DK181550B1

DK181550B1 - Method for producing a pouch composition

Info

Publication number: DK181550B1
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: 2024-05-02
Also published as: DK202270040A1; 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, the method characterized in that the liquid mixture of step ii. comprises water, nicotine and flavour, and that the dry mixture of step i. and the liquid mixture of step ii. are mixed together to obtain a pouch composition.

Description

DK 181550 B1 1

Method for producing a pouch composition

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 delivery.

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 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.

Prior art WO 2021/086367 discloses a method for producing a pouch composition. The pouch composition is produced by providing a mixture of dry ingredients of one or more water insoluble fibres (cellulose), one or more sweetener (sucralose), one or more texturizing agents (alginate, natural gum) and one or more salt such as sodiumchloride and a wet mix of water and sodium bicarbonate, where the dry and wet mixtures are mixed before nicotine is added, or nicotine is mixed with propylene glycol and added into the dry mixture, while water is first added later.

DK 181550 B1 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 at least one water insoluble fibre in form of one or more of one or more the botanical fibers from wheat, oat, buckwheat, potatoes, bamboo, apple, cacao, beats, sugar beets, wood, seaweed, barley, rye, corn, tomato and any combination hereof, 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% and 0% tobacco, 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 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 the method characterized in that the liq- uid mixture of step ii. comprises water, nicotine and flavour, and that the dry mixture of step i. and the liquid mixture of step ii. are mixed together to obtain a pouch composition.

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 similar

DK 181550 B1 3 manner throughout the obtained pouch composition. This is especially important as fla- vours at least partly may be added to mask the taste of nicotine.

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 advantage 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 mixture is that the active ingredient may permanently be masked by the flavor because there is simul- taneous release of the flavor and the active ingredient that is evenly distributed through- out the particle.

In some embodiments not all water is provided in step ii in which case additional water 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 botanical fibers for example fibers from wheat, oat, buckwheat, potatoes, bamboo, cellulose, apple, cacao, beats, sugar beets, wood, seaweed, barley, rye, corn, tomato and any combination hereof. De- pending 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 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

DK 181550 B1 4 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%.

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 - 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 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 through the mucous membrane may 20 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 soft- ness 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 deliv- ery product whereby an alternative to products providing nicotine by smoking is achieved.

DK 181550 B1

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% de- pending on 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, 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 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 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%.

DK 181550 B1 6

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-(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)pyr- idine 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 limited to Amberlite IRP64, Purolite C115HMR 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 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 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 relaxes your body is also present. By choosing a combination of active ingredients special targeted and/or synergistic effects may be achieved.

DK 181550 B1 7

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 canna- binoid 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, 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 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, 11or 12 wt% and optionally a second and/or third sugar alcohol may be present in an amount of 0 -12 wt%.

In some embodiment the pouch composition may comprise intense sweeteners in a con- centration of 0.01 — 5 wt%, such as or up to 0.05, 0.1, 0.5, 1, 1.5, 2 or 2.5 wt% combi- nation 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),

DK 181550 B1 8

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 -1:100, 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 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 humectants in the form of sugar alcohols, glycerine and similar they keep 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 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% in order to salt can help the nicotine experience and enhance both flavors and experience of the nicotine as well as it helps create saliva which is good for 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

DK 181550 B1 9 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 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 limited 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 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

DK 181550 B1 10 preservative content of the product possibly together with the desired storage conditions complete protection against fungus and other microbiological growth may be achieved. pH regulating agents may be selected as one or more of sodium bicarbonate, sodium carbonate, magnesium 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 to low there will be a poor nicotine delivery through 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 1502 Butane-1 ,3-diol Flavour solvent 1503 Castor Oil Flavour and solvent 1504 Ethyl acetate Flavour solvent

His OS Triethyl citrate Flavour solvent 1516 Glycerol monoacetate Flavour solvent 1517 Glycerol diacetate Flavour solvent

DK 181550 B1 11

ISIS 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 flavour 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 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 nonpolar solvents than polar solvents.

If a part of the pouch 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 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

DK 181550 B1 12 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 continued until a pouch composition 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 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 addition 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 com- position 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 interme- diate water content may be named an intermediate pouch composition.

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 ac- tive 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

DK 181550 B1 13 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 based on wheat fibers and free base nicotine. texturizing 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) fibers and nicotine based on freebase nicotine mixed with an ion exchange resin. Texturizing agent is Ara- bica 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 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 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 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. Texturizing agent is Agar that is known not be especially white. It is a salty product that together with ammoniumchloride provides maximum nicotine delivery.

DK 181550 B1 14

F6: Composition F6 is 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 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- turizing 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 181550 B1

Table I

Wee Ep AR

Soe 0 [0 [0 [0 [0 [0

Fo 0 ABT [0 0 jo [v_

Free base nicotine in | 0 0 6,3 | 0 9

SE

Ferien [0 [0 PE [0 0 neg [22 [17 [0 [0 [0 [0 [i

Grn [0 [0 [PE æe CC CE

EE CO CC EO CO CO

[See ET RE 3137 [0 [SEEST L [0_|11 [0 [0 [0 _ man CH [0_[0_[0_[0_[03 [48 [07

In table IT and II a salty (table II} and a sweet composition (table III) are shown. The compositions are intended to illustrate different embodiments of the present invention 3 and are not to be construed as limiting to the invention. The compositions in I] and HI are pouch compositions with a low water content (may be named intermediate pouch compositions} Le. pouch campasition intended fo be subintfted fo a hydration step pref- erably after the pouch conywmsiion has been added fs es pouch.

Table IT A salty formulation with 15mg mootine pr 100g

Wet: eee 0

Av 0000 MB S00

Sucmalose 955 030

Re Ed E

Sorlie aetd 206 010

Sihcon dioxide E331 200

Tiqnid flavor: — 53 18

DK 181550 B1 17

Table IH A sweet formulation with 30mg otcolime pr 100g

Wht 0 um

Claims

DK 181550 B1 18 PATENT CLAIM

1. A method for producing a bag composition comprising at least one water-insoluble fiber in the form of one or more of the one or more botanical fibers from wheat, oats, buckwheat, potatoes, bamboo, apple, cocoa, beets, sugar beets, wood, seaweed, barley, rye, corn, tomato and any combination thereof, nicotine, at least one sugar alcohol in a total amount of 0 — 22% by weight, one or more intense sweeteners in a total amount of 0 — 8% by weight water in an amount of 8 — 50% by weight and 0% tobacco, wherein the method comprises the steps i. Providing a dry mixture, comprising - one or more of said at least one water-insoluble fiber - one or more of said at least one sugar alcohol - or more texturizing agents - optionally one or several anti-caking agents - optionally one or more pH adjusting agents - optionally one or more preservatives - optionally one or more salts such as sodium chloride and/or ammonium chloride ii. — Provision of a liquid mixture, the method is characterized by the fact that the liquid mixture in step ii. includes water, nicotine and flavour, and that the dry mixture in step i. and the liquid mixture in step ii. mixed together to obtain a bag composition.

2. The method according to any one of the preceding claims, in which the active ingredient is nicotine, and the concentration of nicotine is in the form of free base nicotine, polarcrilex, free nicotine salts and/or synthetic nicotine in the bag composition is an amount corresponding to 0.1 — 5 wt% free base nicotine.

DK 181550 B1 19

3. The method according to any one of the preceding claims, in which one or more intense sweeteners such as sucralose are present in an amount of 0 - 2.5% by weight sugar alcohols for example in the form of xylitol present in an amount of 0 — 12% by weight, erythrol 0 — 12 present in an amount of sorbitol of 0 — 12% by weight and/or isomalt is present in an amount of 0 — 12% by weight.

4. The method according to any one of the preceding claims, wherein the sachet composition comprises at least one active ingredient selected from the group of free base nicotine, nicotine salt, R,S nicotine, polarcrilexm, 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, prebiotics, probiotics, pain relievers or antihistamines, Viagra, teeth and gum health products such as anti-caries, acid buffer - agents, teeth whiteners, desensitizers, saliva enhancers, herbs such as chamomile, teas such as green tea, thyme, oregano, ginger, turmeric, mint, appetite suppressants, cough suppressants, eucalyptus, relaxants, energisers, caffeine, ginseng , taurine and/or breath fresheners.

5. The method according to any one of the preceding claims, wherein the pouch composition comprises tobacco in an amount of 0-12% by weight.

6. A bag composition produced by the method according to any one of the preceding claims 1 - 5.

A bag product comprising a bag and a bag composition made according to any one of the 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 pages 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.) 01/22/2015; 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. "TT" Document not in conflict with the application. "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). DOCUMENT

S 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. In 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. In 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