Nicotine pouch composition and pouch containing nicotine pouch composition

Abstract

To provide a nicotine-containing pouch as a tobacco substitute.SOLUTION: Provided is a nicotine pouch composition comprising free base nicotine, the nicotine pouch composition comprising water in an amount of at least 15 wt.%of the pouch composition.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a nicotine pouch composition as claimed in claim 1, and to an oral nicotine pouch product comprising the pouch composition as claimed in claim 83, and to a method of manufacturing such a pouch as claimed in claim 93. [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 disadvantages, such as insufficient relief of cravings in ex-smokers. 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 can solve the above problems. [Means for solving the problem]

[0004] The present invention relates to a nicotine pouch composition comprising free-base nicotine and having a moisture content of at least 15% by weight of said pouch composition. An advantage of the present invention may be that a more desirable mouthfeel may be obtained with the same amount of nicotine compared to pouch compositions with lower moisture content. The application of free base nicotine may provide a discernible burn, thereby better mimicking a tobacco-containing product.

[0005] A further advantage of the present invention may be that, for example, a relatively fast release of nicotine can be obtained by avoiding the delay associated with the release of ionized nicotine bound to a carrier. The fast release of nicotine advantageously provides the user with a fast relief of nicotine craving. Also, the high moisture content further promotes the fast release of nicotine, since the delay typically associated with the attraction of moisture to the pouch can be more or less avoided.

[0006] By providing nicotine as free base nicotine, a relatively high pH can be obtained in the user's resulting saliva, since nicotine is provided in its free base form, as compared with, for example, nicotine bitartrate.Therefore, a higher pH value can be obtained, or the amount of pH control agent can be reduced to achieve the same pH value.A higher pH value promotes nicotine absorption at the oral mucosa.

[0007] Also, an advantage of the present invention may be that a relatively fast release and resulting reduction in nicotine craving may be obtained as a result of the combination of using nicotine in its non-ionized free base form and having a relatively high water content, such that the pouch product may provide a relatively fast release of nicotine into the saliva and subsequent fast uptake of nicotine at the oral mucosa due to the high mouth pH, ​​thereby providing a fast effect for the user.

[0008] Moreover, the use of free base nicotine advantageously provides a pouch product that provides the desired texture and mouthfeel, and provides relief from nicotine cravings. Although the decomposition of nicotine due to the presence of water may reduce the amount of nicotine available to the user to some extent, by providing nicotine as free base nicotine, a higher pH value can be obtained, whereby the reduction in the amount of nicotine is compensated both in terms of mouthfeel, because the higher pH promotes more effective uptake of nicotine. At the same time, the higher pH may increase shelf life due to the inhibition of undesirable microbial growth. Also, the water content and the free base form of nicotine synergistically promote the fast uptake of nicotine.

[0009] The pouch composition may also provide a desirable mouthfeel, such as a soft, sticky texture. The desirable texture and mouthfeel may be obtained while still allowing the manufactured pouches to be stored adjacent to one another, for example in a can, without sticking too much to one another that would result in the pouch bursting when removed. The desirable mouthfeel, in some embodiments, also includes a tingling or burning sensation reminiscent of a tobacco pouch, but without many of the undesirable effects associated therewith, for example in terms of health, discoloration, etc.

[0010] A further advantage of the present invention may be that the resulting nicotine pouch product containing the pouch composition has a relatively low tendency to release dust-like material through the permeable pouch wall in packaging such as a can, which is advantageous both in the sense that no or very little expensive nicotine is wasted, and also in the sense that such loose material in a can is typically considered very unappealing by users.

[0011] The inventors have found that the pouch composition of the present invention can provide surprisingly acceptable stability of free base nicotine in the presence of high moisture contents of at least 15% water by weight. More specifically, pouches containing the pouch composition provided relief from nicotine cravings even after storage.

[0012] Obtaining a relatively fast release and effective uptake of nicotine is desirable as this ensures a fast effect for the user. Furthermore, this can be achieved with the use of free base nicotine, along with a reduced need for enhancers such as pH control agents, which can simplify manufacturing.

[0013] In an advantageous embodiment of the invention, the free base nicotine comprises free base nicotine mixed with an ion exchange resin and / or with a water soluble composition such as a sugar alcohol or water soluble fiber.

[0014] An advantage of the above embodiment may be that a relatively fast release of nicotine may be obtained, as compared to the use of a nicotine-ion exchange resin complex, such as, for example, nicotine polacrilex resin.

[0015] In one embodiment of the invention, the free base nicotine consists of free base nicotine mixed with an ion exchange resin and / or with a water soluble composition such as a sugar alcohol or water soluble fiber.

[0016] In an advantageous embodiment of the invention, the free base nicotine comprises free base nicotine mixed with an ion exchange resin. One advantage of the above embodiment is that it can provide a sustained release of nicotine, for example, compared to free base nicotine mixed with a water-soluble composition such as a sugar alcohol. At the same time, the release of nicotine is not too slow to provide the desired craving relief to the user. Thus, for example, a relatively fast release can be obtained, compared to the use of a nicotine-ion exchange resin complex.

[0017] Another advantage of the above embodiment may be that it provides a relatively cost-effective solution. At the same time, relatively high pH values ​​can be obtained during use, relative to the amount of pH control agent used.

[0018] In one embodiment, the free base nicotine comprises free base nicotine mixed with an ion exchange resin. In an advantageous embodiment of the present invention, the free base nicotine comprises free base nicotine mixed with a polacrilex resin.

[0019] In one embodiment, the free base nicotine consists of free base nicotine mixed with polacrilex resin. In one embodiment of the invention, the free base nicotine comprises nicotine mixed with an ion exchange resin, such as a polacrilex resin, and the nicotine pouch composition further comprises nicotine bound to the ion exchange resin, i.e., a nicotine ion exchange resin complex. Thus, the nicotine may be nicotine mixed with a polacrilex resin, where some of the nicotine is bound to the ion exchange resin, while some of the nicotine remains unbound as free base nicotine.

[0020] In an advantageous embodiment of the invention, the free base nicotine comprises free base nicotine mixed with an ion exchange resin, in a weight ratio between free base nicotine and ion exchange resin of from 0.1 to 2.0, preferably from 0.5 to 2.0, and most preferably from about 0.67 to 1.0.

[0021] In an advantageous embodiment of the invention, the free base nicotine comprises free base nicotine mixed with an ion exchange resin in a weight ratio between free base nicotine and 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.

[0022] Here, weight ratio refers to the ratio of the mass of the first component divided by the mass of the second component. The term mix ratio may also be used. Thus, in the above embodiments, the free base nicotine comprises free base nicotine mixed with an ion exchange resin, in a weight ratio between free base nicotine and 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.

[0023] In an advantageous embodiment of the present invention, the free base nicotine comprises free base nicotine mixed with a water soluble composition such as a sugar alcohol or a water soluble fiber. An advantage of the above embodiment may be that a relatively fast release of nicotine may be obtained, as compared to the use of a nicotine-ion exchange resin complex, such as, for example, nicotine polacrilex resin.

[0024] At the same time, relatively high pH values ​​can be obtained during use compared to the amount of pH control agent used. In one embodiment, the free base nicotine consists of free base nicotine mixed with a water soluble composition, such as a sugar alcohol or water soluble fiber.

[0025] In an advantageous embodiment of the invention, the pouch composition comprises a water-soluble composition, such as a sugar alcohol or a water-soluble fiber, in an amount of from 1 to 80% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition.

[0026] When free base nicotine is mixed with a water-soluble composition such as sugar alcohol or water-soluble fiber, the amount of water-soluble composition such as sugar alcohol or water-soluble fiber can typically be at least 5% by weight of the pouch composition, such as at least 10% by weight of the pouch composition.When using a higher concentration of free base nicotine in the pouch composition, it may be advantageous to increase the amount of water-soluble composition such as sugar alcohol or water-soluble fiber used to mix with free base nicotine.Similarly, for a smaller amount of free base nicotine, the need for water-soluble composition such as sugar alcohol or water-soluble fiber may be reduced.In addition, water-soluble composition, especially sugar alcohol, can be used as, for example, bulk sweetener, filler, etc.

[0027] In an advantageous embodiment of the invention, the free base nicotine comprises free base nicotine mixed with a sugar alcohol. In one embodiment, the free base nicotine consists of free base nicotine mixed with a sugar alcohol.

[0028] In an advantageous embodiment of the invention, said sugar alcohol is selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof.

[0029] In one embodiment of the invention, the sugar alcohol is provided as a direct compression (DC) form of the sugar alcohol. An advantage of this embodiment may be that increased flowability may be achieved.

[0030] In an advantageous embodiment of the present invention, the free base nicotine comprises free base nicotine mixed with water soluble fiber. In one embodiment, the free base nicotine comprises free base nicotine mixed with water soluble fiber.

[0031] In an advantageous embodiment of the invention, said water-soluble fibres are selected from the list of inulin, polydextrose, including purified polydextrose, dextrin, maltodextrin and mixtures thereof.

[0032] In an advantageous embodiment of the invention, the free base nicotine mixed with the ion exchange resin further comprises water. Thus, in the above embodiment, the mixture of nicotine and ion exchange resin further comprises water. This mixture containing water can then be mixed with additional ingredients, which typically include additional water, to obtain a water content of at least 15% by weight of the pouch composition.

[0033] In an advantageous embodiment of the invention, the pouch composition comprises a combination of free base nicotine mixed with a first composition and free base nicotine mixed with a second, different composition. It is understood that the first composition and the second composition are different. One example is free base nicotine mixed with ion exchange resin combined with free base nicotine mixed with water soluble composition such as sugar alcohol or water soluble fiber. Another example is a combination of free base nicotine mixed with sugar alcohol and free base nicotine mixed with water soluble fiber. Yet another example is a combination of free base nicotine mixed with one type of ion exchange resin and free base nicotine mixed with another type of ion exchange resin, or a combination of free base nicotine mixed with one type of water soluble fiber and free base nicotine mixed with another type of water soluble fiber, or a combination of free base nicotine mixed with one type of sugar alcohol and free base nicotine mixed with another type of sugar alcohol.

[0034] In an advantageous embodiment of the present invention, the free base nicotine comprises a combination of free base nicotine mixed with a water soluble composition and free base nicotine mixed with a water insoluble composition. An advantage of the above embodiment may be that a nicotine release profile may be obtained that includes both fast release and sustained release components, which may be desirable to users of nicotine pouch products.

[0035] Examples of water-insoluble compositions that can be used may include water-insoluble fibers such as, for example, vegetable fibers, bran fibers, and cellulose fibers, hereinafter microcrystalline cellulose (MCC).

[0036] In an advantageous embodiment of the invention, the free base nicotine comprises a combination of free base nicotine mixed with an ion exchange resin and free base nicotine mixed with an aqueous soluble composition. An advantage of the above embodiment may be that a nicotine release profile may be obtained that includes both fast release and sustained release components, which may be desirable to users of nicotine pouch products.

[0037] In an advantageous embodiment of the invention, the free base nicotine is granulated with a water soluble composition or an ion exchange resin. In an advantageous embodiment of the invention, the pouch composition further comprises a pH controlling agent, such as a basic pH controlling agent, such as a basic buffering agent.

[0038] An advantage of the above embodiment may be that more efficient uptake of nicotine may be obtained. Another advantage of the above embodiment may be that a desirable mouthfeel may be obtained during use. In one embodiment of the invention, the pouch composition further comprises a combination of at least two pH control agents, such as a combination of at least two basic buffering agents, such as a basic buffer pair, such as a combination of at least two basic pH control agents.

[0039] For example, by avoiding the use of nicotine salts such as nicotine bitartrate, smaller amounts of pH control agent may be accommodated in embodiments, but it may still be desirable to further increase the pH by adding a pH control agent.

[0040] In one embodiment of the present invention, the pouch composition includes a pH control agent, for example in an amount of 0.01 to 15% by weight of the pouch composition. In an advantageous embodiment of the invention, the pouch composition comprises a pH control agent in an amount of 0.01 to 15% by weight of the pouch composition, such as 5 to 10% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 0.5 to 10% by weight of the pouch composition.

[0041] In an advantageous embodiment of the invention, the pouch composition is adapted to provide a pH of at least 8.0. In one embodiment of the invention, the pouch composition is adapted to provide a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 grams of the pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate buffer (adjusted to pH 7.4).

[0042] In one embodiment of the invention, the pouch composition is adapted to provide a pH of at least 8.0 during use after placement in the oral cavity. An advantage of the above embodiment may be that relatively efficient nicotine uptake is promoted due to the high pH value obtained.

[0043] 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.

[0044] 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. In an advantageous 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.

[0045] In an advantageous embodiment of the invention, the pH control agent is a basic buffer and / or a basic pH control agent such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

[0046] In an advantageous embodiment of the invention, the pouch composition further comprises a moisture retention agent. The humectants may attract and retain water in the oral cavity during use, however, they may also retard the release of nicotine, for example facilitating a sustained release of nicotine.

[0047] In an advantageous embodiment of the invention, the pouch composition further comprises a water retention agent in an amount of 0.5 to 10% by weight of the pouch composition, such as 1 to 3% by weight of the pouch composition, such as 0.5 to 5% by weight of the pouch composition.

[0048] In an advantageous embodiment of the invention, the humectant comprises one or more from the list consisting of glycerol, propylene glycol, alginate, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

[0049] In an advantageous embodiment of the invention, the pouch composition further comprises an alginate. 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.

[0050] In one embodiment of the invention, the pouch composition further comprises hydroxypropyl cellulose (HPC). An advantage of the above embodiment may be that the pouch composition during use provides a desirable soft texture. The alginate may, for example, be provided as a water retention agent, so as to attract and retain water in the oral cavity during use. However, the alginate may also inhibit the release of nicotine, for example, facilitating a sustained release of nicotine.

[0051] In an advantageous embodiment of the invention, the pouch composition further comprises alginate in an amount of 0.5 to 5% by weight of the pouch composition, such as 1 to 3% by weight of the pouch composition. In an advantageous embodiment of the invention, the pouch composition further comprises xanthan gum.

[0052] An advantage of the above embodiment may be that the pouch composition provides a desirable soft texture during use. Xanthan gum, for example, may be provided as a water retention agent, so as to attract and retain water in the oral cavity during use.

[0053] In an advantageous embodiment of the invention, the pouch composition further comprises silicon dioxide. An advantage of the above embodiment may be that improved flowability of the pouch composition may be obtained. Thus, silicon dioxide may serve as a glidant. Alternative glidants may also be used in embodiments in which a glidant is used.

[0054] In one embodiment of the invention, the pouch composition further comprises silicon dioxide in an amount of 0.5-5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition. In an advantageous embodiment of the invention, the pouch composition comprises flavouring in an amount of from 0.01 to 20% by weight of the pouch composition, such as for example in an amount of from 0.01 to 15% by weight of the pouch composition.

[0055] In one embodiment of the invention, the pouch composition comprises a flavourant in an amount from 0.01 to 15% by weight of the pouch composition, such as from 3 to 10% by weight of the pouch composition, such as from 1 to 10% by weight of the pouch composition, such as from 0.1 to 15% by weight of the pouch composition.

[0056] In an advantageous embodiment of the invention, the flavouring comprises a liquid flavouring. The nature of the water-insoluble ingredients can affect the release of flavor from the pouch composition, which can affect the perception of the flavor by the user.

[0057] In one embodiment of the present invention, the water insoluble fiber may result in a higher or lower perception of the flavor to the user. In one embodiment of the invention, the pouch composition comprises flavoring in an amount of 10% or less by weight of the pouch composition, such as 5% or less by weight of the pouch composition, such as 8% or less by weight of the pouch composition.

[0058] In one embodiment of the invention, the pouch composition comprises flavouring in an amount from 0.01 to 10% by weight of the pouch composition, such as from 0.01 to 5% by weight of the pouch composition, such as from 0.01 to 8% by weight of the pouch composition.

[0059] In an advantageous embodiment of the invention, the pouch composition comprises a water insoluble fiber selected from pea fiber, powdered cellulose, and combinations thereof, and a flavoring agent in an amount of up to 10% by weight of the pouch composition.

[0060] The cellulose prepared by treating α-cellulose obtained as a pulp from multiple types of fibrous plant materials can be obtained, for example, from wood pulp. In one embodiment of the present invention, the pouch composition comprises a water insoluble fiber selected from pea fiber and powdered cellulose, or a combination thereof, and a flavoring agent in an amount of 0.01-10% by weight of the pouch composition.

[0061] In an advantageous embodiment of the invention, the pouch composition is substantially homogeneous. For example, a more homogenous pouch composition having a uniform nicotine distribution may be obtained if at least 90% by weight of the total amount of dry ingredients is mixed before adding nicotine followed by adding water, such as before adding nicotine followed by adding water and liquid flavoring, if any.

[0062] In an advantageous embodiment of the invention, the nicotine content among a series of at least 10 oral pouches comprising said pouch composition has a relative standard deviation (RSD) of less than 10%, preferably less than 8%, more preferably at most 6%, even more preferably at most 4% and most preferably at most 2%.

[0063] In one embodiment of the invention, the nicotine content among a series of at least 10 oral pouches comprising said pouch composition has a relative standard deviation (RSD) of 0.1-10%, preferably 0.1-8%, more preferably 0.1-6%, even more preferably 0.1-4%, and most preferably 0.1-2%.

[0064] The homogeneity of a pouch composition can be assessed by estimating the distribution of one component of the composition among the individual pouches. For example, the standard deviation of nicotine content can be measured as described in Example 3J. The content, i.e., nicotine content uniformity (CU), is related to the homogeneity of the pouch composition. Pouches prepared from the same pouch composition and having a low standard deviation for nicotine content have high pouch composition homogeneity, while pouches prepared from the same pouch composition and having a high standard deviation for nicotine content have low pouch composition homogeneity.

[0065] In an advantageous embodiment of the invention, the pouch composition is obtained by mixing the dry ingredients before adding the nicotine, water and liquid flavouring, if any. An advantage of the above embodiment may be that improved homogeneity of the pouch composition may be obtained.

[0066] In an advantageous embodiment of the invention, the pouch composition is obtained by mixing at least 90% by weight of the total amount of dry ingredients before adding water, such as before adding water and liquid flavor, if any.

[0067] An advantage of the above embodiment may be that improved homogeneity of the pouch composition may be obtained. In an advantageous embodiment of the invention, the pouch composition further comprises an amount of a water insoluble composition.

[0068] An advantage of the above embodiment may be that even after use of the nicotine pouch containing the pouch composition, no residue is left behind, which may result in a pleasant perception of the nicotine pouch by the user due to, for example, its similarity to tobacco-containing products.

[0069] In an advantageous embodiment of the present invention, the water-insoluble composition comprises at least one selected from calcium hydrogen phosphate, calcium carbonate, mono-diglyceride powder, hydrogenated vegetable oil, and combinations thereof.

[0070] In an advantageous embodiment of the invention, said amount of said water-insoluble composition is between 5 and 50% by weight of the pouch composition, such as between 10 and 30% by weight of the pouch composition. In an advantageous embodiment of the present invention, the water insoluble composition comprises or consists of water insoluble fibers such as water insoluble vegetable fibers such as wheat fiber, 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, cellulose fiber, powdered cellulose, bamboo fiber, bran fiber, or combinations thereof.

[0071] 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.

[0072] In one embodiment of the invention, the soluble fiber comprises or consists of cereal fiber. In one embodiment of the invention, the water-soluble fibre comprises or consists of fruit and / or plant fibre.

[0073] In an advantageous embodiment of the invention, 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.

[0074] In an advantageous embodiment of the invention, 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, or a combination thereof.

[0075] In an advantageous embodiment of the invention, 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, or a combination thereof.

[0076] Non-limiting examples of plant fibers that can be used include Vitacel® WF600, Vitacel® HF600, Vitacel® P95, Vitacel® WF200, Vitacel® L00, Vitacel® Erbsenfaser EF150, Vitacel® Bamboo Fiber Buff ... fiberbaf 90, Vitacel® HF 600, Vitacel® Cellulose L700G, Vitacel® PF 200, Vitacel® potatoofiber KF 200, Vitacel® bamboo fiberhaf BAF 40, Vitacel® Haferfaser / oat fiber HF-401 30 US.

[0077] Non-limiting examples of powdered cellulose that can be used include Vitacel® L00, Vitacel® Cellulose L700G, Vitacel® LC1000, Vitacel® L600-20, Vitacel® L600, and the like.

[0078] 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).

[0079] In an advantageous embodiment of the invention, the water-insoluble fibres have a water binding capacity of at least 200%, such as at least 400%, such as at least 300%.

[0080] An advantage of the above embodiment may be that the high water binding capacity allows for a pouch composition having a high moisture content. Additionally, it has been found that pouches having a high moisture content have a desirable texture and mouthfeel, while still allowing the produced pouches to be stored adjacent to one another, for example in a can, without sticking too much to one another which would result in the pouch bursting when removed.

[0081] In one embodiment of the present invention, the water-insoluble fibre has a water binding capacity of 200% to 1500%, such as 400-600%, such as 300-800%, such as 200-800%, such as 300-1300%.

[0082] In one embodiment of the present invention, the water-insoluble fibre has a water binding capacity of 200-1500%, such as 400-700%, such as 300-700%, such as 300-900%, such as 300-1300%.

[0083] In one embodiment of the present invention, the water-insoluble fibre has a water binding capacity of 200-1500%, such as 500-1000%, such as 500-1200%, such as 500-1500%, such as 400-1500%.

[0084] In one embodiment of the invention, the water-insoluble fiber has a swelling capacity of at least 5.0 mL / g, such as 5.0-20 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 a certain amount of water-insoluble fiber substitutes for the water-soluble ingredients, the swelling of the water-insoluble fiber prevents the dissolution of the water-soluble ingredients during use, so that the user does not experience any reduction in pouch contents during use.

[0085] 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.

[0086] In an advantageous embodiment of the invention, the water-insoluble fibre is selected from pea fibre, powdered cellulose, and combinations thereof, and wherein the pouch composition comprises flavourings in an amount of up to 10% by weight of the pouch composition.

[0087] The pouch compositions of the above embodiments may also provide a desirable mouthfeel, such as a soft, sticky texture. The desirable texture and mouthfeel may be obtained while still allowing the manufactured pouches to be stored adjacent to one another, such as in a can, without sticking too much to one another that would result in the pouch bursting when removed. The desirable mouthfeel, in some embodiments, includes the lack of a tingling sensation reminiscent of tobacco pouches, as well as many of the undesirable effects associated therewith, such as in terms of health, discoloration, etc.

[0088] In one embodiment of the invention, the pouch composition comprises water insoluble fiber in an amount of from 5 to 50% by weight of the pouch composition, such as from 10 to 40% by weight of the pouch composition. In an advantageous embodiment of the invention, the pouch composition has a moisture content of at least 20% by weight of said pouch composition, such as at least 40% by weight of said pouch composition, such as at least 30% by weight of said pouch composition, such as at least 25% by weight of said pouch composition.

[0089] Water may be added as a separate ingredient that is fully or partially mixed with other ingredients, such as fiber. For example, if free base nicotine is added as a mixture of free base nicotine with ion exchange resin and water, a significant amount of water in the final pouch composition may come from the free base nicotine-ion exchange resin-water pre-mixture. For example, if the final amount pouch composition contains 5% water from the free base nicotine-ion exchange resin-water pre-mixture, up to 1 / 3 of the water in the pouch composition comes from the free base nicotine-ion exchange resin-water pre-mixture.

[0090] In an advantageous embodiment of the invention, the pouch composition has a moisture content of 15-70% by weight of the pouch composition, such as 30-40% by weight of the pouch composition, such as 25-50% by weight of the pouch composition, such as 15-50% by weight of the pouch composition, such as 15-65% by weight of the pouch composition.

[0091] In an advantageous embodiment of the invention, the pouch composition has a moisture content of 15-70% by weight of said pouch composition, such as 15-25% by weight of said pouch composition, such as 15-30% by weight of said pouch composition, such as 15-40% by weight of said pouch composition, such as 15-50% by weight of said pouch composition.

[0092] In an advantageous embodiment of the invention, the composition has a bulk density of at most 0.8 g / cm3, such as at most 0.5 g / cm3, such as at most 0.6 g / cm3, such as at most 0.7 g / cm3.

[0093] The inventive use of compositions having a relatively low bulk density provides not only good mouthfeel, but also efficient release from the pouch due to the fact that the relatively low bulk density promotes efficient salivation and thereby facilitates the release of the water soluble components of the composition. It is particularly noted that low bulk density, in combination with the claimed moisture content, is attractive when improved user perception is desired.

[0094] At the same time, lower density advantageously reduces raw material requirements, thereby reducing manufacturing costs. An advantage of the above embodiment may be that a low density composition may be obtained. Surprisingly, the combination of water and sugar alcohol did not result in a very dense and compacted unworkable pouch composition, but rather allowed for a relatively light and low density composition.

[0095] In an advantageous embodiment of the invention, the composition has a bulk density of 0.2 g / cm3 to 0.8 g / cm3, such as 0.4 to 0.5 g / cm3, such as 0.3 g / cm3 to 0.6 g / cm3, such as 0.3 g / cm3 to 0.7 g / cm3.

[0096] In one embodiment of the invention, the composition has a bulk density of 0.2 g / cm 3 to 0.8 g / cm 3 , such as 0.2 to 0.5 g / cm 3 , such as 0.2 g / cm 3 to 0.6 g / cm 3 , such as 0.2 g / cm 3 to 0.7 g / cm 3 .

[0097] In one embodiment of the invention, the composition has a bulk density of 0.2 g / cm3 to 0.8 g / cm3, such as 0.5 to 0.8 g / cm3, such as 0.4 g / cm3 to 0.8 g / cm3, such as 0.3 g / cm3 to 0.8 g / cm3.

[0098] In an advantageous embodiment of the invention, the pouch composition comprises water and water insoluble fiber in a weight ratio of 1.0 or less, such as 1.5 or less, such as 2.0 or less, such as 2.5 or less, 3.0 or less.

[0099] In one embodiment, the pouch composition comprises water and water insoluble fiber in a weight ratio of 3.0 to 0.2, such as 2.0 to 1.0, such as 1.5 to 0.5, such as 2.0 to 0.2. 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.

[0100] In general, the inventors found that too low water content caused incomplete wetting of the pouch composition. This typically resulted in a dry formulation with lumpy, i.e. undesirable mouthfeel. In addition, it could be the cause of delayed nicotine release due to the time delay before the pouch composition is wetted by saliva. On the other hand, it was found that too high water content could result in a composition that feels too heavy, with undesirable flow properties. The inclusion of a glidant such as silicon dioxide could at least partially improve such undesirable flow properties, thus allowing a higher water content.

[0101] Having a moisture content within the range of the present invention may promote fast release within an initial fast release period, such as within the first 120 seconds, since the pouch is already wetted or partially wetted with water from the start of use.

[0102] On the other hand, the moisture content should not be too high. Too high moisture content can affect the liquid diffusion into and out of the pouch. A fully wetted pouch can have lower liquid diffusion into and out of the pouch during use, while a partially wetted pouch can have higher liquid diffusion into and out of the pouch. Thus, a pouch with low liquid diffusion can have lower release of nicotine after, for example, 10 minutes.

[0103] In an advantageous embodiment of the invention, the pouch composition has a moisture content of 60% or less by weight of said pouch composition, such as 30% or less by weight of said pouch composition, such as 40% or less by weight of said pouch composition, such as 50% or less by weight of said pouch composition.

[0104] In an advantageous embodiment of the invention, the pouch composition is a powdered composition. In an advantageous embodiment of the invention, the pouch composition has an average particle size of from 1 to 1200 micrometers, such as from 10 to 500 micrometers.

[0105] In one embodiment of the invention, the pouch composition has an average particle size of less than 1200 micrometers. In one embodiment of the invention, the pouch composition has an average particle size greater than 1 micrometer, such as greater than 50 micrometers, such as greater than 10 micrometers.

[0106] In one embodiment of the present invention, all ingredients were passed through a 1400 micron sieve. In one embodiment of the present invention, all ingredients were passed through an 800 micron sieve. In an advantageous embodiment of the invention, at least 50% by weight of the pouch composition is provided in particles having a particle size above 10 micrometers, such as between 10 and 500 micrometers.

[0107] Nicotine release profiles that include both fast and sustained release periods can be obtained. In one embodiment, the fast release period may refer to the first 120 seconds of the nicotine release profile, while the sustained release period may refer to the subsequent period of the release profile, such as the period from 2 minutes to 30 minutes after the start of use until the end of the experiment or use.

[0108] In an advantageous embodiment of the invention, the pouch composition is provided in a pouch and is adapted to release at least 15% by weight of the free base nicotine, such as at least 40% by weight of the free base nicotine, such as at least 30% by weight of the free base nicotine, such as at least 20% by weight of the free base nicotine, within a period of 120 seconds upon contact with oral saliva, when the release is measured as described in Example 3K.

[0109] In an advantageous embodiment of the invention, the pouch composition, when provided in the pouch, is designed to release at least 50% by weight of the free base nicotine within a 120 second period upon contact with oral saliva, preferably as measured in Example 3K.

[0110] In one embodiment of the invention, the pouch composition is adapted to release at least 15% by weight of the free base nicotine, such as at least 30% by weight of the free base nicotine, such as at least 20% by weight of the free base nicotine, within a period of 120 seconds when provided in a pouch and subjected to an in vitro release experiment described in Example 3L.

[0111] In an advantageous embodiment of the invention, the pouch composition is provided in a pouch and is adapted to release at least 30% by weight of the free base nicotine, such as at least 60% by weight of the free base nicotine, such as at least 50% by weight of the free base nicotine, such as at least 40% by weight of the free base nicotine, within a period of 10 minutes upon contact with oral saliva, when release is measured as described in Example 3K.

[0112] In one embodiment of the invention, the pouch composition is adapted to release at least 30% by weight of the free base nicotine, such as at least 60% by weight of the free base nicotine, such as at least 50% by weight of the free base nicotine, such as at least 40% by weight of the free base nicotine, within a 10 minute period when provided in a pouch and subjected to an in vitro release experiment as described in Example 3L.

[0113] The release rate describes the average release of nicotine per minute within a given period of time. In one embodiment of the invention, the pouch composition provided in the pouch to the oral cavity has a release rate of nicotine of at least 0.5% per minute within a release period of 2 to 10 minutes, such as at least 0.4% per minute within a release period of 2 to 10 minutes, such as at least 0.3% per minute within a release period of 2 to 10 minutes, such as at least 0.2% per minute within a release period of 2 to 10 minutes.

[0114] In one embodiment of the invention, the pouch composition provided in a pouch and subjected to the in vitro release experiments described in Example 3L has a release rate of nicotine of at least 0.5% per minute within a release period of 2 to 60 minutes, such as at least 0.4% per minute within a release period of 2 to 60 minutes, such as at least 0.3% per minute within a release period of 2 to 60 minutes, or at least 0.2% per minute within a release period of 2 to 60 minutes.

[0115] In one embodiment of the invention, the pouch composition provided in a pouch and subjected to the in vitro release experiments described in Example 3L has a release rate of nicotine of at least 0.5% per minute within a release period of 2 to 30 minutes, such as at least 0.4% per minute within a release period of 2 to 30 minutes, such as at least 0.3% per minute within a release period of 2 to 30 minutes, or at least 0.2% per minute within a release period of 2 to 30 minutes.

[0116] In advantageous embodiments of the invention, the pouch composition provided in a pouch and subjected to the in vitro release experiments described in Example 3L has a release rate of nicotine of at least 0.5% per minute within a release period of 2 to 10 minutes, such as at least 0.4% per minute within a release period of 2 to 10 minutes, such as at least 0.3% per minute within a release period of 2 to 10 minutes, such as at least 0.2% per minute within a release period of 2 to 10 minutes.

[0117] In one embodiment of the invention, the pouch composition provided in a pouch and subjected to the in vitro release experiments described in Example 3L has a release rate of at least 0.1 mg of nicotine per minute within a release period of 2 to 60 minutes, such as at least 0.2 mg per minute within a release period of 2 to 60 minutes.

[0118] In one embodiment of the invention, a pouch composition provided in a pouch and subjected to the in vitro release experiment described in Example 3L has a release rate of at least 0.4 mg of nicotine per minute within a release period of 2 to 10 minutes.

[0119] In an advantageous embodiment of the invention, the pouch composition further comprises nicotine as a nicotine salt and / or as a complex with an ion exchange resin, such as polacrilex resin. In an advantageous embodiment of the invention, the pouch composition further comprises nicotine as a nicotine salt.

[0120] 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 and nicotine dihydrochloride), nicotine citrate, nicotine fumarate, nicotine gensitate, nicotine lactate, nicotine mutate, 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).

[0121] In one embodiment of the invention, the nicotine salt comprises or consists of nicotine bitartrate. In an advantageous embodiment of the invention, the pouch composition further comprises nicotine as a complex with an ion exchange resin, such as polacrilex resin.

[0122] An advantage of the above embodiment may be that a desirable nicotine release profile may be obtained having both a nicotine release component with a relatively fast release due to free base nicotine, and a sustained release component due to a complex of nicotine with an ion exchange resin.

[0123] In one embodiment of the invention, the pouch composition comprises free base nicotine mixed with an ion exchange resin in combination with nicotine as a complex with an ion exchange resin, such as polacrilex resin.

[0124] In one embodiment of the invention, the pouch composition comprises free base nicotine mixed with a water soluble composition such as a sugar alcohol or water soluble fiber in combination with nicotine as a complex with an ion exchange resin such as polacrilex resin.

[0125] In one embodiment of the present invention, the polacrilex resin is Amberlite® IRP64. In an advantageous embodiment of the invention, the pouch composition further comprises a preservative.

[0126] Preservatives can help protect the pouch composition against undesirable microbial growth. In an advantageous embodiment of the invention, the pouch composition comprises a preservative in an amount of from 0.05 to 0.5% by weight of the pouch composition, such as from 0.1 to 0.2% by weight of the pouch composition.

[0127] 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)).

[0128] In an advantageous embodiment of the invention, the pouch composition comprises less than 0.1% by weight of preservatives, such as less than 0.05% by weight of preservatives. Thus, the pouch composition may include a preservative in an amount of 0-0.1% by weight of the preservative, such as an amount of 0-0.05% by weight of the preservative. This includes zero content of preservative, i.e. the pouch composition does not include preservative. Low levels or even the absence of preservative can be achieved by obtaining a relatively alkaline environment, particularly by the use of free base nicotine.

[0129] In an advantageous embodiment of the invention, the pouch composition is preservative-free. Low levels or even the absence of preservatives can be achieved by obtaining a relatively alkaline environment, particularly through the use of free base nicotine.

[0130] In one embodiment of the invention, the pouch composition comprises an antioxidant. An advantage of the above embodiment may be that the nicotine may have a lower degree of decomposition. In one embodiment of the present invention, the antioxidant is selected from butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), tocopherol, and combinations thereof. Other antioxidants may also be applied.

[0131] In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of at least 0.1% by weight of the pouch composition, such as at least 1.0% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 0.2% by weight of the pouch composition.

[0132] In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of 20% or less by weight of the pouch composition, such as 5% or less by weight of the pouch composition, such as 10% or less by weight of the pouch composition.

[0133] In one embodiment of the invention, the pouch composition comprises nicotine in an amount from 0.1 to 20% by weight of the pouch composition, such as in an amount from 0.5 to 10% by weight of the pouch composition, such as in an amount from 0.2 to 20% by weight of the pouch composition.

[0134] In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount equivalent to 0.5 to 20 mg per pouch, such as 5.0 to 15 mg per pouch, such as 1.0 to 20 mg per pouch.

[0135] In an advantageous embodiment of the invention, the pouch composition further comprises a release controlling composition. In an advantageous embodiment of the invention, the controlled release composition is selected from the list consisting of metal stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearate, tallow, silicates, silicates dioxide, talc, magnesium stearate, calcium stearate, fumed silica, powdered hydrogenated cottonseed oil, hydrogenated vegetable oils, hydrogenated soybean oil, emulsifiers, triglycerides, and mixtures thereof.

[0136] In one embodiment of the invention, the pouch composition does not include triglycerides. In an advantageous embodiment of the present invention, the controlled release composition is hydrophobic. In an advantageous embodiment of the invention, the controlled release composition comprises one or more metal stearates, such as magnesium stearate and / or calcium stearate.

[0137] In one embodiment of the invention, the controlled release composition comprises magnesium stearate. In one embodiment of the invention, the controlled release composition comprises calcium stearate.

[0138] In an advantageous embodiment of the invention, the pouch composition comprises said controlled release composition in an amount of from 1 to 20 percent by weight of said pouch composition. In one embodiment of the invention, the controlled release composition comprises or is a solubilizer, such as a solubilizer selected from the list of monoglycerides, diglycerides, polysorbates (e.g., Tween® XX), sucrose-esters, and combinations thereof.

[0139] Anionic, cationic, amphoteric, or nonionic solubilizers can be used. Suitable solubilizers include lecithin, polyoxyethylene stearic acid esters, polyoxyethylene sorbitan fatty acid esters, fatty acid salts, mono- and diacetyl tartaric acid esters of edible mono- and diglycerides of fatty acids, citric acid esters of edible mono- and diglycerides of fatty acids, saccharose esters of fatty acids, polyglycerol esters of fatty acids, polyglycerol esters of transesterified castor oil acid (E476), sodium stearoyl lathyrate (Sodium stearoyl lathyrate). stearoyllatylate, sodium lauryl sulfate, sorbitan esters of fatty acids and polyoxyethylated hydrogenated castor oil (e.g., products sold under the trade name CREMOPHOR®), block copolymers of ethylene oxide and propylene oxide (e.g., products sold under the trade name PLURONIC® and POLOXAMER), polyoxyethylene fatty alcohol ethers, polyoxyethylene sorbitan fatty acid esters, sorbitan esters of fatty acids, and polyoxyethylene steraric acid esters.

[0140] Particularly suitable solubilizers are polyoxyethylene stearates, such as polyoxyethylene (8) stearate and polyoxyethylene (40) stearate, polyoxyethylene sorbitan fatty acid esters sold under the trade name TWEEN®, such as TWEEN® 20 (monolaurate), TWEEN® 80 (monooleate), TWEEN® 40 (monopalmitate), TWEEN® 60 (monostearate) or TWEEN® 65 (tristearate), mono- and diacetyl tartaric acid esters of mono- and diglycerides of edible fatty acids, citric acid esters of mono- and diglycerides of edible fatty acids, sodium stearoyl lactylate, sodium lauryl sulfate, polyoxyethylated hydrogenated castor oil, block copolymers of ethylene oxide and propylene oxide, and polyoxyethylene fatty alcohol ethers. The solubilizer may be a single compound or a combination of several compounds. The expression "solubilizer" is used in this document to describe both possibilities; the solubilizer used must be suitable for use in food and / or pharmaceutical products.

[0141] In an advantageous embodiment of the present invention, the pouch composition is free of tobacco, tobacco fibre and tobacco-derived fibre. 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.

[0142] 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 in an amount of 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.

[0143] In one embodiment of the invention, the pouch composition contains less than 5.0% tobacco by weight, 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, such as no tobacco.

[0144] In an advantageous embodiment of the invention, the water-insoluble composition does not contain tobacco, tobacco fibre or fibre derived from tobacco, therefore in this embodiment the water-insoluble fibre is a non-tobacco fibre, i.e. does not contain tobacco, tobacco fibre or fibre derived from tobacco.

[0145] In an advantageous embodiment of the invention, the pouch composition is free of microcrystalline cellulose (MCC), such as being cellulose-free. In one embodiment of the invention, the pouch composition comprises cellulose and does not comprise microcrystalline cellulose (MCC).

[0146] 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, and the composition comprises said sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition, such as 5 to 70% by weight of the pouch composition.

[0147] 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 10 to 60% by weight of the pouch composition, such as from 5 to 70% 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.

[0148] 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 said sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, 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; and The water insoluble composition comprises or consists of a water insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof.

[0149] 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 said sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, 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; and The water insoluble composition comprises or consists of a water insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, and wherein the pouch composition comprises a flavoring in an amount from 0.01 to 15% by weight of the pouch composition, such as from 3 to 10% by weight of the pouch composition, such as from 1 to 10% by weight of the pouch composition, such as from 0.1 to 15% by weight of the pouch composition.

[0150] 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 said sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, 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; The water insoluble composition comprises or consists of a water insoluble fiber such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, and wherein the pouch composition comprises a flavoring in an amount from 0.01 to 15% by weight of the pouch composition, such as from 3 to 10% by weight of the pouch composition, such as from 1 to 10% by weight of the pouch composition, such as from 0.1 to 15% by weight of the pouch composition, and the flavoring is oil-based.

[0151] 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 said sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, 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; 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.

[0152] 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 said sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, 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; 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.

[0153] The present invention further relates to an oral nicotine pouch product comprising a pouch and, enclosed in said pouch, an amount of a nicotine pouch composition according to the present invention or any of its embodiments. In an advantageous embodiment of the invention, the pouch product comprises the pouch composition in an amount of 50-1000 mg, such as 300-600 mg, such as 100-700 mg.

[0154] In an advantageous embodiment of the invention, said pouch product comprises nicotine in an amount of from 0.5 to 20 mg, such as from 5.0 to 15 mg, such as from 1.0 to 20 mg. In an advantageous embodiment of the invention, the pouch comprises a water-permeable membrane, for example comprising a woven or non-woven fabric.

[0155] 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.

[0156] 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 a 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.

[0157] 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.

[0158] 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.

[0159] 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.

[0160] The pouch membrane material may have the form of a mesh, a sieve, a paper with holes, a permeable fabric, and the like. For example, pouch materials made from rice paper in a mesh 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 alginates, 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). Preferred pouch materials, 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.

[0161] 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.

[0162] In one embodiment of the invention, the membrane comprises a 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.

[0163] 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. In an advantageous embodiment of the invention, the pouched product comprises said pouches in an amount of up to 20 percent by weight of said pouched product, such as in an amount of up to 15 percent by weight of said pouched product.

[0164] In an advantageous embodiment of the invention, the pouched product comprises said pouches in an amount of from 3 to 20 percent by weight of said pouched product, such as in an amount of from 5 to 15 percent by weight of said pouched product.

[0165] In an advantageous embodiment of the invention, the free base nicotine comprises free base nicotine mixed with an ion exchange resin, in a weight ratio between free base nicotine and ion exchange resin of between 0.1 and 2.0, 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, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bamboo fiber, powdered cellulose, bran fiber, or a combination thereof; The pouch composition contains a sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, and a pH controlling agent in an amount of 0.01 to 15% by weight of the pouch composition.

[0166] The present invention provides a method for producing an oral nicotine pouch product according to the present invention or any of its embodiments, comprising: - providing a nicotine pouch composition according to the present invention or any of its embodiments, - Providing a pouch; - adding a pouch composition to said pouch; and -sealing the pouch, The present invention further relates to a method comprising the steps of: DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0167] As used herein, the term "nicotine pouch composition" refers to a composition for use in an oral nicotine pouch, i.e., a pouch for oral use that contains nicotine. Also, the terms "nicotine pouch composition" and "pouch composition" are used interchangeably.

[0168] As used herein, the term "free base nicotine" refers to nicotine in unprotonated form, and therefore does not include nicotine salts 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 a 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.

[0169] As used herein, the term "pouch" refers to a container typically formed by a web of fibrous material surrounding a cavity. The pouch is a pouch designed for administration of an active ingredient in the oral cavity, and is therefore adapted for use in the mouth, 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 sealed, for example, by bonding two corresponding pieces of web or fabric together along their edges to form a cavity for nicotine and the water-insoluble composition. To release nicotine, the pouch is made water-permeable so that saliva from the oral cavity penetrates the pouch and enters the cavity, where it can contact the nicotine, thereby releasing nicotine from the oral pouch.

[0170] As used herein, the term "powder composition" refers to a composition in the form of a powder, i.e., as a particulate material having a relatively small particle size, e.g., 1 to 1200 micrometers. Specifically, a powder composition does not refer to powdered tobacco.

[0171] As used herein, the term "humectant" is understood to be a moisturizing agent used to attract water in the form of humidity or saliva. A humectant may typically include a composition that is suitably hygroscopic. In some cases, a humectant may also be described as a humectant due to its role in attracting moisture. Examples of humectants include glycerol, propylene glycol, alginate, triacetin, modified starch, hydroxypropyl cellulose, pectin, xanthan gum, and the like.

[0172] As used herein, the term "water soluble" refers to a relatively high water solubility, for example, a water solubility of a water soluble composition or substance 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.

[0173] 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.

[0174] As used herein, the term "flavor" is understood to have its ordinary meaning within the art. Flavors include liquid and powdered flavors. Thus, flavors do not, of course, include sweeteners (such as sugars, sugar alcohols, and high-intensity sweeteners), acids that impart pure acidity / sourness, or compounds that impart pure saltiness (e.g., NaCl) or pure bitterness. Flavor enhancers include substances that impart only saltiness, bitterness, or sourness. Thus, flavor enhancers include, for example, NaCl, citric acid, ammonium chloride, and the like.

[0175] The pouch of the present invention provides nicotine release to the oral cavity. A nicotine release profile can be obtained that includes both fast and sustained release periods. As used herein, the term "fast release" or "fast release period" can refer to the first two minutes of the nicotine release profile, while the term "sustained release period" refers to the subsequent period of the release profile until the end of the experiment or end of use.

[0176] As used herein, "release rate" describes the average release of nicotine per minute within a given period of time, for example, if a pouch releases an additional 16% of the nicotine dose from 2 minutes to 10 minutes, the release rate is 2% per minute within this given period of time. Alternatively, if a pouch releases an additional 2 mg of nicotine from 2 minutes to 10 minutes, the release rate is 0.25 mg per minute within this given period of time. The release rate is determined only from release data at times outside the period of time.

[0177] Typically, the pouch comprises an opening, where characteristic opening dimensions are adapted to characteristic dimensions of the matrix composition to retain the matrix composition inside the pouch prior to use and / or to retain a portion of the matrix composition, such as a water-insoluble composition, inside the pouch during use.

[0178] To obtain a pouch with a suitable opening size having regard to the matrix composition to be used, the material of the pouch may be appropriately selected, including, for example, woven and / or nonwoven fabrics. In other words, according to various embodiments, the pouch forms a membrane that allows the passage of saliva and prevents or blocks the passage of the matrix composition. The membrane of the pouch can be any suitable material, such as woven or nonwoven fabrics (e.g., cotton, fleece, etc.), heat-sealable nonwoven cellulose, or other polymeric materials, such as synthetic, semi-synthetic, or natural polymeric materials. One example of a suitable pouch material 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.

[0179] The pouch composition is filled into the pouch and maintained therein by sealing. An ideal pouch would be chemically and physically stable, pharma- ceutically acceptable, insoluble in water, easy to fill with powder and seal, and provide a semi-permeable membrane layer that prevents the powder from exiting the bag but allows components dissolved or small enough suspended therein, such as saliva and nicotine, to pass from the pouch composition in the pouch through the pouch.

[0180] The pouch may be placed in the oral cavity by the user, and saliva then enters the pouch, causing the nicotine and other components that are soluble in the saliva to begin to dissolve and be carried by the saliva from the pouch to the oral cavity where the nicotine may be absorbed.

[0181] According to embodiments of the present invention, the pouch composition may further comprise one or more strengthening agents. In one embodiment of the invention, the enhancer is selected from the group consisting of bile salts, cetomacrogol, chelating agents, citrates, cyclodextrins, detergents, enamine derivatives, fatty acids, labrasol, lecithin, phospholipids, synthetic and natural surfactants, non-ionic surfactants, cell envelope disrupting compounds, solvents, steroidal detergents, chelating agents, solubilizing agents, charge modifying agents, pH-regulating agents, degradative enzyme inhibitors, mucolytic or mucus clearing agents, membrane permeability enhancers, modulators of epithelial junction physiology, vasodilators, selective transport enhancers, or any combination thereof. The pH regulating agent comprises a buffer.

[0182] In one embodiment of the invention, the enhancer is selected from the group consisting of cetylpyridinium chloride (CPC), benzalkonium chloride, sodium lauryl sulfate, polysorbate 80, polysorbate 20, cetyltrimethylammonium bromide, laureth 9, sodium salicylate, sodium EDTA, EDTA, aprotinin, sodium taurocholate, saponin, bile salt derivatives, fatty acids, sucrose esters, azone emulsion, dextran sulfate, linoleic acid, labrafil, transcutol, urea, azone, non-ionic surfactants, sulfoxides, sauric acid acid) / PG, POE23 Lauryl Ether, Methoxysalicylate, Dextran Sulfate, Methanol, Ethanol, Sodium Cholate, Sodium Taurocholate, Lysophosphatidylcholine, Alkyl Glycosides, Polysorbates, Sorbitan Esters, Poloxamer Block Copolymers, PEG-35 Castor Oil, PEG-40 Hydrogenated Castor Oil, Caprocaproyl Macrogol-8 Glycerides, PEG-8 Caprylic / Capric Acid, Glycerides, Dioctyl Sulfosuccinate, Polyethylene Lauryl Ether, Ethoxydiglycol, Propylene Glycol, Mono-Di-Caprylate, Glycerol Monocaprylate, Glyceryl Fatty Acids (C8-C 18)Ethoxylated oleic acid, linoleic acid, (caprylic / capric) glyceryl, glyceryl monooleate, glyceryl monolaurate, caprylic / capric triglyceride, ethoxylated nonylphenol, PEG-(8-50) stearate, olive oil PEG-6, ester, triolein PEG-6 ester, lecithin, d-alpha tocopherol polyethylene glycol 1,000 Succinate, Citric Acid, Sodium Citrate, BRIJ®, Sodium Laurate, 5-Methoxysalicylic Acid, Bile Salts, Acetylsalicylate, ZOT, Docosahexaenoic Acid, Alkyl Glycosides, Sodium Glycocholate (GC-Na), Sodium Taurocholate (TC-Na), EDTA, Choline Salicylate, Sodium Caprate (Cap-Na), N-Lauryl-beta-D-Maltopyranoside (LM), Diethyl Maleate, Labrasol, Sodium Salicylate, Menthol Toluene, alkali metal alkyl sulfates, sodium lauryl sulfate, glycerin, bile acids, lecithin, phosphatidylcholine, phosphatidylserine, sphingomyelin, phophatidylethanolamine, cephalin, lysolecithin, hyaluronic acid: alkali metal salts, sodium, alkaline earth and aluminum, octylphenoxypolyethoxyethanol, glycolic acid, lactic acid, chamomile extract, cucumber extract, borage oil, evening primrose oil, polyglycerin, lysine, polylysine, toluene. Liolein, monoolein, monooleate, monolaurate, polidocanol alkyl ether, chenodeoxycholate, deoxycholate, glycocholic acid, taurocholic acid, glycodeoxycholic acid, taurodeoxycholic acid, sodium glycocholate, phosphatidylcholine, phosphatidylserine, sphingomyelin, phosphatidylethanolamine, cephalin, lysolecithin, alkali metal hyaluronate, chitosan, poly-L-arginine, alkyl glucosides, sugar alkyl esters, fusidic acid derivatives, taurdihydrofusidic acid (HFA), fusidic acid derivatives, ... sodium taurdihydrofusidate (STDHF), L-α-phosphatidylcholine didecanoyl (DDPC), nitroglycerin, nitroprusside, NOC5 [3-(2-hydroxy-1-(methyl-ethyl)-2-nitrosohydrazino)-1-propanamine], NOC12 [iV-ethyl-2-(1-ethyl-hydroxy-2-nitrosohydrazino)-ethanamine], SNAP [S-nitroso-N-acetyl-DL-penicillamine, NORI, NOR4, deacylmethylsulfoxide, azone, salicylamide, glyceryl-1,3-Diacetoacetate, 1,2-Isopropylideneglycerol-3-acetoacetate), amino acids, amino acid salts, monoaminocarboxylic acids, glycine, alanine, phenylalanine, proline, hydroxyproline, hydroxyamino acids, serine, acidic amino acids, aspartic acid, glutamic acid, basic amino acids, lysine, N-acetylamino acids, N-acetylalanine, N-acetylphenylalanine, TM-acetylserine, N-acetylglycine, N-acetyllysine, N-acetylglutamic acid, N-acetylproline, N-acetylhydroxyproline, lactic acid, malic acid and citric acid and their alkali metal salts, pyrrolidone carboxylic acids, alkylpyrrolidone carboxylic acid esters, N-alkylpyrrolidones, proline acyl esters, sodium lauryl phosphate, sodium lauryl sulfate, sodium oleyl phosphate, sodium myristyl sulfate, polyoxyethylene alkyl ethers, polyoxyethylene alkyl esters, and caproic acid, alkyl sugars, fusidic acid, poly Ethylene glycol, cetyl alcohol, polyvinylpyrrolidone, polyvinyl alcohol, lanolin alcohol, sorbitan monooleate, ethylene glycol tetraacetate, bile acid conjugates with taurine, cholanic acid and salts, cyclodextran, cyclodextrin, cyclodextrin (beta), hydroxypropyl-β-cyclodetran, sulfobutylether-β-cyclodextran, methyl-β-cyclodextrin, chitosan glutamate, chitosan acetate salt, chitosan hydrochloride, chitosan hydrolactate, 1-O-alkyl-2-hydroxy-sn-glycero-3-phosphocholine, 3-O-alkyl-2-acetoyl-sn-glycero-1-phosphocholine, 1-O-alkyl-2-O-acetyl-sn-glycero-3-phospho(N,N,N-trimethyl)hexanolamine, propylene glycol, tetradecyl maltoside (TDM), and sucrose dedecanoate.

[0183] According to an embodiment of the invention, the enhancing agent comprises 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.

[0184] 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.

[0185] 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.

[0186] In one embodiment of the present invention, the pouch composition comprises bulk sweeteners that include sugar and / or sugar-free components. In one embodiment of the present invention, the pouch composition comprises bulk sweeteners in an amount of 1.0 to about 80% by weight of the pouch composition, more typically 5 to about 70% by weight of the pouch composition, more usually 10 to 60% by weight of the pouch composition or 10 to 50% by weight of the pouch composition. The bulk sweeteners may act both as sweeteners and as humectants. In some embodiments, the inclusion of certain ingredients may further limit the about amounts of bulk sweeteners.

[0187] 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, etc., either alone or in combination. These sugar sweeteners may also be included as humectants.

[0188] 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.

[0189] In one embodiment of the invention, the pouch composition comprises a flavouring agent, 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.

[0190] Non-exhaustive examples of flavorings suitable in embodiments of the present invention include coconut, coffee, chocolate, vanilla, grapefruit, orange, lime, 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, and plum essences, etc. Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above.

[0191] 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. The controlled release composition, according to various embodiments, may be selected from the group consisting of metal stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycol, polyoxyethylene monostearate, tallow, silicates, silicate 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.

[0192] The controlled release composition may be added to the pouch composition in a variety of ways. For example, the controlled release composition can be added by fully powder mixture during the last few minutes of final mixing.

[0193] Alternatively, the controlled release composition can be added onto the granulated premix after the granulation step. Still further, the controlled release composition may be added as only a portion of the pouch composition such that two different nicotine release profiles are obtained. Still further, two or more portions of the matrix composition may contain different amounts of the controlled release composition, if any, thereby providing a more complex and tailored nicotine release profile.

[0194] 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. According to one embodiment of the invention, the pouch composition comprises polyvinylpyrrolidone (PVP). The pouch composition may be free of PVP.

[0195] One advantage of the above embodiment may be that a more uniform composition may be obtained. EXAMPLES

[0196] 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.

[0197] 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.

[0198] 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.

[0199] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 1 below.

[0200] [Table 1]

[0201] 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.

[0202] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 2 below.

[0203] [Table 2]

[0204] 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.

[0205] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 3 below.

[0206] [Table 3]

[0207] 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.

[0208] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 4 below.

[0209] [Table 4]

[0210] 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.

[0211] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4B below.

[0212] [Table 5]

[0213] 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.

[0214] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4C below.

[0215] [Table 6]

[0216] 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.

[0217] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4A below.

[0218] [Table 7]

[0219] 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.

[0220] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4A below.

[0221] [Table 8]

[0222] Total processing time was 20 minutes. Example 3A - Pouch Comparative pouches containing nicotine polacrilex resin (NPR) or nicotine bitartrate (NBT) are prepared containing the powdered compositions outlined in Table 5. The pouches are manufactured as follows.

[0223] The fibers and water are mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients are then added thereafter 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.

[0224] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1A made from long fiber paper is used. The powder is filled into the pouch and maintained within the pouch by sealing.

[0225] 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 pouch material of Example 1B can also be used.

[0226] The powder is filled into a pouch and maintained within the pouch by a seal. Nicotine premix containing pouches PPC1-PPC5 are prepared containing the powdered compositions outlined in Table 5. The pouches are manufactured as follows.

[0227] The fiber and water are mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients are then added with subsequent 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.

[0228] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1A made from long fiber paper is used. The powder is filled into the pouch and maintained within the pouch by sealing.

[0229] 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 pouch material of Example 1B can also be used.

[0230] The powder is filled into a pouch and maintained within the pouch by a seal.

[0231] [Table 9]

[0232] Pouch Content: 500mg total, i.e. nicotine concentration of 19.2mg / g The xylitol DC applied is, for example, under the trade name "Xylitab® 200".

[0233] Wheat fiber, under the trade name "Vitacel® 600 WF plus". Other fibers can be used as well, 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, powdered cellulose, bran fiber, bamboo fiber, and water-insoluble vegetable fibers such as cellulose fiber.

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

[0235] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium carbonate is used as the alkaline buffer. Other buffers described herein may be used in combination with or as a substitute for sodium carbonate.

[0236] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium.

[0237] Pouches PPC1-PPC3, PPC5 show that different pouches can be made using free base nicotine with a moisture content of at least 15% by weight of the pouch composition. Pouch PPC4 has a lower moisture content outside the scope of the present invention. Comparative pouches Comp. NBT and Comp. NPR have similar moisture contents to PPC1 but use nicotine that is complexed with a nicotine salt and an ion exchange resin.

[0238] Example 3B - Pouch Pouches PPC11-PPC15 are manufactured similarly to pouches PPC1-PPC5 of Example 3A. Pouches PPC11-PPC15 containing nicotine premix are prepared containing the powdered compositions outlined in Table 5. The pouches are manufactured as follows.

[0239] The fiber and powder ingredients (except glidant) are mixed for 2 minutes using a planetary Bear Varimixer mixer. 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 glidant (if present, mixed for -1 minute). The total mixing time is 9-11 minutes.

[0240] [Table 10]

[0241] Pouch Contents: 500mg total. Applied isomalt DC, e.g. GalenIQ® 720.

[0242] Wheat fiber, under the trade name "Vitacel® 600 WF plus". Other fibers can be used as well, 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, powdered cellulose, bran fiber, bamboo fiber, and water-insoluble vegetable fibers such as cellulose fiber.

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

[0244] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium carbonate is used as the alkaline buffer. Other buffers described herein may be used in combination with or as a substitute for sodium carbonate.

[0245] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium.

[0246] Pouches PPC11 to PPC13, PPC15 exhibit different moisture contents of at least 15% by weight of the pouch composition. Although the moisture content is varied, the ratio of the amount of added purified water to the amount of fiber remains constant.

[0247] Pouch PPC14 has a moisture content outside the range of the present invention and is used for comparison purposes. Example 3C - Pouch Pouches PPC21-PPC25 are prepared similarly to pouches PPC11-PPC15 of Example 3B.

[0248] [Table 11]

[0249] Pouch Contents: 500mg total. Wheat fiber, under the trade name "Vitacel® 600 WF plus". Other fibers can be used as well, 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, powdered cellulose, bran fiber, bamboo fiber, and water-insoluble vegetable fibers such as cellulose fiber.

[0250] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can likewise be used in combination with or in place of the menthol and / or peppermint.

[0251] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium carbonate is used as the alkaline buffer. Other buffers described herein may be used in combination with or as a substitute for sodium carbonate.

[0252] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium.

[0253] 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.

[0254] Pouches PPC23-PPC26 show the use of different 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.

[0255] Example 3D-Pouch Pouches PPC31-PPC32 are prepared similarly to pouches PPC1-PPC5 of Example 3A, but using Nicotine Premix I and III, respectively.

[0256] Pouches PPC31 to PPC35 are manufactured as follows. Nicotine and sugar alcohol (such as xylitol, sorbitol, maltitol, etc.) are weighed out. Nicotine is slowly added to the sugar alcohol powder with stirring (Kitchenaid mixer running at about 30 RPM for about 30 minutes). The resulting granulate is passed through a sieve and placed on a tray. The resulting powder is dried overnight at ambient temperature and then passed through a sieve to obtain the nicotine-sugar alcohol premix. It is also possible to add an amount of water to the nicotine prior to mixing with the sugar alcohol. In that case, such water evaporates during drying.

[0257] The fiber and water are mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients are then added with subsequent continuous mixing: powder ingredients except for the nicotine premix (mixed for 2 minutes), the nicotine-sugar alcohol premix (mixed for 2 minutes), then liquid flavors, if any (mixed for 1 minute), and finally, glidants, if any (mixed for 1 minute). Total mixing time is 9-11 minutes.

[0258] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1A made from long fiber paper is used. The powder is filled into the pouch and maintained within the pouch by sealing.

[0259] 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 pouch material of Example 1B can also be used.

[0260] The powder is filled into a pouch and maintained within the pouch by a seal.

[0261] [Table 12]

[0262] Pouch Contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF plus". Other fibers can be used as well, 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, powdered cellulose, bran fiber, bamboo fiber, and water-insoluble vegetable fibers such as cellulose fiber.

[0263] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can likewise be used in combination with or in place of the menthol and / or peppermint.

[0264] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium carbonate is used as the alkaline buffer. Other buffers described herein may be used in combination with or as a substitute for sodium carbonate.

[0265] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium.

[0266] Pouches PPC31-PPC32 illustrate the use of other nicotine premixes. Pouches PPC33 to PPC35 demonstrate the use of nicotine premixed with different sugar alcohols.

[0267] Pouches PPC36-PPC37 demonstrate the use of nicotine premixed with different soluble fibers. Example 3E-Pouch Pouches PPC41-PPC45 are prepared similarly to pouches PPC1-PPC5 of Example 3A.

[0268] [Table 13]

[0269] Pouch Contents: 500mg total. Wheat fiber, under the trade name "Vitacel® 600 WF plus". Other fibers can be used as well, 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, powdered cellulose, bran fiber, bamboo fiber, and water-insoluble vegetable fibers such as cellulose fiber.

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

[0271] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium carbonate is used as the alkaline buffer. Other buffers described herein may be used in combination with or as a substitute for sodium carbonate.

[0272] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium.

[0273] Pouches PPC41 to PPC44 represent the use of different doses of nicotine, ranging from 4.8 mg to 12 mg. Pouch PPC45 represents a pouch lacking alginate and otherwise equivalent to pouch PPC43.

[0274] Example 3F - Pouch Pouches PPC51 to PPC53 are manufactured as follows. Using a planetary Bear Varimixer mixer, the fiber and powder ingredients (except the nicotine powder and glidant) are mixed for 1 minute. 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 liquid flavors (if present - mix for 1 minute) and glidants (if present - mix for 1 minute). Total mixing time is 9-11 minutes.

[0275] [Table 14]

[0276] Pouch Content: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF plus". Other fibers can be used as well, 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, powdered cellulose, bran fiber, bamboo fiber, and water-insoluble vegetable fibers such as cellulose fiber.

[0277] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can likewise be used in combination with or in place of the menthol and / or peppermint.

[0278] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium carbonate is used as the alkaline buffer. Other buffers described herein may be used in combination with or as a substitute for sodium carbonate.

[0279] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium.

[0280] Pouch PPC51 refers to a pouch that uses a nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT). Pouch PPC52 refers to a pouch that uses a nicotine-ion exchange resin premix in combination with nicotine polacrilex resin (NPR).

[0281] Pouch PPC53 refers to a pouch that uses a nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT) and nicotine polacrilex resin (NPR).

[0282] Example 3G-Pouch Pouches PPC61-PPC65 containing nicotine premixes are prepared containing the powdered compositions outlined in Table 11. The pouches are manufactured as follows.

[0283] Using a Loedige mixer, the fiber and powder ingredients (except for glidant) are mixed for 2 minutes. The nicotine premix is ​​then added and mixed for 2 minutes. With the mixer running, the water is then added over a 15 minute period, followed by the liquid flavors (if present - mix for 15 minutes) and the glidant (if present - mix for 1 minute). The total mixing time is 19-35 minutes.

[0284] [Table 15]

[0285] Pouch Contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF plus". Other fibers can be used as well, 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, powdered cellulose, bamboo fiber, bran fiber, and water-insoluble vegetable fibers such as cellulose fiber.

[0286] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can likewise be used in combination with or in place of the menthol and / or peppermint.

[0287] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants described herein can be used in combination with or as a substitute for sodium alginate, glycerol, or HPC.

[0288] Sodium carbonate and sodium bicarbonate are used as alkaline buffers. Other buffers described herein can also be used in combination with or as a substitute for sodium carbonate.

[0289] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0290] Pouches PPC61-PPC62 demonstrate the use of different sweetener and buffer combinations. Pouches PPC63-PPC64 represent pouches having various fiber contents. Pouches PPC65 to PPC67 show the use of different humectants.

[0291] Example 3H-Pouch Nicotine premix containing pouches PPC71-PPC76 are prepared containing the powdered compositions outlined in Table 12. The pouches are manufactured as follows.

[0292] Using a Loedige mixer, the fiber and powder ingredients (except for glidant) are mixed for 2 minutes. The nicotine premix is ​​then added and mixed for 2 minutes. With the mixer running, the water is then added over a 15 minute period, followed by the liquid flavors (if present - mix for 15 minutes) and the glidant (if present - mix for 1 minute). Total mixing time is 19-35 minutes.

[0293] The final powder composition is filled into pouches (target fill weight pouch: 500 mg powder). The pouch material of Example 1A is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing. The pouch material of Example 1B can also be used.

[0294] [Table 16]

[0295] Nicotine Premix VIII contains pea fiber. Pouch Content: 500mg total, i.e. nicotine concentration of 19.2mg / g Wheat fiber, trade name "Vitacel® 600 WF plus".

[0296] Powdered cellulose, trade name "Vitacel® L00" or "Vitacel® L700G". Oat fiber, trade name "Vitacel® HF600".

[0297] Pea fiber, trade name "Vitacel(R) EF150". Other fibers can be used as well, such as water insoluble vegetable 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, powdered cellulose, bamboo fiber, bran fiber, and cellulose fiber.

[0298] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can likewise be used in combination with or in place of the menthol and / or peppermint.

[0299] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants described herein can be used in combination with or as a replacement for sodium alginate, glycerol, or HPC.

[0300] Sodium carbonate and sodium bicarbonate are used as alkaline buffers. Other buffers described herein can also be used in combination with or as a substitute for sodium carbonate.

[0301] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0302] Pouches PPC71 to PPC74 demonstrate the use of different nicotine premixes. Pouches PPC75 to PPC77 show the use of different fibers. Example 3I-I-Pouch Nicotine premix containing pouches PPC81-PPC94 are prepared containing the powdered compositions outlined in Tables 13I and 13II. The pouches are manufactured as follows.

[0303] Using a Loedige mixer, the fiber and powder ingredients (except for glidant) are mixed for 2 minutes. The nicotine premix is ​​then added and mixed for 2 minutes. With the mixer running, the water is then added over a 15 minute period, followed by the liquid flavors (if present - mix for 15 minutes) and the glidant (if present - mix for 1 minute). Total mixing time is 19-35 minutes.

[0304] The final powder composition is filled into pouches (target fill weight pouch: 500 mg powder). The pouch material of Example 1A is used, made from long fiber paper. The powder is filled into the pouch and maintained within the pouch by sealing. The pouch material of Example 1B can also be used.

[0305] [Table 17]

[0306] [Table 18]

[0307] 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".

[0308] Powdered cellulose, trade name "Vitacel® L00" or "Vitacel® L700G". Oat fiber, trade name "Vitacel® HF600".

[0309] Pea fiber, trade name "Vitacel(R) EF150". Other fibers can be used as well, such as water insoluble vegetable 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, powdered cellulose, cellulose fiber, apple fiber, cocoa fiber, bamboo fiber, bran fiber, and cellulose fiber.

[0310] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can likewise be used in combination with or in place of the menthol and / or peppermint.

[0311] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants described herein can be used in combination with or as a replacement for sodium alginate, glycerol, or HPC.

[0312] Sodium carbonate and sodium bicarbonate are used as alkaline buffers. Other buffers described herein can also be used in combination with or as a substitute for sodium carbonate.

[0313] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium and / or sucralose can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0314] Pouches PPC81 to PPC92 show the use of different fibers in different amounts and with different nicotine premixes. Pouches PPC93-PPC94 demonstrate the use of buffer versus higher amounts of salt, respectively.

[0315] Example 3I-II Pouch Pouches PPC111-PPC117 containing nicotine premixes are prepared containing the powdered compositions outlined in Table 13. The pouches are manufactured as follows.

[0316] 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, followed by liquid flavors, while the mixer is running. Finally, silicon dioxide is added and mixed for approximately 1 minute. Total mixing time is approximately 30 minutes.

[0317] 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.

[0318] 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.

[0319] [Table 19]

[0320] Pouch Content: 500mg total, i.e. nicotine concentration of 19.2mg / g. The sugar alcohol may be xylitol, such as that sold under the trade name Xylitab® 200, and / or isomalt, such as that sold under the trade name GalenIQ® 720.

[0321] Wheat fiber, trade name "Vitacel® 600WF plus". Other fibers can be used as well, such as oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, cocoa fiber, and water insoluble vegetable fibers such as cellulose fiber.

[0322] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can likewise be used in combination with or in place of the menthol and / or peppermint.

[0323] Sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants described herein can be used in combination with or as a replacement for sodium alginate, glycerol, or HPC.

[0324] Silicon dioxide is used as a glidant.Other possible glidants are, for example, magnesium stearate, starch, and talc. Sodium carbonate is used as the alkaline buffer. Other buffers described herein may be used in combination with or as a substitute for sodium carbonate.

[0325] Potassium sorbate is used as a preservative. Other preservatives described herein may be used in combination with or in place of potassium sorbate. As an example, acesulfame potassium can be used as the high-intensity sweetener. Other usable high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium.

[0326] Pouches PPC111 to PPC113 represent pouches having different moisture and water-insoluble fiber contents. PPC114-117 show various amounts of preservative.

[0327] Example 3J Content Uniformity Measurement Content uniformity (CU) of the pouch samples was determined by analysis of 10 replicate sub-samples. Nicotine content was measured in each sub-sample of approximately 500 mg using standard HPLC techniques. The nicotine content of the sub-samples was expressed as a percentage of the nominal content of nicotine in the sample (i.e., % label claim). For example, a pouch sample with a nominal content of 20 mg / g nicotine that was analyzed to have an actual content of 19 mg / g has a nicotine content of 95% of the label claim.

[0328] The content uniformity of the samples is then determined as the relative standard deviation (RSD) of the individual analyses of relative nicotine content in 10 replicates. Example 3K-Release Study (in vivo) The releasability of the pouches was evaluated by assessors, preferably a panel of at least eight assessors, each of whom was given a pouch to place in the oral cavity, specifically on the upper lip.

[0329] After 2, 5, 10, 30, or 60 minutes, the pouch was removed from the subject's mouth. The amount of residual nicotine in the pouches was determined using standard HPLC techniques. Two pouches were tested at each time point. The average of the results obtained at each time point was used to generate a profile of the nicotine content in the pouch over time.

[0330] The amount of nicotine released could then be obtained by subtracting the remaining amount of nicotine in the pouch from the initial dose of nicotine in the pouch tested. Example 3L - Release test (in vitro) The release properties of the pouches were tested in an in vitro experiment.

[0331] Each pouch was placed into a reaction tube approximately 2 cm in diameter containing 10 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4) warmed to 37°C. No stirring or shaking was performed during the release experiments.

[0332] After 2, 5, 10, 30 or 60 minutes, the pouches were removed from the buffer, excess buffer was removed and the amount of remaining nicotine was measured using standard HPLC. Two pouches were tested at each time point. The average of the results obtained at each time point was used to generate a profile of the nicotine content in the pouch over time.

[0333] The amount of nicotine released could then be obtained by subtracting the remaining amount of nicotine in the pouch from the initial dose of nicotine in the pouch tested. Example 3M-Release Results The pouches were subjected to the in vitro release experiment described in Example 3L.

[0334] [Table 20]

[0335] The release results show increased release of nicotine after 10 minutes in pouches containing fibers with relatively high water binding capacity such as pea fiber, cellulose L700G, and wheat fiber (WF200).

[0336] Example 3 N-Release Results Pouches having a pouch composition similar to PPC46, but using the moisture retention agents indicated below, were prepared and subjected to the in vitro release experiments described in Example 3L.

[0337] [Table 21]

[0338] Example 3O - Release Results The pouches were subjected to the in vitro release experiment described in Example 3L.

[0339] [Table 22]

[0340] The results demonstrate that the release after 10 minutes is improved when using Nicotine Premix VI. The release can be further improved by including a buffer system, i.e., 3.5% sodium carbonate and 3.5% sodium bicarbonate (PPC93).

[0341] Also, the addition of 10% NaCl appears to improve the release obtained after 10 minutes (PPC94). 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, for example with respect to a desirable sticky texture. In particular, the pouches of the invention did not require wetting before use, unlike conventional nicotine pouches that have a low moisture content that can initially feel dry when used.

[0342] Pouch product PPC1 was compared to the comparative NPR pouch with respect to the perceived effect from nicotine and with respect to the burning (tingling) sensation. Assessment of the perceived effects from nicotine and burning (tingling) sensation was performed as described below.

[0343] The perceived effects of nicotine and burning sensation were assessed by a test panel of four trained judges. Each judge assessed all samples twice. The average rating was estimated.

[0344] Pouch product PPC1 was rated by all four judges as having a faster onset of action and a higher perceived effect from nicotine compared to the comparative NPR pouch, and all four judges rated pouch product PPC1 as having a higher burning sensation compared to the comparative NPR pouch.

[0345] Similarly, the comparative NBT pouch and pouch product PPC1 were compared with respect to perceived effect from nicotine as described above. Pouch product PPC1 was rated as having a higher perceived effect from nicotine compared to the comparative NBT pouch by all four judges.

Claims

1. 1. A nicotine pouch composition comprising free base nicotine, the nicotine pouch composition having a moisture content of at least 15% by weight of said pouch composition.

2. 10. The nicotine pouch composition of claim 1, wherein the free base nicotine comprises free base nicotine mixed with an ion exchange resin and / or with a water soluble composition, such as a sugar alcohol or a water soluble fiber.

3. 3. The nicotine pouch composition of claim 1 or 2, wherein the free base nicotine comprises free base nicotine mixed with an ion exchange resin.

4. 4. The nicotine pouch composition of claim 3, wherein the free base nicotine comprises free base nicotine mixed with a polacrilex resin.

5. 2. The nicotine pouch composition of claim 1, wherein said free base nicotine comprises free base nicotine mixed with an ion exchange resin, in a weight ratio between said free base nicotine and said ion exchange resin of 0.1 to 2.0, preferably 0.5 to 2.0, and most preferably about 0.67 to 1.

0.

6. 6. The nicotine pouch composition of any one of claims 1 to 5, wherein the free base nicotine comprises free base nicotine mixed with an ion exchange resin, in a weight ratio between the free base nicotine and the ion exchange resin of from 1:1 to about 1:10, preferably from 1:2 to 1:6, and most preferably from about 1:4 to 1:

5.

7. 7. The nicotine pouch composition of any one of claims 1 to 6, wherein the nicotine comprises free base nicotine mixed with a water soluble composition such as a sugar alcohol or a water soluble fiber.

8. 8. The nicotine pouch composition of any one of claims 1 to 7, comprising a water soluble composition such as a sugar alcohol or a water soluble fiber in an amount of 1 to 80% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition, such as 5 to 70% by weight of the pouch composition.

9. 9. The nicotine pouch composition of any one of claims 1 to 8, wherein the free base nicotine comprises free base nicotine mixed with a sugar alcohol.

10. 10. The nicotine pouch composition of any one of claims 7 to 9, wherein the sugar alcohol is selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof.

11. 11. The nicotine pouch composition of any one of claims 1 to 10, wherein the free base nicotine comprises free base nicotine mixed with water soluble fiber.

12. 12. The nicotine pouch composition of any one of claims 1 to 11, wherein the water soluble fibre is selected from the list of inulin, polydextrose including purified polydextrose, dextrin, maltodextrin and mixtures thereof.

13. 13. The nicotine pouch composition of any one of claims 1 to 12, wherein the free base nicotine mixed with an ion exchange resin further comprises water.

14. 14. The nicotine pouch composition of any one of claims 1 to 13, wherein the pouch composition comprises a combination of free base nicotine mixed with a first composition and free base nicotine mixed with a second, different composition.

15. 15. The nicotine pouch composition of any one of claims 1 to 14, wherein the free base nicotine comprises a combination of free base nicotine mixed with a water soluble composition and free base nicotine mixed with a water insoluble composition.

16. 16. The nicotine pouch composition of any one of claims 1 to 15, wherein the free base nicotine comprises a combination of free base nicotine mixed with an ion exchange resin and free base nicotine mixed with a water soluble composition.

17. 17. The nicotine pouch composition of any one of claims 1 to 16, wherein the free base nicotine is granulated with a water soluble composition or an ion exchange resin.

18. 18. The nicotine pouch composition of any one of claims 1 to 17, wherein the pouch composition further comprises a pH controlling agent, such as a basic pH controlling agent, such as a basic buffering agent.

19. 19. The nicotine pouch composition of any one of claims 1 to 18, wherein the pouch composition further comprises a pH control agent in an amount of 0.01 to 15% by weight of the pouch composition, such as 2 to 10% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 0.5 to 10% by weight of the pouch composition.

20. 20. The nicotine pouch composition of any one of claims 1 to 19, wherein the pouch composition is adapted to provide a pH of at least 8.

0.

21. 21. The nicotine pouch composition of any one of claims 18-20, wherein the pH control agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentaposodium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

22. 22. The nicotine pouch composition of any one of claims 18 to 21, wherein the pH controlling agent is 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.

23. 23. The nicotine pouch composition of any one of claims 1 to 22, wherein the pouch composition further comprises a humectant.

24. 24. The nicotine pouch composition of any one of claims 1 to 23, wherein the pouch composition further comprises a humectant in an amount of 0.5 to 10% by weight of the pouch composition, such as 1 to 3% by weight of the pouch composition, such as 0.5 to 5% by weight of the pouch composition.

25. 25. The nicotine pouch composition of claim 24, wherein the humectant comprises one or more from the list consisting of glycerol, propylene glycol, alginate, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

26. 26. The nicotine pouch composition of any one of claims 1 to 25, wherein the pouch composition further comprises an alginate.

27. 27. The nicotine pouch composition of any one of claims 1 to 26, wherein the pouch composition further comprises alginate in an amount of 0.5 to 5% by weight of the pouch composition, such as 1 to 3% by weight of the pouch composition.

28. 28. The nicotine pouch composition of any one of claims 1 to 27, wherein the pouch composition further comprises xanthan gum.

29. 29. The nicotine pouch composition of any one of claims 1 to 28, wherein the pouch composition further comprises silicon dioxide.

30. 30. The nicotine pouch composition of any one of claims 1 to 29, wherein the pouch composition comprises a flavouring.

31. 31. The nicotine pouch composition of any one of claims 1 to 30, wherein the pouch composition comprises an oil-based flavouring.

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

33. 33. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition comprises flavourant in an amount from 0.01 to 15% by weight of the pouch composition, such as from 3 to 10% by weight of the pouch composition, such as from 1 to 10% by weight of the pouch composition, such as from 0.1 to 15% by weight of the pouch composition.

34. 34. The nicotine pouch composition of any one of claims 1 to 33, wherein the flavourant comprises a liquid flavourant.

35. 35. The nicotine pouch composition of any one of claims 1 to 34, wherein the pouch composition is substantially homogenous.

36. 36. The nicotine pouch composition of any one of claims 1 to 35, wherein the dose of free base nicotine among a series of at least 10 oral pouches comprising the pouch composition has a relative standard deviation (RSD) of less than 10%, preferably less than 8%, more preferably at most 6%, even more preferably at most 4%, and most preferably at most 2%.

37. 37. The nicotine pouch composition of any one of claims 1 to 36, wherein the pouch composition is obtained by mixing dry ingredients before adding nicotine, water and, if any, liquid flavouring.

38. 38. The nicotine pouch composition of any one of claims 1 to 37, wherein the pouch composition is obtained by mixing at least 90% by weight of the total amount of dry ingredients before adding water, such as before adding water and liquid flavouring, if any.

39. 39. The nicotine pouch composition of any one of claims 1 to 38, wherein the pouch composition further comprises an amount of a water insoluble composition.

40. 40. The nicotine pouch composition of claim 39, wherein the water insoluble composition comprises at least one selected from calcium hydrogen phosphate, calcium carbonate such as calcium carbonate DC, mono-, diglyceride powders, hydrogenated vegetable oils, and combinations thereof.

41. 41. The nicotine pouch composition of claim 39 or 40, wherein the amount of the water insoluble composition is from 5 to 50% by weight of the pouch composition, such as from 10 to 30% by weight of the pouch composition.

42. 42. The nicotine pouch composition of any one of claims 39 to 41, wherein the water insoluble composition comprises or consists of water insoluble fibres such as water insoluble vegetable fibres such as wheat fibre, oat fibre, pea fibre, rice fibre, maize fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, cellulose fibre, powdered cellulose, bamboo fibre, bran fibre, or combinations thereof.

43. 43. The nicotine pouch composition of any one of claims 1 to 42, wherein 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.

44. 44. The nicotine pouch composition of any one of claims 1 to 43, wherein the water insoluble fibre has a water binding capacity of at least 200%, such as at least 400%, such as at least 300%.

45. 45. The nicotine pouch composition of any one of claims 1 to 44, 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.

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

47. 47. The nicotine pouch composition of any one of claims 1 to 46, wherein the water insoluble fiber is selected from pea fiber, powdered cellulose, and combinations thereof, and the pouch composition comprises a flavoring in an amount of 10% or less by weight of the pouch composition.

48. 48. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition has a moisture content of at least 20% by weight of the pouch composition, such as at least 40% by weight of the pouch composition, such as at least 30% by weight of the pouch composition, such as at least 25% by weight of the pouch composition.

49. 49. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition has a moisture content of from 15 to 70% by weight of the pouch composition, such as from 30 to 60% by weight of the pouch composition, such as from 25 to 70% by weight of the pouch composition, such as from 20 to 40% by weight of the pouch composition, such as from 15 to 25% by weight of the pouch composition, such as from 15 to 30% by weight of the pouch composition, such as from 15 to 70% by weight of the pouch composition.

50. 50. The nicotine pouch composition of any one of claims 1 to 49, wherein the pouch composition comprises a powdered composition.

51. 51. The nicotine pouch composition of any one of claims 1 to 50, wherein the pouch composition has an average particle size of 1 to 1200 micrometers, such as 10 to 500 micrometers.

52. 52. The nicotine pouch composition of any one of claims 1-51, wherein at least 50% by weight of the pouch composition is provided in particles having a particle size greater than 10 micrometers, such as from 10 to 500 micrometers.

53. 53. The nicotine pouch composition of any one of claims 1-52, wherein the pouch composition is adapted to release at least 15% by weight of the free base nicotine, such as at least 40% by weight of the free base nicotine, such as at least 30% by weight of the free base nicotine, such as at least 20% by weight of the free base nicotine, within a period of 120 seconds upon contact with oral saliva when provided in a pouch and release is measured as described in Example 3K.

54. 53. The nicotine pouch composition of any one of claims 1-52, wherein the pouch composition is designed to release at least 50% by weight of the free base nicotine within a 120 second period upon contact with oral saliva when provided in the pouch.

55. 55. The nicotine pouch composition of any one of claims 1-54, wherein the pouch composition is adapted to release at least 30% by weight of the free base nicotine, such as at least 60% by weight of the free base nicotine, such as at least 50% by weight of the free base nicotine, such as at least 40% by weight of the free base nicotine, within a 10 minute period upon contact with oral saliva when provided in a pouch and release is measured as described in Example 3K.

56. 56. The nicotine pouch composition of any one of claims 1-55, wherein the pouch composition provided in a pouch and subjected to an in vitro release experiment as described in Example 3L has a release rate of nicotine of at least 0.5% per minute within a release period of 2 to 10 minutes, such as at least 0.4% per minute within a release period of 2 to 10 minutes, such as at least 0.3% per minute within a release period of 2 to 10 minutes, or at least 0.2% per minute within a release period of 2 to 10 minutes.

57. 57. The nicotine pouch composition of any one of claims 1-56, wherein the pouch composition further comprises nicotine as a nicotine salt and / or as a complex with an ion exchange resin, such as polacrilex resin.

58. 58. The nicotine pouch composition of any one of claims 1 to 57, wherein the pouch composition further comprises nicotine as a nicotine salt.

59. 59. The nicotine pouch composition of any one of claims 1-58, wherein the pouch composition further comprises nicotine as a complex with an ion exchange resin, such as a polacrilex resin.

60. 60. The nicotine pouch composition of any one of claims 1 to 59, wherein the pouch composition further comprises a preservative.

61. 61. The nicotine pouch composition of any one of the preceding claims, wherein the pouch composition further comprises a preservative in an amount of 0.05-0.5% by weight of the pouch composition, such as 0.1-0.2% by weight of the pouch composition.

62. 62. The nicotine pouch composition of any one of claims 1 to 61, wherein the pouch composition comprises less than 0.1% by weight of a preservative, such as less than 0.05% by weight of a preservative.

63. 63. The nicotine pouch composition of any one of claims 1 to 62, wherein the pouch composition is free of preservatives.

64. 64. The nicotine pouch composition of any one of claims 1 to 63, wherein the pouch composition comprises nicotine in an amount of at least 0.1% by weight of the pouch composition, such as at least 1.0% by weight of the pouch composition, such as at least 0.5% by weight of the pouch composition, such as at least 0.2% by weight of the pouch composition.

65. 65. The nicotine pouch composition of any one of claims 1 to 64, wherein the pouch composition comprises nicotine in an amount of 20% or less by weight of the pouch composition, such as 5% or less by weight of the pouch composition, such as 10% or less by weight of the pouch composition.

66. 66. The nicotine pouch composition of any one of claims 1 to 65, wherein the pouch composition comprises nicotine in an amount equivalent to 0.5 to 20 mg per pouch, such as 5.0 to 15 mg per pouch, such as 1.0 to 20 mg per pouch.

67. 67. The nicotine pouch composition of any one of claims 1 to 66, wherein the pouch composition further comprises a controlled release composition.

68. 68. The nicotine pouch composition of any one of claims 1-67, wherein the controlled release composition is selected from the list consisting of metal stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycol, polyoxyethylene monostearate, tallow, silicates, silicate dioxide, talc, magnesium stearate, calcium stearate, fumed silica, powdered hydrogenated cottonseed oil, hydrogenated vegetable oils, hydrogenated soybean oil, emulsifiers, triglycerides, and mixtures thereof.

69. 69. The nicotine pouch composition of any one of claims 1-68, wherein the controlled release composition is hydrophobic.

70. 70. The nicotine pouch composition of any one of claims 1-69, wherein the controlled release composition comprises one or more metal stearates, such as magnesium stearate and / or calcium stearate.

71. 71. The nicotine pouch composition of any one of claims 1 to 70, wherein the pouch composition comprises the controlled release composition in an amount of 1 to 20 percent by weight of the pouch composition.

72. 72. The nicotine pouch composition of any one of claims 1-71, wherein the controlled release composition comprises or is a solubilizer, such as a solubilizer selected from the list of mono / di-glycerides, polysorbates (e.g., TWEEN® XX), sucrose-esters, and combinations thereof.

73. 73. The nicotine pouch composition of any one of claims 1 to 72, wherein the pouch composition is free of tobacco, tobacco fibre and tobacco-derived fibre.

74. 74. The nicotine pouch composition of any one of claims 1 to 73, wherein the free base nicotine is mixed with a microcrystalline cellulose (MCC)-free composition, such as a cellulose-free composition.

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

76. 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 10 to 60% by weight of the pouch composition, such as 5 to 70% by weight of the pouch composition, and 76. The nicotine pouch composition of any one of the preceding claims, wherein 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.

77. 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 10-60% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; and 77. The nicotine pouch composition of any one of claims 1 to 76, 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.

78. 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 10-60% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; 78. The nicotine pouch composition of any one of the preceding claims, 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 flavourant in an amount from 0.01 to 15% by weight of the pouch composition, such as from 3 to 10% by weight of the pouch composition, such as from 1 to 10% by weight of the pouch composition, such as from 0.1 to 15% by weight of the pouch composition.

79. 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 10-60% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; 79. The nicotine pouch composition of any one of claims 1 to 78, 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, the pouch composition comprises flavourant in an amount of 0.01 to 15% by weight of the pouch composition, such as 3 to 10% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 0.1 to 15% by weight of the pouch composition, and the flavourant is oil-based.

80. 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 10-60% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; and 80. The nicotine pouch composition of any one of claims 1-79, wherein the pouch composition comprises a pH control agent selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta-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.

81. 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 10-60% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; and 81. The nicotine pouch composition of any one of claims 1-80, wherein the pouch composition comprises a pH controlling agent, such as a basic buffering agent and / or a basic pH controlling agent, such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

82. 82. The nicotine pouch composition of any one of claims 1 to 81, which is cellulose-free, i.e. microcrystalline cellulose (MCC)-free.

83. 83. An oral nicotine pouch product comprising a pouch and an amount of the nicotine pouch composition of any one of claims 1-82 enclosed in said pouch.

84. 84. The oral nicotine pouch product of claim 83, wherein the pouch product comprises the pouch composition in an amount of 50-1000 mg, such as 300-600 mg, such as 100-700 mg.

85. 85. The oral nicotine pouch product of claim 83 or 84, wherein the pouch product comprises nicotine in an amount of 0.5 to 20 mg, such as 5.0 to 15 mg, such as 1.0 to 20 mg.

86. 86. An oral nicotine pouch product according to any one of claims 83 to 85, wherein the pouch comprises a water permeable membrane, for example comprising a woven or non-woven fabric.

87. 87. The nicotine pouch product of any one of claims 83 to 86, wherein the membrane of the pouch comprises a water-insoluble fiber of a different origin than the water-insoluble fiber contained in the pouched product.

88. 88. The nicotine pouch product of any one of claims 83 to 87, wherein both the water-insoluble fiber of the membrane and the water-insoluble fiber of the pouch composition comprise natural fibers.

89. 89. The nicotine pouch product of any one of claims 83 to 88, wherein the water-insoluble fiber of the membrane and the water-insoluble fiber of the pouch composition are both natural fibers.

90. 90. The nicotine pouch product of any one of claims 83 to 89, wherein the pouched product comprises the pouch in an amount of up to 20 percent by weight of the pouched product, such as in an amount of up to 15 percent by weight of the pouched product.

91. 91. The nicotine pouch product of any one of claims 83 to 90, wherein the pouched product comprises the pouch in an amount of 3 to 20 percent by weight of the pouched product, such as in an amount of 5 to 15 percent by weight of the pouched product.

92. said free base nicotine comprising free base nicotine mixed with an ion exchange resin, in a weight ratio between said free base nicotine and said ion exchange resin of 0.1 to 2.0; 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, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bamboo fiber, powdered cellulose, bran fiber, or a combination thereof; the pouch composition comprises a sugar alcohol in an amount of 1 to 80% by weight of the pouch composition; and 92. The nicotine pouch product of any one of claims 83 to 91, wherein the pouch composition comprises a pH control agent in an amount of 0.01 to 15% by weight of the pouch composition.

93. A method for producing an oral nicotine pouch product according to any one of claims 83 to 92, comprising the steps of: - providing a nicotine pouch composition according to any one of claims 1 to 82, - providing said pouch, - adding the pouch composition to the pouch, and - sealing the pouch The method includes:

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