Nicotine pouch product

Abstract

To provide a nicotine-containing pouch as a tobacco substitute.SOLUTION: A pouched nicotine product comprises a pouch composition and a pouch membrane enclosing the pouch composition, wherein the pouch composition comprises at least one water-insoluble fiber, water in an amount of at least 15 wt.% of the composition, and nicotine, and the pouch membrane comprises additional nicotine in an amount of at least 15 wt.% of the total nicotine content in the pouched product.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to nicotine pouch compositions as claimed. [Background technology]

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

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

[0004] Moreover, a further problem associated with the prior art may be that the pouch as a delivery vehicle for nicotine is somewhat costly and therefore restrictions are placed on how the pouch is designed to control manufacturing costs. [Means for solving the problem]

[0005] The present invention relates to a nicotine pouched product, the nicotine pouched product comprising: A pouch composition; a pouch membrane enclosing the pouch composition; Including, The pouch composition comprises: At least one water insoluble fiber; Water in an amount of at least 15% by weight of the composition; Nicotine and Including, The pouch membrane further comprises nicotine in an amount of at least 15% by weight of the total nicotine content in the pouched product.

[0006] An advantage of the present invention may be that the inclusion of said additional nicotine in the pouch membrane promotes a relatively rapid release of nicotine, whereby the pouched product releases nicotine from the pouch composition, but in addition, nicotine is also released from the pouch membrane itself, whereby the release of nicotine is significantly improved over pouches that contain nicotine only in the pouch composition.

[0007] In many conventional pouches, attention is usually focused on the total amount of nicotine released within the period of use, which is 30 or 60 minutes. However, the relief of nicotine craving is still not necessarily optimal. Instead, adding nicotine to the pouch membrane increases the release of nicotine, especially in the first few minutes after starting to use, thereby providing a very desirable release of nicotine and relief of craving. This advantage is achieved without requiring, for example, special modification of the pouch composition, but instead by carefully distributing the nicotine in the pouched product so that at least a portion of the nicotine is located within the pouch membrane. Also, it is achieved without requiring an increase in the total amount of nicotine, since the nicotine dose can be distributed into the pouch composition and the pouch membrane instead.

[0008] A further advantage of the present invention may be that by providing a combination of the claimed moisture content and said at least one water insoluble fiber, a highly desirable mouthfeel can be obtained without the use of tobacco, while at the same time having the claimed moisture content may promote a more rapid release, especially within the first few minutes of use.

[0009] Therefore, in the context of the present invention, it should be understood that the pouch membrane contains an amount of nicotine, and that said amount of nicotine in the pouch membrane is at least 15% by weight of the total nicotine content in the pouched product.

[0010] Further, the pouched product includes nicotine in both the pouch composition and the pouch membrane. Thus, the nicotine in the pouched product includes the nicotine in the pouch composition and the nicotine in the pouch membrane.

[0011] In an advantageous embodiment of the invention, said at least one water-insoluble fibre is provided as a powder and said pouch membrane comprises at least one further water-insoluble fibre. In an advantageous embodiment of the invention, at least 15% by weight of the total nicotine content in the pouched product is released within a period of not more than 120 seconds upon oral administration.

[0012] In one embodiment of the invention, this is measured by placing the pouched product into a reaction tube containing 10 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4), removing the pouched product, and determining the remaining portion of nicotine in the pouched product.

[0013] The above in vitro methods are described in more detail in Example 5F. In an advantageous embodiment of the invention, 15-40% by weight of the total nicotine content in the pouched product is released within a period of not more than 120 seconds upon oral administration.

[0014] In one embodiment of the invention, the pouch composition is provided in a pouch and adapted to release at least 15% by weight of the total nicotine content of the pouched product within a period of 120 seconds when subjected to the in vitro release experiment described in Example 5F, such as at least 20% by weight of the total nicotine content of the pouched product, such as at least 30% by weight of the total nicotine content of the pouched product.

[0015] In one embodiment of the invention, the pouch composition is provided in a pouch and adapted to release 15-50% by weight of the total nicotine content of the pouched product, such as 20-45% by weight of the total nicotine content of the pouched product, such as 30-40% by weight of the total nicotine content of the pouched product, within a period of 120 seconds when subjected to the in vitro release experiment described in Example 5F.

[0016] In an advantageous embodiment of the invention, the nicotine in the pouched product is selected from a nicotine salt, free base nicotine mixed with an ion exchange resin, free base nicotine complexed with an ion exchange resin, free base nicotine mixed with a soluble composition such as a sugar alcohol or water soluble fiber, nicotine in association with a fatty acid such as oleic acid, and any combination thereof.

[0017] In an advantageous embodiment of the invention, the nicotine in the pouched product does not consist of nicotine chemically bound to a carrier, such as an ion exchange resin, such as polacrilex resin.

[0018] Thus, in the above embodiments, the nicotine in the pouched product can come from any source, with the exception of only nicotine that is chemically bound to a carrier. In particular, the above embodiments do not include the case where all of the nicotine is bound to an ion exchange resin, such as a polacrilex resin. On the other hand, the above embodiments include at least some nicotine that may or may not be bound to a carrier, so long as this binding is physical, rather than chemical.

[0019] In an advantageous embodiment of the present invention, the nicotine in the pouched product does not consist of a nicotine salt. In one embodiment of the invention, the nicotine in the pouched product does not include a nicotine salt.

[0020] In one embodiment of the invention, the nicotine in the pouched product does not include nicotine bitartrate. In one embodiment of the invention, the nicotine in the pouched product does not consist of nicotine bitartrate.

[0021] In an advantageous embodiment of the invention, the nicotine in the pouched product is selected from nicotine salts, free base nicotine mixed with an ion exchange resin, free base nicotine mixed with a soluble composition such as a sugar alcohol or water soluble fiber, nicotine in association with a fatty acid such as oleic acid, and any combination thereof.

[0022] In an advantageous embodiment of the invention, the nicotine in the pouched product is free base nicotine mixed with an ion exchange resin. In one embodiment of the invention, the nicotine in the pouched product comprises free base nicotine mixed with an ion exchange resin.

[0023] 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 the free base nicotine and the ion exchange resin of from 0.1 to 2.0, preferably from 0.5 to 2.0, most preferably from about 0.67 to 1.0.

[0024] Here, the weight ratio means the ratio of the mass of the first component divided by the mass of the second component. The term mixing ratio may also be used. In one embodiment of the invention, the nicotine of the pouched product comprises or is a nicotine salt.

[0025] In one embodiment of the invention, the nicotine in the pouched product comprises free base nicotine, such as free base nicotine mixed with an ion exchange resin, or is free base nicotine.

[0026] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol. In an advantageous embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition.

[0027] In one embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of 1-80% by weight of the composition, such as 2-70% by weight of the composition, such as 5-60% by weight of the composition, such as 10-50% by weight of the composition.

[0028] In one embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of 5-40% by weight of the composition, such as 5-30% by weight of the composition. In an advantageous embodiment of the invention, the sugar alcohol is selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolyzates, isomalt, or any combination thereof.

[0029] In one embodiment of the invention, the sugar alcohol comprises a DC (directly compressible) grade sugar alcohol. In one embodiment of the invention, at least 50% by weight of the sugar alcohol is a DC (directly compressible) grade sugar alcohol.

[0030] In one embodiment of the invention, the sugar alcohol comprises a non-DC (non-directly compressible) grade sugar alcohol. In an advantageous embodiment of the invention, the pouched product comprises said pouch membrane 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.

[0031] In an advantageous embodiment of the invention, the pouched product comprises said pouch membrane in an amount of 3 to 20 percent by weight of said pouched product, such as in an amount of 5 to 15 percent by weight of said pouched product.

[0032] In an advantageous embodiment of the invention, the pouch membrane comprises a nonwoven or woven material. In one embodiment of the invention, the pouch membrane comprises a nonwoven membrane. In one embodiment of the invention, the pouch membrane comprises a woven membrane.

[0033] In one embodiment of the invention, the pouch membrane comprises rayon fibers, such as viscose. In one embodiment of the invention, the fibers of the pouch membrane comprise cellulose in an amount of at least 60% of the fibers, such as at least 80% of the fibers.

[0034] In one embodiment of the present invention, the pouch membrane comprises fibers, and the fibers of the pouch membrane comprise cellulose in an amount of 60-100% by weight of the fibers, such as 80-100% by weight of the fibers. In one embodiment of the invention, the fibers of the pouch membrane consist essentially of cellulose.

[0035] In the context of the present invention, cellulose includes both natural cellulose, ie unmodified cellulose, and regenerated cellulose, such as, for example, rayon fibres. A high cellulose content may facilitate rapid release of nicotine from the pouch product.

[0036] In one embodiment of the invention, the pouch membrane comprises fibers, and the fibers of the pouch membrane comprise regenerated cellulose in an amount of at least 60% of the fibers, such as at least 80% of the fibers. In one embodiment of the present invention, the pouch membrane comprises fibers, the fibers of the pouch membrane comprising regenerated cellulose in an amount of 60-100% by weight of the fibers, such as 80-100% by weight of the fibers.

[0037] In one embodiment of the invention, the pouch membrane comprises fibers, the fibers of the pouch membrane comprising rayon in an amount of at least 60% by weight of the fibers, such as at least 80% by weight of the fibers, which may, for example, comprise or consist of viscose.

[0038] In one embodiment of the invention, the pouch membrane comprises fibers, the fibers of the pouch membrane comprising rayon in an amount of 60-100% by weight of the fibers, such as 80-100% by weight of the fibers, which may, for example, comprise or consist of viscose.

[0039] In one embodiment of the invention, the fibers of the pouch membrane are natural. In one embodiment of the invention, the fibers of the pouch membrane are free of synthetic fibers. In one embodiment of the invention, the pouch membrane is uncoated.

[0040] In one embodiment of the invention, the pouch membrane does not include a synthetic coating. In one embodiment of the invention, the pouch membrane includes a coating, such as a non-fibrous coating.

[0041] In an advantageous embodiment of the invention, the amount of nicotine located in the pouch membrane is between 15 and 50% by weight of said total nicotine content in the pouched product, such as between 15 and 35% by weight of said total nicotine content in the pouched product.

[0042] In one embodiment of the invention, the amount of nicotine located in the pouch membrane is between 15 and 45% by weight of the total content of said nicotine in the pouched product. In one embodiment of the invention, the amount of nicotine located in the pouch membrane is between 15 and 40% by weight of the total content of said nicotine in the pouched product.

[0043] In one embodiment of the invention, the amount of nicotine located in the pouch membrane is between 15 and 30% by weight of the total content of said nicotine in the pouched product. In one embodiment of the invention, the amount of nicotine located in the pouch membrane is 20-50% by weight of the total nicotine content in the pouched product, such as 25-50% by weight of the total nicotine content in the pouched product, such as 30-50% by weight of the total nicotine content in the pouched product.

[0044] In an advantageous embodiment of the invention, the amount of nicotine located in the pouch membrane is at least 20% by weight of said total nicotine content in the pouched product, such as at least 25% by weight of said total nicotine content in the pouched product.

[0045] In an advantageous embodiment of the invention, the amount of nicotine located in the pouch membrane is between 20 and 50% by weight of said total nicotine content in the pouched product, such as at least 25 to 50% by weight of said total nicotine content in the pouched product.

[0046] In an advantageous embodiment of the invention, the additional nicotine in the pouch membrane is provided by processing nicotine from the pouch composition into the pouch membrane.

[0047] In one embodiment of the invention, the processing of nicotine from the pouch composition into the pouch membrane may include exposing the pouched product to a predetermined temperature and humidity. In one embodiment of the invention, the nicotine in the pouch membrane is applied to the pouch membrane by a nicotine dispenser.

[0048] In an advantageous embodiment of the invention, the nicotine in the pouch membrane is applied to the pouch membrane by film coating or spraying. In an advantageous embodiment of the invention, the nicotine in the pouch membrane is applied to the pouch membrane by immersing the pouched product in liquid nicotine, for example diluted liquid nicotine.

[0049] In one embodiment of the invention, the nicotine in the pouch membrane is applied to the pouch membrane prior to filling the pouch membrane with the pouch composition. In an advantageous embodiment of the invention, additional nicotine is applied to the pouch membrane during its manufacture.

[0050] In an advantageous embodiment of the invention, the nicotine in the pouch composition is in the same form as the further nicotine in the pouch membrane. 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 15-65% by weight of said pouch composition, such as 15-50% by weight of said pouch composition, such as 25-50% by weight of said pouch composition, such as 30-40% by weight of said pouch composition.

[0051] 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 15-50% by weight of said pouch composition, such as 15-40% by weight of said pouch composition, such as 15-30% by weight of said pouch composition, such as 15-25% by weight of said pouch composition.

[0052] Water may be added as a separate ingredient that is mixed completely or partially with other ingredients such as fiber. For example, if free base nicotine is added as a mixture of free base nicotine with ion exchange resin and water, a significant amount of the water in the final pouch composition will come from the free base nicotine-ion exchange resin-water premix. For example, if the final amount pouch composition contains 5% water from the free base nicotine-ion exchange resin-water premix, up to 1 / 3 of the water in the pouch composition will come from the free base nicotine-ion exchange resin-water premix.

[0053] 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 50% or less by weight of said pouch composition, such as 40% or less by weight of said pouch composition, such as 30% or less by weight of said pouch composition.

[0054] In an advantageous embodiment of the present invention, the water insoluble fibers of the pouch composition are selected from water insoluble vegetable fibers, wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bamboo fiber, bran fibers, powdered cellulose and any combination thereof.

[0055] 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.

[0056] In an advantageous embodiment of the invention, the water insoluble fibre of the pouch composition is selected from oat fibre, wheat fibre, pea fibre, powdered cellulose and any combination thereof.

[0057] In an advantageous embodiment of the invention, the water-insoluble fibre comprises MCC. In an advantageous embodiment of the invention, the water-insoluble fibres are powdered. In an advantageous embodiment of the invention, the water insoluble fibres of the pouch composition have a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.

[0058] An advantage of the above embodiment may be that the high water binding capacity allows for a pouch composition having a high moisture content. In one embodiment of the present invention, the water-insoluble fiber of the pouch composition has a water binding capacity of 200% to 1500%, such as 300 to 1300%, such as 200 to 800%, such as 300 to 800%, such as 400 to 600%.

[0059] In one embodiment of the present invention, the water-insoluble fiber has a water binding capacity of 200 to 1500%, such as 300 to 1300%, such as 300 to 900%, such as 300 to 700%, such as 400 to 700%.

[0060] In one embodiment of the present invention, the water-insoluble fiber has a water binding capacity of 200 to 1500%, such as 400 to 1500%, such as 500 to 1500%, such as 500 to 1200%, such as 500 to 1000%.

[0061] In one embodiment of the invention, the water-insoluble fiber has a swelling capacity of at least 5.0 mL / g, such as from 5.0 to 20 mL / g. 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 will prevent the dissolution of the water-soluble ingredients during use, so that the user will not experience any reduction in the pouch contents during use.

[0062] In an advantageous embodiment of the invention, the composition has a bulk density of at most 0.8 g / cm3, such as at most 0.7 g / cm3, such as at most 0.6 g / cm3, such as at most 0.5 g / cm3.

[0063] The inventive use of compositions having a relatively low bulk density will not only provide good mouthfeel, but also provide efficient release from the pouch due to the fact that the relatively low bulk density promotes efficient salivation and thereby the release of the water soluble components of the composition. It is noted that low bulk density in particular in combination with the claimed moisture content is attractive where improved user cognition is desired.

[0064] At the same time, low density has the advantage of reducing the amount of raw material used, thereby lowering manufacturing costs. An advantage of the above described embodiment may be that it results in a low density composition. Surprisingly, the combination of water and sugar alcohol did not result in a very dense and compacted unworkable pouch composition, but rather allowed for a relatively light weight and low density composition.

[0065] In an advantageous embodiment of the invention, the pouch composition comprises water and water insoluble fibre in a weight ratio of 3.0 or less, such as 2.5 or less, such as 2.0 or less, such as 1.5 or less, such as 1.0 or less.

[0066] In an advantageous embodiment of the 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.

[0067] In one embodiment, the pouch composition may include tobacco, tobacco fiber, or tobacco-derived fiber in an amount of 0.1-5.0% by weight of the pouch composition, such as 0.1-3.0% by weight of the pouch composition. Thus, the pouch composition may, in some embodiments, include small amounts of tobacco, but this is in addition to the free base nicotine, and thus the pouch composition is not tobacco-based.

[0068] In one embodiment of the invention, the pouch composition comprises, for example, no tobacco, such as less than 0.1% by weight of the pouch composition, such as less than 0.5% by weight of the pouch composition, such as less than 1.0% by weight of the pouch composition, such as less than 3.0% by weight of the pouch composition, or less than 5.0% by weight of tobacco.

[0069] In one embodiment of the invention, the water-insoluble composition does not include tobacco, tobacco fiber, or tobacco-derived fiber, and therefore in this embodiment, the water-insoluble fiber is a non-tobacco fiber, i.e., does not include tobacco, tobacco fiber, or tobacco-derived fiber.

[0070] In one embodiment of the invention, the membrane comprises water-insoluble fiber of a different origin than the water-insoluble fiber contained in the pouched product. In one embodiment of the invention, the water insoluble fiber of the membrane and the water insoluble fiber of the pouch composition both comprise natural fibers.

[0071] 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 pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition.

[0072] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, The composition comprises the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition, and The composition further comprises water insoluble fiber in an amount of from 5 to 50% by weight of the pouch composition, such as from 10 to 30% by weight of the pouch composition.

[0073] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, the composition comprises the sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; and The water-insoluble composition comprises or consists of a water-insoluble fiber, such as, for example, 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 pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, the composition comprises the sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; and The water insoluble composition comprises or consists of a water insoluble fiber, such as a water insoluble vegetable fiber, such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, and wherein the pouch composition comprises a flavoring in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.1 to 15% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 3 to 10% by weight of the pouch composition.

[0075] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, the composition comprises the sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; and The water insoluble composition comprises or consists of a water insoluble fiber, such as a water insoluble vegetable fiber, such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, and the pouch composition comprises a flavoring in an amount of 0.01-15% by weight of the pouch composition, such as 0.1-15% by weight of the pouch composition, such as 1-10% by weight of the pouch composition, such as 3-10% by weight of the pouch composition, and the flavoring is oil-based.

[0076] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, the composition comprises the sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; and The pouch composition comprises a pH 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.

[0077] In an advantageous embodiment of the invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, the composition comprises the sugar alcohol in an amount of from 1 to 80% by weight of the pouch composition, such as from 5 to 70% by weight of the pouch composition, such as from 10 to 60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition; and The pouch composition includes a 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.

[0078] In a second aspect, the present invention relates to a packed nicotine pouch product, the packed nicotine pouch product comprising: A pouch composition; a pouch membrane enclosing the pouch composition; Including, The pouch composition comprises: At least one water insoluble fiber; Water in an amount of at least 15% by weight of the composition; Nicotine and and the pouch membrane further comprises at least 1.0 mg of nicotine.

[0079] In one embodiment of the present invention, a nicotine pouched product of the second aspect is conceived according to the first aspect of the invention or any of its embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0080] As used herein, the term "nicotine" refers to nicotine used as a purified / isolated substance. In particular, nicotine does not refer to tobacco materials that contain nicotine.

[0081] As used herein, the term "pouch composition" refers to a composition for use in a pouched product, i.e., a pouch for oral use, that contains nicotine. Also, the terms "nicotine pouch composition" and "pouch composition" are used interchangeably. The pouch composition is not a tobacco-based pouch composition. In some embodiments, the pouch composition may contain a small amount of tobacco as a flavoring, e.g., less than 2% by weight of the composition. In other embodiments, the pouch composition does not contain tobacco.

[0082] 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 a water-soluble composition, such as an amount of ion exchange resin or sugar alcohol or water-soluble fiber.Free base nicotine can also be mixed with a water-insoluble composition, such as water-insoluble 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.

[0083] As used herein, the term "pouch membrane" is intended to refer to a material that forms a container that encloses a cavity. The pouch membrane is designed for administering nicotine into the oral cavity, and is therefore suitable for use in the oral cavity, non-toxic, and non-water-soluble. The pouch membrane, which may also be referred to as a web of fibrous material, may form, for example, a woven or non-woven web or fabric. The pouched product may, for example, be sealed by gluing two corresponding parts of the web or fabric together along their edges to form a cavity for the nicotine and non-water-soluble composition. To release the nicotine, flavorings, and other water-soluble substances, the pouch membrane is water-permeable so that saliva from the oral cavity penetrates the pouch membrane, where it contacts the nicotine, and also enters the cavity, where it contacts the nicotine, flavorings, and other water-soluble substances, thereby releasing the nicotine, flavorings, and other water-soluble substances from the pouch membrane and pouch composition from the pouched product.

[0084] As used herein, the term "powder composition" refers to a composition in the form of a powder, i.e., a composition as particulate matter having a relatively small particle size, for example, of 1 to 1200 micrometers. In particular, powder composition does not refer to powdered tobacco.

[0085] As used herein, the term "humectant" is understood as a moisturizing agent used to attract moisture or water in the form of saliva. Humectants typically include compositions that are suitably hygroscopic. In some cases, humectants may also be described as humectants, since they act to attract moisture. Examples of humectants include glycerol, propylene glycol, alginate, pectin, xanthan gum, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), and the like.

[0086] As used herein, the term "water soluble" refers to a relatively high water solubility, e.g., a water solubility of a water soluble composition or substance greater than 5 grams per 100 mL of water, measured at 25 degrees Celsius and a pH of 7.0. When referring to a "soluble" composition or substance, water soluble is meant unless otherwise specified.

[0087] 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.

[0088] 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.

[0089] The materials of the pouch membrane, including, for example, woven and / or nonwoven fabrics, may be appropriately selected to obtain a pouch membrane with a suitable opening size in view of the pouch composition to be used. In other words, according to various embodiments, the pouch membrane allows the passage of saliva and prevents or blocks the passage of undissolved composition and water-insoluble fibers. The pouch membrane can be any suitable material, such as woven or nonwoven fabrics (e.g., cotton, fleece, etc.), heat-sealable nonwoven cellulose such as long fiber paper, or other polymeric materials such as synthetic, semi-synthetic, or natural polymeric materials. One example of a suitable material for the pouch membrane is paper made of pulp and a small amount of a wet enhancer. The material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from exiting the bag or pouch during use. The suitable material is also one that does not have a significant effect on the release of nicotine from the pouch.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] The pouch membrane material may have the form of a net, a sieve, a paper with holes, a permeable fabric, and the like. For example, a pouch material made from rice paper in a net form or rice paper with holes may dissolve in the mouth of the user. In some exemplary embodiments, the pouch membrane material may be made using water-dispersible film-forming materials (e.g., binders such as alginate, carboxymethylcellulose, xanthan gum, pullulan, and the like), as well as those materials in combination with materials such as ground cellulose derivatives (e.g., fine grain wood pulp). The preferred pouch material, while water-dispersible or soluble, may be designed and manufactured such that a significant amount of the nicotine content will permeate the pouch material under normal use conditions before the time at which the pouch loses its physical integrity. If desired, flavoring ingredients, disintegration aids, and other desired ingredients may be incorporated into or applied to the pouch material.

[0094] 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, which are incorporated herein by reference.

[0095] According to one embodiment of the present invention, the pouch composition includes one or more pH controlling agents, such as a buffering agent. In one embodiment of the invention, the pH control agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentaposodium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0096] In one embodiment of the present invention, the pH control agent is selected from sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, or any combination thereof.

[0097] According to various embodiments of the present invention, one or more sugar alcohols may be included in the pouched product as part of the pouch composition, for example, as a sweetener, as a humectant, or as a carrier or part thereof. 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.

[0098] 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.

[0099] In one embodiment of the invention, the pouch composition comprises sugar and / or sugarless sweeteners, such as sugar alcohols. In one embodiment of the present invention, the pouch composition comprises sugar and / or sugarless sweeteners in an amount of 1.0 to about 80% by weight of the pouch composition, more typically comprising 5 to about 70% by weight of the pouch composition, and more commonly comprising 10 to 30% by weight of the pouch composition or 5 to 25% by weight of the pouch composition. In some other embodiments, the sugar and / or sugarless sweeteners comprise 10 to 60% by weight of the pouch composition, or 10 to 50% by weight of the pouch composition. The sugar and / or sugarless sweeteners may function not only as sweeteners but also as humectants. In some embodiments, the inclusion of certain ingredients can further limit the about amounts of sugar and / or sugarless sweeteners. In some embodiments, the content of sugar and / or sugarless sweeteners in the pouch composition is 20% by weight or less of the pouch composition, such as 15% by weight or less of the pouch composition, such as 10% by weight or less of the pouch composition, such as 5% by weight or less of the pouch composition.

[0100] 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.

[0101] 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.

[0102] In an embodiment of the present invention, the pouch composition further comprises water-soluble fiber. Non-limiting examples of water-soluble fiber include inulin, polydextrose, and psyllium plant fiber. Other water-soluble dietary fibers may also be used.

[0103] In one embodiment of the invention, the pouch composition comprises a flavouring. The flavouring may typically be present in an amount of 0.01-15% by weight of the total composition of the pouch, such as 0.01-5% by weight of the total composition. In an alternative embodiment, the pouch composition may be free of flavouring.

[0104] Non-exhaustive examples of flavorings suitable for an embodiment of the present invention are coconut, coffee, chocolate, vanilla, citrus such as grapefruit, orange, lime, bergamot, or lemon, menthol, licorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruits, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essences such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, lemongrass, lime, chili (capsaicin), citrus, tobacco flavoring, bergamot, and plum essence. Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above.

[0105] In various embodiments of the present invention, the pouch composition comprises a release controlling composition for controlling the release of the pouch composition and / or portions thereof, particularly nicotine.

[0106] The controlled release composition, according to various embodiments, may be selected from the group consisting of metal stearates, modified calcium carbonate, triglycerides (e.g., hydrogenated vegetable oils, partially hydrogenated vegetable oils, and / or tallow), polyethylene glycol, polyoxyethylene monostearate, tallow, silicates, silicon dioxide, talc, magnesium stearate, calcium stearate, fumed silica, powdered hydrogenated cottonseed oil, emulsifiers, hydrogenated soybean oil, and mixtures thereof. In particular, metal stearates such as magnesium stearate may be advantageous.

[0107] 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.

[0108] Alternatively, the controlled release composition may be added after the granulation step of the granulated premix. Further, the controlled release composition may be added only as part of the pouch composition such that two different nicotine release profiles are obtained. Furthermore, two or more portions of the pouch composition may contain different amounts of the controlled release composition, if any, thereby providing more complex and tailored nicotine release profiles.

[0109] A controlled release composition such as magnesium stearate may have an occlusive effect and may be used to control the release of nicotine and the dissolution rate of the pouch. EXAMPLES

[0110] Example 1A - Preparation of a pouch designed for administration of nicotine The pouch membrane is manufactured using a heat-sealable nonwoven cellulose, such as long fiber paper, and is heat sealed along its edges except for an opening at one end to the interior cavity formed by the pouch membrane.

[0111] The powdered pouch composition is filled into the cavity formed by the pouch membrane and maintained within the pouch by a hermetic seal. Pouches not in the form of nonwoven cellulosic fabrics may also be used in accordance with the present invention.

[0112] Example 1B - Preparation of a pouch designed for administration of nicotine The pouch membrane is manufactured using rayon fibers, such as viscose rayon staple fibers, and is heat sealed along its edges except for an opening at one end to the interior cavity formed by the pouch membrane.

[0113] The powdered pouch composition is filled into the cavity formed by the pouch membrane and maintained within the pouch by a hermetic 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.

[0114] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 1 below.

[0115] [Table 1]

[0116] 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.

[0117] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 2 below.

[0118] [Table 2]

[0119] 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.

[0120] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 3 below.

[0121] [Table 3]

[0122] 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.

[0123] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 4 below.

[0124] [Table 4]

[0125] 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.

[0126] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4A below.

[0127] [Table 5]

[0128] 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.

[0129] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4B below.

[0130] [Table 6]

[0131] 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.

[0132] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set forth in Table 4C below.

[0133] [Table 7]

[0134] Total processing time was 20 minutes. Example 2H-Nicotine Premix VIII-Resin The water was placed in a 60 liter planetary Bear Varimixer mixer and the nicotine was weighed in. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, Amberlite® IRP64 ion exchange resin was weighed and added to the mixer. The mixer was closed and mixed at high speed for 5 minutes, opening and scraping as needed. Finally, the mixer was mixed at high speed for an additional 5 minutes.

[0135] Thereby, a mixture of nicotine and cation exchange resin was prepared from the components set out in Table 4D below.

[0136] [Table 8]

[0137] Total processing time was 20 minutes. Example 3A - Pouch Pouches PPC6-PPC7 containing nicotine polacrilex resin (NPR) or nicotine bitartrate (NBT) were prepared with the powdered compositions as outlined in Table 5. The pouches are manufactured as follows.

[0138] 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 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.

[0139] The final powder composition is filled into pouches (target fill weight pouch of 500 mg powder). The pouch membrane of Example 1A made from long fiber paper is used. The powder is filled into the pouch and kept in the pouch by sealing. A pouched product was also produced using the pouch membrane of Example 1B.

[0140] 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 powder compositions outlined in Table 5. The pouches are manufactured as follows.

[0141] The fiber and water are mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients are then added successively with continuous mixing: nicotine premix (mixed for 2 minutes), then the remaining ingredients except for liquid flavor and glidant, if present (mixed for 2 minutes), then liquid flavor, if present (mixed for 1 minute), then glidant, if present (mixed for 1 minute). Total mixing time is 9-11 minutes.

[0142] The final powder composition is filled into pouches (target fill weight pouch of 500 mg powder). The pouch membrane of Example 1A made from long fiber paper is used. The powder is filled into the pouch and kept in the pouch by sealing. A pouched product was also produced using the pouch membrane of Example 1B.

[0143] The powder is filled into a pouch and maintained within the pouch by a seal.

[0144] [Table 9]

[0145] Pouch Content: 500mg total, i.e. nicotine concentration of 19.2mg / g. An example of the xylitol that can be used is the product name "Xylitab® 200".

[0146] Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers, such as water-insoluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber and powdered cellulose can be used as well.

[0147] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0148] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0149] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0150] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0151] Pouches PPC1-PPC3 and PPC5 demonstrate that different pouches can be made using free base nicotine with a moisture content of at least 15% by weight of the pouch composition. Pouches PPC6-PPC7 have a similar moisture content as PPC1 but use nicotine that is complexed with a nicotine salt and an ion exchange resin.

[0152] Example 3B - Pouch Pouches PPC11-PPC15 are manufactured similarly to pouches PPC1-PPC5 of Example 3A. Pouches PPC11-PPC15 containing nicotine premixes were prepared with the powdered compositions as outlined in Table 6. The pouches are manufactured as follows.

[0153] The fiber and powder ingredients (except glidants) are blended for 2 minutes using a planetary Bear Varimixer mixer. The nicotine premix is ​​then added and blended for 2 minutes. Water is then added and blended for 5 minutes, followed by liquid flavors (if present, blended for 1 minute) and glidants (if present, blended for 1 minute). Total blend time is 9-11 minutes.

[0154] [Table 10]

[0155] Pouch contents: 500mg total. The applied isomalt DC is for example GalenIQ™ 720. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers, such as water-insoluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber and powdered cellulose can be used as well.

[0156] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0157] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0158] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0159] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0160] 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.

[0161] Example 3C - Pouch Pouches PPC21 to PPC25 are produced in the same manner as pouches PPC11 to PPC15 of Example 3B.

[0162] [Table 11]

[0163] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers, such as water-insoluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber and powdered cellulose can be used as well.

[0164] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0165] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0166] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0167] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0168] 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.

[0169] Pouches PPC23-PPC26 show the use of various amounts of buffering agent (here sodium carbonate). With more basic buffering agent to achieve a more alkaline environment, the need for a preservative (here potassium sorbate) is reduced and therefore omitted in PPC25-PPC26 which have the highest amount of alkaline buffering agent.

[0170] Example 3D-Pouch Pouches PPC31-PPC32 are prepared similarly to pouches PPC1-PPC5 of Example 3A, but using Nicotine Premix I and III, respectively.

[0171] Pouches PPC31 to PPC35 are manufactured as follows. Weigh out the nicotine and sugar alcohol (xylitol, sorbitol, maltitol, etc.). Slowly add the nicotine to the sugar alcohol powder while stirring (Kitchenaid mixer operates at about 30 RPM for about 30 minutes). Sift the resulting granules and place on a tray. Dry the resulting powder overnight at ambient temperature and then sieve to obtain the nicotine-sugar alcohol premix. It is also possible to add a certain amount of water to the nicotine before mixing with the sugar alcohol. Such water will then evaporate during drying.

[0172] The fiber and water are mixed for 5 minutes using a planetary Bear Varimixer mixer. The following ingredients are then added successively with continuous mixing: powder ingredients except for the nicotine premix (mixed for 2 minutes), the nicotine-sugar alcohol premix (mixed for 2 minutes), then the liquid flavoring (if present) (mixed for 1 minute), and finally the glidant (if present) (mixed for 1 minute). The total mixing time is 9-11 minutes.

[0173] The final powder composition is filled into pouches (target fill weight pouch of 500 mg powder). The pouch membrane of Example 1A made from long fiber paper is used. The powder is filled into the pouch and kept in the pouch by sealing. A pouched product was also produced using the pouch membrane of Example 1B.

[0174] [Table 12]

[0175] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers, such as water-insoluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber and powdered cellulose can be used as well.

[0176] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0177] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0178] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0179] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0180] Pouches PPC31-PPC32 demonstrate the use of other nicotine premixes. Pouches PPC33 to PPC35 demonstrate the use of nicotine pre-mixed with different sugar alcohols.

[0181] Pouches PPC36-PPC37 demonstrate the use of nicotine premixed with different soluble fibers. Example 3E-Pouch Pouches PPC41 to PPC46 are manufactured in the same manner as pouches PPC1 to PPC5 of Example 3A.

[0182] [Table 13]

[0183] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers, such as water-insoluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber and powdered cellulose can be used as well.

[0184] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0185] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0186] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0187] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0188] Pouches PPC41 to PPC44 represent the use of different doses of nicotine, ranging from 4.8 mg to 12 mg. Pouch PPC45 denotes a pouch that does not contain alginate but otherwise corresponds to pouch PPC43.

[0189] Pouch PPC46 represents a pouch that combines two sugar alcohols. Example 3F - Pouch Pouches PPC51 to PPC55 are manufactured as follows.

[0190] The fiber and powder ingredients (except the nicotine powder and glidant) are mixed for 1 minute using a planetary Bear Varimixer mixer. The NPR and NBT are then added and mixed for 2 minutes (if applicable). The nicotine premix is ​​then added and mixed for 2 minutes. Water is then added and mixed for 5 minutes, followed by the liquid flavors (if present and mixed for 1 minute) and glidants (if present and mixed for 1 minute). The total mixing time is 9-11 minutes.

[0191] The final powder composition is filled into pouches (target fill weight pouch of 500 mg powder). The pouch membrane of Example 1A made from long fiber paper is used. The powder is filled into the pouch and kept in the pouch by sealing. A pouched product was also produced using the pouch membrane of Example 1B.

[0192] [Table 14]

[0193] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers, such as water-insoluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber and powdered cellulose can be used as well.

[0194] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0195] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. Sodium carbonate is used as an alkaline buffer, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0196] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0197] The high-intensity sweetener may be, for example, acesulfame potassium. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium or as a substitute for acesulfame potassium.

[0198] Pouch PPC51 represents a pouch that uses a nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT). Pouch PPC52 represents a pouch that uses a nicotine-ion exchange resin premix in combination with nicotine polacrilex resin (NPR).

[0199] Pouch PPC53 represents a pouch that uses a nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT) and nicotine polacrilex resin (NPR).

[0200] Example 3G-Pouch Pouches PPC61-PPC65 containing nicotine premixes were prepared containing the powdered compositions as outlined in Table 11. The pouches are manufactured as follows.

[0201] The fiber and powder ingredients (except for the glidant) are mixed for 2 minutes using a Loedige mixer. The nicotine premix is ​​then added and mixed for 2 minutes. Then, with the mixer running, the water is added and mixed for 15 minutes, followed by the liquid flavors (if present, mixed for 15 minutes) and the glidant (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

[0202] [Table 15]

[0203] Pouch contents: 500mg total. Wheat fiber, trade name "Vitacel® 600 WF Plus". Other fibers, such as water-insoluble vegetable fibers, for example, oat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bamboo fiber, bran fiber and powdered cellulose, can be used as well.

[0204] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0205] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. As humectants, sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used, and other humectants described herein may be used in combination with or as an alternative to sodium alginate, glycerol or HPC.

[0206] Sodium carbonate and sodium bicarbonate are used as alkaline buffers, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

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

[0208] Acesulfame potassium and / or sucralose can be used as high-intensity sweeteners, by way of example. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose or as a substitute for acesulfame potassium and / or sucralose.

[0209] Pouches PPC61-PPC62 demonstrate the use of different sweetener and buffer combinations. Pouches PPC63 to PPC64 represent pouches with different fiber contents. Pouches PPC65 to PPC67 show the use of different humectants.

[0210] Example 3H-Pouch Pouches PPC71-PPC76 containing nicotine premixes were prepared containing the powdered compositions as outlined in Table 12. The pouches are manufactured as follows.

[0211] The fiber and powder ingredients (except for the glidant) are mixed for 2 minutes using a Loedige mixer. The nicotine premix is ​​then added and mixed for 2 minutes. Then, with the mixer running, the water is added and mixed for 15 minutes, followed by the liquid flavors (if present, mixed for 15 minutes) and the glidant (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

[0212] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1 made from long fiber paper is used. The powder is filled into the pouch and maintained within the pouch by sealing.

[0213] [Table 16-1]

[0214] [Table 16-2]

[0215] 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".

[0216] Powdered cellulose, trade name "Vitacel® L00" or "Vitacel® L700G". Oat fiber, trade name "Vitacel® HF600".

[0217] Pea fiber, trade name "Vitacel(R) EF150". Other fibers that can be used similarly include 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, apple fiber, cocoa fiber, bamboo fiber, bran fiber, and powdered cellulose.

[0218] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0219] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. As humectants, sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used, and other humectants described herein may be used in combination with or as an alternative to sodium alginate, glycerol or HPC.

[0220] Sodium carbonate and sodium bicarbonate are used as alkaline buffers, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0221] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0222] Acesulfame potassium and / or sucralose can be used as high-intensity sweeteners, by way of example. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose or as a substitute for acesulfame potassium and / or sucralose.

[0223] Pouches PPC71 to PPC74 demonstrate the use of different nicotine premixes. Pouches PPC75 to PPC77 show the use of different fibers. Example 3I - Pouch Pouches PPC81-PPC92 containing nicotine premixes were prepared containing the powder compositions as outlined in Table 13. The pouches are manufactured as follows.

[0224] The fiber and powder ingredients (except for the glidant) are mixed for 2 minutes using a Loedige mixer. The nicotine premix is ​​then added and mixed for 2 minutes. Then, with the mixer running, the water is added and mixed for 15 minutes, followed by the liquid flavors (if present, mixed for 15 minutes) and the glidant (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

[0225] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1 made from long fiber paper is used. The powder is filled into the pouch and maintained within the pouch by sealing.

[0226] [Table 17]

[0227] [Table 18]

[0228] 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".

[0229] Powdered cellulose, trade name "Vitacel® L00" or "Vitacel® L700G". Oat fiber, trade name "Vitacel® HF 600".

[0230] Pea fiber, trade name "Vitacel(R) EF150". Other fibers that can be used similarly include 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, apple fiber, cocoa fiber, bamboo fiber, bran fiber, and powdered cellulose.

[0231] For example, a mixture of menthol and peppermint can be used. Of course, other flavors described herein can be used in combination with or in place of the menthol and / or peppermint as well.

[0232] Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, talc, etc. As humectants, sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used, and other humectants described herein may be used in combination with or as an alternative to sodium alginate, glycerol or HPC.

[0233] Sodium carbonate and sodium bicarbonate are used as alkaline buffers, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

[0234] Potassium sorbate is used as a preservative, and other preservatives described herein may also be used in combination with or as a substitute for potassium sorbate.

[0235] Acesulfame potassium and / or sucralose can be used as high-intensity sweeteners, by way of example. Other usable high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose or as a substitute for acesulfame potassium and / or sucralose.

[0236] Pouches PPC81 to PPC92 show the use of different fibers, different amounts and different nicotine premixes. Pouches PPC93-PPC94 demonstrate the use of buffer pairs and large amounts of salt, respectively.

[0237] Example 3J-Pouch Nicotine premix-containing pouches, Comparative 10 (Comp. 10), PPC101, PPC102, were prepared with the powdered compositions as outlined in Table 14. The pouches are manufactured as follows.

[0238] The fiber and powder ingredients (except for the glidant) are mixed for 2 minutes using a Loedige mixer. The nicotine premix is ​​then added and mixed for 2 minutes. Then, with the mixer running, the water is added and mixed for 15 minutes, followed by the liquid flavors (if present, mixed for 15 minutes) and the glidant (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

[0239] The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of Example 1 made from long fiber paper is used. The powder is filled into the pouch and maintained within the pouch by sealing.

[0240] [Table 19]

[0241] 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".

[0242] Other fibers that can be used similarly include 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, apple fiber, cocoa fiber, bamboo fiber, bran fiber, and powdered cellulose.

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

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

[0245] Sodium carbonate and sodium bicarbonate are used as alkaline buffers, and other buffers described herein may be used in combination with or as a replacement for sodium carbonate.

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

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

[0248] Example 4A - Nicotine Application to Pouch Membrane The nicotine pouches were placed in a closed treatment container at a temperature of about 25° C. The temperature of the nicotine pouches was kept constant for 14 days while the container remained sealed.

[0249] After 14 days of treatment, the containers were opened and the pouch membrane and pouch composition were examined for nicotine content. Example 4B - Application of Nicotine to Pouch Membrane The pouched products were soaked in liquid nicotine (diluted with propylene glycol to approximately 20% nicotine concentration) and the nicotine was applied to the pouch membrane.

[0250] The soaking process lasted for approximately 5 minutes. The pouch membrane and pouch composition were then tested for nicotine content. Example 4C - Application of Nicotine by Spray A liquid nicotine solution (diluted with propylene glycol to approximately 20% nicotine concentration) was applied to the pouched products by spraying.

[0251] The pouched product was then allowed to dry at ambient conditions for approximately 10 minutes. The pouch membrane and pouch composition were then tested for nicotine content.

[0252] Example 4D - Pouch Membrane Pouched products were made using different pouch membranes with pouch composition PPC55. PPC55-A was made with a pouch membrane having fibers consisting essentially of regenerated cellulose (viscose) and processed according to Example 4A. PPC55-B was made with a pouch membrane having fibers that were a combination of regenerated cellulose (viscose) and synthetic fibers and processed according to Example 4A. PPC55-C was made with a pouch membrane having fibers that were a combination of viscose and synthetic fiber materials and processed according to Example 4A. The fiber composition of the pouch membrane of PPC55-C was different from that of PPC55-B, with PPC55-C having a slightly denser composition.

[0253] Example 5A - Nicotine Application to Pouch Membrane The pouched product was produced according to Example 4A using the pouch composition PPC44 of Example 3E. The obtained pouched product was examined for the nicotine content in the pouch membrane. Of the total nicotine amount in the pouched product of about 12 mg added to the pouch composition during production, the processed pouched product contains about 8.5 mg nicotine in the pouch composition and about 3.5 mg nicotine in the pouch membrane, which corresponds to about 29% by weight of the total amount of nicotine. The pouch membrane had a weight corresponding to about 12% by weight of the pouched product when the pouched product was produced.

[0254] Example 5B - Nicotine Release Next, the pouch composition and pouch membrane of the processed pouch PPC44 of Example 5A are tested separately to evaluate the amount of nicotine released.In the in vitro experiment according to Example 5F, it is observed that the pouch composition itself (without pouch membrane) releases about 40% by weight of its nicotine content at 10 minutes.The pouch membrane itself releases about 92% by weight at 10 minutes when the corresponding test is applied.This confirms that the nicotine of the pouch membrane is released much faster and more effectively than the nicotine of the pouch composition.

[0255] Example 5C - Treatment Time Pouched products of PPC44, PPC54, and PPC55 were treated according to Example 4A. At 0, 1, 4, and 7 days after the start of treatment, each of the pouched products of PPC44, PPC54, and PPC55 was tested for the content of nicotine in the pouch membrane. The results are shown in Table 15.

[0256] [Table 20]

[0257] As can be seen from Table 15, the amount of nicotine in the pouch membrane can be altered by adjusting the nicotine source and by adjusting the treatment time. Longer treatment times result in higher amounts of nicotine in the pouch membrane. Also, replacement of Nicotine Premix II (PPC44) with Nicotine Premix VI (PPC55) results in significantly faster and more efficient delivery of nicotine to the pouch membrane.

[0258] Example 5D - Release from Pouched Products Similarly, the in vitro release from the pouched products of PPC44, PPC54 and PPC55 was tested at 0, 1, 4 and 7 days after the start of treatment. The results of nicotine release from the pouched products at 10 minutes are shown in Table 16.

[0259] [Table 21]

[0260] As shown in Table 16, the application of nicotine to the pouch membrane clearly leads to a more efficient release of nicotine from the pouched product. The longer the treatment time, the more nicotine is applied to the pouch membrane. As shown above, the extremely high release rate of 92% from the pouch membrane indicates that the increased amount of nicotine in the pouch membrane through treatment leads to a more efficient release of nicotine from the pouched product.

[0261] Example 5E - 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.

[0262] After 2, 5, 10, 30, or 60 minutes, the pouch was removed from the subject's mouth. The amount of nicotine remaining in the pouch was measured using standard HPLC techniques.

[0263] Two pouches were tested at each time point, and the average of the results obtained at each time point was used to generate a profile of the nicotine content in the pouch over time. The amount of nicotine released was then obtained by subtracting the amount of nicotine remaining in the pouch from the initial dose of nicotine in the pouch tested.

[0264] Example 5F - Release Testing (In Vitro) The release properties of the pouches were verified in an in vitro experiment. At a temperature of T=37° C., each pouch was placed in a reaction tube containing 10 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4).

[0265] No stirring or shaking was performed during the release experiments. The pouch was removed from the buffer after 2, 5, 10, 30, and 60 minutes. The wet pouch was allowed to drip, and then the pouch was gently pulled over the edge of the reaction tube to remove excess buffer associated with the wet pouch.

[0266] The amount of nicotine remaining in the pouch was determined using standard HPLC techniques. Two pouches were tested at each time point, and the average of the results obtained at each time point was used to generate a profile of the nicotine content in the pouch over time.

[0267] The amount of nicotine released was then obtained by subtracting the amount of nicotine remaining in the pouch from the initial dose of nicotine in the pouch tested. Example 5H - Release from pouches with different pouch membranes The release of nicotine from pouched products PPC55-A, PPC55-B and PPC55-C according to Example 4D was tested according to the method of Example 5F. The results are shown in Table 17.

[0268] [Table 22]

[0269] Pouches PPC55-A, PPC55-B and PPC55-C were also tested for nicotine content in the pouch membrane prior to release testing. The pouch membrane of pouched product PPC55-A had a nicotine content of 22.4% by weight of the total nicotine content in the pouched product. The pouch membrane of pouched product PPC55-B had a nicotine content of 19.0% by weight of the total nicotine content in the pouched product. The pouch membrane of pouched product PPC55-C had a nicotine content of 29.7% by weight of the total nicotine content in the pouched product.

[0270] These results indicate that the pouch membrane material influences both the amount of nicotine that can be accommodated in the pouch membrane and, in turn, the amount of nicotine released during the study. In particular, it has been shown that the use of a viscose-based pouch membrane (i.e., a pouch membrane with fibers consisting essentially of viscose, PPC55-A) resulted in significantly higher release, especially at the earliest time points, compared to pouch membranes that contained both viscose and synthetic fibers (PPC55-B and PPC55-C).

[0271] Example 5I - Nicotine Content in Pouch Membrane The nicotine content in the pouch membrane of the pouched products Comp. 10, PPC101 and PPC102 processed according to Example 4A was measured at a shortened time period. Tests were performed one day after processing and the average results are shown in Table 18.

[0272] [Table 23]

[0273] The results in Table 18 demonstrate that having a high moisture content in the pouch composition promotes effective dispensing of nicotine into the pouch membrane. The test results of PPC101 show that the nicotine content in the pouch membrane increases significantly during the initial measurement, and complete treatment is not yet achieved. Example 4A shows a treatment period of 14 days until the desired level of nicotine in the membrane is achieved. Nevertheless, the treatment time can be highly dependent on, for example, the amount of water.

Claims

1. A nicotine pouch product comprising: A pouch composition; a pouch membrane enclosing the pouch composition; Including, The pouch composition comprises: At least one water insoluble fiber; Water in an amount of at least 15% by weight of the composition; Nicotine and Including, A nicotine pouched product, wherein the pouch membrane further comprises nicotine in an amount of at least 15% by weight of the total nicotine content in the pouched product.

2. 10. The nicotine pouched product of claim 1, wherein the at least one water insoluble fiber is provided as a powder and the pouch membrane comprises at least one additional water insoluble fiber.

3. 3. The nicotine pouched product of claim 1 or claim 2, wherein at least 15% by weight of the total nicotine content in the pouched product is released within a period of 120 seconds or less upon oral administration.

4. 4. The nicotine pouched product of claim 1, wherein 15-40% by weight of the total nicotine content in the pouched product is released within a period of not more than 120 seconds upon oral administration.

5. 5. The nicotine pouched product of any one of claims 1 to 4, wherein the nicotine in the pouched product is selected from a nicotine salt, free base nicotine mixed with an ion exchange resin, free base nicotine complexed with an ion exchange resin, free base nicotine mixed with a soluble composition such as a sugar alcohol or a water soluble fiber, nicotine associated with a fatty acid such as oleic acid, and any combination thereof.

6. 6. The nicotine pouched product of any one of claims 1 to 5, wherein the nicotine of the pouched product does not consist of nicotine chemically bound to a carrier, such as an ion exchange resin, such as polacrilex resin.

7. 7. The nicotine pouched product of any one of claims 1 to 6, wherein the nicotine in the pouched product does not consist of a nicotine salt.

8. 8. The nicotine pouched product of any one of claims 1 to 7, wherein the nicotine in the pouched product is selected from a nicotine salt, free base nicotine mixed with an ion exchange resin, free base nicotine mixed with a soluble composition such as a sugar alcohol or a water soluble fiber, nicotine in association with a fatty acid such as oleic acid, and any combination thereof.

9. 9. A nicotine pouched product according to any one of claims 1 to 8, wherein the nicotine in the pouched product is free base nicotine mixed with an ion exchange resin.

10. 10. The nicotine pouched product of any one of claims 1 to 9, wherein the pouch composition comprises a sugar alcohol.

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

12. 12. The nicotine pouched product of any one of claims 1 to 11, 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.

13. 13. The nicotine pouched product of any one of claims 1 to 12, wherein the sugar alcohol comprises a DC (directly compressible) grade sugar alcohol.

14. 14. The nicotine pouched product of any one of claims 1 to 13, wherein the pouched product comprises the pouch membrane in an amount of up to 20 percent by weight of the pouched product, such as up to 15 percent by weight of the pouched product.

15. 15. The nicotine pouched product of any one of claims 1 to 14, wherein the pouched product comprises the pouch membrane in an amount of 3 to 20 percent by weight of the pouched product, such as an amount of 5 to 15 percent by weight of the pouched product.

16. 16. The nicotine pouched product of any one of claims 1 to 15, wherein the pouch membrane comprises a non-woven or woven material.

17. 17. The nicotine pouched product of any one of claims 1 to 16, wherein the pouch membrane comprises a nonwoven membrane.

18. 18. A nicotine pouched product according to any one of claims 1 to 17, wherein the pouch membrane comprises fibres, the fibres of the pouch membrane comprising cellulose in an amount of at least 60% of the fibres, such as at least 80% of the fibres.

19. 19. The nicotine pouched product of any one of claims 1 to 18, wherein the pouch membrane is uncoated.

20. 20. The nicotine pouched product of any one of claims 1 to 19, wherein the pouch membrane comprises a coating, such as a non-fibrous coating.

21. 21. The nicotine pouched product of any one of claims 1 to 20, wherein the amount of nicotine located in the pouch membrane is 15-50% by weight of the total nicotine content in the pouched product, such as 15-35% by weight of the total nicotine content in the pouched product.

22. 22. The nicotine pouched product of any one of claims 1 to 21, wherein the amount of nicotine located in the pouch membrane is at least 20% by weight of the total content of nicotine in the pouched product, such as at least 25% by weight of the total content of nicotine in the pouched product.

23. 23. The nicotine pouched product of any one of claims 1 to 22, wherein the amount of nicotine located in the pouch membrane is 20-50% by weight of the total content of nicotine in the pouched product, such as at least 25-50% by weight of the total content of nicotine in the pouched product.

24. 24. The nicotine pouched product of any one of claims 1 to 23, wherein the additional nicotine in the pouch membrane is provided by processing nicotine from the pouch composition into the pouch membrane.

25. 25. The nicotine pouched product of any one of claims 1 to 24, wherein the nicotine of the pouch membrane is applied to the pouch membrane by film coating or spraying.

26. 26. A nicotine pouched product according to any one of claims 1 to 25, wherein the nicotine of the pouch membrane is applied to the pouch membrane by immersing the pouched product in liquid nicotine, such as diluted liquid nicotine.

27. 27. The nicotine pouched product of any one of claims 1 to 26, wherein additional nicotine is applied to the pouch membrane during manufacture of the pouch membrane.

28. 28. A nicotine pouched product according to any one of claims 1 to 27, wherein the nicotine in the pouch composition is in the same form as the further nicotine in the pouch membrane.

29. 29. The nicotine pouched product of any one of claims 1 to 28, wherein the water insoluble fibre of the base pouch composition is selected from water insoluble vegetable fibre, wheat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, apple fibre, cocoa fibre, bamboo fibre, bran fibre, powdered cellulose and any combination thereof.

30. A nicotine pouch filling composition according to any one of claims 1 to 29, wherein the water insoluble fibre is selected from oat fibre, wheat fibre, pea fibre, powdered cellulose, and any combination thereof.

31. 31. The nicotine pouched product of any one of claims 1 to 30, wherein the water insoluble fibre comprises MCC.

32. A nicotine pouched product according to any one of claims 1 to 31, wherein the water-insoluble fibre is powdered.

33. 33. A nicotine pouched product according to any one of the preceding claims, wherein the composition has a bulk density of at most 0.8g / cm3, such as at most 0.7g / cm3, such as at most 0.6g / cm3, such as at most 0.5g / cm3.

34. 34. A nicotine pouched product according to any one of claims 1 to 33, wherein the water insoluble fibre of the pouch composition has a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.

35. 35. The nicotine pouched product of any one of claims 1 to 34, wherein the pouch composition has a moisture content of 15 to 70% by weight of the pouch composition, such as 15 to 50% by weight of the pouch composition, such as 15 to 40% by weight of the pouch composition, such as 15 to 30% by weight of the pouch composition, such as 15 to 25% by weight of the pouch composition.

36. 36. The nicotine pouched product of any one of claims 1 to 35, wherein the pouch composition has a moisture content of 60% or less by weight of the pouch composition, such as 50% or less by weight of the pouch composition, such as 40% or less by weight of the pouch composition, such as 30% or less by weight of the pouch composition.

37. 37. A nicotine pouched product according to any one of claims 1 to 36, wherein the pouch composition comprises water and water insoluble fibre in a weight ratio of 3.0 or less, such as 2.5 or less, such as 2.0 or less, such as 1.5 or less, such as 1.0 or less.

38. 38. The nicotine pouched product of any one of claims 1 to 37, wherein the pouch composition does not contain tobacco, tobacco fiber, or tobacco-derived fiber.

39. 39. A nicotine pouched product according to any one of claims 1 to 38, wherein the membrane of the pouch comprises water insoluble fibre of a different origin than the water insoluble fibre contained in the pouched product.

40. 40. The nicotine pouched product of any one of claims 1 to 39, wherein both the water-insoluble fiber of the membrane and the water-insoluble fiber of the pouch composition comprise natural fibers.

41. 41. The nicotine pouched product of any one of claims 1 to 40, wherein both the water-insoluble fibre of the membrane and the water-insoluble fibre of the pouch composition are natural fibres.

42. 42. The nicotine pouched product of any one of claims 1 to 41, wherein the composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof, and the composition comprises the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, such as 5 to 70% by weight of the pouch composition, such as 10 to 60% by weight of the pouch composition.

43. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises the sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition; and 43. The nicotine pouched product of any one of claims 1 to 42, wherein the composition further comprises water insoluble fibre in an amount of 5 to 50% by weight of the pouch composition, such as 10 to 30% by weight of the pouch composition.

44. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises the sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition; and 44. The nicotine pouch product of any one of claims 1 to 43, 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.

45. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises the sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition; and 45. The nicotine pouched product of any one of claims 1 to 44, wherein the water insoluble composition comprises or consists of a water insoluble fibre, such as a water insoluble vegetable fibre, such as wheat fibre, oat fibre, pea fibre, powdered cellulose, or a combination thereof, and the pouch composition comprises flavourant in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.1 to 15% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 3 to 10% by weight of the pouch composition.

46. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises the sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition; 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; 46. ​​The nicotine pouched product of any one of claims 1 to 45, 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, and the pouch composition comprises a flavourant in an amount of 0.01 to 15% by weight of the pouch composition, such as 0.1 to 15% by weight of the pouch composition, such as 1 to 10% by weight of the pouch composition, such as 3 to 10% by weight of the pouch composition, and the flavourant is oil based.

47. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises the sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition; 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; 47. The nicotine pouched product of any one of claims 1-46, 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.

48. the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof; the composition comprises the sugar alcohol in an amount of 1-80% by weight of the pouch composition, such as 5-70% by weight of the pouch composition, such as 10-60% by weight of the pouch composition; the composition further comprises water insoluble fiber in an amount of 5-50% by weight of the pouch composition, such as 10-30% by weight of the pouch composition; and 48. The nicotine pouched product of any one of claims 1 to 47, 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.

49. A nicotine pouch product comprising: A pouch composition; a pouch membrane enclosing the pouch composition; Including, The pouch composition comprises: At least one water insoluble fiber; Water in an amount of at least 15% by weight of the composition; Nicotine and and said pouch membrane further comprises at least 1.0 mg of nicotine.

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