DK202270040A1

DK202270040A1 - Method for producing a pouch composition

Info

Publication number: DK202270040A1
Application number: DKPA202270040A
Authority: DK
Inventors: Boje Peter
Original assignee: Mac Baren Tobacco Company As
Priority date: 2022-01-28
Filing date: 2022-01-28
Publication date: 2023-11-03
Also published as: DK181550B1; WO2023143689A1

Abstract

A method for producing a pouch composition, said pouch composition comprising at least one water insoluble fibre, nicotine, 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 wt% water in an amount of 8 – 48 wt%, wherein the method comprises the steps of i. Providing a dry mixture comprising - one or more of said at least one water insoluble fibres - one or more of said at least one sugar alcohol - one or more texturizing agents - optionally one anti caking agent - optionally one pH adjusting agent - optionally one preservative - optionally one salt ii. Providing a liquid mixture comprising water, nicotine and flavour iii. Mixing the liquid mixture and the dry mixture to obtain a pouch composition.

Description

DK 2022 70040 A1 1

Field of the Invention

This invention relates to a pouch composition, a pouch product comprising said pouch composition in a pouch and a method of manufacturing said pouch composition.

Background of the Invention

Nicotine consumption by smoking has traditionally been the man method of nicotine delivery. However, due to the many health related problems smoking as a method of nicotine delivery is being challenge by several alternative systems for nicotine deliv- ery.

One range of products developed as smoking alternatives are oral delivery products in 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 in- creased 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. Nico- tine is absorbed by the mucous in the mouth.

DK 2022 70040 A1 2

Object of the Invention

In a first object of the invention a method for producing a pouch composition, a pouch product and a pouch composition is provided which in use enables optimize transferal of an active ingredient via the mucous membrane.

Description of the Invention

These and other advantages are achieved by a method for producing a pouch composi- tion, said pouch composition comprising one or more sugar alcohols in a total amount of 0 — 22 wt%, one or more intense sweeteners in a total amount of 0 — 5 wt%, water in an amount of 8 — 51 wt%, at least one texturizing agent in a total amount of 0,3 — 5 wt%, at least one water insoluble fibre, nicotine, wherein the method comprises the steps of i. Providing a dry mixture comprising - one or more of said water insoluble fibres - one or more of said sugar alcohol - one or more of said intense sweeteners - one or more texturizing agents ii. Providing a liquid mixture comprising water iil. Mixing the liquid mixture and the dry mixture, and wherein the liquid mixture further comprises nicotine and one or more flavours.

When nicotine, water and flavour is mixed in a liquid mixture which is followingly mixed with the dry mix an even distribution of flavour, water and nicotine in the dry mix is achieved, thereby avoiding that flavour and nicotine isn’t distributed in a simi- lar manner throughout the obtained pouch composition. This is especially important as flavours at least partly may be added to mask the taste of nicotine.

DK 2022 70040 A1 3

Thus, an advantage of the pouch product provided by the present method is that the flavor is evenly distributed evenly throughout the entire fibre so the user will have a present taste of flavor during the whole period of usage of a pouch containing the pouch product.

Similar advantages may be achieved when there is added an active ingredient, such as nicotine alone or in combination with any other active ingredients mentioned herein.

This active ingredient may have a release through a longer period which is an ad- vantage for active ingredients that has a bad taste or that needs to be delivered more slowly due to the effect of the active ingredient.

An advantage of adding nicotine, water and flavour in a combined liquid mixtureis that the active ingredient may permanently be masked by the flavor because there is simultaneous release of the flavor and the active ingredient that is evenly distributed throughout the particle.

In some embodiments not all water is provided in step ii in which case additional wa- ter is added in an optional subsequent step in order to provide a pouch composition with full water content.

Unless otherwise indicated wt% refers to the weight percentage of all ingredients in the pouch composition with final water content (after all water has been added to the pouch composition) but without pouch.

In various embodiments the insoluble fibre is one or more bothanical fibers for exam- ple fibers from wheat, oat, buckwheat, potatoes, bamboo, cellulose, apple, cacao, beats, sugar beats, wood, seaweed, barley, rye, corn, tomato and any combination hereof. Depending on 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 prod- ucts to very moist products. Furthermore, the fibers in their capacity of being a water insoluble ingredient 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

DK 2022 70040 A1 4 from the pouch composition through the pouch and provide taste, aroma and/or effect of the active ingredient 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%.

Water may for example be present in a contraction of 8 — 55 wt%, such as 10, 20, 25, 30, 35, 40, 45, 48, 50 wt%.

In some embodiments the fibers are selected to have a length of 10 — 300um, such as 20 - 200 um, such as 25 - 100 um, such as 30 - 75 um.

A high content of fibers may provide a product with a dry feel to the user. A dry prod- uct may for some users have an undesirable feel and may also result in a reduced im- pact of the active ingredient as the saliva used to transfer 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 mois- ture 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%.

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 de- livery product whereby an alternative to products providing nicotine by smoking is achieved.

DK 2022 70040 A1

Nicotine may be added to the liquid phase and/or in step b) and/or g) as dissolved in a nicotine solvent such as Propane-1,2,3-triol, Propane-1,2-diol and/or Butan-1,3-diol as these nicotine solvents may provide sweetness as well as may help balance moisture. 5 The solvents Propane-1,2,3-triol, Propane-1,2-diol and/or Butan-1,3-diol are all know solvent 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.

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. T

The at least one active ingredient may be present in a concentration of 0.01 — 20% depending of type and intended effect.

One or more active ingredients may be present. For example other active ingredients may be added 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, vitamin D, vitamin E, antioxidants, minerals, salt, pre-biotics, pro-biotics, pain kill- ers 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, ap- petite suppressors, 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% equiva- lent to free bae nicotine. Depending on the desired strength of the resulting nicotine pouch composition and pouch product in order to achieve a desired nicotine delivery to the user. Preferably the amount of nicotine in the pouch composition is up to or

DK 2022 70040 A1 6 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, nicotine salt and/or as nicotine bound to a resin.

Free base nicotine refers to (S)-3-(1-Methyl-2-pyrroli-dinyl)pyridine, (—)-1-Methyl-2- (3-pyridyl)pyrrolidine CAS number 54-11-5

The wording synthetic nicotine may refer to (S)-3-(1-Methyl-2-pyrroli-dinyl)pyridine derived from a chemical synthesis or a mixture of (S)-3-(1-Methyl-2-pyrroli- dinyl)pyridine and (R)-3-(1-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 lim- ited to Amberlite IRP64, Purolite C115HMR or Doshion P551 mixed with free base nicotine.

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 di- hydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate and nicotine salicylate, and mixtures thereof.

In some embodiments nicotine is provided in more the 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 ex- ample 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 nico- tine craving. A combination of nicotine salt and freebase nitocine can also be used to give another experience of how the nicotine is deliveret throught the oral mucosa.

In some embodiments a second active ingredient taken from the group comprising nicotine, cannabinoids such as CBD, melatonin, turmic, chamomile, and similar active

DK 2022 70040 A1 7 ingredients that relaxes 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 ingredi- ents 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 can- nabinoid such as CBD, CBT and other oils extracted from hemp or cannabis, melato- nin, 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 whiteners, de- sensitizers, saliva enhancers, herbals such as chamomile, tea such as green tea, thyme, oregano, ginger, turmeric, mint, appetite suppressors, cough suppressors, eucalyptus, relaxing agents, energizing agents, caffeine, ginseng, taurine and/or breath fresheners.

In some embodiments the concentration of the 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 the 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 ration between the first active ingredient and the second active ingredient is 0,1 — 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 at 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 or up to 0.1, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 1lor 12 wt% and optionally a second and/or third sugar alcohol may be present in an amount of 0 -12 wt%.

DK 2022 70040 A1 8

In some embodiment the pouch composition may comprise intense sweeteners in a concentration of 0.01 — 5 wt%, such as or up to 0.05, 0.1, 0.5, 1, 1.5, 2 or 2.5 wt% combination with or as an alternative to the one or more sugar alcohol. The intense sweetners may e.g. be Acesulphame potassium, (950) Advantame (969), Alitame (956), Aspartame (951), Aspartame-acesulphame salt (962), Cyclamate (952), Monk fruit extract 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 sorbitol as well as a specific amount of sweetness may be provided to the pouch composition.

The ratio between a first sugar alcohol and a second sugar alcohol may for example be 1:1 —1:100, such as 1:50, such as 1:25 whereby an optimum of e.g. sweetness, cool- ing 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 fibers, 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 a lot of water may result in a dry product. Therefor a texturizing agent may be added to give a nice smooth water full feeling. Together with humec- tants in the form of sugar alcohols, glycerine and similar they keeps the water content high and a nice moist piece of snuff is all ways available also in hot and dry areas.

In some embodiments salt in form of sodiumchloride, ammoniumchloride, and/or potasiumchloride 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% in order to salt can help the nicotine experience and enhance both flavors and experience of the nicotine as well as it helps create saliver which is good for the nicotine delivery.

DK 2022 70040 A1 9

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 nicotine, 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 healty ingredi- ents in tobacco 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 with a nicotine content up to 17 % from tobacco rustica or a more mild version mixed with none tobacco products and/or tobacco nicotiana products. Tobacco may for example be provided as whole or in par- ticulate 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 limite to: coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, hemp, menthol, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, lemongrass, lime, jalapenos, chili (capsaicin), citrus, tobacco flavorvarimixer and/or plum essence. Also or alternatively included may be essential oils including pepper- mint, 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%

DK 2022 70040 A1 10

Preservatives may be selected as one or more of sorbic acid, sodium sorbate, potassi- um sorbate, calcium sorbate, benzoic acid, sodium benzoate, calcium benzoate, propi- onic acid, sodium propionate, potassium propionate, calcium propionate. Depending on preservative content of the product possibly together with the desired storage con- ditions complete protection against fungus and other microbiogical growth may be acheived. pH regulating agents may be selected as one or more of sodium bicarbonate, sodium carbonate, magnsisum carbonate, magnesium bicarbonate, potassium carbonate, po- tassiumbicarbonate, ferrous carbonate. Depending on the nicotine type and other in- gredients 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 be- tween 8 and 9 when free base nicotine is used, because of its caustic properties. pH

Control is important. If pH is to low there will be a poor nicotine delivery throught the oral mucosa, and if it is to 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%, and/or the flavour is present in an amount of 2—12 wt%.

Water may be any of e.g. least tap water, ionexchanged water, reversed osmosis and/or distilled water.

The pouch composition may further comprise one or more solvents, such as flavour solvents, such as

DK 2022 70040 A1 11 1502 Butane-1,3-diol Flavour solvent 1503 Castor Oil Flavour and solvent 1504 Ethyl acetate Flavour solvent

E1505 Triethyl citrate Flavour solvent 15 16 Glycerol monoacetate Flavour solvent 15 17 Glycerol diacetate Flavour solvent

E1518 Glycerol triacetate Flavour solvent 1520 Propylene glycol Solvent for anti-oxidants.

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 Pro- pane-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 mois- ture by acting as humectants. Also, the flavor solvents can be used to adjust the trans- portation 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 solwents than polar solvents. If a part of the pouch contain 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.

DK 2022 70040 A1 12

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 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. 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 contin- ued until a pouch composition with an even distribution of ingredients is obtained.

The pouch composition may be added to storage bags preferably under inert condi- tions for storage until further process steps. Alternatively, the pouch composition may directly be used in following process 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. way 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 pouch composition before being filled into the pouch in case the pouch composition comprises an intermediate water content and the final water content is achieved in a final hydration step (water addition step). This pouch composition with an intermediate water content may be named an intermediate pouch composition.

DK 2022 70040 A1 13

The present also relates to a pouch composition provided by the method described herein.

Said pouch composition, comprising at least one water insoluble fibre, at least one active ingredient, at least one texturizing agent, at least one sugar alcohol in a total amount of 0— 20 wt%, one or more intense sweeteners in a total amount of 0 — 8wt%, water in a total amount of 8 — 50 wt%,

The pouch composition may also comprise any of the other ingredients described herein such as preservatives, flavours and/or pH adjusting agents in amounts described above.

Detailed Description of the Invention via examples

In table I compositions F1 — 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 F1 — 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.

F1: Composition F1 is a based on wheat fibers and free base nicotine. texturizing agent is Arabica Gum. It is a sweet product for maximum delivery of flavor and nico- tine.

F2: Composition F2 is a based on MCC (micro crystalline cellulose) fibers and nico- tine based on freebase nicotine mixed with an ion exchange resin. Texturizing agent is

Arabica Gum. It is a sweet product for maximum delivery of flavor and a slow release of nicotine. The slow release of nicotine provides a better lifetime for the product be- cause the nicotine does not evaporate, and it gives an overall better nicotine uptake

DK 2022 70040 A1 14 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 a 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 gent 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 nicotine.

F4: Composition F4 is a 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 ad- justing agent. Free nicotine salts generally enters 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 a based on wheat fibers and free base nicotine. Texturizing agent 1s Agar that is known not be especially white. It is a salty product that together with ammoniumchloride provides maximum nicotine delivery.

F6: Composition F6 is a based on wheat fibers and free base nicotine. Texturizing 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 de- livery.

F7: Composition F7 is a based on wheat fibers and free base nicotine. Tobacco is add- ed to give a tobacco flavor and because some countries insist on tobacco in the snuff.

Texturizing 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.

DK 2022 70040 A1 15

Table I

Wheaties [5 [0 [0 [03 [3% [50 weme [0 [wr [0 [0 [0 [v Ju sema [FED [0 [0 [0 abortion [PO [7 [0 [0 [0

Fives [15 [0 [0 0 [0 [2 7

Pais EP 0 [0 [0 [v_

Free base nicotine in 6,3 oo PPE

Fema [0 [0 [05s [0 [ov eam [23 [17 [0 [0 [0 [0 0 cec [0 [0 [170 [0 [2 7 æe [vv [vo [ov

EE 90 9 en

Swe [0s [12 Jos [07 [0 Jor er

Seimtows [0 [13 [0 [110 [0 [0 _ ion Core [0_[0_[0_[0_[05 [08 [05 mæ [5 [0 [6 [5 [ses [as

Tow [0 [0 [0 [0 [0 Jo Jor

DK 2022 70040 A1 16

In table II and III a salty (table II} and a sweet composition (table HIT) are shown. The compositions are intended to illustrate different embodiments of the presen! invention and are not fo be construed as lumiting to the mvention. The compositions in H and III are pouch compositions with a low water content (may be named intermediate pouch compositions) Le. pouch composition intended fo be subnutted to a hvdration step preferably after the pouch composition has been added to a pouch.

Table II A salty formulation with 16mg nicotine pr 100g:

DK 2022 70040 A1 17

Table ITT A sweet formulation with 20mg nicotine pr 100g:

Claims

DK 2022 70040 A1 18 CLAIMS

1. A method for producing a pouch composition, said pouch composition com- prising at least one water insoluble fibre, nicotine, 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 wt% water in an amount of 8 — 50 wt%, wherein the method compris- es the steps of i. Providing a dry mixture comprising - one or more of said at least one water insoluble fibres - one or more of said at least one sugar alcohol - one or more texturizing agents - optionally one or more anti caking agent - optionally one or more pH adjusting agent - optionally one or more preservative - optionally one or more salt such as sodiumchloride and/or ammoniumchloride ii. Providing a liquid mixture comprising water, nicotine and flavour iii. Mixing the liquid mixture and the dry mixture to obtain a pouch composition.

2. The method according to any of the preceding claims, wherein the active in- gredient is nicotine and the concentration of nicotine is in the form of freebase nicotine, polarcrilex, free nicotine salts and/or synthetic nicotine in the pouch composition is an amount corresponding to 0.1 — 5 wt% free base nicotine.

3. The method according to any of the preceding claims, wherein the insoluble fibre is one or more of one or more the bothanical fibers or example fibers from wheat, oat, buckwheat, potatoes, bamboo, cellulose, apple, cacao, beats, sugar beats, wood, seaweed, barley, rye, corn, tomato and any combination hereof.

DK 2022 70040 A1 19

4. The method 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 wt%, sugar alcohols for example in the form of xylitol present in an amount of 0-12 wt%, erytrol 0 - 12 present in an amount of sorbitol 0 — 12 wt% and/or isomalt is present in an amount of 0 — 12 wt%.

5. The method according to any of the preceding claims, wherein the pouch composition comprises at last one active ingredient selected from the group of free base nicotine, nicotine salt, R,S Nic- otine, polarcrilex, Caffeine, cannabinoid such as CBD, CBT and other oils ex- tracted 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, Viagra, products for teeth and gum health such as an- ti-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 suppressors, eucalyptus, re- laxing agents, energizing agents, caffeine, ginseng, taurine and/or breath fresh- eners.

6. The method according to any of the preceding claims, wherein the pouch com- position comprises tobacco in an amount of 0 — 12 wt%.

7. A pouch composition prepared by the method according to any of the preced- ing claims 1 — 6.

8. A pouch product comprising a pouch and a pouch composition according to any of preceding claims.

SEARCH REPORT — PATENT Application No. PA 2022 70040

1.U] Certain claims were found unsearchable (See Box No. I).

2.[] Unity of invention is lacking prior to search (See Box No. ID.

A. CLASSIFICATION OF SUBJECT MATTER A24B 13/00 (2006.01), A24B 15/16 (2020.01), A61K 31/465 (2006.01) According to International Patent Classification (IPC)

B. FIELDS SEARCHED PCT-minimum documentation searched (classification system followed by classification symbols) CPC&IPC: A24B, A24F, A61K Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched DK, NO, SE, FI: IPC-classes as above. Electronic database consulted during the search (name of database and, where practicable, search terms used) EPODOC, WPI, FULL TEXT: ENGLISH

C. DOCUMENTS CONSIDERED TO BE RELEVANT Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant for claim No. X WO 2021/086367 A1 (NICOVENTURES TRADING LTD) 06.05.2021; see page 1-8 7, lines 19-30; page 12, lines 17-30; page 14, lines 10-22; claims; examples 1-4. A US 2015/0020813 Al (GAO, FENG et al.) 22.01.2015; see paragraphs [0028]- 1-8

[0033]. A WO 2018/233795 Al (FERTIN PHARMA A/S) 27.12.2018; see examples. 1-8 A US 2015/0272875 A1 (NILSSON, PER-GUNNAR) 01.10.2015; see examples; 1-8 claim 8. NI Further documents are listed in the continuation of Box C. + Special categories of cited documents: "pr Document published prior to the filing date but later than the "A" — Document defining the general state of the art which is not priority date claimed. considered to be of particular relevance. "TT" Document not in conflict with the application but cited to nym Document cited in the application. understand the principle or theory underlying the invention. "E" Earlier application or patent but published on or after the filing date. | "x — Document of particular relevance; the claimed invention cannot be . . Co considered novel or cannot be considered to involve an inventive "" Document which may throw doubt on priority claim(s) or which is step when the document is taken alone cited to establish the publication date of another citation or other won . Co . . special reason (as specified). Y Document of particular relevance; the claimed invention cannot be . . Lo considered to involve an inventive step when the document is "O" Document referring to an oral disclosure, use, exhibition or other combined with one or more other such documents, such means. combination being obvious to a person skilled in the art. "&" Document member of the same patent family. Danish Patent and Trademark Office Date of completion of the search report Helgeshøj Allé 81 15 July 2022 DK-2630 Taastrup Denmark Authorized officer Birgitte Myru

Tel.: +45 4350 8000 9! yIUup

Tel.: +45 43 50 81 14 October 2021 1/4

Application No.

SEARCH REPORT - PATENT bprication Ho PA 2022 70040

C (Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT

Citation of document, with indication, where appropriate, of the relevant passages Relevant for claim No.

A WO 2020/157280 A1 (SWEDISH MATCH NORTH EUROPE AB) 06.08.2020; 1-8 see examples 1, 3; claims 46-48. October 2021 2/4

Application No. SEARCH REPORT - PATENT PA 2022 70040 Box No. I Observations where certain claims were found unsearchable This search report has not been established in respect of certain claims for the following reasons:

1.[] Claims Nos.: because they relate to subject matter not required to be searched, namely:

2. U] Claims Nos.: because they relate to parts of the patent application that do not comply with the prescribed requirements to such an extent that no meaningful search can be carried out, specifically:

3. I Claims Nos. because of other matters, Box No. II Observations where unity of invention is lacking prior to the search The Danish Patent and Trademark Office found multiple inventions in this patent application, as follows: October 2021 3/4

Application No.

SEARCH REPORT - PATENT

PA 2022 70040 SUPPLEMENTAL BOX Continuation of Box [.] October 2021 4/4