by long term use.
Preferably, the preservative is present in an amount of 0,01 - 2 wt%, such as or up to 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.2, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9 2 wt%, the pH regulating agent is present in an amount of 0,2 - 4 wt% such as or up to 0.2, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5 or wt%, and/or the flavour is present in an amount of 2 - 12 wt% such as or up to 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 wt%.
Water may be any of e.g. tap water, ionexchanged water, reversed osmosis and/or dis- tilled water.
The pouch composition may further comprise one or more solvents, such as flavour solvents, such as
Figure imgf000010_0001
Figure imgf000011_0001
Further flavour solvents may comprise ethanol in combination with water in a 0,5 to 80 w%.
The pouch composition may also comprise one or more flavor solvents such as Propane- 1,2,3-triol, Propane- 1 ,2-diol and/or Butan- 1,3 -diol.
The nicotine solvents may also provide sweetness as well as may help balance moisture by acting as humectants. Also, the flavor solvents can be used to adjust the transporta- tion time of nicotine to the oral mucosa. This adjustment can be done by using the fact the free base nicotine has higher affinity towards none-polar solvents than polar sol- vents. If a part of the pouch such as the center or surface region contains more solvent that is less polar than water, this part will automatically have a higher percentage of nicotine, especially when the pouch is worked in the mouth.
The present application also relates to a pouch product comprising a pouch and a pouch composition as described herein.
The pouch may in some embodiments be at least partly from a water permeable mem- brane e.g. a non-woven fabric or paper.
In some embodiments, the pouch comprises at least one chamber for containing the pouch composition. When filled, the at least one chamber may have a length of 2 - 50 mm, such as 10 - 40mm, such as or up to 20, 25, 30, 35, 40 mm.
When filled, the at least one chamber may have a width of 5 - 20 mm, such as or up to 7 - 15mm, such as or up to 5, 7, 10, 12, 15, 17, 20mm.
When filled, the at least one chamber may have a thickness of 2 - 12 mm, such as or up to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 mm.
The present application also relates to a method for producing a pouch composition as described herein, the method comprising the steps of a) providing a dry mix comprising: i. said at least one water insoluble fibre ii. said at least one sugar alcohol iii. said at least one intense sweetener iv. Said at least one texturizing agent b) Providing a liquid mix comprising nicotine and nicotine solvent present in a ratio of 10:90 - 30:70, such as 20:80. c) Mixing the dry mix and the liquid phase to obtain a pouch composition.
When the nicotine is added in a nicotine solvent in a ratio of 10:90 - 30:70, such as 20:80, the safety hazards of handling nicotine in higher concentrations may be avoided.
Furthermore, a ratio of 10:90 - 30:70, such as 20:80, may deliver nicotine in an appro- priate concentration while also providing the nicotine solvent which also provides ben- eficial properties to the pouch composition such as an excellent solvent for nicotine. The solvent also acts as humectants that keeps the pouch moist and is much harder to evaporate than water.
If desired, other liquid ingredients such as water and/or flavour may be added to the liquid mix in step b. Water and/or flavour and/or glycerin may also or alternatively be added as a second or third liquid mix which may be added to the dry mix together with, before and/or after the mixing of the dry mix and the liquid mix comprising nicotine and nicotine solvent present in a ratio of 10:90 - 30:70, such as 20:80.
In some embodiments, said at least one anti caking agent, said at least one preservative, said at least one pH adjusting agent and/or said at least one salt (sodiumchloride, am- moniumchloride and similar) may be added to the dry mix in step a).
In some embodiments the water content of the pouch composition is adjusted to a final water content by adding water to the pouch containing the pouch composition e.g. by spraying, dipping and/or soaking.
The pouch product may be manufactured as follows. The pouch composition may be provided by a process in which all dry matter is weighted off and added together to a dry mix. Similarly, all liquid matter may be added together and preferably mixed to obtain a liquid mix. Alternatively, the liquid matter may be added together in a liquid mix comprising nicotine and nicotine solvent present in a ratio of 10:90 - 30:70, such as 20:80 and in a second or third liquid mix comprising e.g. water and flavor(s). The liquid mix may hereafter be added to the dry mix by spraying during mixing. .After all liquid has been added to the dry mix stirring may be continued until a pouch composi- tion with an even distribution of ingredients is obtained. The pouch composition may be added to storage bags, preferably under inert conditions for storage until further pro- cess steps. Alternatively, the pouch composition may directly be used in following pro- cess step. The pouch composition may then be filled into pouches with at least one chamber for the pouch composition where after the pouch is closed. If desired, further water may be sprayed unto the pouch with pouch material.
Each pouch with pouch composition may e.g. weigh 0,425 g before a final water addi- tion step and 0,525 g after water addition.
The water content in the pouch composition in the pouch product may thus be higher than in the (intermediate) pouch composition before being filled into the pouch in case the pouch composition comprises an intermediate water content and the final water con- tent is achieved in a final hydration step (water addition step). Detailed Description of the Invention via examples
In table I compositions Fl - F7 are shown. The compositions are intended to illustrate different embodiments of the present invention and are not to be construed as limiting to the invention. Compositions Fl - F7 are either the finished pouch composition in- tended to be filled in to pouches without a water addition step or pouch compositions in a pouch to which a final amount of water has been added, i.e. pouch composition with full water content.
Fl : Composition Fl is based on wheat fibres and free base nicotine. Texturing agent is Arabica Gum. It is a sweet product for maximum delivery' of flavor and nicotine.
F2: Composition F2 is based on MCC (micro crystalline cellulose) fibres and nicotine based on freebase nicotine mixed with an ion exchange resin. Texturing agent is Arabica Gum. It is a sweet product for maximum delivery of flavor and a slow release of nico- tine. The slow release of nicotine provides a beter lifetime for the product because the nicotine does not evaporate, and it gives an overall better nicotine uptake because the nicotine is slowly going to the oral mucosa. This also helps less nicotine to enter the stomach with can create stomach problems for users.
F3: Composition F3 is based on sea wheat fibers and free base nicotine in VG. The 20 nicotine in VG makes nicotine safer to handle and it does not so easy get oxidated by- air because it is diluted. Texturizing agent is Guar Gum. Guar Gum is a bit more jelly- like than Arabica Gum and creates a smooth feeling outside the pouch when used orally. It is a sweet product for maximum delivery of flavor and ni cotine.
F4: Composition F4 is based on bamboo fibers and free nicotine salt. Texturizing agent is Sodium Alginate in combination with a free nicotine salt. Free nicotine salts are more acidic than free base nicotine, therefor sodium carbonate is added ad pH adjusting agent. Free nicotine salts generally enter the body more through the throat than the upper oral mucosa. This is a different feeling that some users prefer when using snuff.
F5: Composition F5 is based on wheat fibers and free base nicotine. Texturing agent is Agar that is known to be especially white. It is a salty product that together with ammo- niumchloride provides maximum nicotine delivery'. F6: Composition F6 is based on wheat fibers and free base nicotine. Texturing agent is Guar Gum that is known to provide a moist feeling outside on the snuff. It is a salty product that together with ammoniumchloride provides maximum nicotine delivery.
F7: Composition F7 is based on wheat fibers and free base nicotine. Tobacco is added to give a tobacco flavor and because some countries insist on tobacco in the snuff. Tex- turing agent is Guar Gum that is known to provide a moist feeling outside on the snuff It is a salty product that together with ammoniumchloride provides maximum nicotine delivery.
Table I
Figure imgf000016_0001
In table II and III, a salty (table II) and a sweet composition (table III) are shown. The compositions are intended to illustrate different embodiments of the present invention and are not to be constmed as limiting to the invention. The compositions in II and III are pouch compositions with a low water content i.e. pouch composition intended to be submitted to a hydration step preferably after the pouch composition has been added to a pouch.
Table II A salty formulation with 16mg nicotine pr 100g:
Figure imgf000017_0001
Table III A sweet formulation with 20mg nicotine pr 100g:
Figure imgf000018_0001

Claims

1. A pouch composition comprising at least one water insoluble fibre, at least one sugar alcohol in a total amount of 0 - 22 wt%, one or more intense sweeteners in a total amount of 0 - 8%, water in an amount of 12 - 50 wt%, nicotine and a nicotine solvent in form of a hygroscopic sweet substance capable of dissolving nicotine, wherein the nicotine and nicotine solvent is present in a ratio of 10:90 - 30:70.
2. The pouch composition according to any of the preceding claims, wherein the con- centration of nicotine equivalent to free base nicotine in the pouch composition is 0,2 - 5 wt%.
3. The pouch composition according to any of the preceding claims, wherein the nico- tine solvent is Propane- 1,2, 3 -tri ol, Propane- 1,2-diol and/or Butan- 1,3 -diol.
4. The pouch composition according to any of the preceding claims, wherein the insol- uble fibre is one or more of wheat, oat, buckwheat, potatoes, bamboo, cellulose, apple, cacao, beets, sugar beets, wood, seaweed, barley, rye, corn, tomato and any combination hereof.
5. The pouch composition according to any of the preceding claims, comprising at last one further active ingredient, wherein the further active ingredient is at least one of caffeine, cannabinoid such as CBD, CBT and other oils extracted from hemp or canna- bis, melatonin, vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, antioxidants, minerals, salt, pre-biotics, pro-biotics, pain killers or antihistamines, Viagra, products for teeth and gum health such as anti-caries agents, acid buffering agents, tooth whiten- ers, desensitizers, saliva enhancers, herbals such as chamomile, tea such as green tea, thyme, oregano, ginger, turmeric, mint, appetite suppressors, cough suppressors, euca- lyptus, relaxing agents, energizing agents, caffeine, ginseng, taurine and/or breath fresh- eners.
6. The pouch composition according to any of the preceding claims, wherein the one or more sugar alcohol is one or more of sorbitol, erythritol, isomalt, lactitol, maltitol, man- nitol, sorbitol, xylitol, and hydrogenated starch.
7. The pouch composition according to any of the preceding claims, wherein the one or more intense sweetener such as sucralose is present in an amount of 0 - 2.5 wi/’ o and/or one or more sugar alcohols in the form of xylitol present in an amount of 0-12 wt%, erythritol 0 - 12 present in an amount of sorbitol 0 — 12 wt% and/or isomalt present in an amount of 0 - 12 wt%.
8. The pouch composition according to any of the preceding claims, comprising tobacco in an amount of 0 - 12 wt%.
9. The pouch composition according to any of the preceding claims, comprising one or more salts, a texturing agent, a preservative, a pH regulating agent, and/or a flavour.
10. The pouch composition according to any of the preceding claims, wherein the tex- turing agent is present in an amount of 0.1 - 5 wt%, the preservative is present in an amount of 0,01 - 3 wt%, the pH regulating agent is present in an amount of 0,1 - 5 wt%, and/or the flavour is present in an amount of 0,5 - 12 wt%.
11. The pouch composition according to any of the preceding claims comprising at least one water insoluble fibre, at least one sugar alcohol in a total amount of 1 - 10 wt%, one or more intense sweeteners in a total amount of 0.1 - 2%, water in an amount of 12 - 50 wt%, nicotine and nicotine solvent in form of a hygroscopic sweet substance capable of dissolving nicotine, wherein the nicotine and nicotine solvent is present in a ratio of 10:90 - 30:70, further comprising the texturing agent in an amount of 0.1 - 5 wt%, the preservative in an amount of 0,01 - 3 wt%, the pH regulating agent in an amount of 0, 1 - 5 wt%, and the flavour in an amount of 0,5 - 12 wt %.
12. A pouch product comprising a pouch and a pouch composition according to any of the claims 1 - 11.
13. A method for producing a pouch product according to claim 12, comprising the steps of a) providing a dry mix comprising: i. said one or more water insoluble fibre ii. said one or more sugar alcohol iii. said one or more intense sweetener iv. optionally, one or more salts such as sodium chloride and/or ammoni- umchloride b) Providing a liquid mix comprising nicotine and nicotine solvent present in a ratio of 10:90 - 30:70, such as 20:80. c) Mixing the dry' mix and the liquid mix to obtain a pouch composition
14. The method according to claim 13 wherein v. one or more texturizing agent vi. one or more anti caking agent vii. one or more pH adjusting agent and/or viii. one or more preservative, is added in step a).
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