Nicotine pouch products

Abstract

We provide nicotine-containing pouches as a cigarette substitute. [Solution] A nicotine pouch product comprising a pouch composition and a pouch membrane for enclosing the pouch composition, wherein the pouch composition comprises at least one water-insoluble fiber, at least 15% by weight of the composition in the amount of water and nicotine, and the pouch membrane comprises a further amount of nicotine at least 15% by weight of the total nicotine content in the pouch product.

Description

Technical Field

[0001] The present invention relates to a nicotine pouch composition as described in the claims.

Background Art

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

Summary of the Invention

Problems to be Solved by the Invention

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

[0004] Furthermore, a further problem related to the prior art may be that the pouch as a delivery vehicle for nicotine is somewhat costly, so there are limitations imposed on the method of designing the pouch in order to suppress manufacturing costs.

Means for Solving the Problems

[0005] The present invention relates to a nicotine pouched product, which comprises: a pouch composition, a pouch film enclosing the pouch composition, and 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 The pouch membrane further contains 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 the additional nicotine in the pouch membrane promotes relatively rapid nicotine release. As a result, the pouched product releases nicotine not only from the pouch composition but also from the pouch membrane itself. This significantly improves nicotine release compared to pouches containing nicotine only in the pouch composition.

[0007] Many conventional pouches have typically focused on the total amount of nicotine released within a 30 or 60-minute usage period. However, mitigating nicotine cravings is still not always optimal. Instead, by adding nicotine to the pouch membrane, the release of nicotine is increased, particularly in the first few minutes after use, thereby providing a much more desirable nicotine release and craving reduction. This benefit is achieved, for example, without requiring special modifications to the pouch composition, but rather by carefully distributing the nicotine in the pouch product so that at least some of the nicotine is located within the pouch membrane. Furthermore, since the nicotine dose can be distributed instead to the pouch composition and pouch membrane, this is achieved without requiring an increase in the total amount of nicotine.

[0008] A further advantage of the present invention may be that, by providing the combination of the claimed water content and the at least one water-insoluble fiber, a very desirable mouthfeel can be obtained without using tobacco. At the same time, having the claimed water content may facilitate a faster release, particularly within the first few minutes of use.

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

[0010] Furthermore, pouch-packaged products contain nicotine in both the pouch composition and the pouch membrane. Therefore, the nicotine in pouch-packaged products includes the nicotine in the pouch composition and the nicotine in the pouch membrane.

[0011] In a convenient embodiment of the present invention, the at least one water-insoluble fiber is provided as a powder, and the pouch membrane comprises at least one further water-insoluble fiber. In a favorable embodiment of the present invention, at least 15% by weight of the total nicotine content in the pouch-packaged product is released within a period of 120 seconds or less upon oral administration.

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

[0013] The above in vitro method is described in more detail in Example 5F. In a convenient embodiment of the present invention, 15 to 40% by weight of the total nicotine content in the pouch-packaged product is released within a period of 120 seconds or less upon oral administration.

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

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

[0016] In a convenient embodiment of the present invention, the nicotine in the pouch-packaged product is selected from nicotine salts, free base nicotine mixed with an ion exchange resin, free base nicotine forming a complex 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 fatty acids such as oleic acid, and any combination thereof.

[0017] In a convenient embodiment of the present invention, the nicotine in the pouch-packaged product is not composed of nicotine chemically bonded to a carrier such as an ion-exchange resin such as Polarcrilex resin.

[0018] Therefore, in the above embodiments, the nicotine in the pouch-packaged product can be obtained from any source, except for the nicotine chemically bound to the carrier. In particular, the above embodiments do not include the case where all the nicotine is bound to an ion exchange resin such as Polarcrylex resin. On the other hand, the above embodiments include at least some nicotine that may or may not be bound to the carrier, as long as this binding is physical and not chemical.

[0019] In a convenient embodiment of the present invention, the nicotine in the pouch-packaged product is not composed of nicotine salts. In one embodiment of the present invention, the nicotine in the pouch-packaged product does not contain nicotine salts.

[0020] In one embodiment of the present invention, the nicotine in the pouch-packaged product does not contain nicotine bicarbonate. In one embodiment of the present invention, the nicotine in the pouch-packed product is not composed of nicotine bitartrate.

[0021] In a preferred embodiment of the present invention, the nicotine in the pouch-packed 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 a water-soluble fiber, nicotine associated with a fatty acid such as oleic acid, and any combination thereof.

[0022] In a preferred embodiment of the present invention, the nicotine in the pouch-packed product is free base nicotine mixed with an ion exchange resin. In one embodiment of the present invention, the nicotine in the pouch-packed product includes free base nicotine mixed with an ion exchange resin.

[0023] In a preferred embodiment of the present invention, the free base nicotine includes free base nicotine mixed with an ion exchange resin, where the weight ratio between the free base nicotine and the ion exchange resin is 0.1 to 2.0, preferably 0.5 to 2.0, and most preferably about 0.67 to 1.0.

[0024] Here, the weight ratio means the ratio obtained by dividing the mass of the first component by the mass of the second component. The term "mixing ratio" may also be used. In one embodiment of the present invention, the nicotine in the pouch-packed product includes a nicotine salt or is a nicotine salt.

[0025] In one embodiment of the present invention, the nicotine in the pouch-packed product includes free base nicotine such as free base nicotine mixed with an ion exchange resin or is free base nicotine.

[0026] In a preferred embodiment of the present invention, the pouch composition includes a sugar alcohol. In a convenient embodiment of the present invention, the pouch composition contains a sugar alcohol in an amount such as at least 1% by weight of the composition, for example at least 2% by weight of the composition, for example at least 5% by weight of the composition, for example at least 10% by weight of the composition.

[0027] In one embodiment of the present invention, the pouch composition contains a sugar alcohol in an amount of 1 to 80% by weight of the composition, for example, 2 to 70% by weight of the composition, for example, 5 to 60% by weight of the composition, for example, 10 to 50% by weight of the composition.

[0028] In one embodiment of the present invention, the pouch composition contains a sugar alcohol in an amount of 5 to 40% by weight of the composition, for example, 5 to 30% by weight of the composition. In a convenient embodiment of the present invention, the sugar alcohol is selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed starch hydrolyzates, isomalt, or any combination thereof.

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

[0030] In one embodiment of the present invention, the sugar alcohol includes a non-DC (indirectly compressible) grade sugar alcohol. In a convenient embodiment of the present invention, the pouch product comprises the pouch film in an amount up to 20% by weight of the pouch product, for example, up to 15% by weight of the pouch product.

[0031] In a convenient embodiment of the present invention, the pouch-packaged product comprises the pouch membrane in an amount of 3 to 20 percent by weight of the pouch-packaged product, for example, 5 to 15 percent by weight of the pouch-packaged product.

[0032] In a preferred embodiment of the present invention, the pouch film comprises a nonwoven fabric material or a woven fabric material. In one embodiment of the present invention, the pouch film includes a nonwoven fabric film. In one embodiment of the present invention, the pouch film includes a woven fabric film.

[0033] In one embodiment of the present invention, the pouch film includes rayon fibers such as viscose. In one embodiment of the present invention, the fibers of the pouch membrane contain cellulose in an amount of at least 60% of the fibers, for example, at least 80% of the fibers.

[0034] In one embodiment of the present invention, the pouch membrane contains fibers, and the fibers of the pouch membrane contain cellulose in an amount of 60 to 100% by weight of the fibers, for example, 80 to 100% by weight of the fibers. In one embodiment of the present invention, the fibers of the pouch membrane are essentially made of cellulose.

[0035] In the context of the present invention, cellulose includes both natural cellulose, i.e., unmodified cellulose, and regenerated cellulose, such as rayon fibers. A higher cellulose content may promote the rapid release of nicotine from pouch products.

[0036] In one embodiment of the present invention, the pouch membrane contains fibers, and the fibers of the pouch membrane contain regenerated cellulose in an amount of at least 60% of the fibers, for example, at least 80% of the fibers. In one embodiment of the present invention, the pouch membrane contains fibers, and the fibers of the pouch membrane contain regenerated cellulose in an amount of 60 to 100% by weight of the fibers, for example, 80 to 100% by weight of the fibers.

[0037] In one embodiment of the present invention, the pouch film contains fibers, and the fibers of the pouch film contain rayon in an amount of at least 60% by weight of the fibers, for example, at least 80% by weight of the fibers. The rayon may contain, for example, viscose, or may consist of viscose.

[0038] In one embodiment of the present invention, the pouch film contains fibers, and the fibers of the pouch film contain rayon in an amount of 60 to 100% by weight of the fibers, for example, 80 to 100% by weight of the fibers. The rayon may contain viscose, or may consist of viscose.

[0039] In one embodiment of the present invention, the fibers of the pouch membrane are natural. In one embodiment of the present invention, the fibers of the pouch membrane do not contain synthetic fibers. In one embodiment of the present invention, the pouch film is not coated.

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

[0041] In a convenient embodiment of the present invention, the amount of nicotine located in the pouch membrane is 15 to 50% by weight of the total nicotine content in the pouch-packed product, for example, 15 to 35% by weight of the total nicotine content in the pouch-packed product.

[0042] In one embodiment of the present invention, the amount of nicotine located in the pouch membrane is 15 to 45% by weight of the total nicotine content in the pouch-packed product. In one embodiment of the present invention, the amount of nicotine located in the pouch membrane is 15 to 40% by weight of the total nicotine content in the pouch-packed product.

[0043] In one embodiment of the present invention, the amount of nicotine located in the pouch membrane is 15 to 30% by weight of the total nicotine content in the pouch-packed product. In one embodiment of the present invention, the amount of nicotine located in the pouch membrane is 20 to 50% by weight of the total nicotine content in the pouch product, for example 25 to 50% by weight of the total nicotine content in the pouch product, or for example 30 to 50% by weight of the total nicotine content in the pouch product.

[0044] In a favorable embodiment of the present invention, the amount of nicotine located in the pouch membrane is at least 20% by weight of the total nicotine content in the pouch-packed product, for example, at least 25% by weight of the total nicotine content in the pouch-packed product.

[0045] In a favorable embodiment of the present invention, the amount of nicotine located in the pouch membrane is 20 to 50% by weight of the total nicotine content in the pouch-packed product, for example, at least 25 to 50% by weight of the total nicotine content in the pouch-packed product.

[0046] In a convenient embodiment of the present invention, further nicotine in the pouch film is provided by processing nicotine from the pouch composition into the pouch film.

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

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

[0049] In one embodiment of the present invention, nicotine in the pouch film is applied to the pouch film before the pouch film is filled with the pouch composition. In a convenient embodiment of the present invention, additional nicotine is applied to the pouch film during the manufacturing of the pouch film.

[0050] In a convenient embodiment of the present invention, the nicotine in the pouch composition is in the same form as further nicotine in the pouch membrane. In a convenient embodiment of the present invention, the pouch composition has a water content of 15 to 70% by weight of the pouch composition, for example 15 to 65% by weight of the pouch composition, for example 15 to 50% by weight of the pouch composition, for example 25 to 50% by weight of the pouch composition, for example 30 to 40% by weight of the pouch composition.

[0051] In a convenient embodiment of the present invention, the pouch composition has a water content of 15 to 70% by weight of the pouch composition, for example 15 to 50% by weight of the pouch composition, for example 15 to 40% by weight of the pouch composition, for example 15 to 30% by weight of the pouch composition, for example 15 to 25% by weight of the pouch composition.

[0052] Water may be added as a separate component, either completely or partially mixed with other components such as fibers. For example, if free base nicotine is added as a mixture of free base nicotine with ion exchange resin and water, a significant amount of water in the final pouch composition will be obtained from the free base nicotine-ion exchange resin-water premixture. For example, if the final amount pouch composition contains 5% water from the free base nicotine-ion exchange resin-water premixture, up to one-third of the water in the pouch composition will be derived from the free base nicotine-ion exchange resin-water premixture.

[0053] In a convenient embodiment of the present invention, the pouch composition has a water content of 60% by weight or less of the pouch composition, for example, 50% by weight or less of the pouch composition, for example, 40% by weight or less of the pouch composition, for example, 30% by weight or less of the pouch composition.

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

[0055] The powdered cellulose within the scope of this invention is understood to be cellulose prepared by processing α-cellulose obtained as pulp from multiple types of fibrous plant materials, such as wood pulp.

[0056] In a convenient embodiment of the present invention, the water-insoluble fibers of the pouch composition are selected from oat fibers, wheat fibers, pea fibers, powdered cellulose, and any combination thereof.

[0057] In a convenient embodiment of the present invention, the water-insoluble fiber comprises MCC. In a convenient embodiment of the present invention, the water-insoluble fibers are in powder form. In a convenient embodiment of the present invention, the water-insoluble fibers of the pouch composition have a water-binding capacity of at least 200%, for example, at least 300%, for example, at least 400%.

[0058] An advantage of the above embodiment may be that a high water-binding capacity enables a pouch composition with a high water content. In one embodiment of the present invention, the water-insoluble fibers of the pouch composition have a water-binding capacity of 200% to 1500%, for example 300 to 1300%, for example 200 to 800%, for example 300 to 800%, for example 400 to 600%, etc.

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

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

[0061] In one embodiment of the present invention, the water-insoluble fiber has a swelling capacity of at least 5.0 mL / g, such as 5.0 to 20 mL / g. The advantage of the above embodiment is that the amount of water-insoluble fiber can be reduced without compromising the mouthfeel during use. When a certain amount of water-insoluble fiber replaces a water-soluble component, the swelling of the water-insoluble fiber will prevent the dissolution of the water-soluble component during use, but as a result, the user will not experience any reduction in the contents of the pouch during use.

[0062] In a favorable embodiment of the present invention, the composition has a bulk density of up to 0.8 g / cm³, a bulk density of, for example, up to 0.7 g / cm³, a bulk density of, for example, up to 0.6 g / cm³, or a bulk density of, for example, up to 0.5 g / cm³.

[0063] The use of the invention of a composition having a relatively low bulk density will not only provide a good mouthfeel, but will also provide effective release from the pouch, due to the fact that the relatively low bulk density promotes effective saliva secretion, thereby promoting the release of the water-soluble components of the composition. In particular, it should be noted that a low bulk density combined with the water content described in the claims is attractive when improved user perception is desired.

[0064] At the same time, low density also has the advantage of reducing the amount of raw materials used, thereby lowering manufacturing costs. An advantage of the embodiments described above is that a low-density composition can be obtained. Surprisingly, the combination of water and sugar alcohol did not result in a very dense, compact, and unprocessable pouch composition, but rather enabled a relatively lightweight and low-density composition.

[0065] In a convenient embodiment of the present invention, the pouch composition contains water and water-insoluble fibers in a weight ratio of 3.0 or less, for example 2.5 or less, for example 2.0 or less, for example 1.5 or less, for example 1.0 or less.

[0066] In a convenient embodiment of the present invention, the pouch composition does not contain tobacco, tobacco fibers, or tobacco-derived fibers. In some alternative embodiments, the pouch composition may contain a small amount of tobacco. Nicotine, provided as part of tobacco, such as in powdered tobacco, is further added to free base nicotine. Such tobacco may be included, for example, to provide tobacco flavor.

[0067] In one embodiment, the pouch composition may contain tobacco, tobacco fibers, or tobacco-derived fibers in an amount of 0.1 to 5.0% by weight of the pouch composition, for example, 0.1 to 3.0% by weight of the pouch composition. Therefore, in some embodiments, the pouch composition may contain a small amount of tobacco, but this is added to free base nicotine, and therefore the pouch composition is not tobacco-based.

[0068] In one embodiment of the present invention, the pouch composition contains, for example, no tobacco, for example, less than 0.1% by weight of the pouch composition, for example less than 0.5% by weight of the pouch composition, for example less than 1.0% by weight of the pouch composition, for example 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 present invention, the water-insoluble composition does not contain tobacco, tobacco fibers, or tobacco-derived fibers. Therefore, in this embodiment, the water-insoluble fibers are non-tobacco fibers, that is, they do not contain tobacco, tobacco fibers, or tobacco-derived fibers.

[0070] In one embodiment of the present invention, the membrane includes water-insoluble fibers of a different origin from the water-insoluble fibers contained in the pouch-packaged product. In one embodiment of the present invention, both the water-insoluble fibers of the membrane and the water-insoluble fibers of the pouch composition include natural fibers.

[0071] In one embodiment of the present invention, both the water-insoluble fibers of the membrane and the water-insoluble fibers of the pouch composition are natural fibers. In a convenient embodiment of the present invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof, wherein the composition comprises the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example 5 to 70% by weight of the pouch composition, for example 10 to 60% by weight of the pouch composition.

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

[0073] In a convenient embodiment of the present invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof. The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fibers in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, The water-insoluble composition includes or consists of water-insoluble fibers, such as water-insoluble plant fibers, including, for example, wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof.

[0074] In a convenient embodiment of the present invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof. The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fibers in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, The water-insoluble composition includes or consists of water-insoluble plant fibers such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or a combination thereof, wherein the pouch composition contains flavorings in an amount of 0.01 to 15% by weight of the pouch composition, for example 0.1 to 15% by weight of the pouch composition, for example 1 to 10% by weight of the pouch composition, for example 3 to 10% by weight of the pouch composition.

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

[0076] In a convenient embodiment of the present invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof. The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition. The composition further contains water-insoluble fibers in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, The pouch composition contains 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, pentasodium 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 a convenient embodiment of the present invention, the pouch composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof. The composition contains the sugar alcohol in an amount of 1 to 80% by weight of the pouch composition, for example, 5 to 70% by weight of the pouch composition, for example, 10 to 60% by weight of the pouch composition, The composition further contains water-insoluble fibers in an amount of 5 to 50% by weight of the pouch composition, for example, 10 to 30% by weight of the pouch composition, The pouch composition contains a pH control agent, such as a basic buffer and / or a basic pH control agent, such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

[0078] In a second embodiment, the present invention relates to a nicotine pouch product, wherein the nicotine pouch product is: Pouch composition and A pouch membrane that encloses the pouch composition, Includes, Pouch composition: At least one water-insoluble fiber, Water in an amount of at least 15% by weight of the composition, Nicotine and, The pouch membrane contains at least 1.0 mg of nicotine.

[0079] In one embodiment of the present invention, a nicotine pouch product of the second embodiment is devised according to the first embodiment or any embodiment of the present invention. [Modes for carrying out the invention]

[0080] As used herein, the term "nicotine" refers to nicotine used as a purified / isolated substance. In particular, nicotine does not refer to tobacco material containing 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 containing nicotine. The terms “nicotine pouch composition” and “pouch composition” are used interchangeably. A pouch composition is not a tobacco-based pouch composition. In some embodiments, a pouch composition may contain, for example, a small amount of tobacco (less than 2% by weight) as a flavoring agent. In other embodiments, the pouch composition does not contain tobacco.

[0082] As used herein, the term “free base nicotine” refers to nicotine in a non-protonated form and therefore does not include nicotine salts or nicotine offered as a complex of nicotine with an ion-exchange resin. However, free base nicotine may be mixed with a certain amount of ion-exchange resin or a water-soluble composition such as a sugar alcohol or water-soluble fiber. Free base nicotine may also be mixed with a water-insoluble composition such as a water-insoluble fiber. Free base nicotine includes both free base nicotine extracted from tobacco and free base nicotine produced by synthesis, but free base nicotine is not offered in the form of tobacco or powdered tobacco. Typically, free base nicotine is offered as a liquid.

[0083] As used herein, the term “pouch membrane” is intended to refer to the material forming a container enclosing a cavity. The pouch membrane is designed for oral administration of nicotine and is therefore suitable for oral use, 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 cloth. The pouched product may be sealed, for example, by bonding two corresponding parts of a web or cloth together along their edges to form a cavity for nicotine and a non-water-soluble composition. To release nicotine, flavorings, and other water-soluble substances, the pouch membrane is water-permeable so that saliva from the oral cavity penetrates the pouch membrane, there comes into contact with the nicotine, and also enters the cavity, there comes into contact with 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 "powdered composition" refers to a composition in powder form, i.e., a composition as particulate matter having a relatively small particle size, for example, 1 to 1200 micrometers. In particular, "powdered composition" does not mean powdered tobacco.

[0085] As used herein, the term “humectant” is understood to mean a wetting agent used to attract moisture or water in the form of saliva. Humidants typically include compositions that are appropriately hygroscopic. In some cases, humectants may also be referred to as moisturizers because of their role in attracting moisture. Examples of humectants include glycerol, propylene glycol, arginate, pectin, xanthan gum, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), and others.

[0086] As used herein, the term “water-soluble” refers to a relatively high water solubility, for example, the 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 composition or substance “solubility,” water solubility is assumed unless otherwise specified.

[0087] As used herein, the term “water-insoluble” refers to a relatively low level of water solubility, for example, less than 0.1 grams per 100 mL of water when measured at 25 degrees Celsius and a pH of 7.0. When “insoluble” is used, it means water-insoluble unless otherwise specified.

[0088] Typically, the pouch membrane includes an opening, and the characteristic opening dimensions are adapted to the characteristic dimensions of the pouch composition to retain the pouch composition inside the pouch before use and / or retain a portion of the pouch composition, such as a water-insoluble composition, inside the pouch during use.

[0089] In order to obtain a pouch membrane with suitable opening dimensions considering the pouch composition to be used, the material of the pouch membrane, including, for example, woven fabric and / or nonwoven fabric, can be appropriately selected. In other words, according to various embodiments, the pouch membrane allows the passage of saliva while preventing or blocking the passage of undissolved compositions and water-insoluble fibers. The pouch membrane may 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. An example of a suitable material for the pouch membrane is paper made of pulp and a small amount of wetting enhancer. Suitable materials must provide a semipermeable membrane layer to prevent powder or composition from leaking out of the bag or pouch during use. Suitable materials also do not significantly affect the release of nicotine from the pouch.

[0090] More specifically, with respect to materials, the pouch membrane can be a natural, synthetic, or semi-synthetic hydrophilic or hydrophobic membrane. It can be manufactured from one or more biocompatible and physiologically acceptable polymeric materials. Examples of suitable materials for the pouch membrane include cellulose acetate and its derivatives, carboxymethylcellulose, polycellulose esters, ethylcellulose, propylcellulose and other cellulose derivatives, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinyl acetate, methacrylate and acrylate polymers, natural rubber, polycarbonate, polyethylene terephthalate, polyester, polyamide, and nylon. Other suitable materials are mentioned earlier herein.

[0091] Rayon fibers (i.e., regenerated cellulose), such as viscose rayon fibers, can also be used in combination with acrylic polymers, for example, which act as binders in nonwoven materials and provide heat sealing of the pouch film during their manufacture. Other binders, such as copolymers of one or more vinyl acetates and acrylic acid esters, may also be used.

[0092] Suitable pouch membranes are available for the following product names: Taboka, CatchDry, Ettan, General, Granit, Goteborgs Rape, GrovSnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf, TreAnkrare, Camel Snus Original, Camel Snus Frost, and Camel Snus Spice. The pouch membrane provides a type of liquid-permeable container that can be considered to be similar in properties to the mesh-type material used in the construction of tea bags. The desired components of the nicotine composition to be released diffuse into the user's mouth through the pouch membrane.

[0093] The pouch membrane material may take the form of a mesh, sieve, perforated paper, or permeable cloth. For example, a pouch material made from mesh-like rice paper or perforated rice paper may dissolve in the user's mouth. In some exemplary embodiments, the pouch membrane material may be manufactured using those materials in combination with materials such as water-dispersible film-forming materials (e.g., binders such as arginate, carboxymethylcellulose, xanthan gum, and pullulan) and pulverized cellulose derivatives (e.g., fine-particle wood pulp). A preferred pouch material may be water-dispersible or soluble, but designed and manufactured so that under normal use conditions, a considerable amount of nicotine content permeates the pouch material before the time it takes for the pouch to lose its physical integrity. If desired, flavorings, disintegrants, and other desired components 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 granted to Kjerstad. Fleece materials for use as pouch membranes are described, for example, in International Publication No. 2008 / 152469, British Patent No. 673,587, and European Patent No. 2692254, which are incorporated herein by reference.

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

[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 a pouch-packaged product as part of the pouch composition, for example, as a sweetener, as a water-retaining agent, or as a carrier or part thereof. Suitable sugar alcohols include those selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed hydrogenated starch, isomalt, or any combination thereof.

[0098] In one embodiment of the present invention, the pouch composition contains a high-intensity sweetener. Preferred high-intensity sweeteners, used alone or in combination, include, but are not limited to, sucralose, aspartame, acesulfame salts such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcone, thaumatin, monellin, and stevioside.

[0099] In one embodiment of the present invention, the pouch composition contains a sugar and / or a sugar-free sweetener, such as a sugar alcohol. In one embodiment of the present invention, the pouch composition contains a sugar and / or sugar-free sweetener 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 or 5 to 25% by weight of the pouch composition. In some other embodiments, the sugar and / or sugar-free sweetener constitutes 10 to 60% by weight or 10 to 50% by weight of the pouch composition. The sugar and / or sugar-free sweetener may function not only as a sweetener but also as a water-retaining agent. In some embodiments, the approximate amount of the sugar and / or sugar-free sweetener can be further limited by including certain components. In some embodiments, the content of sugars and / or sugar-free sweeteners in the pouch composition is 20% by weight or less of the pouch composition, for example, 15% by weight or less of the pouch composition, for example, 10% by weight or less of the pouch composition, for example, 5% by weight or less of the pouch composition.

[0100] Sweeteners can often enhance the flavor profile of a pouch composition. Common sugar sweeteners include, but are not limited to, sugar-containing components commonly known in the pouch industry, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levose, galactose, solid corn syrup, glucose syrup, and hydrogenated glucose syrup, either alone or in combination. These sugar sweeteners may also be included as water-retaining agents.

[0101] Sweeteners can be used in combination with sugarless sweeteners. Generally, sugarless sweeteners contain sugar-free components that have sweetening properties but are not commonly known, and may include, alone or in combination with, sugar alcohols such as sorbitol, mannitol, xylitol, hydrolyzed hydrogenated starch, maltitol, isomalt, erythritol, and lactitol. These sugarless sweeteners may also be included as hydrating agents.

[0102] In embodiments 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 present invention, the pouch composition contains a flavoring agent. The flavoring agent may typically be present in an amount of 0.01 to 15% by weight of the total composition of the pouch, for example, 0.01 to 5% by weight of the total composition. In an alternative embodiment, the pouch composition may not contain a flavoring agent.

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

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

[0106] The release-controlled composition 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 animal fats), polyethylene glycol, polyoxyethylene monostearate, animal fats, silicates, silicon dioxide, talc, magnesium stearate, calcium stearate, fumed silica, powdered hydrogenated cottonseed oil, emulsifiers, hydrogenated soybean oil, and mixtures thereof, according to various embodiments. In particular, metal stearates such as magnesium stearate may be advantageous.

[0107] The release control composition can be added to the pouch composition in various ways. For example, the release-controlled composition may be added by the full powder mixture during the last few minutes of the final mixing.

[0108] Alternatively, the release control composition may be added after the granulation step of the granulation premix. Furthermore, the release control composition may be added only as part of the pouch composition to obtain two different nicotine release profiles. Additionally, two or more pouch compositions may contain different amounts of the release control composition, if any, thereby providing more complex and tuned nicotine release profiles.

[0109] Release control compositions such as magnesium stearate may have a sealing effect and can be used to control nicotine release and pouch solubility. [Examples]

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

[0111] The powdered pouch composition is filled into a cavity formed by the pouch membrane and maintained inside the pouch by sealing. Pouches that are not in the form of nonwoven cellulose cloth can also be used according to the present invention.

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

[0113] The powdered pouch composition is filled into a cavity formed by the pouch membrane and maintained inside the pouch by sealing. Example 2A - Nicotine Premix I - Resin Water was added to a Stephan mixer (vacuum premixer), nicotine was weighed and added, the mixer was closed and stirred for 5 minutes. Next, ion exchange resin Amberlite (registered trademark) IRP64 was weighed and added to the mixer. The mixer was closed and stirred for 10 to 60 minutes.

[0114] As a result, a mixture of nicotine and cation exchange resin was produced from the components listed in Table 1 below.

[0115] [Table 1]

[0116] Example 2B - Nicotine Premix II - Resin Water was added to a 60-liter planetary Bear Varimixer, and weighed nicotine was added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, weighed Amberlite® IRP64 ion exchange resin was added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, then opened and scraped off if necessary. Finally, the mixer was stirred at high speed for another 5 minutes.

[0117] As a result, a mixture of nicotine and cation exchange resin was produced from the components listed in Table 2 below.

[0118] [Table 2]

[0119] The total processing time was 20 minutes. Example 2C - Nicotine Premix III - Resin Water was added to a 60-liter planetary Bear Varimixer, and weighed nicotine was added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, weighed Amberlite® IRP64 ion exchange resin was added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, then opened and scraped off if necessary. Finally, the mixer was stirred at high speed for another 5 minutes.

[0120] As a result, a mixture of nicotine and cation exchange resin was produced from the components listed in Table 3 below.

[0121] [Table 3]

[0122] The total processing time was 20 minutes. Example 2D-Nicotine Premix IV-Resin Water was added to a 60-liter planetary Bear Varimixer, and weighed nicotine was added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, weighed Amberlite® IRP64 ion exchange resin was added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, then opened and scraped off if necessary. Finally, the mixer was stirred at high speed for another 5 minutes.

[0123] As a result, a mixture of nicotine and cation exchange resin was produced from the components listed in Table 4 below.

[0124] [Table 4]

[0125] The total processing time was 20 minutes. Example 2E-Nicotine Premix V-Resin Water was added to a 60-liter planetary Bear Varimixer, and weighed nicotine was added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, weighed Amberlite® IRP64 ion exchange resin was added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, then opened and scraped off if necessary. Finally, the mixer was stirred at high speed for another 5 minutes.

[0126] As a result, a mixture of nicotine and cation exchange resin was produced from the components listed in Table 4A below.

[0127] [Table 5]

[0128] The total processing time was 20 minutes. Example 2F-Nicotine Premix VI-Resin Water was added to a 60-liter planetary Bear Varimixer, and weighed nicotine was added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, weighed Amberlite® IRP64 ion exchange resin was added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, then opened and scraped off if necessary. Finally, the mixer was stirred at high speed for another 5 minutes.

[0129] As a result, a mixture of nicotine and cation exchange resin was produced from the components listed in Table 4B below.

[0130] [Table 6]

[0131] The total processing time was 20 minutes. Example 2G-Nicotine Premix VII-Resin Water was added to a 60-liter planetary Bear Varimixer, and weighed nicotine was added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, weighed Amberlite® IRP64 ion exchange resin was added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, then opened and scraped off if necessary. Finally, the mixer was stirred at high speed for another 5 minutes.

[0132] As a result, a mixture of nicotine and cation exchange resin was prepared from the components listed in Table 4C below.

[0133] [Table 7]

[0134] The total processing time was 20 minutes. Example 2: H-Nicotine Premix VIII - Resin Water was added to a 60-liter planetary Bear Varimixer, and weighed nicotine was added. The mixer was stirred at low speed for 1 minute at ambient temperature. Next, the ion exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed and stirred at high speed for 5 minutes, then opened and scraped off as needed. Finally, the mixer was stirred at high speed for another 5 minutes.

[0135] As a result, a mixture of nicotine and cation exchange resin was produced from the components listed in Table 4D below.

[0136] [Table 8]

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

[0138] Using a planetary Bear Varimixer, the fiber and water were mixed for 5 minutes. Then, the following ingredients were added, continuously mixing: first, if applicable, nicotine bicarbonate xH2O (NBT, 32.5% nicotine content) or nicotine polarilex resin (NPR, 15.9% nicotine content) (mixed for 2 minutes), then the remaining ingredients other than liquid flavorings and flow accelerators, if any (mixed for 2 minutes), then the liquid flavorings, if any (mixed for 1 minute), then the flow accelerators, if any (mixed for 1 minute). The total mixing time was 9-11 minutes.

[0139] The final powder composition is filled into pouches (target filling weight: 500 mg of powder per pouch). The pouch membrane of Example 1A, manufactured from long-fiber paper, is used. The powder is filled into the pouch and sealed to maintain its presence within the pouch. A pouch-filled product using the pouch membrane of Example 1B was also manufactured.

[0140] The powder is filled into a pouch and sealed to maintain its contents within the pouch. Pouches PPC1 to PPC5 containing the nicotine premix are prepared, including the powdered compositions outlined in Table 5. The pouches are manufactured as follows.

[0141] Using a planetary Bear Varimixer, mix the fiber and water for 5 minutes. Then, continuously add the following ingredients while mixing: nicotine premix (mix for 2 minutes), then the remaining ingredients (mix for 2 minutes) if there are liquid flavors and flow accelerators, then liquid flavors if any (mix for 1 minute), then flow accelerators if any (mix for 1 minute). The total mixing time is 9-11 minutes.

[0142] The final powder composition is filled into pouches (target filling weight: 500 mg of powder per pouch). The pouch membrane of Example 1A, manufactured from long-fiber paper, is used. The powder is filled into the pouch and sealed to maintain its presence within the pouch. A pouch-filled product using the pouch membrane of Example 1B was also manufactured.

[0143] The powder is filled into a pouch and sealed to maintain its contents within the pouch.

[0144] [Table 9]

[0145] Pouch contents: 500mg total, i.e., nicotine concentration of 19.2mg / g. The applicable xylitol product is, for example, the product name "Xylitab (registered trademark) 200".

[0146] Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". Other fibers that can be used include water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, and powdered cellulose.

[0147] For example, a mixture of menthol and peppermint can be used. Naturally, the other flavorings described herein can also be used in combination with or as substitutes for menthol and / or peppermint.

[0148] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include magnesium stearate, starch, and talc. Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

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

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

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

[0153] Mix the fiber and powder components (excluding the flow accelerator) for 2 minutes using a planetary Bear Varimixer. Next, add the nicotine premix and mix for 2 minutes. Then, add the water and mix for 5 minutes, followed by the liquid flavoring (mix for 1 minute if used) and the flow accelerator (mix for 1 minute if used). The total mixing time is 9-11 minutes.

[0154] [Table 10]

[0155] Contents of the pouch: 500mg total. The applicable isomalt DC is, for example, GalenIQ(trademark) 720. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". Other fibers that can be used include water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, and powdered cellulose.

[0156] For example, a mixture of menthol and peppermint can be used. Naturally, the other flavorings described herein can also be used in combination with or as substitutes for menthol and / or peppermint.

[0157] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include magnesium stearate, starch, and talc. Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

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

[0160] Pouches PPC11-PPC13 and PPC15 exhibit varying water content of at least 15% by weight of the pouch composition. Although the water content varies, the ratio of the amount of purified water added to the amount of fiber remains constant.

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

[0162] [Table 11]

[0163] Contents of the pouch: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". Other fibers that can be used include water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, and powdered cellulose.

[0164] For example, a mixture of menthol and peppermint can be used. Naturally, the other flavorings described herein can also be used in combination with or as substitutes for menthol and / or peppermint.

[0165] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include magnesium stearate, starch, and talc. Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

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

[0168] Pouch PPC21 indicates the use of materials such as microcrystalline cellulose (MCC) instead of wheat fiber. Pouch PPC22 demonstrates the use of a combination of nicotine-ion exchange resin premix and nicotine-sugar alcohol premix.

[0169] Pouches PPC23 to PPC26 demonstrate the use of varying amounts of buffer (in this case, sodium carbonate). With larger amounts of basic buffer to achieve a more alkaline environment, the need for a preservative (in this case, potassium sorbate) decreases, and therefore, it is omitted in PPC25 to PPC26, which have the highest amount of alkaline buffer.

[0170] Example 3D-pouch Pouches PPC31 to PPC32 are manufactured in the same manner as pouches PPC1 to PPC5 in Example 3A, but using nicotine premixes 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 (a KitchenAid mixer will take about 30 minutes at about 30 RPM). Sift the resulting granules and place them in a tray. Dry the resulting powder overnight at ambient temperature, then sift it to obtain the nicotine-sugar alcohol premix. It is also possible to add a certain amount of water to the nicotine before mixing it with the sugar alcohol. Such water will then evaporate during drying.

[0172] Using a planetary Bear Varimixer, mix the fiber and water for 5 minutes. Then, continuously add the following ingredients, mixing as you go: powder ingredients other than the nicotine premix (mix for 2 minutes), nicotine-sugar alcohol premix (mix for 2 minutes), then liquid flavoring (if any) (mix for 1 minute), and finally flow enhancer (if any) (mix for 1 minute). The total mixing time is 9-11 minutes.

[0173] The final powder composition is filled into pouches (target filling weight: 500 mg of powder per pouch). The pouch membrane of Example 1A, manufactured from long-fiber paper, is used. The powder is filled into the pouch and sealed to maintain its presence within the pouch. A pouch-filled product using the pouch membrane of Example 1B was also manufactured.

[0174] [Table 12]

[0175] Contents of the pouch: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". Other fibers that can be used include water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, and powdered cellulose.

[0176] For example, a mixture of menthol and peppermint can be used. Naturally, the other flavorings described herein can also be used in combination with or as substitutes for menthol and / or peppermint.

[0177] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include magnesium stearate, starch, and talc. Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

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

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

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

[0182] [Table 13]

[0183] Contents of the pouch: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". Other fibers that can be used include water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, and powdered cellulose.

[0184] For example, a mixture of menthol and peppermint can be used. Naturally, the other flavorings described herein can also be used in combination with or as substitutes for menthol and / or peppermint.

[0185] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include magnesium stearate, starch, and talc. Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

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

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

[0189] Pouch PPC46 indicates a pouch containing two sugar alcohols. Example 3F - Pouch Pouches PPC51 to PPC55 will be manufactured as follows.

[0190] Mix the fiber and powder components (excluding nicotine-containing powder and flow accelerator) for 1 minute using a planetary Bear Varimixer. Then add NPR and NBT and mix for 2 minutes (if applicable). Next, add the nicotine premix and mix for 2 minutes. Next, add water and mix for 5 minutes, followed by the liquid flavoring (mix for 1 minute if present) and flow accelerator (mix for 1 minute if present). The total mixing time is 9-11 minutes.

[0191] The final powder composition is filled into pouches (target filling weight: 500 mg of powder per pouch). The pouch membrane of Example 1A, manufactured from long-fiber paper, is used. The powder is filled into the pouch and sealed to maintain its presence within the pouch. A pouch-filled product using the pouch membrane of Example 1B was also manufactured.

[0192] [Table 14]

[0193] Contents of the pouch: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". Other fibers that can be used include water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, and powdered cellulose.

[0194] For example, a mixture of menthol and peppermint can be used. Naturally, the other flavorings described herein can also be used in combination with or as substitutes for menthol and / or peppermint.

[0195] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include magnesium stearate, starch, and talc. Sodium carbonate is used as an alkaline buffer. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

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

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

[0199] Pouch PPC53 refers to a pouch that uses a nicotine-ion exchange resin premix in combination with nicotine bicarbonate (NBT) and nicotine polarilex resin (NPR).

[0200] Example 3G-Pouch Pouches PPC61 to PPC65 containing a nicotine premix were prepared with the powdered composition outlined in Table 11. The pouches were manufactured as follows.

[0201] Mix the fiber and powder components (excluding the flow accelerator) for 2 minutes using a Loedige mixer. Next, add the nicotine premix and mix for 2 minutes. Then, with the mixer running, add the water and mix for 15 minutes, followed by the liquid flavoring (mix for 15 minutes if used) and the flow accelerator (mix for 1 minute if used). The total mixing time is 19-35 minutes.

[0202] [Table 15]

[0203] Contents of the pouch: 500mg total. Wheat fiber, trade name "Vitacel (registered trademark) 600 WF Plus". Other fibers that can be used include water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bamboo fiber, bran fiber, and powdered cellulose.

[0204] For example, a mixture of menthol and peppermint can be used. Naturally, the other flavorings described herein can also be used in combination with or as substitutes for menthol and / or peppermint.

[0205] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include magnesium stearate, starch, and talc. Sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) may be used as water-retaining agents. Other water-retaining agents described herein may also be used in combination with or as substitutes for sodium alginate, glycerol, or HPC.

[0206] Sodium carbonate and sodium bicarbonate are used as alkaline buffers. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

[0208] Acesulfame potassium and / or sucralose can be used, for example, as high-intensity sweeteners. Other available high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose, or as substitutes for acesulfame potassium and / or sucralose.

[0209] Pouches PPC61 to PPC62 demonstrate the use of different combinations of sweeteners and buffers. Pouches PPC63 to PPC64 represent pouches with different fiber content. Pouches PPC65 to PPC67 indicate the use of different water-retaining agents.

[0210] Example 3: H-pouch Pouches PPC71 to PPC76 containing a nicotine premix were prepared with the powdered composition outlined in Table 12. The pouches were manufactured as follows.

[0211] Mix the fiber and powder components (excluding the flow accelerator) for 2 minutes using a Loedige mixer. Next, add the nicotine premix and mix for 2 minutes. Then, with the mixer running, add the water and mix for 15 minutes, followed by the liquid flavoring (mix for 15 minutes if used) and the flow accelerator (mix for 1 minute if used). The total mixing time is 19-35 minutes.

[0212] The final powder composition is filled into pouches (target filling weight: 500 mg of powder per pouch). The pouch material from Example 1, manufactured from long-fiber paper, is used. The powder is filled into the pouch and sealed to maintain its presence within the pouch.

[0213] [Table 16-1]

[0214] [Table 16-2]

[0215] Nicotine Premix VIII contains pea fiber. Pouch contents: 500mg total, i.e., nicotine concentration of 19.2mg / g. Wheat fiber, product name "Vitacel (registered trademark) 600 WF Plus".

[0216] Powdered cellulose, product name "Vitacel (registered trademark) L00" or "Vitacel (registered trademark) L700G". Oat fiber, product name "Vitacel (registered trademark) HF600".

[0217] Pea fiber, product name "Vitacel (registered trademark) EF150". Other fibers that can be used include water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bamboo fiber, wheat bran fiber, and powdered cellulose.

[0218] For example, a mixture of menthol and peppermint can be used. Naturally, the other flavorings described herein can also be used in combination with or as substitutes for menthol and / or peppermint.

[0219] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include magnesium stearate, starch, and talc. Sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) may be used as water-retaining agents. Other water-retaining agents described herein may also be used in combination with or as substitutes for sodium alginate, glycerol, or HPC.

[0220] Sodium carbonate and sodium bicarbonate are used as alkaline buffers. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

[0222] Acesulfame potassium and / or sucralose can be used, for example, as high-intensity sweeteners. Other available high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose or as an alternative to acesulfame potassium and / or sucralose.

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

[0224] The fiber and powder components (excluding the flow promoter) are mixed using a Loedige mixer for 2 minutes. Next, the nicotine premix is added and mixed for 2 minutes. Then, with the mixer running, water is added and mixed for 15 minutes, followed by adding the liquid flavor (if any, mixed for 15 minutes) and the flow promoter (if any, mixed for 1 minute). The total mixing time is 19 - 35 minutes.

[0225] The final powder composition is filled into the pouches (target filling 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 pouches and maintained within the pouches by sealing.

[0226] [Table 17]

[0227] [Table 18]

[0228] The nicotine premix contains water in various amounts, thereby contributing to the total water content. Pouch contents: 500mg total, i.e., nicotine concentration of 19.2mg / g. Wheat fiber, product names "Vitacel (registered trademark) 600 WF Plus" or "Vitacel (registered trademark) 200 WF".

[0229] Powdered cellulose, product name "Vitacel (registered trademark) L00" or "Vitacel (registered trademark) L700G". Oat fiber, product name "Vitacel (registered trademark) HF 600".

[0230] Pea fiber, product name "Vitacel (registered trademark) EF150". Other fibers that can be used include water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bamboo fiber, wheat bran fiber, and powdered cellulose.

[0231] For example, a mixture of menthol and peppermint can be used. Naturally, the other flavorings described herein can also be used in combination with or as substitutes for menthol and / or peppermint.

[0232] Silicon dioxide is used as a flow accelerator. Other possible flow accelerators include magnesium stearate, starch, and talc. Sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) may be used as water-retaining agents. Other water-retaining agents described herein may also be used in combination with or as substitutes for sodium alginate, glycerol, or HPC.

[0233] Sodium carbonate and sodium bicarbonate are used as alkaline buffers. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

[0235] Acesulfame potassium and / or sucralose can be used, for example, as high-intensity sweeteners. Other available high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose, or as substitutes for acesulfame potassium and / or sucralose.

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

[0237] Example 3J-Pouch Pouches containing a nicotine premix, namely Comp.10, PPC101, and PPC102, were prepared with the powdered composition outlined in Table 14. The pouches were manufactured as follows.

[0238] Mix the fiber and powder components (excluding the flow accelerator) for 2 minutes using a Loedige mixer. Next, add the nicotine premix and mix for 2 minutes. Then, with the mixer running, add the water and mix for 15 minutes, followed by the liquid flavoring (mix for 15 minutes if used) and the flow accelerator (mix for 1 minute if used). The total mixing time is 19-35 minutes.

[0239] Fill the final powder composition into pouches (500 mg of powder per pouch with the target filling weight). Use the pouch material of Example 1 made from long fiber paper. Fill the powder into the pouches and maintain it inside the pouches by sealing.

[0240]

Table 19

[0241] The nicotine premix contains water in various amounts, thereby contributing to the total water content. Pouch content volume: 500 mg in total, that is, nicotine concentration of 19.2 mg / g. Wheat fiber, trade name “Vitacel® 600 WF Plus” or “Vitacel® 200 WF”.

[0242] As other fibers, water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, maize fiber, barley fiber, tomato fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bamboo fiber, bran fiber and powdered cellulose can be used in the same way.

[0243] For example, a mixture of menthol and peppermint can be used. Of course, other flavoring agents described in this specification can also be combined with menthol and / or peppermint or used instead of these.

[0244] Silicon dioxide is used as a flow promoter. Other possible flow promoters include magnesium stearate, starch, talc and the like. As a water retention agent, sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used. Also, sodium alginate, glycerol, or HPC can be combined with or used instead of other water retention agents described in this specification.

[0245] Sodium carbonate and sodium bicarbonate are used as alkaline buffers. Other buffers described herein may be used in combination with or as substitutes for sodium carbonate.

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

[0247] Acesulfame potassium and / or sucralose can be used, for example, as high-intensity sweeteners. Other available high-intensity sweeteners described herein may be used in combination with acesulfame potassium and / or sucralose, or as substitutes for acesulfame potassium and / or sucralose.

[0248] Example 4A - Treatment of pouch film with nicotine Nicotine pouches were placed in a sealed processing container at a temperature of approximately 25°C. The temperature of the nicotine pouches was kept constant for 14 days while maintaining the container's airtight seal.

[0249] After 14 days of processing, the container was opened and the nicotine content of the pouch membrane and pouch composition was examined. Example 4B - Application of nicotine to pouch film The pouch-packaged product was immersed in liquid nicotine (diluted with propylene glycol to a nicotine concentration of approximately 20%), and the nicotine was then applied to the pouch membrane.

[0250] The immersion process continued for about 5 minutes. Subsequently, the nicotine content of the pouch membrane and pouch composition was investigated. Example 4C - Nicotine application by spraying A liquid nicotine solution (diluted with propylene glycol to a nicotine concentration of approximately 20%) was sprayed onto the pouch-packaged product.

[0251] The pouch-packaged products were then dried under ambient conditions for approximately 10 minutes. Subsequently, the nicotine content of the pouch membrane and pouch composition was investigated.

[0252] Example 4D-Pouch Film Pouch-packed products were manufactured using the pouch composition PPC55 and different pouch membranes. PPC55-A was prepared with a pouch membrane having fibers essentially composed of regenerated cellulose (viscose) and processed according to Example 4A. PPC55-B was prepared with a pouch membrane having fibers that are a combination of regenerated cellulose (viscose) and synthetic fibers and processed according to Example 4A. PPC55-C was prepared with a pouch membrane having fibers that are a combination of viscose and synthetic fiber material and processed according to Example 4A. The fiber composition of the pouch membrane of PPC55-C differed from that of PPC55-B, with PPC55-C having a slightly denser composition.

[0253] Example 5A - Treatment of pouch film with nicotine A pouch-packaged product was prepared according to Example 4A using the pouch composition PPC44 of Example 3E. The nicotine content in the pouch membrane of the obtained pouch-packaged product was examined. Of the total amount of nicotine in the pouch-packaged product, approximately 12 mg, which was added to the pouch composition during preparation, the processed pouch-packaged product contained approximately 8.5 mg of nicotine in the pouch composition and approximately 3.5 mg of nicotine in the pouch membrane, representing approximately 29% by weight of the total nicotine. The pouch membrane had a weight equivalent to approximately 12% by weight of the pouch-packaged product when it was prepared.

[0254] Example 5B - Nicotine release Next, the pouch composition and pouch membrane of the treated pouch PPC44 from Example 5A were tested separately to evaluate the amount of nicotine released. In an in vitro experiment according to Example 5F, it was observed that the pouch composition itself (without the pouch membrane) released approximately 40% by weight of its nicotine content at 10 minutes. The pouch membrane itself, when subjected to the corresponding test, released approximately 92% of its weight at 10 minutes. This confirms that the nicotine in the pouch membrane is released considerably faster and more effectively than the nicotine in the pouch composition.

[0255] Example 5C - Processing time Pouch-packed products containing PPC44, PPC54, and PPC55 were processed according to Example 4A. At 0, 1, 4, and 7 days after the start of processing, each pouch-packed product containing PPC44, PPC54, and PPC55 was tested for nicotine content in the pouch membrane. The results are shown in Table 15.

[0256] [Table 20]

[0257] As is clear from Table 15, the amount of nicotine in the pouch membrane can be changed by adjusting the nicotine source and the processing time. Increasing the processing time increases the amount of nicotine in the pouch membrane. Also, replacing Nicotine Premix II (PPC44) with Nicotine Premix VI (PPC55) significantly speeds up and improves the efficiency of nicotine processing of the pouch membrane.

[0258] Example 5D - Emission from pouch-packaged product Similarly, in vitro releases from the respective pouch-packaged products of PPC44, PPC54, and PPC55 were tested at 0, 1, 4, and 7 days after the start of processing. The results of nicotine release from the pouch-packaged products at 10 minutes are shown in Table 16.

[0259] [Table 21]

[0260] As shown in Table 16, treating the pouch membrane with nicotine clearly leads to more effective nicotine release from the pouched product. Longer treatment times result in more nicotine being processed into the pouch membrane. As mentioned above, the extremely high release rate of 92% from the pouch membrane indicates that increasing the amount of nicotine contained in the pouch membrane through treatment leads to more effective nicotine release from the pouched product.

[0261] Example 5E - Release test (in vivo) The release properties of the pouch were evaluated by an assessor, preferably a panel of at least eight assessors. Each assessor was given a pouch to be placed in the oral cavity, specifically on the upper lip.

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

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

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

[0265] No stirring or shaking was performed during the release experiment. The pouches were removed from the buffer solution after 2 minutes, 5 minutes, 10 minutes, 30 minutes, and 60 minutes. The wet pouches were allowed to drip down, and then the pouches were gently pulled to the end of the reaction tube to remove any excess buffer solution attached to the wet pouches.

[0266] The amount of nicotine remaining in the pouch was measured using standard HPLC techniques. Two pouches were tested at each time point. The average of the results obtained at each time point was used to create a time-course profile of the nicotine content in the pouches.

[0267] Subsequently, the amount of nicotine released was obtained by subtracting the amount of remaining nicotine in the tested pouch from the initial dose of nicotine in the pouch. Example 5H - Emission from pouches with different pouch membranes Nicotine release from pouch-packaged 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 before the release test. The pouch membrane of pouch product PPC55-A contained 22.4% by weight of the total nicotine content in the pouch product. The pouch membrane of pouch product PPC55-B contained 19.0% by weight of the total nicotine content in the pouch product. The pouch membrane of pouch product PPC55-C contained 29.7% by weight of the total nicotine content in the pouch product.

[0270] The results above indicate that the material of the pouch membrane affects both the amount of nicotine that the pouch membrane can process and the amount of nicotine released during testing. In particular, when using a viscose-based pouch membrane (i.e., a pouch membrane with fibers that are essentially made of viscose, PPC55-A), significantly higher release results were obtained, especially at the earliest stage, compared to when the pouch membrane contained both viscose and synthetic fibers (PPC55-B and PPC55-C).

[0271] Example 5I - Nicotine content in pouch film The nicotine content in the pouch membrane of Comp.10, PPC101, and PPC102, which were pouch-packaged products processed according to Example 4A, was measured over a shortened period. The test was 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 water content in the pouch composition promotes the effective treatment of nicotine with the pouch membrane. The test results for PPC101 show a significant increase in nicotine content in the pouch membrane during the initial measurements, indicating that complete treatment has not yet been achieved. Example 4A shows a 14-day treatment period until the desired level of nicotine in the membrane is obtained. Nevertheless, the treatment time can be highly dependent on, for example, the amount of water.

Claims

1. A nicotine pouch product, Pouch composition and A pouch membrane for enclosing the aforementioned pouch composition, Includes, The aforementioned pouch composition is: At least one water-insoluble fiber, The pouch composition contains at least 15% by weight of water, Nicotine and, Includes, The pouch membrane further contains at least 1.0 mg of nicotine, comprising a nicotine pouch product.

2. The nicotine pouch product according to claim 1, wherein the pouch membrane contains nicotine in an amount of at least 15% by weight of the total nicotine content in the pouch product.

3. The nicotine pouch product according to claim 2, wherein the pouch membrane contains nicotine in an amount of 20 to 50% by weight of the total nicotine content in the pouch product.

4. The nicotine pouch product according to claim 2 or 3, wherein the pouch membrane contains nicotine in an amount of 25 to 50% by weight of the total nicotine content in the pouch product.

5. The nicotine pouch product according to any one of claims 1 to 4, wherein the water-insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bamboo fiber, bran fiber, powdered cellulose, MCC, and any combination thereof.

6. The nicotine pouch product according to any one of claims 1 to 5, wherein the water-insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, maize fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bamboo fiber, bran fiber, powdered cellulose, and any combination thereof.

7. The nicotine pouch product according to any one of claims 1 to 6, wherein the pouch composition has a water content of 15 to 50% by weight of the pouch composition.

8. The nicotine pouch product according to any one of claims 1 to 7, wherein the pouch composition has a water content of 15 to 40% by weight of the pouch composition.

9. The nicotine pouch product according to any one of claims 1 to 8, wherein the pouch composition comprises at least 1% by weight of a sugar alcohol.

10. The nicotine pouch product according to any one of claims 1 to 9, wherein the pouch membrane comprises a nonwoven fabric or woven fabric material.

11. The nicotine pouch product according to any one of claims 1 to 10, wherein the pouch membrane comprises fibers, and the fibers of the pouch membrane comprise at least 60% by weight of cellulose.

12. The nicotine pouch product according to any one of claims 1 to 11, wherein the pouch composition does not contain tobacco, tobacco fibers, or tobacco-derived fibers.

13. The nicotine pouch product according to any one of claims 1 to 12, wherein the at least one water-insoluble fiber is provided as a powder, and the pouch membrane comprises at least one further water-insoluble fiber.

14. The nicotine pouch product according to any one of claims 1 to 13, wherein the nicotine in the pouch product is selected from nicotine salts, free base nicotine mixed with an ion exchange resin, free base nicotine forming a complex with an ion exchange resin, free base nicotine mixed with a water-soluble composition such as a sugar alcohol or water-soluble fiber, nicotine associated with fatty acids such as oleic acid, and any combination thereof.

15. The nicotine pouch product according to any one of claims 1 to 14, wherein at least 15% by weight of the total nicotine content in the pouch product is released within a period of 120 seconds or less when administered orally.