Nicotine composition

Abstract

The present disclosure relates to a composition for use in an oral nicotine delivery product, wherein the composition comprises microcrystalline cellulose. The present disclosure also relates to pouches comprising said composition, packages including said pouches, methods of preparing said composition and use of said microcrystalline cellulose as a nicotine release control agent or nicotine uptake control agent. Said composition comprises: a. from about 0.2 to about 5 wt% of nicotine; b. from about 5 to about 60 wt% of native cellulose material; c. at least about 35 wt% water; d. from about 0.5 wt% to about 3 wt% of one or more pH control salts; and e. optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein the native cellulose material comprises at least about 5 wt% of a microcrystalline cellulose X, based on the total weight of native cellulose material, where that material provides a surprising increase in the ability of the composition to deliver nicotine to a user.

Description

[0001] Nicotine Composition

[0002] Field of Invention

[0003] The present invention relates to tobacco-free or low-tobacco nicotine compositions. The compositions are preferably for human consumption, such as may be delivered orally by means of placing a permeable pouch filled with the compositions in the mouth of a user.

[0004] Background of the Invention

[0005] Nicotine-loaded tobacco-free or low-tobacco pouches are replacement products that can help to alleviate cravings associated with smoking cigarettes, cigars, or other nicotine delivery products. When smoking cigarettes or using nicotine-delivery systems based on inhalation, i.e., so-called vaping, nicotine vapor is quickly absorbed through the lungs into the blood stream, reaching the brain within ten seconds of inhalation. The latter produces a feeling of almost instantaneous satisfaction, that lasts also some time after smoking / inhalation.

[0006] Nicotine oral delivery products, such as nicotine pouches, are often known as replacement products for tobacco containing products including cigarettes, as they provide an alternative means of nicotine delivery with a reduced health risk and fewer toxicants. Therefore, nicotine pouches may be beneficial for tobacco harm reduction and smoking cessation.

[0007] However, nicotine delivery is typically more efficient from cigarettes than nicotine pouches. Therefore, it is desirable to develop nicotine products in which the release rate of nicotine can be tuned. For instance, some customers may prefer a rapid nicotine release rate (a so-called 'nicotine kick'), while others may prefer a slower nicotine release which is preceded by a release of flavours.

[0008] Therefore, being able to control the sensory experience during the use of the product, particularly in the first minute, is key for customers to convert from cigarettes to less harmful products. Furthermore, control of the nicotine delivery to the user while maintaining other key parameters of the nicotine pouch, such as moisture content, pH and flavour, can be critical.

[0009] Nicotine-loaded tobacco-free or low-tobacco pouches are intended for use in the mouth by placing the pouch under the lip, thereby enabling the release and absorption of nicotine through oral mucosa. The pouches typically comprise a saliva permeable membrane material and contain particulate filler materials, nicotine or nicotine derivatives and other ingredients such as flavourings.

[0010] Nicotine is an alkaloid, which was traditionally derived from tobacco leaves but may now also be provided in a fully synthetic form. It is available both as a free-base nicotine and in the form of different nicotine salts that are produced from the interaction between nicotine and an acid. Common nicotine salts include chloride, sulfate, benzoate, tartrate salts.

[0011] The nicotine pouch is water-insoluble but permeable to saliva that dissolves and releases the flavors and nicotine. The particulate filler materials, such as polysaccharides or cellulose materials, are often used as nicotine carriers. Cellulose materials are available in many forms.

[0012] Native cellulose, or cellulose I, is the primary form of cellulose found in nature mainly in land plants but also less commonly in algae, bacteria, fungi and tunicates. It is a linear polymer of glucose monomer units linked by -1,4-glycosidic bonds. Other cellulose polymorphs distinguishable from cellulose I (native cellulose) include cellulose II (regenerated cellulose), cellulose III, and cellulose IV. Native cellulose exists in two allomorph forms, i.e., cellulose la (algae-bacterial type) and cellulose ip (ramie-cotton type).

[0013] Dietary fiber food is a broad definition of edible plant components mainly composed of native cellulose, hemicellulose and lignin that are resistant to digestion and absorption in the human small intestine. Hence, such dietary fiber is a less purified form of native cellulose.

[0014] Powdered Cellulose (pharmaceutical grade) is a highly purified, mechanically disintegrated form of alpha cellulose (not to be confused with cellulose la) obtained as a pulp from fibrous plant material. Alpha cellulose is further defined below.

[0015] Microcrystalline cellulose (pharmaceutical grade) is a highly purified, partially depolymerized cellulose prepared by treating alpha-cellulose, obtained as a pulp from fibrous plant material, with mineral acids.

[0016] Alpha Cellulose is the high Mwportion of cellulose that is insoluble in 17.5% sodium hydroxide solution at 20°C. Beta Cellulose is the fraction of cellulose that is soluble in 17.5% sodium hydroxide solution but insoluble in 8.3% sodium hydroxide solution.

[0017] Gamma Cellulose is the low Mw portion of cellulose that is soluble in 8.3% sodium hydroxide solution.

[0018] Powdered cellulose and MCC comply with pharmacopoeial monographs such as those in USP, EuPh, JPh and other similar regulatory documents. For food applications highly purified MCC and PC go under the ingredient code E460.

[0019] Both E460 and dietary fiber have been both descried in prior art as components for making nicotine pouches.

[0020] However, a problem with nicotine pouches is that they can be inefficient at releasing nicotine from the pouch.

[0021] This can mean that the release of nicotine from the pouch is delayed. As a result, the user experiences a slow uptake of nicotine into the oral mucosa, which can lead to reduced user satisfaction, compensatory behaviour by the user (such as users consuming additional pouches or pouches with higher nicotine content), ineffectiveness in alleviating cravings and therefore making it harder for individuals to quit smoking or vaping.

[0022] On the other hand, it may be preferable in some circumstances to have a slow release of nicotine to the user. Therefore, the ability of being able to tune the nicotine release properties of the nicotine pouch is particularly attractive.

[0023] Inefficient release of nicotine can also mean that the nicotine pouch can have a low total release of nicotine as a result of nicotine remaining trapped inside the pouch and effectively wasted. Consequently, inadequate levels of nicotine are released, inconsistent levels of nicotine are delivered, and users may continue to smoke traditional cigarettes or use other nicotine delivery products. This also means that nicotine is manufactured and transported around, without actually providing any benefit to the end user of the nicotine pouch, therefore resulting in significant economic consequences and unnecessary environmental impact in terms of increased energy costs and waste production.

[0024] In addition, it is important that the produce has an acceptable shelf life. For instance, the nicotine should be in a stable form when inside the nicotine pouch so that nicotine degradation is avoided. Moisture evaporation should also be prevented during storage of products intended to be moist, especially those containing more than, say, 20wt% water. These factors may cause discrepancy between the factual and stated nicotine loading (mg nicotine per g).

[0025] Physical instability is also a common problem of moist products. Physical instability may include discoloration, stickiness, lumping, phase transitions, such as dissolutionrecrystallization and evaporation. Discoloration and chemical degradation may be connected to each other. Lumping of powder may require additional sieving for particle size control after compounding, which results in additional costs during processing.

[0026] The physical and chemical instability may lead to accumulation of toxic by-products of nicotine degradation as well as negative product experiences due to colour changes (white product turning yellow, brown, or pink), dusting due to drying and leakage through pouch, product hardening and deteriorated mouthfeel as well as altered nicotine release profile.

[0027] Therefore, there is a strong need for the development of new nicotine pouch formulations that address these issues.

[0028] There is therefore a need to provide a moist tobacco-free or low-tobacco nicotine composition that provides both fast nicotine release (and thus fast absorption to the blood stream), in particular by improving the effectiveness of nicotine release from the nicotine pouch, and to enhance the overall organoleptic experience of the user.

[0029] There is a further need to provide tobacco-free or low-tobacco nicotine compositions which are suitable for use in pouches and in which the nicotine has a high degree of chemical stability, the composition has a high degree of physical stability, the pH is at a level which is comfortable for the user and which contains a relatively high degree of moisture.

[0030] There is a further need to provide such products which may be produced in a simple, reliable and cost-efficient manner.

[0031] This disclosure relates to a novel composition, a method of preparation of said composition, and pouches and packages containing said composition. It has been found that the application of this composition leads to nicotine pouches with unexpectedly improved nicotine release performance, better user experience and greater stability. Brief Description of the Invention

[0032] According to an aspect of the present disclosure, there is provided a composition comprising: a. from about 0.2 to about 5 wt% of nicotine; b. from about 5 to about 60 wt% of native cellulose material; c. at least about 35 wt% water; d. from about 0.2 wt% to about 3 wt% of one or more pH control salts; and e. optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X having a water retention factor (WRF) of less than 40%, based on the total weight of native cellulose material.

[0033] It has been surprisingly found by the inventors that not all microcrystalline cellulose materials release nicotine in the same way. In particular, the provision of microcrystalline cellulose which has a low ability to retain water as a portion of the cellulose in this formulation leads to a faster release of nicotine. This in turn allows for a lower loading of nicotine in the composition to deliver a similar organoleptic experience for the user. As nicotine is a relatively resource intensive material to produce, an ability to reduce the quantity of nicotine in a delivery composition may deliver cost and environmental advantages to users and manufacturers in addition to other advantages set out above.

[0034] According to a further aspect of the present disclosure, there is provided a composition comprising: a. from about 0.2 to about 5 wt% of nicotine; b. from about 5 to about 60 wt% of native cellulose material; c. at least about 35 wt% water; d. from about 0.2 wt% to about 3 wt% of one or more pH control salts; and e. optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X comprising particles of fibrous or elongate form.

[0035] The microcrystalline cellulose material X may have a bulk density of less than about 0.25 g / cm3, for example less than about 0.22 g / cm3.

[0036] According to a further aspect of the present disclosure, there is provided a composition comprising: a. from about 0.2 to about 5 wt% of nicotine; b. from about 5 to about 60 wt% of native cellulose material; c. at least about 35 wt% water; d. from about 0.2 wt% to about 3 wt% of one or more pH control salts; and e. optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X having a bulk density lower than 0.22 g / cm3.

[0037] In embodiments, the bulk density of the microcrystalline cellulose material X is from about 0.1 to about 0.21 g / cm3

[0038] The microcrystalline cellulose material X may comprise particles of fibrous or elongate form. For example, the microcrystalline cellulose material X may have a mean particle aspect ratio (AR) of at least about 1.5, for example at least about 2, such as at least about 2.5, preferably at least about 3, or from about 2 to about 5, preferably from about 2.5 to about 4.5.

[0039] According to a further aspect of the present disclosure, there is provided a process of preparing a composition comprising: a. providing a precursor composition comprising a native cellulose material comprising microcrystalline cellulose material X, b. adding water to the precursor composition and mixing at a temperature of about 50 °C or more, c. adding nicotine to the precursor composition at a temperature of about 50 °C or more to provide a heated composition, and d. allowing the heated composition to cool to provide a composition, wherein the composition comprises: from about 0.2 to about 5 wt% of nicotine; from about 5 to about 60 wt% of native cellulose material; at least about 35 wt% of water; from about 0.5 wt% to about 3 wt% of one or more pH control salts, optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition; and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X, based on the total weight of native cellulose material. According to a further aspect of the present disclosure, there is provided a use of microcrystalline cellulose material X as a nicotine release control agent in a composition comprising: a. from about 0.2 to about 5 wt% of nicotine; b. from about 5 to about 60 wt% of native cellulose material; c. at least about 35 wt% water; d. from about 0.5 wt% to about 3 wt% of one or more pH control salts; and e. optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X, based on the total weight of native cellulose material.

[0040] According to a further aspect of the present disclosure, there is provided a use of microcrystalline cellulose material X as a nicotine uptake control agent in a composition comprising: a. from about 0.2 to about 5 wt% of nicotine; b. from about 5 to about 60 wt% of native cellulose material; c. at least about 35 wt% water; d. from about 0.5 wt% to about 3 wt% of one or more pH control salts; and e. optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X, based on the total weight of native cellulose material.

[0041] Detailed Description of the Invention

[0042] Unless otherwise indicated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0043] The disclosure relates to a pouch containing a tobacco-free or low tobacco nicotine composition that provides fast nicotine release. The composition is designed to quickly release nicotine from the pouch resulting in the potential for improved alleviation of nicotine craving.

[0044] Additional ingredients

[0045] Optionally, the composition may comprise additional ingredients, preferably in an amount of up to about 12 wt%, based on the total weight of the composition. Preferably, the composition comprises additional ingredients, in an amount of from about 1 to about 10 wt% or more preferably in an amount of from about 1 to about 8 wt%, based on the total weight of the composition.

[0046] The additional ingredients may comprise one or more additives selected from flavourings, flavour enhancers, sweeteners, preservatives, and mixtures thereof.

[0047] Flavourings contained within the composition are not limited but preferably include flavonoid compounds to stimulate the olfactory system of the user, typically in an amount of less than about 3 wt% of the total composition. Such compounds are commercially available and are well known to those skilled in the art.

[0048] Preferably, the composition may comprise flavourings (e.g. flavouring compounds) in an amount less than about 5 wt%, based on the total weight of the composition, for example less than about 3 wt%, preferably from about 0.5 to about 3 wt%.

[0049] The flavour of the composition may be improved by the inclusion of sweeteners or flavour enhancers.

[0050] Flavour enhancers may include sodium chloride, salts of glutamic acid (such as sodium glutamate), glycine salts, inosinic acid salts and 5'-ribonucleotide salts (such as one or more disodium ribonucleotides). Quantities of the flavour enhancer present in the composition depend on the properties of the flavour enhancer chosen, as would be understood by a person skilled in the art but typically in an amount of from about 1 to about 8 wt% of the total composition.

[0051] Preferably, any flavour enhancers present are selected from the group comprising sodium chloride, glutamate salts, glycine salts, inosinic acid salts and 5'-ribonucleotide salts. Where sodium chloride is present, it is preferred to be in an amount less than about 8 wt%, preferably from about 1 to about 7 wt%, based on the total weight of the composition.

[0052] Sweeteners may include sugar-based sweeteners such as sucrose, fructose, glucose, dextrose, maltose, lactose, galactose; sugar alcohols such as xylitol, maltitol, sorbitol, erythritol; or other sugar substitutes such as aspartame, saccharin, sucralose, allulose, acesulfame K, cyclamate or steviol glycosides. The sweeteners may be present alone though are preferably used in combination (for example a sugar alcohol and a sugar substitute). A preferred combination is xylitol and acesulfame K. Quantities of the sweetener present in the composition depend on the properties of the sweeteners chosen, as would be understood by a person skilled in the art but typically in an amount of from about 1 to about 3 wt% of the total composition.

[0053] Sweeteners are preferably present in an amount of from about 1 to about 3 wt%, based on the total weight of the composition. The sweeteners may comprise compounds selected from one or more of sugars (such as sucrose, fructose, glucose, dextrose, maltose, lactose, galactose), sugar alcohols (such as xylitol, maltitol, sorbitol, erythritol), sugar substitutes (such as aspartame, saccharin, sucralose, allulose, acesulfame K, cyclamate or steviol glycosides), and mixtures thereof.

[0054] Preferably, the sweeteners include a sugar alcohol in an amount of about 3 wt% or less, preferably about 2 wt% or less, such as from about 1 to about 2 wt%, based on the total weight of the composition. Additionally or alternatively, the sweetener may comprise a sugar substitute in an amount of about 1 wt% or less, preferably about 0.5 wt% or less, such as from about 0.05 to about 0.3 wt% or less, based on the total weight of the composition. Preferred sweeteners include xylitol and / or acesulfame K.

[0055] Preservatives may include antimicrobial preservatives such as sorbic acid salts (such as sodium or potassium sorbate), benzoic acid salts, nitrate salts, nitrite salts, sulfate salts, sulfite salts and propionate salts. Salts such as calcium chloride may also be used as preservatives.

[0056] Preservatives may comprise one or more preservatives selected from calcium chloride, salts of sorbic acid (such as potassium sorbate), salts of benzoic acid (such as sodium benzoate), nitrate salts, nitrite salts, sulfate salts, sulfite salts, propionate salts, and mixtures thereof. Preferably, preservatives are in an amount of about lwt% or less, preferably from about 0.1 to about 0.5wt%, more preferably from about 0.25 to about 0.35 wt%, based on the total weight of the composition. pH control salts

[0057] The composition comprises one or more pH control salts, which may provide optimum pH of the composition while in use in the mouth of a user.

[0058] High alkalinity (especially a pH greater than 9) can be irritating to the gums of the user. The composition comprises from about 0.2 to about 3 wt% of one or more pH control salts, based on the total weight of the composition. For example, from about 0.3 to about 2 wt%, preferably from about 0.4 wt% to about 1 wt%.

[0059] The one or more pH control salts may comprise one or more pH adjusting agents and / or buffering salts selected from one or more of halide salts, such as chloride salts, carbonate, bicarbonate, sesquicarbonate, acetate, glycinate, gluconate, borate, glycerophosphate, citrate, phosphate, and mixtures thereof.

[0060] Preferably, the one or more pH control salts is a pH adjusting agent, such as sodium bicarbonate, or a combination of buffering salts, such as a combination of ammonium chloride and sodium bicarbonate.

[0061] Where ammonium chloride is present it may be in an amount of from about 0.05 to about 1 wt%, preferably from about 0.1wt% to about 0.5 wt%, more preferably from about 0.15 to about 0.25 wt%. Where sodium bicarbonate is present it may be in an amount of less than 1 wt%, preferably from about 0.1 to about 0.5 wt%, more preferably from about 0.2 to about 0.3 wt%.

[0062] Alternative buffering salts may be selected from e.g. carbonate or sesquicarbonate salts; acetate salts, glycinate, acetate, glycinate, gluconate, borate, glycerophosphate or citrate salts; phosphate salts.

[0063] It is preferred that the pH of the composition, when measured according to the Coresta Method No.69, 2017, is from about 6 to about 9, preferably from about 7 to about 9 and more preferably from about 8 to about 8.8.

[0064] Preferably, this can be achieved by providing pH adjusting agents such as sodium bicarbonate or buffering salts such as a combination of ammonium chloride and sodium bicarbonate.

[0065] Water

[0066] The composition comprises at least about 35 wt% water, based on the total weight of the composition.

[0067] Formulations which have low moisture content can feel hard and unpalatable when in use. In contrast, moist nicotine products show enhanced palatability, i.e., soft and pleasant mouthfeel, when used in the mouth. While the water content of the composition should be at least about 35 wt%, it is preferred that a greater proportion of water is contained in the composition. Greater palatability for the user, including greater softness, tends to be found when the water content of the composition is greater than about 40 wt%. Preferred compositions have a water content greater than about 42 wt%.

[0068] Preferably, the composition comprises from about 40 to about 50 wt% water, more preferably from about 44 wt% to about 48 wt% water.

[0069] Nicotine

[0070] The composition comprises from about 0.2 to about 5 wt% of nicotine, based on the total weight of the composition.

[0071] The quantity of nicotine in the composition may vary depending on the desired strength of the product.

[0072] Preferred quantities of nicotine in the composition are from about 0.2 to about 3 wt%, or from about 0.2 to about 2 wt%.

[0073] Preferably, the nicotine is in a free base form.

[0074] The composition may have a ratio of microcrystalline cellulose material X to nicotine of from about 0.1 : 1 to about 34: 1, for example from about 1: 1 to about 16: 1, preferable from about 2: 1 to about 17: 1.

[0075] Native Cellulose Material

[0076] The composition comprises from about 5 to about 60 wt% of native cellulose material, based on the total weight of the composition.

[0077] The native cellulose material is typically used as a nicotine carrier and / or a filler material. Suitable types of native cellulose material include powdered cellulose, microcrystalline cellulose (MCC), or mixtures thereof.

[0078] The inventors have identified several problems encountered with nicotine pouches of the prior art. Controlling the release of nicotine from nicotine pouches can often be challenging, especially without affecting other properties of the product.

[0079] In some cases, the release of nicotine can be inefficient and result in a low amount of nicotine available for uptake during oral use. In other cases, the release of nicotine may be too rapid, leading to an undesirable experience for the user. Additionally, the pouch is sensitive for storage and can display susceptibility for oxidation and the nicotine can migrate out from the pouch during the storage period.

[0080] Furthermore, not all nicotine is typically released from a pouch during oral use, resulting in wasted, unused nicotine remaining inside the pouch.

[0081] Surprisingly, the inventors have found that the composition of the present disclosure exhibits excellent control of nicotine release properties. A person skilled in the art would typically expect that powdered and microcrystalline cellulose products, such as those which comply with pharmacopoeial monographs such as those in USP, EuPh, JPh and other similar regulatory documents, including those under the ingredient code E460, would perform similarly. However, the inventors have found that this is not the case and that different grades have different water retention properties.

[0082] It has been further found that combinations of microcrystalline celluloses having low water retention properties with other forms of cellulose (such as other forms of microcrystalline cellulose) provide for a faster release of nicotine when used as a carrier in, for example, a nicotine pouch context.

[0083] Accordingly, the composition of the present disclosure allows for the release of nicotine to be controlled, thereby tuning for a slow, moderate or fast nicotine release, and it is consequently envisaged that this achieves a low, medium or high uptake of nicotine for the user. In addition, the composition of the present disclosure leads to a high percentage of nicotine in the composition being released during oral use.

[0084] It is observed that the composition of the present disclosure has properties that provides for efficient penetration and transport of fluids, such as water or saliva, throughout the composition, which may result in a better control over the dissolution of nicotine from the composition. For example, a greater and / or faster dissolution of nicotine may be achieved, leading to rapid release of nicotine from the composition into the user when used in an oral pouch. By varying the amount of the microcrystalline cellulose material X in the composition, the nicotine release properties of the composition can be tuned. Consequently, this can allow for the rate of nicotine release to be modified based on the preference of the user.

[0085] The microcrystalline cellulose material X may comprise particles of fibrous or elongate form.

[0086] Without wishing to be bound by theory, it is proposed that the microcrystalline cellulose material X, which may have a fibrous form, for instance in the form of rod-shaped particles or fibres, has properties which may promote sorption of nicotine during preparation of the composition, as well as quick release of nicotine during use. It is proposed that the inclusion of a microcrystalline cellulose material X may have several beneficial properties for this purpose, such as low bulk density.

[0087] For example, the microcrystalline cellulose material X particles may have a large particle aspect ratio (AR). The AR is a common measure of shape which is the ratio of the major diameter (L) to the minor diameter (D). The major diameter is the longest straight line that can be drawn between any two points on the outline. The minor diameter is the longest line perpendicular to the major diameter: AR = L / D. It is preferred that the AR is at least about 1.5, for example at least about 2, such as at least about 2.5, preferably at least about 3, or from about 2 to about 5, preferably from about 2.5 to about 4.5.

[0088] The AR may be measured by passing the microcrystalline cellulose material X through a 75 pm screen, using a scanning electron microscope to obtain a photomicrograph of the collected sample and using image analysis to determine L and D as number averages.

[0089] It appears that a high AR material may have a bulky, open structure that allows for fluids, such as water or saliva, to penetrate into the material and effectively dissolve nicotine. These properties are believed to lead to a more efficient penetration of water / saliva into the composition, resulting in a fast nicotine release during oral use when the composition is incorporated in an oral nicotine pouch.

[0090] The microcrystalline cellulose material X may have a mean particle length L of from about 5 to about 300 pm, such as from about 10 to about 200 pm, preferably from about 25 to about 150 pm. The microcrystalline cellulose material X may have a mean particle width D of from about 0.5 to about 50 pm, such as from about 1 to about 25 pm, preferably from about 2 to about 15 pm.

[0091] The microcrystalline cellulose material X may have a mean particle aspect ratio AR of at least about 1.5, for example at least about 2, such as at least about 2.5, preferably at least about 3, or from about 2 to about 5, preferably from about 2.5 to about 4.5.

[0092] These may provide that the composition may have a structure that facilitates efficient transport of water or saliva through the composition, for example by wicking. For instance, the nature of the microcrystalline cellulose material X particles having a high particle aspect ratio may lead to a high number of contact points between particles, or the aligned microfibrils which may aid in flow of water on the surface of the particles, may facilitate transfer of fluid through the composition and dissolution of nicotine.

[0093] By varying the amount of microcrystalline cellulose material X and other native cellulose material in the composition, the nicotine release properties of the composition can be tuned. Consequently, this can allow for a faster or slower release of nicotine depending on the preference of the intended target user.

[0094] It is further proposed that the composition of the present disclosure may provide for nicotine pouches having a lower weight per pouch compared to nicotine pouches of the prior art.

[0095] For example, the microcrystalline cellulose material X may have a low bulk density, which results in the nicotine product having a low weight. This is advantageous for both economic and environmental reasons as a result of reduced energy consumption and transport costs. For example, the microcrystalline cellulose material X may have a bulk density of less than about 0.25 g / cm3, for example less than about 0.22 g / cm3. In embodiments, it may have a bulk density between 0.1 g / cm3and 0.21 g / cm3.

[0096] The bulk density may be measured by a tapping volume test such as ASTM B527-22. For example, a 50g sample may be added to a 100cm3graduated cylinder which may be tapped until no further reduction in apparent volume take place. The mass of the sample is then divided by the measured volume to give the bulk density.

[0097] Furthermore, the composition of the present disclosure may achieve a high total release of nicotine. Release of a high content of the total nicotine from the composition during oral use means that a lower amount of nicotine remains in the pouch, which may allow for less nicotine to be used in the product.

[0098] The composition may comprise from about 20 to about 60 wt% of native cellulose material, based on the total weight of the composition, such as from about 35 to about 60 wt%, for example from about 40 to about 60 wt%.

[0099] The native cellulose material comprises at least about 5 wt% of microcrystalline cellulose material X, based on the total weight of native cellulose material.

[0100] The inclusion of at least some microcrystalline cellulose material X in the composition will improve the properties of the composition. It should be understood that the exact amount of microcrystalline cellulose material X included in the composition may be determined by the desired properties of the nicotine pouch.

[0101] In some embodiments, the native cellulose material may comprise at least about 10 wt% of microcrystalline cellulose material X, based on the total weight of the native cellulose material, for example at least about 15 wt%, at least about 20 wt%, at least about 22 wt%, at least about 23 wt% or preferably at least about 25 wt%.

[0102] In embodiments, the native cellulose material may comprise up to about 50 wt% of microcrystalline cellulose material X.

[0103] In preferred embodiments, the native cellulose material may comprise from about 5 to about 90 wt% of microcrystalline cellulose material X, such as from about 10 to about 55 wt%, for example from about 15 to about 45 wt%, preferably from about 20 to about 40 wt% or from about 22 wt% to about 40wt% or from about 23 wt% to about 40wt%.

[0104] Alternatively, in particular when a slower nicotine release rate is preferred, the native cellulose material may comprise no more than about 20 wt% of microcrystalline cellulose material X, based on the total weight of the native cellulose material, such as no more than about 15 wt%, for example from about 5 to about 20 wt%.

[0105] In certain embodiments, the microcrystalline cellulose material X may function as a nicotine release agent, for example to control the release of nicotine from the composition. The native cellulose material may comprise a second cellulose material Y, optionally selected from one or more of powdered cellulose, microcrystalline cellulose, and mixtures thereof.

[0106] The second cellulose material Y may be present in an amount of about 95 wt% or less, based on the total weight of the native cellulose material, for example from about 10 to about 95 wt%, such as from about 45 to about 90 wt%, for example from about 55 to about 85 wt%, preferably from about 60 to about 80 wt%.

[0107] The second cellulose material Y may have a mean particle aspect ratio AR of less than 3, for example less than 2, preferably less than 1.5, such as from about 1 to about 1.5. It is preferred that the mean AR of the second cellulose material Y is smaller than the mean AR of the microcrystalline cellulose material X.

[0108] Gelling agents

[0109] The composition may further comprise gelling agents such as agar agar and / or derivatives of agar agar.

[0110] Agar agar is a dried, hydrophilic, colloidal polysaccharide complex extracted from red algae (Rhodophyceae). The structure is believed to be a complex range of polysaccharide chains having alternating o-(1^3) and -(1^4) linkages. Agar agar can be separated into a natural gelling fraction, agarose, and a sulphated nongelling fraction, agaropectin. Agar agar is soluble in hot water to form a viscous solution but has poor solubility in cold water and ethanol (95%). A 1% w / v aqueous solution forms a stiff jelly on cooling.

[0111] The presence of agar agar in the composition may act as an effective nicotine stabilizer and release control agent. Without wishing to be bound by any particular theory, it is postulated that the nicotine may be partially bound within an agar agar gel which may be formed during manufacture. This appears to provide both a highly stable nicotine composition, which despite the use of free base nicotine and high levels of moisture is able to maintain a long shelf life. Moreover, the addition of agar agar can provide a nicotine release profile which is fast and consistent, providing excellent product performance. This performance may be provided despite a relatively small qratiouantity of agar agar being provided in the composition. The composition may comprise from about 0.1 to about 2 wt% of agar agar and / or derivatives of agar agar, based on the total weight of the composition, such as from about 0.1 to about 2 wt%, for example from about 0.1 to about 1.2 wt%.

[0112] In some embodiments, the composition may comprise agar agar and / or derivatives of agar agar in an amount of less than about 1 wt%, such as less than about 0.7 wt%, preferably from about 0.2 to about 0.7 wt%, more preferably from about 0.2 to about 0.5 wt% .

[0113] The ratio of agar agar to nicotine in the composition may be less than about 2.5: 1.

[0114] The composition may have a ratio of agar agar to nicotine of from about 0.1 : 1 to about 2: 1, preferably from about 0.1: 1 to about 1.5: 1, more preferably from about 0.1: 1 to about 1: 1.

[0115] Any food or pharmaceutical grade agar agar may be utilized in the present invention. Specific examples include Rokoagar (RTM) RGM 600 and RGM 800, as supplied by Industrias Roko, S.A..

[0116] Tobacco

[0117] The composition may further comprise a small quantity of tobacco (e.g. tobacco leaf), for example up to about 5 wt%, such as from about 0.01% to about 5 wt%, preferably from about 0.03 to about 3 wt%.

[0118] Where the term "tobacco" is used, we mean any part, such as leaves, stems, and stalks, of any member of the genus Nicotiana. The tobacco may be whole, shredded, threshed, cut, ground, cured, aged, fermented, or treated otherwise, e.g., granulated or encapsulated.

[0119] In some embodiments, the composition may consist essentially of the components described above.

[0120] Pouch and Package

[0121] According to a further aspect of the present disclosure, there is provided a water or saliva permeable pouch comprising a composition as described above and a membrane which forms walls of the pouch. According to a further aspect of the present disclosure, there is provided a package containing a plurality of pouches as described above.

[0122] Composition preparation

[0123] According to a further aspect of the present disclosure, there is provided a process for preparing a composition as described above.

[0124] Native cellulose material may be prepared or obtained from any appropriate source.

[0125] The native cellulose material may be powdered cellulose and / or microcrystalline cellulose.

[0126] Examples of powdered cellulose which may be used in the composition (for example as second cellulose material Y) include Arbocel(RTM) as supplied by J. Rettenmaier & Sdhne GmbH; Elcema; KC Flock(RTM) supplied by Nippon Paper Industries Co. Ltd.; Microcel 3E- 150 supplied by Roquette Freres; Sanacel (RTM) supplied by CFF GmbH; Sanacel Pharma (RTM) supplied by CFF GmbH; Sancel-W supplied by NB Entrepreneurs Company; or Solka-Floc (RTM) supplied by J. Rettenmaier USA LP.

[0127] Examples of microcrystalline cellulose which may be used in the composition (for example as second cellulose material Y) include Avicel (RTM) PH supplied by Dupont Nutrition and Biosciences, Inc.; Cellets (RTM) supplied by Pharmatrans Sanaq AG; Celphere (TM) supplied by Asahi Kasei Corporation;; Emcocel (RTM) supplied by JRS Pharma GmbH; MCC Sanaq (RTM) supplied by Pharmatrans Sanaq AG; Pharmacel (RTM) supplied by DFE Pharma GmbH; Tabulose (RTM) supplied by Roquette Freres; Vivapur (RTM) supplied by JRS Pharma GmbH.

[0128] Examples of microcrystalline cellulose which may be used in the composition as microcrystalline cellulose material X include certain grades of Ceolus (TM) KG supplied by Asahi Kasei Corporation, such as Ceolus (TM) KG-1000 and Ceolus (TM) KG-802.

[0129] In some embodiments, the microcrystalline cellulose material X may be prepared by a heat or steam treatment process.

[0130] Any suitable method may be used to prepare the composition.

[0131] The best results to prepare the composition are obtained when following the process of the disclosure which comprises the steps of: a. providing a precursor composition comprising a native cellulose material comprising microcrystalline cellulose material X, b. adding water to the precursor composition and mixing at a temperature of about

[0132] 50 °C or more, c. adding nicotine to the precursor composition at a temperature of about 50 °C or more to provide a heated composition, and d. allowing the heated composition to cool to provide a composition, wherein the composition comprises: from about 0.2 to about 5 wt% of nicotine; from about 5 to about 60 wt% of native cellulose material; at least about 35 wt% of water; from about 0.2 to about 3 wt% of one or more pH control salts; and optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition; and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X, based on the total weight of native cellulose material.

[0133] Preferably, step (a) comprises: combining in a mixer a native cellulose material comprising microcrystalline cellulose material X, thereby to form the precursor composition.

[0134] Step (a) may comprise mixing in a vessel (such as an autoclave) the components, each in powder or granular form.

[0135] One or more of the other solid components of the composition, such as one or more pH control salts, optional additional ingredients such as flavourings, flavour enhancers, sweeteners and / or preservatives, may also be provided in the precursor composition in step (a), though any tobacco intended for inclusion in the final composition should ideally be held until the remainder of the composition is complete.

[0136] Preferably, step (a) further comprises providing a precursor composition comprising one or more pH control salts and / or optional additional ingredients.

[0137] Step (b) may comprise adding at least a portion of the water (preferably at least 10 wt% of the intended final composition) to the precursor composition.

[0138] Additional water may be added between steps (c) and (d). In preferred embodiments, in steps (b) and (c), the mixing of the precursor composition is at a temperature of about 60 °C or more, preferably about 70 °C or more, more preferably about 80 °C or more.

[0139] Preferably, the precursor composition is heated. The heating may take place in a number of ways. The mixing vessel may be heated, for example by use of a heating manifold. Alternatively, or additionally, the water may be heated prior to its introduction to the mixing vessel or some or all of the water may be added as steam.

[0140] The temperature of the precursor composition should be at least 50°C, preferably at least 60°C and more preferably at least 70°C. Heating may aid in dissolution of agar agar, when agar agar is included. Without wishing to be bound by any theory, it is postulated that the low concentration of agar agar coupled with shear applied during mixing, sufficient dissolution of agar agar may be obtained at such temperatures. Furthermore, heating may aid in the dispersion of the microcrystalline cellulose material X.

[0141] In step (b), the water may be provided to the precursor composition at a temperature of about 70 °C or more, preferably about 80 °C or more. Indeed, in step (b) the water may be provided to the precursor composition in the form of steam or vapour.

[0142] Step (c) may comprise mixing the precursor composition while nicotine is added. The nicotine may be added to the precursor composition in an amount of from about 0.2 wt% to about 5 wt%, based on the total weight of the final composition. At this stage, other liquid components of the composition, may be added.

[0143] The mixing and / or heating of the precursor composition following addition of the nicotine may aid in the incorporation of nicotine into the composition, in particular by allowing for the microcrystalline cellulose material X to take up nicotine (such as sorption of nicotine onto the surface and / or into the pores of the microcrystalline cellulose material X).

[0144] Where additional water is added between steps (c) and (d) it may be at a temperature of about 70 °C or more, preferably about 80 °C or more. Indeed, it may be in the form of steam or vapour.

[0145] Optionally, additional water (preferably at least 10 wt% of the intended final composition) is added to the precursor composition and / or heated composition and heated, again to at least 50°C, preferably at least 60°C and more preferably at least 70°C. In some embodiments, the precursor composition is heated while mixing, for example during steps (b) and / or (c), and / or during or after any addition of water following step (c).

[0146] The heated composition is then allowed to cool, preferably while mixing is continued. The resulting composition may be set aside. Without wishing to be bound by any particular theory, it is believed that when agar agar is used, it forms a gel which at least partially encapsulates the nicotine which is present, stabilizing it and also providing excellent release properties.

[0147] In some embodiments, further water is added to the composition after step (d).

[0148] In an optional finishing step, the resulting composition may have further water added to it, preferably with the water at ambient temperature. This step is to afford a greater water content to the composition where required. In some embodiments, flavour enhancers, sweeteners or preservatives may be added at this stage, additionally to or in the alternative to their addition earlier in the process.

[0149] The finished composition may optionally be mixed with tobacco in an amount of up to 5 wt% of the final composition. The composition is soft to the touch, produces little dust and does not form clumps. The product is white in colour. In preferred embodiments, it is packed into saliva permeable pouches ready for oral delivery.

[0150] Embodiments of the present disclosure will now be described with reference to the following drawings:

[0151] Figure 1 shows nicotine release from pouches containing compositions according to the present disclosure and comparative examples;

[0152] Figure 2 shows nicotine release from pouches containing compositions according to the present disclosure and comparative examples;

[0153] Figure 3 shows nicotine uptake in cells for compositions according to the present disclosure and comparative examples; and

[0154] Figure 4 shows toxicity measurements of compositions according to the present disclosure and comparative examples;

[0155] Figures 5 and 6 show nicotine release profiles from pouches according to the present disclosure and comparative examples;

[0156] Figures 7 and 8 show SEM images of cellulose materials described herein. According to a further aspect of the present disclosure, there is provided a composition for use in a nicotine delivery product, such as an oral nicotine delivery product.

[0157] According to a further aspect of the present disclosure, there is provided a tobacco-free (or in some instances low tobacco) nicotine composition for use in pouches for oral use.

[0158] In a further embodiment, there is provided a process for the manufacture of tobacco-free or low tobacco nicotine compositions.

[0159] The composition has a high water content and may contain nicotine in its free base form. The composition includes a native cellulose material containing microcrystalline cellulose material X. The microcrystalline cellulose material X may function as a nicotine release agent to control (e.g. promote) the release of nicotine from the composition when it is placed (e.g. in a pouch) in the oral cavity of a user.

[0160] In an embodiment, the composition has a general formulation as described below: a. from about 0.2 to about 5 wt% nicotine in free base form; b. native cellulose material, in an amount from about 35 to about 60 wt%; c. water in an amount of at least 35 wt%; d. one or more pH control salts, such as a combination of ammonium chloride and sodium bicarbonate in an amount from about 0.2 to about 3 wt%; e. optional additional ingredients, such as flavourings, flavour enhancers, sweeteners and preservatives, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein at least 20wt% of the native cellulose material comprises a microcrystalline cellulose material X, preferably at least about 22wt%, based on the total weight of native cellulose material.

[0161] In preferred embodiments, the composition may have a general composition as follows: a. from about 0.2 to about 3 wt% nicotine in free base form; b. native cellulose material, in an amount from about 35 to about 60 wt%; c. water in an amount at least about 35 wt%, preferably above about 40 wt%; d. buffer salts ammonium chloride in an amount from about 0.05 to about 1 wt% and sodium bicarbonate in an amount from about 0.1 to about 1 wt%; e. optional additional ingredients, such as a. flavourings in an amount from about 0.5 wt% to about 3 wt%, b. flavour enhancers such as sodium chloride in an amount from about

[0162] 2 to about 8 wt%, c. sweeteners such as xylitol in an amount from about 1 to about 2 wt% and / or acesulfame K in an amount from about 0.05 to about 1 wt%; and d. preservatives, such as potassium sorbate in an amount from about 0.25 to about 1 wt%. e. tobacco in a quantity from 0 wt% to about 3 wt%, based on the total weight of the composition, and wherein at least 20wt% of the native cellulose material comprises a microcrystalline cellulose material X, preferably from about 20 to about 40 wt% or from about 22wt% to about 40 wt%, based on the total weight of native cellulose material.

[0163] Examples

[0164] A number of compositions were produced according to the method described above.

[0165] Table 1

[0166] Different grades of native cellulose material were evaluated according to the compositions in Table 1. In Example 1, the native cellulose material was replaced by microcrystalline cellulose material X present in the composition was 100%. In Comparative Examples 1 to 4, other types of native cellulose material were used, so that the proportion of native cellulose material that was microcrystalline cellulose material X present in the composition was 0%.

[0167] The in vitro dissolution release of nicotine from nicotine pouches containing the compositions of Example 1 and Comparative Examples 1 to 4 was analysed by High- performance Liquid Chromatography (HPLC). Nicotine release was monitored in volumes mimicking what is produced by a nicotine pouch user for 30 minutes. Nicotine dissolution was compared using different grades of native cellulose material based on the contents of a commercially available nicotine pouch with an equivalent nicotine loading (Comparative Example 1), and MCC-90, MCC-101 and MCC-200, which correspond to Comparative Examples 2, 3 and 4, respectively. Example 1 corresponds to a composition comprising Ceolus (TM) KG-1000 as the microcrystalline cellulose material X.

[0168] The results of the in vitro dissolution release tests are plotted in Figure 1. As can be seen, the total amount of nicotine released from the composition comprising microcrystalline cellulose material X was about 54% within a period of 30 minutes, whereas the total amount of nicotine released from comparative compositions was under 40%. Accordingly, comparative samples showed delayed less nicotine release compared to compositions according to the invention.

[0169] Table 2

[0170] Pouches with different concentrations of microcrystalline cellulose material X were evaluated according to the compositions in Table 2. In Examples 2, 3, 4 and 5, the native cellulose material contained microcrystalline cellulose material X in proportions of 15%, 20%, 25% and 30%, respectively. In Comparative Examples 5 and 6, other types of native cellulose material were used, so that the proportion of native cellulose material that was microcrystalline cellulose material X was 0%. The in vitro dissolution release of nicotine from nicotine pouches containing the compositions of Examples 2 to 5 and Comparative Examples 5 and 6 was analysed by High-performance Liquid Chromatography (HPLC). Nicotine release was monitored within 1 minute. Nicotine dissolution was compared to other grades of native cellulose material by comparing with the contents of a commercially available nicotine pouch provided by Habit Factory (Comparative Example 5) and another commercially available nicotine pouch (Comparative Example 6), in both cases having equivalent nicotine loadings as Examples 2 to 5. Examples 2 to 5 correspond to compositions comprising varying amounts of Ceolus (TM) KG-1000 as the microcrystalline cellulose material X.

[0171] The results of the in vitro dissolution release tests are plotted in Figure 2. As can be seen, the total amount of nicotine released within a period of 1 minute was highest for compositions comprising at least 25 wt% of microcrystalline cellulose material X. In contrast, comparative samples showed less nicotine release according to compositions according to the invention.

[0172] In vivo uptake

[0173] The cellular uptake of nicotine was measured for compositions prepared according to the invention containing microcrystalline cellulose material X, wherein the native cellulose material contained varying amounts of microcrystalline cellulose material X (10 wt%, 20 wt%, 30 wt% and 100 wt% microcrystalline cellulose material X, based on the total weight of native cellulose material).

[0174] Extracts from the pouches were brought into contact with human epithelial cells for 30 minutes and proteins were subsequently precipitated using trichloroacetic acid. The remaining supernatant was neutralized by NaOH and subsequently analyzed by HPLC. In vivo uptake of nicotine 30 minutes after corresponds to at least about 30% of the total content of nicotine in the nicotine pouch.

[0175] The results of the in vivo dissolution release tests are plotted in Figure 3. As can be seen, a higher relative nicotine uptake in cells was seen for compositions with higher contents of microcrystalline cellulose material X, which displayed a rapid appearance of nicotine in human cells. pH tests

[0176] The effect of microcrystalline cellulose material X content on pH was also determined. As can be seen in Table 3, this showed that the concentration of microcrystalline cellulose material X in the composition did not affect the pH of the nicotine pouches compared to the contents of a commercially available product with an equivalent nicotine loading (Comparative Sample). Table 3

[0177] The Coresta Method No.69, 2017 was used to determine pH values. A pH electrode is calibrated using at least two pH buffers (4 and 7 or 7 and 10) to produce a two-point calibration that will cover the pH range of the products tested. Calibration is performed in conjunction with the measurements of samples and at 23°C. The calibration slope must be within 95% - 105% before the electrode can be used for sample measurements. The electrode must be rinsed, before and after each measurement, with water.

[0178] The samples for testing are allowed to reach room temperature before preparation. Samples are then mixed with water at a concentration of 5 wt% and shaken or stirred for 30 minutes. The pH electrode is then used to determine the pH of the water in the sample mixture.

[0179] Moisture content

[0180] The effect of microcrystalline cellulose material X content on moisture content was also determined. As can be seen in Table 4, this showed that the concentration of microcrystalline cellulose material X in the composition did not affect the moisture content of the nicotine pouches compared to the Comparative Sample.

[0181] Table 4

[0182] Toxicity tests

[0183] The effect on toxicity to human cells of fast nicotine release provided by the compositions according to the invention was compared to comparative samples.

[0184] A composition containing 30 wt% of microcrystalline cellulose material X (30% KG-1000), based on the total weight of native cellulose, was compared to the Comparative Sample. The results are plotted in Figure 4. Extracts from the nicotine pouches were brought into contact with human epithelial cells for 30 minutes and the toxicity was measured using Toxilight luminescence-based kit on a GloMax machine.

[0185] As can be seen, this shows that a faster nicotine release achieved by the 30 wt% composition did not result in additional harm to cells compared to the Comparative Sample.

[0186] Table 5 In Table 5, there are shown a series of compositions which were tested for nicotine release as described above for periods of 1 minute, 10 minutes and 30 minutes. Example 6 uses as the microcrystalline cellulose material X Ceolus KG-1000 and Example 7 uses Ceolus KG-802, which has a mean particle AR of greater than 2 and bulk density which is 0.21 g / cm3.

[0187] Comparative Example 7 includes an alternative MCC, Ceolus UF-711 (also available from Asahi Kasai). Comparative Example 9 uses Arbocell M80 (JRS Pharma, Rosenberg DE) as an alternative cellulose material which is a powdered cellulose material of generally fibrous form which is not a microcrystalline cellulose. All of these examples include MCC-90 (HiCell 90M, Sigachi Industries LTD) as the main cellulose material.

[0188] The results in Figure 5 show that the compositions of Examples 6 and 7 provide far greater release of nicotine after 10 minutes than the Comparative Examples 7, 8 and 9. Moreover, Figure 6 shows that the release profile over 30 minutes is far quicker and more complete for the inventive examples. This implies that a smaller loading of nicotine may be possible when utilizing compositions of the invention.

[0189] Water Retention Factor

[0190] The following experiments calculate a water retention factor (WRF) for samples of cellulose material. In each experiment, a 4.5g sample of the cellulose material is added to a petri dish to which is added 4.5ml (4.5g) water.

[0191] Each sample is then subjected to a loss on drying test (LOD) where dishes are placed in a drying oven at 160°C for 12 minutes and weighed to determine the water retention. The results are shown in Table 6, below:

[0192] Table 6

[0193] The inventive materials of Reference Examples 8 and 9 surprisingly show a far lower ability to retain water, which appears to contribute to the ability to deliver nicotine to a user in an oral pouch, given that nicotine is soluble in water. SEM Images

[0194] Scanning electron microscopy (SEM) images were obtained for samples of MCC-90 and Ceolus KG-1000. These images are shown in Figures 7 and 8. Figure 7 shows a collection of particles of each grade of cellulose (Figures 7a and 7b correspond to MCC-90 and Ceolus KG-1000, respectively), whereas Figure 8 shows a close up image of a single particle with indicative L / D dimensions shown (Figure 8a and 8b correspond to MCC-90 and Ceolus KG- 1000, respectively). The Ceolus KG-1000 material is seen to be of generally fibrous, rodlike form in comparison to the MCC-90.

[0195] Methods to determine an aspect ratio of the particles is described above and similar methods are described in the patent application EP1300420, the contents of which are incorporated herein by reference.

[0196] All embodiments of the invention and particular features mentioned herein may be taken in isolation or in combination with any other embodiments and / or particular features mentioned herein (hence describing more particular embodiments and particular features as disclosed herein) without departing from the disclosure of the invention.

[0197] As used herein, the term 'comprises' will take its usual meaning in the art, namely indicating that the component includes but is not limited to the relevant features (i.e. including, among other things). As such, the term 'comprises' will include references to the component consisting essentially of the relevant substance(s).

[0198] Wherever the word 'about' is employed herein in the context of amounts, for example absolute amounts, weights, volumes, sizes, diameters etc., or relative amounts (e.g. percentages) of individual constituents in a composition or a component of a composition (including concentrations and ratios), timeframes, and parameters such as temperatures etc., it will be appreciated that such variables are approximate and as such may vary by ±10%, for example ±5% and preferably ±2% (e.g. ±1%) from the actual numbers specified herein. This is the case even if such numbers are presented as percentages in the first place (for example 'about 10%' may mean ±10% about the number 10, which is anything between 9% and 11%).'

[0199] The invention is as defined in the following claims.

Claims

Claims l.A composition, wherein the composition comprises: a. from about 0.2 to about 5 wt% of nicotine; b. from about 5 to about 60 wt% of native cellulose material; c. at least about 35 wt% water; d. from about 0.2 to about 3 wt% of one or more pH control salts; and e. optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X having a water retention factor (WRF) of less than 40%, based on the total weight of native cellulose material.

2. The composition according to Claim 1, wherein the WRF is measured by adding to a sample of material X a mass of water equal to the mass of the sample of material X; measuring the mass of the wet sample; drying the wet sample at 160°C for 12 minutes; measuring the mass of the dried sample and determining the % mass of added water remaining in the sample.

3. The composition according to Claim 1 or Claim 2, wherein the microcrystalline cellulose material X is present in an amount of at least 10 wt%, based on the total weight of the native cellulose material.

4. The composition according to Claim 3, wherein the microcrystalline cellulose materialX is present in an amount of at least 22wt%, based on the total weight of the native cellulose material.

5. The composition according to Claim 3 or Claim 4, wherein the microcrystalline cellulose material X is present in an amount of from about 10 to about 55 wt%, based on the total weight of the native cellulose material, preferably from about 20 to about 40 wt% or 22wt% to about 40wt%.

6. The composition according to any of Claims 1 to 5, wherein the native cellulose material comprises a second cellulose material Y, optionally selected from one or more of powdered cellulose, microcrystalline cellulose, and mixtures thereof.

7. The composition according to Claim 6, wherein the second cellulose material Y has aWRF greater than 40%.

8. The composition according to Claims 6 or 7, wherein the second cellulose material Y is present in an amount of about 95 wt% or less, based on the total weight of the native cellulose material.

9. The composition according to any of Claims 6 to 8, wherein the second cellulose material Y is present in an amount of from about 45 to about 90 wt%, preferably from about 60 to about 80 wt%, based on the total weight of the native cellulose material.

10. The composition according to any one of the preceding claims, wherein the microcrystalline cellulose material X has a bulk density of less than about 0.26 g / cm3, preferably less than about 0.25 g / cm3, for example less than 0.22 g / cm3.

11. The composition according to any one of the preceding claims, wherein the microcrystalline cellulose material X is in the form of fibres or rod-shaped particles or elongate form.

12. The composition according to any preceding Claim, wherein the microcrystalline cellulose material X has a mean particle length of from about 10 to about 200 pm, and / or a mean particle width of from about 1 to about 25 pm.

13. The composition according to any preceding Claim, wherein the microcrystalline cellulose material X has a mean particle aspect ratio of at least about 2, preferably at least about 3, wherein particle aspect ratio is defined as the ratio of the particle length to the particle width.

14. The composition according to any preceding Claim, wherein the microcrystalline cellulose material X has a mean particle thickness of from about 0.5 to about 5 pm.

15. The composition according to any one of Claims 6 to 14, wherein the second cellulose material Y has a mean particle aspect ratio which is smaller than that of the microcrystalline cellulose material X, preferably wherein the second cellulose material Y has a mean particle aspect ratio of less than 3, for example less than 2, preferably less than 1.5.

16. The composition according to any one of the preceding claims, wherein the nicotine is in free base form.

17. The composition according to any one of the preceding claims, wherein the composition comprises from about 0.2 to about 3 wt% nicotine or from about 0.2 to about 2 wt%.

18. The composition according to any one of the preceding claims, wherein the ratio of microcrystalline cellulose material X to nicotine is from about 0.1 : 1 to about 34: 1.

19. The composition according to any one of the preceding claims, wherein the composition comprises at least about 40 wt% water, preferably from about 40 to about 50 wt% water, based on the total weight of the composition.

20. The composition according to any one of the preceding claims, wherein the composition further comprises a gelling agent.

21. The composition according to Claim 20, wherein the gelling agent comprises agar agar and / or derivatives of agar agar, preferably in an amount of from about 0.1 to about 2 wt%, based on the total weight of the composition.

22. The composition according to Claim 21, wherein the gelling agent is present in an amount in an amount less than about lwt%, preferably less than 0.7wt%, such as in an amount from about 0.2 wt% to about 0.7wt%, preferably in an amount from about 0.2wt% to about 0.5wt%.

23. The composition according to Claim 20 to 22, wherein the ratio of gelling agent (e.g. agar agar and / or derivatives of agar agar) to nicotine is between 0.1: 1 and 2.5: 1, preferably between 0.2: 1 and 1.5: 1, e.g. between 0.5: 1 and 1: 1.

24. A water or saliva permeable pouch comprising a composition according to any one of the preceding claims.

25. A package containing a plurality of pouches according to Claim 24.

26. Use of microcrystalline cellulose material X as a nicotine release control agent in a composition comprising: a. from about 0.2 to about 5 wt% of nicotine;b. from about 5 to about 60 wt% of native cellulose material; c. at least about 35 wt% water; d. from about 0.2 to about 3 wt% of one or more pH control salts; and e. optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X, based on the total weight of native cellulose material, wherein the microcrystalline cellulose material X has a water retention factor (WRF) of less than 40%.

27. Use of microcrystalline cellulose material X as a nicotine uptake control agent in a composition comprising: a. from about 0.2 to about 5 wt% of nicotine; b. from about 5 to about 60 wt% of native cellulose material; c. at least about 35 wt% water; d. from about 0.2 to about 3 wt% of one or more pH control salts; and e. optional additional ingredients, preferably in an amount up to about 12 wt%, based on the total weight of the composition, and wherein at least 5wt% of the native cellulose material comprises a microcrystalline cellulose material X, based on the total weight of native cellulose material, wherein the microcrystalline cellulose material X has a water retention factor (WRF) of less than 40%.

28. The use according to Claims 26 or 27, wherein the composition is according to any one of Claims 1 to 23.

Images