Nicotine pouch composition

Abstract

To provide a nicotine containing pouch as a tobacco substitute.SOLUTION: 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 pouch composition; and nicotine, is used as a tobacco substitute.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a nicotine pouch composition as claimed in claim 1, an oral pouched nicotine product as claimed in claim 56, and a method for producing an oral pouched product as claimed in claim 64. [Background technology]

[0002] Delivery of nicotine through smoking has many well-known drawbacks, particularly health-related issues such as the inclusion of carcinogens. However, tobacco substitutes also have drawbacks, such as insufficient craving relief for users. Summary of the Invention [Problem 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, that can solve the above problems. A further problem with the prior art is that the desired nicotine release should be appealing from the user's perspective to the user of the pouch.

[0004] Furthermore, a further problem associated with the prior art is that pouches as a delivery vehicle for nicotine can be somewhat costly, which may impose limitations on how the pouches can be designed to control manufacturing costs. [Means for solving the problem]

[0005] The present invention relates to a nicotine pouch composition, the 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 and Includes.

[0006] An advantage of the present invention is that the pouch composition has surprisingly high mobility, which facilitates effective processing of the pouch composition, particularly when filling the pouch composition into pouches. Generally, when dealing with powdered compositions, flowability is used as an indicator of processability. However, adding a large amount of water to a sugar alcohol-containing pouch composition can cause the pouch composition to clump, significantly reducing its flowability, sometimes to the point where it cannot be measured by conventional methods. However, the present inventors unexpectedly discovered that the pouch composition can still be processed into individual pouches in a filling machine. Thus, the present invention allows for an efficient process by avoiding manual filling of pouches and the use of very complex and specially designed filling machines, thereby providing 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 appealing soft, moist, moldable texture and mouthfeel. While providing the desired texture and mouthfeel, the produced pouches can still be stored adjacent to each other, for example, in a can, without sticking too much to each other, which would cause the pouch to burst when removed.

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

[0009] The inventive use of compositions having a relatively low bulk density not only provides a good mouthfeel, but also provides 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. It is noted that low bulk density in combination with the claimed moisture content is particularly attractive when improved user perception is desired.

[0010] An advantage of the above-described embodiment may be that it results in a low density composition. Surprisingly, the combination of water and sugar alcohol did not result in a very dense, compact, unprocessable pouch composition, but rather allowed for a relatively light weight, low density composition.

[0011] In an advantageous embodiment of the invention, 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.

[0012] In one embodiment of the present invention, the composition has a bulk density of 0.2 g / cm 3 to 0.8 g / cm 3 , such as 0.2 g / cm 3 to 0.7 g / cm 3 , such as 0.2 g / cm 3 to 0.6 g / cm 3 , such as 0.2 to 0.5 g / cm 3 .

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

[0014] The inventive use of compositions having a relatively low bulk density not only provides a good mouthfeel, but also provides 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. It is noted that low bulk density in combination with the claimed moisture content is particularly attractive when improved user perception is desired.

[0015] At the same time, the low density advantageously reduces raw material requirements, thereby lowering manufacturing costs. 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 process. For example, varying the amount of water also affects flowability, with too much water resulting in a compact, dense pouch formulation, but selecting a fiber with a high water-binding capacity can at least partially offset a higher water content. It has also been observed that excessive mixing can result in a very dense, dense pouch composition.

[0016] In an advantageous embodiment of the present invention, the 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 polacrilex resin, nicotine inclusion complexes or any non-covalently bound nicotine, nicotine bound to a zeolite, nicotine bound to a cellulose such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.

[0017] An example of a combination of different types of nicotine is a combination of free base nicotine mixed with polacrilex resin, with some nicotine binding to the ion exchange resin and some nicotine remaining unbound.

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

[0019] In an advantageous embodiment of the invention, the nicotine comprises non-salt nicotine. In an advantageous embodiment of the present invention, the nicotine comprises free base nicotine.

[0020] A very important advantage of the above embodiment may be the extended shelf life of the pouched product and the long-lasting taste and texture. By providing nicotine in free base form, it is easier to achieve a high pH in the pouch composition without the need for significant alkaline pH control agents.

[0021] Therefore, in the above embodiments, the amount of alkaline pH control agent can be reduced without compromising shelf life and long-lasting taste and texture. In an advantageous embodiment, the nicotine comprises nicotine mixed with an ion exchange resin.

[0022] In an advantageous embodiment of the invention, the nicotine comprises free base nicotine mixed with an ion exchange resin in a weight ratio between the free base nicotine and the ion exchange resin of from 0.1 to 2.0, preferably from 0.5 to 2.0, most preferably from about 0.67 to 1.0.

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

[0024] Here, the weight ratio means the ratio of the mass of the first component divided by the mass of the second component. The term "mixing ratio" may also be used. Thus, in the above embodiment, the nicotine comprises free base nicotine mixed with an ion exchange resin in a weight ratio between the free base nicotine and the ion exchange resin of from 0.1 to about 1, preferably from 0.17 to 0.5, and most preferably from about 0.2 to 0.25.

[0025] In an advantageous embodiment of the invention, the nicotine comprises a nicotine salt. In one embodiment of the present invention, the nicotine salt is selected from nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine monotartrate, nicotine bitartrate, 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, nicotine zinc chloride, nicotine sulfate, nicotine tosylate, and hydrates thereof (e.g., nicotine zinc chloride monohydrate).

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

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

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

[0029] An advantage of the above embodiment may be that the complex of nicotine with the ion exchange resin provides a sustained release component. In one embodiment of the present invention, the pouch composition comprises free base nicotine mixed with an ion exchange resin that combines nicotine as a complex with the ion exchange resin, such as polacrilex resin.

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

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

[0032] Nicotine release profiles can be obtained that include both fast and sustained release periods. 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, e.g., from 2 to 30 minutes after use begins.

[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 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, when the release is measured as described in Example 3K.

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

[0035] In one embodiment of the invention, the pouch composition is provided in a pouch and 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 subjected to the in vitro release experiment described in Example 3L.

[0036] In one embodiment of the 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 of contact with saliva in the oral cavity when the release is measured as described in Example 3K.

[0037] In one embodiment of the 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 10 minute period when subjected to the in vitro release experiment described in Example 3L.

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

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

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

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

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

[0043] In one embodiment of the present invention, a pouch composition provided in a pouch and subjected 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 invention, the pouch composition further comprises a pH controlling agent, such as a basic pH controlling agent, such as a basic buffering agent. An advantage of the above embodiment may be that more efficient nicotine uptake may be obtained, especially when a basic (alkaline) pH control agent is used.

[0045] Another advantage of the above embodiment may be that a desirable mouthfeel may be achieved during use. In embodiments, by avoiding the use of nicotine salts, such as nicotine bitartrate, a lower amount of pH control agent can be applied, although 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 an alkaline 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 buffering agents, such as a basic buffer pair, or a combination of at least two basic pH control agents.

[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 invention, the pouch composition comprises a pH controlling 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 no pH controlling agent.

[0049] In one embodiment of the present invention, the pouch composition comprises a pH controlling 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 comprises a pH controlling agent in an amount of 0.1 to 6% by weight of the pouch composition, such as 0.1 to 5% by weight of the pouch composition, such as 0.5 to 5% by weight of the pouch composition, such as 0.5 to 4% by weight of the pouch composition, such as 0.1 to 3% by weight of the pouch composition, such as 0.1 to 2% by weight of the pouch composition, such as 0.1 to 1% by weight of the pouch composition.

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

[0052] In an advantageous embodiment of the 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 (adjusted to pH 7.4).

[0053] In an advantageous embodiment of the 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 embodiment may be that relatively efficient nicotine uptake is promoted due to the high pH value obtained. A further advantage of the above embodiment may be that the need for preservatives may be reduced or even eliminated, and that such preservatives may be used in smaller amounts, if not absent.

[0055] The resulting high pH value may also advantageously impart a tingling sensation in the mouth that may be perceived as a desirable mouthfeel, for example, similar to tobacco-based pouch products.

[0056] In an advantageous 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 advantageous embodiments of the present invention, the pH control agent is a basic buffer 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, the at least one sugar alcohol may be xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, or a mixture thereof.The at least one sugar alcohol may also contain other sugar alcohols.As an exemplary embodiment, a hydrogenated starch hydrolysate containing a mixture of sorbitol, maltitol, and other sugar alcohols may be used.

[0059] In an advantageous embodiment of the invention, the at least one sugar alcohol is chosen from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.

[0060] In an advantageous embodiment of the invention, the at least one sugar alcohol is chosen from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

[0061] In one embodiment of the invention, the at least one sugar alcohol comprises xylitol and / or erythritol. In an advantageous embodiment of the invention, the pouch composition comprises at least two sugar alcohols.

[0062] It should be noted that for taste and salivation purposes, different sugar alcohols can be applied, where the sugar alcohol composition is made with different sugar alcohols having different properties with respect to shelf life, bacterial growth, processability and / or taste.

[0063] In one embodiment of the invention, the at least two sugar alcohols are selected from xylitol, maltitol, mannitol, erythritol, and isomalt. In an advantageous embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition.

[0064] It is noted that in relation to a composition comprising a sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition, a bulk density of 0.2 g / cm to 0.8 g / cm, such as 0.3 g / cm to 0.7 g / cm, such as 0.3 g / cm to 0.6 g / cm, such as 0.4 to 0.5 g / cm provides attractive dissolution of the nicotine-containing pouch contents when contacted with the mucosa.

[0065] In an advantageous embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition.

[0066] In one embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of 5 to 40% by weight of the composition, such as 5 to 30% by weight of the composition. In an advantageous embodiment of the invention, the sugar alcohol comprises a DC (directly compressible) grade sugar alcohol.

[0067] In an advantageous embodiment of the invention, at least 50% by weight of the sugar alcohol is a DC (directly compressible) grade sugar alcohol. In one embodiment of the present invention, the sugar alcohol comprises a non-DC (non-direct compressible) grade sugar alcohol.

[0068] In an advantageous embodiment of the invention, the water-insoluble fiber is a vegetable fiber. In an advantageous 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 processing α-cellulose obtained as pulp from several types of fibrous plant material, such as wood pulp.

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

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

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

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

[0074] Non-limiting examples of water-insoluble fibers that may 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® potatoofiber KF200, Vitacel® bamboo fiberhaf BAF40, and Vitacel® Haferfaser / oat fiber HF-401-30 US.

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

[0076] In one embodiment, the powdered cellulose is not chemically modified, and therefore the powdered cellulose can be, for example, a chemically unmodified cellulose fiber that does not contain microcrystalline cellulose (MCC).

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

[0078] An advantage of the above embodiment may be that the high water binding capacity allows for a pouch composition with a high moisture content. Furthermore, it has been found that pouches having a high moisture content have a desirable texture and mouthfeel, while still allowing the produced pouches to be stored adjacent to each other, for example in a can, without sticking too much to each other, which would result in the pouch bursting when removed.

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

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

[0081] In one embodiment of the present invention, the water-insoluble fiber has a water binding capacity of 200 to 1500%, such as 400 to 1500%, such as 500 to 1500%, such as 500 to 1200%, such as 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, such as from 5.0 to 20 mL / g. An advantage of this embodiment is that the amount of water-insoluble fiber can be reduced without compromising mouthfeel during use: when the water-soluble ingredient is replaced with water-insoluble fiber, the water-insoluble fiber swells during use and prevents the water-soluble ingredient from dissolving, so the user will not experience a loss of pouch content during use.

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

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

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

[0086] In an advantageous embodiment of the invention, the water-insoluble fibre has a density of 50 to 500 grams per litre, such as 100 to 400 grams per litre, such as 200 to 300 grams per litre.

[0087] In an advantageous embodiment of the invention, the pouch composition has an angle of repose of at least 40 degrees, such as at least 45 degrees, such as at least 50 degrees. Therefore, in the above embodiment, the flowability is quite low.

[0088] In one embodiment, the angle of repose may be 45 to 70 degrees, such as 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 onto a flat, horizontal surface from a height of approximately 10 cm.

[0089] In an advantageous embodiment of the present invention, the pouch composition comprises water in an amount of 8 to 60% by weight of the composition, such as 8 to 50% by weight of the composition, such as 8 to 40% by weight of the composition, such as 20 to 40% by weight of the composition.

[0090] In one embodiment of the invention, the pouch composition comprises water in an amount of 8 to 60% by weight of the composition, such as 10 to 60% by weight of the composition, such as 15 to 60% by weight of the composition, such as 20 to 60% by weight of the composition.

[0091] In one embodiment of the invention, the pouch composition comprises water in an amount of 8 to 60% by weight of the composition, such as 8 to 50% by weight of the composition, such as 8 to 40% by weight of the composition, such as 8 to 30% by weight of the composition.

[0092] In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of 10 to 40% by weight of the composition. In an advantageous embodiment of the present invention, the pouch composition comprises water in an amount of 20 to 65% by weight of the composition, such as 20 to 60% by weight of the composition, such as 20 to 50% by weight of the composition, such as 20 to 40% by weight of the composition.

[0093] In an advantageous embodiment of the present invention, the pouch composition has a water content of 15 to 65% by weight of said pouch composition, such as 15 to 50% by weight of said pouch composition, such as 15 to 40% by weight of said pouch composition, such as 15 to 30% by weight of said pouch composition, such as 15 to 25% by weight of said pouch composition.

[0094] Water can be added as a separate ingredient that is fully or partially mixed with other ingredients, such as fiber. For example, if free base nicotine is added as a mixture of free base nicotine with ion exchange resin and water, a significant amount of the water in the final pouch composition will come 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 one-third of the water in the pouch composition will come from the free base nicotine-ion exchange resin-water pre-mixture.

[0095] In an advantageous embodiment of the invention, the pouch composition comprises water and water-insoluble fiber in a weight ratio of not more than 3.0, such as not more than 2.5, such as not more than 2.0, such as not more than 1.5, such as not more than 1.0.

[0096] In an embodiment, the pouch composition comprises water and water insoluble fiber 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 weight ratio has the water content, in weight percent, of the pouch composition in the numerator and the water-insoluble fiber content, in weight percent, of the pouch composition in the denominator. Having a moisture content within the range of the present invention may promote fast release within an initial fast release period, such as within the first 120 seconds, since the pouch is already wetted or partially wetted with water from the start of use.

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

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

[0100] In an advantageous embodiment of the present invention, the pouch composition is free of tobacco, tobacco fiber, and tobacco-derived fiber. In some alternative embodiments, the pouch composition may include trace amounts of tobacco. For example, nicotine provided as part of tobacco, such as powdered tobacco, is in addition to the free base nicotine. Such tobacco may be included, for example, to provide tobacco flavor.

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

[0102] In one embodiment of the invention, the pouch composition is tobacco-free, such as tobacco-free, such as tobacco-free at less than 5.0% by weight, such as tobacco-free at less than 0.1% by weight of the pouch composition, such as tobacco-free at less than 0.5% by weight of the pouch composition, such as tobacco-free at less than 1.0% by weight of the pouch composition, such as tobacco-free at less than 3.0% by weight of the pouch composition.

[0103] In one embodiment of the invention, the water-insoluble composition does not include tobacco, tobacco fiber, or fiber derived from tobacco, and therefore, in this embodiment, the water-insoluble fiber is a non-tobacco fiber, i.e., does not include tobacco, tobacco fiber, or fiber derived from tobacco.

[0104] In one embodiment of the invention, the pouch composition is free of microcrystalline cellulose (MCC), such as being cellulose-free. In one embodiment of the present invention, the pouch composition comprises cellulose and does not comprise microcrystalline cellulose (MCC).

[0105] In an advantageous embodiment of the present invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, wherein the composition comprises said 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.

[0106] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; The composition comprises 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, and The composition further comprises 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 an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; The composition comprises 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, the composition further comprises a 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 comprises or consists of a water-insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof.

[0108] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; The composition comprises 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, the composition further comprises a 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 comprises or consists of a water-insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, and wherein the pouch composition comprises a flavoring in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.1 to 15% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 3 to 10% by weight of the pouch composition.

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

[0110] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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 pouch composition comprises a pH controlling agent 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 an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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 pouch composition includes a basic pH controlling agent, such as a basic buffer, and / or a pH controlling agent that is sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

[0112] In an advantageous embodiment of the present invention, the pouch composition further comprises a humectant. In one embodiment, the humectant 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 humectant is or comprises an amount of humectant in the pouch composition of from 0.5 to 10% by weight of the pouch composition, such as from 0.5 to 5% by weight of the pouch composition, such as from 1 to 3% by weight of the pouch composition.

[0114] The humectant may attract and retain water in the oral cavity during use, but may also further moderate the release of nicotine, for example, to facilitate a sustained release of nicotine.

[0115] In one embodiment the humectant is or comprises an alginate, such as sodium alginate, for example in an amount of 0.5 to 10% by weight of the pouch composition, such as 0.5 to 5% by weight, such as 1 to 3% by weight.

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

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

[0118] In an advantageous embodiment of the invention, the pouch composition comprises a flavouring, for example in an amount of 0.01 to 20% by weight of the pouch composition, such as 0.01 to 15% by weight of the pouch composition.

[0119] In one embodiment of the invention, the pouch composition comprises flavoring in an amount of 0.01 to 15% by weight of the pouch composition, such as an amount of 0.1 to 15% by weight of the pouch composition, such as an amount of 1 to 10% by weight of the pouch composition, such as an amount of 3 to 10% by weight of the pouch composition.

[0120] The properties of the water-insoluble ingredients can affect the release of flavor from the pouch composition, thereby affecting the perception of the flavor by the user. In one embodiment of the present invention, the water insoluble fiber may cause a higher or lower perception of the flavor to the user.

[0121] In one embodiment of the invention, the pouch composition comprises flavoring in an amount of 10% or less by weight of the pouch composition, such as 8% or less by weight of the pouch composition, such as 5% or less by weight of the pouch composition.

[0122] In one embodiment of the invention, the pouch composition comprises flavoring in an amount of 0.01 to 10% by weight of the pouch composition, such as 0.01 to 8% by weight of the pouch composition, such as 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, mixing at least 90% by weight of the total amount of dry ingredients before adding the nicotine followed by the water, e.g., before adding the nicotine followed by the water and liquid flavoring (if any), can result in a more homogeneous pouch composition with a uniform distribution of nicotine.

[0124] In an advantageous embodiment of the invention, the nicotine content among a series of at least 10 oral pouches comprising said pouch composition maintains a relative standard deviation (RSD) of no more than 10%, preferably no more than 8%, more preferably at most 6%, even more preferably at most 4%, and most preferably at most 2%.

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

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

[0127] In an advantageous embodiment of the present invention, the composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, and the composition comprises 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 invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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, and The composition further comprises 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.

[0129] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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 comprises or consists of a water-insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof.

[0130] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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 comprises or consists of water-insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, and the pouch composition comprises a flavoring in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.1 to 15% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 3 to 10% by weight of the pouch composition.

[0131] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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; The water-insoluble composition comprises or consists of a water-insoluble fiber, for example, wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, and the pouch composition comprises a flavoring in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.1 to 15% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 3 to 10% by weight of the pouch composition, and the flavoring is oil-based.

[0132] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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 pouch composition comprises a pH controlling agent 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.

[0133] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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 pouch composition includes a basic pH controlling agent, such as a basic buffer, and / or a pH controlling agent that is sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, 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 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, and nicotine, wherein 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 is that it provides a very pleasant mouthfeel. Up to now, the focus has been on the pouch composition, which of course plays an important role. The inventors have surprisingly discovered that filling the pouch to near its maximum internal volume significantly improves the mouthfeel.

[0136] Furthermore, the use of the claimed pouch composition provides high composition mobility, allowing for effective filling of the pouch without excessive compression of the pouch composition. This allows for a relatively low density and large volume pouch. The low density allows for effective contact with saliva during use, which again facilitates rapid release of, for example, nicotine. At the same time, the low density reduces the need for raw materials, leading to reduced manufacturing costs.

[0137] A further advantage of the present invention is that it provides a high mobility of the pouch composition. This mobility can be used to obtain a high degree of pouch filling, preferably with a relatively low-density pouch composition. It was anticipated that the presence of a large amount of water in a composition comprising sugar alcohol and fiber would pose significant problems in the manufacture of pouch products. A typical measure of the processability of a powder composition is flowability, and a certain minimum flowability is required for the composition to be effectively processed. High water content typically results in very low flowability and therefore very poor processability.

[0138] However, the resulting pouch compositions were shown to be processable and to have mobility within a processable range. This high mobility allowed the pouches to be filled at high fill rates while maintaining a relatively low density composition. Advantageously, this allowed the resulting pouches to have a high volume while still using low raw material. This is surprising, since the addition of water would have been expected to result in poor mobility and a high density composition, which would have increased manufacturing complexity and raw material costs if not offset by the user experience associated with a full pouch.

[0139] In an advantageous embodiment of the invention, the composition has a bulk density in the pouch of less than 0.8 g / cm 3 , such as less than 0.7 g / cm 3 , such as less than 0.6 g / cm 3 , such as less than 0.5 g / cm 3 .

[0140] In an advantageous embodiment of the invention, the pouch comprises a water-permeable membrane, for example comprising a woven or nonwoven fabric. Typically, the pouch membrane includes an opening with characteristic opening dimensions adapted to the characteristic dimensions of the pouch composition to retain the pouch composition inside the pouch prior to use and / or to retain a portion of the pouch composition, such as a water-insoluble composition, inside the pouch during use.

[0141] In order to obtain a pouch membrane having a suitable opening size in consideration of the pouch composition to be used, the material of the pouch membrane, including, for example, woven fabric and / or nonwoven fabric, can be appropriately selected. In other words, according to various embodiments, the pouch membrane allows the passage of saliva and prevents or blocks the passage of undissolved composition and water-insoluble fibers. The pouch membrane can be any suitable material, for example, woven or nonwoven fabrics (e.g., cotton, fleece, etc.), heat-sealable nonwoven cellulose such as long-fiber paper, or other polymeric materials such as synthetic, semi-synthetic, or natural polymeric materials. One example of a suitable material for the pouch membrane is paper made of pulp and a small amount of wet-strength agent. Materials suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from leaving the bag or pouch during use. Suitable materials also do not significantly affect the release of nicotine from the pouch.

[0142] More specifically, in terms of material, the pouch membrane can be a natural, synthetic, or semi-synthetic hydrophilic or hydrophobic membrane. It can be made from one or more biocompatible and physiologically acceptable polymeric materials. Examples of suitable materials for the pouch membrane include cellulose acetate and its derivatives, carboxymethylcellulose, polycellulose esters, other cellulose derivatives including ethylcellulose and propylcellulose, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinyl acetate, methacrylate and acrylate polymers, natural rubber, polycarbonate, polyethylene terephthalate, polyester, polyamide, and nylon. Other suitable materials have been mentioned previously in this specification.

[0143] Rayon fibers (i.e., regenerated cellulose), such as viscose rayon fibers, may also be used, for example, in combination with an acrylic polymer to act as a binder in the nonwoven material and provide heat sealing of the pouch membrane during its manufacture. Other binders, such as one or more copolymers of vinyl acetate and acrylic acid esters, may also be used.

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

[0145] The pouch membrane material may have the form of a mesh, a sieve, perforated paper, a permeable fabric, or the like. For example, pouch materials made from mesh-like rice paper or perforated straw paper may dissolve in the user's mouth. In some exemplary embodiments, the pouch membrane material may be manufactured using water-dispersible film-forming materials (e.g., binders such as alginate, carboxymethylcellulose, xanthan gum, pullulan, etc.), as well as those materials in combination with materials such as comminuted cellulose derivatives (e.g., fine-grained wood pulp). Preferred pouch materials, while water-dispersible or soluble, may be designed and manufactured so that, under normal use conditions, a significant amount of the nicotine content will permeate the pouch material before the pouch loses its physical integrity. If desired, flavoring ingredients, disintegration aids, and other desired ingredients may be incorporated into or applied to the pouch material.

[0146] Examples of various types of pouch membrane materials are described in U.S. Patent No. 5,167,244 to Kjerstad. Fleece materials for use as pouch membranes are described, for example, in WO 2008 / 152469, GB 673,587, and EP 2692254.

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

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

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

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

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

[0152] In an advantageous embodiment of the invention, the maximum inner pouch volume is at least 0.5 mL, such as at least 1.0 mL. In one embodiment, the maximum inner pouch volume is between 0.5 mL and 3.0 mL, such as between 1.0 and 2.0 mL.

[0153] In an advantageous embodiment of the present invention, an oral nicotine pouched 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 producing an oral pouched product according to the present invention or any of its embodiments, the method comprising the steps of: - providing a pouch composition according to the present invention or any of its embodiments, - providing a saliva-permeable pouch; - adding a pouch composition to said pouch, and -sealing the pouch, Includes. DETAILED DESCRIPTION OF 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 that contain nicotine.

[0156] As used herein, the term "nicotine pouch composition" refers to a composition for use in a pouched product, i.e., a pouch for oral use, that contains 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 as a flavoring agent, less than 2% by weight of the composition. In other embodiments, the nicotine pouch composition does not contain tobacco.

[0157] As used herein, the term "free base nicotine" refers to nicotine in unprotonated form, and therefore does not include nicotine salt and nicotine provided as a complex of nicotine and ion exchange resin.However, free base nicotine can be mixed with a certain amount of ion exchange resin or a water-soluble composition such as sugar alcohol or 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" typically refers to a container formed by a web of fibrous material surrounding a cavity. Because the pouch is designed for administering active ingredients into the oral cavity, it is suitable for use in the oral cavity, non-toxic, and non-water-soluble. The fibrous material may form, for example, a woven or non-woven web or fabric. The pouch may be formed, for example, by sealing two corresponding sections of the web or fabric together along their edges to form a cavity for the nicotine and water-insoluble composition. To release the nicotine, flavorings, and other water-soluble substances, the pouch is water-permeable so that saliva from the oral cavity can penetrate the pouch and enter the cavity, where it comes into contact with the nicotine, flavorings, and other water-soluble substances, thereby releasing the nicotine, flavorings, 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 composition as particulate matter having a relatively small particle size, for example, of 1 to 1200 micrometers. In particular, powder composition does not refer to powdered tobacco.

[0160] As used herein, where flowability is not applicable, the term mobility is a parameter of powder processability. As used herein, the term "humectant" is understood to mean a moisturizing agent used to attract moisture or water in the form of saliva. Humectants include compositions that are suitably hygroscopic. In some cases, humectants may also be called humectants because of their role in attracting moisture. Examples of humectants include glycerol, propylene glycol, triacetin, modified starch, hydroxypropyl cellulose, alginate, pectin, xanthan gum, etc.

[0161] As used herein, the term "water soluble" refers to a relatively high water solubility, e.g., a water solubility of a water soluble composition or substance greater than 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 water-soluble composition or substance with a relatively low water solubility, for example, a water solubility of less than 0.1 grams per 100 mL of water, measured at 25 degrees Celsius and a pH of 7.0. When referring to "insoluble," water insolubility 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 pure acidity / sourness, or compounds that impart pure saltiness (e.g., NaCl) or pure bitterness. Flavor enhancers include substances that impart only saltiness, bitterness, or sourness. Thus, flavor enhancers include, for example, NaCl, citric acid, ammonium chloride, etc.

[0164] The pouches of the present invention provide nicotine release to the oral cavity. A nicotine release profile can be obtained that includes both fast and sustained release periods. As used herein, the term "fast release" or "fast 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 end of use.

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

[0166] Generally, the pouch has an opening whose characteristic opening dimensions match the characteristic dimensions of the pouch composition to retain the pouch composition within the pouch prior to 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 an appropriate opening size taking into account the pouch composition to be used, the material of the pouch can be appropriately selected, for example, from a woven fabric and / or a nonwoven fabric.

[0168] In other words, according to various embodiments, the pouch forms a membrane that allows the passage of saliva while preventing or inhibiting the passage of undissolved composition and water-insoluble fibers. The pouch membrane may be any suitable material, such as a woven or nonwoven fabric (e.g., cotton, fleece, etc.), a heat-sealable nonwoven cellulose, or other polymeric materials, such as synthetic, semi-synthetic, or natural polymeric materials. Examples of suitable pouch materials include paper made from pulp and a small amount of a wet-strength agent. Materials suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from escaping the bag or pouch during use. Additionally, suitable materials are those that do not significantly affect the release of nicotine from the pouch.

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

[0170] The pouch can be placed in the mouth by the user, after which saliva enters the pouch, causing the nicotine and other components that are soluble in the saliva to begin to dissolve and be carried with the saliva out of the pouch into the mouth, where the nicotine can be absorbed.

[0171] According to one embodiment of the present invention, the pouch composition includes one or more pH controlling agents, such as buffering agents. In one embodiment of the 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, pentapassium 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 may be included in the pouch as part of the pouch composition, for example, as a carrier or portion thereof, as a humectant, or as a sweetener. Suitable sugar alcohols include sugar alcohols selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, 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, but are not limited to, sucralose, aspartame, salts of acesulfame such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside, and the like, alone or in combination.

[0174] In one embodiment of the present invention, the pouch composition comprises sugar and / or sugarless sweeteners, such as sugar alcohols. In one embodiment of the present invention, the pouch composition comprises sugar and / or sugarless sweeteners in an amount of 1.0 to about 80% by weight of the pouch composition, more typically 5 to about 70% by weight of the pouch composition, and more commonly 10 to 30% by weight or 5 to 25% by weight of the pouch composition. In some other embodiments, the sugar and / or sugarless sweeteners comprise 10 to 60% by weight of the pouch composition, or 10 to 50% by weight of the pouch composition. The sugar and / or sugarless sweeteners may function not only as sweeteners but also as humectants. In some embodiments, the approximate amounts of sugar and / or sugarless sweeteners can be further limited by the inclusion of certain ingredients. In some embodiments, the content of sugar and / or sugarless sweeteners in the pouch composition is 20% or less by weight of the pouch composition, such as 15% or less by weight of the pouch composition, such as 10% or less by weight of the pouch composition, such as 5% or less by weight of the pouch composition.

[0175] Sweeteners can often support the flavor profile of the pouch composition. Sugar sweeteners generally include, but are not limited to, sugar-containing ingredients commonly known in the pouch art, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dry invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup, etc., alone or in combination. These sugar sweeteners may also be included as humectants.

[0176] The sweetener can be used in combination with a sugar-free sweetener. Generally, sugar-free sweeteners include sugar-free ingredients that are commonly known for their sweetening properties, including, but not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, isomalt, erythritol, and lactitol, either alone or in combination. These sugar-free sweeteners can also be used as humectants.

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

[0178] In one embodiment of the present invention, the pouch composition comprises a flavoring agent. The flavoring agent may typically be present in an amount of 0.01 to 15% by weight of the total composition of the pouch, such as 0.01 to 5% by weight of the total composition. In an alternative embodiment, the pouch composition may be free of a flavoring agent.

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

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

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

[0182] The controlled release composition can be added to the pouch composition in a variety of ways. In one embodiment of the present invention, the pouch composition does not include triglycerides. For example, the controlled release composition can be added by fully powder mixture during the last few minutes of final mixing.

[0183] Alternatively, the controlled release composition may be added after the granulation step in a granulated premix. Additionally, the controlled release composition may be added only as part of the pouch composition, such that two different nicotine release profiles are obtained. Additionally, two or more portions of the pouch composition may contain different amounts of the controlled release composition, if any, thereby providing more complex and tailored nicotine release profiles.

[0184] Controlled release compositions such as magnesium stearate may have an occlusive effect and can be used to control the release of nicotine and the dissolution rate of the pouch. [Example]

[0185] Example 1A - Preparation of a pouch designed for administration of nicotine The material of the pouch is a heat-sealable nonwoven cellulose, such as long fiber paper. Pouches not in the form of nonwoven cellulose fabrics can also be used in accordance with the present invention.

[0186] The powder is filled into the pouch and maintained within the pouch by a seal. Example 1B - Preparation of a pouch designed for administration of nicotine The pouch material is made using rayon fibers, such as viscose rayon staple fibers, and the pouch membrane is heat sealed along its edges except for an opening at one end to the interior void formed by the pouch membrane.

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

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

[0189] [Table 1]

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

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

[0192] [Table 2]

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

[0194] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 3 below.

[0195] [Table 3]

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

[0197] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 4 below.

[0198] [Table 4]

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

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

[0201] [Table 5]

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

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

[0204] [Table 6]

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

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

[0207] [Table 7]

[0208] The total processing time was 20 minutes. Example 2H-Nicotine Premix VIII-Resin The water was placed in a 60 liter planetary Bear Varimixer mixer and the nicotine was weighed in. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, Amberlite® IRP64 ion exchange resin and fibers were weighed and added to the mixer. The mixer was closed and mixed at high speed for 5 minutes, opening and scraping as needed. Finally, the mixer was mixed at high speed for an additional 5 minutes.

[0209] A nicotine and cation exchange resin mixture was thereby prepared from the components set out in Table 4E below.

[0210] [Table 8]

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

[0212] The fiber and water were mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients were then added sequentially with continuous mixing: nicotine premix (mixed for 2 minutes), then the remaining ingredients except for liquid flavor and glidant, if present (mixed for 2 minutes), then liquid flavor, if present (mixed for 1 minute), then glidant, if present (mixed for 1 minute). Total mixing time was 9-11 minutes.

[0213] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1A is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing.

[0214] The pouch material is a heat-sealable nonwoven cellulose, such as long fiber paper. Pouches not in the form of nonwoven cellulose fabrics can also be used in accordance with the present invention. The pouch material of Example 1B can also be used.

[0215] The powder is filled into a pouch and maintained within the pouch by a seal. Pouches PPC6-PPC7 containing nicotine as a nicotine salt or nicotine polacrilex resin as outlined in Table 5. The pouches are manufactured as follows.

[0216] The fiber and water were mixed for 5 minutes using a planetary Bear Varimixer. The following ingredients were then added with continuous mixing: first, nicotine bitartrate xH2O (NBT, 32.5% nicotine content) or nicotine polacrilex resin (NPR, 15.9% nicotine content), if applicable (mixed for 2 minutes), then the remaining ingredients except for liquid flavor and glidant, if present (mixed for 2 minutes), then liquid flavor, if present (mixed for 1 minute), then glidant, if present (mixed for 1 minute). Total mixing time was 9-11 minutes.

[0217] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1A is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing.

[0218] The pouch material is a heat-sealable nonwoven cellulose, such as long fiber paper. Pouches not in the form of nonwoven cellulose fabrics can also be used in accordance with the present invention. The pouch material of Example 1B can also be used.

[0219] The powder is filled into a pouch and maintained within the pouch by a seal.

[0220] [Table 9]

[0221] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g. An example of the xylitol that can be used is the product name "Xylitab (registered trademark) 200".

[0222] Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus." Other fibers that can be used similarly include 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, apple fiber, bran fiber, bamboo fiber, powdered cellulose, cocoa fiber, and cellulose fiber.

[0223] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0224] The humectants may be sodium alginate, glycerol, or hydroxypropyl cellulose (HPC), and other humectants described herein may be used in combination with or in place of the sodium alginate, glycerol, or HPC.

[0225] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffering agent, and other buffering agents described herein may be used in combination with or as a replacement for sodium carbonate.

[0226] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

[0227] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with or as a substitute for acesulfame potassium.

[0228] Pouches PPC1-PPC5 demonstrate that different pouches can be made with free base nicotine having a moisture content of at least 10% by weight of the pouch composition. Pouches PPC6 and PPC7 have a similar water content to PPC1, but use nicotine that is complexed with a nicotine salt and an ion exchange resin.

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

[0230] The fiber and powder ingredients (except glidant) are blended for 2 minutes using a planetary Bear Varimixer. The nicotine premix is then added and blended for 2 minutes. Water is then added and blended for 5 minutes, followed by liquid flavor (if present, blended for 1 minute) and glidant (if present, blended for 1 minute). The total blending time is 9-11 minutes.

[0231] [Table 10]

[0232] Pouch contents: 500mg total. The isomalt applied is for example GalenIQ™ 720. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus." Other fibers that can be used similarly include 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, and cellulose fiber.

[0233] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0234] The humectants may be sodium alginate, glycerol, or hydroxypropyl cellulose (HPC), and other humectants described herein may be used in combination with or in place of the sodium alginate, glycerol, or HPC.

[0235] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffering agent, and other buffering agents described herein may be used in combination with or as a replacement for sodium carbonate.

[0236] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

[0237] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with or as a substitute for acesulfame potassium.

[0238] Pouches PPC11 to PPC15 exhibit varying moisture contents of at least 10% by weight of the pouch composition. While the moisture content varies, the ratio of the amount of added purified water to the amount of fiber remains constant.

[0239] Example 3C - Pouch Pouches PPC21-PPC26 were prepared containing the powdered compositions as outlined in Table 7 and manufactured similarly to pouches PPC11-PPC15 of Example 3B.

[0240] [Table 11]

[0241] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus." Other fibers that can be used similarly include 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, and cellulose fiber.

[0242] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0243] The humectants may be sodium alginate, glycerol, or hydroxypropyl cellulose (HPC), and other humectants described herein may be used in combination with or in place of the sodium alginate, glycerol, or HPC.

[0244] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffering agent, and other buffering agents described herein may be used in combination with or as a replacement for sodium carbonate.

[0245] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

[0246] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with or as a substitute for acesulfame potassium.

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

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

[0249] Example 3D - Pouch Pouches PPC31-PPC32 were prepared containing the powdered compositions as outlined in Table 8 and manufactured similarly to pouches PPC1-PPC5 of Example 3A, but using Nicotine Premix I and III, respectively.

[0250] Pouches PPC33 to PPC37 are manufactured as follows. Nicotine and sugar alcohol (e.g., xylitol, sorbitol, maltitol) are weighed. Nicotine is slowly added to the sugar alcohol powder while stirring (KitchenAid mixer operated at approximately 30 RPM for approximately 30 minutes). The resulting granules are sieved and placed on a tray. The resulting powder is dried overnight at ambient temperature and then sieved to obtain the 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] The fiber and water are mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients are then added sequentially with continuous mixing: powder ingredients except for the nicotine premix (mixed for 2 minutes), the nicotine-sugar alcohol premix (mixed for 2 minutes), then the liquid flavoring (if present) (mixed for 1 minute), and finally the glidant (if present) (mixed for 1 minute). The total mixing time is 9-11 minutes. The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1A, made from long fiber paper, is used. The powder is filled into the pouch and maintained within the pouch by sealing.

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

[0253] The powder is filled into a pouch and maintained within the pouch by a seal.

[0254] [Table 12]

[0255] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus." Other fibers that can be used similarly include 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, and cellulose fiber.

[0256] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0257] The humectants may be sodium alginate, glycerol, or hydroxypropyl cellulose (HPC), and other humectants described herein may be used in combination with or in place of the sodium alginate, glycerol, or HPC.

[0258] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffering agent, and other buffering agents described herein may be used in combination with or as a replacement for sodium carbonate.

[0259] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

[0260] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with or as a substitute for acesulfame potassium.

[0261] Pouches PPC31-PPC32 illustrate the use of other nicotine premixes. Pouches PPC33 to PPC35 demonstrate the use of nicotine pre-mixed with different sugar alcohols.

[0262] Pouches PPC36-PPC37 demonstrate the use of nicotine pre-mixed with different water-soluble fibers. Example 3E - Pouch Pouches PPC41-PPC46 were prepared containing the powdered compositions as outlined in Table 9 and manufactured similarly to pouches PPC1-PPC5 of Example 3A.

[0263] [Table 13]

[0264] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus." Other fibers that can be used similarly include 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, and cellulose fiber.

[0265] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0266] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. The humectants may be sodium alginate, glycerol, or hydroxypropyl cellulose (HPC), and other humectants described herein may be used in combination with or in place of the sodium alginate, glycerol, or HPC.

[0267] Sodium carbonate is used as an alkaline buffering agent, and other buffering agents described herein may be used in combination with or as a replacement for sodium carbonate.

[0268] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

[0269] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with or as a substitute for acesulfame potassium.

[0270] Pouches PPC41 to PPC44 represent different amounts of nicotine used, from 4.8 mg to 12 mg. Pouch PPC45 denotes a pouch that does not contain alginate but otherwise corresponds to pouch PPC43.

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

[0272] The fiber and powder ingredients (except the nicotine powder and glidant) are blended for 1 minute using a planetary Bear Varimixer. NPR and NBT are then added and blended for 2 minutes (if applicable). The nicotine premix is then added and blended for 2 minutes. Water is then added and blended for 5 minutes, followed by liquid flavoring (if present and blended for 1 minute) and glidant (if present and blended for 1 minute). The total blending time is 9-11 minutes.

[0273] [Table 14]

[0274] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus." Other fibers that can be used include 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, and cellulose fiber.

[0275] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0276] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffering agent, and other buffering agents described herein may be used in combination with or as a replacement for sodium carbonate.

[0277] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

[0278] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with or as a substitute for acesulfame potassium.

[0279] Pouch PPC51 represents a pouch that uses a nicotine ion exchange resin premix in combination with nicotine bitartrate (NBT). Pouch PPC52 represents a pouch that uses a nicotine ion exchange resin premix in combination with nicotine polacrilex resin (NPR).

[0280] Pouch PPC53 represents a pouch using a nicotine ion exchange resin premix in combination with nicotine bitartrate (NBT) and nicotine polacrilex resin (NPR).

[0281] Example 3G-Pouch Nicotine premix-containing pouches PPC61-PPC64 and comparative P3 (COMP. P3) were prepared with powdered compositions as outlined in Table 11. The pouches are manufactured as follows.

[0282] The powdered ingredients, including powdered flavoring (if any), are blended for 2 minutes using a planetary Bear Varimixer mixer. Nicotine is then added and blended for 2 minutes. Water is then slowly added with the mixer running, followed by liquid flavoring. Finally, silicon dioxide is added and blended for approximately 1 minute. Total blending time is approximately 30 minutes.

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

[0284] The pouch material is a heat-sealable nonwoven cellulose, such as long fiber paper. Pouches not in the form of nonwoven cellulose fabrics can also be used in accordance with the present invention. The pouch material of Example 1B can also be used.

[0285] The powder is filled into a pouch and maintained within the pouch by a seal.

[0286] [Table 15]

[0287] Pouch contents: 500mg total, or nicotine concentration of 19.2mg / g. The sugar alcohol may be xylitol (eg, trade name "Xylitab® 200") and / or isomalt (eg, trade name "GalenIQ® 720").

[0288] Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus." Other fibers that can be used similarly include 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, and cellulose fiber.

[0289] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0290] The humectants may be sodium alginate, glycerol, or hydroxypropyl cellulose (HPC), and other humectants described herein may be used in combination with or in place of the sodium alginate, glycerol, or HPC.

[0291] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffering agent, and other buffering agents described herein may be used in combination with or as a replacement for sodium carbonate.

[0292] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

[0293] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with or as a substitute for acesulfame potassium.

[0294] Pouches PPC61 to PPC63 represent pouches with different contents of water and water-insoluble fiber. Example 3H - Pouch Nicotine premix-containing pouches PPC71-PPC76 were prepared with powdered compositions as outlined in Table 12. The pouches are manufactured as follows.

[0295] The fiber and powder ingredients (except glidant) are blended for 2 minutes using a Loedige mixer. The nicotine premix is then added and blended for 2 minutes. Next, with the mixer running, water is added and blended for 15 minutes, followed by liquid flavoring (if present, blended for 15 minutes) and glidant (if present, blended for 1 minute). The total blending time is 19-35 minutes.

[0296] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1A is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing. Alternatively, the pouch material of Example 1B may be used.

[0297] [Table 16-1]

[0298] [Table 16-2]

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

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

[0301] Pea fiber, trade name "Vitacel(R) EF150". Other fibers that can be used similarly include 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, apple fiber, cocoa fiber, bamboo fiber, powdered cellulose, bran fiber, and cellulose fiber.

[0302] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0303] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. The humectants may be sodium alginate, glycerol, or hydroxypropyl cellulose (HPC), and other humectants described herein may be used in combination with or in place of the sodium alginate, glycerol, or HPC.

[0304] Sodium carbonate and sodium bicarbonate are used as alkaline buffers, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0305] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

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

[0307] Pouches PPC71 to PPC74 demonstrate the use of different nicotine premixes. Pouches PPC75 to PPC77 show the use of different fibers. Example 3I - Pouch Nicotine premix-containing pouches PPC81-PPC92 were prepared with the powdered compositions as outlined in Tables 13-I and 13-II. The pouches were made as follows.

[0308] The fiber and powder ingredients (except glidant) are blended for 2 minutes using a Loedige mixer. The nicotine premix is then added and blended for 2 minutes. Next, with the mixer running, water is added and blended for 15 minutes, followed by liquid flavoring (if present, blended for 15 minutes) and glidant (if present, blended for 1 minute). The total blending time is 19-35 minutes.

[0309] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1A is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing. Alternatively, the pouch material of Example 1B may be used.

[0310] [Table 17]

[0311] [Table 18]

[0312] Nicotine premixes contain varying amounts of water, thereby contributing to the total water content. Pouch contents: 500 mg 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, brand name "Vitacel® 600 WF Plus".

[0314] Pea fiber, trade name "Vitacel(R) EF150". Other fibers that can be used similarly include 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, apple fiber, cocoa fiber, bamboo fiber, powdered cellulose, bran fiber, and cellulose fiber.

[0315] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0316] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. The humectants may be sodium alginate, glycerol, or hydroxypropyl cellulose (HPC), and other humectants described herein may be used in combination with or in place of the sodium alginate, glycerol, or HPC.

[0317] Sodium carbonate and sodium bicarbonate are used as alkaline buffers, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0318] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

[0319] Acesulfame potassium and / or sucralose can be used as high-intensity sweeteners, for example. Other usable high-intensity sweeteners described herein may be used in combination with or as a substitute for acesulfame potassium and / or sucralose.

[0320] Pouches PPC81-PPC92 represent the use of different fibers, different amounts, and different nicotine premixes. Pouches PPC93-PPC94 show the use of buffer pairs and large amounts of salt, respectively.

[0321] Example 3J - Pouch Nicotine premix-containing pouches PPC101-PPC107 were prepared with powdered compositions as outlined in Table 14. The pouches are manufactured as follows.

[0322] The fiber and powder ingredients (except glidant) are blended for 2 minutes using a Loedige mixer. The nicotine premix is then added and blended for 2 minutes. Next, with the mixer running, water is added and blended for 15 minutes, followed by liquid flavoring (if present, blended for 15 minutes) and glidant (if present, blended for 1 minute). The total blending time is 19-35 minutes.

[0323] [Table 19]

[0324] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus." Other fibers that can be used similarly include 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, apple fiber, powdered cellulose, cocoa fiber, bamboo fiber, bran fiber, and cellulose fiber.

[0325] For example, a mixture of menthol and peppermint can be used. Of course, other flavorings described herein can likewise be used in combination with or in place of menthol and / or peppermint.

[0326] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. The humectants may be sodium alginate, glycerol, or hydroxypropyl cellulose (HPC), and other humectants described herein may be used in combination with or in place of the sodium alginate, glycerol, or HPC.

[0327] Sodium carbonate and sodium bicarbonate are used as alkaline buffers, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0328] Potassium sorbate is used as a preservative, and other preservatives described herein can also be used in combination with or as a substitute for potassium sorbate.

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

[0330] Pouches PPC101-PPC102 demonstrate the use of different sweetener and buffer combinations. Pouches PPC103-PPC104 represent pouches with different fiber contents.

[0331] Pouches PPC105-PPC107 demonstrate the use of different humectants. Example 3K - Release Test (In Vivo) The releasability of the pouches was evaluated by assessors, preferably a panel of at least 8 assessors, each of whom was given a pouch to place in the oral cavity, specifically on the upper lip.

[0332] After 2, 5, 10, 30, or 60 minutes, the pouch was removed from the subject'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, and the average of the results obtained at each time point was used to generate a profile of the nicotine content in the pouch over time. The amount of nicotine released was then obtained by subtracting the amount of nicotine remaining in the pouch from the initial dose of nicotine in the pouch tested.

[0334] Example 3L - Release Test (In Vitro) The release properties of the pouches were verified in an in vitro experiment. Each pouch was placed in a reaction tube 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] No stirring or shaking was performed during the release experiments. After 2, 5, 10, 30 or 60 minutes, the pouches were removed from the buffer, excess buffer was removed and the amount of nicotine remaining was measured using standard HPLC.

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

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

[0338] The content uniformity of the samples is then determined as the relative standard deviation (RSD) of the individual analyses of the relative nicotine content in the 10 replicate experiments. Example 4 - Evaluation The produced pouches of the present invention were evaluated and found to be highly suitable as delivery vehicles for nicotine, in that they provide a favorable release of nicotine while at the same time being pleasant to the user, for example, with respect to a desirable sticky texture. In particular, the pouches of the present invention did not require moistening before use, in contrast to conventional nicotine pouches with low moisture content that initially feel dry upon use.

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

[0340] The angles of repose were measured for PPC61 to PPC63. PPC63 had a water content 15% higher than PPC62, which 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 were processable on a pouch packaging machine. It was also found that pouches PPC1 and PPC46 had a high degree of fill, while the density of the pouch composition in the finished pouch was significantly lower.

[0342] Example 6 - Filling Degree To evaluate the effect of fill level, several pouches were made using the same pouch composition, PPC62. Fill level was determined by comparing the weight with that of a full pouch (100%). Each pouch was evaluated to determine whether it felt sufficiently full. This evaluation was performed by first touching the pouch with the hand and then inserting the pouch into the mouth. Each pouch is given a thumbs up or thumbs down rating for feel in the hand and feel in the mouth.

[0343] [Table 20]

[0344] As can be seen from Table 15, pouches that are at least 65% filled are given an approved rating for hand feel, and pouches that are at least 70% filled are given an approved rating for mouth feel.

[0345] Example 7 - Filling and Moisture Content To evaluate how moisture content affects user preference for fill level, a number of pouches were manufactured using pouch compositions with different moisture contents: PPC61, PPC62 (see results above), and comparative P3 (COMP. P3).

[0346] The degree of fill was confirmed by comparing the weight with a full pouch (100%). Each pouch was rated for whether it felt sufficiently full. This was done by first feeling the pouch with the hand and then inserting the pouch into the mouth. Each pouch was given an approval or disapproval rating for hand feel and mouth feel.

[0347] [Table 21]

[0348] As can be seen from Table 16, pouches containing 5% water are given an approved rating for hand feel when at least 65% filled, and pouches containing 15% water are already given an approved rating for hand feel when at least 60% filled.

[0349] Pouches containing 5% water are given an approved mouth feel rating when at least 75% full, and pouches containing 15% water are given an approved mouth feel rating when at least 60% full.

[0350] Example 8 - User Evaluation Pouch product PPC1 was evaluated for perceived nicotine effect and burning (tingling) sensation.

[0351] The perceived effects of nicotine and the burning sensation were assessed as follows: The cognitive effects and burning sensation of nicotine were assessed by a test panel of four trained judges, each assessor assessing all samples twice. An average rating was estimated.

[0352] Pouch product PPC1 was rated by all four judges as having a fast onset of action and a high nicotine cognitive effect, and all four judges rated pouch product PPC1 as having a high burning sensation.

[0353] Similarly, pouch product PPC1 was evaluated for nicotine cognitive effects using the same method as above. Pouch product PPC1 was rated by all four judges as having a high nicotine cognitive effect.

[0354] Example 9 - Release Results The pouches were subjected to the in vitro release experiment described in Example 3L.

[0355] [Table 22]

[0356] The release results show that pouches made from fibers with relatively high water binding capacity, such as pea fiber, cellulose L700G, and wheat fiber (WF200), show increased nicotine release after 10 minutes.

[0357] Example 10 - Release Results Pouches having a pouch composition similar to PPC46, but using the following moisture retention agents, were prepared and subjected to the in vitro release experiments described in Example 3L.

[0358] [Table 23]

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

[0360] [Table 24]

[0361] The results show that the use of Nicotine Premix VI improves release after 10 minutes. The release is further improved by including a buffer system, i.e., 3.5% sodium carbonate and 3.5% sodium bicarbonate (PPC93).

[0362] Also, the addition of 10% NaCl appears to improve the release obtained after 10 minutes (PPC94).

Claims

1. 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 and 1. A nicotine pouch composition comprising:

2. 2. The nicotine pouch composition of claim 1, wherein the composition has a bulk density of at most 0.8 g / cm, such as at most 0.7 g / cm, such as at most 0.6 g / cm, such as at most 0.5 g / cm.

3. 3. A nicotine pouch composition according to claim 1 or claim 2, wherein the composition has a bulk density of from 0.2g / cm to 0.8g / cm, such as from 0.3g / cm to 0.7g / cm, such as from 0.3g / cm to 0.6g / cm, such as from 0.4 to 0.5g / cm.

4. 4. The nicotine pouch composition of any one of claims 1 to 3, wherein the nicotine is selected from the group consisting of nicotine salts, nicotine free base, nicotine bound to an ion exchanger such as an ion exchange resin such as nicotine polacrilex resin, nicotine inclusion complexes or any non-covalently bound nicotine, nicotine bound to a zeolite, nicotine bound to a cellulose such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.

5. 5. The nicotine pouch composition of claim 1, wherein the nicotine comprises non-salt nicotine.

6. 6. The nicotine pouch composition of any one of claims 1 to 5, wherein the nicotine comprises nicotine free base.

7. 7. The nicotine pouch composition of any one of claims 1 to 6, wherein the nicotine comprises nicotine mixed with an ion exchange resin.

8. 8. The nicotine pouch composition of any one of claims 1 to 7, wherein the nicotine comprises free base nicotine mixed with an ion exchange resin in a weight ratio between the free base nicotine and the ion exchange resin of 0.1 to 2.0, preferably 0.5 to 2.0, most preferably about 0.67 to 1.

0.

9. 9. The nicotine pouch composition of any one of claims 1 to 8, wherein the nicotine comprises a nicotine salt.

10. 10. The nicotine pouch composition of any one of claims 1 to 9, wherein the nicotine comprises nicotine bound to an ion exchange resin.

11. 11. The nicotine pouch composition of any one of claims 1 to 10, wherein the nicotine comprises synthetic nicotine.

12. 12. The nicotine pouch composition of any one of claims 1 to 11, wherein the pouch composition comprises nicotine in an amount of at least 0.1% by weight of the pouch composition, such as at least 0.2% by weight.

13. 13. The nicotine pouch composition of any one of claims 1 to 12, wherein the pouch composition comprises nicotine in an amount of 0.1 to 5.0% by weight of the pouch composition, such as 0.2 to 4.0% by weight of the pouch composition, such as 1.0 to 2.0% by weight of the pouch composition.

14. 14. The nicotine pouch composition of any one of claims 1 to 13, wherein the pouch composition is provided in a pouch and 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, when the release is measured as described in Example 3K.

15. 15. The nicotine pouch composition of any one of claims 1 to 14, wherein the pouch composition provided to the oral cavity in a pouch has a release rate of nicotine of at least 0.2% per minute within a release period of from 2 to 10 minutes, such as at least 0.3% per minute within a release period of from 2 to 10 minutes, such as at least 0.4% per minute within a release period of from 2 to 10 minutes, such as at least 0.5% per minute within a release period of from 2 to 10 minutes.

16. 16. The nicotine pouch composition of any one of claims 1 to 15, wherein the pouch further comprises a pH control agent, such as a basic pH control agent, such as a basic buffer.

17. 17. The nicotine pouch composition of any one of claims 1 to 16, wherein the pouch composition comprises an alkaline buffer.

18. 18. The nicotine pouch composition of any one of claims 1 to 17, wherein the pouch composition comprises a pH control agent in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.5 to 10% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 5 to 10% by weight of the pouch composition.

19. 19. The nicotine pouch composition of any one of claims 1 to 18, wherein the pouch composition comprises the pH controlling agent in an amount 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, e.g., no pH controlling agent.

20. 20. The nicotine pouch composition of any one of claims 1 to 19, wherein 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 7.4).

21. 21. The nicotine pouch composition of any one of claims 1-20, wherein 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.

22. 22. The nicotine pouch composition of any one of claims 1 to 21, wherein the pH control agent is a basic pH control agent, such as a basic buffer, and / or sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

23. 23. The nicotine pouch composition of any one of claims 1 to 22, wherein the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.

24. 24. The nicotine pouch composition of any one of claims 1 to 23, wherein the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

25. 25. The nicotine pouch composition of any one of claims 1 to 24, wherein the pouch composition comprises at least two sugar alcohols.

26. 26. The nicotine pouch composition of any one of claims 1 to 25, wherein the pouch composition comprises sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition.

27. 27. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition.

28. 28. The nicotine pouch composition of any one of claims 1 to 27, wherein the sugar alcohol comprises a DC (directly compressible) grade sugar alcohol.

29. 29. The nicotine pouch composition of any one of claims 1 to 28, wherein at least 50% by weight of the sugar alcohol is a DC (directly compressible) grade sugar alcohol.

30. 30. The nicotine pouch composition of any one of claims 1 to 29, wherein the water-insoluble fiber is a vegetable fiber.

31. 31. The nicotine pouch composition of any one of claims 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. 32. The nicotine pouch composition of any one of claims 1 to 31, wherein the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof.

33. 33. A nicotine pouch composition according to any preceding claim, wherein the water insoluble fibre has a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.

34. 34. The nicotine pouch composition of any one of claims 1 to 33, wherein the water-insoluble fiber has a swelling capacity of at least 5.0 mL / g, such as from 5.0 to 20 mL / g.

35. 35. The nicotine pouch composition of any one of claims 1 to 34, wherein the water-insoluble composition comprises or consists of 5 to 50% water-insoluble fiber by weight of the pouch composition, and a water content of 15 to 70% by weight of the pouch composition.

36. 36. The nicotine pouch composition of any one of claims 1 to 35, wherein the water-insoluble composition is selected from pea fiber, powdered cellulose, and combinations thereof, and the pouch composition comprises a flavorant in an amount of 10% or less by weight of the pouch composition.

37. 37. A nicotine pouch composition according to any one of the preceding claims, wherein the water-insoluble composition has a density of from 50 to 500 grams per litre, such as from 100 to 400 grams per litre, such as from 200 to 300 grams per litre.

38. 38. The nicotine pouch composition of any one of claims 1 to 37, wherein the pouch composition has an angle of repose of at least 45 degrees, such as at least 50 degrees.

39. 39. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition comprises water in an amount of 10 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 10 to 40% by weight of the composition, such as 20 to 40% by weight of the composition.

40. 40. The nicotine pouch composition of any one of claims 1 to 39, wherein the pouch composition comprises water in an amount of 10 to 40% by weight of the composition.

41. 41. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition comprises water in an amount of 20 to 65% by weight of the composition, such as 20 to 60% by weight of the composition, such as 20 to 50% by weight of the composition, such as 20 to 40% by weight of the composition.

42. 42. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition has a water content of 15 to 65% by weight of the pouch composition, such as 15 to 50% by weight of the pouch composition, such as 15 to 40% by weight of the pouch composition, such as 15 to 30% by weight of the pouch composition, such as 15 to 25% by weight of the pouch composition.

43. 43. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition comprises a weight ratio of water and water insoluble fibre of 3.0 or less, such as 2.5 or less, such as 2.0 or less, such as 1.5 or less, such as 1.0 or less.

44. 44. The nicotine pouch composition of any one of claims 1 to 43, wherein the pouch composition does not contain tobacco, tobacco fiber, or tobacco-derived fiber.

45. 45. The nicotine pouch composition of any one of claims 1 to 44, wherein the pouch composition further comprises a humectant.

46. 46. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition comprises a glidant such as silicon dioxide, for example in an amount of 0.5 to 5% by weight of the composition, such as 1 to 3% by weight of the composition.

47. 47. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition comprises a flavouring, for example in an amount of 0.01 to 20% by weight of the pouch composition, such as 0.01 to 15% by weight of the pouch composition.

48. 48. The nicotine pouch composition of any one of claims 1 to 47, wherein the content of nicotine among a series of at least 10 oral pouches comprising the pouch composition maintains a relative standard deviation (RSD) of no more than 10%, preferably no more than 8%, more preferably no more than 6%, even more preferably no more than 4%, and most preferably no more than 2%.

49. 49. The nicotine pouch composition of any one of claims 1 to 48, wherein the composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, and the composition comprises 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.

50. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; and 50. The nicotine pouch composition of any one of the preceding claims, wherein the composition further comprises 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.

51. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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 51. The nicotine pouch composition of any one of claims 1 to 50, wherein the water-insoluble composition comprises or consists of a water-insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof.

52. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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 52. The nicotine pouch composition of any one of the preceding claims, wherein the water insoluble composition comprises or consists of water insoluble fibre such as wheat fibre, oat fibre, pea fibre, powdered cellulose, or a combination thereof, and the pouch composition comprises flavourant in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.1 to 15% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 3 to 10% by weight of the pouch composition.

53. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises water-insoluble fiber in an amount of 5 to 50% by weight of said pouch composition, such as 10 to 30% by weight of said pouch composition; 53. The nicotine pouch composition of any one of claims 1 to 52, wherein the water insoluble composition comprises or consists of water insoluble fibre, for example wheat fibre, oat fibre, pea fibre, powdered cellulose, or a combination thereof, and the pouch composition comprises flavouring in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.1 to 15% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 3 to 10% by weight of the pouch composition, and wherein the flavouring is oil based.

54. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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; 54. The nicotine pouch composition of any one of claims 1-53, wherein the pouch composition comprises a pH control agent 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.

55. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises 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; the composition further comprises 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 55. The nicotine pouch composition of any one of claims 1-54, wherein the pouch composition comprises a basic pH controlling agent, such as a basic buffer, and / or a pH controlling agent that is sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

56. 1. An oral pouched nicotine product comprising: a saliva-permeable pouch; a nicotine pouch composition; wherein the nicotine pouch composition 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 Including, An oral pouched nicotine product, wherein 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.

57. 57. An oral pouched nicotine product according to claim 56, wherein the composition has a bulk density within the pouch of less than 0.8 g / cm, such as less than 0.7 g / cm, such as less than 0.6 g / cm, such as less than 0.5 g / cm.

58. 58. An oral pouched nicotine product according to claim 56 or claim 57, 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, such as at least 80% of the maximum inner pouch volume, such as at least 90% by the maximum inner pouch volume, such as at least 95% by the maximum inner pouch volume.

59. 59. An oral pouched nicotine product according to any one of claims 56 to 58, wherein the maximum inner pouch volume is at least 0.5 mL, such as at least 1.0 mL.

60. 60. An oral pouched nicotine product according to any one of claims 56 to 59, wherein the membrane of the pouch comprises water-insoluble fibre of a different origin to the water-insoluble fibre contained in the pouched product.

61. 61. An oral pouched nicotine product according to any one of claims 56 to 60, wherein both the water-insoluble fibre of the membrane and the water-insoluble fibre of the pouch composition comprise natural fibre.

62. 62. An oral pouched nicotine product according to any one of claims 56 to 61, wherein both the water-insoluble fibre of the membrane and the water-insoluble fibre of the pouch composition are natural fibres.

63. 63. An oral nicotine pouched product according to any one of claims 56 to 62, comprising a nicotine pouch composition according to any one of claims 1 to 55.

64. 64. A method of producing an oral pouched product according to any one of claims 56 to 63, said method comprising adding: - providing a pouch composition according to any one of claims 1 to 55; - providing said saliva-permeable pouch; - adding said pouch composition to said pouch; - sealing the pouch; A method comprising:

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