Classifications

• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/10—Chemical features of tobacco products or tobacco substitutes
  • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B13/00—Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/10—Chemical features of tobacco products or 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 which comprises nicotine for oral delivery.
• This disclosure also relates to methods of manufacturing the smokeless article.
• 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 tobacco contained within the smokeless article.
• Smokeless articles are placed in the mouth where saliva extracts the soluble element from the content 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 present disclosure provides in a first aspect a smokeless article for oral consumption comprising a pouch enclosing a content.
• the smokeless article for oral consumption comprises a pouch enclosing an oral nicotine delivery (OND) formulation, the OND formulation comprising a water insoluble bulking agent and an active component comprising a complex of a sugar alcohol and nicotine.
• OND oral nicotine delivery
• sugar alcohols can be used to control or adjust the nicotine release of the smokeless article.
• the step of premixing the sugar alcohol with the nicotine to form a complex absorbs the nicotine into the sugar alcohol, which can then be mixed with the rest of the pouch contents.
• the smokeless articles according to the present invention may provide a more desirable user experience, e.g. stronger nicotine perception (e.g. nicotine "hit") to users, compared to other comparable smokeless articles comprising the same overall amount of nicotine (e.g. 10 mg). This is expected to lead to improved user perception of the product and improved overall user satisfaction.
• the smokeless articles may have an active lifetime of from about 20 minutes to about 50 minutes.
• the release profile of nicotine from the smokeless article may involve an initial spike in the rate of nicotine release followed by a gradual tailing off of nicotine release rate over the active lifetime of the smokeless article. This is thought to lead to desirable nicotine perception for users.
• the smokeless article From the perspective of overall user satisfaction, it is also important for the smokeless article to have a good overall mouthfeel.
• the nicotine smokeless article it is important for the nicotine smokeless article to have a fibrous mouthfeel which provides the smokeless article with bulk and allows users to squeeze against something when they squeeze the smokeless article in their mouths.
• a fibrous mouthfeel can result from the preferred use of a water insoluble natural fibres as the bulking agent in the smokeless article.
• the complex of sugar alcohol and nicotine in the smokeless article may comprise from 10 to 20 wt.% nicotine, based on the total weight of the complex. It is believed that having a preferred nicotine content of between 10 wt.% and 20 wt.% in the complex means that the user has an improved nicotine perception (e.g. nicotine "hit), whilst still meaning that the complex can be handled and processed easily. Using a preferred nicotine content of between 10 wt.% and 20 wt.% means that the complex is a smooth free flowing powder. At higher percentages of nicotine, the complex may become more "wet", which may lead to difficulties handling the mixture during production and also issues with the nicotine absorbing into the bulking agent, which may affect the release profile.
• the step of premixing the sugar alcohol with nicotine to form a complex is thought to absorb the nicotine into the sugar alcohol, which can then be mixed with the rest of the pouch contents such as the fibrous bulking agent.
• the nicotine may be present mainly (e.g. >95wt% of the total nicotine content), or completely, in the complex with the sugar alcohol and not, or only minimally (e.g. ⁇ 5wt% of the total nicotine content), absorbed into the fibrous bulking agent.
• This adjusts the release profile of the nicotine because release is primarily regulated by dissolution of the sugar alcohol rather than release of nicotine from a bulking agent, as is typical in some known products.
• the present disclosure provides, in a second aspect, a method of manufacturing a smokeless article for oral consumption according to the present invention.
• the method of manufacturing a smokeless article according to the present proposals comprises the steps of
• the method according to the present invention allows the efficient manufacture of a smokeless article according to the first aspect.
• the methods and products according to the present invention provide an improved or desired nicotine release profile while also providing a fibrous sensory perception, e.g. mouthfeel
• 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.
• the smokeless article is an oral nicotine delivery (OND) article when the active agent within the content comprises a nicotinic compound.
• OND oral nicotine delivery
• the smokeless article comprises a pouch enclosing a content, e.g. an OND formulation, wherein the content (including e.g. a nicotinic compound and non-tobacco plant material fibres) is completely enclosed by the pouch.
• the pouch is sealed to ensure that the content of the pouch does not scatter inside the mouth.
• 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.
• 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.
• the smokeless article may have an active lifetime of about 20 minutes to about 50 minutes, such about 20 minutes to about 45 minutes, or about 20 minutes to about 30 minutes after being placed in the mouth.
• One advantage of the smokeless article according to the present invention may be a faster delivery of nicotine to the user in order to increase nicotine perception; this faster delivery may lead to a shorter relative active lifetime than comparable smokeless articles.
• the release profile of nicotine from the smokeless article may involve an initial spike in the rate of nicotine release followed by a gradual tailing off of nicotine release rate over the active lifetime of the smokeless article. This is thought to lead to desirable nicotine perception for users and an appreciable nicotine experience.
• 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.
• 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.
• 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. a nicotinic compound 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.
• 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 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 smokeless article according to the present invention comprises nicotine as a biologically active compound.
• the nicotine is present at least in part, and preferably mainly (e.g. >95wt% of the nicotine), or totally as a complex of sugar alcohol and nicotine.
• the nicotine may be provided as a nicotine salt, a nicotine base, stabilized nicotine or mixtures thereof.
• nicotine salts include nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate and nicotine salicylate.
• the nicotine is provided as the nicotine base.
• the nicotine base may be added as a liquid solution to the solid sugar alcohol.
• the smokeless article is tobacco free.
• the user may experience a similar or enhanced recreational/pharmaceutical effect as compared to conventional tobaccocontaining products without experiencing undesirable components inherent to tobacco (e.g. tobacco flavour).
• the smokeless article comprises a complex of sugar alcohol and nicotine wherein the complex comprises from 5 to 35 wt.% nicotine, based on the total weight of the complex, preferably from 5 to 25 wt.% nicotine, more preferably from 10 to 25 wt.% nicotine, more preferably from 10 to 20 wt.% nicotine, more preferably from 10 to 15 wt.% nicotine. Most preferably about 10 wt.% nicotine.
• the complex of sugar alcohol and nicotine is preferably a powder, for example a flowable powder. Having the complex present as a powder may also lower or minimise the absorption of the nicotine into the bulking agent. Such absorption of nicotine into other components of the pouch content (e.g.
• the bulking agent is preferably reduced or avoided because it could impair the desired release profile of the nicotine. Consequently, it is desirable to balance the amount of nicotine added with the amount of sugar alcohol and it is preferred not to go above the specific concentrations of nicotine specified in the ranges above when preparing the complex. Above these levels of nicotine the complex of sugar alcohol and nicotine may be "wet" in character or a liquid. Therefore, high levels of nicotine can lead to handling difficulties, impaired flow characteristics and allow a portion of the nicotine to become absorbed into the bulking agent.
• the total nicotine content in an individual pouch is from 1 to 20 mg, preferably from 5 to 15 mg, more preferably about 10 mg.
• the amount of nicotine determines the amount of sugar alcohol added to the smokeless article. For example, when 10 mg of nicotine is wanted in the final product and the complex of sugar alcohol and nicotine comprises 10 wt.% nicotine this involves adding 10 mg nicotine and 90 mg of the sugar alcohol.
• complex in the present disclosure (including the claims) is used to define a material in which the components are physically or chemically combined into a single composition of relatively, uniform composition.
• a complex of nicotine and a sugar alcohol may include the two components chemically bonded together or may include the nicotine absorbed onto/into the sugar alcohol to form a single composition.
• a complex as defined herein may be formed by a simple mixing process but does not include compositions in which the components do not interact in some manner.
• Sugar alcohols may be provided to improve the release profile of the nicotine. As set out above, combining the sugar alcohol with nicotine leads to the formation of a solid complex. This then dissolves in saliva when the smokeless article is placed in the mouth of a user. It is believed that having a highly soluble sugar alcohol in a complex with nicotine means that the complex dissolves quickly in the mouth of a user leading to a relatively fast release of nicotine in the mouth, delivering the nicotine rapidly to the oral mucosa.
• Suitable sugar alcohols include xylitol, maltitol, mannitol, erthritol, isomalt, sorbitol, lactitol, hydrogenated starch hydrolysates, or a mixture thereof.
• the sugar alcohol is xylitol, mannitol and sorbitol or combinations thereof. Most preferably the sugar alcohol is sorbitol.
• the complex of a sugar alcohol and nicotine is preferably a dry free flowing powder. It is believed that having the nicotine present in a complex with a sugar alcohol also leads to quicker release of the nicotine than simply adding nicotine directly into the OND formulation, as in the absence of the formation of a complex, the nicotine may become absorbed or trapped on the fibres of the bulking agent, which may lead to a slower or less desirable release of the nicotine.
• the sugar alcohol and nicotine complex may form from 3 wt.% to 25 wt.% of the OND formulation, based on the total weight of the OND formulation, preferably from 5 wt.% to 20 wt.%, more preferably from 10 wt.% to 20 wt.%, more preferably from 10 wt.% to 17 wt.%, more preferably from 10 wt.% to 15 wt.%, most preferably about 14 wt.%.
• This specific amount of complex is enough to produce the desired nicotine experience, whilst also meaning that the desired amount of other components such as solvents and bulking agents can be included in the formulation to produce the desired mouthfeel.
• Solvents may be provided in the OND formulation 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.
• the solvent is water.
• the smokeless article according to the present invention also comprises a bulking agent.
• the bulking agent may provide physical integrity and may help to improve the mouthfeel of the smokeless article by making the smokeless article have a larger volume and feel soft in the mouth. It is believed that having only sugar alcohol and nicotine present in the smokeless article could deliver the nicotine too quickly leading to an unwanted and undesirable spike in nicotine levels, much higher than the levels required to provide the user with a pleasant experience. Therefore, having the bulking agent present can slow the release of nicotine meaning that an initial nicotine delivery is achieved, but that there is also a sustained release of nicotine over the active lifetime of the product. Furthermore, the presence of a bulking agent, particularly a fibrous bulking agent, provides other desirable user characteristics such as a fibrous feel akin to a tobacco-filled pouch.
• the smokeless article may comprise from 30 wt.% to 60 wt.% bulking agent, based on the total weight of the OND formulation, preferably from 30 wt.% to 50wt.% bulking agent, more preferably from 35 wt.% to 45 wt.% bulking agent, most preferably from 35 wt.% to 40 wt.% bulking agent. This is a preferable amount of bulking agent to achieve a desired mouthfeel and user experience.
• the bulking agent may be a fibrous material.
• the bulking agent may comprise or consist of plant fibres.
• the plant fibres 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 fibres may comprise at 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), Humul
• the bulking agent comprises or consist of one or more of wheat fibres, cellulose fibres, wood fibres, bamboo fibres, pine fibres and eucalyptus fibres.
• the bulking agent comprises or consists of wood and/or cellulose fibres.
• the bulking agent comprises crystalline cellulose, such as microcrystalline cellulose.
• the microcrystalline cellulose may have an average particle size of 10-500 ⁇ m, for example 10-450 ⁇ m, 30-400 ⁇ m, 40-350 ⁇ m, 50-300 ⁇ m.
• the microcrystalline cellulose has a particle size of about 200 ⁇ m.
• the bulking agent comprises two or more different types of crystalline cellulose with different average particle sizes.
• the bulking agent may comprise one type of crystalline cellulose with a particle size of from 30-100 ⁇ m and one type of crystalline cellulose with a particle size of from 150-300 ⁇ m.
• the bulking agent comprises or consists of bamboo and/or wheat fibres.
• the bamboo fibres may have a particle size of 10-500 ⁇ m, for example 10-450 ⁇ m, 10-400 ⁇ m, 10-350 ⁇ m, 10-300 ⁇ m, 10-250 ⁇ m, 10-200 ⁇ m, 10-150 ⁇ m, 10-100 ⁇ m, 10-50 ⁇ m, 15-50 ⁇ m, 10-450 ⁇ m, 15-45 ⁇ m, 20-50 ⁇ m, 20-45 ⁇ m, 20-40 ⁇ m, or 25-35 ⁇ m. In some embodiments, the bamboo fibres have a particle size of about 30 ⁇ m.
• the bamboo fibres have a particle size of 15-500 ⁇ m, for example, 20-500 ⁇ m, 50-500 ⁇ m, 100-500 ⁇ m, 150-500 ⁇ m, 200-500 ⁇ m, 250-500 ⁇ m, 250-450 ⁇ m, 250-400 ⁇ m, 250-350 ⁇ m, 260-340 ⁇ m, 270-330 ⁇ m, 280-320 ⁇ m, 290-310 ⁇ m, or 295-305 ⁇ m. In some embodiments, the bamboo fibres have a particle size of about 300 ⁇ m.
• the bamboo fibres have a particle size of 30-300 ⁇ m.
• the wheat fibres may have a particle size of 10-500 ⁇ m, for example 10-450 ⁇ m, 10-400 ⁇ m, 10-350 ⁇ m, 10-300 ⁇ m, 10-250 ⁇ m, 10-200 ⁇ m, 10-150 ⁇ m, 10-100 ⁇ m, 10-50 ⁇ m, 15-50 ⁇ m, 10-450 ⁇ m, 15-45 ⁇ m, 20-50 ⁇ m, 20-45 ⁇ m, 20-40 ⁇ m, or 25-35 ⁇ m. In some embodiments, the wheat fibres have a particle size of about 30 ⁇ m.
• the wheat fibres have a particle size of 15-500 ⁇ m, for example, 20-500 ⁇ m, 50-500 ⁇ m, 100-500 ⁇ m, 150-500 ⁇ m, 200-500 ⁇ m, 250-500 ⁇ m, 250-450 ⁇ m, 250-400 ⁇ m, 250-350 ⁇ m, 260-340 ⁇ m, 270-330 ⁇ m, 280-320 ⁇ m, 290-310 ⁇ m, or 295-305 ⁇ m. In some embodiments, the wheat fibres have a particle size of about 300 ⁇ m.
• the wheat fibres have a particle size of 30-300 ⁇ m.
• the term "particle size" when referring to fibres such as bamboo fibres, wheat fibres, or crystalline cellulose 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.
• 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 "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 originate from the stem of the plant.
• the fibres may be obtained from commercial sources such as JELUCEL ® BF fibres sold by Jelu-technik, or may be prepared by grinding or milling plant material until fibres of the required particle size are obtained.
• the bulking agent may comprise a plant material, which may be tobacco.
• a plant material which 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 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 .
• tobacco in the pouch filling composition, it may be included at a level of less than 5wt.%, in some cases less than 3 wt.%, such as less than 2wt.% of the total pouch filling.
• 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. These components may have a buffering action, which helps to maintain the pH at the desired level.
• 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, most preferably around pH 8.
• 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.
• the content comprises a pH modifier (e.g. sodium carbonate) 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 0.01 wt% to 0.08 wt%, or from 0.01 wt% to 0.06 wt% based on the total weight of the content.
• a pH modifier e.g. sodium carbonate
• the pH modifier may have a lower limit of at least 0.01 % by weight of the contents 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%.
• Salts may be provided to maintain the osmolarity of the OND formulation 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.
• 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), additional sugar alcohols (e.g. mannitol, xylitol, sorbitol), natural fibres (e.g. non-tobacco fibres), the filler content is 5 to 10 wt% of the contents e.g. around 6 to 9 wt%. Fillers may have additional functions, for example xylitol may also be added to provide a cooling mouth feel.
• Flavouring compounds may be provided in solid or liquid form. Suitable flavouring compounds include coffee, eucalyptus, menthol, liquorice, peppermint, spearmint (e.g. cool blast), chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour.
• the flavouring compounds may be evenly dispersed throughout the contents or may be provided in isolated locations and/or varying concentrations throughout the contents.
• the term "flavouring compound” denotes a compound having a desirable taste, aroma or both.
• the content comprises one or more flavouring compounds (e.g. peppermint flavour) in an amount of from 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%, or from 2 wt% to 6 wt% based on the total weight of the content.
• flavouring compounds e.g. peppermint flavour
• 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 sweetener is acesulfame K.
• 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%, or from 0.01 wt% to 0.08 wt% based on the total weight of the content.
• a sweetener e.g. acesulfame K
• the sweetener may have a lower limit of at least 0.01 % by weight of the contents 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%.
• 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.
• 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%, such as at most 20 wt%, such as at most 10 wt %, such as at most 5 wt %, or 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 OND has an overall amount of water of between 5 and 60 wt% based on the weight of the OND such as between 30 to 50 wt% or 35 to 45 wt%, for example 35 to 40 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'.
• 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.
• 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
• the smokeless article comprises a pouch enclosing an oral nicotine delivery (OND) formulation, the OND formulation comprising a water insoluble bulking agent and an active component comprising a complex of a sugar alcohol and nicotine, wherein the OND addition comprises a solvent, a salt, a pH modifier, a flavour extract, a filler and a sweetener.
• OND oral nicotine delivery
• the present invention also relates to a method of manufacturing a smokeless article for oral consumption according to the present invention.
• the method comprising the steps of
• the preferred aspects referring to the smokeless article also refer to the method of manufacture.
• the method may involve blending a nicotinic substance, such as nicotine or nicotine salt, with a sugar alcohol in step (i) to form a complex.
• a nicotinic substance such as nicotine or nicotine salt
• the method according to the present invention may comprise preparing a precursor blend composition.
• preparing the precursor blend composition comprises mixing together components of the precursor blend composition in high-shear mixing apparatus.
• a suitable mixing apparatus may be known to the skilled person.
• One example of the mixing apparatus which may be used for powder blending is a Cube Mixer KB, which can be attached to an Erweka AR403 all-purpose system to provide mixing apparatus.
• preparing the precursor blend composition comprises mixing together two or more components selected from plant fibres, water, flavourant, sodium chloride, ammonium chloride, propylene glycol and sodium carbonate. In some examples, preparing the precursor blend composition comprises mixing together two or more components selected from plant fibres, water, flavourant, sodium chloride, ammonium chloride, propylene glycol and sodium carbonate in high-shear mixing apparatus.
• the precursor blend composition comprises or consists of: water, bulking agents, buffers, flavourants and sweeteners.
• step (ii) of preparing a precursor blend composition comprises adding each component of the precursor blend composition to a suitable mixer and mixing for a predetermined period of time. In some examples, mixing is continued until a homogeneous mixture is obtained. In some embodiments, step (ii) comprises first mixing the liquid components of the precursor blend composition together, before adding the mixed liquid components to the solid components while mixing, until a homogeneous composition is obtained.
• mixing is performed in a mixer operating at 10-20 RPM, for example about 15 RPM.
• the method further comprises, a step between steps (ii) and (iii) above of blending the precursor blend composition with a lubricant prior to step (iii) of adding the content to a suitable pouch and sealing the pouch to form a smokeless article.
• the precursor blend composition does not contain any stearic acid or salts thereof. In some examples, the precursor blend composition does not contain any powdered lubricant materials.
• the precursor blend composition does not contain any source of nicotine.
• the precursor blend composition further comprises sodium chloride, ammonium chloride, propylene glycol and sodium carbonate.
• the present invention also relates to the use of a complex of sugar alcohol and nicotine in an OND formulation for use in a smokeless article.
• the present invention also relates to a kit comprising a plurality of the smokeless articles according to the present invention and a container.
• a smokeless article 10 having a pouch 12 containing contents (OND powder formulation) 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.
• FIG. 2 shows a second embodiment of a smokeless article 10' having a pouch 12 containing contents (OND powder formulation) 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 (OND powder formulation) 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.
• Example 1 contained the following components: Material Purpose %w/w Nicotine Active 1.4 Sorbitol Carrier 12.6 Water Solvent 38.77 Powdered cellulose Bulking agent 28.16 Microcrystalline cellulose Bulking agent 9.39 Sodium Chloride Salt 2.0 Sodium Carbonate pH Modifier 0.06 Flavour Cooling Sensate 7.50 Sweetener Sweetener 0.12 Total 100.00

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• 2024
  • 2024-04-08 EP EP24169047.8A patent/EP4631366A1/fr active Pending
• 2025
  • 2025-04-02 WO PCT/EP2025/058995 patent/WO2025214846A1/fr active Pending

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