Oral pouched products

Abstract

An oral pouched product is disclosed, the oral pouched product comprising a saliva-permeable pouch and a pouch composition, the pouch composition comprising heat-treated fiber, nicotine, water in an amount less than 65% by weight of the pouch composition, and at least one sugar alcohol. A method for producing the oral pouched product is also disclosed.

Description

[Technical field]

[0001] The present invention relates to an oral pouched product according to claim 1 and to a method for producing an oral pouched product according to claim 61. [Background technology]

[0002] Delivery of nicotine through smoking has many well-known drawbacks, particularly health-related problems such as the inclusion of carcinogens. However, tobacco substitutes also have drawbacks, such as insufficient relief of cravings in users. Summary of the Invention [Problem to be solved by the invention]

[0003] It is an object of the present invention to provide a nicotine-containing pouch, for example as a tobacco substitute, which is able to solve the above problems while minimizing undesirable side effects. [Means for solving the problem]

[0004] The present invention relates to an oral pouched product, the oral pouched product comprising: A saliva permeable pouch; A pouch composition; Including, The pouch composition comprises: - heat treated fibres; - Nicotine and water in an amount of less than 65% by weight of the pouch composition; at least one sugar alcohol, Includes.

[0005] The advantage of the present invention is that an oral pouch product can be obtained that has a long-lasting taste and mouthfeel, while the combination of water, sugar alcohol and fiber provides a very pleasant taste and mouthfeel, resulting in a pouch composition that is soft, moist, moldable and has an appealing texture.

[0006] On the other hand, this combination may be somewhat more susceptible to the growth of undesirable microorganisms.Nevertheless, by utilizing nicotine also as an antimicrobial preservative, a long-lasting taste and mouthfeel can be obtained.

[0007] The advantage of the present invention is that it can be an oral pouched product with a long shelf life. This can be achieved with only low or even no preservatives. The present invention can use pretreated fiber instead of tobacco in combination with another nicotine source, for example to avoid the risks associated with tobacco. This allows the fiber to be pretreated separately before adding the volatile nicotine. Furthermore, nicotine is used in part for its antibacterial properties and in some cases to increase the pH level.

[0008] A further advantage of the present invention is that it provides a desirable taste and mouthfeel. The sugar alcohol and its desirable taste and mouthfeel, combined with a microbial-resistant pouch composition, provide a long-term stable taste and mouthfeel. Conventional pouches usually do not emphasize the long-term antimicrobial stability of the product or ensure antimicrobial stability by incorporating preservatives. If shelf life is not considered, high moisture content makes the product susceptible to the growth of microorganisms such as yeast, mold, and bacteria. This not only compromises health safety, but can also significantly impair the user's experience, such as changes in appearance, taste, and deterioration of the product.

[0009] A further advantage of the present invention is that it provides a long shelf life for the product, even when using fibers that may typically have a relatively high microbial content, however, by utilizing nicotine as an antimicrobial agent and optionally an alkaline pH control agent, a long shelf life is nonetheless provided.

[0010] A further advantage of the present invention is that it is not tobacco based, thus avoiding many of the adverse substances associated with tobacco. Furthermore, this allows the texturing fibre and the nicotine to be handled separately. This allows the fibre to be processed without the risk of volatile nicotine evaporating or decomposing.

[0011] The use of nicotine as an antimicrobial preservative has the advantage that the impact on shelf life can be taken into account when adjusting the amount of nicotine, and therefore the ratio between nicotine and fibre can be adjusted, something that is not possible in tobacco-based products where the fibre and nicotine are provided by the tobacco.

[0012] Moreover, a further advantage of the present invention would be that improved shelf life and taste of the product can be obtained without reducing the water activity to undesirable levels where texture and mouthfeel may be compromised. Nevertheless, the inventors have surprisingly found that even with a relatively high water activity in the product, improved shelf life and taste of the product can still be obtained.

[0013] In one embodiment of the present invention, this can be done without using too many preservatives. In an advantageous embodiment, the pouch composition further comprises a preservative in an amount such as less than 0.5% by weight of the composition, such as less than 0.3% by weight of the composition, such as less than 0.15% by weight of the composition, such as less than 0.2% by weight of the composition, such as less than 0.1% by weight of the composition, such as no preservative.

[0014] In an advantageous embodiment, the pouch composition further comprises a preservative in an amount of at least 0.05% by weight of the composition. In one embodiment of the present invention, the pouch composition comprises a preservative in an amount of 0.05-0.5% by weight of the pouch composition.

[0015] In one embodiment of the invention, the pouch composition comprises a preservative in an amount of 0.10 to 0.5% by weight of the pouch composition. In one embodiment of the invention, the pouch composition comprises a preservative in an amount of 0.15-0.5% by weight of the pouch composition.

[0016] In one embodiment of the invention, the pouch composition comprises a preservative in an amount of 0.05-0.5% by weight of the pouch composition, such as 0.10-0.5% by weight of the pouch composition, such as 0.15-0.5% by weight of the pouch composition.

[0017] In one embodiment of the present invention, the pouch 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 pouch composition comprises a preservative in an amount from 0.05 to 0.5% by weight of the pouch composition, such as from 0.10 to 0.5% by weight of the pouch composition, such as from 0.15 to 0.5% by weight of the pouch composition.

[0018] In one 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 pouch composition comprises a preservative in an amount from 0.05 to 0.5% by weight of the pouch composition, such as from 0.10 to 0.5% by weight of the pouch composition, such as from 0.15 to 0.5% by weight of the pouch composition.

[0019] In the above advantageous embodiment within the scope of the present invention, the application of the sugar alcohol is possible with a small amount of preservative and an optimal trigger for saliva secretion, thereby resulting in the release of the composition and nicotine.

[0020] In one embodiment of the invention, the pouch composition comprises a preservative in an amount of 0-0.5% by weight of the pouch composition. In an advantageous embodiment, the pouch composition is preservative-free.

[0021] In an advantageous embodiment, the preservative is selected from sorbic acid and its salts, benzoic acid and its salts, sulphur dioxide salts, nitrates, nitrites, acetic acid and its salts, lactic acid and its salts, malic acid and its salts.

[0022] Non-limiting examples of preservatives that can be used within the scope of the present invention include sorbic acid (E200) and its salts (e.g., sodium sorbate (E201), potassium sorbate (E202), calcium sorbate (E203)), benzoic acid (E210) and its salts (e.g., sodium benzoate (E211), potassium benzoate (E212), calcium benzoate (E213)), acetic acid (E260) and its salts (e.g., sodium acetate (E262), potassium acetate (E261), calcium acetate (E263)), lactic acid (E264), These include: nitrites (sodium nitrite (E250), potassium nitrite (E249)), nitrates (sodium nitrate (E252), potassium nitrate (E252)), sulphur dioxide (E220), sulphites (sodium sulphite (E221), potassium sulphite (E225), calcium sulphite (E226), sodium bisulphite (E222), sodium metabisulphite (E223), potassium metabisulphite (E224), calcium bisulphite (E227), potassium bisulphite (E228)).

[0023] In an advantageous embodiment, the heat treated fibers are water insoluble. An advantage of the above described embodiment is that the combination of sugar alcohol, water insoluble fiber and water provides a very appealing soft, moist, moldable texture and mouthfeel. While the desired texture and mouthfeel is achieved, 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 result in the pouch bursting when removed.

[0024] In one embodiment of the invention, the pouch composition further comprises an amount of water soluble fiber, which may be mixed with water insoluble fiber, such as when the fiber source is comprised of a combination of water soluble and water insoluble fiber.

[0025] In an advantageous embodiment, the water-insoluble fiber is a vegetable fiber. In an advantageous embodiment, 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.

[0026] Powdered cellulose within the scope of the present invention is understood to be cellulose prepared by processing α-cellulose obtained as a pulp from several types of fibrous plant material, such as wood pulp.

[0027] In one embodiment of the invention, the soluble fiber comprises or consists of cereal fiber. In one embodiment of the invention, the soluble fibre comprises or consists of fruit fibre and / or vegetable fibre.

[0028] In an advantageous embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof.

[0029] In one embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, pea fiber, or combinations thereof.

[0030] In one embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, or a combination thereof. 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, Vitacel® Haferfaser / oat fiber HF-401-30 US.

[0031] Non-limiting examples of powdered cellulose that can be used include Vitacel® L00, Vitacel® Cellulose L700G, Vitacel® LC1000, Vitacel® L600-20, Vitacel® L600.

[0032] In one embodiment, the powdered cellulose is not chemically modified, and therefore the powdered cellulose can be a chemically unmodified cellulose fiber, e.g., free of microcrystalline cellulose (MCC).

[0033] In an advantageous embodiment, the water insoluble fibres have a water binding capacity of at least 200%, such as at least 300%, such as at least 400%. In one embodiment of the present invention, the water-insoluble fiber has a water binding capacity of 200-1500%, such as 300-1500%, such as 400-1300%, such as 500-1200%, such as 500-1000%.

[0034] 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%.

[0035] In one embodiment of the present invention, the water-insoluble fiber has a swelling capacity of at least 5.0 mL / g, such as 5.0 to 20 mL / g. The advantage of the above embodiment is that the amount of water-insoluble fiber can be reduced without compromising the 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 that the user will not experience a loss of pouch content during use.

[0036] In an advantageous embodiment of the invention, the water-insoluble composition comprises or consists of water-insoluble fibres in an amount between 5 and 50% by weight of the pouch composition and a water content between 15 and 70% by weight of said pouch composition.

[0037] In an advantageous embodiment, 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 described embodiments would be that by increasing the pH in the pouch composition, a longer shelf life could be obtained, while at the same time more efficient nicotine uptake could be obtained, especially when a basic (alkaline) pH control agent is used.

[0038] Another advantage of the above embodiment may be that a desirable mouthfeel may be obtained 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, but it may still be desirable to further increase the pH by adding a pH control agent.

[0039] In an advantageous embodiment, the pouch composition comprises an alkaline buffer. 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.

[0040] In an advantageous embodiment, the pouch composition comprises a pH controlling agent in an amount 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.

[0041] In one embodiment of the present invention, the pouch composition comprises a pH controlling agent in an amount of 0-6% by weight of the pouch composition, such as 0-5% by weight of the pouch composition, such as 0-4% by weight of the pouch composition, such as 0-3% by weight of the pouch composition, such as 0-2% by weight of the pouch composition, such as 0-1% by weight of the pouch composition. In one embodiment of the present invention, the pouch composition comprises a pH controlling agent in an amount of 0.1-6% by weight of the pouch composition, such as 0.1-5% by weight of the pouch composition, such as 0.5-5% by weight of the pouch composition, such as 0.5-4% by weight of the pouch composition, such as 0.1-3% by weight of the pouch composition, such as 0.1-2% by weight of the pouch composition, such as 0.1-1% by weight of the pouch composition.

[0042] In an advantageous embodiment, the pouch composition is adapted to provide a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 grams of the pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4).

[0043] In one 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).

[0044] 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 embodiments 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.

[0045] 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.

[0046] In an advantageous embodiment, 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, pentaposodium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0047] In an advantageous embodiment, 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.

[0048] In one embodiment, the at least one sugar alcohol may be xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and their mixtures.The at least one sugar alcohol may also include additional sugar alcohols.As an exemplary embodiment, the hydrolyzed hydrogenated starch may be used that includes sorbitol, maltitol, and a mixture of additional sugar alcohols.

[0049] In an advantageous embodiment, the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.

[0050] In an advantageous embodiment, the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

[0051] In an advantageous embodiment, the at least one sugar alcohol comprises xylitol and / or erythritol. In an advantageous embodiment, the pouch composition comprises at least two alcohols.

[0052] 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 preservation, bacterial growth, processability and / or taste.

[0053] 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 highly appealing taste profile. It is noted that in relation to a composition comprising 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 / 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 provides attractive dissolution of the pouch contents including nicotine when contacted with the mucosa.

[0054] In one embodiment of the invention, the at least two sugar alcohols are selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.

[0055] In an advantageous embodiment, the pouch composition comprises at least one 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.

[0056] In an advantageous embodiment, the pouch composition comprises at least one sugar alcohol in an amount of from 1 to 80% by weight of the composition, such as from 2 to 70% by weight of the composition, such as from 5 to 60% by weight of the composition, such as from 10 to 50% by weight of the composition.

[0057] In one embodiment of the invention, the pouch composition comprises at least one sugar alcohol in an amount of 5-40% by weight of the composition, such as 5-30% by weight of the composition. In an advantageous embodiment, the at least one sugar alcohol comprises a DC (directly compressible) grade sugar alcohol.

[0058] In an advantageous embodiment, at least 50% by weight of the at least one sugar alcohol is a DC (directly compressible) grade sugar alcohol. In one embodiment of the invention, the sugar alcohol comprises a non-DC (non-directly compressible) grade sugar alcohol.

[0059] In an advantageous embodiment, the pouch composition comprises water in an amount of less than 60% by weight of the pouch composition, such as less than 50% by weight of the pouch composition, such as less than 40% by weight of said composition.

[0060] In an advantageous embodiment, the pouch composition comprises water in an amount of from 8 to 65% by weight of the composition, such as from 8 to 60% by weight of the composition, such as from 8 to 50% by weight of the composition, such as from 8 to 40% by weight of the composition, such as from 20 to 40% by weight of the composition.

[0061] In an advantageous embodiment, the pouch composition comprises water in an amount of 10-40% by weight of the composition. In an advantageous embodiment, the pouch composition comprises water in an amount of from 20 to 65% by weight of the composition, such as from 20 to 60% by weight of the composition, such as from 20 to 50% by weight of the composition, such as from 20 to 40% by weight of the composition.

[0062] In an advantageous embodiment, the pouch composition comprises water and water insoluble fibre in a weight ratio 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.

[0063] In one 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.

[0064] Thus, the above weight ratio has in the numerator the water content, in weight %, of the pouch composition, and in the denominator the water insoluble fiber content, in weight %, of the pouch composition. In one embodiment, the pouch composition has a water activity of at least 0.6.

[0065] An advantage of the above embodiment is that the product has a desirable soft, moist, moldable texture and mouthfeel. A further advantage is that the desired soft, moist, moldable texture and mouthfeel is maintained / preserved during use as water in the form of saliva comes into contact with the pouch material.

[0066] Further advantages may be that the product has desirable moisture migrating properties, allowing for faster moisture equilibrium in the oral cavity, and provides a desirable texture and mouthfeel.

[0067] An additional advantage may be that the product has desirable moisture transport properties, allowing for faster moisture equilibration in the oral cavity and facilitating faster onset of release of water soluble pouch ingredients such as nicotine, sugar alcohols and flavors.

[0068] In one embodiment of the present invention, the pouch composition has a water activity of 0.6 to 0.8. In one embodiment of the present invention, the pouch composition comprises 5×10 3 Have a total aerobic microbial count (TAMC) of less than or equal to CFU / gram.

[0069] The content of aerobic microorganisms was determined according to method NMKL 86:2013 applying the colony forming unit method. The samples were then grown for 3 days at 30 degrees Celsius. The number of viable aerobic microorganisms per gram was counted.

[0070] In an advantageous embodiment, the pouch composition has a total aerobic microbial count (TAMC) growth of less than 50% over a three month period when stored at 30 degrees Celsius. In one embodiment of the present invention, the pouch composition is 1 to 5 × 10 3 with a total aerobic microbial count (TAMC) of CFU / gram.

[0071] In one embodiment of the present invention, the pouch composition is 2×10 2 Have a total yeast / mold count (TYMC) of less than or equal to CFU / gram. The mould and yeast contents were determined according to method NMKL98:2005 applying the colony forming unit method.

[0072] In an advantageous embodiment, the pouch composition has less than 50% total yeast / mold count (TYMC) growth over a three month period when stored at 30 degrees Celsius. In one embodiment of the present invention, the pouch composition is 10 to 2 × 10 2 with total yeast / mold count (TYMC) CFU / gram.

[0073] In an advantageous embodiment, 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 cellulose such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.

[0074] One example of a combination of different types of nicotine is a combination of free base nicotine mixed with polacrilex resin, where some nicotine binds to the ion exchange resin and some nicotine remains unbound.

[0075] 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 International Patent Application Publication No. WO2010 / 121619, which is incorporated herein by reference.

[0076] In an advantageous embodiment, the nicotine comprises non-salt nicotine. In an advantageous embodiment, the nicotine comprises free base nicotine. A very important advantage of the above embodiment would be that a long shelf life of the pouched product can be obtained with a long life taste and texture. By providing nicotine in free base form, it is easier to obtain a higher pH in the pouch composition with less alkaline pH control agents.

[0077] Therefore, in the above embodiments, the amount of alkaline pH control agent can be reduced without compromising shelf life and long life taste and texture. In an advantageous embodiment, the nicotine comprises nicotine mixed with an ion exchange resin.

[0078] 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.

[0079] In one embodiment of the invention, the nicotine comprises free base nicotine mixed with 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.

[0080] 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 embodiments, the nicotine comprises free base nicotine mixed with 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.

[0081] In one embodiment, the pouch composition comprises water and water insoluble fiber in a weight ratio of 0.2 to 0.8. In an advantageous embodiment, the nicotine comprises a nicotine salt.

[0082] In one embodiment of the 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).

[0083] In one embodiment of the invention, the nicotine salt comprises or consists of nicotine bitartrate. In an advantageous embodiment, the nicotine comprises nicotine bound to an ion exchange resin.

[0084] In one embodiment of the invention, the ion exchange resin is a polacrilex resin. In one embodiment of the present invention, the polacrilex resin is Amberlite® IRP64.

[0085] In an advantageous embodiment, the nicotine comprises synthetic nicotine. In an advantageous embodiment, the nicotine comprises nicotine isolated from tobacco.

[0086] In an advantageous embodiment, 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, 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 0.5 to 3.0% by weight of the pouch composition, such as 1.0 to 2.0% by weight of the pouch composition.

[0087] In an advantageous embodiment, the composition has a bulk density of at most 0.8 g / cm3, such as at most 0.7 g / cm3, such as at most 0.6 g / cm3, such as at most 0.5 g / cm3.

[0088] 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 and unprocessable pouch composition, but rather allowed for a relatively light weight and low density composition.

[0089] In an advantageous embodiment, 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.

[0090] In an advantageous embodiment, the pouch composition further comprises a humectant. The humectant may attract and retain water in the oral cavity during use, however, the humectant may also further moderate the release of nicotine, for example to facilitate a sustained release of nicotine.

[0091] In an advantageous embodiment of the invention, the pouch composition comprises a water retention agent in an amount of 0.5-10% by weight of the pouch composition, such as 0.5-5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition.

[0092] In one embodiment, the humectant is selected from the list of glycerol, propylene glycol, alginate, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, xanthan gum, and combinations thereof.

[0093] In one embodiment the humectant is or comprises an alginate, such as sodium alginate, for example in an amount of 0.5-10% by weight of the pouch composition, such as 0.5-5% by weight, such as 1-3% by weight.

[0094] In one embodiment of the invention, the pouch composition further comprises glycerol. In one embodiment of the invention, the pouch composition further comprises a modified starch. In one embodiment of the invention, the pouch composition further comprises hydroxypropyl cellulose (HPC).

[0095] In an advantageous embodiment, 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 invention, the glidant is selected from talc powder, colloidal silica, silicon dioxide, corn starch, magnesium stearate, and combinations thereof.

[0096] In an advantageous embodiment, the pouch composition comprises a flavouring, for example in an amount such as 0.01 to 15% by weight of the pouch composition. In one embodiment of the invention, the pouch composition comprises flavouring 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.

[0097] In an alternative embodiment, the pouch composition does not include flavorings. In one embodiment of the present invention, the pouch composition is free of preservatives and includes a pH controlling agent in an amount of 0-6% by weight of the pouch composition.

[0098] In one embodiment of the invention, the pouch composition comprises a pH controlling agent in an amount 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.

[0099] In one embodiment of the invention, the pouch composition does not comprise a preservative and comprises a pH controlling agent in an amount of 0-6% by weight of the pouch composition, such as 0-5% by weight of the pouch composition, such as 0-4% by weight of the pouch composition, such as 0-3% by weight of the pouch composition, such as 0-2% by weight of the pouch composition, such as 0-1% by weight of the pouch composition.

[0100] In one embodiment of the present invention, the pouch composition comprises a pH control agent in an amount of 0.1 to 6 wt% of the pouch composition, such as 0.1 to 5 wt% of the pouch composition, such as 0.5 to 5 wt% of the pouch composition, such as 0.5 to 4 wt% of the pouch composition, such as 0.1 to 3 wt% of the pouch composition, such as 0.1 to 2 wt% of the pouch composition, such as 0.1 to 1 wt% of the pouch composition.

[0101] In one embodiment of the invention, the pouch composition is free of pH control agents and preservatives. In one embodiment of the present invention, the pouch composition does not include a pH control agent and includes a preservative in an amount of 0-0.5% by weight of the pouch composition.

[0102] In one embodiment of the invention, the pouch composition does not include a pH controlling agent and includes a preservative in an amount of 0-0.5% by weight of the pouch composition, such as 0-0.4% by weight of the pouch composition, such as 0-0.3% by weight of the pouch composition, such as 0-0.2% by weight of the pouch composition, such as 0-0.1% by weight of the pouch composition.

[0103] In one embodiment of the invention, the pouch composition comprises nicotine free base, a preservative in an amount of 0-0.5% by weight of the pouch composition, and a pH controlling agent in an amount of 0-6% by weight of the pouch composition.

[0104] In one embodiment of the invention, the pouch composition comprises nicotine free base, a preservative in an amount of 0-0.5% by weight of the pouch composition, and no pH controlling agent. In one embodiment of the invention, the pouch composition comprises nicotine free base, a pH controlling agent in an amount of 0-6% by weight of the pouch composition, and no preservatives.

[0105] In one embodiment of the invention, the pouch composition is free of tobacco, tobacco fiber, and tobacco-derived fiber. In some alternative embodiments, the pouch composition may include a trace amount of tobacco. For example, nicotine provided as part of a tobacco such as powdered tobacco is in addition to the free base nicotine. Such tobacco may be included, for example, to provide a tobacco flavor.

[0106] 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 small amounts of tobacco, but this is in addition to the free base nicotine, and thus the pouch composition is not tobacco-based.

[0107] In one embodiment of the invention, the pouch composition comprises, for example, no tobacco, such as less than 0.1% by weight of the pouch composition, such as less than 0.5% by weight of the pouch composition, such as less than 1.0% by weight of the pouch composition, such as less than 3.0% by weight of the pouch composition, or less than 5.0% by weight of tobacco.

[0108] In an advantageous embodiment of the invention, the pouch comprises a water-permeable membrane, for example comprising a woven or non-woven fabric. Typically, the pouch membrane includes an opening with characteristic opening dimensions adapted to 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.

[0109] The materials of the pouch membrane, including, for example, woven and / or nonwoven fabrics, may be appropriately selected to obtain a pouch membrane with a suitable opening size in view of the pouch composition to be used. 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, such as 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 a wet enhancer. The material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from exiting the bag or pouch during use. The suitable material is also one that does not have a significant effect on the release of nicotine from the pouch.

[0110] More specifically, in terms of material, the pouch membrane can be a natural, synthetic, semi-synthetic hydrophilic or hydrophobic membrane. It can be made of one or more biocompatible and physiologically acceptable polymeric materials. Examples of suitable materials for the pouch membrane are cellulose acetate and its derivatives, carboxymethylcellulose, polycellulose esters, other cellulose derivatives including ethylcellulose, 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 earlier in this specification.

[0111] Rayon fibers, such as viscose rayon fibers (i.e., regenerated cellulose), may also be used, for example, in combination with an acrylic polymer to act as a binder in the nonwoven material and provide a heat seal for 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.

[0112] 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 may 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.

[0113] The pouch membrane material may have the form of a net, a sieve, a paper with holes, a permeable cloth, and the like. For example, a pouch material made from rice paper in a net form, or straw paper with holes, may dissolve in the mouth of the user. In some exemplary embodiments, the pouch membrane material may be made using water-dispersible film-forming materials (e.g., binders such as alginate, carboxymethylcellulose, xanthan gum, pullulan, and the like), as well as those materials in combination with materials such as ground cellulose derivatives (e.g., fine grain wood pulp). The preferred pouch material, while water-dispersible or soluble, may be designed and manufactured such that a significant amount of the nicotine content will permeate the pouch material under normal use conditions before the time at which 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.

[0114] 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 2 692 254.

[0115] 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, wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition.

[0116] 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 from 5 to 50% by weight of the pouch composition, such as from 10 to 30% by weight of the pouch composition.

[0117] 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 from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and The water insoluble composition comprises or consists of a water insoluble fiber, such as, for example, wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof.

[0118] 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 from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and The water insoluble composition comprises or consists of a water insoluble fiber, such as a water insoluble vegetable 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.

[0119] 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 from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and The water insoluble composition comprises or consists of a water insoluble fiber, such as a water insoluble vegetable 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 0.01-15% by weight of the pouch composition, such as 0.1-15% by weight of the pouch composition, such as 1-10% by weight of the pouch composition, such as 3-10% by weight of the pouch composition, and the flavoring is oil-based.

[0120] 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 from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and 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, pentaposodium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0121] 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 from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and The pouch composition includes a pH controlling agent, such as a basic buffer and / or a basic pH controlling agent, such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

[0122] In one embodiment of the invention, the membrane comprises water-insoluble fiber of a different origin than the water-insoluble fiber contained in the pouched product. In one embodiment of the invention, the water insoluble fiber of the membrane and the water insoluble fiber of the pouch composition both comprise natural fibers.

[0123] In one embodiment of the invention, the water insoluble fibers of the membrane and the water insoluble fibers of the pouch composition are both natural fibers. The present invention further relates to a method for producing an oral pouched product according to the present invention or any of its embodiments, comprising the steps of: - providing a pouch composition according to the 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 PREFERRED EMBODIMENTS

[0124] As used herein, the term "nicotine" refers to nicotine used as a refined / isolated / purified / synthetic substance. In particular, nicotine does not refer to tobacco materials that contain nicotine.

[0125] As used herein, the term "preservative" means an antimicrobial agent, i.e., an agent that kills or slows the growth of microorganisms. Microorganisms include yeasts, molds, and bacteria. Thus, antioxidants are not preservatives.

[0126] As used herein, the term "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.

[0127] 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 an amount of ion exchange resin or water-soluble composition such as sugar alcohol or water-soluble fiber.Free base nicotine includes both free base nicotine extracted from tobacco and synthetically produced free base nicotine, but free base nicotine is not provided in the form of tobacco or powdered tobacco.Typically, free base nicotine is provided as a liquid.

[0128] As used herein, the term "pouch" is intended to mean a container typically formed by a web of fibrous material surrounding a cavity. The pouch is designed for administering the active ingredient into the oral cavity, and is therefore 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 parts of the web or fabric together along their edges to form a cavity for the nicotine and non-water-soluble 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 the saliva 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.

[0129] 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, a powder composition does not refer to powdered tobacco.

[0130] As used herein, the term "humectant" is understood as 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 referred to as moistening agents, since they act to attract moisture. Examples of humectants include glycerol, propylene glycol, alginate, modified starch, hydroxypropyl cellulose, polyethylene glycol (PEG), triacetin, pectin, xanthan gum, and the like.

[0131] 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.

[0132] As used herein, the term "water-insoluble" refers to a relatively low water solubility, for example, a water soluble composition or substance having 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.

[0133] As used herein, the term "flavor" is understood to have its usual meaning within the art. Flavors include liquid and powdered flavors. Thus, flavors do not include, by definition, 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, and the like.

[0134] 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.

[0135] The materials of the pouch membrane, including, for example, woven and / or nonwoven fabrics, may be appropriately selected to obtain a pouch membrane with a suitable opening size in view of the pouch composition to be used. 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, such as 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 a wet enhancer. The material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from exiting the bag or pouch during use. The suitable material is also one that does not have a significant effect on the release of nicotine from the pouch.

[0136] The pouch composition is filled into the pouch and maintained within the pouch by sealing. An ideal pouch would be chemically and physically stable, pharma- ceutically acceptable, insoluble in water, capable of being filled with powder and sealed, providing a semipermeable membrane layer to prevent the powder from exiting the bag, but allowing saliva and components from the pouch composition within the pouch, such as nicotine and flavorings, dissolved therein or suspended in small enough amounts, to pass through the pouch.

[0137] The pouch can be placed in the mouth of a user, after which saliva enters the pouch and nicotine and other components that are soluble in the saliva begin to dissolve and are carried with the saliva out of the pouch into the mouth where the nicotine can be absorbed.

[0138] According to one embodiment of the present invention, the pouch composition includes one or more pH controlling agents, such as a buffering agent. 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, pentaposodium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0139] 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 part thereof, as a humectant, or as a sweetener.Suitable sugar alcohols include sugar alcohols selected from the group of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof.

[0140] 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, either alone or in combination.

[0141] In one embodiment of the invention, the pouch composition comprises sugar and / or non-sugar 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 comprising 5 to about 70% by weight of the pouch composition, and more commonly comprising 10 to 30% by weight of the pouch composition or 5 to 25% by weight of the pouch composition. In some other embodiments, the sugar and / or 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 inclusion of certain ingredients can further limit the about amounts of sugar and / or sugarless sweeteners. In some embodiments, the content of sugar and / or non-sugar 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.

[0142] Sweeteners can often support the flavor profile of a 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, alone or in combination, which may also be included as humectants.

[0143] The sweetener may be used in combination with sugarless sweeteners. Generally, sugarless sweeteners include sugar-free ingredients that are generally known to have sweetening properties, including, but not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, isomalt, erythritol, lactitol, alone or in combination. These sugarless sweeteners may also be included as humectants.

[0144] 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 plant fiber. Other water-soluble dietary fibers may also be used.

[0145] In one embodiment of the invention the pouch composition comprises a flavouring, which may typically be present in an amount of from 0.01 to 15% by weight of the total composition of the pouch, such as from 0.01 to 5% by weight of the total composition.

[0146] In an alternative embodiment, the pouch composition does not include flavorings. Non-exhaustive examples of flavors suitable for embodiments of the present invention are coconut, coffee, chocolate, vanilla, citrus 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 mint, fruit essences such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, lemongrass, lime, jalapeno, chili (capsaicin), citrus, tobacco flavors, bergamot, smoky, dark and moldy aromas, plum essence, and any combination thereof. Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above.

[0147] In various embodiments of the present invention, the pouch composition comprises a controlled release composition for controlling the release of the pouch composition and / or portions thereof, particularly nicotine. 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 glycols, polyoxyethylene monostearate, tallow, 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.

[0148] The controlled release composition may be added to the pouch composition in a variety of ways. In one embodiment of the invention, the pouch composition is free of triglycerides. For example, the controlled release composition can be added by fully powder mixture during the last few minutes of final mixing.

[0149] Alternatively, the controlled release composition may be added after the granulation step of the granulated premix. Further, the controlled release composition may be added only as part of the pouch composition such that two different nicotine release profiles are obtained. Furthermore, 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.

[0150] A controlled release composition such as magnesium stearate may have an occlusive effect and may be used to control the release of nicotine and the dissolution rate of the pouch. EXAMPLES

[0151] Example 1A - Preparation of a pouch designed for administration of nicotine The material of the pouch is a heat-sealable nonwoven cellulosic material such as filament paper, etc. Pouches not in the form of a nonwoven cellulosic fabric may also be used in accordance with the present invention.

[0152] The powder is filled into a pouch and maintained within the pouch by a seal. Example 1B - Preparation of a pouch designed for administration of nicotine The pouch material is manufactured using rayon fibers, such as viscose rayon staple fibers. The pouch membrane is heat sealed along its edges except for an opening at one end to the interior cavity formed by the pouch membrane.

[0153] The powder is filled into a pouch and maintained within the pouch by a seal. Example 2A - Nicotine Premix I - Resin Water was placed in a Stephan mixer (vacuum premix), nicotine was weighed and added, the mixer was closed and mixed for 5 minutes. Ion exchange resin Amberlite® IRP64 was then weighed and added to the mixer. The mixer was closed and mixed for 10-60 minutes.

[0154] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 1 below.

[0155] [Table 1]

[0156] 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. Ion exchange resin Amberlite® IRP64 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 necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0157] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 2 below.

[0158] [Table 2]

[0159] 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. Ion exchange resin Amberlite® IRP64 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 necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0160] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 3 below.

[0161] [Table 3]

[0162] 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. Ion exchange resin Amberlite® IRP64 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 necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0163] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 4 below.

[0164] [Table 4]

[0165] 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. Ion exchange resin Amberlite® IRP64 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 necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0166] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4B below.

[0167] [Table 5]

[0168] 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. Ion exchange resin Amberlite® IRP64 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 necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0169] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4C below.

[0170] [Table 6]

[0171] 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. Ion exchange resin Amberlite® IRP64 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 necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0172] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4D below.

[0173] [Table 7]

[0174] Total processing time was 20 minutes. Example 2H-Nicotine Premix VIII-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. Ion exchange resin Amberlite® IRP64 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 necessary. Finally, the mixer was stirred at high speed for an additional 5 minutes.

[0175] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4E below.

[0176] [Table 8]

[0177] 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.

[0178] The fiber and water are mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients are then added successively 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 is 9-11 minutes.

[0179] The final powder composition is filled into pouches (target fill weight pouch: 500 mg powder). The pouch material of Example 1 is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing.

[0180] The material of the pouch is a heat-sealable nonwoven cellulosic material such as filament paper. Pouches not in the form of a nonwoven cellulosic fabric may also be used in accordance with the present invention. The powder is filled into a pouch and maintained within the pouch by a seal.

[0181] Pouches PPC6-PPC7 containing nicotine as a nicotine salt or nicotine polacrilex resin as outlined in Table 5. The pouches are manufactured as follows. The fiber and water are mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients are then added with continuous mixing: first, Nicotine Bitartrate xH2O (NBT, 32.5% nicotine content) or Nicotine Polacrylex Resin (NPR, 15.9% nicotine content), if applicable (mixed for 2 minutes), then the remaining ingredients except for liquid flavors and glidants, if any (mixed for 2 minutes), then liquid flavors, if any (mixed for 1 minute), then glidants, if any (mixed for 1 minute). Total mixing time is 9-11 minutes.

[0182] The final powder composition is filled into pouches (target fill weight pouch: 500 mg powder). The pouch material of Example 1 is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing.

[0183] The material of the pouch is a heat-sealable nonwoven cellulosic material such as filament paper. Pouches not in the form of a nonwoven cellulosic fabric may also be used in accordance with the present invention. The powder is filled into a pouch and maintained within the pouch by a seal.

[0184] [Table 9]

[0185] Pouch Content: 500mg total, i.e. nicotine concentration of 19.2mg / g. An example of the xylitol that can be used is the product name "Xylitab® 200".

[0186] Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers may be used as well, such as water-insoluble vegetable fibers 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, cellulose fiber, etc.

[0187] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0188] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0189] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0190] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0191] Pouches PPC1-PPC5 demonstrate that different pouches can be made using free base nicotine with a moisture content of at least 10% by weight of the pouch composition. Pouches PPC6 and PPC7 have a similar moisture content as PPC1, but use nicotine that is complexed with a nicotine salt and an ion exchange resin.

[0192] Example 3B - Pouch Pouches PPC11-PPC15 containing nicotine premixes were prepared containing the powdered compositions as outlined in Table 6. The pouches are manufactured as follows.

[0193] The fiber and powder ingredients (except glidants) are mixed for 2 minutes using a planetary Bear Varimixer mixer. The nicotine premix is ​​then added and mixed for 2 minutes. The nicotine premix is ​​then added and mixed for 2 minutes. The water is then added and mixed for 5 minutes, followed by the liquid flavors (if present, mixed for 1 minute) and glidants (if present, mixed for 1 minute). The total mixing time is 9-11 minutes.

[0194] Comparative NN1 to NN2 (Comp. NN1-NN2) were prepared in the same manner as pouches PPC11 to PPC15, but of course no nicotine premix was added.

[0195] [Table 10]

[0196] Pouch Contents: 500mg total. The applied isomalt is for example GalenIQ™ 720. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers may be used as well, such as water-insoluble vegetable fibers 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, cellulose fiber, etc.

[0197] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0198] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0199] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0200] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0201] Pouches PPC11-PPC15 exhibit different moisture contents of at least 10% by weight of the pouch composition. Although the moisture content varies, the ratio of the amount of added purified water to the amount of fiber remains constant. Comparative pouches Comparative NN1-NN2 do not contain nicotine.

[0202] Example 3C - Pouch Pouches PPC21-PPC27 were prepared containing the powdered compositions as outlined in Table 7 and manufactured similarly to pouches PPC11-PPC15 of Example 3B.

[0203] [Table 11]

[0204] Pouch Contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers may be used as well, such as water-insoluble vegetable fibers 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, cellulose fiber, etc.

[0205] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0206] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0207] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0208] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0209] Pouch PPC21 illustrates 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.

[0210] Pouches PPC23-PPC26 show the use of various amounts of buffering agent (here sodium carbonate). With more basic buffering agent to achieve a more alkaline environment, the need for a preservative (here potassium sorbate) is reduced and therefore omitted in PPC25-PPC26 which have the highest amount of alkaline buffering agent.

[0211] Pouch PPC27 does not contain a preservative or buffer. 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.

[0212] Pouches PPC33 to PPC37 are manufactured as follows. Weigh out the nicotine and sugar alcohol (xylitol, sorbitol, maltitol, etc.). Slowly add the nicotine to the sugar alcohol powder while stirring (Kitchenaid mixer operates at about 30 RPM for about 30 minutes). Sift the resulting granules and place on a tray. Dry the resulting powder overnight at ambient temperature and then sieve 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.

[0213] The fiber and water are mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients are then added successively 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 any) (mixed for 1 minute), and finally the glidant (if any) (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 1 made from long fiber paper is used. The powder is filled into the pouch and maintained in the pouch by sealing.

[0214] The material of the pouch is a heat-sealable nonwoven cellulosic material such as filament paper. Pouches not in the form of a nonwoven cellulosic fabric may also be used in accordance with the present invention. The powder is filled into a pouch and maintained within the pouch by a seal.

[0215] [Table 12]

[0216] Pouch Contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers may be used as well, such as water-insoluble vegetable fibers 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, cellulose fiber, etc.

[0217] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0218] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0219] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0220] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0221] Pouches PPC31-PPC32 demonstrate the use of other nicotine premixes. Pouches PPC33-PPC35 demonstrate the use of nicotine premixed with various sugar alcohols.

[0222] Pouches PPC36-PPC37 demonstrate the use of nicotine premixed with different 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.

[0223] [Table 13]

[0224] Pouch Contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers may be used as well, such as water-insoluble vegetable fibers 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, cellulose fiber, etc.

[0225] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0226] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0227] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0228] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0229] Pouches PPC41 to PPC44 represent different amounts of nicotine usage from 4.8 mg to 12 mg. Pouch PPC45 denotes a pouch that does not contain alginate but otherwise corresponds to pouch PPC43.

[0230] 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.

[0231] The fiber and powder ingredients (except the nicotine powder and glidant) are mixed for 1 minute using a planetary Bear Varimixer mixer. The NPR and NBT are then added and mixed for 2 minutes (if applicable). The nicotine premix is ​​then added and mixed for 2 minutes. Water is then added and mixed for 5 minutes, followed by the liquid flavors (if present and mixed for 1 minute) and glidants (if present and mixed for 1 minute). The total mixing time is 9-11 minutes.

[0232] [Table 14]

[0233] Pouch Contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers may be used as well, such as water-insoluble vegetable fibers 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, cellulose fiber, etc.

[0234] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0235] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers 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 may also be used in combination with or as a substitute for potassium sorbate.

[0237] Other acceptable high intensity sweeteners described herein may be used in combination with or as a substitute for acesulfame potassium. Pouch PPC51 represents a pouch that uses a nicotine ion exchange resin premix in combination with nicotine bitartrate (NBT).

[0238] Pouch PPC52 represents a pouch that uses a nicotine ion exchange resin premix in combination with nicotine polacrilex resin (NPR). Pouch PPC53 represents a pouch that uses a nicotine ion exchange resin premix in combination with nicotine bitartrate (NBT) and nicotine polacrilex resin (NPR).

[0239] Example 3G-Pouch Pouches PPC61-PPC65 containing nicotine premixes were prepared with the powdered compositions as outlined in Table 10A. The pouches are manufactured as follows.

[0240] The fiber and powder ingredients (except for the glidant) are mixed for 2 minutes using a Loedige mixer. The nicotine premix is ​​then added and mixed for 2 minutes. Then, with the mixer running, the water is added and mixed for 15 minutes, followed by the liquid flavors (if present, mixed for 15 minutes) and the glidant (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

[0241] [Table 15]

[0242] Pouch Contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers may be used as well, such as water-insoluble vegetable fibers 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, cellulose fiber, etc.

[0243] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0244] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. As humectants, sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used, and other humectants described herein may be used in combination with or as an alternative to sodium alginate, glycerol or HPC.

[0245] 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.

[0246] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0247] Acesulfame potassium and / or sucralose can be used as high-intensity sweeteners, by way of example. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose or as a substitute for acesulfame potassium and / or sucralose.

[0248] Pouches PPC61-PPC62 demonstrate the use of different sweetener and buffer combinations. Pouches PPC63 to PPC64 represent pouches with different fiber contents. Pouches PPC65 to PPC67 show the use of different humectants.

[0249] Example 3H-Pouch Pouches PPC71-PPC76 containing nicotine premixes were prepared with the powdered compositions as outlined in Table 10B. The pouches are manufactured as follows.

[0250] The fiber and powder ingredients (except for the glidant) are mixed for 2 minutes using a Loedige mixer. The nicotine premix is ​​then added and mixed for 2 minutes. Then, with the mixer running, the water is added and mixed for 15 minutes, followed by the liquid flavors (if present, mixed for 15 minutes) and the glidant (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

[0251] The final powder composition is filled into pouches (target fill weight pouch: 500 mg powder). The pouch material of Example 1 is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing.

[0252] [Table 16-1]

[0253] [Table 16-2]

[0254] Pouch Content: 500mg total, i.e. nicotine concentration of 19.2mg / g. Wheat fiber, trade name "Vitacel® 600 WF Plus".

[0255] Powdered cellulose, trade name "Vitacel® L00" or "Vitacel® L700G". Oat fiber, brand name "Vitacel® 600 WF Plus."

[0256] 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, cellulose fiber, and the like.

[0257] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0258] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. As humectants, sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used, and other humectants described herein may be used in combination with or as an alternative to sodium alginate, glycerol or HPC.

[0259] 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.

[0260] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0261] Acesulfame potassium and / or sucralose can be used as high-intensity sweeteners, by way of example. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose or as a substitute for acesulfame potassium and / or sucralose.

[0262] Pouches PPC71 to PPC74 demonstrate the use of different nicotine premixes. Pouches PPC75 to PPC77 show the use of different fibers. Example 3I - Pouch Pouches PPC81-PPC92 containing nicotine premixes were prepared with the powdered compositions as outlined in Table 10C. The pouches are manufactured as follows.

[0263] The fiber and powder ingredients (except for the glidant) are mixed for 2 minutes using a Loedige mixer. The nicotine premix is ​​then added and mixed for 2 minutes. Then, with the mixer running, the water is added and mixed for 15 minutes, followed by the liquid flavors (if present, mixed for 15 minutes) and the glidant (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

[0264] The final powder composition is filled into pouches (target fill weight pouch: 500 mg powder). The pouch material of Example 1 is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing.

[0265] [Table 17]

[0266] [Table 18]

[0267] Nicotine premixes contain water in varying amounts, thereby contributing to the total water content. Pouch Content: 500mg total, i.e. nicotine concentration of 19.2mg / g. Wheat fiber, trade name "Vitacel® 600 WF Plus" or "Vitacel® 200 WF".

[0268] Powdered cellulose, trade name "Vitacel® L00" or "Vitacel® L700G". Oat fiber, brand name "Vitacel® 600 WF Plus."

[0269] 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, cellulose fiber, and the like.

[0270] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0271] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. As humectants, sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used, and other humectants described herein may be used in combination with or as an alternative to sodium alginate, glycerol or HPC.

[0272] 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.

[0273] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0274] Acesulfame potassium and / or sucralose can be used as high-intensity sweeteners, by way of example. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose or as a substitute for acesulfame potassium and / or sucralose.

[0275] Pouches PPC81 to PPC92 show the use of different fibers, different amounts and different nicotine premixes. Example 3J-Pouch Pouches PPC101-PPC103 containing nicotine premixes as well as Comparative P1 (COMP.P1) and Comparative P2 (COMP.P2) were prepared with powdered compositions as outlined in Table 10D. The pouches are manufactured as follows.

[0276] The fiber and powder ingredients (except for the glidant) are mixed for 2 minutes using a Loedige mixer. The nicotine premix is ​​then added and mixed for 2 minutes. Then, with the mixer running, the water is added and mixed for 15 minutes, followed by the liquid flavors (if present, mixed for 15 minutes) and the glidant (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

[0277] The final powder composition is filled into pouches (target fill weight pouch: 500 mg powder). The pouch material of Example 1 is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing.

[0278] [Table 19]

[0279] Pouch Content: 500mg total, i.e. nicotine concentration of 19.2mg / g. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers may be used as well, such as water-insoluble vegetable fibers as oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, cocoa fiber, cellulose fiber, etc.

[0280] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0281] As humectants, sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used, and other humectants described herein may be used in combination with or as an alternative to sodium alginate, glycerol or HPC.

[0282] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0283] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0284] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0285] Example 3 K-pouch Pouches PPC111-PPC117 containing nicotine premixes were prepared with the powdered compositions as outlined in Table 10E. The pouches are manufactured as follows.

[0286] The powdered ingredients, including powdered flavors (if any), are mixed for 2 minutes using a planetary Bear Varimixer mixer. Nicotine is then added and mixed for 2 minutes. Water is then slowly added with the mixer running, followed by liquid flavors. Finally, silicon dioxide is added and mixed for approximately 1 minute. Total mixing time is approximately 30 minutes.

[0287] The final powder composition is filled into pouches (target fill weight of 500 mg powder per pouch). The pouch material of Example 1 is used, made from long fiber paper. The powder is filled into the pouch and kept in the pouch by sealing.

[0288] The material of the pouch is a heat-sealable nonwoven cellulosic material such as filament paper, etc. Pouches not in the form of a nonwoven cellulosic fabric may also be used in accordance with the present invention. The powder is filled into a pouch and maintained within the pouch by a seal.

[0289] [Table 20]

[0290] Pouch Content: 500mg total, i.e. 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").

[0291] Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers may be used as well, such as water-insoluble vegetable fibers as oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, cocoa fiber, cellulose fiber, etc.

[0292] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0293] As humectants, sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used, and other humectants described herein may be used in combination with or as an alternative to sodium alginate, glycerol or HPC.

[0294] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0295] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0296] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0297] Pouches PPC111 to PPC113 represent pouches having different moisture and water-insoluble fiber contents. PPC114-117 show various amounts of preservative.

[0298] Example 4 - Evaluation The produced pouches of the invention were evaluated and found to be highly suitable as delivery vehicles for nicotine, in that they provide a convenient release of nicotine while at the same time being pleasant to the user, e.g., with respect to a desirable soft, moist and moldable texture. In particular, the pouches of the invention did not require wetting prior to use, unlike conventional nicotine pouches that have a low moisture content that can initially feel dry upon use.

[0299] Example 5 - Shelf Life Pouch products PPC1 and PPC46 were compared with comparative NN1 and NN2 (Comp. NN1 and NN2) pouches with respect to shelf life.

[0300] Shelf life evaluation was performed as follows. Samples of pouched products PPC1 and PP46 were stored in sealed containers for three months at 25 degrees Celsius. The pouched products were then visually inspected for microbial growth.

[0301] Additionally, six batches of pouch composition PPC1 were tested for selected microorganisms.

[0302] [Table 21]

[0303] The aerobic microbial content (TAMC) was determined according to method NMKL86:2013 applying the colony forming unit method. The samples were then grown for 3 days at 30 degrees Celsius. The number of viable aerobic microorganisms per gram was counted.

[0304] The mould and yeast content (TYMC) was determined according to method NMKL98:2005 applying the colony forming unit method. The tested content of aerobic microorganisms as well as the content of molds and yeasts were within the desired ranges allowing for a product with preserved visual appearance, taste and mouthfeel. The pouched products PPC1 and PPC46 were found to have significantly better appearance than the comparative NN2 (Comp. NN2) and also had significantly lower content of the tested microorganisms.

[0305] Example 6 - User evaluation Pouch product PPC1 was evaluated for perceived nicotine effect and burning (tingling) sensation.

[0306] The perceived effects of nicotine and the burning sensation were assessed as follows: The cognitive effects of nicotine and the burning sensation were evaluated by a test panel of four trained judges. Each judge evaluated all samples in duplicate. The average rating was estimated.

[0307] Pouch product PPC1 was rated by all four reviewers as having a fast onset of action and a high nicotine cognitive effect, and pouch product PPC1 was rated by all four reviewers as having a high burning sensation.

[0308] Similarly, the pouch product PPC1 was evaluated for nicotine-induced cognitive effects in the same manner as above. The pouch product PPC1 was rated as having a high nicotine-induced cognitive effect by all four judges.

[0309] Example 7 - User evaluation Pouches with different sugar alcohol contents and different fiber identities were prepared according to Example 3G.

[0310] PPC101, PPC102 and PPC103 are pouches containing nicotine, various amounts of erythritol, and either MCC or wheat fiber. Comparative P1 (COMP.P1) and Comparative P2 (COMP.P2) are pouches containing nicotine, no sugar alcohol, and either MCC or wheat fiber.

[0311] The pouches were evaluated by a test panel of four trained judges, with each judge evaluating all samples in duplicate, over a 10 minute period. The test panel evaluated the pouches on three different parameters: salivation effect, sweetness intensity, and overall taste.

[0312] [Table 22]

[0313] The test panel found that the pouches containing sugar alcohol had an increased sweetness perception: Comparatives P1 and P2, which contained no sugar alcohol, had the lowest sweetness scores, whereas the pouches containing 10% sugar alcohol were higher in sweetness and the pouches containing 20% ​​sugar alcohol were even sweeter.

[0314] The salivary flow effect was also evaluated. The test panel found that pouches containing MCC and 20% sugar alcohols improved the salivary flow effect (PPC103). In the case of pouches containing wheat fibre, this improved salivary flow could already be observed at a content of 10% sugar alcohols (PPC101). This further supports that the water binding capacity of wheat fibre is higher than that of MCC, which may thereby promote increased salivary flow.

[0315] In general, the pouches containing wheat fiber (Comparative P1 and PPC101) had improved overall flavor intensity compared to the pouches containing MCC (Comparative P2 and PPC102). The test panel further noted that Comparative P2 tasted very salty with no detectable lemon flavor.

[0316] Additionally, the test panel evaluated the mouthfeel of the pouches. Comparative P2 and PPC102 were found to have a significantly more unpleasant mouthfeel than PPC103, Comparative P1 and PPC101. For Comparative P2 and PPC102, the test panel noted that the pouch composition was clumpy, the pouch was filled too low, and gum irritation was observed upon use, which was not observed for PPC103, Comparative P1, or PPC101.

[0317] In the case of Comparatives P1 and PPC101, the test panel noted that the pouches had a comfortable fill and that the powders were moldable. The use of fibers with improved water binding capacity can provide a pouch with a more comfortable mouthfeel during use. Yet another aspect of the present invention may be as follows. 〔1〕 An oral pouched product, the oral pouched product comprising: A saliva-permeable pouch; A pouch composition; Including, The pouch composition comprises: Heat treated fibers; Nicotine and Water in an amount less than 65% by weight of the pouch composition; at least one sugar alcohol; 4. An oral pouched product comprising: 〔2〕 The pouch composition further comprises a preservative in an amount of less than 0.5% by weight of the composition, such as less than 0.3% by weight of the composition, such as less than 0.2% by weight of the composition, such as less than 0.15% by weight of the composition, such as less than 0.1% by weight of the composition, or for example no preservative. The oral pouched product of [1]. 〔3〕 The oral pouched product according to claim 1 or 2, wherein the pouch composition further comprises a preservative in an amount of at least 0.05% by weight of the composition. 〔4〕 The oral pouched product according to claim 1 or 2, wherein the pouch composition does not contain a preservative. 〔5〕 The oral pouched product according to any one of [1] to [3], wherein the preservative is selected from sorbic acid and its salts, benzoic acid and its salts, sulfur dioxide salts, nitrates, nitrites, acetic acid and its salts, lactic acid and its salts, and malic acid and its salts. 〔6〕 The oral pouched product according to any one of [1] to [5] above, wherein the heat-treated fiber is water-insoluble. 〔7〕 The oral pouched product according to any one of the above [1] to [6], wherein the water-insoluble fiber is a vegetable fiber. 〔8〕 The oral pouched product according to any one of [1] to [7], 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, bran fiber, bamboo fiber, powdered cellulose, cocoa fiber, cellulose fiber, and combinations thereof. 〔9〕 The oral pouched product according to any one of [1] to [8], 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. 〔10〕 The oral pouched product according to any one of [1] to [9], wherein the water-insoluble fiber has a water binding capacity of at least 200%, such as at least 300%, for example at least 400%. 〔11〕 The oral pouched product according to any one of [1] to

[10] above, wherein 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 the pouch composition. 〔12〕 The oral pouched product according to any one of [1] to

[11] above, wherein the pouch composition further comprises a pH control agent, such as a basic pH control agent, such as a basic buffering agent. 〔13〕 The oral pouched product according to any one of [1] to

[12] above, wherein the pouch composition comprises an alkaline buffering agent. 〔14〕 The pouch composition contains a pH control agent in an amount of less than 6% by weight of the pouch composition, for example, less than 5% by weight of the pouch composition, for example, less than 4% by weight of the pouch composition, for example, less than 2% by weight of the pouch composition, for example, less than 1% by weight of the pouch composition, or for example, no pH control agent. The oral pouched product according to any one of [1] to

[13] above. 〔15〕 The pouch composition is adapted to provide a pH of at least 8.0, such as 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, such as a pH of at least 9.0, when 2.0 grams of the pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4). The oral pouched product according to any one of [1] to

[14] . 〔16〕 The oral pouched product according to any one of [1] to

[15] , 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, pentaposodium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof. 〔17〕 The oral pouched product according to any one of [1] to

[16] , wherein 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. 〔18〕 The oral pouched product according to any one of [1] to

[17] , wherein the at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof. 〔19〕 The oral pouched product according to any one of [1] to

[18] , wherein the at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol and mixtures thereof. 〔20〕 The oral pouched product according to any one of [1] to

[19] , wherein the at least one sugar alcohol comprises xylitol and / or erythritol. 〔21〕 The oral pouched product according to any one of [1] to

[20] above, wherein the pouch composition comprises at least two alcohols. 〔22〕 The oral pouched product according to any one of [1] to

[21] , wherein the pouch composition comprises the at least one 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. 〔23〕 The oral pouched product according to any one of [1] to

[22] , wherein the pouch composition comprises the at least one 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. 〔24〕 The oral pouched product according to any one of [1] to

[23] , wherein the at least one sugar alcohol comprises a DC (directly compressible) grade sugar alcohol. 〔25〕 The oral pouched product according to any one of [1] to

[24] , wherein at least 50% by weight of the at least one sugar alcohol is a DC (directly compressible) grade sugar alcohol. 〔26〕 The pouch composition comprises water in an amount of less than 60% by weight of the pouch composition, such as less than 50% by weight of the pouch composition, such as less than 40% by weight of the composition. The oral pouched product according to any one of [1] to

[25] . 〔27〕 The oral pouched product according to any one of [1] to

[26] above, wherein the pouch composition contains water in an amount of 8 to 65% by weight of the composition, such as 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. 〔28〕 The oral pouched product according to any one of [1] to

[27] above, wherein the pouch composition contains water in an amount of 10 to 40% by weight of the composition. 〔29〕 The oral pouched product according to any one of [1] to

[28] , wherein the pouch composition contains 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. 〔30〕 The oral pouched product according to any one of [1] to

[29] , wherein the pouch composition contains water and water-insoluble fiber in a weight ratio 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. 〔31〕 The oral pouched product according to any one of [1] to

[30] above, wherein the pouch composition has a total aerobic microbial count (TAMC) growth of less than 50% over a period of three months when stored at 30 degrees Celsius. 〔32〕 The oral pouched product according to any one of [1] to

[31] , wherein the pouch composition has a total yeast / mold count (TYMC) growth of less than 50% over a period of three months when stored at 30 degrees Celsius. 〔33〕 The oral pouched product according to any one of [1] to

[32] above, wherein the pouch composition has a water activity of at least 0.6. 〔34〕 The oral pouched product according to any one of [1] to

[33] , wherein 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. 〔35〕 The oral pouched product according to any one of [1] to

[34] , wherein the nicotine comprises non-salt nicotine. 〔36〕 The oral pouched product according to any one of [1] to

[35] , wherein the nicotine comprises free base nicotine. 〔37〕 The oral pouched product according to any one of [1] to

[36] , wherein the nicotine comprises nicotine mixed with an ion exchange resin. 〔38〕 The oral pouched product according to any one of the above [1] to

[37] , wherein the nicotine comprises free base nicotine mixed with an ion exchange resin, the weight ratio between the free base nicotine and the ion exchange resin being 0.1 to 2.0, preferably 0.5 to 2.0, and most preferably about 0.67 to 1.0. 〔39〕 The oral pouched product according to any one of [1] to

[38] , wherein the nicotine comprises a nicotine salt. 〔40〕 The oral pouched product according to any one of [1] to

[39] , wherein the nicotine comprises nicotine bound to an ion exchange resin. 〔41〕 The oral pouched product according to any one of [1] to

[40] above, wherein the nicotine comprises synthetic nicotine. 〔42〕 The oral pouched product according to any one of [1] to

[41] , 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. 〔43〕 The pouched oral product according to any one of [1] to

[42] , wherein the pouch composition contains 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 0.5 to 3.0% by weight of the pouch composition, such as 1.0 to 2.0% by weight of the pouch composition. 〔44〕 The oral pouched product according to any one of [1] to

[43] above, wherein the pouch composition has a bulk density of at most 0.8 g / cm3, such as at most 0.7 g / cm3, such as at most 0.6 g / cm3, such as at most 0.5 g / cm3. 〔45〕 The oral pouched product according to any one of the above [1] to

[44] , wherein the pouch 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. 〔46〕 The oral pouched product according to any one of [1] to

[45] above, wherein the pouch composition further comprises a water retention agent. 〔47〕 The oral pouched product according to any one of [1] to

[46] , wherein the pouch composition contains a water retention agent in an amount of 0.5 to 10% by weight of the pouch composition, such as an amount of 0.5 to 5% by weight of the pouch composition, for example, an amount of 1 to 3% by weight of the pouch composition. 〔48〕 The oral pouched product according to any one of [1] to

[47] , 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, for example in an amount of 1 to 3% by weight of the composition. 〔49〕 The oral pouched product according to any one of [1] to

[48] , wherein the pouch composition contains, for example, a flavoring in an amount of 0.01 to 15% by weight of the pouch composition. 〔50〕 The oral pouched product according to any one of [1] to

[49] , 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, for example, 10 to 60% 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, and The oral pouched product according to any one of [1] to

[50] , 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. 〔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 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and The oral pouched product according to any one of [1] to

[50] above, 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. 〔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 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and The oral pouched product according to any one of [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, 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. 〔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 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and The oral pouched product according to any one of the above [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, 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. 〔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 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and The oral pouched product according to any one of [1] to

[50] , 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, pentaposodium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof. 〔56〕 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 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition, and The oral pouched product according to any one of [1] to

[50] above, wherein the pouch composition comprises a pH control agent, such as 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. 〔57〕 The oral pouched product according to any one of [1] to

[56] , wherein the membrane of the pouch contains a water-insoluble fiber of a different origin from the water-insoluble fiber contained in the pouched product. 〔58〕 The oral pouched product according to any one of [1] to

[57] , wherein both the water-insoluble fiber of the membrane and the water-insoluble fiber of the pouch composition comprise natural fibers. 〔59〕 The oral pouched product according to any one of [1] to

[58] , wherein both the water-insoluble fiber of the membrane and the water-insoluble fiber of the pouch composition are natural fibers. 〔60〕 The oral pouched product according to any one of [1] to

[59] , wherein the pouch composition comprises a preservative in an amount of 0.05 to 0.5% by weight of the pouch composition, such as 0.10 to 0.5% by weight of the pouch composition, such as 0.15 to 0.5% by weight of the pouch composition. 〔61〕 the composition comprises the sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition, and The oral pouched product according to any one of [1] to

[60] , wherein the pouch composition comprises a preservative in an amount of 0.05 to 0.5% by weight of the pouch composition, such as 0.10 to 0.5% by weight of the pouch composition, for example, 0.15 to 0.5% by weight of the pouch composition. 〔62〕 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 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition, and The oral pouched product according to any one of [1] to

[60] , wherein the pouch composition comprises a preservative in an amount of 0.05 to 0.5% by weight of the pouch composition, such as 0.10 to 0.5% by weight of the pouch composition, for example, 0.15 to 0.5% by weight of the pouch composition. 〔63〕 A method for producing an oral pouched product according to any one of [1] to

[62] , comprising the steps of: - providing said pouch composition; - providing a saliva-permeable pouch; - adding said pouch composition to said pouch; and - sealing said pouch; The method includes:

Claims

1. An oral pouched product, the oral pouched product comprising: A saliva-permeable pouch; A pouch composition; Including, The pouch composition comprises: tobacco in an amount less than 1.0% by weight of said pouch composition; Heat treated fibers; Nicotine in an amount of 0.1-5.0% by weight of the pouch composition; Water in an amount of 20 to 65% by weight of the pouch composition; at least one sugar alcohol in an amount of 1-70% by weight of the pouch composition, the at least one sugar alcohol comprising a DC (direct compressible) grade sugar alcohol; a preservative in an amount of 0.05 to 0.5% by weight of the pouch composition; 4. An oral pouched product comprising:

2. 10. The oral pouched product of claim 1, wherein the pouch composition comprises a preservative in an amount of from 0.05% to less than 0.3% by weight of the pouch composition.

3. 3. Oral pouched product according to claim 1 or 2, wherein the preservative is selected from sorbic acid and its salts, benzoic acid and its salts, sulphur dioxide salts, nitrates, nitrites, acetic acid and its salts, lactic acid and its salts, malic acid and its salts.

4. 10. The oral pouched product of claim 1, wherein said heat treated fiber is water insoluble.

5. 5. The oral pouched product of claim 4, wherein said water insoluble fiber is a vegetable fiber.

6. 6. The oral pouched product of claim 4 or 5, 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, bran fiber, bamboo fiber, powdered cellulose, cocoa fiber, and combinations thereof.

7. 10. The oral pouched product of claim 1, wherein the pouch composition further comprises a basic pH control agent.

8. 8. The oral pouched product of claim 7, wherein the pouch composition is adapted to provide a pH of at least 8.0 when 2.0 grams of the pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4).

9. 2. The oral pouched product of claim 1, wherein the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.

10. 10. The oral pouched product of claim 1, wherein said pouch composition comprises said at least one sugar alcohol in an amount of 10-70% by weight of said pouch composition.

11. 10. The oral pouched product of claim 1, wherein said pouch composition comprises said at least one sugar alcohol in an amount of 10-50% by weight of said pouch composition.

12. 10. The oral pouched product of claim 1, wherein the pouch composition comprises water in an amount of 20-40% by weight of the pouch composition.

13. 10. The oral pouched product of claim 1, wherein the pouch composition has a water activity of at least 0.

6.

14. 2. The oral pouched product of claim 1, wherein the nicotine is selected from the group consisting of nicotine salts, free base nicotine, nicotine bound to an ion exchanger, nicotine inclusion complexes or any non-covalently bound nicotine, nicotine bound to a zeolite, nicotine bound to cellulose, and mixtures thereof.

15. 15. The oral pouched product of claim 14, wherein the nicotine comprises nicotine mixed with an ion exchange resin.

16. 15. The oral pouched product of claim 14, wherein the nicotine comprises a nicotine salt.

17. 15. The oral pouched product of claim 14, wherein the nicotine comprises nicotine bound to an ion exchange resin.

18. 10. The oral pouched product of claim 1, wherein the pouch composition comprises nicotine in an amount of 1.0-2.0% by weight of the pouch composition.

19. 10. The oral pouched product of claim 1, wherein said pouch composition further comprises a moisture retention agent.

20. 10. The oral pouched product of claim 1, wherein said pouch composition comprises a flavoring agent in an amount of 0.01 to 15% by weight of said pouch composition.

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