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EP3868223A1 - Smokeless article - Google Patents

Smokeless article Download PDF

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Publication number
EP3868223A1
EP3868223A1 EP20158082.6A EP20158082A EP3868223A1 EP 3868223 A1 EP3868223 A1 EP 3868223A1 EP 20158082 A EP20158082 A EP 20158082A EP 3868223 A1 EP3868223 A1 EP 3868223A1
Authority
EP
European Patent Office
Prior art keywords
nicotine
fibres
smokeless
smokeless article
plant material
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP20158082.6A
Other languages
German (de)
French (fr)
Inventor
designation of the inventor has not yet been filed The
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nerudia Ltd
Original Assignee
Nerudia Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nerudia Ltd filed Critical Nerudia Ltd
Priority to EP20158082.6A priority Critical patent/EP3868223A1/en
Priority to PCT/EP2021/054060 priority patent/WO2021165418A1/en
Priority to EP21705544.1A priority patent/EP4106556A1/en
Publication of EP3868223A1 publication Critical patent/EP3868223A1/en
Priority to US17/818,444 priority patent/US20220386685A1/en
Ceased legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24BMANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B13/00Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24BMANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10Chemical features of tobacco products or tobacco substitutes
    • A24B15/16Chemical features of tobacco products or tobacco substitutes of tobacco substitutes

Definitions

  • the present disclosure relates to a smokeless article.
  • the disclosure relates to a smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising nicotine-dosed non-tobacco plant material fibres, wherein the plant material fibres have a particle size of up to 30 ⁇ m.
  • Smoking is generally considered to expose a smoker to potentially harmful substances. It is generally thought that the majority of the potentially harmful substances are formed by the heat generated during burning (combustion) of the article. There is interest in so-called heat not burn products, which heat a tobacco or similar substrate at a lower temperature than a conventional cigarette. These products are usually described as less harmful than conventional cigarettes. Both conventional cigarettes and heat not burn products are visible during use and produce smoke or vapour.
  • Smokeless articles are a suitable alternative 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 tobacco contained within the smokeless article.
  • Conventional smokeless articles have a saliva permeable pouch housing a content.
  • the content is generally in the form of tobacco, said tobacco containing a soluble element, typically nicotine.
  • a product may be referred to as portion snus. It is typically provided as prepackaged (traditionally moist) powder in small teabag-like pouches. Each pouch is a single portion or unit. This moistened product may be referred to as original snus.
  • Smokeless articles are placed in the mouth where saliva extracts the soluble element from the tobacco contained within.
  • 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.
  • the resulting saliva which contains extracts, subsequently contacts a mucous membrane in the mouth, or at another point of the gastrointestinal tract, to deliver the soluble element across the membrane and into the bloodstream.
  • the soluble element is then transported by the bloodstream to the site of action. For example, nicotine is delivered to the brain where it acts upon acetylcholine receptors.
  • Snuff is smokeless tobacco made from ground or pulverised tobacco leaves. Snuff is available in dry form or wet (moist) form. Moist snuff may be referred to as snus. Two common varieties of snus are Scandinavian snus and American snus. Both varieties of snus are available in a loose form, but are often contained within a saliva permeable pouch.
  • snus is typically manufactured by grinding a blend of leaf tobaccos to specified particle sizes.
  • the ground tobacco is then mixed with water and sodium chloride in closed process blenders.
  • the mixture is subjected to a heat treatment, involving temperatures up to 80 - 100 °C, for several hours to pasteurize the snus. Thereafter, the snus is cooled and other ingredients may be added.
  • Snus is typically manufactured to meet the GothiaTek® standard, as detailed in " Swedish snus and the GothiaTek® standard” (2005), Rutqvist , et al.
  • the present disclosure relates to a smokeless article e.g. a snus article for oral use.
  • a smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising nicotine-dosed non-tobacco plant material fibres, wherein the plant material fibres have a particle size of up to 30 ⁇ m.
  • the use of plant material fibres having a particle size of up to 30 ⁇ m provides a more material-efficient product with a smaller amount of material used to manufacture each article. This is due to the higher bulk density of the smaller 30 ⁇ m plant fibres compared with existing products, which enables the same level of nicotine to be provided within a pouch of smaller size containing a smaller volume of plant fibres.
  • the smokeless article of the invention is therefore more economical to manufacture and more environmentally friendly in that the amount of pouch material necessary per article is reduced and less material is wasted when the article is disposed of.
  • the nicotine-dosed non-tobacco plant material fibres comprise or consist of wheat fibres.
  • wheat fibres provide additional advantages.
  • a smokeless article comprising wheat fibres having a particle size of up to 30 ⁇ m provides an unexpectedly high nicotine release rate from the article.
  • a higher nicotine release rate provides a more effective product which is more desirable to some consumers.
  • the wheat fibres provide the product with a paler appearance which increases the eye appeal of the product to consumers.
  • the plant material fibres have a particle size of up to 30 ⁇ m. In some embodiments, the plant material fibres have a particle size of up to 29 ⁇ m, for example up to 28 ⁇ m, for example up to 27 ⁇ m, for example up to 26 ⁇ m, for example up to 25 ⁇ m or up to 20 ⁇ m.
  • the plant material fibres have a particle size of from 1 to 30 ⁇ m, for example from 2 to 30 ⁇ m, for example from 5 to 30 ⁇ m, for example from 10 to 30 ⁇ m, for example from 15 to 30 ⁇ m, for example from 20 to 30 ⁇ m, for example from 1 to 25 ⁇ m, for example from 2 to 25 ⁇ m, for example from 5 to 25 ⁇ m, for example from 10 to 25 ⁇ m, for example from 15 to 25 ⁇ m.
  • the plant material fibres have a particle size of about 30 ⁇ m.
  • the nicotine-dosed plant material fibres comprise a nicotinic compound selected from nicotine, nicotine salt(s), nicotine complex(es); and nicotine solvate(s).
  • the nicotinic compound is provided in a plant material.
  • the plant material is tobacco.
  • the smokeless article is tobacco-free.
  • the user may experience a similar or enhanced recreational/pharmaceutical effect as compared to conventional tobacco-containing products without experiencing undesirable components inherent to tobacco (e.g. tobacco flavour).
  • tobacco flavour undesirable components inherent to tobacco
  • the total nicotine content is from 5 to 15 mg, preferably about 10 mg.
  • greater than 75 wt%, preferably greater than 80 wt%, of the total nicotine content of the smokeless article is released from the smokeless article after 20 minutes immersed in water.
  • Another aspect of the invention is the use of nicotine-dosed non-tobacco plant material fibres, wherein the plant material fibres have a particle size of up to 30 ⁇ m, to increase the material efficiency of a smokeless article and/or reduce manufacturing cost.
  • the smokeless article is according to the first aspect.
  • Another aspect of the invention is the use of nicotine-dosed wheat fibres, wherein the wheat fibres have a particle size of up to 30 ⁇ m, as a nicotine release accelerant in a smokeless article for oral consumption.
  • the smokeless article is according to the first aspect.
  • particle size when referring to fibres such as wheat fibres indicates the maximum size of the longest dimension of the fibres. For example, a particle size of 50 ⁇ m indicates that in the population of fibres, the maximum fibre length is 50 ⁇ m.
  • 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 ⁇ m (i.e. a maximum fibre length of 300 ⁇ m), a population of fibres are passed through a sieve with 300 ⁇ m diameter apertures in the mesh. In this way, fibres with a length of 300 ⁇ m or less pass through the mesh and fibres longer than 300 ⁇ m 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 ⁇ m. Fibres of a desired particle size are also available from commercial suppliers such as Jelu-technik.
  • the term "wheat fibres” refers to natural fibres from plants of the Triticum genus of grasses, for example T. aestivum (common wheat).
  • the fibres may originate from any part of the plant, but in some embodiments may be originate from the stem of the plant.
  • the fibres may be obtained from commercial sources such as JELUCEL® WF fibres sold by Jelu-technik, or may be prepared by grinding or milling plant material until fibers of the required particle size are obtained.
  • the term "nicotine-dosed wheat fibres” refers to a composition comprising wheat fibres and a nicotinic compound.
  • the nicotinic compound may be added to or mixed with the wheat fibres prior to incorporation into the smokeless article.
  • the wheat fibres are loaded into a suitable dryer, sprayed with a solution of nicotinic compound and dried to form nicotine-dosed wheat fibres.
  • the dryer may be a fluidised bed dryer.
  • the solution may be a solution of nicotinic compound in glycerin.
  • the solution of nicotinic compound in glycerin may comprise from 10 to 50 wt% nicotinic compound based on the total solution weight, for example from 10 to 40 wt% or from 10 to 30 wt%.
  • saliva is intended to refer to the liquid substance formed in the mouth of animals, such as humans, that includes water, electrolytes and enzymes. Other components of saliva may include mucus, white blood cells, epithelial cells and/or antimicrobial agents.
  • saliva-soluble is intended to refer to compounds, ingredients, or any other substances which can dissolve in saliva present in the oral cavity of the user at physiological temperature. Such substances may include, for example, nicotine and/or flavours. In some cases a standard commercially available artificial saliva may be used to test saliva solubility. Alternatively, “saliva-soluble” may equate to “water-soluble” and refer to compounds, ingredients, or any other substances which can dissolve in water present in the oral cavity of the user at physiological temperature.
  • plant material is intended to refer to a portion and/or part(s) of a plant (e.g. leaf, stem, flower or bud).
  • the plant material may be processed (for example, by shredding, grinding or drying) or it may be non-processed (that is, used whole).
  • the plant material is typically fibrous (comprising or characterised by fibres).
  • plant material is not intended to include pulp and/or paper which is derived from a plant material (typically wood) and chemically and/or mechanically processed to extract fibres before use.
  • moisture content may include water, humectants, liquid flavourants and/or other liquid compounds.
  • 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, sublingual, periodontal, gingival and ingestion.
  • the smokeless article may be described as a snus article.
  • the smokeless article comprises a pouch having a contents, wherein the contents (e.g. nicotine-dosed non-tobacco plant material fibres) is completely enclosed by the pouch.
  • the pouch is sealed to ensure that the contents of the pouch does not scatter inside the mouth.
  • the smokeless article preferably has 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.
  • the smokeless article preferably has 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.
  • the smokeless article preferably has 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.
  • 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.
  • the active lifetime may be defined as the in use period of time in which 90%wt of the available pharmacologically active is released.
  • 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.
  • 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.
  • HPC hydroxypropyl cellulose
  • HPMC hydroxypropyl methylcellulose
  • PVH polyvinyl alcohol
  • PVP polyvinylpyrrolidone
  • 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).
  • 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. nicotine-dosed non-tobacco plant material fibres) may be placed before completely sealing the pouch closed.
  • the sheets may be the same thickness or different thicknesses.
  • the pouch is porous.
  • at least 50% of the pores have a diameter of 50 ⁇ m to 200 ⁇ m, such as 100 ⁇ m to 175 ⁇ m or 125 ⁇ m or 150 ⁇ m.
  • at least 50% of the pores have a diameter of at least 100 ⁇ m.
  • at least 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% of the pores have such diameters.
  • 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.
  • the contents comprise nicotine-dosed plant material fibres and may comprise one or more additional substances.
  • the or each additional substance may individually be a biologically/pharmacologically active compound, pH stabilisers or adjusters, humectants, flavourants, fillers, preservatives, aqueous/non-aqueous solvents and binders.
  • the or each additional substance may be provided for more than one purpose.
  • the contents of 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.
  • 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.
  • 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.
  • the content may include at least one nicotine salt selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate and mixtures thereof.
  • pH stabilisers or adjusters may be provided to adjust the user experience and/or modify the bioavailability of a pharmacologically active compound. For instance, under acidic conditions, nicotine is protonated and does not readily cross mucous membranes.
  • 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.
  • 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.
  • Fillers 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).
  • Suitable fillers 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.
  • the filler content is 5 to 10 wt% of the contents e.g. around 6 to 9 wt%.
  • 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.
  • the term "flavourant” denotes a compound having a desirable taste, aroma or both.
  • 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 vegetable glycerine (VG)) and their esters (e.g. glycerol mono-, di- or tri-acetate).
  • 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%.
  • the humectant may have an upper limit of at most 50% by weight of the contents, such as at most 40 wt%, such as at most 30 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%.
  • the amount of humectant is 1 to 40 wt% of the contents, such as 2 to 20 wt% or 5 to 10 wt%.
  • the contents has an overall amount of water of between 5 and 50 wt% based on the weight of the contents such as between 10 to 20 wt% or 40 to 50 wt%.
  • 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'.
  • 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.
  • the amount of sweetener is in some cases 1 to 20 % by weight of the contents, such as 2 to 15 wt% or 5 to 10 wt%.
  • Stabilisers are provided to prevent decomposition or degradation overtime 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.
  • vitamin E such as tocopherole, ascorbic acid, sodium pyrosulfite, butylhydroxytoluene, butylated hydroxyanisole, edetic acid and salts thereof
  • preservatives including citric acid, tartaric acid, lactic acid, malic acid, acetic acid, benzoic acid, sorbic acid and salts thereof.
  • 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%.
  • Colourants may be provided to modify the user impression of the smokeless article. Colourants include whitening agents. 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 (E
  • 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, Amica, Artemisia vulgaris, Yellow Tees, Galea zacatechichi, Canavalia maritima (Baybean), Cecropia mexicana (Guamura), Cestrum noctumum, Cynoglossum virginianum (wild comfrey), Cytisus scoparius, Damiana, Entada rheedii, Eschscholzia califomica (California Poppy), Fittonia albivenis, Hippobroma longiflora, Humulus japonica (Japanese Hops), Humulus lup
  • the plant material may be tobacco. Any type of tobacco may be used. This includes, but is not limited to, flue-cured tobacco, burley tobacco, Maryland Tobacco, dark-air cured tobacco, oriental tobacco, dark-fired tobacco, perique tobacco and rustica tobacco. This also includes blends of the above mentioned tobaccos.
  • any suitable parts of the tobacco plant may be used. This includes leaves, stems, roots, bark, seeds and flowers.
  • the tobacco may comprise one or more of leaf tobacco, stem tobacco, tobacco powder, tobacco dust, tobacco derivatives, expanded tobacco, homogenised tobacco, shredded tobacco, extruded tobacco, cut rag tobacco and/or reconstituted tobacco (e.g. slurry recon or paper recon).
  • the contents may comprise at least 50 wt% plant material based on the weight of the contents, e.g. at least 60 wt% plant material e.g. around 65 wt% plant material.
  • the contents may comprise 80 wt% or less plant material e.g. 75 or 70 wt% or less plant material.
  • the contents may comprise a gathered sheet of homogenised (e.g. paper/slurry recon) tobacco or gathered shreds/strips formed from such a sheet.
  • homogenised e.g. paper/slurry recon
  • the sheet may have a grammage greater than or equal to 100 g/m 2 , e.g. greater than or equal to 110 g/m 2 such as greater than or equal to 120 g/m 2 .
  • the sheet may have a grammage of less than or equal to 300 g/m 2 e.g. less than or equal to 250 g/m 2 or less than or equal to 200 g/m 2 .
  • the sheet may have a grammage of between 120 and 190 g/m 2 .
  • 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 14.
  • 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.
  • 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.
  • 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.
  • Figure 4 shows a fourth embodiment of a smokeless article 10'" that comprises the third embodiment enclosed by outer pouch 12" having an outer contents 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".
  • 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.
  • a sample was prepared which contained wheat fibres with an average length of 30 ⁇ m (Sample 1).
  • the wheat fibres used were JELUCEL® WF-30 fibres sold by Jelu-technik.
  • the master batch was prepared by mixing the ingredients together on the laboratory scale with high-shear mixing apparatus. Product was then manually filled into pouches and sealed using an industry standard heat sealer.
  • Superwhite #3 is a commercially available smokeless article which includes wheat fibres with a particle size of 200 ⁇ m
  • Lyft #3 is a commercially available smokeless article which includes eucalyptus and pine fibres.
  • the samples were then tested by immersing each of the samples in the same model solution representing human saliva.
  • the model solution was made with deionised water containing the following ingredients: Ingredient Content (g/1000mL) Magnesium chloride hexahydrate 0.17 Potassium hydrogen phosphate anhydrous 0.68 Sodium chloride 0.33 Potassium chloride 0.75 Calcium chloride dehydrate 0.15 Potassium carbonate 0.53 Hydrochloric acid to pH 6.8 ⁇ 0.1
  • the model solution was prepared by mixing all ingredients in the table except hydrochloric acid and transferring to a 2 L glass reservoir. 500 mL of deionised water was added and the solution was mixed well to dissolve. Further deionised water was added to bring the total amount of deionised water added to 1 L. The reservoir was sealed and mixed well. The pH was then adjusted to 6.8 by the addition of HCI. The solution was used within 2 days of preparation.
  • Nicotine concentration in the model solution was determined at certain time intervals by an optimised HPLC method using USP 4 flow-through dissolution apparatus with online UV system, thereby providing an indication of the rate of release of nicotine from the immersed pouch.
  • Figure 5 is a plot showing the results of nicotine release tests for the smokeless article of the invention and the comparative articles.
  • Sample 1 demonstrated significantly improved nicotine release characteristics over the comparative articles.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

A smokeless article for oral consumption comprising a pouch is described. The pouch encloses a content which comprises non-tobacco plant material fibres. The fibres have a particle size of up to 30 µm. The smokeless article may be used for the oral delivery of nicotine to a consumer.

Description

    Field of the Disclosure
  • 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, the content comprising nicotine-dosed non-tobacco plant material fibres, wherein the plant material fibres have a particle size of up to 30 µm.
  • Background
  • Smoking is generally considered to expose a smoker to potentially harmful substances. It is generally thought that the majority of the potentially harmful substances are formed by the heat generated during burning (combustion) of the article. There is interest in so-called heat not burn products, which heat a tobacco or similar substrate at a lower temperature than a conventional cigarette. These products are usually described as less harmful than conventional cigarettes. Both conventional cigarettes and heat not burn products are visible during use and produce smoke or vapour.
  • As a result of these considerations and because of consumer preferences, it is desirable to find and improve alternative substance delivery routes that continue to meet user expectations. Smokeless articles are a suitable alternative 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 tobacco contained within the smokeless article.
  • Conventional smokeless articles have a saliva permeable pouch housing a content. The content is generally in the form of tobacco, said tobacco containing a soluble element, typically nicotine. Such a product may be referred to as portion snus. It is typically provided as prepackaged (traditionally moist) powder in small teabag-like pouches. Each pouch is a single portion or unit. This moistened product may be referred to as original snus.
  • Smokeless articles are placed in the mouth where saliva extracts the soluble element from the tobacco 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.
  • The resulting saliva, which contains extracts, subsequently contacts a mucous membrane in the mouth, or at another point of the gastrointestinal tract, to deliver the soluble element across the membrane and into the bloodstream. The soluble element is then transported by the bloodstream to the site of action. For example, nicotine is delivered to the brain where it acts upon acetylcholine receptors.
  • The above described extraction and delivery process continues until the soluble element is depleted from the smokeless article. The smokeless article must then be removed from the mouth and disposed of.
  • Some commercially available smokeless articles contain snuff. Snuff is smokeless tobacco made from ground or pulverised tobacco leaves. Snuff is available in dry form or wet (moist) form. Moist snuff may be referred to as snus. Two common varieties of snus are Scandinavian snus and American snus. Both varieties of snus are available in a loose form, but are often contained within a saliva permeable pouch.
  • Typically, production of snus is achieved by grinding a blend of leaf tobaccos to specified particle sizes. The ground tobacco is then mixed with water and sodium chloride in closed process blenders. The mixture is subjected to a heat treatment, involving temperatures up to 80 - 100 °C, for several hours to pasteurize the snus. Thereafter, the snus is cooled and other ingredients may be added. Snus is typically manufactured to meet the GothiaTek® standard, as detailed in "Swedish snus and the GothiaTek® standard" (2005), Rutqvist, et al.
  • The World Health Organisation states that smokeless articles are considerably less hazardous than cigarettes. Action on Smoking and Health considers smokeless articles to be about one hundred times less harmful than cigarettes. Smokeless articles are therefore thought to provide a healthier alternative for smokers.
  • There is a need for improved design of smokeless articles to enhance the user experience and improve the function of its constituent components.
  • The present disclosure has been devised in the light of the above considerations.
  • Summary of the Disclosure
  • At its most general, the present disclosure relates to a smokeless article e.g. a snus article for oral use.
  • According to a first aspect, there is provided a smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising nicotine-dosed non-tobacco plant material fibres, wherein the plant material fibres have a particle size of up to 30 µm.
  • The use of plant material fibres having a particle size of up to 30 µm provides a more material-efficient product with a smaller amount of material used to manufacture each article. This is due to the higher bulk density of the smaller 30 µm plant fibres compared with existing products, which enables the same level of nicotine to be provided within a pouch of smaller size containing a smaller volume of plant fibres. The smokeless article of the invention is therefore more economical to manufacture and more environmentally friendly in that the amount of pouch material necessary per article is reduced and less material is wasted when the article is disposed of.
  • In some embodiments, the nicotine-dosed non-tobacco plant material fibres comprise or consist of wheat fibres. In addition to the above-mentioned advantages of material-efficiency, the inventors have found that wheat fibres provide additional advantages. A smokeless article comprising wheat fibres having a particle size of up to 30 µm provides an unexpectedly high nicotine release rate from the article. A higher nicotine release rate provides a more effective product which is more desirable to some consumers. Aside from this, the wheat fibres provide the product with a paler appearance which increases the eye appeal of the product to consumers.
  • The plant material fibres have a particle size of up to 30 µm. In some embodiments, the plant material fibres have a particle size of up to 29 µm, for example up to 28 µm, for example up to 27 µm, for example up to 26 µm, for example up to 25 µm or up to 20 µm. In some embodiments, the plant material fibres have a particle size of from 1 to 30 µm, for example from 2 to 30 µm, for example from 5 to 30 µm, for example from 10 to 30 µm, for example from 15 to 30 µm, for example from 20 to 30 µm, for example from 1 to 25 µm, for example from 2 to 25 µm, for example from 5 to 25 µm, for example from 10 to 25 µm, for example from 15 to 25 µm.
  • In some embodiments, the plant material fibres have a particle size of about 30 µm.
  • In some embodiments, the nicotine-dosed plant material fibres comprise a nicotinic compound selected from nicotine, nicotine salt(s), nicotine complex(es); and nicotine solvate(s).
  • In some embodiments, the nicotinic compound is provided in a plant material. In some embodiments, the plant material is tobacco.
  • In some embodiments, the smokeless article is tobacco-free.
  • In this way, the user may experience a similar or enhanced recreational/pharmaceutical effect as compared to conventional tobacco-containing products without experiencing undesirable components inherent to tobacco (e.g. tobacco flavour).
  • In some embodiments, the total nicotine content is from 5 to 15 mg, preferably about 10 mg.
  • In some embodiments, greater than 75 wt%, preferably greater than 80 wt%, of the total nicotine content of the smokeless article is released from the smokeless article after 20 minutes immersed in water.
  • Another aspect of the invention is the use of nicotine-dosed non-tobacco plant material fibres, wherein the plant material fibres have a particle size of up to 30 µm, to increase the material efficiency of a smokeless article and/or reduce manufacturing cost. In some embodiments, the smokeless article is according to the first aspect.
  • Another aspect of the invention is the use of nicotine-dosed wheat fibres, wherein the wheat fibres have a particle size of up to 30 µm, as a nicotine release accelerant in a smokeless article for oral consumption. In some embodiments, the smokeless article is according to the first aspect.
  • As used herein, the term "particle size" when referring to fibres such as wheat fibres indicates the maximum size of the longest dimension of the fibres. For example, a particle size of 50 µm indicates that in the population of fibres, the maximum fibre length is 50 µm.
  • 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 µm (i.e. a maximum fibre length of 300 µm), a population of fibres are passed through a sieve with 300 µm diameter apertures in the mesh. In this way, fibres with a length of 300 µm or less pass through the mesh and fibres longer than 300 µm 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 µm. Fibres of a desired particle size are also available from commercial suppliers such as Jelu-werk.
  • As used herein, the term "wheat fibres" refers to natural fibres from plants of the Triticum genus of grasses, for example T. aestivum (common wheat). The fibres may originate from any part of the plant, but in some embodiments may be originate from the stem of the plant. The fibres may be obtained from commercial sources such as JELUCEL® WF fibres sold by Jelu-werk, or may be prepared by grinding or milling plant material until fibers of the required particle size are obtained.
  • As used herein, the term "nicotine-dosed wheat fibres" refers to a composition comprising wheat fibres and a nicotinic compound. The nicotinic compound may be added to or mixed with the wheat fibres prior to incorporation into the smokeless article. In some embodiments, the wheat fibres are loaded into a suitable dryer, sprayed with a solution of nicotinic compound and dried to form nicotine-dosed wheat fibres. The dryer may be a fluidised bed dryer. The solution may be a solution of nicotinic compound in glycerin. In some embodiments, the solution of nicotinic compound in glycerin may comprise from 10 to 50 wt% nicotinic compound based on the total solution weight, for example from 10 to 40 wt% or from 10 to 30 wt%.
  • As used herein, the term "saliva" is intended to refer to the liquid substance formed in the mouth of animals, such as humans, that includes water, electrolytes and enzymes. Other components of saliva may include mucus, white blood cells, epithelial cells and/or antimicrobial agents.
  • As used herein, the term "saliva-soluble" is intended to refer to compounds, ingredients, or any other substances which can dissolve in saliva present in the oral cavity of the user at physiological temperature. Such substances may include, for example, nicotine and/or flavours. In some cases a standard commercially available artificial saliva may be used to test saliva solubility. Alternatively, "saliva-soluble" may equate to "water-soluble" and refer to compounds, ingredients, or any other substances which can dissolve in water present in the oral cavity of the user at physiological temperature.
  • As used herein, the term "plant material" is intended to refer to a portion and/or part(s) of a plant (e.g. leaf, stem, flower or bud). The plant material may be processed (for example, by shredding, grinding or drying) or it may be non-processed (that is, used whole). The plant material is typically fibrous (comprising or characterised by fibres). For the avoidance of doubt, the term "plant material" is not intended to include pulp and/or paper which is derived from a plant material (typically wood) and chemically and/or mechanically processed to extract fibres before use.
  • As used herein, the term "moisture content" may include water, humectants, liquid flavourants and/or other liquid compounds.
  • 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, sublingual, periodontal, gingival and ingestion.
  • The smokeless article may be described as a snus article.
  • The smokeless article comprises a pouch having a contents, wherein the contents (e.g. nicotine-dosed non-tobacco plant material fibres) is completely enclosed by the pouch. The pouch is sealed to ensure that the contents of the pouch does not scatter inside the mouth.
  • The smokeless article preferably has 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.
  • The smokeless article preferably has 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.
  • The smokeless article preferably has 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.
  • 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).
  • 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. nicotine-dosed non-tobacco plant material fibres) may be placed before completely sealing the pouch closed. The sheets may be the same thickness or different thicknesses.
  • The pouch is porous. Preferably, at least 50% of the pores have a diameter of 50 µm to 200 µm, such as 100 µm to 175 µm or 125 µm or 150 µm. at least 50% of the pores have a diameter of at least 100 µm. For example, at least 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% of the pores have such diameters.
  • 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.
  • The contents comprise nicotine-dosed plant material fibres and may comprise one or more additional substances.
  • The or each additional substance may individually be a biologically/pharmacologically active compound, pH stabilisers or adjusters, humectants, flavourants, fillers, preservatives, aqueous/non-aqueous solvents and binders. The or each additional substance may be provided for more than one purpose.
  • 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.
  • 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.
  • 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 bitartrate, nicotine bitartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate and mixtures thereof.
  • pH stabilisers or adjusters may be provided to adjust the user experience and/or modify the bioavailability 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.
  • 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.
  • Fillers 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). Suitable fillers 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 content is 5 to 10 wt% of the contents e.g. around 6 to 9 wt%.
  • 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. As used herein, the term "flavourant" denotes a compound having a desirable taste, aroma or both.
  • 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 vegetable glycerine (VG)) and their esters (e.g. glycerol mono-, di- or tri-acetate).
  • 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%.
  • The humectant may have an upper limit of at most 50% by weight of the contents, such as at most 40 wt%, such as at most 30 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%.
  • Preferably, the amount of humectant is 1 to 40 wt% of the contents, such as 2 to 20 wt% or 5 to 10 wt%.
  • Preferably, the contents has an overall amount of water of between 5 and 50 wt% based on the weight of the contents such as between 10 to 20 wt% or 40 to 50 wt%.
  • 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'.
  • 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. The amount of sweetener is in some cases 1 to 20 % by weight of the contents, such as 2 to 15 wt% or 5 to 10 wt%.
  • Stabilisers are provided to prevent decomposition or degradation overtime 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.
  • 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%.
  • Colourants may be provided to modify the user impression of the smokeless article. Colourants include whitening agents. 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 (E161b), cryptoxanthin (E161c), rubixanthin (E161d), violaxanthin (E161e), rhodoxanthin (E161f), canthaxanthin (E161g), citranaxanthin (E161h), beetroot extract (E162), anthocyanins (E163), calcium carbonate (E170), titanium dioxide (E171), iron oxides (E172), aluminium (E173), silver (E174), gold (E175), lithol rubine BK (E180), tannins (E181). The amount of colourant may be up to about 3% by weight of the smokeless article, such as about 0.5% to about 2.5% or about 1% to about 2%.
  • 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, Amica, Artemisia vulgaris, Yellow Tees, Galea zacatechichi, Canavalia maritima (Baybean), Cecropia mexicana (Guamura), Cestrum 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.
  • The plant material may be tobacco. Any type of tobacco may be used. This includes, but is not limited to, flue-cured tobacco, burley tobacco, Maryland Tobacco, dark-air cured tobacco, oriental tobacco, dark-fired tobacco, perique tobacco and rustica tobacco. This also includes blends of the above mentioned tobaccos.
  • Any suitable parts of the tobacco plant may be used. This includes leaves, stems, roots, bark, seeds and flowers.
  • The tobacco may comprise one or more of leaf tobacco, stem tobacco, tobacco powder, tobacco dust, tobacco derivatives, expanded tobacco, homogenised tobacco, shredded tobacco, extruded tobacco, cut rag tobacco and/or reconstituted tobacco (e.g. slurry recon or paper recon).
  • The contents may comprise at least 50 wt% plant material based on the weight of the contents, e.g. at least 60 wt% plant material e.g. around 65 wt% plant material. The contents may comprise 80 wt% or less plant material e.g. 75 or 70 wt% or less plant material.
  • The contents may comprise a gathered sheet of homogenised (e.g. paper/slurry recon) tobacco or gathered shreds/strips formed from such a sheet.
  • The sheet may have a grammage greater than or equal to 100 g/m2, e.g. greater than or equal to 110 g/m2 such as greater than or equal to 120 g/m2. The sheet may have a grammage of less than or equal to 300 g/m2 e.g. less than or equal to 250 g/m2 or less than or equal to 200 g/m2. The sheet may have a grammage of between 120 and 190 g/m2.
  • The skilled person will appreciate that except where mutually exclusive, a feature or parameter described in relation to any one of the above aspects may be applied to any other aspect. Furthermore, except where mutually exclusive, any feature or parameter described herein may be applied to any aspect and/or combined with any other feature or parameter described herein.
  • Summary of the Figures
  • So that the invention may be understood, and so that further aspects and features thereof may be appreciated, embodiments illustrating the principles of the invention will now be discussed in further detail with reference to the accompanying figures, in which:
    • Figure 1 shows a cross sectional view of a first embodiment of a smokeless article.
    • Figure 2 shows a cross sectional view of a second embodiment of a smokeless article.
    • Figure 3 shows a cross sectional view of a third embodiment of a smokeless article.
    • Figure 4 shows a cross sectional view of a fourth embodiment of a smokeless article.
    • Figure 5 shows a plot of nicotine release rate for an embodiment of the invention and two comparative compositions.
    Detailed Description of the Figures
  • As shown in 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 14. 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.
  • 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.
  • 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.
  • Figure 4 shows a fourth embodiment of a smokeless article 10'" that comprises the third embodiment enclosed by outer pouch 12" having an outer contents 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".
  • 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
  • Various snus samples were prepared and tested for nicotine release rate.
  • A sample was prepared which contained wheat fibres with an average length of 30 µm (Sample 1). The wheat fibres used were JELUCEL® WF-30 fibres sold by Jelu-werk.
  • 100 g master batch was prepared containing ingredients according to the following table:
    Ingredient Content / g
    Nicotine ditartrate dihydrate 1.40
    Wheat fibres (JELUCEL WF-30) 56.02
    Salt 4.20
    Water 30.00
    Ammonium chloride solution 2.03
    Propylene glycol 3.65
    Sodium carbonate solution 0.41
    Flavour (mint) 2.30
    Total 100
  • The master batch was prepared by mixing the ingredients together on the laboratory scale with high-shear mixing apparatus. Product was then manually filled into pouches and sealed using an industry standard heat sealer.
  • In addition, as a comparative article, commercially available Superwhite #3 and Lyft #3 samples were tested. Superwhite #3 is a commercially available smokeless article which includes wheat fibres with a particle size of 200 µm, and Lyft #3 is a commercially available smokeless article which includes eucalyptus and pine fibres.
  • The samples were then tested by immersing each of the samples in the same model solution representing human saliva. The model solution was made with deionised water containing the following ingredients:
    Ingredient Content (g/1000mL)
    Magnesium chloride hexahydrate 0.17
    Potassium hydrogen phosphate anhydrous 0.68
    Sodium chloride 0.33
    Potassium chloride 0.75
    Calcium chloride dehydrate 0.15
    Potassium carbonate 0.53
    Hydrochloric acid to pH 6.8 ± 0.1
  • The model solution was prepared by mixing all ingredients in the table except hydrochloric acid and transferring to a 2 L glass reservoir. 500 mL of deionised water was added and the solution was mixed well to dissolve. Further deionised water was added to bring the total amount of deionised water added to 1 L. The reservoir was sealed and mixed well. The pH was then adjusted to 6.8 by the addition of HCI. The solution was used within 2 days of preparation.
  • Nicotine concentration in the model solution was determined at certain time intervals by an optimised HPLC method using USP 4 flow-through dissolution apparatus with online UV system, thereby providing an indication of the rate of release of nicotine from the immersed pouch.
  • Figure 5 is a plot showing the results of nicotine release tests for the smokeless article of the invention and the comparative articles.
  • Sample 1 demonstrated significantly improved nicotine release characteristics over the comparative articles.
  • The features disclosed in the foregoing description, or in the following claims, or in the accompanying drawings, expressed in their specific forms or in terms of a means for performing the disclosed function, or a method or process for obtaining the disclosed results, as appropriate, may, separately, or in any combination of such features, be utilised for realising the invention in diverse forms thereof.
  • While the invention has been described in conjunction with the exemplary embodiments described above, many equivalent modifications and variations will be apparent to those skilled in the art when given this disclosure. Accordingly, the exemplary embodiments of the invention set forth above are considered to be illustrative and not limiting. Various changes to the described embodiments may be made without departing from the scope of the invention.
  • For the avoidance of any doubt, any theoretical explanations provided herein are provided for the purposes of improving the understanding of a reader. The inventors do not wish to be bound by any of these theoretical explanations.
  • Any section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.
  • Throughout this specification, including the claims which follow, unless the context requires otherwise, the words "have", "comprise", and "include", and variations such as "having", "comprises", "comprising", and "including" will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.
  • It must be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by the use of the antecedent "about," it will be understood that the particular value forms another embodiment. The term "about" in relation to a numerical value is optional and means, for example, +/- 10%.
  • The words "preferred" and "preferably" are used herein refer to embodiments of the invention that may provide certain benefits under some circumstances. It is to be appreciated, however, that other embodiments may also be preferred under the same or different circumstances. The recitation of one or more preferred embodiments therefore does not mean or imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the disclosure, or from the scope of the claims.

Claims (15)

  1. A smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising nicotine-dosed non-tobacco plant material fibres, wherein the plant material fibres have a particle size of up to 30 µm.
  2. A smokeless article according to claim 1, wherein the plant material fibres comprise or consist of wheat fibres.
  3. The smokeless article according to claim 1 or 2, wherein the plant material fibres have a particle size of from 5 to 30 µm.
  4. The smokeless article according to any one of claims 1 to 3, wherein the plant material fibres have a particle size of about 30 µm.
  5. The smokeless article according to any one of claims 1 to 4, wherein the nicotine-dosed plant material fibres comprise a nicotinic compound selected from nicotine, nicotine salt(s), nicotine complex(es); and nicotine solvate(s).
  6. The smokeless article according to claim 5, wherein the nicotinic compound is provided in a plant material.
  7. The smokeless article of claim 6, wherein the plant material is tobacco.
  8. The smokeless article according to any one of claims 1 to 5, wherein the smokeless article is tobacco-free.
  9. The smokeless article according to any one of claims 1 to 8, wherein the total nicotine content is from 5 to 15 mg, preferably about 10 mg.
  10. The smokeless article according to any one of claims 1 to 9, wherein greater than 75 wt%, preferably greater than 80 wt%, of the total nicotine content of the smokeless article is released from the smokeless article after 20 minutes immersed in water.
  11. Use of nicotine-dosed non-tobacco plant material fibres, wherein the plant material fibres have a particle size of up to 30 µm, to increase the material efficiency of a smokeless article and/or reduce manufacturing cost.
  12. Use of nicotine-dosed wheat fibres, wherein the wheat fibres have a particle size of up to 30 µm, as a nicotine release accelerant in a smokeless article for oral consumption.
  13. The use according to claim 12 wherein the smokeless article is according to any one of claims 1 to 10.
  14. A method of manufacturing a smokeless article according to any one of the claims 1 to 10 comprising the steps of;
    (i) forming one or more sheets of pouch material around the contents; and
    (ii) thermally or chemically sealing the pouch material to enclose the contents.
  15. A kit comprising a plurality of smokeless articles according to any one of claims 1 to 10 and a container.
EP20158082.6A 2020-02-18 2020-02-18 Smokeless article Ceased EP3868223A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP20158082.6A EP3868223A1 (en) 2020-02-18 2020-02-18 Smokeless article
PCT/EP2021/054060 WO2021165418A1 (en) 2020-02-18 2021-02-18 Smokeless article
EP21705544.1A EP4106556A1 (en) 2020-02-18 2021-02-18 Smokeless article
US17/818,444 US20220386685A1 (en) 2020-02-18 2022-08-09 Smokeless article

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20158082.6A EP3868223A1 (en) 2020-02-18 2020-02-18 Smokeless article

Publications (1)

Publication Number Publication Date
EP3868223A1 true EP3868223A1 (en) 2021-08-25

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP20158082.6A Ceased EP3868223A1 (en) 2020-02-18 2020-02-18 Smokeless article

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Country Link
EP (1) EP3868223A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023143687A1 (en) * 2022-01-28 2023-08-03 Mac Baren Tobacco Company A/S Pouch composition with specific nicotine to solvent ratio

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130108741A1 (en) * 2007-06-01 2013-05-02 Philip Morris Usa Inc. Coated colloidal ground plant materials
WO2013152918A1 (en) * 2012-04-10 2013-10-17 Swedish Match North Europe Ab A smokeless tobacco composition comprising non-tobacco fibers and a method for its manufacture
US20150020818A1 (en) * 2013-07-19 2015-01-22 Altria Client Services Inc. Methods and Systems for Incorporating Nicotine into Oral Products
EP3491940A1 (en) * 2017-11-29 2019-06-05 Reemtsma Cigarettenfabriken GmbH Method of manufacturing a filling material for a pouched smokeless snus product and filling material manufactured therefrom

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130108741A1 (en) * 2007-06-01 2013-05-02 Philip Morris Usa Inc. Coated colloidal ground plant materials
WO2013152918A1 (en) * 2012-04-10 2013-10-17 Swedish Match North Europe Ab A smokeless tobacco composition comprising non-tobacco fibers and a method for its manufacture
US20150020818A1 (en) * 2013-07-19 2015-01-22 Altria Client Services Inc. Methods and Systems for Incorporating Nicotine into Oral Products
EP3491940A1 (en) * 2017-11-29 2019-06-05 Reemtsma Cigarettenfabriken GmbH Method of manufacturing a filling material for a pouched smokeless snus product and filling material manufactured therefrom

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023143687A1 (en) * 2022-01-28 2023-08-03 Mac Baren Tobacco Company A/S Pouch composition with specific nicotine to solvent ratio

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