Nicotine pouch composition

Abstract

A pouch composition comprising a nicotine-ion exchange resin combination, water in an amount of at least 15 wt% of the pouch composition, and inorganic divalent cations is disclosed. In addition, an oral pouch nicotine product comprising a saliva permeable pouch and a pouch composition in the pouch and a pouch composition are disclosed.

Description

TECHNICAL FIELD

[0001] The present invention relates to a pouch composition and an oral pouch nicotine product. BACKGROUND

[0002] Delivery of nicotine by smoking has a number of well-known disadvantages, in particular health-related issues, such as introduction of carcinogens.

[0003] However, tobacco substitutes also have disadvantages, such as insufficient relief of the user's craving.

[0004] Another challenge in the prior art is that the desired release of nicotine from the user's perspective should be attractive to the user of the pouch.

[0005] However, a further challenge associated with the prior art can be that the pouch as a delivery vehicle for nicotine can be somewhat expensive and therefore imposes restrictions on the way the pouch is designed in order to control the manufacturing costs.

[0006] It is an object of one embodiment of the present invention to provide a nicotine-containing pouch, such as a tobacco substitute, which can solve the above-mentioned problems. SUMMARY

[0007] The present invention relates to a pouch composition comprising

[0008] a nicotine-ion exchange resin combination,

[0009] water in an amount of at least 15 wt.-% of the pouch composition, and

[0010] an inorganic divalent cation.

[0011] One advantage of the present invention can be that a relatively high stability of the provided nicotine can be obtained, while at the same time a relatively fast release of nicotine is obtained. High stability can result in that the nicotine is too effectively bound, for example, to the carrier and thus results in a slow release. By means of the claimed pouch composition comprising the combination of water in an amount of at least 15 wt.-% of the composition and a divalent inorganic cation, a high stability but still fast release will be facilitated, while at the same time a very desirable mouth feel and taste is obtained. The high water content contributes to an effective release of nicotine during use.

[0012] One advantage of the present invention is that due to the presence of the divalent cation, a relatively fast release rate of nicotine from the pouch composition can be obtained. At the same time, due to the high water content, a desirable moist mouth feel is provided, which high water content also facilitates a fast release of nicotine.

[0013] Furthermore, the present application can advantageously provide for a more efficient nicotine release during use of the pouch comprising the pouch composition. Due to the minimization of any residual nicotine not released from the pouch composition, an efficient release of nicotine can be obtained which can result in a lower total dose of nicotine while the amount of nicotine released is the same.

[0014] In an advantageous embodiment of the present application, the solid oral nicotine formulation comprises the inorganic divalent cations in a molar ratio of at least 0.1 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at least 0.25 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at least 0.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0015] In an advantageous embodiment of the present application, the pouch composition comprises the inorganic divalent cations in a molar ratio of at least 0.1 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at least 0.25 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at least 0.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0016] The amount of divalent cations should advantageously be high enough to enable the complexed nicotine to ion exchange with the divalent cations during use of the pouch comprising the pouch composition.

[0017] Furthermore, the amount of inorganic divalent cations can also advantageously reduce the probability of the exchanged nicotine to re-complex with the ion exchange resin, simply by occupying binding sites on the ion exchange resin during use.

[0018] In an embodiment of the present application, the amount of inorganic divalent cations can even prevent the exchanged nicotine to re-complex with the ion exchange resin during use.

[0019] In addition, the amount of inorganic divalent cations can reduce the probability of any un-complexed nicotine, such as free base nicotine and / or exchanged nicotine, to complex / re-complex with the ion exchange resin during use.

[0020] In an advantageous embodiment of the present application, the solid oral nicotine formulation comprises the inorganic divalent cations in a molar ratio of at most 6.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 6 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 3.75 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 2.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0021] In an advantageous embodiment of the application, the pouch composition comprises inorganic divalent cations in a molar ratio of at most 5, such as at most 3.75, such as at most 2.5, relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0022] An advantage of the above embodiment can be that the inclusion of inorganic divalent cations in not too high amounts will promote desirable taste and mouthfeel by avoiding or minimizing undesirable taste and / or mouthfeel such as undesirable saltiness, local dehydration or even mouth dehydration sensation.

[0023] In an embodiment of the application, the pouch composition comprises inorganic divalent cations in a molar ratio of between 0.1 and 6.5, such as between 0.1 and 6.0, such as between 0.1 and 5.0, such as between 0.1 and 4.0, such as between 0.1 and 3.0, such as between 0.1 and 2.0, such as between 0.1 and 1.0, relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0024] In an embodiment of the application, the pouch composition comprises inorganic divalent cations in a molar ratio of between 0.1 and 5.0, such as between 0.5 and 5.0, such as between 0.75 and 5.0, such as between 1.0 and 4.0, such as between 2.0 and 4.0, relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0025] In an embodiment of the application, the pouch composition comprises inorganic divalent cations in a molar ratio of between 0.01 and 5.0, such as between 0.01 and 4.0, such as between 0.01 and 3.0, such as between 0.01 and 2.0, such as between 0.01 and 1.0, relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0026] Herein, the molar ratio refers to the molar content of the divalent cations divided by the molar content of the nicotine.

[0027] In an advantageous embodiment of the present application, the inorganic divalent cations are selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc and any combination thereof.

[0028] In an advantageous embodiment of the present application, the inorganic divalent cations are selected from the group consisting of divalent cations of calcium and magnesium.

[0029] In an embodiment of the present application, the inorganic divalent cations are provided as salts comprising inorganic or organic anions.

[0030] In an advantageous embodiment of the present application, the inorganic divalent cations are provided as salts comprising anions selected from the group consisting of carboxylates, such as acetate, lactate, oxalate, propionate or acetylpropionate; organic sulfonates; organic sulfates; organic phosphates; chloride, bromide, nitrate, sulfate, hydrogenphosphate, oxide and any combination thereof.

[0031] In an embodiment of the present application, the inorganic divalent cations are provided as salts in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition.

[0032] In an embodiment of the present application, the organic anions are selected from the group consisting of carboxylates, such as acetate, lactate, oxalate, propionate, acetylpropionate; organic sulfonates; organic sulfates; organic phosphates; and any combination thereof.

[0033] In an advantageous embodiment of the present application, the inorganic divalent cations are provided as inorganic salts.

[0034] In an advantageous embodiment of the present application, the inorganic divalent cations are provided as inorganic salts in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition.

[0035] In an embodiment of the present application, the inorganic divalent cations are provided as inorganic salts in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition.

[0036] In one embodiment of the application, the inorganic divalent cation is provided as an inorganic salt in an amount between 0.1 and 15.0 wt% of the composition, such as between 0.1 and 10.0 wt% of the composition, such as between 0.5 and 7.0 wt% of the composition, such as between 0.1 and 7.0 wt% of the composition, such as between 0.5 and 5.0 wt% of the composition, such as between 0.5 and 4.0 wt% of the composition.

[0037] In one advantageous embodiment of the application, the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chloride, bromide, nitrate, sulfate, bicarbonate, hydrogenphosphate, oxide, hydroxide, and any combination thereof.

[0038] It is noted that in some embodiments, the inorganic anion can be combined, e.g. such that the cation forms separate salts with two different types of anions. One example can e.g. be magnesium chloride combined with magnesium bromide.

[0039] In one advantageous embodiment of the application, wherein the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chloride, bromide, sulfate, bicarbonate, and any combination thereof.

[0040] In one advantageous embodiment of the application, wherein the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chloride, bromide, sulfate, and any combination thereof.

[0041] In one advantageous embodiment of the application, wherein the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chloride, bromide, and any combination thereof.

[0042] In one advantageous embodiment of the application, the inorganic anion comprises chloride.

[0043] In one embodiment of the application, the inorganic cation is magnesium and / or calcium and the anion comprises chloride.

[0044] In one embodiment of the application, the inorganic anion is chloride.

[0045] In one embodiment of the application, the inorganic cation is magnesium and / or calcium and the anion is chloride.

[0046] In one advantageous embodiment of the application, the inorganic divalent cation is provided as an inorganic salt selected from calcium chloride or magnesium chloride or a combination thereof.

[0047] In one embodiment of the application, the divalent cation is provided as a pharmaceutically acceptable salt.

[0048] In one embodiment of the present application, the divalent cations are provided as pharmaceutically acceptable inorganic salts.

[0049] In one embodiment of the present application, the inorganic divalent cations are provided as hydrated salts.

[0050] In one embodiment of the present application, the inorganic divalent cations are provided as hydrated inorganic salts.

[0051] In one embodiment of the present application, the divalent cations are provided as gastrointestinal acceptable salts.

[0052] In one embodiment of the present application, the divalent cations are provided as gastrointestinal acceptable inorganic salts.

[0053] In one advantageous embodiment of the present application, the divalent cations are provided as water soluble salts having a water solubility of at least 5 g / 100 ml water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.

[0054] Atmospheric pressure is understood as a pressure of about 101.3 kPa or a pressure in the range of 90 to 110 kPa.

[0055] In one embodiment of the present application, the pouch composition comprises inorganic divalent cations provided as water soluble salts, wherein the pouch composition comprises the inorganic divalent cations provided as water soluble salts in a molar ratio between 0.1 and 6.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 6.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 5.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 4.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 3.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 2.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 1.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0056] In one embodiment of the present application, the inorganic divalent cations are provided as water soluble salts in an amount between 0.1 and 15.0 weight-% of the composition.

[0057] In one embodiment of the present application, the divalent cations are provided as inorganic, water soluble salts having a water solubility of at least 5 g / 100 ml water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.

[0058] In one embodiment of the present application, the inorganic divalent cations are provided as inorganic, water soluble salts in an amount between 0.1 and 15.0 wt-% of the composition, such as between 0.1 and 10.0 wt-% of the composition, such as between 0.5 and 7.0 wt-% of the composition, such as between 0.1 and 7.0 wt-% of the composition, such as between 0.5 and 5.0 wt-% of the composition, such as between 0.5 and 4.0 wt-% of the composition.

[0059] In one embodiment of the present application, the pouch composition comprises inorganic divalent cations provided as inorganic, water soluble salts, wherein the pouch composition comprises the inorganic divalent cations provided as inorganic, water soluble salts in a molar ratio between 0.1 and 6.5 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 6.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 5.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 4.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 3.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 2.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination, such as between 0.1 and 1.0 relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0060] In one embodiment of the present application, the inorganic divalent cations are provided as inorganic, water soluble salts in an amount between 0.1 and 15.0 wt-% of the composition, such as between 0.1 and 10.0 wt-% of the composition, such as between 0.5 and 7.0 wt-% of the composition, such as between 0.1 and 7.0 wt-% of the composition, such as between 0.5 and 5.0 wt-% of the composition, such as between 0.5 and 4.0 wt-% of the composition.

[0061] "Provided" is herein to be understood as the inorganic cations are added to the composition as salts.

[0062] By providing the divalent cations as water soluble salts, the salt dissociation into cations can advantageously be faster and more efficient, whereby a relatively fast nicotine release can be achieved.

[0063] In one advantageous embodiment of the present application, the pouch composition comprises nicotine in an amount of at least 0.1 wt-%, such as at least 0.2 wt-% of the pouch composition.

[0064] In one embodiment of the present application, the pouch composition comprises nicotine in an amount between 0.1 and 5.0 wt-% of the pouch composition, such as between 0.2 and 4.0 wt-% of the pouch composition, such as between 1.0 and 2.0 wt-% of the pouch composition.

[0065] The pouch composition should have a desired content of nicotine which is capable of providing a desired dose of nicotine to a user while also providing a desired volume of the composition enclosed in the pouch to the user.

[0066] In an advantageous embodiment of the application, the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt.-% of the pouch composition.

[0067] It is to be understood here that the divalent cations do not form part of the nicotine-ion exchange combination when the pouch composition is prepared. If the combination is pre-combined prior to the preparation of the pouch composition. Pre-combining can cause stability problems as the divalent cations can induce premature release of nicotine from the ion exchange resin. This can be particularly problematic when incorporating such a combination into a pouch composition having a high water content such as a pouch composition having a water content of at least 15 wt.-%.

[0068] In an embodiment of the application, the divalent cations are not comprised in the provided nicotine-ion exchange combination.

[0069] In an embodiment of the application, the nicotine-ion exchange combination does not comprise divalent cations.

[0070] In an embodiment of the application, the divalent cations are provided as a salt.

[0071] In an embodiment of the application, the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt.-% of the pouch composition, such as 1.0 to 15 wt.-% of the pouch composition, such as 3.0 to 15 wt.-% of the pouch composition, such as 5.0 to 15 wt.-% of the pouch composition.

[0072] In an embodiment of the application, the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt.-% of the pouch composition, such as 1.0 to 15 wt.-% of the pouch composition, such as 1.0 to 10 wt.-% of the pouch composition, such as 3.0 to 10 wt.-% of the pouch composition.

[0073] In an advantageous embodiment of the application, the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 to 50 wt.-%.

[0074] In an embodiment of the application, the nicotine-ion exchange resin combination comprises nicotine complexed with the ion exchange resin, wherein the nicotine constitutes an amount of between 5 to 50 wt.-% of the nicotine-ion exchange resin combination.

[0075] In one embodiment of the present application, the nicotine-ion exchange resin combination consists of nicotine complexed with an ion exchange resin, wherein the nicotine constitutes an amount between 10 and 50 wt% of the nicotine-ion exchange resin combination, such as between 10 and 40 wt% of the nicotine-ion exchange resin combination, such as between 10 and 30 wt% of the nicotine-ion exchange resin combination, such as between 10 and 25 wt% of the nicotine-ion exchange resin combination.

[0076] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin, wherein the nicotine constitutes an amount between 5 and 50 wt% of the nicotine-ion exchange resin combination.

[0077] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin, wherein the nicotine constitutes an amount between 5 and 50 wt% of the nicotine-ion exchange resin combination, such as between 10 and 50 wt% of the nicotine-ion exchange resin combination, such as between 20 and 50 wt% of the nicotine-ion exchange resin combination, such as between 25 and 50 wt% of the nicotine-ion exchange resin combination, such as between 25 and 45 wt% of the nicotine-ion exchange resin combination.

[0078] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises free base nicotine mixed with an ion exchange resin, wherein the nicotine constitutes an amount between 5 and 40 wt% of the nicotine-ion exchange resin combination, such as between 10 and 40 wt% of the nicotine-ion exchange resin combination, such as between 10 and 35 wt% of the nicotine-ion exchange resin combination, such as between 10 and 25 wt% of the nicotine-ion exchange resin combination, such as between 10 and 15 wt% of the nicotine-ion exchange resin combination.

[0079] In one advantageous embodiment of the present application, the nicotine-ion exchange resin combination comprises nicotine in an amount between 5 and 50 wt% and ion exchange resin in an amount between 10 and 95 wt%.

[0080] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises nicotine in an amount between 5 and 50 wt% and ion exchange resin in an amount between 10 and 95 wt%.

[0081] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises nicotine in an amount between 10 and 30 wt% and ion exchange resin in an amount between 20 and 90 wt%.

[0082] In one embodiment of the present application, the nicotine-ion exchange resin combination consists of nicotine in an amount of between 10 and 30 weight-% and ion exchange resin in an amount of between 70 and 90 weight-%.

[0083] In one embodiment of the present application, the nicotine-ion exchange resin combination is essentially free of water.

[0084] In one embodiment of the present application, the nicotine-ion exchange resin combination further comprises a C3 sugar alcohol.

[0085] In one embodiment, the C3 sugar alcohol can be selected from the group consisting of glycerol, propylene glycol and any combination thereof.

[0086] In one embodiment of the present application, the nicotine-ion exchange resin combination further comprises glycerol.

[0087] In one embodiment of the present application, the nicotine-ion exchange resin combination further comprises glycerol in an amount of 0.1 to 50 weight-%, such as 5 to 40 weight-%, such as 5 to 30 weight-%.

[0088] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50 weight-% and ion exchange resin in an amount of between 20 and 75 weight-%.

[0089] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises water in an amount of not more than 75 weight-%, such as not more than 50 weight-%, such as not more than 40 weight-%, such as not more than 30 weight-%, such as not more than 20 weight-%, such as not more than 10 weight-%, such as not more than 5 weight-%.

[0090] In one advantageous embodiment of the present application, the ion exchange resin comprises one or more resins selected from the group consisting of:

[0091] (i) a resin of the methacrylic weakly acidic type containing carboxylic functional groups,

[0092] (ii) a copolymer of methacrylic acid and divinylbenzene containing carboxylic functional groups,

[0093] (iii) a resin of the polystyrene strongly acidic type containing sulfonic functional groups,

[0094] (iv) a resin of the polystyrene medium acidic type containing phosphoric functional groups, and

[0095] (v) combinations thereof.

[0096] In one advantageous embodiment of the present application, the ion exchange resin comprises a polacrilex resin.

[0097] In an advantageous embodiment of the application, the ion exchange resin is a polacrilex resin.

[0098] In an advantageous embodiment of the application, the ion exchange resin is a polacrilex resin.

[0099] In an advantageous embodiment of the application, the polacrilex resin comprises or is IRP64.

[0100] In an advantageous embodiment of the application, the nicotine-ion exchange resin combination comprises nicotine complexed with the ion exchange resin.

[0101] In an advantageous embodiment of the application, the nicotine-ion exchange resin combination is nicotine complexed with the ion exchange resin.

[0102] Thus, in the above embodiment, the nicotine-ion exchange resin combination consists of nicotine complexed with the ion exchange resin.

[0103] In an advantageous embodiment of the application, the nicotine-ion exchange resin combination comprises free base nicotine mixed with the ion exchange resin.

[0104] An advantage of the above embodiment can be to provide a sustained release of nicotine. At the same time, the release rate of nicotine is not too slow to fail to give the user the desired relief from craving.

[0105] In an advantageous embodiment of the application, the nicotine-ion exchange resin combination is free base nicotine mixed with the ion exchange resin.

[0106] In an embodiment of the application, the pouch composition further comprises nicotine.

[0107] In an embodiment of the application, the pouch composition further comprises nicotine.

[0108] In an embodiment of the application, the pouch composition further comprises nicotine selected from the group consisting of: a nicotine salt, nicotine free base, nicotine bound to an ion exchanger such as an ion exchange resin (e.g. nicotine polacrilex resin), a nicotine inclusion complex or any non-covalently bound nicotine; nicotine bound to a zeolite; nicotine bound to a cellulose such as microcrystalline cellulose or starch microspheres, and mixtures thereof.

[0109] In an advantageous embodiment of the application, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 15-40 wt% of the composition.

[0110] In an embodiment of the application, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 20-65 wt% of the composition, such as 25-65 wt% of the composition.

[0111] In an embodiment of the application, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 15-40 wt% of the composition.

[0112] In an embodiment of the application, the pouch composition comprises water in an amount of 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 15-40 wt% of the composition, such as 15-30 wt% of the composition.

[0113] In an embodiment of the application, the pouch composition comprises water in an amount of 15-40 wt% of the composition.

[0114] The water can be added as a separate component to be mixed completely or partially into other components, such as the fibres. For example, when a nicotine ion exchange resin combination consisting of a mixture of freebase nicotine and ion exchange resin and water is added, a significant amount of water in the final pouch composition can come from this mixture. For example, if the final amount of the pouch composition comprises 5% water from the nicotine-ion exchange resin combination, then up to one third of the water in the pouch composition originates from the nicotine-ion exchange resin combination.

[0115] In an advantageous embodiment of the application, the pouch composition comprises at least one sugar alcohol.

[0116] In an embodiment of the application, xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and mixtures thereof are used as the at least one sugar alcohol. The at least one sugar alcohol can also include additional sugar alcohols. As an example embodiment, a hydrogenated starch hydrolysate comprising a mixture of sorbitol, maltitol and other sugar alcohols can be used.

[0117] The sugar alcohol can advantageously facilitate and induce salivation of the pouch composition, whereby dissociation of the inorganic divalent cations and release of nicotine is obtained, such as release of nicotine from the ion exchange resin and release of nicotine from the pouch.

[0118] Sugar alcohols can advantageously be used to further increase the release of nicotine from the pouch.

[0119] In addition, sugar alcohols can advantageously be used to obtain a desired mouth feel by increasing salivation and thereby counteract any local dehydration or mouth dryness feeling experienced by the pouch user.

[0120] Thus, sugar alcohols can advantageously be used in combination with inorganic divalent cations to achieve a desired nicotine release while also achieving a desired taste.

[0121] In one embodiment of the present application, the at least one sugar alcohol is selected from sugar alcohols having at least 4 carbon atoms.

[0122] In one advantageous embodiment of the present application, the at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and mixtures thereof.

[0123] In one advantageous embodiment of the present application, the pouch composition comprises at least two sugar alcohols.

[0124] It should be noted that different sugar alcohols can be applied for taste and salivation purposes, where the sugar alcohol composition is made from different sugar alcohols having different properties in terms of storage, bacterial growth, processability and / or taste.

[0125] In one embodiment of the present application, the at least two sugar alcohols are selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and mixtures thereof.

[0126] In one advantageous embodiment of the present application, the pouch composition comprises sugar alcohol in an amount of at least 1 wt% of the composition, such as at least 2 wt% of the composition, such as at least 5 wt% of the composition, such as at least 10 wt% of the composition, such as at least 15 wt% of the composition.

[0127] In one advantageous embodiment of the present application, the pouch composition comprises sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition.

[0128] In one embodiment, the pouch composition comprises sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition.

[0129] In one embodiment, the pouch composition comprises a sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 10 to 70 wt% of the composition, such as 10 to 60 wt% of the composition, such as 15 to 60 wt% of the composition, such as 20 to 60 wt% of the composition, such as 20 to 50 wt% of the composition.

[0130] In an advantageous embodiment of the present application, the pouch composition comprises at least one water insoluble fibre.

[0131] In an advantageous embodiment of the present application, the pouch composition comprises said water insoluble fibre in an amount between 5 to 50 wt% of the pouch composition, such as 10-45 wt% of the pouch composition, such as 15-40 wt% of the pouch composition.

[0132] In one embodiment of the present application, the pouch composition comprises said water insoluble fibre in an amount between 5 to 50 wt% of the pouch composition, such as 5-45 wt% of the pouch composition, such as 5-40 wt% of the pouch composition.

[0133] In one embodiment of the present application, the pouch composition comprises said water insoluble fibre in an amount between 5 to 50 wt% of the pouch composition, such as 10-50 wt% of the pouch composition, such as 15-50 wt% of the pouch composition.

[0134] One advantage of the above embodiments can be that a residue is left even after use of a nicotine pouch comprising said pouch composition. This can give a pleasant perception to the user of the nicotine pouch, for example due to similarity with tobacco containing products.

[0135] The water insoluble fibre can advantageously provide a desired mouthfeel throughout the use of the pouch.

[0136] In an advantageous embodiment of the present application, the water insoluble fibre is a plant fibre.

[0137] In an advantageous embodiment of the present application, the water insoluble fibre is selected from the group consisting of wheat fibre, pea fibre, rice fibre, corn fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, cellulose fibre, bran fibre, bamboo fibre, powdered cellulose, and combinations thereof.

[0138] Powdered cellulose within the scope of the present application is to be understood as cellulose made by processing a-celulose obtained from pulp such as wood pulp from a line of fibrous plant material.

[0139] In one embodiment of the present application, the water insoluble fibre comprises or consists of cereal plant fibre.

[0140] In one embodiment of the present application, the water insoluble fiber comprises or consists of fruit and / or vegetable fiber.

[0141] In one embodiment of the present application, the water insoluble composition comprises or consists of water insoluble fiber selected from the group consisting of wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof.

[0142] In one embodiment of the present application, the water insoluble fiber is selected from the group consisting of wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof.

[0143] In one embodiment of the present application, the water insoluble composition comprises or consists of water insoluble fiber selected from the group consisting of wheat fiber, oat fiber, pea fiber, or combinations thereof.

[0144] In one embodiment of the present application, the water insoluble fiber is selected from the group consisting of wheat fiber, oat fiber, pea fiber, or combinations thereof.

[0145] In one embodiment of the present application, the water insoluble composition comprises or consists of water insoluble fiber selected from the group consisting of wheat fiber, oat fiber, or combinations thereof.

[0146] In one embodiment of the present application, the water insoluble fiber is selected from the group consisting of wheat fiber, oat fiber, or combinations thereof.

[0147] In one embodiment of the present application, the water insoluble fiber is powdered cellulose.

[0148] Non-limiting examples of useful water insoluble fibers include Vitacel WF 600, Vitacel HF 600, Vitacel P95, Vitacel WF 200, Vitacel L00, Vitacel Erbsenfaser EF 150, Vitacel bamboo fiber baf 90, Vitacel HF 600, Vitacel Cellulose L700G, Vitacel PF200, Vitacel potato fiber KF200, Vitacel bamboo fiber haf BAF40, Vitacel Haferfaser / oat fiber HF-401-30US.

[0149] Non-limiting examples of useful powdered cellulose include Vitacel L 00, Vitacel Cellulose L700G, Vitacel LC1000, Vitacel L600-20, Vitacel L600, and the like.

[0150] In one embodiment, the powdered cellulose is not chemically modified. Thus, the powdered cellulose can be a non-chemically modified cellulose fiber which does not include, for example, microcrystalline cellulose (MCC).

[0151] In an advantageous embodiment of the present application, the water insoluble fiber has a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.

[0152] One advantage of the above-mentioned embodiments can be that the high water binding capacity enables the pouch composition to have a high water content.

[0153] Furthermore, it was found that pouches having a high water content have a desirable texture and mouthfeel, while still being able to be stored together abutting each other in, for example, a jar without sticking together too much resulting in breakage of the pouches upon removal.

[0154] In addition, the water insoluble fiber having a high water binding capacity can reduce any nicotine exchange caused by divalent cations that occurs before the pouches are used.

[0155] Thus, pouches comprising the water insoluble fiber having a high water binding capacity can advantageously have a reduced relative standard deviation (RSD) of nicotine content.

[0156] In an advantageous embodiment of the present application, the nicotine content between a series of at least 10 oral pouches comprising the pouch composition remains below a relative standard deviation (RSD) of 10%, preferably below 8%, more preferably at most 6%, even more preferably at most 4%, most preferably at most 2%.

[0157] In one embodiment of the present application, the nicotine content between a series of at least 10 oral pouches comprising the pouch composition remains a relative standard deviation (RSD) of 0.1-10%, preferably 0.1-8%, more preferably 0.1-6%, even more preferably 0.1-4%, most preferably 0.1-2%.

[0158] In one embodiment of the present application, the water insoluble fiber has a water binding capacity of 300 to 1500%, such as 400 to 1300%.

[0159] In an embodiment of the application, the water insoluble fibre has a water binding capacity of 200 to 1500 %, such as 300 to 1300 %, such as 200 to 800 %, such as 300 to 800 %, such as 400 to 600 %.

[0160] In an embodiment of the application, the water insoluble fibre has a water binding capacity of 200 to 1500 %, such as 300 to 1300 %, such as 300 to 900 %, such as 300 to 700 %, such as 400 to 700 %.

[0161] In an embodiment of the application, the water insoluble fibre has a water binding capacity of 200 to 1500 %, such as 400 to 1500 %, such as 500 to 1500 %, such as 500 to 1200 %, such as 500 to 1000 %.

[0162] In an embodiment of the application, the water insoluble fibre has a swelling capacity of at least 5.0 mL / g, such as 5.0-20 mL / g.

[0163] One advantage of the above embodiments is that the amount of water insoluble fibre can be reduced without compromising the mouthfeel during use. If an amount of water insoluble fibre is used instead of water soluble component, the swelling of the water insoluble fibre will counteract the dissolution of the water soluble component during use, and thus the user will not experience any reduction of the contents of the pouch during use.

[0164] In an embodiment of the application, the water insoluble fibre is selected from the group consisting of pea fibre, powdered cellulose and combinations thereof, and wherein the pouch composition comprises flavouring in an amount of not more than 10 % by weight of the pouch composition.

[0165] In an embodiment of the application, the pouch composition comprises water insoluble fibre selected from the group consisting of pea fibre and powdered cellulose or combinations thereof and flavouring in an amount of 0.01-10 % by weight of the pouch composition.

[0166] In an advantageous embodiment of the application, the water insoluble fibre has a density of 50 to 500 grams / litre, such as 100 to 400 grams / litre, such as 200 to 300 grams / litre.

[0167] The use of water insoluble fibre having a relatively low bulk density will not only provide a good mouthfeel, but also provide an efficient release from the pouch due to the fact that the relatively low bulk density facilitates an efficient saliva secretion dissolving and releasing the water soluble components of the composition.

[0168] In an advantageous embodiment of the application, the pouch composition comprises a pH adjusting agent.

[0169] In an advantageous embodiment of the application, the pouch composition comprises a pH adjusting agent in an amount between 0.01 and 15 weight-% of the pouch composition, such as between 0.5 and 10 weight-% of the pouch composition, such as between 1 and 10 weight-% of the pouch composition, such as between 5 and 10 weight-% of the pouch composition.

[0170] It can be desirable to obtain a relatively fast nicotine release rate and an efficient uptake / absorption, as this will ensure a fast effect on the user, i.e. craving relief.

[0171] Furthermore, the combination of an efficient release and an efficient absorption advantageously enables a relatively high utilization of the nicotine dose within the pouch. A relatively high utilization of the nicotine dose within the pouch can further provide a reduction of the necessary nicotine dose of the pouch without compromising the effect produced. A lower nicotine dose can in turn result in a reduction of the production costs, as nicotine can be relatively expensive, but can also help users who want to reduce their nicotine intake.

[0172] In an advantageous embodiment of the application, the pH adjusting agent is a basic pH adjusting agent, such as a basic buffer.

[0173] In an advantageous embodiment of the application, the pH adjusting agent is a buffer, such as a basic buffer.

[0174] In an embodiment of the application, the pH adjusting agent is water soluble.

[0175] In an embodiment of the application, the pH adjusting agent has a water solubility of at least 5 g / 100 mL water at 25 degrees Celsius, atmospheric pressure and pH 7.0.

[0176] In an embodiment of the application, the pouch composition is adapted to give a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 grams of the pouch composition is added to 20 mL of a 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4).

[0177] An advantage of the above-mentioned embodiment can be that a relatively efficient nicotine uptake is facilitated due to the high pH value obtained.

[0178] Another advantage of the above-mentioned embodiment can be that the need for preservatives can be reduced or even eliminated, and if not absent, a low amount of such preservatives can be used.

[0179] In addition, the high pH value obtained can advantageously provide a tingling sensation in the mouth that can be perceived as a desirable mouth feel, e.g. due to similarities with tobacco-based pouch products.

[0180] In one embodiment of the present application, the pH adjusting agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, penta potassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0181] In one embodiment of the present application, the pH adjusting agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, sodium diphosphate, potassium diphosphate, pentasodium triphosphate, penta potassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

[0182] In one advantageous embodiment of the present application, the pH adjusting agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate; potassium bicarbonate; tromethamine; phosphate buffers, amino acids, or any combination thereof.

[0183] In one embodiment, the pouch composition comprises inorganic divalent cations, which can be provided as water-soluble salts, and in addition thereto comprises a pH adjusting agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate; potassium bicarbonate; tromethamine; phosphate buffers; amino acids, or any combination thereof.

[0184] In one embodiment, the pouch composition comprises inorganic divalent cations, which can be provided as water-soluble salts, and in addition thereto comprises a pH adjusting agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate; potassium bicarbonate; tromethamine; phosphate buffers; or any combination thereof.

[0185] In one embodiment, the pouch composition comprises inorganic divalent cations, which can be provided as water-soluble salts, and in addition thereto comprises a pH adjusting agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate; potassium bicarbonate; tromethamine; or any combination thereof.

[0186] In the present context, the term "tromethamine" refers to (tris(hydroxymethyl)aminomethane), also sometimes referred to as tris buffer.

[0187] In the present context, the term "phosphate buffers" refers to alkali and alkaline earth metal phosphates such as sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, penta potassium triphosphate, sodium polyphosphate, potassium polyphosphate.

[0188] In an advantageous embodiment of the present application, the pH adjusting agent is selected from tromethamine, an amino acid, and a phosphate buffer or any combination thereof.

[0189] In an advantageous embodiment of the present application, the pH adjusting agent is selected from tromethamine and a phosphate buffer or any combination thereof.

[0190] Tromethamine and phosphate buffers have a desirable relatively neutral taste, so use of these pH adjusting agents can not compromise the taste and mouthfeel of the pouch composition.

[0191] In an advantageous embodiment of the present application, the pH adjusting agent is selected from tromethamine.

[0192] In an embodiment of the present application, the pH adjusting agent is tromethamine.

[0193] In an embodiment of the present application, the pH adjusting agent comprises tromethamine.

[0194] In an embodiment of the present application, the pH adjusting agent is an amino acid.

[0195] In an embodiment of the present application, the pH adjusting agent comprises an amino acid.

[0196] In an embodiment of the present application, the pH adjusting agent is a phosphate buffer.

[0197] In an embodiment of the present application, the pH adjusting agent comprises a phosphate buffer.

[0198] In an embodiment of the present application, the pH adjusting agent is a phosphate buffer selected from the group consisting of sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, penta potassium triphosphate, sodium polyphosphate, potassium polyphosphate, and combinations thereof.

[0199] In an embodiment, the pH adjusting agent is an alkali metal phosphate buffer.

[0200] In an embodiment, the phosphate buffer is an alkali metal phosphate buffer.

[0201] In an embodiment, the phosphate buffer is an alkali metal phosphate buffer selected from the group consisting of sodium orthophosphate, potassium orthophosphate, sodium diphosphate, potassium diphosphate, pentasodium triphosphate, penta potassium triphosphate, sodium polyphosphate, potassium polyphosphate, and combinations thereof.

[0202] In an embodiment, the phosphate buffer is provided as a water-soluble composition.

[0203] In one embodiment of the application, the pH adjusting agent does not comprise a carbonate and / or a bicarbonate.

[0204] In one embodiment of the application, the pH adjusting agent is a non-carbonate and / or non-bicarbonate buffer or a combination thereof.

[0205] In one embodiment of the application, the pouch composition does not comprise a carbonate.

[0206] In one embodiment of the application, the pouch composition comprises a humectant.

[0207] In one embodiment, the humectant is selected from the following list: glycerol, propylene glycol, alginate, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum and combinations thereof.

[0208] In one embodiment, the humectant is or comprises alginate, such as sodium alginate, for example in an amount of 0.5 to 10%, such as 0.5 to 5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition.

[0209] In one embodiment, the humectant is or comprises alginate, such as sodium alginate, for example in an amount of 0.5 to 10%, such as 0.5 to 5% by weight of the pouch composition, such as 1-3% by weight of the pouch composition.

[0210] In one embodiment of the application, the pouch composition does not comprise alginate.

[0211] In one embodiment of the application, the pouch composition does not comprise a humectant consisting of alginate, pectin and xanthan gum.

[0212] In one embodiment of the application, the pouch composition does not comprise a humectant selected from the following list: glycerol, propylene glycol, alginate, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum and combinations thereof.

[0213] In one embodiment of the application, the pouch composition does not comprise a humectant.

[0214] In one advantageous embodiment of the application, the pouch composition is adapted to release at least 30% of the nicotine within 10 minutes when exposed to the in vitro conditions described in Example 7A.

[0215] In one advantageous embodiment of the application, the pouch composition is adapted to release at least 25% more nicotine within 5 minutes when exposed to the in vitro conditions described in Example 7A than a corresponding pouch composition not comprising a divalent cation.

[0216] In an advantageous embodiment of the application, the pouch composition comprises sodium chloride in an amount of 0.0-3.0 wt.%, such as 0.05-1.0 wt.% of the pouch composition, such as 0.1-1.0 wt.% of the pouch composition.

[0217] Sodium chloride can advantageously be added in small amounts, i.e. 0.0-3.0 wt.% as a flavour enhancer. Adding higher amounts of sodium chloride can cause an undesired taste or mouthfeel.

[0218] In an advantageous embodiment of the application, the pouch composition further comprises a preservative.

[0219] The preservative can help to keep the pouch composition free from undesired microbial growth.

[0220] In an advantageous embodiment of the application, the pouch composition further comprises a preservative in an amount of 0.05 to 0.5 wt.% of the pouch composition, such as 0.1 to 0.2 wt.% of the pouch composition.

[0221] Non-limiting examples of preservatives that can be used within the scope of the present application include sorbic acid (E200) and its salts (e.g. sodium sorbate (E201), potassium sorbate (E202), calcium sorbate (E203)), benzoic acid (E210) and its salts (e.g. sodium benzoate (E211), potassium benzoate (E212), calcium benzoate (E213)).

[0222] In an advantageous embodiment of the application, the pouch composition comprises less than 0.1 wt.% of a preservative, such as less than 0.05 wt.% of a preservative.

[0223] Thus, the pouch composition can comprise a preservative in an amount of 0 to 0.1 wt.%, such as in an amount of 0 to 0.05 wt.%. This includes zero content of preservative, i.e. the pouch composition is free of preservative. A low amount of preservative or even no preservative can be achieved by obtaining a relatively alkaline environment, in particular by using freebase nicotine.

[0224] In an advantageous embodiment of the application, the pouch composition is free of preservative.

[0225] In an advantageous embodiment of the application, the pouch composition is a non-tobacco pouch composition.

[0226] In an advantageous embodiment of the application, the pouch composition comprises less than 2.0 wt.% of tobacco, such as less than 1.0 wt.% of tobacco, such as less than 0.5 wt.% of tobacco, such as 0.0 wt.% of tobacco.

[0227] In an advantageous embodiment of the application, the pouch composition comprises non-tobacco fibres. In an advantageous embodiment of the application, the pouch composition comprises non-tobacco fibres.

[0228] In an advantageous embodiment of the application, the pouch composition is a powderous composition.

[0229] The present application also relates to an oral pouch nicotine product comprising a saliva permeable pouch and a pouch composition according to the present application or any embodiment thereof enclosed in the pouch.

[0230] In an advantageous embodiment of the application, the pouch nicotine product comprises nicotine in an amount of 0.5 to 20 mg, such as 1.0 to 20 mg, such as 5.0 to 15 mg.

[0231] In an advantageous embodiment of the application, the pouch nicotine product comprises a nicotine-ion exchange combination in an amount of 1 to 100 mg per pouch.

[0232] In an embodiment of the application, the pouch nicotine product comprises a nicotine-ion exchange combination in an amount of 1 to 100 mg per pouch, such as 10 to 90 mg per pouch, such as 10 to 80 mg per pouch, such as 20 to 80 mg per pouch, such as 30 to 80 mg per pouch, such as 40 to 80 mg per pouch, such as 50 to 80 mg per pouch.

[0233] In an embodiment of the application, the pouch nicotine product comprises a nicotine-ion exchange combination in an amount of 1 to 100 mg per pouch, such as 10 to 80 mg per pouch, such as 10 to 60 mg per pouch, such as 20 to 60 mg per pouch, such as 20 to 50 mg per pouch.

[0234] In an embodiment of the application, the divalent cation is provided as a salt having a water solubility of 5-500 g / 100 mL water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0, such as 5-350 g / 100 mL water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.

[0235] In an embodiment of the application, the inorganic divalent cation is provided as a salt in an amount between 0.1 to 15.0 weight % of the composition, such as between 0.1 to 10.0 weight % of the composition, such as between 0.5 to 10.0 weight % of the composition, and the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chloride, bromide, bicarbonate, sulfate and any combination thereof.

[0236] In one embodiment of the application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition, and the water-soluble salt has a water solubility of at least 5 g per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.

[0237] In one embodiment of the application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition, and the water-soluble salt has a water solubility of at least 5 g per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0.

[0238] In one embodiment of the application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition, and the pouch composition comprises nicotine in an amount of at least 0.1 wt.-%, such as at least 0.2 wt.-% of the pouch composition.

[0239] In one embodiment of the application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition, the pouch composition comprises nicotine in an amount of at least 0.1 wt.-%, such as at least 0.2 wt.-% of the pouch composition, and the solid oral nicotine formulation comprises the inorganic divalent cations in a molar ratio of at most 5, such as at most 3.75, such as at most 2.5, relative to the amount of nicotine in the nicotine-ion exchange resin combination.

[0240] In one embodiment of the application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition, the pouch composition comprises nicotine in an amount of at least 0.1 wt.-%, such as at least 0.2 wt.-% of the pouch composition, and the pouch composition comprises the inorganic divalent cations in a molar ratio of at most 6.5 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 6.0 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 5 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 3.75 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 2.5 to the amount of nicotine in the nicotine-ion exchange resin combination.

[0241] In one embodiment of the application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition, and the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt.-% of the pouch composition.

[0242] In one embodiment of the application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition, the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt.-% of the pouch composition, and the solid oral nicotine formulation comprises the inorganic divalent cations in a molar ratio of at most 5 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 3.75 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 2.5 to the amount of nicotine in the nicotine-ion exchange resin combination.

[0243] In one embodiment of the present application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition, the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt.-% of the pouch composition, and the pouch composition comprises the inorganic divalent cations in a molar ratio of at most 6.5 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 6.0 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 5 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 3.75 to the amount of nicotine in the nicotine-ion exchange resin combination, such as at most 2.5 to the amount of nicotine in the nicotine-ion exchange resin combination.

[0244] In one embodiment of the present application, the nicotine-ion exchange resin combination comprises nicotine in an amount between 5 and 50 wt.-% and ion exchange resin in an amount between 10 and 95 wt.-%, and the ion exchange resin is a polacrillin resin.

[0245] In one embodiment of the present application, the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt.-% of the pouch composition, and the nicotine-ion exchange resin combination comprises nicotine in an amount between 5 and 50 wt.-% and ion exchange resin in an amount between 10 and 95 wt.-%, and the ion exchange resin is a polacrillin resin.

[0246] In one embodiment of the present application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt.-% of the composition, such as between 0.1 and 10.0 wt.-% of the composition, such as between 0.5 and 10.0 wt.-% of the composition, the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt.-% of the pouch composition, and the pouch composition comprises water in an amount of 15-65 wt.-% of the composition, such as 15-60 wt.-% of the composition, such as 15-50 wt.-% of the composition, such as 20-50 wt.-% of the composition, such as 20-40 wt.-% of the composition.

[0247] In one embodiment, the at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof, and the pouch composition comprises the sugar alcohol in an amount of 1 to 80 wt.-% of the composition, such as 2 to 70 wt.-% of the composition, such as 5 to 60 wt.-% of the composition, such as 10 to 50 wt.-% of the composition, such as 15 to 50 wt.-% of the composition.

[0248] In one embodiment of the application, the inorganic divalent cations are provided as a salt in an amount between 0.1 and 15.0 wt% of the composition, such as between 0.1 and 10.0 wt% of the composition, such as between 0.5 and 10.0 wt% of the composition, the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt% of the pouch composition, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 20-50 wt% of the composition, such as 20-40 wt% of the composition, and the pouch composition comprises a sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition.

[0249] In one embodiment of the application, the pouch composition comprises a sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition, and the pouch composition comprises water insoluble fibers in an amount between 5 to 50 wt% of the pouch composition, such as 10-45 wt% of the pouch composition, such as 15-40 wt% of the pouch composition.

[0250] In one embodiment of the application, the pouch composition comprises a sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition, the pouch composition comprises water insoluble fibers in an amount between 5 to 50 wt% of the pouch composition, such as 10-45 wt% of the pouch composition, such as 15-40 wt% of the pouch composition, and the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 20-50 wt% of the composition, such as 20-40 wt% of the composition.

[0251] In one embodiment of the application, the pouch composition comprises water insoluble fibers in an amount between 5 to 50 wt% of the pouch composition, such as 10-45 wt% of the pouch composition, such as 15-40 wt% of the pouch composition, and the water insoluble fibers are selected from the group consisting of wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof.

[0252] In one embodiment of the present application, the inorganic divalent cation is provided as a salt in an amount between 0.1 and 15.0 wt% of the composition, such as between 0.1 and 10.0 wt% of the composition, such as between 0.5 and 10.0 wt% of the composition, the pouch composition comprises a nicotine-ion exchange combination in an amount of 0.1 to 20 wt% of the pouch composition, the pouch composition comprises water in an amount of 15-65 wt% of the composition, such as 15-60 wt% of the composition, such as 15-50 wt% of the composition, such as 20-50 wt% of the composition, such as 20-40 wt% of the composition, the pouch composition comprises a sugar alcohol in an amount of 1 to 80 wt% of the composition, such as 2 to 70 wt% of the composition, such as 5 to 60 wt% of the composition, such as 10 to 50 wt% of the composition, such as 15 to 50 wt% of the composition, and the pouch composition comprises the water insoluble fiber in an amount between 5 to 50 wt% of the pouch composition, such as 10-45 wt% of the pouch composition, such as 15-40 wt% of the pouch composition.

[0253] In one embodiment of the present application, the pouch composition comprises a pH adjusting agent in an amount between 0.01 and 15 wt% of the pouch composition, such as between 0.5 and 10 wt% of the pouch composition, such as between 1 and 10 wt% of the pouch composition, such as between 5 and 10 wt% of the pouch composition, and the pH adjusting agent is selected from sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate; potassium bicarbonate; tromethamine; phosphate buffer, or any combination thereof.

[0254] In one embodiment of the present application, the pouch composition comprises a pH adjusting agent in an amount between 0.01 and 15 wt% of the pouch composition, such as between 0.5 and 10 wt% of the pouch composition, such as between 1 and 10 wt% of the pouch composition, such as between 5 and 10 wt% of the pouch composition, and the pH adjusting agent is selected from sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate; potassium bicarbonate; tromethamine; phosphate buffer, or any combination thereof, and the divalent cation is provided as a water soluble salt having a water solubility of at least 5 g / 100 mL water measured at 25 degrees Celsius, atmospheric pressure, and pH 7.0.

[0255] In one embodiment of the present application, the pouch composition comprises a pH adjusting agent in an amount between 0.01 and 15 wt% of the pouch composition, such as between 0.5 and 10 wt% of the pouch composition, such as between 1 and 10 wt% of the pouch composition, such as between 5 and 10 wt% of the pouch composition, and the pH adjusting agent is selected from sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate; potassium bicarbonate; tromethamine; phosphate buffer, or any combination thereof, and the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from chloride, bromide, bicarbonate, sulfate, and any combination thereof.

[0256] The present application also relates to a pouch composition comprising

[0257] a nicotine-ion exchange resin combination, and

[0258] an inorganic polyvalent cation.

[0259] In an advantageous embodiment of the present application, the polyvalent cation is selected from the group consisting of polyvalent ions of calcium, magnesium, zinc, aluminum, barium, iron, manganese, copper, lead, cobalt, nickel, such as Ca2+, Mg2+, Zn2+, Al3+, Ba2+, Fe2+, Fe3+, Fe4+, Mn2+, Mn4+, Cu4+or any combination thereof.

[0260] In an embodiment of the present application, the polyvalent cation is selected from the group consisting of Ca2+, Mg2+, Zn2+, Ba2+, Fe2+, Fe3+, Fe4+, Al3+, Mn2+, Mn4+, Cu4+and any combination thereof.

[0261] In an advantageous embodiment of the present application, the polyvalent cation is selected from the group consisting of trivalent cations of aluminum, divalent cations of calcium, magnesium, iron, zinc and any combination thereof.

[0262] In an advantageous embodiment of the present application, the polyvalent cation is a trivalent cation.

[0263] In an embodiment, the trivalent cation is aluminum.

[0264] In an embodiment of the present application, the polyvalent cation comprises aluminum chloride.

[0265] In an embodiment of the present application, the polyvalent cation is selected from the group consisting of aluminum chloride, divalent cations of calcium, magnesium, iron, zinc and any combination thereof.

[0266] In an advantageous embodiment of the present application, the polyvalent cation is selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc and any combination thereof.

[0267] In an advantageous embodiment of the present application, the polyvalent cation is selected from the group consisting of divalent cations of calcium, magnesium and any combination thereof. DETAILED DESCRIPTION

[0268] As used herein, the term "pouch composition" refers to a composition for use in an oral pouch, i.e. a pouch for oral use. Thus, the pouch composition refers to a composition enclosed within a pouch. In addition, the terms "pouch composition", "nicotine pouch composition" and "solid oral nicotine formulation" are used interchangeably when referring to a composition enclosed within a pouch.

[0269] As used herein, the term "nicotine" refers to nicotine used as a refined / isolated substance. In particular, nicotine does not refer to tobacco material having a nicotine content. Thus, when referring to a nicotine amount (which is also to be understood as a nicotine dose), this amount refers to the amount of pure nicotine.

[0270] Nicotine also encompasses nicotine not obtained from tobacco, often referred to as synthetic nicotine.

[0271] As used herein, "molar ratio" refers to the ratio of the molar content of a first component divided by the molar content of a second component.

[0272] The relative content between the first component and the second component can also be presented in terms of the number of equivalents of the first component relative to the second component.

[0273] Thus, a pouch containing divalent cations at a molar ratio of 0.1 relative to the amount of nicotine in the nicotine-ion exchange resin combination can also be presented as a pouch containing 0.1 equivalents of divalent cations relative to the amount of nicotine in the nicotine-ion exchange resin combination, i.e. a pouch containing 0.1 equivalents of divalent cations and 1 equivalent of nicotine in the nicotine-ion exchange resin combination.

[0274] As used herein, the term "free base nicotine" refers to the non-protonated form of nicotine and thus does not include nicotine salts or nicotine provided as a complex between nicotine and an ion exchange resin. However, the free base nicotine can be mixed with an amount of ion exchange resin or a water-soluble composition such as a sugar alcohol or a water-soluble fibre. While the free base nicotine includes both free base nicotine extracted from tobacco as well as free base nicotine manufactured synthetically, the free base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, the free base nicotine is provided in a liquid.

[0275] As used herein, the term "pouch" is intended to mean a container typically formed from a web of fibrous material enclosing a cavity. The pouch is a pouch designed for administration of the active ingredient in the oral cavity and is thus suitable for oral use, it is non-toxic and is water-insoluble. The fibrous material may, for example, form a woven or non-woven web or fabric. The pouch can be sealed, for example, by bonding two respective webs or fabrics to each other along their edges to form a cavity for nicotine and the non-water-soluble composition. In order to release the nicotine, the pouch is made water-permeable so as to allow saliva from the oral cavity to penetrate the pouch and into the cavity, where the saliva can come into contact with the nicotine, whereby the nicotine is released from the oral pouch.

[0276] As used herein, the term "nicotine-ion exchange resin combination" refers to a combination comprising nicotine complexed with an ion exchange resin and / or free base nicotine mixed with an ion exchange resin.

[0277] As used herein, the term "nicotine complexed with ion exchange resin" refers to nicotine bound to an ion exchange resin.

[0278] In the present context, the term "free base nicotine mixed with ion exchange resin" refers to a mixture comprising free base nicotine and ion exchange resin. It is noted that even if some embodiments comprise a combination of nicotine complexed with ion exchange resin and nicotine in its free base form mixed with ion exchange resin, the term "free base nicotine mixed with ion exchange resin" requires the presence of nicotine in its free base form. In some embodiments, the mixture is an aqueous mixture. The free base nicotine and water are mixed with the ion exchange resin, whereby a mixture comprising both free base nicotine and ion exchange resin is obtained. The free base nicotine mixed with ion exchange resin is referred to as "premix" in the examples.

[0279] As used herein, the term "powder composition" refers to a composition in the form of a powder, i.e. as a particulate material having a relatively small particle size, e.g. between 1 and 1200 micrometers. In particular, the powder composition does not imply a powdered tobacco.

[0280] As used herein, the term "humectant" is to be understood as a wetting agent for keeping the pouches moist, i.e. a humectant is added to the pouch composition for the purpose of keeping the pouches moist. Thus, the term humectant does not refer to substances added for other purposes, and below also hygroscopic substances added for other purposes, such as sugar alcohols, water insoluble fibers and glycerol associated with the nicotine-ion exchange resin combination, such as the ion exchange resin in nicotine polacrilex. Examples of humectants include alginate, propylene glycol, hydroxypropyl cellulose and glycerol. It is noted that when glycerol is introduced as a humectant, the glycerol is added as free glycerol and is thus a liquid at room temperature. Further examples of humectants include triacetin, modified starch, pectin, xanthan gum etc. The term humectant does not refer to sugar alcohols comprising 4 or more carbons. In addition, the term humectant does not refer to fibers, such as water insoluble fibers, such as wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose and combinations thereof. In addition, the term humectant does not include e.g. NaCI.

[0281] As used herein, the term "water soluble" refers to a relatively high water solubility, e.g. a water solubility of more than 5 grams of the water soluble composition or substance per 100 mL water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0. Unless otherwise specified, when referring to "soluble" compositions or substances, water solubility is intended.

[0282] As used herein, the term "water insoluble" refers to a relatively low water solubility, for example a water solubility of less than 0.1 gram of the composition or substance per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0. When referring to "insolubility", water insolubility is meant unless otherwise specified. Thus, a composition or substance having a water solubility of between 0.1 and 5 grams of the composition or substance per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH 7.0 is neither considered water soluble nor water insoluble, but has intermediate water solubility.

[0283] The pouch of the present application provides nicotine release into the oral cavity. A nicotine release profile can be obtained that comprises both a fast release phase and a sustained release phase.

[0284] As used herein, the term "fast release" or "fast release phase" can refer to the initial 2 minutes of the nicotine release profile, while the term "sustained release phase" refers to the subsequent time period of the release profile up to the end of the experiment or use.

[0285] As used herein, the term "fast release rate" refers to the nicotine released per minute in the initial 2 minutes.

[0286] As used herein, the term "effective release" refers to the total release of nicotine during the release phase or use phase of the experiment.

[0287] As used herein, the term "dissolution" is the process in which a solid substance enters a solvent, such as oral cavity saliva or water inside the pouch, to produce a solution.

[0288] Typically, the pouch comprises an opening, wherein the characteristic opening size is adapted to the characteristic size of the matrix composition in order to retain the matrix composition inside the pouch before use and / or to retain a portion of the matrix composition, such as a water insoluble composition, inside the pouch during use.

[0289] In order to obtain a pouch with a suitable opening size in view of the matrix composition to be used, the material of the pouch can be chosen accordingly, for example comprising a woven and / or non-woven fabric, for example.

[0290] In other words, according to various embodiments, the pouch forms a membrane that allows saliva to pass through and prevents or inhibits the passage of the matrix composition. The membrane of the pouch can be any suitable material, for example a woven or non-woven fabric (e.g., cotton, pile fabric, etc.), a heat-sealable non-woven cellulose or other polymeric material, such as a synthetic, semi-synthetic or natural polymeric material. One example of a suitable pouch material is paper made from pulp and a small amount of wet strength agent. The material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from exiting the pouch or bag during use. Suitable materials are also those that do not have a significant influence on the release of nicotine from the pouch.

[0291] The pouch composition is filled into the pouch and held in the pouch by a seal. The ideal pouch is chemically and physically stable, it is pharmaceutically acceptable, it is insoluble in water, it is easy to fill with powder and seal, and it provides a semi-permeable membrane layer that prevents the powder from exiting the pouch but allows saliva and dissolved components from the pouch composition that are dissolved therein or small enough suspended components such as nicotine to pass through the pouch.

[0292] The pouch can be placed in the oral cavity by the user. Saliva then enters the pouch, the nicotine and other components that are soluble in saliva begin to dissolve and pass out of the pouch with the saliva into the oral cavity where the nicotine can be absorbed.

[0293] According to one embodiment of the present application, the pouch composition can further comprise one or more additives.

[0294] In one embodiment of the present application, the additive is selected from the group consisting of a bile salt, a polysorbate, a chelating agent, a citrate, a cyclodextrin, a detergent, an enamine derivative, a fatty acid, labrasol, lecithin, a phospholipid, a synthetic and natural surfactant, a non-ionic surfactant, a cell envelope perturbation compound, a solvent, a steroid detergent, a chelating agent, a solubilizer, a charge modifier, a pH modifier, a degradative enzyme inhibitor, a mucolytic or mucorepulsive agent, a membrane penetration enhancer, a modulator of epithelial junction physiology, a vasodilator, a selective transport enhancer, or any combination thereof. The pH modifier includes a buffer.

[0295] In one embodiment of the present application, the additive is selected from the group consisting of cetylpyridinium chloride (CPC), benzalkonium chloride, sodium lauryl sulfate, polysorbate 80, polysorbate 20, cetyltrimethylammonium bromide, laureth 9, sodium salicylate, sodium EDTA, EDTA, aprotinin, sodium taurocholate, saponin, bile salt derivatives, fatty acids, sucrose esters, azone emulsion, dextran sulfate, linoleic acid, labrafil, transcutol, urea, azone, non-ionic surfactants, sulfoxides, sauric acid / PG, POE 23 lauryl ether, methoxysalicylate, dextran sulfate, methanol, ethanol, sodium cholate, sodium taurocholate, lysophosphatidylcholine, alkylglycoside, polysorbate, sorbitan ester, poloxamer block copolymer, PEG-35 castor oil, PEG-hydrogenated castor oil, caprylocaproyl macrogol-8 glycerides, PEG-8 caprylic / capric glycerides, dioctyl sulfosuccinate, polyethylene lauryl ether, ethoxydiglycol, propylene glycol, mono-dioctanole, glyceryl monocaprylate, glyceryl fatty acid (C.sub.8-C.sub.18) ethoxylated oleic acid, linoleic acid, caprylic / capric glycerides, glyceryl monooleate, glyceryl monolaurate, capric caprylic triglyceride, ethoxylated nonylphenol, PEG-(8-50) stearate, olive oil PEG-6, esters, triolein PEG-6 ester, lecithin, d-alpha tocopherol polyethylene glycol 1,000 succinates, citric acid, sodium citrate, BRIJ, sodium laurate, 5-methoxysalicylic acid, bile salts, acetylsalicylate, ZOT, docosahexaenoic acid, alkylglycosides, sodium glycocholate (GC-Na), sodium taurocholate (TC-Na), EDTA, choline salicylate, sodium caprate (Cap-Na), N-lauryl-β-D-maltopyranoside (LM), diethyl maleate, Labrasol, sodium salicylate, menthol, alkali metal alkyl sulfates, sodium dodecyl sulfate, glycerol, cholic acid, lecithin, phosphatidylcholine, phosphatidylserine, sphingomyelin, phosphatidylethanolamine, cephalin, lysophosphatidylcholine, hyaluronic acid: alkali metal salts, sodium, alkaline earth metals and aluminum, octylphenoxy polyethoxyethanol, glycolic acid, lactic acid, chamomile extract, cucumber extract, borage oil, evening primrose oil, polyglycerol, lysine, polylysine, triolein, monoolein, monooleate, monolaurate, Polydocanol alkyl ether, chenodeoxycholate, deoxycholate, glycocholate, taurocholate, glycodeoxycholate, taurodeoxycholate, sodium glycocholate, phosphatidylcholine, phosphatidylserine, sphingomyelin, phosphatidylethanolamine, cephalin, lysophosphatidylcholine, alkali metal hyaluronate, chitosan, poly-L-arginine, alkyl glucoside, sugar alkyl ester, fusidic acid derivatives, sodium taurodihydrofusidate (STDHF), didecyl-L-α-phosphatidylcholine (DDPC), nitroglycerin, sodium nitroprusside, NOC5 [3-(2-hydroxy-1-(methyl-ethyl)-2-nitrosylhydrazino)-1- propylamine], NOC12 [N-ethyl-2-(1-ethyl-hydroxy-2-nitrosylhydrazino)-ethylamine, SNAP [S-nitroso-N-acetyl-DL-penicillamine, NORI, NOR4, deacylmethyl sulfoxide, azones, salicylamides, glyceryl-1,3-diacetylacetate, 1,2-isopropylidene glycerol-3-acetyl acetic acid ester), amino acids, amino acid salts, monoamino carboxylic acids, glycine, alanine, phenylalanine, proline, hydroxyproline, hydroxy amino acids, serine, acidic amino acids, aspartic acid, glutamic acid, basic amino acids, lysine, N-acetyl amino acids, N-acetylalanine, N-acetylphenylalanine, N-acetylserine, N-acetylglycine, N-acetyllysine, N-acetylglutamic acid, N-acetylproline, N-acetyihydroxyproline, lactic acid, malic acid, and citric acid and alkali metal salts thereof, pyrrolidone carboxylic acid, alkyl pyrrolidone carboxylate, N-alkyl pyrrolidone, proline acyl ester, sodium lauryl phosphate, sodium lauryl sulfate, sodium oleyl phosphate, sodium myristyl sulfate, polyoxyethylene alkyl ether, polyoxyethylene alkyl ester, hexanoic acid, alkyl sugar, fusidic acid, polyethylene glycol, cetyl alcohol, polyvinylpyrrolidone, polyvinyl alcohol, lanolin alcohol, sorbitan monooleate, ethylene glycol tetraacetic acid, cholic acid-taurine conjugate, cholanate and salts, cyclodextran, cyclodextrin (beta), hydroxypropyl-beta-cyclodetran, sulfobutyl ether-beta-cyclodextran, methyl-beta-cyclodextrin, chitosan glutamate, chitosan acetate, chitosan hydrochloride, chitosan hydrolactate, 1-O-alkyl-2-hydroxy-sn-glycero-3-phosphocholine, 3-O-alkyl-2-acetyl-sn-glycero-1-phosphocholine, 1-O-alkyl-2-O-acetyl-sn-glycero-3-phosphoric acid (N,N,N-trimethyl) hexanol amine, propylene glycol, tetradecyl maltoside (TDM), sucrose decanoate.

[0296] As used herein, the term "pH adjusting agent" refers to an agent that actively regulates and adjusts the pH of a solution to which they have been or will be added. Thus, the pH adjusting agent can be acids and bases, including acidic and basic buffers. On the other hand, the pH adjusting agent does not include substances and compositions that affect the pH only by dilution. In addition, the pH adjusting agent does not include, for example, flavoring agents, fillers, and the like.

[0297] In one embodiment of the present application, the pH adjusting agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, gluconic acid-delta-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, penta potassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, tromethamine, phosphate buffer, amino acid, or any combination thereof.

[0298] According to various embodiments of the present application, one or more sugar alcohols can be included in the pouch composition as part of the carrier or as a sweetener as part of the pouch composition. Suitable sugar alcohols include a sugar alcohol selected from sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysate, isomalt, or any combination thereof.

[0299] In one embodiment of the present application, the pouch composition comprises a high intensity sweetener.

[0300] Preferred high intensity sweeteners include, but are not limited to, sucralose, aspartame, salts of acesulfame such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, rebaudioside A, and the like, alone or in combination.

[0301] In one embodiment of the present application, the pouch composition comprises a bulk sweetener, which includes sugar and / or sugarless components.

[0302] In one embodiment of the present application, the pouch composition comprises a bulk sweetener in an amount of from 1.0 to about 80% by weight of the pouch composition, more typically from 5 to about 70% by weight of the pouch composition, more usually from 10 to 60% by weight of the pouch composition, or from 10 to 50% by weight of the pouch composition. The bulk sweetener can act as both a sweetener and a humectant. In some embodiments, the introduction of certain ingredients can further limit the approximate amount of bulk sweetener.

[0303] The sweetener can generally support the flavor profile of the pouch composition.

[0304] Sugar sweeteners generally include, but are not limited to, sugar containing components generally known in the art of pouches, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination.

[0305] The sweetener can be used in combination with sugarless sweeteners. Generally, sugarless sweeteners include components having sweetening properties but not containing generally known sugars, and include, but are not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysate, maltitol, isomalt, erythritol, lactitol, and the like, alone or in combination.

[0306] As used herein, the term "flavor" is to be understood as having its ordinary meaning within the art. Flavors include liquid and powdered flavors. Flavors thus certainly do not include sweeteners (such as sugars, sugar alcohols and high intensity sweeteners) or acids providing pure sourness / acidity, nor do they include compounds providing pure saltiness (e.g. NaCI) or pure bitterness. Flavor enhancers include substances that provide only saltiness, bitterness or sourness. Flavor enhancers thus include e.g. NaCI, citric acid, ammonium chloride, etc.

[0307] The flavor can be a natural or synthetic flavor.

[0308] In one embodiment of the application, the pouch composition comprises a flavor. The flavor can typically be present in an amount between 0.01 and 15 wt% of the total composition of the pouch, such as between 0.01 and 5 wt% of the total composition.

[0309] Non-exhaustive examples of flavors suitable for use in embodiments of the application are coconut, coffee, chocolate, vanilla, grapefruit, orange, lime, menthol, licorice, caramel, honey, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint fruit essential oils, such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essential oils. Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils from the above fruits.

[0310] In various embodiments of the application, the pouch composition comprises a composition modifier. The composition modifier can be added to design properties of the pouch composition and / or portions thereof, such as flowability, texture, uniformity, etc.

[0311] According to various embodiments, the composition modifier can be selected from the group consisting of metal stearates, modified calcium carbonate, hydrogenated vegetable oil, partially hydrogenated vegetable oil, polyethylene glycol, polyoxyethylene monostearate, animal fat, silicate, silicate dioxide, talc, magnesium stearate, calcium stearate, fumed silica, powdered hydrogenated cottonseed oil, hydrogenated vegetable oil, hydrogenated soybean oil, emulsifiers, triglycerides, and mixtures thereof. In particular, metal stearates such as magnesium stearate can be advantageous.

[0312] The composition modifier can be added to the pouch composition in various ways.

[0313] For example, the composition modifier can be added as a full powder mix during the last few minutes of the final mixing.

[0314] Alternatively, the composition modifier can be added after the granulation step of the granulated premix.

[0315] Composition modifiers, such as magnesium stearate, can have a sealing effect and can be used to control the release of nicotine and the solubility of the pouch.

[0316] According to one embodiment of the present application, the pouch composition comprises polyvinylpyrrolidone (PVP). The pouch composition can also be free of PVP.

[0317] One advantage of the above-mentioned embodiments can be that a more uniform composition can be obtained.

[0318] Examples

[0319] Example 1A - Preparation of a pouch designed for administration of nicotine

[0320] The material of the pouch is a heat-sealable non-woven cellulose, such as long-fiber paper. Pouches that are not in the form of non-woven cellulose fabric can also be used according to the present application.

[0321] The powder is filled into the pouch and retained in the pouch by the seal.

[0322] Example 1B - Preparation of a pouch designed for administration of nicotine

[0323] The material of the pouch is manufactured using rayon fibers, such as viscose rayon. The pouch film is heat-sealed along its edges, except for an opening in one end into the interior cavity formed by the pouch film.

[0324] The powder is filled into the pouch and retained in the pouch by the seal.

[0325] Example 2: Preparation of a nicotine premix

[0326] A 60 liter planetary Bear Varimixer mixer is charged with water and nicotine is weighed and added. The mixer is stirred at low speed for 1 minute at ambient temperature. Then the ion exchange resin Amberlite IRP64 is weighed and added to the mixer. The mixer is closed and stirred at high speed for 5 minutes, if necessary, opened and scraped down. Finally the mixer is stirred at high speed for another 5 minutes. The total processing time is 20 minutes.

[0327] From the composition ingredients stated in the table below, a mixture of nicotine and cation exchange resin is thus produced.

[0328] Premix I:

[0329] Ingredients Amount (kg) Amount (%) Nicotine Water Resin 1.0 5.7 Total 12.5 71.4 Ingredients Amount (kg) Amount (%) 4.0 22.9 Nicotine 17.5 100.0

[0330] Table 1. Ingredients for the manufacture of nicotine premix I (5.7% nicotine). % water in the resulting nicotine-resin composition: 71.4

[0331] Premix II:

[0332] Water Resin Total Ingredients Amount (kg) Amount (%) 1.08 13.2 Nicotine 2.80 34.1 Water 4.32 52.7 Resin 8.20 100.0

[0333] Table 2. Ingredients used to make nicotine premix II (13.2% nicotine).

[0334] % water in resulting nicotine-resin composition: 34.1.

[0335] Premix III:

[0336] Total Ingredients Amount (kg) Amount (%) Nicotine Water 1.08 18.5 Resin 0.44 7.5 Total 4.32 74.0 Ingredients Amount (kg) Amount (%) 5.84 100.0

[0337] Table 3. Ingredients used to make nicotine premix III (18.5% nicotine). % water in resulting nicotine-resin composition: 7.5.

[0338] Premix IV:

[0339] Nicotine Water Resin Total 1.08 10.0 Ingredients Amount (kg) Amount (%) 5.40 50.0 Nicotine 4.32 40.0 Water 10.8 100.0

[0340] Table 4. Ingredients used to make nicotine premix IV (10% nicotine). % water in resulting nicotine-resin composition: 50.0.

[0341] Premix V:

[0342] Resin Total Ingredients Amount (kg) Amount (%) Nicotine 1.78 20.0 Water 2.80 31.5 Resin 4.32 48.5 Total 8.90 100.0

[0343] Table 5. Ingredients used to make nicotine premix V (20% nicotine). % water in resulting nicotine-resin composition: 31.5.

[0344] Premix VI:

[0345]

[0346]

[0347] Table 6. Ingredients used to make nicotine premix VI (30% nicotine). % water in resulting nicotine-resin composition: 27.5.

[0348] Premix VII

[0349] Ingredients Amount (kg) Amount (%) Nicotine Water Resin 3.83 35.0 Total 2.80 25.6 Ingredients Amount (kg) Amount (%) 4.32 39.4 Nicotine 10.95 100.0

[0350] Table 7. Ingredients used to make nicotine premix VII (35% nicotine). % water in resulting nicotine-resin composition: 25.6.

[0351] Premix VIII:

[0352] Water Resin Total ​ 5.15 42.0 ​ 2.80 22.8 ​ 4.32 35.2 ​ 12.27 100.0

[0353] Table 8. Ingredients for making nicotine premix VIII (42% nicotine). % water in resulting nicotine-resin composition: 22.8.

[0354] Example 3: Preparation of pouch compositions

[0355] Pouches containing the powdered compositions as listed in Tables 9-21 were prepared. Pouches were prepared as follows.

[0356] The fibers and water were mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients were subsequently added under continuous mixing: first the nicotine-ion exchange combination (NPR or premix) (mix for 2 minutes), then the remaining ingredients except for the liquid flavorant and flow agent (if any) (mix for 2 minutes), then the liquid flavorant (if any) (mix for 1 minute), then the flow agent (if any) (mix for 1 minute). Total mixing time was 9-11 minutes.

[0357] Example 4: Preparation of filled pouches

[0358] The final pouch compositions were filled into pouches (target fill weight was 500 mg of powder per pouch). The pouch material of Example 1A or 1B can be used. The powder was filled into the pouches and held in the pouches by sealing.

[0359] Example 5A: Pouches

[0360] The pouch compositions were prepared from the ingredients in Table 9 using the preparation method described in Example 3.

[0361] The pouch compositions were filled into pouches as described in Example 4 (using the pouch material of Example 1A, but 1B can also be applied).

[0362]

[0363] Table 9: Pouch compositions.

[0364] *Inorganic divalent cations are presented in equivalent numbers relative to the nicotine in the nicotine ion exchange combination.

[0365] **The divalent cations can be provided as hydrated salts, such as dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0366] Pouch content: 500 mg total, i.e. nicotine concentration 19.2 mg / g.

[0367] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber.

[0368] Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with sodium alginate, glycerin, or HPC or as a replacement for sodium alginate, glycerin, or HPC.

[0369] Sodium carbonate is used as a basic buffer. Other buffers as described herein can be used in combination with sodium carbonate or as a replacement for sodium carbonate.

[0370] As an example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can be used in combination with menthol and / or peppermint or as a replacement for menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e., both a liquid flavoring agent and a powdered flavoring agent are added.

[0371] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other available high intensity sweeteners as described herein can be used in combination with acesulfame potassium and / or sucralose or as a replacement for acesulfame potassium and / or sucralose.

[0372] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with potassium sorbate or as a replacement for potassium sorbate.

[0373] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0374] Example 5B:

[0375] The pouch compositions were prepared from the ingredients in Table 10 using the preparation method described in Example 3.

[0376] The pouch compositions were filled into pouches as described in Example 4 (using the pouch material of Example 1A, but also applicable to IB).

[0377]

[0378] Table 10: Pouch Compositions.

[0379] *Inorganic divalent cations are presented in equivalent numbers relative to the nicotine in the nicotine ion exchange combination.

[0380] The divalent cation can be provided as a hydrated salt, such as dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0381] ***Corresponds to 1 equivalent of NaCI relative to the nicotine in the nicotine ion exchange combination.

[0382] ****Corresponds to 10 equivalents of NaCI relative to the nicotine in the nicotine ion exchange combination.

[0383] Bag contents: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0384] Wheat fibre, trade name "Vitacel 600WF plus". Other fibres can also be used, such as water insoluble plant fibres such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, powdered cellulose, bran fibre, bamboo fibre and cellulose fibre.

[0385] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with sodium alginate, glycerol or HPC or as an alternative to sodium alginate, glycerol or HPC.

[0386] Sodium carbonate is used as a basic buffer. Other buffers as described herein can be used in combination with sodium carbonate or as an alternative to sodium carbonate.

[0387] As an example, a mixture of menthol and peppermint can be used as a flavourant. Of course, other flavourants as described herein can be used in combination with menthol and / or peppermint or as an alternative to menthol and / or peppermint. The flavourant can be liquid or flavouring or a combination, i.e. both a liquid flavourant and a powdered flavourant are added.

[0388] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other available high intensity sweeteners as described herein can be used in combination with acesulfame potassium and / or sucralose or as an alternative to acesulfame potassium and / or sucralose.

[0389] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with potassium sorbate or as an alternative to potassium sorbate.

[0390] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch and talc.

[0391] Example 5C:

[0392] The pouch compositions were prepared from the ingredients in Table 11 using the preparation method described in Example 3.

[0393] The pouch compositions were filled into pouches as described in Example 4 (using the pouch material of Example 1A, but also applicable to IB).

[0394]

[0395]

[0396] Table 11: Pouch compositions.

[0397] *The inorganic cation is presented in equivalent numbers relative to the nicotine in the nicotine ion exchange complex.

[0398] **The polyvalent cation can be provided as a hydrated salt, such as a dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0399] Pouch contents: 500 mg total.

[0400] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber.

[0401] Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with sodium alginate, glycerin, or HPC or as an alternative to sodium alginate, glycerin, or HPC.

[0402] Sodium carbonate was used as the alkaline buffer. Other buffers as described herein can be used in combination with sodium carbonate or as an alternative to sodium carbonate.

[0403] As an example, a mixture of menthol and peppermint can be used as a flavorant. Of course, other flavorants as described herein can be used in combination with menthol and / or peppermint or as an alternative to menthol and / or peppermint. The flavorant can be liquid or flavored or a combination, i.e., both a liquid flavorant and a powdered flavorant are added.

[0404] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other available high intensity sweeteners as described herein can be used in combination with acesulfame potassium and / or sucralose or as an alternative to acesulfame potassium and / or sucralose.

[0405] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with or instead of potassium sorbate.

[0406] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0407] Example 5D:

[0408] The pouch compositions are prepared from the ingredients in Table 12 using the preparation method described in Example 3.

[0409] The pouch compositions are filled into pouches as described in Example 4 (using the pouch material of Example 1A, but 1B can also apply).

[0410]

[0411]

[0412] Table 12: Pouch compositions.

[0413] * The inorganic cations are presented in equivalent numbers relative to the nicotine in the nicotine ion exchange combination.

[0414] ** The polyvalent cations can be provided as hydrated salts, such as dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0415] Pouch contents: 500 mg total.

[0416] Wheat fiber, trade name “Vitacel 600WF plus”. Other fibers can also be used, such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber.

[0417] Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with or instead of sodium alginate, glycerin, or HPC.

[0418] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0419] A flavouring agent, for example, a mixture of menthol and peppermint can be used. Of course, other flavouring agents as described herein can be used in combination with or instead of menthol and / or peppermint. The flavouring agent can be liquid or powdered or a combination, i.e. both a liquid flavouring agent and a powdered flavouring agent are added.

[0420] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners as described herein can be used in combination with or instead of acesulfame potassium and / or sucralose.

[0421] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with or instead of potassium sorbate.

[0422] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch and talc.

[0423] Example 5E:

[0424] The pouch compositions are prepared from the ingredients in Table 13 using the preparation method described in Example 3.

[0425] The pouch compositions are filled into pouches as described in Example 4 (using the pouch material of Example 1A, but also applicable to IB).

[0426]

[0427] Table 13: Pouch compositions.

[0428] * The inorganic divalent cation is present in an equivalent number relative to the nicotine in the nicotine ion exchange combination.

[0429] ** The divalent cation can be provided as a hydrated salt, such as a dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0430] Pouch content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0431] Wheat fibre, trade name "Vitacel 600WF plus". Other fibres can also be used, such as water insoluble plant fibres, such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, powdered cellulose, bran fibre, bamboo fibre and cellulose fibre.

[0432] Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with or as an alternative to sodium alginate, glycerin, or HPC.

[0433] Sodium carbonate is used as a basic buffer. Other buffers as described herein can be used in combination with or as an alternative to sodium carbonate.

[0434] As an example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can be used in combination with or as an alternative to menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e., both a liquid flavoring agent and a powdered flavoring agent are added.

[0435] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners as described herein can be used in combination with or as an alternative to acesulfame potassium and / or sucralose.

[0436] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with or as an alternative to potassium sorbate.

[0437] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0438] Example 5F:

[0439] The pouch composition is prepared from the ingredients in Table 14 using the preparation method described in Example 3.

[0440] The pouch composition is filled into a pouch as described in Example 4 (using the pouch material of Example 1A, but also applicable to IB).

[0441]

[0442]

[0443] Table 14: Pouch composition.

[0444] *The inorganic divalent cation is present in an equivalent number relative to the nicotine in the nicotine ion exchange combination.

[0445] **The divalent cation can be provided as a hydrated salt, such as a dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0446] Pouch contents: 500 mg total, i.e., nicotine concentration 19.2 mg / g.

[0447] Wheat fiber, trade name "Vitacel 600WF plus". Other fibers can also be used, such as water insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, powdered cellulose, bran fiber, bamboo fiber, and cellulose fiber.

[0448] Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with sodium alginate, glycerin, or HPC or as a replacement for sodium alginate, glycerin, or HPC.

[0449] Sodium carbonate is used as a basic buffering agent. Other buffering agents as described herein can be used in combination with sodium carbonate or as a replacement for sodium carbonate.

[0450] As an example, a mixture of menthol and peppermint can be used as a flavoring agent. Of course, other flavoring agents as described herein can be used in combination with menthol and / or peppermint or as a replacement for menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e., both a liquid flavoring agent and a powdered flavoring agent are added.

[0451] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other available high intensity sweeteners as described herein can be used in combination with acesulfame potassium and / or sucralose or as a replacement for acesulfame potassium and / or sucralose.

[0452] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with potassium sorbate or as a replacement for potassium sorbate.

[0453] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0454] Example 5G:

[0455] The pouch compositions were prepared from the ingredients in Table 15 using the preparation method described in Example 3.

[0456] The pouch compositions were filled into pouches as described in Example 4 (using the pouch material of Example 1A, but also applicable to IB).

[0457]

[0458] Table 15: Pouch Compositions.

[0459] * The inorganic divalent cations are presented in equivalent numbers relative to the nicotine in the nicotine ion exchange combination.

[0460] The divalent cations can be provided as hydrated salts, such as dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0461] Bag contents: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0462] Wheat fibre, trade name "Vitacel 600WF plus". Other fibres can also be used, such as water insoluble plant fibres such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, powdered cellulose, bran fibre, bamboo fibre and cellulose fibre.

[0463] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with sodium alginate, glycerol or HPC or as an alternative to sodium alginate, glycerol or HPC.

[0464] Sodium carbonate is used as a basic buffer. Other buffers as described herein can be used in combination with sodium carbonate or as an alternative to sodium carbonate.

[0465] As an example, a mixture of menthol and peppermint can be used as a flavourant. Of course, other flavourants as described herein can be used in combination with menthol and / or peppermint or as an alternative to menthol and / or peppermint. The flavourant can be liquid or flavouring or a combination, i.e. both a liquid flavourant and a powdered flavourant are added.

[0466] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other available high intensity sweeteners as described herein can be used in combination with acesulfame potassium and / or sucralose or as an alternative to acesulfame potassium and / or sucralose.

[0467] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with potassium sorbate or as an alternative to potassium sorbate.

[0468] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch and talc.

[0469] Example 5H:

[0470] The bag composition is prepared from the ingredients in Table 16 using the preparation method described in Example 3.

[0471] The bag composition is filled into a bag as described in Example 4 (using the bag material of Example 1A, but also applicable to 1B).

[0472] Table 16: Pouch composition.

[0473] * The inorganic divalent cation is present in equivalent numbers relative to the nicotine in the nicotine ion exchange set.

[0474] ** The divalent cation can be provided as a hydrated salt, such as dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0475] Pouch content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0476] Wheat fibre, trade name "Vitacel 600WF plus" or "Vitacel 200WF".

[0477] Powdered cellulose, trade name "Vitacel L00" or "Vitacel L700G".

[0478] Oat fibre, trade name "Vitacel HF 600".

[0479] Pea fibre, trade name "Vitacel EF150".

[0480] Other fibres can also be used, such as water-insoluble plant fibres, such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, powdered cellulose, cellulose fibre, apple fibre, cocoa fibre, bamboo fibre, bran fibre and cellulose fibre.

[0481] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with sodium alginate, glycerol or HPC or as an alternative to sodium alginate, glycerol or HPC.

[0482] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with sodium carbonate or as an alternative to sodium carbonate.

[0483] Flavouring agents, for example, a mixture of menthol and peppermint can be used. Of course, other flavouring agents as described herein can also be used in combination with menthol and / or peppermint or as an alternative to menthol and / or peppermint. The flavouring agent can be liquid or flavoured or a combination, i.e. a liquid flavouring agent and a powdered flavouring agent are added.

[0484] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0485] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with or in place of potassium sorbate.

[0486] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0487] Example 5I:

[0488] The pouch compositions are prepared from the ingredients in Table 17 using the preparation method described in Example 3.

[0489] The pouch compositions are filled into pouches as described in Example 4 (using the pouch material of Example 1A, but also applicable to IB).

[0490]

[0491]

[0492] Table 17: Pouch compositions.

[0493] * The inorganic divalent cation is present in an equivalent number relative to the nicotine in the nicotine ion exchange combination.

[0494] ** The divalent cation can be provided as a hydrated salt, such as a dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0495] Pouch contents: 500 mg total, i.e. nicotine concentration 19.2 mg / g.

[0496] Wheat fibre, trade name "Vitacel 600WF plus" or "Vitacel 200WF".

[0497] Powdered cellulose, trade name "Vitacel L00" or "Vitacel L700G".

[0498] Oat fibre, trade name "Vitacel HF 600".

[0499] Pea fibre, trade name "Vitacel EF150".

[0500] Other fibers can also be used, such as water-insoluble plant fibers, such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, beet fiber, buckwheat fiber, potato fiber, powdered cellulose, cellulose fiber, apple fiber, cocoa fiber, bamboo fiber, bran fiber, and cellulose fiber.

[0501] Sodium alginate, glycerol, and hydroxypropyl cellulose (HPC) can be used as wetting agents. They can be used in combination with sodium alginate, glycerol, or HPC, or as alternatives to sodium alginate, glycerol, or HPC, as described herein.

[0502] Sodium carbonate is used as an alkaline buffer. It can also be used in combination with or as a substitute for sodium carbonate, or other buffers as described herein.

[0503] Flavoring agents, for example, can be a mixture of menthol and peppermint. Of course, other flavoring agents as described herein can also be used in combination with or in place of menthol and / or peppermint. Flavoring agents can be liquid or flavored or a combination thereof; that is, liquid flavoring agents and powdered flavoring agents can be added.

[0504] As an example, acesulfame potassium and / or sucralose can be used as high-intensity sweeteners. Other available high-intensity sweeteners described herein can be used in combination with or in place of acesulfame potassium and / or sucralose.

[0505] Potassium sorbate is used as a preservative. It can be used in combination with potassium sorbate or as a substitute for potassium sorbate with other preservatives as described herein.

[0506] Silica is used as a flow aid. Other possible flow aids include, for example, magnesium stearate, starch, and talc.

[0507] Example 5J:

[0508] The bag composition was prepared from the ingredients in Table 18 using the preparation method described in Example 3.

[0509] The bag composition is filled into the bag as described in Example 4 (using the bag material of Example 1A, but 1B can also be applied).

[0510]

[0511]

[0512] Table 18: Bag Compositions.

[0513] *Inorganic divalent cations are represented as equivalents of nicotine relative to the nicotine in the nicotine ion exchange assembly.

[0514] The divalent cations can be provided as hydrated salts, such as dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0515] Bag contents: 500 mg total, i.e. nicotine concentration 19.2 mg / g.

[0516] Wheat fibre, trade name "Vitacel 600WF plus". Other fibres can also be used, such as water insoluble plant fibres such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, powdered cellulose, bran fibre, bamboo fibre and cellulose fibre.

[0517] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with sodium alginate, glycerol or HPC or as an alternative to sodium alginate, glycerol or HPC.

[0518] Sodium carbonate is used as a basic buffer. Other buffers as described herein can be used in combination with sodium carbonate or as an alternative to sodium carbonate.

[0519] As an example, a mixture of menthol and peppermint can be used as a flavourant. Of course, other flavourants as described herein can be used in combination with menthol and / or peppermint or as an alternative to menthol and / or peppermint. The flavourant can be liquid or flavouring or a combination, i.e. both a liquid flavourant and a powdered flavourant are added.

[0520] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other available high intensity sweeteners as described herein can be used in combination with acesulfame potassium and / or sucralose or as an alternative to acesulfame potassium and / or sucralose.

[0521] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with potassium sorbate or as an alternative to potassium sorbate.

[0522] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch and talc.

[0523] Example 5K:

[0524] The bag composition is prepared from the ingredients in Table 19 using the preparation method described in Example 3.

[0525] The bag composition is filled into a bag as described in Example 4 (using the bag material of Example 1A, but also applicable to 1B).

[0526]

[0527]

[0528] Table 19: Pouch composition.

[0529] * The inorganic divalent cation is present in equivalent numbers relative to the nicotine in the nicotine ion exchange set.

[0530] ** The divalent cation can be provided as a hydrated salt, such as dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0531] Pouch content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0532] Wheat fibre, trade name "Vitacel 600WF plus". Other fibres can also be used, such as water insoluble plant fibres, such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, powdered cellulose, bran fibre, bamboo fibre and cellulose fibre.

[0533] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with sodium alginate, glycerol or HPC or as an alternative to sodium alginate, glycerol or HPC.

[0534] Sodium carbonate is used as a basic buffer. Other buffers as described herein can be used in combination with sodium carbonate or as an alternative to sodium carbonate.

[0535] Flavouring agents, for example, a mixture of menthol and peppermint can be used. Of course, other flavouring agents as described herein can be used in combination with menthol and / or peppermint or as an alternative to menthol and / or peppermint. The flavouring agent can be liquid or flavouring or a combination, i.e. both a liquid flavouring agent and a powdered flavouring agent are added.

[0536] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other available high intensity sweeteners as described herein can be used in combination with acesulfame potassium and / or sucralose or as an alternative to acesulfame potassium and / or sucralose.

[0537] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with potassium sorbate or as an alternative to potassium sorbate.

[0538] Silicon dioxide is used as a flow agent. Other possible flow agents include, for example, magnesium stearate, starch and talc.

[0539] Example 5L:

[0540] The pouch compositions are prepared from the ingredients in Table 20 using the preparation method described in Example 3.

[0541] The pouch compositions are filled into pouches as described in Example 4 (using the pouch material of Example 1A, but also applicable 1B).

[0542]

[0543]

[0544] Table 20: Pouch compositions.

[0545] * The inorganic divalent cations are presented in equivalent numbers relative to the nicotine in the nicotine ion exchange combination.

[0546] ** The divalent cations can be provided as hydrated salts, such as dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0547] Pouch content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g (for samples P116, P117 and C12, 16 mg / g).

[0548] Wheat fibre, trade name "Vitacel 600WF plus". Powdered cellulose, trade name "Powdered cellulose L700G". Other fibres can also be used, such as water insoluble plant fibres, such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, bran fibre, bamboo fibre and cellulose fibre.

[0549] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0550] The flavouring agent, for example, a mixture of menthol and peppermint can be used. Of course, other flavouring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavouring agent can be liquid or flavouring or a combination, i.e. both a liquid flavouring agent and a powdered flavouring agent are added.

[0551] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners described herein can be used in combination with or instead of acesulfame potassium and / or sucralose.

[0552] Potassium sorbate is used as a preservative. Other preservatives as described herein can be used in combination with or instead of potassium sorbate.

[0553] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch, and talc.

[0554] Example 5M:

[0555] The pouch compositions are prepared from the ingredients in Table 21 using the preparation method described in Example 3.

[0556] The pouch compositions are filled into pouches as described in Example 4 (using the pouch material of Example 1A, but 1B can also be applied).

[0557]

[0558]

[0559] Table 21: Pouch compositions.

[0560] * The inorganic divalent cation is present in an equivalent number relative to the nicotine in the nicotine ion exchange combination.

[0561] ** The divalent cation can be provided as a hydrated salt, such as a dihydrate, tetrahydrate, hexahydrate, etc. The weight % in the table is based on the non-hydrated salt.

[0562] Pouch content: 500 mg in total, i.e. nicotine concentration 19.2 mg / g.

[0563] Wheat fibre, trade name "Vitacel 600WF plus". Other fibres can also be used, such as water insoluble plant fibres such as oat fibre, pea fibre, rice fibre, maize fibre, oat fibre, tomato fibre, barley fibre, rye fibre, sugar beet fibre, buckwheat fibre, potato fibre, cellulose fibre, apple fibre, cocoa fibre, powdered cellulose, bran fibre, bamboo fibre and cellulose fibre.

[0564] Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) can be used as humectants. Other humectants as described herein can be used in combination with or instead of sodium alginate, glycerol or HPC.

[0565] Sodium carbonate is used as a basic buffer. Other buffers as described herein can also be used in combination with or instead of sodium carbonate.

[0566] As an example, menthol and / or peppermint can be used as a flavoring agent. Other flavoring agents as described herein can also be used in combination with or instead of menthol and / or peppermint. The flavoring agent can be liquid or flavored or a combination, i.e. both a liquid flavoring agent and a powdered flavoring agent are added.

[0567] As an example, acesulfame potassium and / or sucralose can be used as a high intensity sweetener. Other useful high intensity sweeteners as described herein can also be used in combination with or instead of acesulfame potassium and / or sucralose.

[0568] Potassium sorbate is used as a preservative. Other preservatives as described herein can also be used in combination with or instead of potassium sorbate.

[0569] Silicon dioxide is used as a glidant. Other possible glidants include, for example, magnesium stearate, starch and talc.

[0570] Example 6A: Release experiments and different salts.

[0571] Release experiments were performed by adding an amount of NPR (16%) and different equivalent numbers of CaCl2to 900 mL of water (corresponding to a nicotine concentration of 28 mg / L). The equivalent numbers of CaCl2are relative to nicotine. The temperature of the water was 25 degrees Celsius throughout the experiment and stirring of 100 rpm was applied throughout the experiment. The pH was measured at the start and end of the experiment. The pH in all experiments was below 7.0 at the start and end of the experiment.

[0572] A relatively low nicotine concentration was used to reduce the influence of the equilibrium on the release rate and effective release of nicotine from the ion exchange resin.

[0573] Samples were taken at different time points and the nicotine content was analyzed using standard HPLC. The results are presented as percentage of nicotine released.

[0574]

[0575]

[0576] Table 22: Release of nicotine over time in the presence of different salts and different equivalent numbers of cations.

[0577] Evaluation: The results show that the presence of CaCl2 significantly increases the release of nicotine from NPR. Increasing the amount of CaCl2 leads to an increase in the release of nicotine. The presence of CaCl2 both increases the initial release rate and seems to increase the effective release of nicotine.

[0578] Furthermore, the results show that NaCl has much less effect on the release of nicotine, so a large amount of NaCl is needed to achieve a comparable release of nicotine as in the presence of e.g. 1 equivalent CaCl2.

[0579] Example 6B: Release experiment using NPR and different equivalents of CaCl2.

[0580] The release experiment was performed by adding NPR (16%) and different equivalents of CaCl2 to a volume of water (corresponding to a nicotine concentration of 28 mg / L). The equivalents of CaCl2 are relative to nicotine. The temperature of the water was 25 degrees Celsius throughout the experiment and stirring of 100 rpm was applied throughout the experiment. The pH was measured at the start and end of the experiment. The pH in all experiments was below 7.0 at the start and end of the experiment.

[0581] A relatively low nicotine concentration was used to reduce the influence of the equilibrium on the release rate and effective release of nicotine from the ion exchange resin.

[0582] Samples were taken at different time points and the nicotine content was analyzed using standard HPLC. The results are presented as percentage of nicotine released.

[0583]

[0584]

[0585] Table 23: Shows the percentage of nicotine released from NPR at different time points in the presence of different equivalents of CaCl2.

[0586] Evaluation: The results show that the presence of CaCl2 significantly increases the release of nicotine from NPR. Increasing the amount of CaCl2 leads to an increase in the release of nicotine. The presence of CaCl2 both increases the initial release rate and seems to increase the effective release of nicotine.

[0587] Example 6C: Release experiment using NPR and different equivalents of MgCl2.

[0588] Release experiments were performed by adding NPR (16%) and different amounts of MgCI2to a volume of water, corresponding to a nicotine concentration of 28 mg / L. The amount of MgCI2was relative to nicotine. The temperature of the water was 25 degrees Celsius throughout the experiment and stirring was applied at 100 rpm throughout the experiment. The pH was measured at the start and end of the experiment. The pH in all experiments was below 7.0 at the start and end of the experiment.

[0589] A relatively low nicotine concentration was used to reduce the influence of equilibration on the release rate and effective release of nicotine from the ion exchange resin.

[0590] At different time points samples were taken and the nicotine content was analyzed using standard HPLC. The results are presented as percentage of nicotine released.

[0591] Table 24: shows the percentage of nicotine released from NPR at different time points in the presence of different amounts of MgCI2.

[0592] Evaluation: The results show that the presence of MgCI2significantly increases the release of nicotine from NPR. Increasing the amount of MgCI2results in an increased release of nicotine. The presence of MgCI2increases both the initial release rate and seems to increase the effective release of nicotine. The results are comparable to the results presented in Example 6B.

[0593] Example 6D: Release experiments using 1 equivalent of CaCI2and nicotine pre-mixes with different nicotine content.

[0594] Release experiments were performed by adding nicotine pre-mixes with different nicotine content and 1 equivalent of CaCI2to a volume of water, thereby obtaining a corresponding nicotine concentration of 28 mg / L. The amount of CaCI2was relative to nicotine. The temperature of the water was 25 degrees Celsius throughout the experiment and stirring was applied at 150 rpm throughout the experiment. The pH was measured at the start and end of the experiment. The pH in all experiments was below 7.0 at the start and end of the experiment.

[0595] A relatively low nicotine concentration was used to reduce the influence of equilibration on the release rate and effective release of nicotine from the ion exchange resin.

[0596] At different time points samples were taken and the nicotine content was analyzed using standard HPLC. The results are presented as percentage of nicotine released.

[0597]

[0598] Table 25: shows the percentage of nicotine released from the nicotine pre-mix at different time points in the presence of 1 equivalent of MgCh.

[0599] Evaluation: The results show that the presence of CaCh significantly increases the release of nicotine from the pre-mix. The presence of CaCh increases both the initial release rate and seems to increase the effective release of nicotine. Furthermore, the results show that increasing the nicotine content of the pre-mix also increases the release of nicotine.

[0600] Example 6E: Release experiment using 1 equivalent of AlCh.

[0601] The release experiment was performed by adding NPR (16%) and 1 equivalent of AlCh to a volume of water (corresponding to a nicotine concentration of 28 mg / L). The equivalent number is relative to nicotine. The temperature of the water was 25 degrees Celsius throughout the experiment and stirring of 150 rpm was applied throughout the experiment. The pH was measured at the start and end of the experiment. The pH in all experiments was below 7.0 at the start and end of the experiment.

[0602] A relatively low nicotine concentration was used to reduce the influence of equilibration on the release rate and effective release of nicotine from the ion exchange resin.

[0603] Samples were taken at different time points and the nicotine content was analyzed using standard HPLC. The results are presented as the percentage of nicotine released.

[0604]

[0605] Table 24: shows the percentage of nicotine released from the NPR at different time points in the presence of 1 equivalent of AlCh.

[0606] Evaluation: The results show that the presence of 1 equivalent of AlCh significantly increases the release of nicotine from the NPR. The presence of AlCh increases both the initial release rate and seems to increase the effective release of nicotine.

[0607] Example 7A: Bag release experiment (in vitro)

[0608] The release properties of the bags were tested in an in vitro experiment.

[0609] Reaction tubes with a diameter of approximately 2 cm and containing 10 mL of 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 7.4) were warmed to 37 degrees Celsius. One reaction tube was used per time point.

[0610] The pouch was submerged in the buffer of the first reaction tube using tweezers. After the specified time period, the pouch was pinched with the tweezers and gently swirled in the buffer, then removed from the first reaction tube and added to the next reaction tube, which represented the next time point. This procedure was repeated until the desired number of time points were tested.

[0611] The entire release experiment was performed at 37 degrees Celsius. No agitation or shaking was applied during the release experiment.

[0612] The amount of nicotine released was determined by analyzing the buffer samples at different time points using standard HPLC.

[0613] Example 8A: Release experiment performed on pouches

[0614] The release experiment was performed as described in Example 7A.

[0615]

[0616] Table 27A: Shows the percentage of nicotine released from the nicotine pouches at different time points in the presence of different amounts of CaCl2.

[0617]

[0618] Table 27B: Shows the percentage of nicotine released from the nicotine pouches at different time points in the presence of different amounts of CaCl2.

[0619] Evaluation: Comparing P110 and P113 to C10 and C11, respectively, the results show that the presence of CaCl2increases the release of nicotine from the pouch. This is also confirmed by the comparison of P116 to C12. The presence of CaCl2increases both the initial release rate and seems to increase the effective release of nicotine. Comparing P40 and P42, and comparing P116 and P117, confirms that increasing the amount of CaCl2in the pouch also increases the release of nicotine from the pouch. In addition, it should be noted that improved release results have been confirmed with various formulations comprising different fibers, here wheat fibers and powdered cellulose.

[0620] Furthermore, comparing P40 to P43, P42 to P45 and P110 to P113, the results show that increasing the nicotine content of the premix also increases the release of nicotine from the pouch.

[0621] Finally, it should be noted that in order to obtain a release comparable to that obtained from pouches comprising only 0.75 equivalents of CaCl2, a much higher amount of NaCl would be required, here at least 2.9 equivalents of NaCl would be required to obtain a release comparable to 0.75 equivalents of CaCl2(see C4, C5, P40 and P43).

[0622] Example 9A: User evaluation.

[0623] The resulting bags of the application were evaluated and found to be highly suitable as delivery vehicles for nicotine, as they provided good nicotine release while being pleasurable to the user, e.g. in terms of desired mouthfeel, such as moistness and malleable structure, and desired taste.

[0624] Example 9B: User evaluation.

[0625] Bag products P03, P44 and P117 were evaluated in terms of nicotine perception and mouthfeel.

[0626] The evaluation of nicotine perception and mouthfeel was performed as described below.

[0627] Nicotine perception and mouthfeel were evaluated by a test panel consisting of 4 trained assessors. Each assessor evaluated all samples twice. The average evaluation was estimated.

[0628] All four assessors evaluated bag products P03, P44 and P117 to be fast-acting and to have a high nicotine perception. In addition, all four assessors evaluated the bag products to have a desired mouthfeel, i.e. the bags were found to be moist and to have a desired taste.

[0629] Similarly, bags P08 and P127 were evaluated. All four assessors evaluated these bags to be fast-acting and to have a high nicotine perception. However, these bags were found to provide a less desired mouthfeel, which were perceived to be somewhat dry, sticky to the oral mucosa and / or to have an off-taste or a less desired taste, i.e. too salty.

[0630] Also evaluated were bags comparable to P127 but containing a higher amount of flavoring agent, i.e. P128 and P129. Despite the increased flavoring agent level compared to P127, these bags were also perceived to be dry and sticky to the oral mucosa. In addition, the taste of these bags was also found to be less desired, as a salty taste note was still perceived and the flavor profile was perceived to be unbalanced.

[0631] These observations indicate that the less desired mouthfeel and taste effects associated with high levels of inorganic divalent cations cannot be counteracted by increasing the flavoring agent level in the bag composition. I.e. simply masking the taste by means of a high flavoring agent level cannot counteract the adverse effects at high levels of inorganic divalent cations.

Claims

1. A pouch composition comprising a nicotine-ion exchange resin combination, water in an amount of at least 15% by weight of the pouch composition, and an inorganic divalent cation, wherein the pouch composition comprises the inorganic divalent cation in a molar ratio of at most 5 relative to the amount of nicotine in the nicotine-ion exchange resin combination.

2. The pouch composition according to claim 1, wherein the pouch composition comprises the inorganic divalent cation in a molar ratio of at least 0.1 relative to the amount of nicotine in the nicotine-ion exchange resin combination.

3. The pouch composition according to claim 1, wherein the inorganic divalent cation is selected from the group consisting of divalent cations of calcium, magnesium, iron, zinc, and any combination thereof.

4. The pouch composition according to claim 1, wherein the inorganic divalent cation is selected from the group consisting of divalent cations of calcium and magnesium.

5. The pouch composition according to claim 1, wherein the inorganic divalent cation is provided as a salt comprising an anion selected from the group consisting of carboxylate, organic sulfonate, organic sulfate, organic phosphate, chloride, bromide, nitrate, sulfate, hydrogen phosphate, oxide, and any combination thereof.

6. The pouch composition according to claim 1, wherein the inorganic divalent cation is provided as a salt in an amount of between 0.1 and 15.0% by weight of the pouch composition.

7. The pouch composition according to claim 1, wherein the inorganic divalent cation is provided as an inorganic salt comprising an inorganic anion selected from the group consisting of chloride, bromide, nitrate, sulfate, bicarbonate, hydrogen phosphate, oxide, hydroxide, and any combination thereof.

8. The pouch composition according to claim 1, wherein the divalent cation is provided as a water-soluble salt having a water-solubility of at least 5 g / 100 mL water measured at 25 degrees Celsius, atmospheric pressure, and pH 7.

0.

9. The pouch composition according to claim 1, wherein the pouch composition comprises nicotine in an amount of at least 0.1% by weight of the pouch composition.

10. The pouch composition according to claim 1, wherein the pouch composition comprises a nicotine-ion exchange resin combination in an amount of between 0.1 and 20% by weight of the pouch composition.

11. The pouch composition according to claim 1, wherein the ion exchange resin comprises a polacrillin resin.

12. The pouch composition according to claim 1, wherein the nicotine-ion exchange resin combination comprises nicotine complexed with an ion exchange resin.

13. The pouch composition according to claim 1, wherein the nicotine-ion exchange resin combination comprises freebase nicotine mixed with an ion exchange resin.

14. The pouch composition according to claim 1, wherein the pouch composition comprises at least one sugar alcohol.

15. The pouch composition according to claim 14, wherein the at least one sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.

16. The pouch composition according to claim 1, wherein the pouch composition comprises at least one water-insoluble fiber.

17. The pouch composition of claim 16, wherein the water insoluble fiber is selected from the group consisting of wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, and combinations thereof.

18. The pouch composition of claim 16, wherein the water insoluble fiber is powdered cellulose.

19. The pouch composition of claim 1, wherein the pouch composition comprises a pH adjusting agent.

20. An oral pouch nicotine product comprising a saliva permeable pouch and the pouch composition of claim 1 enclosed in the pouch.

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