Smokeless article

Abstract

Disclosed herein is a smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising a filler, a nicotinic compound, 0-5 wt% tobacco solids, and from 0.05 to 5 wt% of a darkening agent, as well as a smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising a filler, a nicotinic compound, 0-5 wt% tobacco solids, and a darkening agent and wherein the RGB colour values of the content are within the ranges R: 0-140, G: 0-125, B: 0-100, and the G and B values are each at most 20 higher than the R value. Also provided is a method of manufacturing the smokeless article, and use of a darkening agent to darken the colour of the content in a smokeless article.

Description

[0001] SMOKELESS ARTICLE

[0002] FIELD

[0003] The present disclosure relates to a smokeless article. In particular, the disclosure relates to a smokeless article for oral consumption comprising a pouch enclosing a content which comprises a nicotinic compound for oral delivery. This disclosure also relates to methods of manufacturing the smokeless article and use of a darkening agent in a smokeless article.

[0004] BACKGROUND

[0005] Smokeless articles are a suitable alternative to conventional cigarettes because they do not require heating for substance delivery to the user. Instead, smokeless articles rely on saliva to extract soluble substances, typically nicotine and / or flavours, from the content contained within the smokeless article.

[0006] Smokeless articles are placed in the mouth where saliva extracts the soluble element from the content contained within. Typically, the smokeless article is placed in the oral cavity, sublingually or in the oral vestibule (between the teeth and lips / cheeks). The user may assist extraction by oral manipulation, such as by chewing and / or sucking or pressing on the outside of the mouth to squeeze the pouch.

[0007] The above-described extraction and delivery process continues until the soluble element is depleted from the smokeless article. The smokeless article is then removed from the mouth and disposed of. One example of a smokeless article is traditional snus, which may be provided as a pouch containing a content comprising tobacco.

[0008] It is desirable to provide alternative smokeless articles. In particular, smokeless articles with low or no tobacco content which a user perceives to be similar in appearance to traditional snus may be desirable.

[0009] The present disclosure has been devised in the light of the above considerations.

[0010] SUMMARY

[0011] At its most general, the present disclosure relates to a smokeless article e.g. an oral nicotine delivery (OND) article, for oral consumption.

[0012] In a first aspect, the present disclosure provides a smokeless article for oral consumption comprising a pouch enclosing a content. The content is an oral nicotine (OND) formulation. The content comprises a nicotinic compound, optionally tobacco solids, and a darkening agent.

[0013] The smokeless article comprises a pouch enclosing a content, wherein the content (including e.g. a nicotinic compound, darkening agent, and filler materials) is completely enclosed by the pouch. The pouch may typically be sealed to ensure that the content of the pouch does not scatter inside the mouth.

[0014] In some examples, the content comprises a filler, a nicotinic compound, 0-5 weight% (wt%) tobacco solids, and from 0.05 to 5 wt% of a darkening agent. Weight percentages of tobacco solids and darkening agent provided herein are relative to the total weight of the content wherein the total weight of the content is 100 wt%.

[0015] The content comprises a filler or bulking agent. Fillers or bulking agents may be provided to increase the volume of the smokeless article (e.g. by increasing the volume contained within the pouch and to strengthen the contents). The filler may be plant material, as defined elsewhere herein. Suitable fillers also include calcium carbonate, calcium phosphate, corn starch, grains, lactose, polysaccharides (e.g. maltodextrin), polyols, sugars (e.g. dextrose, manitol, xylitol, sorbitol), natural fibres (e.g. non-tobacco fibres), microcrystalline cellulose, cellulose and cellulose derivatives (e.g. finely divided cellulose), lignocellulose fibres (e.g. wood fibres), jute fibres and combinations thereof. In some cases, the filler is not tobacco. In some examples the filler is 25 to 60 wt% of the content, e.g. 30 to 50 wt% or 35 to 45 wt%.

[0016] In some examples, the content comprises an active agent. In some examples, the active agent comprises or consists of an active compound. In some examples the active agent comprises or consists of a nicotinic compound.

[0017] The smokeless article may be an oral nicotine delivery (OND) article when the active agent within the content comprises a nicotinic compound.

[0018] In some examples the active agent comprises or consists of a nicotinic compound.

[0019] The nicotinic compound may be selected from nicotine, nicotine salt(s), nicotine complex(es); and nicotine solvate(s). In some examples the nicotinic compound is selected from one or more nicotine salts. In some examples the nicotinic compound is selected from the group consisting of nicotine salts, nicotine base, stabilized nicotine and mixtures thereof. For example, the content may include at least one nicotine salt selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine ditartrate, nicotine ditartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate and mixtures thereof.

[0020] In some examples, the content comprises a nicotinic compound (e.g. nicotine) in an amount of from 0.3 wt% to 2 wt%, for example from 0.4 wt% to 2 wt%, from 0.5 wt% to 2 wt%, from 0.5 wt% to 1 .9 wt%, from 0.8 wt% to 1.8 wt%, from 1 wt% to 1.6 wt%, from 1 wt% to 1.4 wt%, from 1.2 wt% to 1.6 wt%, or from 1.3 wt% to 1 .5 wt%, based on the total weight of the content.

[0021] In some examples, the total nicotinic compound (e.g. nicotine) content per pouch is from 4 to 15 mg. In some examples, the nicotinic compound content per pouch is about 7-10 mg, for example the nicotinic compound content per pouch is about 8 mg.

[0022] In some examples, the content comprises less than 5 wt% tobacco solids, such as less than 4 wt%, less than 3 wt%, or less than 2 wt% tobacco solids. In some examples, the content comprises less than 2 wt% tobacco solids. In some examples, the content comprises less than 1 wt% tobacco solids, such as less than 0.5 wt% tobacco solids. In some examples, the content is substantially free from, or free from i.e. contains 0 wt%, tobacco solids. In examples where the content has a similar colour to traditional snus, the user may experience a similar effect as with conventional tobacco-containing products while minimising, reducing or eliminating undesirable effects that accompany contents high in tobacco solids.

[0023] In some examples, the content is also low in non-solid forms of tobacco, such as tobacco extract, so that the content is low in tobacco (generally). In some examples, the content comprises less than 5 wt% tobacco, such as less than 4 wt%, less than 3 wt%, or less than 2 wt% tobacco. In some examples, the content comprises less than 2 wt% tobacco. In some examples, the content comprises less than 1 wt% tobacco, such as less than 0.5 wt% tobacco. In some examples, the content is substantially free from, or free from i.e. contains 0 wt%, tobacco. In examples where the content has a similar colour to traditional snus, the user may experience a similar effect as with conventional tobacco-containing products while minimising, reducing or eliminating undesirable effects that accompany contents high in tobacco.

[0024] As used herein, “darkening agent” refers to a component having a colour which gives the content an overall darker colour, as compared to the content in the absence of the darkening agent. In some examples, the darkening agent darkens the colour of the content. In some examples, the darkening agent causes the content to reflect less light in the visible range. In some examples, the darkening agent reduces at least one of an R, G, or B value of the colour of the content. In some examples, the darkening agent reduces the sum of the R, G, and B values of the colour of the content. In some examples, the darkening agent reduces the G value of the colour of the content by at least 10, at least 20, or at least 30. In some examples, the darkening agent reduces the R value of the colour of the content by at least 5. For example, a darkening agent may have the opposite effect on colour to a whitening, brightening, or lightening agent. In some examples, a darkening agent gives an appearance closer to black. The darkening agent may be a component which itself is dark in colour, and in some examples the darkening agent is black. The darkening agent may be a dark or black pigment, dye, or other organic matter. The darkening agent is not tobacco, and particularly not a tobacco solid. The comparisons used herein to describe the darkening agent are all made as compared to an identical composition without the darkening agent.

[0025] The content may comprise at most 5 wt%, at most 3 wt%, at most 2 wt%, at most 1.5 wt%, at most 1 wt%, at most 0.75 wt%, at most 0.6 wt%, at most 0.5 wt%, at most 0.4 wt%, at most 0.3 wt%, at most 0.25 wt%, or at most 0.2 wt% of darkening agent. The content may comprise at least 0.05 wt%, or at least 0.08 wt%, or at least 0.1 wt% of a darkening agent. The content may comprise around 0.15 wt% of darkening agent.

[0026] In some examples, the content comprises between 0.05-5 wt% darkening agent, such as between 0.05- 3 wt%, between 0.05-2 wt%, between 0.05-1.5 wt%, between 0.08-1.5 wt%, or between 0.08-1 wt% darkening agent. The content may comprise between 0.05-1 wt% darkening agent, or between 0.05- 0.75 wt% darkening agent, or between 0.05-0.6 wt% darkening agent. The content may comprise 0.05 to 0.5 wt% darkening agent.

[0027] In this way a desirable appearance of the smokeless article can be achieved, wherein the content appears tobacco-like or similar to the content of a traditional snus pouch. In some examples, the darkening agent is intimately mixed with the content. Typically, the darkening agent is evenly distributed throughout the content so as to affect the overall colour or hue of the content e.g. to give the content a uniform colour.

[0028] In some examples, the smokeless article may have similar characteristics to traditional snus or other tobacco-containing smokeless articles even when the smokeless article is low in, substantially free from, or free from, tobacco. For example, the content may appear dark in colour. The content may be black, grey, or brown. The content may be uniformly black, grey or brown. The content may visually resemble a tobacco-containing formulation.

[0029] In some examples, references to colours such as “black”, “brown” and the like, may each referto colours within the ranges defined by the RGB values given herein to describe the content.

[0030] In some examples, RGB colour values of the content are within the ranges R: 0-140, G: 0-125, B: 0- 100, and the G and B values are each at most 20 higher than the R value.

[0031] In the RGB colour model referred to herein, each value ranges from 0 to 255, wherein when all the components are at 0 the result is the darkest black and when all the components are at 255 the result is the brightest representable white.

[0032] The RGB values of the colour of the content may be determined using a colorimeter such as colorimeter model POE XXM20. Measurements may be taken in different colour spaces (such as CIE LAB, XYZ, LCh, and LUV) and converted to RGB values using standard conversions or, for example, an online tool such as https: / / colordesiqner.io / convert / labtorqb.

[0033] The RGB values referred to herein are mean values, which may be determined by taking the mean of two or more measurements from a colorimeter and converting the mean readings from the colorimeter to the RGB colour space. The colour of the content may refer to the colour of the content alone or as visible / measured through the pouch enclosing the content. In some examples, the colour of the content refers to the colour of the content as measured when the content is inside the pouch. The colour of the content may be measured with a colorimeter from at least two positions or at least three positions on the surface of the pouch.

[0034] In some examples the G and B values are each at most 20 higher than the R value, such as at most 15 higher, or at most 10 higher than the R value.

[0035] In some examples, G is greater than B, such as at least 5 higher than B. In some examples, R is greater than B, such as at least 15 higher than B.

[0036] In some examples, the R value is the highest of each of the RGB components.

[0037] In some examples the R value is at least 10 higher than each of the G and B values. In some examples the R value is at least, 20 higher, or at least 30 higher than each of the G and B values.

[0038] In some examples, the R value is at most 140. In some examples, the R value is at most 120.

[0039] The lowest R value may be 0. The R value may be at least 50, at least 60, or at least 70. In some examples, the R value is in the range 0-140. In some examples, the R value is in the range 0- 120. In some examples, the R value is in the range 60-120.

[0040] In some examples, the G value is at most 125. In some examples, the G value is at most 120, at most 100, at most 90, at most 85, or at most 80.

[0041] The lowest G value may be 0. The G value may be at least 30, at least 40, or at least 50.

[0042] In some examples, the G value is in the range 0-125. In some examples, the G value is in the range 0- 100. In some examples, the G value is in the range 40-90.

[0043] In some examples, the B value is at most 100. In some examples, the R value is at most 90, at most 80, or at most 75.

[0044] The lowest B value may be 0. The B value may be at least 20, at least 30, at least 40, or at least 45.

[0045] In some examples, the B value is in the range 0-100. In some examples, the B value is in the range 0- 90. In some examples, the B value is in the range 20-80, or 40-80.

[0046] In some examples, the R value is in the range 0-120, the G value is in the range 0-90, and the B value is in the range 0-80, and the G and B values are lower than or equal to the R value.

[0047] In some examples, the R value is in the range 70-120, the G value is in the range 50-90, and the B value is in the range 40-80.

[0048] In some examples, the R value is in the range 100-120, the G value is in the range 70-90, and the B value is in the range 60-80.

[0049] In this way, the content colour may be adjusted so as to resemble the content of a traditional snus pouch. In some examples, the content resembles a tobacco content. These colours may be perceived as being the same as, or similar to, the typical colour of tobacco. Such may be achieved even in the absence of tobacco.

[0050] “Black” may be understood as the darkest colour owing to the absence of or complete absorption of light; the opposite of white. Black may include the colours defined by the RGB values wherein R, G, and B are each at most 50, or each at most 30.

[0051] In some examples, the content may appear to contain black particles.

[0052] In some examples, the content may appear entirely black in colour.

[0053] The appearance and colour of the content may affect the overall appearance and colour of the pouch or smokeless article. In some examples the pouch is made of a transparent or translucent material, so that the colour of the content may be at least partially visible through the pouch enclosing the content.

[0054] In some examples, the pouch enclosing the content may appear to contain black particles.

[0055] In some examples, the pouch enclosing the content may appear entirely black in colour. In some examples, the darkening agent is a particulate component. In some examples, the darkening agent is a black particulate component.

[0056] In some examples, the darkening agent is provided in the form of a powder. In this way the darkening agent may be easily incorporated into the content and / or an even distribution throughout the content may be obtained easily to provide an even (uniform) colour.

[0057] In some examples, the darkening agent is or comprises a material selected from the group consisting of carbonaceous material, black powder dye, or black coloured organic matter. For example, the darkening agent may be carbon, carbon black, activated carbon, soot, ash, graphite, common charcoal, sugar charcoal, activated charcoal, iron oxide powder, or coal.

[0058] In some examples, the darkening agent comprises or is carbonaceous material.

[0059] In some examples, the darkening agent is or comprises a form of charcoal (a charcoal). In some examples, the darkening agent is or comprises activated charcoal.

[0060] Consumers may have a positive perception of activated charcoal as a consumable ingredient, so this may be more desirable than alternative forms of darkening agent.

[0061] In some examples, the darkening agent is not carbon black (E153).

[0062] In some examples, the D90 particle size of the darkening agent is from 10 to 1000 pm.

[0063] In some examples, the D90 particle size of the darkening agent is at least 10 pm, at least 20 pm, at least 30 pm, at least 40 pm, at least 45 pm, at least 50 pm, or at least 55 pm. In some examples, the D90 particle size of the darkening agent is at most 1000 pm, at most 750 pm, at most 500 pm, at most 250 pm, at most 150 pm, at most 100 pm, at most 80 pm, at most 70 pm, or at most 65 pm.

[0064] In some examples, the D90 particle size of the darkening agent is between 10-500 pm, between IQ- 250 pm, between 50-500 pm, between 30-750 pm, or between 10-150 pm. In some examples the D90 particle size of the darkening agent is 10-100 pm

[0065] The choice of particle size may improve user perception of the colour of the content. The particle size may improve the texture of the content, so that the user perceives the smokeless article to be more similar to a conventional snus product.

[0066] Herein, the D90 particle size refers to the particle size value of which 90% of the particles in a sample distribution are smaller than. That is, the D90 particle size corresponds to a 90% cumulative (from 0 to 100%) undersize particle size distribution. In other words, the D90 particle size is the value at which 90% of a sample of particles have a dimension, such as a diameter, of said value or less. Unless otherwise specified, the particle size of a particle refers to the length of its longest axis, for example when viewed as a projection. In the case of spherical or approximately spherical particles, this can be interpreted as its diameter. The particle size distribution can be determined using laser diffraction methods (such as described in ISO 13320:2020), or light / electron microscopy static image analysis (such as described in ISO 13322-1:2014). The skilled person is able to select a suitable sample size of particles, for example, at least 25 particles, at least 50, or at least 100.

[0067] In reference to size distributions, DXX may be interpreted as the size of which XX% of the particles in the distribution are smaller than. For example, D90 may be the size which 90% of the particles are smaller than. The median size can be described as the D90. Unless otherwise specified, the average particle size may be interpreted as the median particle size.

[0068] As used herein, a “smokeless article for oral consumption” is an article that does not need to be heated or burned in order to function. The smokeless article is for oral consumption, as used herein, the term “oral consumption” is intended to refer to any oral administration route achieved by placing the smokeless article into the oral cavity. This includes, but is not limited to, buccal, sub-lingual, periodontal, gingival and ingestion.

[0069] The smokeless article may have a mass of about 0.1 g to 5.0 g, such as about 0.5 g to about 4.0 g or about 1 .0 g to about 3.0 g.

[0070] The smokeless article may have a length of about 30 mm, such as about 28 mm or 26 mm, a width of about 12 mm, such as about 10 mm or 8 mm, and a depth of about 5 mm, such as about 4 mm or 3 mm.

[0071] The smokeless article may have an active lifetime of about 20 minutes to about 60 minutes, such as about 25 minutes to 50 minutes or about 30 minutes to about 45 minutes, after being placed in the mouth. As used herein, the term “active lifetime” is intended to refer to the amount of time after being placed in the mouth that the smokeless article provides the user with a perceptible taste and / or physiological experience. For example, for an article containing an active ingredient such as nicotine or other pharmacologically active ingredient the active lifetime may be defined as the in use period of time in which 90%wt of the available pharmacologically active is released. In other words, the active lifetime may be the duration of time from insertion into the oral cavity for 90%wt of the total amount of nicotine pharmacologically active ingredient that is capable of being released during normal use to dissolve into the user’s saliva and / or enter the user’s bloodstream. It will therefore be appreciated that the active lifetime of a product may vary from user to user and for a user based on oral conditions, in particular extent of salivation. Nonetheless, the skilled person is able to mimic oral conditions to determine the active lifetime in one instance, which can be used as a comparison or analysis point.

[0072] The pouch may be formed from one or more materials. The pouch material may be formed from fiber, paper, cloth, and fabric. The pouch material may be formed from one or more polymeric materials. The polymeric material may be selected from one or more of hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol (PVOH), polyvinylpyrrolidone (PVP), polyethylene oxide (PEO), hydroxyethyl cellulose (HEC), polyethylene glycol (PEG), pullulan, sodium alginate, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, maltodextrin, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, and gelatin. The pouch is typically completely insoluble in saliva. Suitable insoluble pouch materials include, but are not limited to, fiber, paper, water-insoluble polymers, cloth, and fabric. Suitable soluble pouch materials include, but are not limited to, water-soluble polymers such as polyethylene oxide (PEO), hydroxypropyl cellulose (HPC), and hydroxypropyl methylcellulose (HPMC).

[0073] The pouch may be formed by, for example, folding a single sheet on itself or bringing two or more sheets together and sealing the edges. The edges may initially be partially sealed to provide an open pouch in which the content (e.g. a nicotinic compound, darkening agent and non-tobacco plant material fibres) may be placed before completely sealing the pouch closed. The sheets may be the same thickness or different thicknesses.

[0074] The pouch may be porous. In some examples, at least 50% of the pores have a diameter of 50 pm to 200 pm, such as 100 pm to 175 pm, or 125 pm to 150 pm. In some examples, at least 50% of the pores have a diameter of at least 100 pm. For example, in some examples at least 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% of the pores have such diameters.

[0075] The pouch may be coloured or include markings, such as brand logos and text, to improve user perception. The pouch may be partially or completely coloured by a colourant.

[0076] In some examples, the amount of water in the content is from 30 wt% to 60 wt%, for example from 35 wt% to 60 wt%, from 40 wt% to 60 wt%, from 40 wt% to 55 wt%, from 40 wt% to 50 wt%, or from 42 wt% to 50 wt% based on the total weight of the content. In some examples, the amount of water in the content is from 42 wt% to 48 wt%, based on the total weight of the content.

[0077] The content may comprise one or more additional substance. Each additional substance may individually be a biologically / pharmacologically active compound, humectants, flavourants, fillers, preservatives, aqueous / non-aqueous solvents, and binders. Each additional substance may be provided for more than one purpose.

[0078] The contents of the pouch (i.e. the ingredients, material and / or substances enclosed within the pouch) preferably occupies substantially all of the internal volume of the pouch. The contents may occupy 80%, 85%, 90%, 95% or 100% of the internal volume of the pouch. The contents may comprise a solid material to provide physical integrity, such as an organic material (e.g. plant material) or an inorganic material. Such solid materials may naturally or inherently contain one or more biologically / pharmacologically active compounds and / or additives.

[0079] In some examples, the pouch may comprise an inner content enclosed by an inner pouch, and an outer content surrounding the inner pouch and enclosed by the pouch. In such cases, the inner content and the outer content may independently comprise one or more features described herein in relation to the content. For example, the outer content may comprise a first portion and a second portion, as described herein, and / or the inner content may comprise a first portion and a second portion, as described herein. The inner content and / or the outer content may comprise darkening agent as described herein. Biologically / pharmacologically active compounds are provided to produce a pharmacological effect in the user. Suitable biologically / pharmacologically active compounds include the group consisting of: nicotine, cocaine, caffeine, opiates and opioids, cathine and cathinone, kavalactones, mysticin, beta-carboline alkaloids, salvinorin A, together with any combinations, functional equivalents to, and / or synthetic alternatives of the foregoing. Biologically / pharmacologically active compounds may also have additive properties.

[0080] In some embodiments the content includes an active compound comprising nicotine and wherein the form of nicotine is selected from the group consisting of nicotine salts, nicotine base, stabilized nicotine and mixtures thereof. For example, the content may include at least one nicotine salt selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine ditartrate, nicotine ditartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate and mixtures thereof.

[0081] Solvents may be provided in the content to improve the mouthfeel of the smokeless article and reduce the amount of saliva wetting required before the user experience begins. The addition of solvents to the precursor blend can also assist with the mixing of the components and ensure that a homogeneous coating of the bulking agent is achieved. Suitable solvents may be any solvent approved for use in food products in the UK and Europe, such as water, saline or water alcohol mixtures. Preferably the solvent is water. pH stabilisers or adjusters may be provided to adjust the user experience and / or modify the bicavailability of a pharmacologically active compound. For instance, under acidic conditions, nicotine is protonated and does not readily cross mucous membranes. Examples of suitable pH stabilisers include ammonia, ammonium carbonate, sodium carbonate and calcium carbonate. The overall pH of the smokeless article is preferably pH 7 to pH 9, such as pH 7.25 to pH 8.75 or pH 7.5 to pH 8.5.

[0082] The overall pH of a smokeless article may be determined by, for example, (i) placing the smokeless article in 10 mL of distilled water (ii) agitating the mixture for at least 5 minutes and (iii) measuring the pH of the solution with a pH probe.

[0083] Salts may be provided to maintain the osmolarity of the content within the smokeless article / pouch. Salts contribute to the overall positive user experience of the smokeless article, such as pleasant mouth feel. Examples of salts which may be used include sodium chloride, potassium chloride, magnesium chloride and calcium chloride.

[0084] Flavourants may be provided in solid or liquid form. Suitable flavourants include coffee, eucalyptus, menthol, liquorice, peppermint, spearmint, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour. The flavourant may be evenly dispersed throughout the contents or may be provided in isolated locations and / or varying concentrations throughout the contents.

[0085] As used herein, the term “flavourant” denotes a compound having a desirable taste, aroma or both. In some examples, the content comprises one or more flavourants (e.g. peppermint flavour) in an amount of from above 0 wt% to 10 wt%, for example from 1 wt% to 10 wt%, from 1 wt% to 8 wt%, from 1 wt% to 6 wt%, from 2 w% to 8 wt%, from 2 wt% to 7 wt%, or from 3 wt% to 7 wt% based on the total weight of the content.

[0086] Humectants may be provided to control moisture content thereby preventing the smokeless article from drying out during storage and reducing the amount of saliva wetting required before the user experience begins. Suitable humectants include polyhydric alcohols (e.g. propylene glycol (PG), triethylene glycol, 1 ,2-butane diol and glycerol such as vegetable glycerine (VG)) and their esters (e.g. glycerol mono-, di- or tri-acetate). The humectant component may consist of a single humectant compound or may consist of two or more different humectant compounds.

[0087] The humectant may have a lower limit of at least 1 % by weight of the contents such as at least 2 wt%, such as at least 5 wt%, such as at least 10 wt%, such as at least 20 wt%, such as at least 30 wt%, or such as least 40 wt%.

[0088] The humectant may have an upper limit of at most 70% by weight of the contents, such as at most 65 wt%, such as at most 60 wt%, or such as at most 20 wt%, such as at most 10 wt%, such as at most 5 wt%, such as at most 2 wt%.

[0089] In some examples, the amount of humectant is 1 to 70 wt% of the contents, such as 10 to 60 wt% or 50 to 60 wt%.

[0090] In some examples, the content has an overall amount of water of between 5 and 60 wt% based on the weight of the contents such as between 40 and 60 wt%, or between 50 and 60 wt%, for example between 52 and 60 wt%.

[0091] Smokeless articles having a total moisture content of 10% or less are generally considered to be ‘dry’. Smokeless articles having a total moisture content of 40% or more are generally considered to be ‘wet’.

[0092] The humectant in the content (e.g. OND formulation) may comprise or consist of water and one or more polyhydric alcohols, for example water and glycerol. In some examples, the humectant may comprise propylene glycol.

[0093] Sweeteners may be provided to modify the user taste perception and, in particular, overcome bitter flavours that result from other substances. Suitable sweeteners include honey, sugar, brown sugar, glucose, fructose, sucrose, aspartame, xylitol, maltitol, saccharin sodium, glycyrrhizin tripotassium liquorice, jujube, or a mixture thereof.

[0094] In some examples, the content comprises a sweetener (e.g. acesulfame K) in an amount of from 0 wt% to 1 wt%, for example from 0.01 wt% to 1 wt%, from 0.01 wt% to 0.5 wt%, from 0.01 wt% to 0.2 wt%, from 0.01 wt% to 0.1 wt%, from 0.05 wt% to 0.2 wt%, or from 0.05 wt% to 0.15 wt% based on the total weight of the content. The amount of sweetener may have a lower limit of at least 0.01 % by weight of the content such as at least 0.02 wt%, such as at least 0.03 wt%, such as at least 0.04 wt%, such as at least 0.05 wt%, or such as least 0.06 wt%.

[0095] Stabilisers are provided to prevent decomposition or degradation over time during storage by, for example, retarding oxidation or unwanted biological activity. Stabilisers may be selected from the group consisting of antioxidants including vitamin E, such as tocopherole, ascorbic acid, sodium pyrosulfite, butylhydroxytoluene, butylated hydroxyanisole, edetic acid and salts thereof; and preservatives including citric acid, tartaric acid, lactic acid, malic acid, acetic acid, benzoic acid, sorbic acid and salts thereof.

[0096] Binders may be provided. Suitable binders include starches and / or cellulosic binders such as methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose and carboxymethyl cellulose, gums such as xanthan, guar, arabic and / or locust bean gum, organic acids and their salts such as alginic acid (sodium alginate), agar and pectins. In some embodiments the binder content is 5 to 10 wt% of the contents, e.g. around 6 to 9 wt% or 7 to 8 wt%.

[0097] Additional colourants may be provided to modify the user impression of the smokeless article. Additional colourants may be selected from one or more of common colourants such as curcumin (E100), turmeric (E100(ii)), riboflavin (E101), riboflavin-5'-phosphate (E101(ii)), tartrazine (E102), quinoline yellow (E104), riboflavin-5-sodium phosphate (E106), yellow 2G (E107), sunset yellow FCF (E110), carmine, cochineal (E120), azorubine (E122), amaranth (E123), ponceau 4R (E124), erythrosine (E127), red 2G (E128), allura red AC (E129), patent blue V (E131), indigotine (E132), brilliant blue FCF (E133) chlorophylls (E140), copper complexes of chlorophyll (E141), green S (E142), caramel (E150a-d), brilliant black BN (E151 ), carbon (E153), brown FK (E154), brown HT (E155), alfa-, beta- and gamma- carotene (E160a), annatto, bixin, norbixin (E160b), bell pepper (Paprika) extract (E160c), lycopene (E160d), beta- apo-8'-carotenal (E160e), ethyl ester of beta-apo- 8'-carotenic acid (E160f), flavoxanthin (E161a), lutein (E161 b), cryptoxanthin (E161 c), rubixanthin (E161d), violaxanthin (E161 e), rhodoxanthin (E161f), canthaxanthin (E1619), citranaxanthin (E161 h), beetroot extract (E162), anthocyanins (E163), calcium carbonate (£170), titanium dioxide (E171 ), iron oxides (E172), aluminium (E173), silver (E174), gold (E175), lithol rubine BK (E180), and tannins (E181 ). In some examples, the additional colourant is not selected from brilliant black BN (E151 ), or carbon (E153).

[0098] Plant material may be provided for physical integrity and may function as a natural source of substances such as, for example, biologically / pharmacologically active compounds, flavourants, pH stabilisers etc. The plant material may comprise least one plant material selected from the list including Amaranthus dubius, Arctostaphylos uva-ursi (Bearberry), Argemone mexicana, Arnica, Artemisia vulgaris, Yellow Tees, Galea zacatechichi, Canavalia maritima (Baybean), Cecropia mexicana (Guamura), Oestrum noctumum, Cynoglossum virginianum (wild comfrey), Cytisus scoparius, Damiana, Entada rheedii, Eschscholzia califomica (California Poppy), Fittonia albivenis, Hippobroma longiflora, Humulus japonica (Japanese Hops), Humulus lupulus (Hops), Lactuca virosa (Lettuce Opium), Laggera alata, Leonotis leonurus, Leonurus cardiaca (Motherwort), Leonurus sibiricus (Honeyweed), Lobelia cardinalis, Lobelia inflata (Indian-tobacco), Lobelia siphilitica, Nepeta cataria (Catnip), Nicotiana species (Tobacco), Nymphaea alba (White Lily), Nymphaea caerulea (Blue Lily), Opium poppy, Passiflora incamata (Passionflower), Pedicularis densiflora (Indian Warrior), Pedicularis groenlandica (Elephant's Head), Salvia divinorum, Salvia dorrii (Tobacco Sage), Salvia species (Sage), Scutellaria galericulata, Scutellaria lateriflora, Scutellaria nana, Scutellaria species (Skullcap), Sida acuta (Wireweed), Sida rhombifolia, Silene capensis, Syzygium aromaticum (Clove), Tagetes lucida (Mexican Tarragon), Tarchonanthus camphoratus, Tumera diffusa (Damiana), Verbascum (Mullein), Zamia latifolia (Maconha Brava) together with any combinations, functional equivalents to, and / or synthetic alternatives of the foregoing.

[0099] In some examples, the plant material comprises or consist of one or more of wheat fibres, cellulose fibres, bamboo fibres, pine fibres and eucalyptus fibres.

[0100] In some examples, the plant material fibres may have a particle size of 15-500 pm, for example, 20- 500 pm, 30-300 pm, 50-500 pm, 100-500 pm, 150-500 pm, 200-500 pm, 200-300 pm, 250-500 pm, 250-450 pm, 250-400 pm, 250-350 pm, 260-340 pm, 270-330 pm, 280-320 pm, 290-310 pm, or 295- 305 pm. In some embodiments, the plant material fibres have a particle size of about 300 pm.

[0101] In some embodiments, the plant material fibres are wheat fibres. The wheat fibres may be obtained from commercial sources such as VITACEL® Wheat Fiber WF 200 or may be prepared by grinding or milling plant material until wheat fibers of the required particle size are obtained.

[0102] As used herein, the term “particle size” when referring to plant material fibres such as bamboo fibres indicates the maximum size of the longest dimension of the fibres. For example, a particle size of 50 pm indicates that in the population of fibres, the maximum fibre length is 50 pm.

[0103] Particles having the desired particle size may be obtained by passing a population of fibres through a sieve of corresponding mesh size. For example, to obtain fibres of particle size 300 pm (i.e. a maximum fibre length of 300 pm), a population of fibres are passed through a sieve with 300 pm diameter apertures in the mesh. In this way, fibres with a length of 300 pm or less pass through the mesh and fibres longer than 300 pm are retained by the mesh. The fibres which pass through the mesh may then be used in the smokeless article of the invention, having a particle size of 300 pm. Fibres of a desired particle size are also available from commercial suppliers such as Jelu-werk.

[0104] As used herein, the term “bamboo fibres” refers to natural fibres from plants of the Bambusoideae subfamily of the Poaceae family of grasses. The fibres may originate from any part of the plant, but in some embodiments may be originate from the stem of the plant. The bamboo fibres may be obtained from commercial sources such as JELUCEL® BF fibres sold by Jelu-werk or may be prepared by grinding or milling plant material until bamboo fibers of the required particle size are obtained.

[0105] In a second aspect, the present disclosure provides a smokeless article for consumption comprising a pouch enclosing a content, the content comprising a filler, a nicotinic compound, 0-5 wt% tobacco solids, and a darkening agent, wherein the RGB colour values of the content are within the ranges R: 0-140, G: 0-125, B: 0-100, and the G and B values are each at most 20 higher than the R value.

[0106] The features of the second aspect may each be as described with reference to corresponding features of the first aspect.

[0107] In this way, the content may appear dark in colour. The content may be black, grey, or brown. Thus, the content may visually resemble a tobacco formulation. Therefore, the smokeless article may have similar characteristics to traditional snus or other tobacco-containing smokeless articles even when the smokeless article is low in or free from tobacco.

[0108] In a third aspect, the present disclosure provides a method of manufacturing a smokeless article according to any of the preceding aspects comprising:

[0109] (i) providing a content comprising a filler, a nicotinic compound, 0-5 wt% tobacco solids, and from 0.05 to 5 wt% of a darkening agent; and

[0110] (ii) enclosing the content within a pouch.

[0111] The filler, nicotinic compound, tobacco solids, and darkening agent may be as described with reference to the darkening agent of the first aspect.

[0112] In some examples, the step of providing the content comprises a step of weighing all materials which make up the content into one or more vessels.

[0113] In some examples, the method further comprises a step of blending. In some examples the step of blending may comprise blending the darkening agent with additional components of the content, for example one or more of flavourants, salts, humectants, biologically and / or pharmaceutically active compounds, sweeteners, stabilisers, and binders.

[0114] In some examples, the blending step comprises blending the darkening agent with other solid components. In some examples, the blending step comprises blending the darkening agent with one or more components selected from a salt, a sweetener, a flavourant, a binder, a stabiliser, and a biologically / pharmaceutically active compound.

[0115] In some examples, whilst the blending step is on-going, liquid components, such as water and / or one or more humectants, are added. In some examples, the liquid components include nicotine in water and / or one or more flavourants.

[0116] In some examples, the darkening agent is mixed with a liquid, gel, or cream before being blended with other components of the content.

[0117] In some examples, the content produced following the blending step is filled into open or partially unformed pouches. In some examples, the pouches are then sealed.

[0118] In a fourth aspect, the present disclosure provides use of a darkening agent to darken the colour of the content in a smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising a filler, a nicotinic compound, and 0-5 wt% tobacco solids. The filler, nicotinic compound, tobacco solids and darkening agent may be as described with reference to the darkening agent of the first aspect.

[0119] Also disclosed is use of the smokeless article according to the first aspect or second aspect in oral consumption. A user may perceive that the smokeless article resembles snus, such as in terms of its appearance.

[0120] Also disclosed is a kit comprising one or more smokeless articles according to the first aspect or second aspect and a container. In some examples, the kit comprises 2 to 20 smokeless articles.

[0121] In any of the examples of the aspects disclosed herein, the content may also be free of additional components which alter its physical characteristics, for example its appearance. In some examples, the content may be free of at least one of sweeteners, flavourants, and additional colourants. It may be desirable that the smokeless article resembles snus without at least one of these physical characteristic modifiers.

[0122] The preceding summary is provided for purposes of summarizing some examples to provide a basic understanding of aspects of the subject matter described herein. Accordingly, the above-described features should not be construed to narrow the scope or spirit of the subject matter described herein in any way. Moreover, the above and / or proceeding examples may be combined in any suitable combination to provide further examples, except where such a combination is clearly impermissible or expressly avoided. Other features, aspects, and advantages of the subject matter described herein will become apparent from the following text and the accompanying drawings.

[0123] BRIEF DESCRIPTION OF THE FIGURES

[0124] Aspects, features, and advantages of the present disclosure will become apparent from the following description of examples in reference to the appended drawings in which like numerals denote like elements.

[0125] Figure 1 shows a cross sectional view of a first embodiment of a smokeless article.

[0126] Figure 2 shows a cross sectional view of a second embodiment of a smokeless article.

[0127] Figure 3 shows a cross sectional view of a third embodiment of a smokeless article.

[0128] Figure 4 shows a cross sectional view of a fourth embodiment of a smokeless article.

[0129] Figure 5 shows photographs of an example blend (content) [left] and a plurality of pouches enclosing said blend [right],

[0130] DETAILED DESCRIPTION OF EMBODIMENTS

[0131] Before describing several examples implementing the present disclosure, it is to be understood that the present disclosure is not limited by specific construction details or process steps set forth in the following description and accompanying drawings. Rather, it will be apparent to those skilled in the art having the benefit of the present disclosure that the systems, apparatuses and / or methods described herein could be embodied differently and / or be practiced or carried out in various alternative ways.

[0132] Unless otherwise defined herein, scientific and technical terms used in connection with the presently disclosed inventive concept(s) shall have the meanings that are commonly understood by those of ordinary skill in the art, and known techniques and procedures may be performed according to conventional methods well known in the art and as described in various general and more specific references that may be cited and discussed in the present specification.

[0133] Any patents, published patent applications, and non-patent publications mentioned in the specification are hereby incorporated by reference in their entirety.

[0134] All examples implementing the present disclosure can be made and executed without undue experimentation in light of the present disclosure. While particular examples have been described, it will be apparent to those of skill in the art that variations may be applied to the systems, apparatus, and / or methods and in the steps or in the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the inventive concept(s). All such similar substitutions and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the inventive concept(s) as defined by the appended claims.

[0135] The use of the term “a” or “an” in the claims and / or the specification may mean “one,” as well as “one or more,” “at least one,” and “one or more than one.” As such, the terms “a,” “an,” and “the,” as well as all singular terms, include plural referents unless the context clearly indicates otherwise. Likewise, plural terms shall include the singular unless otherwise required by context.

[0136] The use of the term “or” in the present disclosure (including the claims) is used to mean an inclusive “and / or” unless explicitly indicated to refer to alternatives only or unless the alternatives are mutually exclusive. For example, a condition “A or B” is satisfied by any of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).

[0137] As used in this specification and claim(s), the words “comprising, “having,” “including,” or “containing” (and any forms thereof, such as “comprise” and “comprises,” “have” and “has,” “includes” and “include,” or “contains” and “contain,” respectively) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0138] Unless otherwise explicitly stated as incompatible, or the physics or otherwise of the embodiments, examples, or claims prevent such a combination, the features of examples disclosed herein, and of the claims, may be integrated together in any suitable arrangement, especially ones where there is a beneficial effect in doing so. This is not limited to only any specified benefit, and instead may arise from an “ex post facto” benefit. This is to say that the combination of features is not limited by the described forms, particularly the form (e.g. numbering) of example(s), embodiment(s), or dependency of claim(s). Moreover, this also applies to the phrase “in one embodiment,” “according to an embodiment,” and the like, which are merely a stylistic form of wording and are not to be construed as limiting the following features to a separate embodiment to all other instances of the same or similar wording. This is to say, a reference to ‘an,’ ‘one,’ or ‘some’ embodiment(s) may be a reference to any one or more, and / or all embodiments, or combination(s) thereof, disclosed. Also, similarly, the reference to “the” embodiment may not be limited to the immediately preceding embodiment. Further, all references to one or more embodiments or examples are to be construed as non-limiting to the claims.

[0139] The present disclosure may be better understood in view of the following explanations, wherein the terms used that are separated by “or” may be used interchangeably:

[0140] Referring now to Figure 1 there is provided a first embodiment of a smokeless article 10 having a pouch 12 containing contents 14. The pouch 12 is substantially rectangular. The pouch 12 is formed from a single sheet of material and is substantially filled by the contents 1 . The pouch 12 has a seal 16 along each of the three edges where the inner face of the single sheet meets itself to seal the contents 14 in the pouch 12.

[0141] Figure 2 shows a second embodiment of a smokeless article 10’ having a pouch 12 containing contents 14. The pouch 12 is substantially circular. The pouch 12 is formed from two opposing sheets of material and is substantially filled by the contents 14. The pouch has a circumferential seal 16 along the edges where the two opposing sheets of material meet to seal the contents 14 in the pouch 12.

[0142] Figure 3 shows a third embodiment of a smokeless article 10” that, like the first embodiment, has a pouch 12 made from a single sheet of material. However, one of the three seals 16’ is formed by an overlap of the inner face and the outer face of the single sheet meet to seal the contents 14 in the pouch 12. The remaining two seals at opposing ends of the pouch 12 are formed where the inner face of the single sheet meets itself.

[0143] Figure 4 shows a fourth embodiment of a smokeless article 10’” that comprises the third embodiment enclosed by outer pouch 12” having an outer content 14” positioned in the space between the inner pouch 12’ and the outer pouch 12”. The outer pouch 12” also has a circumferential seal 16’” to seal the outer contents 14” and inner pouch 12’ in the outer pouch 12”.

[0144] Use of the fourth embodiment begins when the smokeless article 10’” is placed in the user’s mouth where it is exposed to saliva. Saliva first permeates outer pouch 12” and dissolves and extracts the saliva soluble substances of outer contents 14”. Upon leaving the outer pouch 12”, the saliva soluble substances of outer contents 14” therefore provide the user with a first experience. Saliva subsequently further permeates the inner pouch 12’ where it dissolves and extracts the saliva soluble substances of inner contents 14’. The saliva soluble substances of inner contents 14’ therefore provide the user with a complimentary and secondary experience. When the extractable amount of saliva soluble substances in the inner contents 14’ and outer contents 14” drops below perceivable levels the active lifetime of the smokeless article 10’” has ended. EXAMPLES

[0145] Preparation of formulations

[0146] The example formulations were prepared according to the following method at the lab scale using a food processor.

[0147] 1. All materials are dispensed into appropriately sized beakers using a 2 d.p. balance to determine weights.

[0148] 2. All materials are blended together in a food processor.

[0149] 3. The content is filled into open or partially unformed pouches.

[0150] 4. The open or partially unformed pouches are sealed.

[0151] Formulations

[0152] Example formulation 1

[0153] Further example formulations are provided with the same components but different proportions of activated charcoal. The bulking agent content is adjusted to keep the proportions of other ingredients the same.

[0154] Example formulation 2

[0155] As formulation 1 above, with 0.25% activated charcoal and 40.50% bulking agent.

[0156] Example formulation 3

[0157] As formulation 1 above, with 0.15% activated charcoal and 40.60% bulking agent.

[0158] Example formulation 4 As formulation 1 above, with 0.10% activated charcoal and 40.65% bulking agent.

[0159] Example formulation 5

[0160] As formulation 1 above, with 0.05% activated charcoal and 40.70% bulking agent.

[0161] Example formulation 6

[0162] As formulation 1 above, with 0.75% activated charcoal and 40.70% bulking agent.

[0163] An example blend (content) of this formulation and set of smokeless articles made using said blend are depicted in Figure 5. It can be seen that the content (left image in Figure 5) has a uniform dark colour. The particles of the darkening agent are not individually identifiable. When enclosed in a pouch (right image in Figure 5), the content colour can be discerned through the pouch material. The sealed edges of the pouch do not contain content, and therefore these areas appear lighter than the areas of the pouch containing the content. The uniform colour of the content can be seen through the pouch. The content of the pouch has a closer visual resemblance to traditional snus than corresponding content without the darkening agent.

[0164] Comparative Example formulation 1

[0165] As formulation 1 above, with 0% activated charcoal and 40.75% bulking agent.

[0166] Comparative Example formulation 2

[0167] Comparative Example 2 is a conventional tobacco-containing snus pouch.

[0168] Measurement of RGB values

[0169] The RGB values of each smokeless article were measured by using a colorimeter model (PCE XXM20). 3 readings of each pouch (containing the content) were taken (left right and middle, on the side without the long seal) which provided readings in the CIE LAB colour space and then each of the A, B and L values were averaged to give an overall value for the pouch. The average A, B and L values were converted to RGB using the online conversion tool at https: / / colordesiqner.io / convert / labtorqb.

[0170] T able 1 shows the average A, B and L values for each formulation, the difference in colour from a conventional snus product (Comparative Example 2), and the RGB values.

[0171] Table 1

[0172]

Claims

CLAIMS1. A smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising a filler, a nicotinic compound, 0-5 wt% tobacco solids, and from 0.05 to 5 wt% of a darkening agent.

2. The smokeless article according to claim 1 , wherein the content comprises 0.05 to 1.5 wt% of the darkening agent.

3. The smokeless article according to claims 1 or 2, wherein the RGB colour values of the content are within the ranges R: 0-140, G: 0-125, B: 0-100, and the G and B values are each at most 20 higher than the R value.

4. The smokeless article according to any preceding claim, wherein the darkening agent is a particulate component.

5. The smokeless article according to any preceding claim, wherein the darkening agent is selected from the group consisting of carbonaceous material, black powder dye, or black coloured organic matter.

6. The smokeless article according to claim 5, wherein the darkening agent is carbonaceous.

7. The smokeless article according to claim 6, wherein the darkening agent is activated charcoal.

8. The smokeless article according to any preceding claim, wherein the D90 particle size of the darkening agent is 10 pm to 1000 pm.

9. The smokeless article according to claim 8, wherein the D90 particle size of the darkening agent is 10 pm to 150 pm.

10. The smokeless article according to any preceding claim, wherein the content is free from tobacco.

11. The smokeless article according to any preceding claim, wherein the filler comprises plant material fibers.

12. The smokeless article according to claim 11 , wherein the plant material fibers have a particle size from 50 pm to 500 pm.

13. A smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising a filler, a nicotinic compound, 0-5 wt% tobacco solids, and a darkening agent, wherein the RGB colour values of the content are within the ranges R: 0-140, G: 0-125, B: 0-100, and the G and B values are each at most 20 higher than the R value.

14. A method of manufacturing a smokeless article according to any one of the preceding claims comprising:(i) providing a content comprising a darkening agent; and(ii) enclosing the content within a pouch.

15. Use of a darkening agent to darken the colour of the content of a smokeless article for oral consumption, the smokeless article comprising a pouch enclosing a content, the content comprising a filler, a nicotinic compound, and 0-5 wt% tobacco solids.

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