Nicotine pouch composition

Abstract

A nicotine pouch composition is disclosed, the pouch composition comprising at least one sugar alcohol, at least one water-insoluble fiber, 8-65% water by weight of the composition, and nicotine. Also disclosed are an oral pouched nicotine product and a method for making the oral pouched product.

Description

Technical Field

[0001] The present invention relates to a nicotine pouch composition according to claim 1, an oral pouch-filled nicotine product according to claim 56, and a method for manufacturing an oral pouch-filled product according to claim 64.

Background Art

[0002] Delivery of nicotine by smoking has many well-known drawbacks, especially health-related problems such as the presence of carcinogenic substances. However, tobacco substitutes also have drawbacks such as insufficient reduction of the user's desires.

Summary of the Invention

Problems to be Solved by the Invention

[0003] An object of one embodiment of the present invention is to provide a nicotine-containing pouch, for example, as a tobacco substitute, which can solve the above problems. A further problem with the prior art is that the desired release of nicotine should be attractive from the user's perspective to the user of the pouch.

[0004] Furthermore, a further problem associated with the prior art is that the pouch as a nicotine delivery vehicle is somewhat costly, which may impose limitations on the design method of the pouch in order to suppress the manufacturing cost.

Means for Solving the Problems

[0005] The present invention relates to a nicotine pouch composition, which comprises at least one sugar alcohol, at least one water-insoluble fiber, water in an amount of 8 to 65% by weight of the composition, nicotine, and.

[0006] An advantage of the present invention would be the surprisingly high mobility of the pouch composition. This facilitates the effective processing of the pouch composition, particularly when filling the pouch with the pouch composition. Generally, when handling a powdered composition, fluidity is used as an indicator of processability. However, when a large amount of water is added to the sugar alcohol-containing pouch composition, the pouch composition tends to aggregate, resulting in a significant decrease in fluidity and, in some cases, becoming so low that it cannot be measured by conventional methods. However, the inventors of the present application unexpectedly found that this pouch composition is still processable into individual pouches by a filling machine. Thus, in the present invention, effective processing can be performed by avoiding filling the pouches manually or using a very complex and special-designed filling machine, thereby enabling a cost-effective setup.

[0007] A further advantage of the present invention is that the combination of sugar alcohol, water-insoluble fiber, and water provides a very attractive soft, moist, moldable texture and mouthfeel. While obtaining the desired texture and mouthfeel, they do not stick to each other so much as to cause the pouch to burst when taken out, and it is still possible to store the manufactured pouches adjacent to each other in, for example, a can.

[0008] A further advantage of the present invention is that the combination of sugar alcohol, water-insoluble fiber, and water provides not only an attractive mouthfeel but also a very attractive taste profile. In a preferred embodiment of the present invention, the composition has a bulk density of up to 0.8 g / cm3, such as up to 0.7 g / cm3, such as up to 0.6 g / cm3, such as up to 0.5 g / cm3.

[0009] The use of the invention of a composition having a relatively low bulk density provides not only a good mouthfeel, but also effective release from the pouch due to the fact that the relatively low bulk density promotes effective salivation, thereby promoting the release of the water-soluble components of the composition. In particular, it should be noted that a low bulk density in combination with the water content described in the claims is attractive when an improvement in the user's perception is desired.

[0010] An advantage of the above-described embodiments would be that a low-density composition is obtained. Surprisingly, the combination of water and sugar alcohol does not result in a very high-density and compacted non-processable pouch composition, but allows for a relatively lightweight and low-density composition.

[0011] In a preferred embodiment of the present invention, the composition has a bulk density of from 0.2 g / cm3 to 0.8 g / cm3, such as from 0.3 g / cm3 to 0.7 g / cm3, such as from 0.3 g / cm3 to 0.6 g / cm3, such as from 0.4 to 0.5 g / cm3, etc.

[0012] In one embodiment of the present invention, the composition has a bulk density of from 0.2 g / cm3 to 0.8 g / cm3, such as from 0.2 g / cm3 to 0.7 g / cm3, such as from 0.2 g / cm3 to 0.6 g / cm3, such as from 0.2 to 0.5 g / cm3, etc.

[0013] In one embodiment of the present invention, the composition has a bulk density of from 0.2 g / cm3 to 0.8 g / cm3, such as from 0.3 g / cm3 to 0.8 g / cm3, such as from 0.4 g / cm3 to 0.8 g / cm3, such as from 0.5 to 0.8 g / cm3, etc.

[0014] The use of the invention of a composition having a relatively low bulk density provides not only a good mouthfeel, but also effective release from the pouch due to the fact that the relatively low bulk density promotes effective salivation, thereby promoting the release of the water-soluble components of the composition. In particular, it should be noted that a low bulk density in combination with the water content described in the claims is attractive when an improvement in the user's perception is desired.

[0015] At the same time, the low density advantageously reduces the need for raw materials, thereby lowering the manufacturing cost. The density of the pouch composition can be affected by many parameters, particularly the type and amount of sugar alcohol, the type and amount of fiber, the water content, and the mixing time of the following processes. For example, changing the amount of water affects the fluidity such that if the amount of water is too high, a compact and high-density pouch formulation results, but by selecting fibers with a high binding affinity for water, the higher water content can at least partially be offset. Also, excessive mixing has been observed to result in a very dense and compact pouch composition.

[0016] In a preferred embodiment of the present invention, nicotine is selected from the group consisting of nicotine salts, free-base nicotine, nicotine bound to an ion exchanger such as an ion exchange resin such as nicotine polacrilrex resin, nicotine inclusion complexes or any non-covalent nicotine, nicotine bound to zeolite, nicotine bound to cellulose such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.

[0017] As an example of a combination of different types of nicotine, there is a combination of free-base nicotine mixed with polacrilrex resin, where some nicotine is bound to the ion exchange resin and some nicotine remains unbound.

[0018] Free-base nicotine includes nicotine mixed with sugar alcohol, modified calcium carbonate, water-soluble fiber, ion exchange resin, and combinations thereof. Nicotine bound to modified calcium carbonate is described in WO 2010 / 121619, which is incorporated herein by reference.

[0019] In a preferred embodiment of the present invention, nicotine includes non-salt nicotine. In a preferred embodiment of the present invention, nicotine includes free base nicotine.

[0020] A very important advantage of the above embodiment is that a long shelf life of the pouch-packed product can be obtained, and a long-life taste and texture can be obtained. By providing nicotine in the form of a free base, it becomes easy to increase the pH of the pouch composition without using much alkaline pH control agent.

[0021] Therefore, in the above embodiment, the amount of the alkaline pH control agent can be reduced without impairing the shelf life and the long-life taste and texture. In a preferred embodiment, nicotine includes nicotine mixed with an ion exchange resin.

[0022] In a preferred embodiment of the present invention, nicotine includes free base nicotine mixed with an ion exchange resin, wherein the weight ratio between the free base nicotine and the ion exchange resin is 0.1 to 2.0, preferably 0.5 to 2.0, and most preferably about 0.67 to 1.0.

[0023] In one embodiment of the present invention, nicotine includes free base nicotine mixed with an ion exchange resin, wherein the weight ratio between the free base nicotine and the ion exchange resin is 1:1 to about 1:10, preferably 1:2 to 1:6, and most preferably about 1:4 to 1:5.

[0024] Here, the weight ratio means the ratio obtained by dividing the mass of the first component by the mass of the second component. Also, the term "mixing ratio" may be used. Therefore, in the above embodiment, nicotine includes free base nicotine mixed with an ion exchange resin, wherein the weight ratio between the free base nicotine and the ion exchange resin is 0.1 to about 1, preferably 0.17 to 0.5, and most preferably about 0.2 to 0.25.

[0025] In a preferred embodiment of the present invention, nicotine includes a nicotine salt. In one embodiment of the present invention, the nicotine salt is selected from nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine mono-tartrate, nicotine hydrogen tartrate, nicotine chloride (e.g., nicotine hydrochloride, nicotine dihydrochloride), nicotine citrate, nicotine fumarate, nicotine gensitate, nicotine lactate, nicotine mucate, nicotine laurate, nicotine levulinate, nicotine malate, nicotine perchlorate, nicotine pyruvate, nicotine salicylate, nicotine sorbate, nicotine succinate, zinc nicotine chloride, nicotine sulfate, nicotine tosylate, and hydrates thereof (e.g., zinc nicotine chloride monohydrate).

[0026] In one embodiment of the present invention, the nicotine salt contains or consists of nicotine hydrogen tartrate. In an advantageous embodiment of the present invention, the nicotine contains nicotine bound to an ion exchange resin.

[0027] In one embodiment of the present invention, the ion exchange resin is a polacrillex resin. In one embodiment of the present invention, the polacrillex resin is Amberlite® IRP64.

[0028] In an advantageous embodiment of the present invention, the nicotine contains synthetic nicotine. In one embodiment of the present invention, the pouch composition further contains nicotine as a complex with an ion exchange resin such as polacrillex resin.

[0029] The advantage of the above-described embodiment would be that a sustained-release component is obtained by the complex of nicotine and the ion exchange resin. In one embodiment of the present invention, the pouch composition contains free-base nicotine mixed with an ion exchange resin combined with nicotine as a complex with an ion exchange resin such as polacrillex resin.

[0030] In one embodiment, nicotine consists of free-base nicotine mixed with polyacrylic resin. In one embodiment of the present invention, nicotine includes nicotine mixed with an ion-exchange resin such as polyacrylic resin, and the nicotine pouch composition further includes nicotine bound to the ion-exchange resin, i.e., a nicotine ion-exchange resin complex. Therefore, the nicotine may be nicotine mixed with polyacrylic resin, where some of the nicotine is bound to the ion-exchange resin, while some of the nicotine remains unbound as free-base nicotine.

[0031] In an advantageous embodiment of the present invention, the pouch composition contains nicotine in an amount of at least 0.1% by weight of the pouch composition, such as at least 0.2% by weight, etc. In an advantageous embodiment of the present invention, the pouch composition contains nicotine in an amount of 0.1 - 5.0% by weight of the pouch composition, such as 0.2 - 4.0% by weight of the pouch composition, such as 1.0 - 2.0% by weight of the pouch composition, etc.

[0032] A nicotine release profile including both a fast release period and a sustained release period can be obtained. In one embodiment, the fast release period may refer to the first 120 seconds of the nicotine release profile, while the sustained release period may refer to the subsequent period of the release profile until the end of the experiment or use, such as the period from 2 minutes to 30 minutes after the start of use.

[0033] In an advantageous embodiment of the present invention, the pouch composition is provided in a pouch and is adapted to release at least 15% by weight of nicotine, such as at least 20% by weight, such as at least 30% by weight, such as at least 40% by weight of nicotine within a period of 120 seconds upon contact with saliva in the oral cavity when measured as described in Example 3K.

[0034] In one embodiment of the present invention, the pouch composition is adapted to release at least 50% by weight of nicotine within a period of 120 seconds upon contact with saliva in the oral cavity when provided in the pouch. Preferably, the release is measured as described in Example 3K.

[0035] In one embodiment of the present invention, the pouch composition is provided in a pouch and is adapted to release at least 15% by weight of nicotine, such as at least 20% by weight of nicotine, such as at least 30% by weight of nicotine, within a period of 120 seconds when exposed to the in vitro release experiment described in Example 3L.

[0036] In one embodiment of the present invention, the pouch composition is provided in a pouch and is adapted to release at least 30% by weight of nicotine, such as at least 40% by weight of nicotine, such as at least 50% by weight of nicotine, such as at least 60% by weight of nicotine within 10 minutes upon contact with saliva in the oral cavity when the release described in Example 3K is measured.

[0037] In one embodiment of the present invention, the pouch composition is provided in a pouch and is adapted to release at least 30% by weight of nicotine, such as at least 40% by weight of nicotine, such as at least 50% by weight of nicotine, such as at least 60% by weight of nicotine within a period of 10 minutes when exposed to the in vitro release experiment described in Example 3L.

[0038] The release rate describes the average amount of nicotine released per minute within a predetermined period. In an advantageous embodiment of the present invention, the pouch composition provided in the pouch in the oral cavity has a nicotine release rate of at least 0.2% per minute within a release period from 2 to 10 minutes, such as at least 0.3% per minute within a release period from 2 to 10 minutes, such as at least 0.4% per minute within a release period from 2 to 10 minutes, such as at least 0.5% per minute within a release period from 2 to 10 minutes.

[0039] The above release rate may be calculated based on the release results measured as described in Example 3K. In one embodiment of the present invention, the pouch composition provided in the pouch and exposed to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.2% per minute within a release period of 2 to 60 minutes, for example, at least 0.3% per minute within a release period of 2 to 60 minutes, for example, at least 0.4% per minute within a release period of 2 to 60 minutes, for example, at least 0.5% per minute within a release period of 2 to 60 minutes.

[0040] In one embodiment of the present invention, the pouch composition provided in the pouch and exposed to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.2% per minute within a release period of 2 to 30 minutes, for example, at least 0.3% per minute within a release period of 2 to 30 minutes, for example, at least 0.4% per minute within a release period of 2 to 30 minutes, for example, at least 0.5% per minute within a release period of 2 to 30 minutes.

[0041] In an advantageous embodiment of the present invention, the pouch composition provided in the pouch and exposed to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.2% per minute within a release period of 2 to 10 minutes, for example, at least 0.3% per minute within a release period of 2 to 10 minutes, for example, at least 0.4% per minute within a release period of 2 to 10 minutes, for example, at least 0.5% per minute within a release period of 2 to 10 minutes.

[0042] In one embodiment of the present invention, the pouch composition provided in the pouch and exposed to the in vitro release experiment described in Example 3L has a nicotine release rate of at least 0.1 mg per minute within a release period of 2 to 60 minutes, for example, at least 0.2 mg per minute within a release period of 2 to 60 minutes.

[0043] In one embodiment of the present invention, the pouch composition provided in the pouch and exposed to the in vitro release experiment described in Example 3L has a release rate of at least 0.4 mg of nicotine per minute within a release period of 2 to 10 minutes.

[0044] In an advantageous embodiment of the present invention, the pouch composition further comprises a pH control agent, such as a basic pH control agent, such as a basic buffer. The advantage of the above embodiment would be that more effective nicotine uptake is obtained, especially when using a basic (alkaline) pH control agent.

[0045] Another advantage of the above embodiment could be that a desirable taste can be obtained during use. In embodiments, by avoiding the use of nicotine salts such as nicotine bitartrate, a smaller amount of pH control agent can be applied, but it may still be desirable to further increase the pH by adding a pH control agent.

[0046] In an advantageous embodiment of the present invention, the pouch composition comprises a basic buffer. In one embodiment of the present invention, the pouch composition further comprises a combination of at least two pH control agents, such as a combination of at least two basic pH control agents, such as a combination of at least two basic buffers such as a basic buffer pair.

[0047] As used herein, the term alkaline buffer is used interchangeably with basic buffer, i.e., alkaline is used in the sense of "basic" as opposed to acidic.

[0048] In an advantageous embodiment of the present invention, the pouch composition comprises a pH control agent in an amount of less than 6% by weight of the pouch composition, such as less than 5% by weight of the pouch composition, such as less than 4% by weight of the pouch composition, such as less than 2% by weight of the pouch composition, such as less than 1% by weight of the pouch composition, such as not containing a pH control agent.

[0049] In one embodiment of the present invention, the pouch composition contains a pH control agent in an amount of 0 to 6% by weight of the pouch composition, such as 0 to 5% by weight of the pouch composition, such as 0 to 4% by weight of the pouch composition, such as 0 to 3% by weight of the pouch composition, such as 0 to 2% by weight of the pouch composition, such as 0 to 1% by weight of the pouch composition.

[0050] In one embodiment of the present invention, the pouch composition contains a pH control agent in an amount of 0.1 to 6% by weight of the pouch composition, such as in an amount of 0.1 to 5% by weight of the pouch composition, such as in an amount of 0.5 to 5% by weight of the pouch composition, such as in an amount of 0.5 to 4% by weight of the pouch composition, such as in an amount of 0.1 to 3% by weight of the pouch composition, such as in an amount of 0.1 to 2% by weight of the pouch composition, such as in an amount of 0.1 to 1% by weight of the pouch composition.

[0051] In one embodiment of the present invention, the pouch composition contains a pH control agent, for example, in an amount of 0.01 to 15% by weight of the pouch composition. In a preferred embodiment of the present invention, the pouch composition contains a pH control agent in an amount of 0.01 to 15% by weight of the pouch composition, such as in an amount of 0.5 to 10% by weight of the pouch composition, such as in an amount of 1 to 10% by weight of the pouch composition, such as in an amount of 5 to 10% by weight of the pouch composition.

[0052] In a preferred embodiment of the present invention, the pouch composition is adapted to provide a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 grams of the pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4).

[0053] In a preferred embodiment of the present invention, the pouch composition is adapted to provide a pH of at least 8.2, such as a pH of at least 8.5, such as a pH of at least 8.7, when 2.0 grams of the pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4).

[0054] An advantage of the above-described embodiment may be that the relatively effective nicotine uptake is promoted due to the high pH value obtained. A further advantage of the above-described embodiment may be that the need for a preservative may be reduced or even eliminated, and that such a preservative, if not non-existent, may be used in a smaller amount.

[0055] Also, the high pH value obtained may advantageously provide a tingling sensation in the mouth that is desirably recognized as a pleasant taste, for example, because it is similar to a tobacco-based pouch product.

[0056] In a preferred embodiment of the present invention, the pH control agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0057] In a preferred embodiment of the present invention, the pH control agent is a basic buffer such as, and / or a basic pH control agent such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

[0058] In one embodiment, at least one sugar alcohol may be used, such as xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof. Also, at least one sugar alcohol may contain additional sugar alcohols. As an exemplary embodiment, hydrolyzed hydrogenated starch containing a mixture of sorbitol, maltitol and additional sugar alcohols may be used.

[0059] In a preferred embodiment of the present invention, at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.

[0060] In a preferred embodiment of the present invention, at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

[0061] In one embodiment of the present invention, at least one sugar alcohol contains xylitol and / or erythritol. In a preferred embodiment of the present invention, the pouch composition contains at least two sugar alcohols.

[0062] For the purposes of taste and saliva secretion, different sugar alcohols can be applied, noting that the sugar alcohol composition is made of different sugar alcohols with different properties regarding preservation, bacterial growth, processability and / or taste.

[0063] In one embodiment of the present invention, at least two sugar alcohols are selected from xylitol, maltitol, mannitol, erythritol, and isomalt. In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol in an amount of at least 1% by weight of the composition, for example at least 2% by weight of the composition, for example at least 5% by weight of the composition, for example at least 10% by weight of the composition, etc.

[0064] In relation to a composition containing a sugar alcohol in an amount of at least 1% by weight of the composition, for example at least 2% by weight of the composition, for example at least 5% by weight of the composition, for example at least 10% by weight of the composition, etc., it should be noted that a bulk density of 0.2 g / cm3 to 0.8 g / cm3, for example a bulk density of 0.3 g / cm3 to 0.7 g / cm3, for example a bulk density of 0.3 g / cm3 to 0.6 g / cm3, for example a bulk density of 0.4 to 0.5 g / cm3, etc. provides an attractive dissolution of the pouch contents containing nicotine when brought into contact with the mucosa.

[0065] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol in an amount of 1 to 80% by weight of the composition, for example 2 to 70% by weight of the composition, for example 5 to 60% by weight of the composition, for example 10 to 50% by weight of the composition, etc.

[0066] In one embodiment of the present invention, the pouch composition contains a sugar alcohol in an amount of 5 to 40% by weight of the composition, for example 5 to 30% by weight of the composition, etc. In a preferred embodiment of the present invention, the sugar alcohol includes a DC (direct compressibility) grade sugar alcohol.

[0067] In a preferred embodiment of the present invention, at least 50% by weight of the sugar alcohol is a DC (direct compressibility) grade sugar alcohol. In one embodiment of the present invention, the sugar alcohol includes a non-DC (non-direct compressibility) grade sugar alcohol.

[0068] In a preferred embodiment of the present invention, the water-insoluble fiber is a plant fiber. In a preferred embodiment of the present invention, the water-insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof.

[0069] Powdered cellulose within the scope of the present invention is understood to be cellulose prepared by treating α-cellulose obtained as pulp from multiple fibrous plant materials such as wood pulp.

[0070] In one embodiment of the present invention, the water-soluble fiber comprises or consists of cereal fiber. In one embodiment of the present invention, the water-soluble fiber comprises or consists of fruit fiber and / or plant fiber.

[0071] In a preferred embodiment of the present invention, the water-insoluble composition comprises or consists of water-insoluble fibers selected from wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof.

[0072] In a preferred embodiment of the present invention, the water-insoluble composition comprises or consists of water-insoluble fibers selected from wheat fiber, oat fiber, pea fiber, or combinations thereof.

[0073] In a preferred embodiment of the present invention, the water-insoluble composition comprises or consists of water-insoluble fibers selected from wheat fiber, oat fiber, or combinations thereof.

[0074] Non-limiting examples of water-insoluble fibers that can be used include Vitacel® WF 600, Vitacel® HF 600, Vitacel® P95, Vitacel® WF 200, Vitacel® L00, Vitacel® Erbsenfaser EF 150, Vitacel® bamboo fiberbaf 90, Vitacel® HF 600, Vitacel® Cellulose L700G, Vitacel® PF200, Vitacel® potatofiber KF200, Vitacel® bamboo fiberhaf BAF40, Vitacel® Haferfaser / oat fiber HF-401-30 US.

[0075] Non-limiting examples of powder cellulose that can be used include Vitacel® L00, Vitacel® Cellulose L700G, Vitacel® LC1000, Vitacel® L600-20, Vitacel® L600, etc.

[0076] In one embodiment, the powder cellulose is not chemically modified. Therefore, the powder cellulose can be unmodified cellulose fibers that do not contain, for example, microcrystalline cellulose (MCC).

[0077] In an advantageous embodiment of the present invention, the water-insoluble fibers have a water binding capacity of at least 300%, at least 400%, etc., such as at least 200%.

[0078] The advantage of the above embodiment may be to enable a pouch composition having a high water content with a high water binding capacity. Furthermore, it has been found that a pouch having a high water content has a desirable texture and mouthfeel, while not adhering too strongly to each other such that it causes the pouch to rupture when taken out, and it is still possible to store the manufactured pouches adjacent to each other in, for example, a can.

[0079] In one embodiment of the present invention, the water-insoluble fiber has a water-binding capacity of 300 to 1500%, for example, 400 to 1300%. In one embodiment of the present invention, the water-insoluble fiber has a water-binding capacity of 200% to 1500%, for example, 300 to 1300%, for example, 200 to 800%, for example, 300 to 800%, for example, 400 to 600%.

[0080] In one embodiment of the present invention, the water-insoluble fiber has a water-binding capacity of 200 to 1500%, for example, 300 to 1300%, for example, 300 to 900%, for example, 300 to 700%, for example, 400 to 700%.

[0081] In one embodiment of the present invention, the water-insoluble fiber has a water-binding capacity of 200 to 1500%, for example, 400 to 1500%, for example, 500 to 1500%, for example, 500 to 1200%, for example, 500 to 1000%.

[0082] In an advantageous embodiment of the present invention, the water-insoluble fiber has a swelling capacity of at least 5.0 mL / g, for example, 5.0 to 20 mL / g. The advantage of the above embodiment is that the amount of water-insoluble fiber can be reduced without impairing the mouthfeel during use. When using water-insoluble fiber instead of the water-soluble component, the water-insoluble fiber swells during use and prevents the dissolution of the water-soluble component, so that the user will not experience a decrease in the content of the pouch during use.

[0083] In an advantageous embodiment of the present invention, the water-insoluble composition comprises or consists of 5 to 50% by weight of water-insoluble fiber in the amount of the pouch composition and 15 to 70% by weight of water content of the pouch composition.

[0084] In a preferred embodiment of the present invention, the water-insoluble fiber is selected from pea fiber, powdered cellulose, and combinations thereof, and the pouch composition contains a flavoring agent in an amount of 10% by weight or less of the same pouch composition.

[0085] In one embodiment of the present invention, the pouch composition contains a water-insoluble fiber selected from pea fiber and powdered cellulose, or combinations thereof, and a flavoring agent in an amount of 0.01 to 10% by weight of the pouch composition.

[0086] In a preferred embodiment of the present invention, the water-insoluble fiber has a density of 50 to 500 grams per liter, for example, 100 to 400 grams per liter, for example, 200 to 300 grams per liter.

[0087] In a preferred embodiment of the present invention, the pouch composition has an angle of repose of at least 40 degrees, for example, at least 45 degrees, for example, at least 50 degrees. Therefore, in the above embodiment, the fluidity is quite low.

[0088] In one embodiment, the angle of repose may be 45 to 70 degrees, for example, 45 to 70 degrees, for example, 50 to 70 degrees. The angle of repose may be measured by slowly pouring 50 g of the pouch composition from a height of about 10 cm onto a flat horizontal surface.

[0089] In a preferred embodiment of the present invention, the pouch composition contains water in an amount of 8 to 60% by weight of the composition, for example, 8 to 50% by weight of the composition, for example, 8 to 40% by weight of the composition, for example, 20 to 40% by weight of the composition.

[0090] In one embodiment of the present invention, the pouch composition contains water in an amount of 8 to 60% by weight of the composition, for example, 10 to 60% by weight of the composition, for example, 15 to 60% by weight of the composition, for example, 20 to 60% by weight of the composition.

[0091] In one embodiment of the present invention, the pouch composition contains water in an amount of 8 to 60% by weight of the composition, for example 8 to 50% by weight of the composition, for example 8 to 40% by weight of the composition, for example 8 to 30% by weight of the composition.

[0092] In a preferred embodiment of the present invention, the pouch composition contains water in an amount of 10 to 40% by weight of the composition. In a preferred embodiment of the present invention, the pouch composition contains water in an amount of 20 to 65% by weight of the composition, for example 20 to 60% by weight of the composition, for example 20 to 50% by weight of the composition, for example 20 to 40% by weight of the composition.

[0093] In a preferred embodiment of the present invention, the pouch composition has a water content of 15 to 65% by weight of the pouch composition, for example 15 to 50% by weight of the pouch composition, for example 15 to 40% by weight of the pouch composition, for example 15 to 30% by weight of the pouch composition, for example 15 to 25% by weight of the pouch composition.

[0094] Water can be added as another component that is completely or partially mixed with other components such as fibers. For example, when free base nicotine is added as a mixture of free base nicotine with an ion exchange resin and water, a significant amount of water in the final pouch composition is obtained from the free base nicotine - ion exchange resin - water pre-mixture. For example, if the final amount pouch composition contains 5% water from the free base nicotine - ion exchange resin - water pre-mixture, up to 1 / 3 of the water in the pouch composition is from the free base nicotine - ion exchange resin - water pre-mixture.

[0095] In a preferred embodiment of the present invention, the pouch composition contains water and water-insoluble fibers in a weight ratio of 3.0 or less, for example 2.5 or less, for example 2.0 or less, for example 1.5 or less, for example 1.0 or less.

[0096] In an embodiment, the pouch composition contains water and water-insoluble fibers in a weight ratio of 3.0 to 0.2, such as 2 to 0.2, such as 2.0 to 1.0, such as 1.5 to 0.5.

[0097] Thus, the above weight ratio has the water content in weight % of the pouch composition in the numerator and the content of water-insoluble fibers in weight % of the pouch composition in the denominator. Having a water content within the scope of the present invention, since the pouch is already wet with water or partially wet with water from the start of use, rapid release can be promoted within the first rapid release period, such as within the first 120 seconds.

[0098] On the other hand, the water content should not be too high. Having too high a water content can affect liquid diffusion into and out of the pouch. A fully wet pouch may have lower liquid diffusion both inside and outside the pouch during use, while a partially wet pouch may have higher liquid diffusion both inside and outside the pouch. Therefore, a pouch with low liquid diffusion may have lower nicotine release, for example, after 10 minutes.

[0099] In one embodiment of the present invention, the pouch composition has a water content of 60% by weight or less of the pouch composition, such as 50% by weight or less of the pouch composition, such as 40% by weight or less of the pouch composition, such as 30% by weight or less of the pouch composition.

[0100] In a preferred embodiment of the present invention, the pouch composition does not contain tobacco, tobacco fibers, and fibers derived from tobacco. In some alternative embodiments, the pouch composition may contain trace amounts of tobacco. Nicotine provided as part of tobacco, such as powdered tobacco, is further added to free base nicotine. Such tobacco may be included, for example, to provide the flavor of tobacco.

[0101] In one embodiment, the pouch composition may contain tobacco, tobacco fibers, or fibers derived from tobacco in an amount of 0.1 to 5.0% by weight of the pouch composition, such as in an amount of 0.1 to 3.0% by weight of the pouch composition. Thus, in some embodiments, the pouch composition may contain a small amount of tobacco, but this is in addition to free base nicotine, and thus the pouch composition is not tobacco-based.

[0102] In one embodiment of the present invention, the pouch composition contains less than 5.0% by weight of tobacco, for example, does not contain tobacco, such as less than 0.1% by weight of the pouch composition, such as less than 0.5% by weight of the pouch composition, such as less than 1.0% by weight of the pouch composition, such as less than 3.0% by weight of the pouch composition.

[0103] In one embodiment of the present invention, the water-insoluble composition does not contain tobacco, tobacco fibers, or fibers derived from tobacco. Thus, in this embodiment, the water-insoluble fibers are non-tobacco fibers, that is, they do not contain tobacco, tobacco fibers, or fibers derived from tobacco.

[0104] In one embodiment of the present invention, the pouch composition does not contain microcrystalline cellulose (MCC), such as does not contain cellulose. In one embodiment of the present invention, the pouch composition contains cellulose and does not contain microcrystalline cellulose (MCC).

[0105] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, wherein the composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as in an amount of 5 to 70% by weight of the pouch composition, such as in an amount of 10 to 60% by weight of the pouch composition.

[0106] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as 5 to 70% by weight of the pouch composition, for example 10 to 60% by weight of the pouch composition, and The composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition.

[0107] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as 5 to 70% by weight of the pouch composition, for example 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition, and The water-insoluble composition contains or consists of water-insoluble fibers such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof.

[0108] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as 5 to 70% by weight of the pouch composition, for example 10 to 60% by weight of the pouch composition, The composition further comprises water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, etc., and The water-insoluble composition comprises or consists of water-insoluble fibers such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof, wherein the pouch composition comprises flavoring in an amount of 0.01 to 15% by weight of the pouch composition, for example, 0.1 to 15% by weight of the pouch composition, for example, 1 to 10% by weight of the pouch composition, for example, 3 to 10% by weight of the pouch composition.

[0109] In a preferred embodiment of the present invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition comprises the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition, etc. The composition further comprises water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, etc. The water-insoluble composition comprises or consists of water-insoluble fibers such as, for example, wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof, and the pouch composition comprises flavoring in an amount of 0.01 to 15% by weight of the pouch composition, for example, 0.1 to 15% by weight of the pouch composition, for example, 1 to 10% by weight of the pouch composition, for example, 3 to 10% by weight of the pouch composition, and the flavoring is oil-based.

[0110] In a preferred embodiment of the present invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, and The pouch composition contains a pH regulator selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0111] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, and The pouch composition contains a basic pH regulator such as a basic buffering agent and / or a pH regulator which is sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

[0112] In a preferred embodiment of the present invention, the pouch composition further contains a water retention agent. In one embodiment, the water retention agent is selected from the list of glycerol, propylene glycol, alginate, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum, and combinations thereof.

[0113] In one embodiment, the water retention agent is an amount of water retention agent of 0.5 to 10% of the pouch composition, such as 0.5 to 5 wt% of the pouch composition, such as 1 to 3 wt% of the pouch composition, or includes a water retention agent.

[0114] The water retention agent can attract and hold water in the oral cavity during use. However, the water retention agent may further moderate the release of nicotine, for example, to facilitate the sustained release of nicotine.

[0115] In one embodiment, the water retention agent is an alginate such as sodium alginate, or includes an alginate, for example, in an amount of 0.5 to 10 wt% of the pouch composition, such as 0.5 to 5 wt%, such as 1 to 3 wt%.

[0116] In one embodiment of the present invention, the pouch composition further includes glycerol. In one embodiment of the present invention, the pouch composition further includes modified starch. In one embodiment of the present invention, the pouch composition further includes hydroxypropyl cellulose (HPC).

[0117] In an advantageous embodiment of the present invention, the pouch composition includes a flow promoter such as silicon dioxide in an amount of, for example, 0.5 to 5 wt% of the composition, such as 1 to 3 wt% of the composition. In one embodiment of the present invention, the flow promoter is selected from talc powder, colloidal silica, silicon dioxide, starch, magnesium stearate, and combinations thereof.

[0118] In a convenient embodiment of the present invention, the pouch composition contains a flavorant, for example, in an amount of 0.01 to 20% by weight of the pouch composition, for example, in an amount of 0.01 to 15% by weight of the pouch composition.

[0119] In one embodiment of the present invention, the pouch composition contains a flavorant in an amount of 0.01 to 15% by weight of the pouch composition, for example, in an amount of 0.1 to 15% by weight of the pouch composition, for example, in an amount of 1 to 10% by weight of the pouch composition, for example, in an amount of 3 to 10% by weight of the pouch composition.

[0120] The properties of the water-insoluble components affect the release of the flavorant from the pouch composition, and thereby may affect the perception of the flavorant by the user. In one embodiment of the present invention, the water-insoluble fibers can cause either higher or lower perception of the flavorant by the user.

[0121] In one embodiment of the present invention, the pouch composition contains a flavorant in an amount of 10% by weight or less of the pouch composition, for example, in an amount of 8% by weight or less of the pouch composition, for example, in an amount of 5% by weight or less of the pouch composition.

[0122] In one embodiment of the present invention, the pouch composition contains a flavorant in an amount of 0.01 to 10% by weight of the pouch composition, for example, in an amount of 0.01 to 8% by weight of the pouch composition, for example, in an amount of 0.01 to 5% by weight of the pouch composition.

[0123] In one embodiment of the present invention, the pouch composition is substantially homogeneous. For example, if at least 90% by weight of the total amount of the dry components is mixed before adding water following nicotine, or before adding water and liquid flavorant (if any) following nicotine, a more homogeneous pouch composition with a uniform distribution of nicotine can be obtained.

[0124] In an advantageous embodiment of the present invention, the relative standard deviation (RSD) of the nicotine content among a series of at least 10 oral pouches composed of the pouch composition is 10% or less, preferably 8% or less, more preferably at most 6%, still more preferably at most 4%, and most preferably at most 2%.

[0125] In one embodiment of the present invention, the relative standard deviation (RSD) of the nicotine content among a series of at least 10 oral pouches composed of the pouch composition is maintained at 0.1 to 10%, preferably 0.1 to 8%, more preferably 0.1 to 6%, still more preferably 0.1 to 4%, and most preferably 0.1 to 2%.

[0126] The homogeneity of the pouch composition can be evaluated by estimating the distribution among individual pouches of one component of the composition. For example, the standard deviation of the nicotine content, i.e., the content uniformity (CU) of the nicotine content, is related to the homogeneity of the pouch composition. Pouches prepared from the same pouch composition with a low standard deviation of the nicotine content have a high homogeneity of the pouch composition, while pouches prepared from the same pouch composition with a high standard deviation of the nicotine content have a low homogeneity of the pouch composition.

[0127] In an advantageous embodiment of the present invention, the composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, and the composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition.

[0128] In an advantageous embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof. The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition, and the composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition.

[0129] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition. the composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, and the water-insoluble composition contains or consists of water-insoluble fibers such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof.

[0130] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition. the composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, and The water-insoluble composition contains or consists of water-insoluble fibers such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof, and the pouch composition contains a flavoring agent in an amount of 0.01 to 15% by weight of the pouch composition, for example, 0.1 to 15% by weight of the pouch composition, for example, 1 to 10% by weight of the pouch composition, for example, 3 to 10% by weight of the pouch composition.

[0131] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof. The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition. The composition further contains water-insoluble fibers in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition. The water-insoluble composition contains or consists of water-insoluble fibers such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof, and the pouch composition contains a flavoring agent in an amount of 0.01 to 15% by weight of the pouch composition, for example, 0.1 to 15% by weight of the pouch composition, for example, 1 to 10% by weight of the pouch composition, for example, 3 to 10% by weight of the pouch composition, and the flavoring agent is an oil-based one.

[0132] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof. The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition. The composition further contains water-insoluble fibers in an amount of 5 to 50% by weight, for example 10 to 30% by weight, etc., of the pouch composition, and The pouch composition contains a pH regulator selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium hydrogen carbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0133] In a preferred embodiment of the present invention, the pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight, for example 5 to 70% by weight, etc., for example 10 to 60% by weight, etc., of the pouch composition, The composition further contains water-insoluble fibers in an amount of 5 to 50% by weight, for example 10 to 30% by weight, etc., of the pouch composition, and The pouch composition contains a basic pH regulator such as a basic buffering agent, and / or a pH regulator which is sodium carbonate, sodium hydrogen carbonate, potassium carbonate, potassium hydrogen carbonate, magnesium carbonate, or any combination thereof.

[0134] The present invention further relates to an oral pouched nicotine product comprising a saliva-permeable pouch and a nicotine pouch composition, The nicotine pouch composition is: At least one sugar alcohol, At least one water-insoluble fiber, water in an amount of 8 to 65% by weight of the composition, and nicotine, and the pouch has a maximum inner pouch volume, and the nicotine pouch composition has a volume corresponding to at least 65% of the maximum inner pouch volume.

[0135] An advantage of the present invention would be that a very favorable mouthfeel is obtained. Heretofore, the focus has been on the pouch composition, which of course plays an important role. The inventors have surprisingly discovered that by filling up to near the maximum inner volume of the pouch, the mouthfeel is significantly improved.

[0136] Furthermore, by using the pouch composition according to the claims, a high mobility of the composition is obtained, and the pouch can be effectively filled without causing excessive compression of the pouch composition. Thereby, a relatively low-density and large-capacity pouch is obtained. Due to the low density, it can effectively contact saliva during use, which in turn facilitates, for example, the rapid release of nicotine. At the same time, the low density reduces the need for raw materials and also leads to a reduction in manufacturing costs.

[0137] A further advantage of the present invention is that a high mobility of the pouch composition is obtained. Using this high mobility, a high degree of filling of the pouch is obtained, preferably with a relatively low-density pouch composition. It was expected that a large amount of water in a composition containing sugar alcohol and fiber would cause major problems in the manufacture of pouch products. A typical measure of the processability of a powder composition is fluidity, and a certain minimum fluidity is required to effectively process the composition. High water content usually results in very low fluidity and very poor processability.

[0138] However, it has been shown that the obtained pouch composition is actually processable and has mobility within the processable range. Due to this high mobility, the pouch can be filled with high fillability and a relatively low density composition can be maintained. Thereby, advantageously, the manufactured pouch can have a high volume while keeping the consumption of raw materials low. This is surprising. The reason is that when water is added, the mobility deteriorates, resulting in a high density composition, and if the user experience associated with a full pouch is not offset, the manufacturing becomes complex and the raw material cost is expected to increase.

[0139] In a preferred embodiment of the present invention, the composition has a bulk density of less than 0.8 g / cm3, for example less than 0.7 g / cm3, for example less than 0.6 g / cm3, for example less than 0.5 g / cm3, within the pouch.

[0140] In a preferred embodiment of the present invention, the pouch includes a water-permeable membrane including, for example, a woven fabric or a non-woven fabric. Typically, the pouch membrane includes an opening, and the characteristic opening dimensions are adapted to the characteristic dimensions of the pouch composition so as to hold the pouch composition inside the pouch before use and / or hold a part of the pouch composition such as a water-insoluble composition inside the pouch during use.

[0141] To obtain a pouch membrane having suitable opening dimensions in consideration of the pouch composition to be used, for example, the material of the pouch membrane including woven fabric and / or non-woven fabric can be appropriately selected. In other words, according to various embodiments, the pouch membrane allows the passage of saliva and impedes or prevents the passage of undissolved compositions and water-insoluble fibers. The pouch membrane can be any suitable material, such as a woven or non-woven fabric (e.g., cotton, fleece, etc.), heat-sealable non-woven cellulose such as long fiber paper, or other polymeric materials such as synthetic, semi-synthetic, or natural polymeric materials. An example of a suitable material for the pouch membrane is paper made from pulp and a small amount of wet strength agent. The material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from exiting the bag or pouch during use. The suitable material also has no significant effect on the release of nicotine from the pouch.

[0142] More specifically, with regard to the material, the pouch membrane can be a natural, synthetic, or semi-synthetic hydrophilic or hydrophobic membrane. It can be manufactured from one or more biocompatible and physiologically acceptable polymeric materials. Examples of suitable materials for the pouch membrane include cellulose acetate and its derivatives, carboxymethyl cellulose, other cellulose derivatives including polycellulose esters, ethyl cellulose, propyl cellulose, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinyl acetate, polymers of methacrylates and acrylates, natural rubber, polycarbonate, polyethylene terephthalate, polyester, polyamide, and nylon. Other suitable materials have been mentioned earlier herein.

[0143] Rayon fibers such as viscose rayon fibers (i.e., regenerated cellulose) can also be used, for example, in combination with an acrylic polymer that acts as a binder in a non-woven material and provides heat sealing of the pouch membrane during its manufacture. Other binders such as copolymers of one or more vinyl acetates and acrylic esters can also be used.

[0144] Suitable pouch membranes are available under the trade names "Taboka", "CatchDry", "Ettan", "General", "Granit", "Goteborgs Rape", "GrovSnus White", "Metropol Kaktus", "Mocca Anis", "Mocca Mint", "Mocca Wintergreen", "Kicks", "Probe", "Prince", "Skruf", "TreAnkrare", "Camel Snus Original", "Camel Snus Frost", and "Camel Snus Spice". The pouch membrane provides a type of liquid-permeable container that may be considered similar in properties to the net-like type of material used in the construction of tea bags. The desired components of the nicotine composition to be released diffuse through the pouch membrane into the user's mouth.

[0145] The material of the pouch membrane can have forms such as a net, sieve, perforated paper, permeable cloth, etc. For example, a pouch material made from rice paper in a net-like form or perforated straw paper can dissolve in the user's mouth. In some exemplary embodiments, the material of the pouch membrane can be manufactured using a water-dispersible film-forming material (such as binders like alginate, carboxymethyl cellulose, xanthan gum, pullulan, etc.), and those materials combined with materials such as ground cellulose derivatives (such as fine particle size wood pulp). Preferred pouch materials are water-dispersible or soluble, but are designed and manufactured such that a significant amount of the nicotine content permeates through the pouch material before the time when the pouch loses its physical integrity under normal use conditions. If desired, flavoring components, disintegration aids, and other desired components may be incorporated into or applied to the pouch material.

[0146] Examples of various types of pouch film materials are described in U.S. Patent No. 5,167,244, issued to Kjerstad. Fleece materials for use as pouch films are described, for example, in International Publication No. 2008 / 152469, British Patent No. 673,587, and European Patent No. 2692254.

[0147] In one embodiment of the present invention, the film comprises water-insoluble fibers of a different origin than the water-insoluble fibers contained in the pouched product. In one embodiment of the present invention, both the water-insoluble fibers of the film and the water-insoluble fibers of the pouch composition include natural fibers.

[0148] In one embodiment of the present invention, both the water-insoluble fibers of the film and the water-insoluble fibers of the pouch composition are natural fibers. In a preferred embodiment of the present invention, the pouched product comprises the pouch in an amount up to 20 weight percent of the pouched product, such as in an amount up to 15 weight percent of the pouched product.

[0149] In a preferred embodiment of the present invention, the pouched product comprises the pouch in an amount of 3 to 20 weight percent of the pouched product, such as in an amount of 5 to 15 weight percent of the pouched product.

[0150] In a preferred embodiment of the present invention, the pouch has a maximum inner pouch volume, and the nicotine pouch composition has a volume corresponding to at least 70% of the maximum inner pouch volume, such as at least 80% of the maximum inner pouch volume, such as at least 90% of the maximum inner pouch volume, such as at least 95% of the maximum inner pouch volume.

[0151] In one embodiment of the present invention, the pouch has a maximum inner pouch volume, and the nicotine pouch composition has a volume corresponding to at least 90% of the maximum inner pouch volume, such as at least 95% of the maximum inner pouch volume.

[0152] In a preferred embodiment of the present invention, the maximum inner pouch volume is at least 0.5 mL, such as at least 1.0 mL or the like. In one embodiment, the maximum inner pouch volume is from 0.5 mL to 3.0 mL, such as from 1.0 to 2.0 mL, for example.

[0153] In a preferred embodiment of the present invention, an oral nicotine pouch-filled product according to the present invention or any of its embodiments comprises a nicotine pouch composition according to the present invention or any of its embodiments.

[0154] The present invention further relates to a method for manufacturing an oral pouch-filled product according to the present invention or any of its embodiments, the method comprising the following addition steps: - providing a pouch composition according to the present invention or any of its embodiments, - providing a saliva-permeable pouch, - adding the pouch composition to the pouch, and - sealing the pouch. comprises.

Embodiments for Carrying Out the Invention

[0155] As used herein, the term "nicotine" refers to nicotine used as a purified / isolated substance. In particular, nicotine does not refer to tobacco materials containing nicotine.

[0156] As used herein, the term "nicotine pouch composition" refers to a composition for use in a pouch-filled product, i.e., a pouch for oral use containing nicotine. Also, the terms "nicotine pouch composition" and "pouch composition" are used interchangeably. The nicotine pouch composition is not a tobacco-based pouch composition. In some embodiments, the nicotine pouch composition may contain a small amount of tobacco, less than 2% by weight of the composition, as a flavorant. In other embodiments, the nicotine pouch composition does not contain tobacco.

[0157] As used herein, the term "free base nicotine" refers to nicotine in its non-protonated form and thus does not include nicotine provided as a nicotine salt or a complex of nicotine with an ion exchange resin. However, free base nicotine can be mixed with a certain amount of an ion exchange resin or a water-soluble composition such as a sugar alcohol or a water-soluble fiber. Free base nicotine includes both free base nicotine extracted from tobacco and free base nicotine produced synthetically, but free base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, free base nicotine is provided as a liquid.

[0158] As used herein, the term "pouch" is intended to typically mean a container formed by a web of fibrous material surrounding a cavity. Since the pouch is designed to administer the active ingredient into the oral cavity, it is suitable for use in the oral cavity, non-toxic, and not water-soluble. The fibrous material may form, for example, a woven or non-woven web or cloth. The pouch may, for example, adhere and seal two corresponding portions of the web or cloth to each other along its ends to form a cavity for nicotine and the water-insoluble composition. To release nicotine, flavorants, and other water-soluble substances, the pouch is water-permeable such that saliva from the oral cavity penetrates the pouch into the cavity where the saliva contacts the nicotine, flavorants, and other water-soluble substances, thereby releasing the nicotine, flavorants, and other water-soluble substances from the oral pouch.

[0159] As used herein, the term "powder composition" refers to a composition in the form of a powder, i.e., a particulate material having a relatively small particle size, for example, from 1 to 1200 micrometers. In particular, the powder composition does not mean powdered tobacco.

[0160] As used herein, when fluidity is not applicable, the term "mobility" is a parameter of powder processability. As used herein, the term "humectant" is understood as a wetting agent used to attract moisture or water in the form of saliva. Humectants include compositions that are suitably hygroscopic. In some cases, because humectants serve to attract moisture, they may also be referred to as moisturizers. Examples of humectants include glycerol, propylene glycol, triacetin, modified starch, hydroxypropyl cellulose, alginate, pectin, xanthan gum, and the like.

[0161] As used herein, the term "water-soluble" refers to a relatively high water solubility, for example, a water solubility of a water-soluble composition or substance that exceeds 5 grams per 100 mL of water, measured at 25 degrees Celsius and a pH of 7.0. When referring to a "soluble" composition or substance, water-soluble is meant unless otherwise specified.

[0162] As used herein, the term "water-insoluble" refers to a relatively low water solubility, for example, a water solubility of a water-soluble composition or substance that is less than 0.1 gram per 100 mL of water, measured at 25 degrees Celsius and a pH of 7.0. When referring to "insoluble", water-insoluble is meant unless otherwise specified.

[0163] As used herein, the term "flavor" is understood to have its ordinary meaning within the art. Flavors include liquid and powdered flavors. Thus, flavors do not, of course, include sweeteners (such as sugars, sugar alcohols, and high-intensity sweeteners), acids that impart a pure acidity / sourness, or compounds that impart a pure saltiness (such as NaCl) or a pure bitterness. Flavor enhancers include substances that impart only saltiness, bitterness, or sourness. Thus, examples of flavor enhancers include NaCl, citric acid, ammonium chloride, and the like.

[0164] The pouch of the present invention provides nicotine release into the oral cavity. A nicotine release profile can be obtained that includes both a rapid release period and a sustained release period. As used herein, the term "rapid release" or "rapid release period" may refer to the first 2 minutes of the nicotine release profile, while the term "sustained release period" refers to the subsequent period of the release profile until the end of the experiment or the end of use.

[0165] As used herein, "release rate" describes the average release of nicotine per minute within a given period. For example, if the pouch further releases 16% of the nicotine dose during the period from 2 minutes to 10 minutes, the release rate is 2% per minute within this given period. Alternatively, if the pouch further releases 2 mg of nicotine during the period from 2 minutes to 10 minutes, the release rate is 0.25 mg per minute within this given period. The release rate is determined from only the release data at time points outside the period.

[0166] Generally, the pouch has an opening, and the characteristic dimensions of the opening are adapted to the characteristic dimensions of the pouch composition in order to retain the pouch composition within the pouch before use and / or to retain a portion of the pouch composition, such as a water-insoluble composition, within the pouch during use.

[0167] In order to obtain a pouch having appropriate opening dimensions considering the pouch composition to be used, the material of the pouch can be appropriately selected, such as, for example, a material made of a woven fabric and / or a non-woven fabric.

[0168] In other words, according to various embodiments, the pouch forms a membrane that allows the passage of saliva and prevents or inhibits the passage of undissolved compositions and water-insoluble fibers. The membrane of the pouch can be made of any suitable material, such as, for example, a woven fabric or a non-woven fabric (e.g., cotton, fleece, etc.), a heat-sealable non-woven cellulose, or other polymeric materials such as synthetic, semi-synthetic, or natural polymeric materials. Examples of suitable pouch materials include paper made of pulp and a small amount of wet strength agent. The material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from exiting the bag or pouch during use. Also, a suitable material is one that does not significantly affect the release of nicotine from the pouch.

[0169] The pouch composition is filled into the pouch and maintained therein by sealing. An ideal pouch is chemically and physically stable, pharmaceutically acceptable, insoluble in water, capable of being filled with powder and sealed, provides a semi-permeable membrane layer to prevent the powder from exiting the bag, but allows components from the pouch composition within the pouch, such as saliva and nicotine and flavorings dissolved therein or sufficiently finely suspended therein, to pass through the pouch.

[0170] The pouch can be placed by the user into the oral cavity. Thereafter, saliva enters the pouch, nicotine and other components soluble in saliva begin to dissolve, and are carried from the pouch into the oral cavity together with the saliva, where the nicotine can be absorbed.

[0171] According to one embodiment of the present invention, the pouch composition includes one or more pH control agents such as a buffering agent. In one embodiment of the present invention, the pH control agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0172] According to various embodiments of the present invention, one or more sugar alcohols can be included in the pouch as part of the pouch composition, for example, as a carrier or part thereof, as a water retention agent, or as a sweetening agent. Suitable sugar alcohols include sugar alcohols selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof.

[0173] In one embodiment of the present invention, the pouch composition comprises a high intensity sweetener. Preferred high intensity sweeteners include, alone or in combination, sucralose, aspartame, salts of acesulfame such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcone, thaumatin, monellin, stevioside, and the like, but are not limited thereto.

[0174] In one embodiment of the present invention, the pouch composition comprises a sugar and / or sugar-free sweetener, such as a sugar alcohol. In one embodiment of the present invention, the pouch composition comprises a sugar and / or sugar-free sweetener in an amount of 1.0 to about 80% by weight of the pouch composition, more typically constituting 5 to about 70% by weight of the pouch composition, more generally constituting 10 to 30% by weight of the pouch composition or 5 to 25% by weight of the pouch composition. In some other embodiments, the sugar and / or sugar-free sweetener constitutes 10 to 60% by weight of the pouch composition, or 10 to 50% by weight of the pouch composition. The sugar and / or sugar-free sweetener may function not only as a sweetener but also as a water retention agent. In some embodiments, the approximate amounts of the sugar and / or sugar-free sweetener can be further restricted by including certain components. In some embodiments, the content of the sugar and / or sugar-free sweetener in the pouch composition is 20% by weight or less of the pouch composition, such as 15% by weight or less of the pouch composition, such as 10% by weight or less of the pouch composition, such as 5% by weight or less of the pouch composition.

[0175] The sweetener can often support the flavor profile of the pouch composition. As sugar sweeteners, generally, sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, solid corn syrup, glucose syrup, hydrogenated glucose syrup, etc., alone or in combination, are included, but not limited to these. These sugar sweeteners can also be included as water retention agents.

[0176] The sweetener can be used in combination with a sugar-free sweetener. Generally, the sugar-free sweetener contains components that have sweetening properties but do not contain commonly known sugars, and includes, alone or in combination, sugar alcohols such as sorbitol, mannitol, xylitol, hydrolyzed hydrogenated starch, maltitol, isomalt, erythritol, lactitol, etc., but is not limited to these. These sugar-free sweeteners can also be included as water retention agents.

[0177] In one embodiment of the present invention, the pouch composition further contains water-soluble fiber. Non-limiting examples of water-soluble fiber include inulin, polydextrose, and psyllium plant fiber. Also, other water-soluble dietary fibers may be used.

[0178] In one embodiment of the present invention, the pouch composition contains a flavoring agent. The flavoring agent may typically be present in an amount of 0.01 to 15% by weight, for example, 0.01 to 5% by weight of the total composition of the pouch. In an alternative embodiment, the pouch composition may not contain a flavoring agent.

[0179] Non-exhaustive examples of flavorings suitable for one embodiment of the present invention are coconut, coffee, chocolate, vanilla, grapefruit, orange, lime, bergamot, or citrus fruits such as lemon, menthol, licorice, caramel aroma, honey aroma, peanuts, walnuts, cashews, hazelnuts, almonds, pineapple, strawberry, raspberry, tropical fruits, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essences such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, lemongrass, lime, chili (capsaicin), citrus, tobacco flavoring, bergamot, plum essence. Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cider leaf oil, nutmeg, and the oils of the fruits described above.

[0180] In various embodiments of the present invention, the pouch composition includes a release controlling composition for controlling the release of the pouch composition and / or a portion thereof, particularly nicotine.

[0181] According to various embodiments, the release controlling composition may be selected from the group consisting of metal stearates, modified calcium carbonate, hydrogenated vegetable oil, partially hydrogenated vegetable oil, polyethylene glycol, polyoxyethylene monostearate, animal fat, silicate, silicon dioxide, talc, magnesium stearate, calcium stearate, fumed silica, powdered hydrogenated cottonseed oil, hydrogenated vegetable oil, hydrogenated soybean oil, emulsifier, triglyceride, and mixtures thereof. In particular, metal stearates such as magnesium stearate may be advantageous.

[0182] The release controlling composition can be added to the pouch composition in various ways. In one embodiment of the present invention, the pouch composition does not contain triglyceride. For example, the release control composition can be obtained by being added by a fully powder mixture during the last few minutes of the final mixing.

[0183] Alternatively, the release control composition may be added after the granulation step in the granulation premix. Furthermore, the release control composition may be added only as part of the pouch composition so that two different nicotine release profiles can be obtained. Further, two or more portions of the pouch composition may, if any, contain different amounts of the release control composition, thereby providing a more complex and adjusted nicotine release profile.

[0184] Release control compositions such as magnesium stearate can have a sealing effect and can be used to control the release of nicotine and the solubility of the pouch.

Examples

[0185] Example 1A - Preparation of a Pouch Designed for Administration of Nicotine The material of the pouch is a heat-sealable non-woven cellulose such as long fiber paper. Pouches not in the form of non-woven cellulose cloth can also be used according to the present invention.

[0186] The powder is filled into the pouch and maintained in the pouch by sealing. Example 1B - Preparation of a Pouch Designed for Administration of Nicotine The material of the pouch is manufactured using rayon fibers such as viscose rayon staple fibers. The pouch film is heat-sealed along its edge except for an opening at one end leading to an internal void formed by the pouch film.

[0187] The powder is filled into the pouch and maintained in the pouch by sealing. Example 2A - Nicotine Premix I - Resin Water was added to a Stephan mixer (vacuum premixing), nicotine was weighed and added, the mixer was closed, and stirred for 5 minutes. Next, the ion exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed and stirred for 10 - 60 minutes.

[0188] Thereby, a mixture of nicotine and cation exchange resin was produced from the components described in Table 1 below.

[0189]

Table 1

[0190] Example 2B - Nicotine Premix II - Resin Water was added to a 60 - liter planetary Bear Varimixer, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, the ion exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened, and scraped if necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0191] Thereby, a mixture of nicotine and cation exchange resin was produced from the components described in Table 2 below.

[0192]

Table 2

[0193] The total processing time was 20 minutes. Example 2C - Nicotine Premix III - Resin Water was added to a 60 - liter planetary Bear Varimixer, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, the ion - exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, then opened and scraped if necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0194] Thereby, a mixture of nicotine and cation - exchange resin was produced from the components described in Table 3 below.

[0195]

Table 3

[0196] The total processing time was 20 minutes. Example 2 D - Nicotine Premix IV - Resin Water was added to a 60 - liter planetary Bear Varimixer, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, the ion - exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, then opened and scraped if necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0197] Thereby, a mixture of nicotine and cation - exchange resin was produced from the components described in Table 4 below.

[0198]

Table 4

[0199] The total processing time was 20 minutes. Example 2 E - Nicotine Premix V - Resin Water was added to a 60 liter planetary Bear Varimixer, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, the ion exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, opened, and scraped if necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0200] Thereby, a mixture of nicotine and cation exchange resin was produced from the components described in Table 4B below.

[0201] [Table 5]

[0202] The total processing time was 20 minutes. Example 2F - Nicotine Premix VI - Resin Water was added to a 60 liter planetary Bear Varimixer, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, the ion exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, opened, and scraped if necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0203] Thereby, a mixture of nicotine and cation exchange resin was produced from the components described in Table 4C below.

[0204] [Table 6]

[0205] The total processing time was 20 minutes. Example 2G - Nicotine Premix VII - Resin Water was added to a 60-liter planetary Bear Varimixer, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, the ion exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, opened, and scraped if necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0206] Thereby, a mixture of nicotine and the cation exchange resin was produced from the components described in Table 4D below.

[0207] [Table 7]

[0208] The total processing time was 20 minutes. Example 2H - Nicotine Premix VIII - Resin Water was added to a 60-liter planetary Bear Varimixer, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, the ion exchange resin Amberlite® IRP64 and the fiber were weighed and added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, opened, and scraped if necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0209] Thereby, a mixture of nicotine and the cation exchange resin was produced from the components described in Table 4E below.

[0210] [Table 8]

[0211] The total processing time was 20 minutes. Example 3A - Pouch Pouches PPC1 - PPC5 containing nicotine premix are prepared, including the powdered compositions outlined in Table 5. The pouches are manufactured as follows.

[0212] Using a planetary Bear Varimixer, mix the fibers and water for 5 minutes. Then, the following ingredients were subsequently added while mixing continuously: nicotine premix (mixed for 2 minutes), then the remaining ingredients other than liquid flavoring and flow promoter if any (mixed for 2 minutes), then liquid flavoring if any (mixed for 1 minute), then flow promoter if any (mixed for 1 minute). The total mixing time is 9 - 11 minutes.

[0213] Fill the final powder composition into pouches (500 mg of powder per pouch with a target filling weight). Use the pouch material of Example 1A made from long fiber paper. Fill the powder into the pouches and maintain it inside the pouches by sealing.

[0214] The material of the pouch is heat-sealable non-woven cellulose such as long fiber paper. Pouches not in the form of non-woven cellulose cloth can also be used according to the present invention. Also, the pouch material of Example 1B can be used.

[0215] Fill the powder into the pouches and maintain it inside the pouches by sealing. As outlined in Table 5, pouches PPC6 - PPC7 containing nicotine as nicotine salt or nicotine polacrilrex resin. The pouches are manufactured as follows.

[0216] Mix the fibers and water using a planetary Bear Varimixer for 5 minutes. Then, the following ingredients were subsequently added while mixing continuously: first, nicotine hydrogen tartrate xH2O (NBT, nicotine content of 32.5%) or nicotine polacrilrex resin (NPR, nicotine content of 15.9%) if applicable (mixed for 2 minutes), then the remaining ingredients other than liquid flavoring and flow promoter if any (mixed for 2 minutes), then liquid flavoring if any (mixed for 1 minute), then flow promoter if any (mixed for 1 minute). The total mixing time is 9 - 11 minutes.

[0217] Fill the final powder composition into pouches (500 mg of powder per pouch with a target filling weight). Use the pouch material of Example 1A made from long fiber paper. Fill the powder into the pouches and maintain it inside the pouches by sealing.

[0218] The material of the pouch is a heat-sealable non-woven cellulose such as long fiber paper. Pouches not in the form of non-woven cellulose cloth can also be used according to the present invention. Also, the pouch material of Example 1B may be used.

[0219] Fill the powder into the pouches and maintain it inside the pouches by sealing.

[0220]

Table 9

[0221] Pouch internal volume: 500 mg in total, that is, nicotine concentration 19.2 mg / g. The xylitol applied is, for example, the product named "Xylitab (registered trademark) 200".

[0222] Wheat fiber, product named "Vitacel (registered trademark) 600 WF Plus". As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, barley fiber, tomato fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, bran fiber, bamboo fiber, powdered cellulose, cocoa fiber, cellulose fiber, etc. can be used in the same way.

[0223] For example, a mixture of menthol and peppermint can be used. Naturally, other flavoring agents described in this specification can also be used in combination with menthol and / or peppermint, or instead of these.

[0224] As a water retention agent, sodium alginate, glycerol, hydroxypropyl cellulose (HPC) may be used. Also, in combination with or as an alternative to sodium alginate, glycerol, HPC, other water retention agents described herein may be used.

[0225] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, and the like. Sodium carbonate is used as an alkaline buffer. Also, other buffers described herein may be used in combination with or as an alternative to sodium carbonate.

[0226] Potassium sorbate is used as a preservative. Also, other preservatives described herein can be used in combination with or as an alternative to potassium sorbate.

[0227] As a high-intensity sweetener, for example, acesulfame potassium can be used. Other usable high-intensity sweeteners described herein may be used in combination with or as an alternative to acesulfame potassium.

[0228] Pouches PPC1 - PPC5 show that different pouches having a water content of at least 10% by weight of the pouch composition can be produced using free base nicotine. Pouches PPC6 and PPC7 have the same water content as PPC1, but use nicotine which is a complex of a nicotine salt and an ion exchange resin.

[0229] Example 3B - Pouch Pouches PPC11 - PPC15 and Comparative 1 - 2 (Com.1 - 2) containing a nicotine premix were prepared containing a powdered composition as outlined in Table 6. The pouches were manufactured as follows.

[0230] Mix the fiber and powder components (excluding the flow promoter) using a planetary Bear Varimixer for 2 minutes. Next, add the nicotine premix and mix for 2 minutes. Then, add water and mix for 5 minutes, followed by adding the liquid flavoring (if any, mix for 1 minute) and the flow promoter (if any, mix for 1 minute). The total mixing time is 9 - 11 minutes.

[0231]

Table 10

[0232] Contents of the pouch: 500 mg in total. The isomalt applied is, for example, GalenIQ™ 720. Wheat fiber, trade name “Vitacel® 600 WF Plus”. As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, barley fiber, tomato fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, cocoa fiber, cellulose fiber, etc. can be used in the same way.

[0233] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described in this specification can also be used in combination with menthol and / or peppermint, or instead of them.

[0234] Sodium alginate, glycerol, hydroxypropyl cellulose (HPC) may be used as the water retention agent. Also, sodium alginate, glycerol, HPC can be combined or alternatively, other water retention agents described in this specification can be used.

[0235] Silicon dioxide is used as the flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer. Other buffers described in this specification may be used in combination with sodium carbonate or as an alternative to sodium carbonate.

[0236] Potassium sorbate is used as a preservative. Other preservatives described in this specification can also be used in combination with potassium sorbate or as an alternative to potassium sorbate.

[0237] As a high-intensity sweetener, for example, acesulfame potassium can be used. Other usable high-intensity sweeteners described in this specification may be used in combination with acesulfame potassium or as an alternative to acesulfame potassium.

[0238] Pouches PPC11 to PPC15 exhibit various water contents of at least 10% by weight of the pouch composition. Although the water contents vary, the ratio of the amount of purified water added to the amount of fiber remains constant.

[0239] Example 3C - Pouch Pouches PPC21 to PPC26 are prepared by including the powdered composition as outlined in Table 7 and are manufactured in the same manner as pouches PPC11 to PPC15 of Example 3B.

[0240] [Table 11]

[0241] Contents of the pouch: 500 mg in total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, barley fiber, tomato fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, cocoa fiber, cellulose fiber, etc. can be used in the same way.

[0242] For example, a mixture of menthol and peppermint can be used. Naturally, other flavoring agents described in this specification can also be used in combination with menthol and / or peppermint, or alternatively, in place of them.

[0243] As the water retention agent, sodium alginate, glycerol, hydroxypropyl cellulose (HPC) may be used. Also, other water retention agents described in this specification can be used in combination with sodium alginate, glycerol, HPC, or alternatively, in place of them.

[0244] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, and the like. Sodium carbonate is used as an alkaline buffer. Also, other buffers described in this specification can be used in combination with sodium carbonate or alternatively, in place of it.

[0245] Potassium sorbate is used as a preservative. Also, other preservatives described in this specification can be used in combination with potassium sorbate or alternatively, in place of potassium sorbate.

[0246] As the high-intensity sweetener, for example, acesulfame potassium can be used. Other usable high-intensity sweeteners described in this specification can be used in combination with acesulfame potassium or alternatively, in place of acesulfame potassium.

[0247] Pouch PPC21 indicates the use of, for example, microcrystalline cellulose (MCC) instead of wheat fiber. Pouch PPC22 indicates the use of a combination of nicotine-ion exchange resin premix and nicotine-sugar alcohol premix.

[0248] Pouches PPC23 - PPC26 show the use of various amounts of buffer (here sodium carbonate). With a greater amount of basic buffer to achieve a more alkaline environment, the need for a preservative (here potassium sorbate) is reduced, and thus it is omitted in PPC25 - PPC26 which have the highest amount of alkaline buffer.

[0249] Example 3D - Pouch Pouches PPC31 - PPC32 are prepared containing the powdered compositions as outlined in Table 8 and are manufactured in the same manner as Pouches PPC1 - PPC5 of Example 3A, but using nicotine premixes I and III respectively.

[0250] Pouches PPC33 - PPC37 are manufactured as follows. Weigh nicotine and sugar alcohols (such as xylitol, sorbitol, maltitol, etc.). Slowly add nicotine to the sugar alcohol powder while stirring (a Kitchenaid mixer operates at approximately 30 RPM for about 30 minutes). Sieve the resulting granules and place them on a tray. Dry the resulting powder overnight at ambient temperature and then sieve to obtain a nicotine - sugar alcohol premix. It is also possible to add a certain amount of water to the nicotine before mixing with the sugar alcohol. Such water will then evaporate during drying.

[0251] Mix the fibers and water for 5 minutes using a planetary Bear Varimixer. Then, the following components are subsequently added while mixing continuously: powder components other than the nicotine premix (mix for 2 minutes), the nicotine - sugar alcohol premix (mix for 2 minutes), then liquid flavorant (if any) (mix for 1 minute), and finally the flow promoter (if any) (mix for 1 minute). The total mixing time is 9 - 11 minutes. Fill the final powder composition into pouches (target fill weight 500 mg powder per pouch). Use the pouch material of Example 1A made from long - fiber paper. Fill the powder into the pouches and maintain it inside the pouches by sealing.

[0252] The material of the pouch is a heat-sealable non-woven cellulose such as long-fiber paper. Pouches not in the form of non-woven cellulose fabric can also be used in accordance with the present invention. Also, the pouch material of Example 1B may be used.

[0253] The powder is filled into the pouch and maintained inside the pouch by sealing.

[0254] [Table 12]

[0255] Contents of the pouch: 500 mg in total. Wheat fiber, trade name "Vitacel® 600 WF Plus". As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, cocoa fiber, cellulose fiber, etc. can be used in the same manner.

[0256] For example, a mixture of menthol and peppermint can be used. Of course, other flavoring agents described in this specification can also be used in combination with menthol and / or peppermint, or instead of these.

[0257] As the water retention agent, sodium alginate, glycerol, hydroxypropyl cellulose (HPC) may be used. Also, other water retention agents described in this specification can be used in combination with sodium alginate, glycerol, HPC, or as an alternative.

[0258] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer. Also, other buffers described in this specification may be used in combination with sodium carbonate or as an alternative.

[0259] Potassium sorbate is used as a preservative. Also, other preservatives described in this specification can be used in combination with potassium sorbate or as an alternative to potassium sorbate.

[0260] As a high-intensity sweetener, for example, acesulfame potassium can be used. Other usable high-intensity sweeteners described in this specification may be used in combination with acesulfame potassium or as an alternative to acesulfame potassium.

[0261] Pouches PPC31 - PPC32 indicate the use of other nicotine premixes. Pouches PPC33 - PPC35 indicate the use of nicotine premixed with different sugar alcohols.

[0262] Pouches PPC36 - PPC37 indicate the use of nicotine premixed with different water-soluble fibers. Example 3E - Pouch Pouches PPC41 - PPC46 are prepared containing the powdered composition as outlined in Table 9 and are manufactured in the same manner as Pouches PPC1 - PPC5 of Example 3A.

[0263]

Table 13

[0264] Contents of the pouch: 500 mg in total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, cocoa fiber, cellulose fiber, etc. can be used in the same way.

[0265] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described in this specification can also be used in combination with menthol and / or peppermint or instead of these.

[0266] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, etc. As a water retention agent, sodium alginate, glycerol, hydroxypropyl cellulose (HPC) may be used. Also, other water retention agents described in this specification can be used in combination with or as an alternative to sodium alginate, glycerol, HPC.

[0267] Sodium carbonate is used as an alkaline buffer. Also, other buffers described in this specification may be used in combination with or as an alternative to sodium carbonate.

[0268] Potassium sorbate is used as a preservative. Also, other preservatives described in this specification can be used in combination with or as an alternative to potassium sorbate.

[0269] As a high-intensity sweetener, for example, acesulfame potassium can be used. Other usable high-intensity sweeteners described in this specification may be used in combination with acesulfame potassium or as an alternative to acesulfame potassium.

[0270] Pouches PPC41 - PPC44 indicate the use of different amounts of nicotine from 4.8 mg to 12 mg. Pouch PPC45 does not contain alginate but otherwise corresponds to pouch PPC43 and is shown as a pouch.

[0271] Pouch PPC46 shows a pouch that combines two sugar alcohols. Example 3F - Pouch Pouches PPC51 - PPC53 are prepared containing the powdered composition as outlined in Table 10 and are manufactured as follows.

[0272] The fiber and powder components (excluding nicotine-containing powder and fluidizing agent) are mixed for 1 minute using a planetary Bear Varimixer. Then, NPR and NBT are added (if applicable) and mixed for 2 minutes. Next, the nicotine premix is added and mixed for 2 minutes. Next, water is added and mixed for 5 minutes, followed by addition of liquid flavoring (if any, for 1 minute) and fluidizing agent (if any, for 1 minute). The total mixing time is 9 - 11 minutes.

[0273] [Table 14]

[0274] Contents of the pouch: 500 mg in total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, cocoa fiber, cellulose fiber, etc. can be used in the same way.

[0275] For example, a mixture of menthol and peppermint can be used. Of course, other flavoring agents described in this specification can also be used in combination with menthol and / or peppermint, or used instead of them.

[0276] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer. Also, other buffers described in this specification may be used in combination with sodium carbonate or used as an alternative.

[0277] Potassium sorbate is used as a preservative. Also, other preservatives described in this specification can be used in combination with potassium sorbate or as an alternative to potassium sorbate.

[0278] As a high-intensity sweetener, for example, acesulfame potassium can be used. Other usable high-intensity sweeteners described in this specification may be used in combination with acesulfame potassium or as an alternative to acesulfame potassium.

[0279] Pouch PPC51 shows a pouch using a nicotine ion exchange resin premix in combination with nicotine hydrogen tartrate (NBT). Pouch PPC52 shows a pouch that uses a nicotine ion-exchange resin premix in combination with nicotine polyacrylate resin (NPR).

[0280] Pouch PPC53 shows a pouch that uses a nicotine ion-exchange resin premix in combination with nicotine hydrogen tartrate (NBT) and nicotine polyacrylate resin (NPR).

[0281] Example 3G - Pouch Pouches PPC61 - PPC64 containing a nicotine premix and Comparative P3 (COMP.P3) were prepared containing a powdered composition as outlined in Table 11. The pouches were manufactured as follows.

[0282] The powdered components, including powdered flavorant (if any), are mixed using a planetary Bear Varimixer for 2 minutes. Next, nicotine is added and mixed for 2 minutes. Next, water is slowly added during operation of the mixer, followed by liquid flavorant. Finally, silicon dioxide is added and mixed for about 1 minute. The total mixing time is about 30 minutes.

[0283] The final powdered composition is filled into the pouches (target fill weight 500 mg of powder per pouch). The pouch material of Example 1A made from long fiber paper is used. The powder is filled into the pouches and maintained within the pouches by sealing.

[0284] The material of the pouch is a heat-sealable non-woven cellulose such as long fiber paper. Pouches not in the form of non-woven cellulose cloth can also be used according to the present invention. Also, the pouch material of Example 1B may be used.

[0285] The powder is filled into the pouches and maintained within the pouches by sealing.

[0286]

Table 15

[0287] Pouch content volume: 500 mg in total, that is, nicotine concentration 19.2 mg / g. The sugar alcohol may be xylitol (for example, trade name "Xylitab (registered trademark) 200") and / or isomalt (for example, trade name "GalenIQ (registered trademark) 720").

[0288] Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, barley fiber, tomato fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, cocoa fiber, cellulose fiber, etc. can be used in the same way.

[0289] For example, a mixture of menthol and peppermint can be used. Naturally, other flavoring agents described in this specification can also be combined with menthol and / or peppermint or used instead of them.

[0290] As the water retention agent, sodium alginate, glycerol, hydroxypropyl cellulose (HPC) may be used. Also, other water retention agents described in this specification can be used in combination with or as an alternative to sodium alginate, glycerol, HPC.

[0291] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer. Also, other buffers described in this specification may be used in combination with or as an alternative to sodium carbonate.

[0292] Potassium sorbate is used as a preservative. Also, other preservatives described in this specification can be used in combination with potassium sorbate or as an alternative to potassium sorbate.

[0293] As the high-intensity sweetener, for example, acesulfame potassium can be used. Other usable high-intensity sweeteners described in this specification may be used in combination with acesulfame potassium or as an alternative to acesulfame potassium.

[0294] Pouches PPC61 - PPC63 indicate pouches with different contents of water and water-insoluble fibers. Example 3 H-pouch Pouches PPC71 - PPC76 containing nicotine premix were prepared to contain a powdered composition as outlined in Table 12. The pouches are manufactured as follows.

[0295] Mix the fiber and powder components (excluding the flow promoter) using a Loedige mixer for 2 minutes. Next, add the nicotine premix and mix for 2 minutes. Next, with the mixer operating, add water and mix for 15 minutes, followed by adding the liquid flavoring (if any, mix for 15 minutes) and the flow promoter (if any, mix for 1 minute). The total mixing time is 19 - 35 minutes.

[0296] Fill the final powder composition into the pouches (target filling weight 500 mg of powder per pouch). Use the pouch material of Example 1A made from long fiber paper. Fill the powder into the pouches and maintain it inside the pouches by sealing. Also, the pouch material of Example 1B may be used.

[0297]

Table 16 - 1

[0298]

Table 16 - 2

[0299] Nicotine Premix VIII contains pea fiber. Contents of the pouch: 500 mg in total, i.e., nicotine concentration 19.2 mg / g. Wheat fiber, trade name "Vitacel® 600 WF Plus".

[0300] Powdered cellulose, trade name "Vitacel® L00" or "Vitacel® L700G". Barley fiber, trade name "Vitacel® 600 WF Plus".

[0301] Broad bean fiber, trade name "Vitacel® EF150". As other fibers, water-insoluble plant fibers such as barley fiber, broad bean fiber, rice fiber, maize fiber, barley fiber, tomato fiber, rye fiber, lime fiber, sugar radish fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, bamboo fiber, powdered cellulose, bran fiber, cellulose fiber, etc. can be used in the same way.

[0302] For example, a mixture of menthol and peppermint can be used. Of course, other flavoring agents described in this specification can also be combined with or used instead of menthol and / or peppermint.

[0303] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, etc. As a water retention agent, sodium alginate, glycerol, hydroxypropyl cellulose (HPC) may be used. Also, other water retention agents described in this specification can be used in combination with or as an alternative to sodium alginate, glycerol, and HPC.

[0304] Sodium carbonate and sodium hydrogen carbonate are used as alkaline buffers. Also, other buffers described herein may be used in combination with sodium carbonate or as an alternative.

[0305] Potassium sorbate is used as a preservative. Also, other preservatives described herein can be used in combination with potassium sorbate or as an alternative to potassium sorbate.

[0306] Acesulfame potassium and / or sucralose can be used, for example, as high-intensity sweeteners. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose or as an alternative to acesulfame potassium and / or sucralose.

[0307] Pouches PPC71 - PPC74 indicate the use of different nicotine premixes. Pouches PPC75 - PPC77 indicate the use of different fibers. Example 3I - Pouch Pouches PPC81 - PPC92 containing nicotine premixes were prepared containing a powdered composition as outlined in Tables 13 - I and 13 - II. The pouches were made as follows.

[0308] The fiber and powder components (excluding the flow promoter) are mixed using a Loedige mixer for 2 minutes. Next, the nicotine premix is added and mixed for 2 minutes. Next, with the mixer running, water is added and mixed for 15 minutes, followed by adding the liquid flavoring (if any, mixed for 15 minutes) and the flow promoter (if any, mixed for 1 minute). The total mixing time is 19 - 35 minutes.

[0309] Fill the final powder composition into a pouch (500 mg of powder per target filled weight pouch). Use the pouch material of Example 1A made from long fiber paper. Fill the powder into the pouch and maintain it inside the pouch by sealing. Also, the pouch material of Example 1B may be used.

[0310]

Table 17

[0311]

Table 18

[0312] The nicotine premix contains water in various amounts, thereby contributing to the total water content. Contents of the pouch: 500 mg in total, i.e., nicotine concentration of 19.2 mg / g. Wheat fiber, trade name "Vitacel® 600 WF Plus" or "Vitacel® 200 WF".

[0313] Powdered cellulose, trade name "Vitacel® L00" or "Vitacel® L700G". Oat fiber, trade name "Vitacel® 600 WF Plus".

[0314] Pea fiber, trade name "Vitacel® EF150". As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar radish fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, bamboo fiber, powdered cellulose, rice bran fiber, cellulose fiber, etc. can be used in the same way.

[0315] For example, a mixture of menthol and peppermint can be used. Naturally, other flavoring agents described in this specification can also be used in combination with, or instead of, menthol and / or peppermint.

[0316] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, and the like. As a water retention agent, sodium alginate, glycerol, hydroxypropyl cellulose (HPC) may be used. Also, other water retention agents described in this specification can be used in combination with, or as an alternative to, sodium alginate, glycerol, and HPC.

[0317] Sodium carbonate and sodium bicarbonate are used as alkaline buffers. Also, other buffers described in this specification may be used in combination with, or as an alternative to, sodium carbonate.

[0318] Potassium sorbate is used as a preservative. Also, other preservatives described in this specification can be used in combination with, or as an alternative to, potassium sorbate.

[0319] As an example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other usable high-intensity sweeteners described in this specification may be used in combination with, or as an alternative to, acesulfame potassium and / or sucralose.

[0320] Pouches PPC81 - PPC92 indicate the use of various fibers, in various amounts, and various nicotine premixes. Pouches PPC93 - PPC94 each indicate the use of a buffer pair and a large amount of salt.

[0321] Example 3J - Pouch Pouches PPC101 to PPC107 containing nicotine premixes were prepared to contain a powdered composition as outlined in Table 14. The pouches are manufactured as follows.

[0322] Mix the fibers and powder components (excluding the flow promoter) using a Loedige mixer for 2 minutes. Next, add the nicotine premix and mix for 2 minutes. Next, with the mixer operating, add water and mix for 15 minutes, followed by adding the liquid flavoring (if any, mix for 15 minutes) and the flow promoter (if any, mix for 1 minute). The total mixing time is 19 to 35 minutes.

[0323] [Table 19]

[0324] Contents of the pouch: 500 mg in total. Wheat fiber, trade name "Vitacel® 600 WF Plus". As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, barley fiber, tomato fiber, rye fiber, turnip fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, powdered cellulose, cocoa fiber, bamboo fiber, bran fiber, cellulose fiber, etc. can be used in the same way.

[0325] For example, a mixture of menthol and peppermint can be used. Naturally, other flavorings described in this specification can similarly be combined with or used instead of menthol and / or peppermint.

[0326] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc, etc. As a water retention agent, sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) may be used. Also, in combination with or as an alternative to sodium alginate, glycerol, and HPC, other water retention agents described herein may also be used.

[0327] Sodium carbonate and sodium hydrogen carbonate are used as alkaline buffers. Also, other buffers described herein may be used in combination with or as an alternative to sodium carbonate.

[0328] Potassium sorbate is used as a preservative. Also, other preservatives described herein can be used in combination with or as an alternative to potassium sorbate.

[0329] Acesulfame potassium and / or sucralose can be used, for example, as high-intensity sweeteners. Other usable high-intensity sweeteners described herein may be used in combination with or as an alternative to acesulfame potassium and / or sucralose.

[0330] Pouches PPC101 - PPC102 show the use of different combinations of sweeteners and buffers. Pouches PPC103 - PPC104 show pouches with different fiber contents.

[0331] Pouches PPC105 - PPC107 show the use of different water retention agents. Example 3 K - Release Test (In Vivo) The release properties of the pouches were evaluated by assessors, preferably a panel of at least eight assessors. Each assessor was given a pouch to place in the mouth, specifically on the upper lip.

[0332] After 2 minutes, 5 minutes, 10 minutes, 30 minutes, or 60 minutes, the pouch was removed from the tester's mouth. The amount of nicotine remaining in the pouch was measured using standard HPLC techniques.

[0333] Two pouches were tested at each time point. The average of the results obtained at each time point was used to create a profile of the nicotine content in the pouch over time. Thereafter, the amount of nicotine released was obtained by subtracting the amount of nicotine remaining in the pouch from the initial dose of nicotine in the pouch being tested.

[0334] Example 3L - Release Test (In Vitro) The release properties of the pouch were verified in an in vitro experiment. Individual pouches were placed into reaction tubes approximately 2 cm in diameter containing 10 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4) warmed to 37 °C.

[0335] During the release experiment, no stirring or shaking was performed. After 2, 5, 10, 30, or 60 minutes, the pouches were removed from the buffer. Excess buffer was removed and the amount of remaining nicotine was measured using standard HPLC.

[0336] Two pouches were tested at each time point. The average of the results obtained at each time point was used to create a profile of the nicotine content in the pouch over time. Thereafter, the amount of nicotine released was obtained by subtracting the amount of nicotine remaining in the pouch from the initial dose of nicotine in the pouch being tested.

[0337] Example 3M - Content Uniformity The uniformity of content (CU) of the pouch samples was determined by the analysis of 10 replicate subsamples. For each subsample of approximately 500 mg, the nicotine content was measured using standard HPLC techniques. The nicotine content of the subsamples was expressed as a percentage of the nominal content of nicotine in the sample (i.e., % label claim). For example, if the analysis of a pouch sample with a nominal nicotine content of 20 mg / g resulted in an actual content of 19 mg / g, the nicotine content of the label claim would be 95%.

[0338] Next, the content uniformity of the sample is determined as the relative standard deviation (RSD) of the individual analysis of the relative nicotine content in 10 replicate experiments. Example 4 - Evaluation When the manufactured pouch of the present invention was evaluated, it was found to be very suitable as a nicotine delivery vehicle, providing a desirable release of nicotine and being comfortable for the user in terms of, for example, a desirable adhesive texture. In particular, the pouch of the present invention did not need to be moistened before use, in contrast to conventional nicotine pouches with a low water content that initially felt dry during use.

[0339] Example 5 - Mobility and Density The pouches of PPC1 and PPC46 were compared with the pouch of Comparative 1 (Comp.1) with respect to mobility and density.

[0340] The angle of repose was measured for PPC61 - PPC63. PPC63 had a water content 15% higher than PPC62, and PPC62 also had a water content 15% higher than PPC61. However, the difference in the angle of repose between PPC63 and PPC62 was significantly greater than the difference between PPC62 and PPC61.

[0341] The pouch compositions of pouches PPC1 and PPC46 were found to have much higher mobility and be processable with a pouch packaging machine. In addition, it was found that while the pouches PPC1 and PPC46 had a high filling degree, the density of the pouch composition in the completed pouches was significantly low.

[0342] Example 6 - Filling Degree To evaluate the influence of the filling degree, several pouches were made using PPC62, which is the same pouch composition. The filling degree was confirmed by comparing the weight with a full pouch (100%). For each pouch, it was evaluated whether it felt sufficiently filled. This evaluation was performed by first touching the pouch by hand and then inserting the pouch into the mouth. Each pouch was given an approval or disapproval evaluation for the feel by hand and the feel by mouth.

[0343] [Table 20]

[0344] As can be seen from Table 15, pouches filled at least 65% were given an approved evaluation for the feel by hand, and pouches filled at least 70% were given an approved evaluation for the feel by mouth.

[0345] Example 7 - Filling Degree and Water Content To evaluate how the water content affects the user's preference regarding the filling degree, a number of pouches were manufactured using pouch compositions with different water contents, PPC61, PPC62 (refer to the above results), and comparative P3 (COMP.P3).

[0346] The filling degree was confirmed by comparing the weight with a full pouch (100%). For each pouch, it was evaluated whether it felt sufficiently filled. This evaluation was performed by first touching the pouch by hand and then inserting the pouch into the mouth. Each pouch was given an approval or disapproval evaluation for the feel by hand and the feel by mouth.

[0347] [Table 21]

[0348] As can be seen from Table 16, the pouch containing 5% water was given an approved evaluation for the feel by hand in a state of being filled at least 65%, and the pouch containing 15% water was already given an approved evaluation for the feel by hand in a state of being filled at least 60%.

[0349] The pouch containing 5% water was given an approved evaluation for the feel in the mouth in a state of being filled at least 75%, and the pouch containing 15% water was already given an approved evaluation for the feel in the mouth at the point when it was filled at least 60%.

[0350] Example 8 - User Evaluation The pouch product PPC1 was evaluated for the perception of the effect of nicotine and the feeling of burning (tingling).

[0351] The evaluation of the perceived effect of nicotine and the feeling of burning (tingling) was conducted as follows. The perceived effect of nicotine and the feeling of burning (tingling) were evaluated by a test panel of 4 trained judges. Each judge evaluated all the samples twice. The average evaluation was estimated.

[0352] The pouch product PPC1 was evaluated by all 4 judges as having a fast onset of action and a high perceived effect of nicotine. Also, the pouch product PPC1 was evaluated by all 4 judges as having a high feeling of burning (tingling).

[0353] Similarly, the pouch product PPC1 was evaluated for the perceived effect of nicotine in the same manner as above. The pouch product PPC1 was evaluated by all 4 judges as having a high perceived effect of nicotine.

[0354] Example 9 - Results of Release The pouch was exposed to the in vitro release experiment described in Example 3L.

[0355]

Table 22

[0356] The release results show that for pouches made of fibers with relatively high water-binding capacity such as pea fiber, cellulose L700G, and wheat fiber (WF200), the nicotine release amount after 10 minutes is increasing.

[0357] Example 10 - Release Results Pouches having a pouch composition similar to PPC46 but using the following water retention agents were manufactured and exposed to the in vitro release experiment described in Example 3L.

[0358]

Table 23

[0359] Example 11 - Release Results The pouches were exposed to the in vitro release experiment described in Example 3L.

[0360]

Table 24

[0361] The results show that using nicotine premix VI improves the release after 10 minutes. By including a buffer system, namely 3.5% sodium carbonate and 3.5% sodium bicarbonate, the release is further improved (PPC93).

[0362] Also, adding 10% NaCl seems to improve the release amount obtained after 10 minutes (PPC94). Another aspect of the present invention may be as follows. 〔1〕 A nicotine pouch composition comprising: at least one sugar alcohol; at least one water-insoluble fiber; water in an amount of 8 to 65% by weight of the composition; nicotine; A nicotine pouch composition containing the same. 〔2〕 The composition has a bulk density of at most 0.8 g / cm3, such as at most 0.7 g / cm3, such as at most 0.6 g / cm3, such as at most 0.5 g / cm3, of the nicotine pouch composition according to [1] above. 〔3〕 The composition has a bulk density of 0.2 g / cm3 to 0.8 g / cm3, such as 0.3 g / cm3 to 0.7 g / cm3, such as 0.3 g / cm3 to 0.6 g / cm3, such as 0.4 to 0.5 g / cm3, of the nicotine pouch composition according to [1] or [2] above. 〔4〕 The nicotine is selected from the group consisting of nicotine salts, free nicotine bases, nicotine bound to an ion exchanger such as an ion exchange resin such as nicotine polacrilrex resin, nicotine inclusion complexes or any non-covalent nicotine, nicotine bound to zeolite, nicotine bound to cellulose such as microcrystalline cellulose, or starch microspheres, and mixtures thereof, of the nicotine pouch composition according to any one of [1] to [3] above. 〔5〕 The nicotine pouch composition according to any one of [1] to [4] above, wherein the nicotine contains non-salt nicotine. 〔6〕 The nicotine pouch composition according to any one of [1] to [5] above, wherein the nicotine contains free nicotine base. 〔7〕 The nicotine pouch composition according to any one of [1] to [6] above, wherein the nicotine contains nicotine mixed with an ion exchange resin. 〔8〕 The nicotine is a free base nicotine mixed with an ion exchange resin, wherein the weight ratio between the free base nicotine and the ion exchange resin is 0.1 to 2.0, preferably 0.5 to 2.0, most preferably about 0.67 to 1.0, of the nicotine pouch composition according to any one of [1] to [7] above. 〔9〕 The nicotine pouch composition according to any one of [1] to [8] above, wherein the nicotine contains a nicotine salt. 〔10〕 The nicotine pouch composition according to any one of [1] to [9] above, wherein the nicotine contains nicotine bound to an ion exchange resin. 〔11〕 The nicotine pouch composition according to any one of [1] to

[10] above, wherein the nicotine contains synthetic nicotine. 〔12〕 The pouch composition contains nicotine in an amount of at least 0.1% by weight, for example at least 0.2% by weight, etc., of the pouch composition, and is the nicotine pouch composition according to any one of the above items [1] to

[11] . 〔13〕 The pouch composition contains nicotine in an amount of 0.1 to 5.0% by weight, for example 0.2 to 4.0% by weight, etc., for example 1.0 to 2.0% by weight, etc., of the pouch composition, and is the nicotine pouch composition according to any one of the above items [1] to

[12] . 〔14〕 The pouch composition is provided in a pouch and, when measured for release as described in Example 3K, is adapted to release at least 15% by weight of nicotine, for example at least 20% by weight, etc., of nicotine, for example at least 30% by weight, etc., of nicotine, for example at least 40% by weight, etc., of nicotine within a period of 120 seconds upon contact with saliva in the oral cavity, and is the nicotine pouch composition according to any one of the above items [1] to

[13] . 〔15〕 The pouch composition provided in the oral cavity in a pouch has a nicotine release rate of at least 0.2% per minute, for example at least 0.3% per minute, etc., for example at least 0.4% per minute, etc., for example at least 0.5% per minute, etc., within a release period of 2 to 10 minutes, and is the nicotine pouch composition according to any one of the above items [1] to

[14] . 〔16〕 The pouch further contains a pH controller such as a basic pH controller such as a basic buffer, and is the nicotine pouch composition according to any one of the above items [1] to

[15] . 〔17〕 The pouch composition contains an alkaline buffer, and is the nicotine pouch composition according to any one of the above items [1] to

[16] . 〔18〕 The pouch composition contains a pH controller in an amount of 0.01 to 15% by weight, for example 0.5 to 10% by weight, etc., for example 1 to 10% by weight, etc., for example 5 to 10% by weight, etc., of the pouch composition, and is the nicotine pouch composition according to any one of the above items [1] to

[17] . 〔19〕 The pouch composition contains the pH control agent in an amount of less than 5% by weight of the pouch composition, for example, less than 4% by weight of the pouch composition, for example, less than 2% by weight of the pouch composition, for example, less than 1% by weight of the pouch composition, or for example, not containing the pH control agent, the nicotine pouch composition according to any one of [1] to

[18] . 〔20〕 The pouch composition is adapted to provide a pH of at least 8.0, for example, a pH of at least 9.0, when 2.0 grams of the pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate buffer (pH 7.4), the nicotine pouch composition according to any one of [1] to

[19] . 〔21〕 The pH control agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, disodium phosphate, dipotassium phosphate, dicalcium phosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof, the nicotine pouch composition according to any one of [1] to

[20] . 〔22〕 The pH control agent is a basic pH control agent such as a basic buffer, and / or is sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof, the nicotine pouch composition according to any one of [1] to

[21] . 〔23〕 The at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof, the nicotine pouch composition according to any one of [1] to

[22] . 〔24〕 The at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof, the nicotine pouch composition according to any one of [1] to

[23] . 〔25〕 The nicotine pouch composition according to any one of [1] to

[24] , wherein the pouch composition contains at least two sugar alcohols. 〔26〕 The nicotine pouch composition according to any one of [1] to

[25] , wherein the pouch composition contains sugar alcohol in an amount of at least 1% by weight of the composition, for example, at least 2% by weight of the composition, for example, at least 5% by weight of the composition, for example, at least 10% by weight of the composition. 〔27〕 The nicotine pouch composition according to any one of [1] to

[26] , wherein the pouch composition contains sugar alcohol in an amount of 1 to 80% by weight of the composition, for example, 2 to 70% by weight of the composition, for example, 5 to 60% by weight of the composition, for example, 10 to 50% by weight of the composition. 〔28〕 The nicotine pouch composition according to any one of [1] to

[27] , wherein the sugar alcohol contains a DC (direct compressibility) grade sugar alcohol. 〔29〕 The nicotine pouch composition according to any one of [1] to

[28] , wherein at least 50% by weight of the sugar alcohol is a DC (direct compressibility) grade sugar alcohol. 〔30〕 The nicotine pouch composition according to any one of [1] to

[29] , wherein the water-insoluble fiber is a plant fiber. 〔31〕 The nicotine pouch composition according to any one of [1] to

[30] , wherein the water-insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof. 〔32〕 The nicotine pouch composition according to any one of [1] to

[31] , wherein the water-insoluble composition contains or consists of water-insoluble fibers selected from wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof. 〔33〕 The nicotine pouch composition according to any one of [1] to

[32] , wherein the water-insoluble fiber has a water-binding capacity of at least 200%, for example, at least 300%, for example, at least 400%. 〔34〕 The nicotine pouch composition according to any one of [1] to

[33] , wherein the water-insoluble fiber has a swelling capacity of at least 5.0 mL / g, such as 5.0 to 20 mL / g. 〔35〕 The nicotine pouch composition according to any one of [1] to

[34] , wherein the water-insoluble composition comprises or consists of 5 to 50% by weight of water-insoluble fibers of the pouch composition and 15 to 70% by weight of water content of the pouch composition. 〔36〕 The nicotine pouch composition according to any one of [1] to

[35] , wherein the water-insoluble composition is selected from pea fiber, powdered cellulose, and combinations thereof, and the pouch composition contains a flavoring agent in an amount of 10% by weight or less of the pouch composition. 〔37〕 The nicotine pouch composition according to any one of [1] to

[36] , wherein the water-insoluble composition has a density of 50 to 500 grams per liter, for example, 100 to 400 grams per liter, for example, 200 to 300 grams per liter. 〔38〕 The nicotine pouch composition according to any one of [1] to

[37] , wherein the pouch composition has an angle of repose of at least 45 degrees, for example, at least 50 degrees. 〔39〕 The nicotine pouch composition according to any one of [1] to

[38] , wherein the pouch composition contains water in an amount of 10 to 60% by weight of the composition, for example, 10 to 50% by weight of the composition, for example, 10 to 40% by weight of the composition, for example, 20 to 40% by weight of the composition. 〔40〕 The nicotine pouch composition according to any one of [1] to

[39] , wherein the pouch composition contains water in an amount of 10 to 40% by weight of the composition. 〔41〕 The nicotine pouch composition according to any one of [1] to

[40] , wherein the pouch composition contains water in an amount of 20 to 65% by weight of the composition, for example, 20 to 60% by weight of the composition, for example, 20 to 50% by weight of the composition, for example, 20 to 40% by weight of the composition. 〔42〕 The nicotine pouch composition according to any one of [1] to

[41] , wherein the pouch composition has a water content of 15 to 65% by weight of the pouch composition, for example, 15 to 50% by weight of the pouch composition, for example, 15 to 40% by weight of the pouch composition, for example, 15 to 30% by weight of the pouch composition, for example, 15 to 25% by weight of the pouch composition. 〔43〕 The nicotine pouch composition according to any one of [1] to

[42] , wherein the pouch composition contains water and water-insoluble fibers in a weight ratio of 3.0 or less, for example, 2.5 or less, for example, 2.0 or less, for example, 1.5 or less, for example, 1.0 or less. 〔44〕 The nicotine pouch composition according to any one of [1] to

[43] , wherein the pouch composition does not contain tobacco, tobacco fibers, or fibers derived from tobacco. 〔45〕 The nicotine pouch composition according to any one of [1] to

[44] , wherein the pouch composition further contains a water retention agent. 〔46〕 The nicotine pouch composition according to any one of [1] to

[45] , wherein the pouch composition contains a flow promoter such as silicon dioxide in an amount of, for example, 0.5 to 5% by weight of the composition, for example, 1 to 3% by weight of the composition. 〔47〕 The nicotine pouch composition according to any one of [1] to

[46] , wherein the pouch composition contains a flavoring agent in an amount of, for example, 0.01 to 20% by weight of the pouch composition, for example, 0.01 to 15% by weight of the pouch composition. 〔48〕 The nicotine pouch composition according to any one of [1] to

[47] , wherein the relative standard deviation (RSD) of nicotine content between a series of at least 10 oral pouches containing the pouch composition is maintained at 10% or less, preferably 8% or less, more preferably at most 6%, even more preferably at most 4%, and most preferably at most 2%. 〔49〕 The nicotine pouch composition according to any one of [1] to

[48] , wherein the composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, and the composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition. 〔50〕 The pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof. The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition, and The nicotine pouch composition according to any one of [1] to

[49] , wherein the composition further contains water-insoluble fibers in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition. 〔51〕 The pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, and The water-insoluble composition contains or consists of water-insoluble fibers such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, The nicotine pouch composition according to any one of [1] to

[50] . 〔52〕 The pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, and The water-insoluble composition contains or consists of water-insoluble fibers such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, and the pouch composition contains a flavoring agent in an amount of 0.01 to 15% by weight of the pouch composition, for example, 0.1 to 15% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, for example, 3 to 10% by weight of the pouch composition, The nicotine pouch composition according to any one of [1] to

[51] . 〔53〕 The pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, The water-insoluble composition contains or consists of water-insoluble fibers such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, and the pouch composition contains a flavoring agent in an amount of 0.01 to 15% by weight of the pouch composition, for example, 0.1 to 15% by weight of the pouch composition, for example, 1 to 10% by weight of the pouch composition, for example, 3 to 10% by weight of the pouch composition, and the flavoring agent is oil-based. The nicotine pouch composition according to any one of [1] to

[52] . 〔54〕 The pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, The pouch composition contains a pH regulator selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof. The nicotine pouch composition according to any one of [1] to

[53] . 〔55〕 The pouch composition contains a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, and The pouch composition contains a basic pH controller such as a basic buffering agent, and / or a pH controller which is sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof. The nicotine pouch composition according to any one of [1] to

[54] . 〔56〕 An oral pouch-filled nicotine product, A saliva-permeable pouch, A nicotine pouch composition, and includes: At least one sugar alcohol, At least one water-insoluble fiber, Water in an amount of 8 to 65% by weight of the composition, Nicotine, and includes. The pouch has a maximum inner pouch volume, and the nicotine pouch composition has a volume corresponding to at least 65% of the maximum inner pouch volume. An oral pouch-filled nicotine product. 〔57〕 The composition has a bulk density of less than 0.8 g / cm3 in the pouch, for example, less than 0.7 g / cm3, such as less than 0.6 g / cm3, for example, less than 0.5 g / cm3. The oral pouch-filled nicotine product according to

[56] . 〔58〕 The pouch has a maximum inner pouch volume, and the nicotine pouch composition has a volume corresponding to at least 70% of the maximum inner pouch volume, for example, at least 80% of the maximum inner pouch volume, such as at least 90% based on the maximum inner pouch volume, for example, at least 95% based on the maximum inner pouch volume. The oral pouch-filled nicotine product according to

[56] or

[57] . 〔59〕 The maximum inner pouch volume is at least 0.5 mL, for example, at least 1.0 mL. The oral pouch-filled nicotine product according to any one of

[56] to

[58] . 〔60〕 The oral pouch-packed nicotine product according to any one of

[56] to

[59] , wherein the film of the pouch contains water-insoluble fibers of an origin different from the water-insoluble fibers contained in the pouch-packed product. 〔61〕 The oral pouch-packed nicotine product according to any one of

[56] to

[60] , wherein both the water-insoluble fibers of the film and the water-insoluble fibers of the pouch composition contain natural fibers. 〔62〕 The oral pouch-packed nicotine product according to any one of

[56] to

[61] , wherein both the water-insoluble fibers of the film and the water-insoluble fibers of the pouch composition are natural fibers. 〔63〕 The oral nicotine pouch-packed product according to any one of

[56] to

[62] , comprising the nicotine pouch composition according to any one of [1] to

[55] . 〔64〕 A method for manufacturing an oral pouch-packed product according to any one of

[56] to

[63] , the method comprising the steps of adding: - providing the pouch composition according to any one of [1] to

[55] ; - providing the saliva-permeable pouch; - adding the pouch composition to the pouch; - sealing the pouch. The method comprising the above steps.

Claims

1. A nicotine pouch composition comprising: at least one sugar alcohol, at least one water-insoluble fiber, water in an amount of 15 to 65% by weight of the nicotine pouch composition, nicotine in an amount of 0.1 to 5.0% by weight of the nicotine pouch composition, and the water-insoluble fiber has a water solubility of less than 0.1 gram per 100 mL of water as measured at 25 degrees Celsius and a pH of 7.0, and The nicotine pouch composition has a bulk density of at most 0.8 g / cm 3 and does not contain tobacco, tobacco fibers, and fibers derived from tobacco. a nicotine pouch composition.

2. The nicotine pouch composition has a bulk density of up to 0.7 g / cm 3 , for example, up to 0.6 g / cm 3 , etc., for example, up to 0.5 g / cm 3 , etc., and is the nicotine pouch composition according to claim 1.

3. The nicotine is selected from the group consisting of nicotine salts, nicotine free base, ion exchangers such as ion exchange resins, nicotine bound to ion exchangers such as nicotine polacrilrex resin, nicotine inclusion complexes or any non-covalent bound nicotine, nicotine bound to zeolites, cellulose such as microcrystalline cellulose, or nicotine bound to starch microspheres, and mixtures thereof, according to the nicotine pouch composition of claim 1 or 2.

4. The nicotine pouch composition according to any one of claims 1 to 3, wherein the nicotine comprises nicotine mixed with an ion exchange resin.

5. The nicotine pouch composition according to any one of claims 1 to 4, wherein the nicotine comprises a nicotine salt.

6. The nicotine pouch composition according to any one of claims 1 to 5, wherein the nicotine comprises nicotine bound to an ion exchange resin.

7. The nicotine pouch composition according to any one of claims 1 to 6, wherein the nicotine pouch composition contains nicotine in an amount of 0.2 to 4.0% by weight of the nicotine pouch composition, such as 1.0 to 2.0% by weight of the nicotine pouch composition.

8. The nicotine pouch composition is adapted to release at least 15% by weight of nicotine, such as at least 20% by weight of nicotine, such as at least 30% by weight of nicotine, such as at least 40% by weight of nicotine within a period of 120 seconds upon contact with saliva in the oral cavity. The amount of nicotine released is determined by the following steps: Providing a pouch containing the nicotine pouch composition to a subject and placing it on the upper lip in the oral cavity, After 120 seconds, removing the pouch from the subject's oral cavity, Measuring the amount of nicotine remaining in the nicotine pouch composition using standard HPLC techniques, Determining the amount of nicotine released by subtracting the remaining amount of nicotine in the nicotine pouch composition from the initial amount of nicotine in the nicotine pouch composition. The nicotine pouch composition according to any one of claims 1 to 7, measured by a method having **Claim 9** The nicotine pouch composition according to any one of claims 1 to 8, wherein the nicotine pouch composition further comprises a pH controller, such as a basic pH controller, such as a basic buffer, etc. **Claim 10** The nicotine pouch composition according to claim 9, wherein the pH controller is a basic pH controller, such as a basic buffer, and / or, for example, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof, etc. **Claim 11** The nicotine pouch composition according to any one of claims 1 to 10, wherein the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof. **Claim 12** The nicotine pouch composition according to any one of claims 1 to 11, wherein the nicotine pouch composition contains sugar alcohol in an amount of 1 to 80% by weight of the nicotine pouch composition, such as 2 to 70% by weight of the nicotine pouch composition, such as 5 to 60% by weight of the nicotine pouch composition, such as 10 to 50% by weight of the nicotine pouch composition, etc. **Claim 13** The nicotine pouch composition according to any one of claims 1 to 12, wherein the sugar alcohol comprises a DC (direct compressibility) grade sugar alcohol. **Claim 14** The nicotine pouch composition according to any one of claims 1 to 13, wherein at least 50% by weight of the sugar alcohol is a DC (direct compressibility) grade sugar alcohol. **Claim 15** The nicotine pouch composition according to any one of claims 1 to 14, wherein the water-insoluble fiber is a plant fiber, and the water-insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof. **Claim 16** The nicotine pouch composition according to any one of claims 1 to 15, wherein the water-insoluble fiber has a water-binding capacity of at least 200%, for example at least 300%, for example at least 400%.

17. The nicotine pouch composition according to any one of claims 1 to 16, wherein the nicotine pouch composition contains 5 to 50% by weight of water-insoluble fiber and 15 to 65% by weight of water content of the nicotine pouch composition.

18. The nicotine pouch composition according to any one of claims 1 to 17, wherein the nicotine pouch composition has a water content of 15 to 50% by weight of the nicotine pouch composition, for example 15 to 40% by weight of the nicotine pouch composition, for example 15 to 30% by weight of the nicotine pouch composition, for example 15 to 25% by weight of the nicotine pouch composition.

19. The nicotine pouch composition according to any one of claims 1 to 18, wherein the nicotine pouch composition contains water and water-insoluble fiber in a weight ratio of 3.0 or less, for example 2.5 or less, for example 2.0 or less, for example 1.5 or less, for example 1.0 or less.

20. A saliva-permeable pouch, A nicotine pouch composition, An oral pouch-packed nicotine product comprising: The nicotine pouch composition is: At least one sugar alcohol, At least one water-insoluble fiber, Water in an amount of 15 to 65% by weight of the nicotine pouch composition, Nicotine in an amount of 0.1 to 5.0% by weight of the nicotine pouch composition, And includes The water-insoluble fiber has a water solubility of less than 0.1 gram per 100 mL of water as measured at 25 degrees Celsius and a pH of 7.

0. The composition has a bulk density of at most 0.8 g / cm 3 and does not contain tobacco, tobacco fibers, or tobacco-derived fibers, and The pouch has a maximum inner pouch volume, and the nicotine pouch composition has a volume corresponding to at least 65% of the maximum inner pouch volume. An oral pouch-packed nicotine product.

21. The nicotine pouch composition has a bulk density of less than 0.7 g / cm 3 in the pouch, for example, less than 0.6 g / cm 3 such as less than 0.5 g / cm 3 such as less than, and is the oral pouch-packed nicotine product according to claim 20.

22. The oral pouch-packed nicotine product according to claim 20 or claim 21, wherein the pouch has a maximum inner pouch volume, and the nicotine pouch composition has a volume corresponding to at least 70% of the maximum inner pouch volume, for example at least 80% of the maximum inner pouch volume, for example at least 90% of the maximum inner pouch volume, for example at least 95% of the maximum inner pouch volume.

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