EP4789554A1

EP4789554A1 - Smokeless article

Info

Publication number: EP4789554A1
Application number: EP25157024.8A
Authority: EP
Inventors: Steven Scott HALL; Zak Paul DAVIES
Original assignee: Imperial Tobacco Ltd
Current assignee: Imperial Tobacco Ltd
Priority date: 2025-02-11
Filing date: 2025-02-11
Publication date: 2026-08-12

Abstract

The present invention relates to a smokeless article for oral delivery (10) comprising a pouch (12) enclosing a content (14), wherein the content contains a component which renders the content hydrophobic, and the pouch comprises a nicotinic compound. A method for manufacturing smokeless articles (10) and a kit comprising smokeless articles (10) is also described. Use of a hydrophobic content to restrict transfer of a nicotinic compound from a pouch (12) of a pouched smokeless article for oral delivery (10) to a content (14) enclosed by the pouch.

Description

FIELD

The present disclosure relates to a smokeless article and a method of manufacturing a smokeless article. In particular, the disclosure relates to a method of manufacturing a smokeless article for oral delivery comprising a pouch enclosing an oral nicotine delivery (OND) powder formulation. The disclosure also relates to smokeless articles manufactured using the method.

BACKGROUND

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

At its most general, the present disclosure relates to a smokeless article e.g. an oral nicotine delivery (OND) article, for oral delivery. As used herein, the term "oral delivery" 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.
In a first aspect, the present disclosure provides a smokeless article for oral delivery comprising a pouch enclosing a content. The content of the pouch contains a component which renders the content hydrophobic, and the pouch comprises a nicotinic compound. The smokeless article comprises a nicotinic compound, and so may be referred to as an oral nicotine delivery (OND) article. Nicotinic compounds may be referred to as an active agent or an active compound.
As used herein, the term "hydrophobic" is used to mean that the content has a low affinity for water.
In other words, the water contact angle of the content is greater than 90°. Contact angle can be measured according to known methods, for example the use of an optical tensiometer and a compressed sample of the content.
When the content is hydrophobic, the transfer of the nicotinic compound from the pouch to the content enclosed by the pouch is restricted or prevented. This allows for the nicotinic compound to be retained on or in the pouch material itself, which may result in quicker release and greater and/or faster uptake of the nicotinic compound by the user and may also provide longer shelf life for the products due to decreased unwanted migration of the nicotinic compound into the pouch content and/or greater availability of the nicotinic compound from the pouch material to the user. Consequently, the user may experience increased nicotine perception, leading to an enhanced user experience.

Nicotinic Compound

In some examples, the nicotinic compound is carried by the material of the pouch. In other examples, the nicotinic compound is adsorbed onto the material of the pouch (e.g. the external or internal surface of the pouch material).
In some examples, the pouch comprises at least 5% of the total nicotine content of the smokeless article, such as at least 10%, such as at least 20%, such as at least 30%, such as at least 40%, such as at least 50%, such as at least 60%, such as at least 70%, such as at least 80%, such as at least 90%, such as at least 95%, such as at least 98%, such as at least 99%. In some examples the pouch comprises 100% of the total nicotine content of the smokeless article, i.e. no nicotine is present in the pouch content. In some examples the pouch content comprises 100% of the total nicotine content of the smokeless article, i.e. no nicotine is present in and/or applied to the pouch material. In some examples, the pouch comprises 95% or less of the total nicotine content of the smokeless article, such as 90% or less, such as 80% or less, such as 70% or less, such as 60% of less, such as 50% or less, such as 40% or less, such as 30% or less, such as 20% or less. The amount of nicotine comprised by the pouch may be selected from a range with upper and lower amounts selected from the values given above. For example, the pouch may comprise 10 to 90% of the total nicotine content of the smokeless article, such as 10 to 80%, such as 10 to 70%, such as 10 to 60%, such as 10 to 50%, such as 10 to 40%, such as 10 to 30%. In some examples, the pouch may comprise 10 to 40% of the total nicotine content of the smokeless article, such as 10 to 35%, such as 10 to 30%, such as 10 to 25%. In some examples, the pouch may comprise 10 to 25% of the total nicotine content of the smokeless article.
In some examples, the pouch comprises a nicotinic compound coating, such as a nicotinic compound spray coating.
Beneficially, spray coating the nicotinic compound onto the pouch can provide a more even distribution of the nicotinic compound over the surface of the pouch, and can improve retention of the nicotinic compound on the surface of the pouch. This leads to more consistent uptake of nicotinic compound by the user, and also a greater and quicker transfer of the nicotinic compound to the user.
This results in an improved user experience. Additionally, spray coating may allow for the amount of nicotinic compound applied to the pouch to be more accurately controlled.
The nicotinic compound may be selected from nicotine, nicotine salt(s), nicotine complex(es); and nicotine solvate(s). In some examples nicotine is selected from the group consisting of nicotine salts, nicotine base, stabilized nicotine and mixtures thereof. For example, the nicotine may include at least one nicotine salt selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine ditartrate, nicotine ditartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate and mixtures thereof. In some examples, the nicotinic compound is freebase nicotine.
In some examples, the nicotinic compound may be applied to the pouch as a nicotinic stock solution. In examples where the pouch comprises a nicotinic compound spray coating, the nicotinic stock solution may be sprayed on the pouch. The nicotinic stock solution may comprise the nicotinic compound and a solvent. In some examples, the solvent is water. In some examples, the nicotinic stock solution may further comprise additional components as described herein.

Content

The content of the smokeless article is an oral nicotine delivery (OND) formulation. The content contains a component which renders the content hydrophobic.
The component which renders the content hydrophobic may, in some examples, be selected from silica (e.g. colloidal silica or fumed silica), metallic stearates, metallic silicates (e.g. magnesium silicate (talc)), stearic acid, hydrophobic cellulose derivatives (e.g. ethylcellulose, hydroxypropylmethyl cellulose), polyvinyl acetate, silicone powders (e.g. dimethicone), and polyethylene glycol stearate.
In some examples, the component which renders the content hydrophobic comprises a metallic stearate. Metallic stearates are hydrophobic. By incorporating a metallic stearate in the content enclosed by the pouch, the pouch content may demonstrate increased hydrophobicity. That is, in some examples, the content comprises a metallic stearate as a hydrophobic component.
A metallic stearate is a metal salt of stearic acid. Stearic acid is a saturated fatty acid with a straight 18-carbon atom chain, and is also known as octadecanoic acid. Herein "metallic stearate" is synonymous with "metallic octadecenoate".
In some examples, the metallic stearate is present in an amount of 0.5 wt% or more based on the total weight of the content, such as 1 wt% or more, such as 2.5 wt% or more, such as 5 wt% or more. In some examples, the metallic stearate is present in an amount of up to and including 10 wt% based on the total weight of the content, such as up to and including 9 wt%, such as up to and including 7.5 wt%, such as up to and including 5 wt%. In some examples, the amount of metallic stearate may be selected from a range with upper and lower amounts selected from the values given above. For example, the metallic stearate may be present in an amount of from 0.5 to 10 wt% based on the total weight of the content, such as from 1 to 10 wt% such as from 2.5 to 10 wt%, such as from 5 to 10 wt%. In other examples, the metallic stearate may be present in an amount of from 0.5 to 9 wt%, such as from 0.5 to 7.5 wt%, such as from 0.5 to 5 wt%. In some examples, the metallic stearate is present in an amount of from 5 to 10 wt%.
The metallic stearate may be formed from any metal cation which forms a salt with the stearate anion. In some examples, the metal cation is a cation from Group 1 or Group 2 of the periodic table. In some examples the metal cation is selected from lithium, sodium, potassium, beryllium, magnesium, and calcium. In some examples the metal cation is selected from sodium, potassium, magnesium, and calcium.
In some examples, the metallic stearate comprises one or more selected from the group consisting of magnesium stearate, calcium stearate, sodium stearate, and potassium stearate. In some examples, the metallic stearate comprises one or more selected from the group consisting of magnesium stearate and calcium stearate. In some examples, the metallic stearate comprises or consists of magnesium stearate. In other examples, the metallic stearate comprises or consists of calcium stearate. When present in the pouch content, metallic stearates such as magnesium stearate and calcium stearate have been found to be a particularly effective at reducing the transfer of a nicotinic compound from a pouch to the content enclosed by the pouch.
Magnesium stearate is commercially available and one possible source is LIGAMED MF-2-V, supplied by IMCD. This product has an average particle size of 7-11 µm.
In some examples, the metallic stearate is uniformly distributed throughout the content. That is, the components of the content are evenly dispersed (e.g. they may appear to be homogeneously mixed on the macroscopic scale). In other words, in some examples, the content is isotropic. Advantageously, uniform distribution of the metallic stearate throughout the content results in more uniform hydrophobicity of the content as a whole. This results in improved restriction/prevention of transfer of a nicotinic compound from the pouch to the content enclosed by the pouch, and thus leads to enhanced user experience.
In some examples, the content comprises filler material. Filler materials 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). In the present proposals, the nature of the filler materials may also impact the release profile of the nicotinic compound and the mouthfeel of the product. Filler materials may also be referred to as "fillers" or "bulking agents". For the avoidance of doubt, the filler material is intended to be distinct from the particles in the content as referred to herein.
In some examples, the content comprises filler material in an amount of 90 wt% or more based on the total weight of the content, such as 92.5 wt% or more, such as 95 wt% or more, such as 97.5 wt% or more. In some examples, the content comprises filler material in an amount of 99.5 wt% or less based on the total weight of the content, such as 98 wt% or less, such as 97.5 wt% or less. In some examples, the amount of filler material may be selected form a range with upper and lower amounts selected from the values given above. For example, the filler material may be present in an amount of from 90 to 99.5 wt% based on the total weight of the content, such as from 92.5 to 99.5 wt%, such as from 95 to 99.5 wt%. In other examples, the filler material may be present in an amount of from 90 to 98 wt%, such as from 90 to 97.5 wt%.
In some examples, the filler material comprises fibrous material. In some examples, the filler material comprises at least one fibrous material. In some examples the filler material comprises a combination of two or more types of fibrous material.
The fibrous material is composed essentially or completely of fibres. The fibrous material may be insoluble in water, so that the fibrous material may comprise or consist of water-insoluble fibres. In some examples, water-insoluble fibres have a water solubility of less than 0.1 gram per 100 mL of water measured at 25 °C and at a pH of 7.0. The fibrous material may be food-grade. The fibrous material may be biocompatible.
The fibrous material may be naturally-occurring (e.g., a plant fibre), bio-derived, or synthetic. In some examples, the fibrous material is naturally-occurring or bio-derived, for example bio-derived. For example, a naturally-occurring fibrous material may be made of collagen, actin, fibrin, starch (e.g., corn starch), cellulose (e.g. powdered cellulose), alginate, or a polyhydroxyalkanoate (PHA), for example cellulose. For example, a bio-derived fibrous powder may be obtained by processing or modifying a natural product. For example, a bio-derived fibrous powder may be made of microcrystalline cellulose (MCC), poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly(ε-caprolactone), or polybutylene succinate (PBS), for example MCC. The fibrous material may consist of a combination of two or more fibrous materials.
In some examples, the fibrous material is cellulosic. Cellulosic fibres are fibres made of cellulose (e.g. powdered cellulose) or derived from cellulose (e.g. to form MCC).
The fibrous material may be obtained from commercial sources such as VIVAPUR^® 200 (MCC powder) sold by JRS Pharma.
In some examples, the fibrous material is colourless (e.g. it does not reflect light in the visible spectrum). In some examples, the fibrous material is white. In some examples, the fibrous material has been bleached. In some examples, the fibrous material has not been coloured by a colourant. In some examples, the fibrous material is a different colour to the particles.
In some examples, the fibrous material comprises or consists of fibres. In some examples, the fibrous material is not particulate. In some examples, the fibrous material comprises or consists of substantially non-spherical fibrous particles or fibres, a fibrous particle being a solid particle made from one or more fibres. In some examples, the fibrous material is powdered. In some examples, the fibrous material comprises or consists of elongate fibres or fibrous particles. In some examples, the fibrous material comprises or consists of fibrous particles, the fibrous particles being distinct from the particles referred to herein.
The fibrous material may comprise or consist of a plant fibre. A plant fibre is a naturally occurring fibrous material obtained from a plant. It may be chemically unmodified. The plant fibre may be a combination of fibres from different plants. In some examples, the plant fibre is essentially or completely water-insoluble. In some examples, the plant fibre comprises elongate fibres. The plant fibre may be included in the content of the pouch to add strength and structure to the content. Additionally, the plant fibre may function as a natural source of substances such as, for example, biologically/pharmacologically active compounds, flavourants, pH stabilisers etc. The plant fibre may, additionally or alternatively, modify the mouthfeel and/or release profile of the nicotinic compound.
For example, the plant fibre may comprise one or more selected form the group consisting of maize fibres, oat fibres, tomato fibres, barley fibres, rye fibres, sugar beet fibres, buck wheat fibres, wheat fibres, pea fibres, potato fibres, apple fibres, cocoa fibres, bamboo fibres, citrus fibres, pine fibres, eucalyptus fibres, and any combination thereof. In some examples, the plant fibre is selected from bamboo fibres, wheat fibres, or a combination thereof.
Additionally or alternatively, the plant fibre may comprise one or more selected from the group consisting of 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)
In some examples, the plant fibre comprises or consists of bamboo fibre. In some examples, the plant fibre comprises or consists of wheat fibre. In some examples, the fibrous material comprises MCC and one or both of bamboo fibre and wheat fibre.
As used herein, the term "bamboo fibre" 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 examples, they originate from the stem of the plant. The fibres may be obtained from commercial sources or may be prepared by grinding or milling plant material until fibres of the required particle size are obtained.
As used herein, the term "wheat fibre" may refer to natural fibres from plants of the Triticum genus of the Poaceae family of grasses. For example, common wheat, T. aestivum. The fibres may originate from any part of the plant, but, in some examples, they 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 VITACEL^® WF fibres sold by JRS Pharma. In some examples, the fibres may be prepared by grinding or milling plant material until fibres of the required particle size are obtained.
In some examples, the fibrous material consists of one or more non-tobacco plant fibres. In some examples, the fibrous material comprises a tobacco fibre and one or more other plant fibres.
In some examples, the smokeless article comprises less than 5 wt% tobacco, based on the total weight of the content. In some examples, the smokeless article comprises less than 1 wt% tobacco, based on the total weight of the content. In some examples, the content comprises tobacco in an amount of about 0.1 wt%, about 0.2 wt%, about 0.3 wt%, about 0.4 wt%, or about 0.5 wt%. In some examples, the smokeless article is free or substantially free of tobacco. The presence of tobacco may affect the considerations relating to shelf-life and nicotine absorption.
In some examples, the fibrous material is a nicotine-dosed fibre. As used herein, the term "nicotine-dosed fibre" refers to a composition comprising a fibre and a nicotinic compound. The nicotinic compound may be added to or mixed with the fibre prior to incorporation into the smokeless article. In some examples, the fibres are loaded into a suitable dryer, sprayed with a solution of nicotinic compound and dried to form nicotine-dosed fibres. The dryer may be a fluidised bed dryer. The solution may be a solution of nicotinic compound in water or glycerin. In some examples, the solution of nicotinic compound 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 "particle size" when referring to fibres indicates the average size of the longest dimension of the fibres, where the average is taken as the median (d50) in a distribution of the longest dimensions of a sample. For example, a particle size of 50 µm indicates that in the population of fibres, the median (d50) fibre length is 50 µm. Fibres of a desired particle size are available from commercial suppliers such as Jelu-werk. The particle size distribution can be determined using laser diffraction methods (such as described in ISO 13320:2020), by light/electron microscopy static image analysis (such as described in ISO 13322-1 :2014), or by sieving methods as described herein.
In some examples, the fibrous material has a monomodal particle size distribution.
The fibres of the fibrous material may have a particle size of 10 to 500 µm, for example 10 to 450 µm, 10 to 400 µm, 10 to 350 µm, 10 to 300 µm, 10 to 250 µm, 10 to 200 µm, 10 to 150 µm, 20 to 150 µm, 30 to 150 µm, 30 to 125 µm, 30 to 100 µm, 30 to 90 µm, 30 to 80 µm, 30 to 75 µm, 30 to 70 µm, 30 to 60 µm, 30 to 50 µm, 30 to 40 µm, 32 to 100 µm, 40 to 150 µm, 40 to 125 µm, 40 to 100 µm, 40 to 90 µm, 40 to 75 µm, 40 to 60 µm, 40 to 50 µm, 10 to 100 µm, 10 to 50 µm, 15 to 50 µm, 10 to 45 µm, 15 to 45 µm, 20 to 50 µm, 20 to 45 µm, 20 to 40 µm, or 25 to 35 µm. In some examples, the fibres have a particle size of about 30 µm. In some examples, the fibres have a particle size of about 40 µm. In some examples, the fibres have a particle size of about 50 µm.
In some examples, the fibres of the fibrous material have a particle size of 15 to 500 µm, for example, 20 to 500 µm, 50 to 500 µm, 50 to 400 µm, 50 to 350 µm, 100 to 350 µm, 150 to 350 µm, 200 to 350 µm, 200 to 300 µm, 225 to 300 µm, 225 to 275 µm, 240 µm to 260 µm, 245 µm to 255 µm, 150 to 250 µm, 160 to 240 µm, 170 to 230 µm, 180 to 220 µm, 190 to 210 µm, 195 to 205 µm, 100 to 500 µm, 150 to 500 µm, 200 to 500 µm, 250 to 500 µm, 250 to 450 µm, 250 to 400 µm, 250 to 350 µm, 260 to 340 µm, 270 to 330 µm, 280 to 320 µm, 290 to 310 µm, or 295 to 305 µm. In some examples, the fibres have a particle size of about 300 µm. In some examples, the fibres have a particle size of about 250 µm. In some examples, the fibres have a particle size of about 200 µm.
In some examples, the fibres of the fibrous material have a particle size of 25 µm or more, 30 µm or more, 32 µm or more, 35 µm or more, 40 µm or more, 45 µm or more, 50 µm or more, 60 µm or more, 70 µm or more, 75 µm or more, 80 µm or more, 90 µm or more, 100 µm or more, 150 µm or more, 175 µm or more, 200 µm or more, 225 µm or more, 250 µm or more, 275 µm or more, 300 µm or more, 325 µm or more, 350 µm or more, 400 µm or more, 500 µm or more, or 600 µm or more. In some examples, the fibres have a particle size of 600 µm or less, 500 µm or less, 450 µm or less, 400 µm or less, 375 µm or less, 350 µm or less, 325 um or less, 300 µm or less, 275 µm or less, 250 µm or less, 225 µm or less, 200 µm or less, 175 µm or less, 150 µm or less, 125 µm or less, 100 µm or less, 90 µm or less, 80 µm or less, 75 µm or less, 70 µm or less, 60 µm or less, 55 µm or less, 50 µm or less, 45 µm or less, 40 µm or less, or 35 µm or less.
In some examples, the fibres of the fibrous material have a particle size of 30 to 300 µm.
In some examples, the fibrous material is contained in an amount by weight, based on the total weight of the content, of from 20 to 80 wt%. In some examples, the amount of the fibrous material is from 20 to 75 wt%, from 25 to 75 wt%, from 25 to 70 wt%, from 30 to 70 wt%, from 30 to 60 wt%, from 30 to 50 wt%, from 25 to 45 wt%, from 30 to 45 wt%, from 35 to 50 wt%, from 35 to 45 wt%, from 30 to 40 wt%, from 40 to 60 wt%, from 40 to 50 wt%, or from 50 to 60 wt%.
In some examples, the fibrous material is contained in an amount by weight, based on the total weight of the content, of 20 wt% or more, 25 wt% or more, 30 wt% or more, 35 wt% or more, 40 wt% or more, 45 wt% or more, 50 wt% or more, 55 wt% or more, 60 wt% or more, 65 wt% or more, 70 wt% or more, or 75 wt% or more. In some examples, the fibrous material is contained in an amount by weight, based on the total weight of the content, of 80 wt% or less, 75 wt% or less, 70 wt% or less, 65 wt% or less, 60 wt% or less, 55 wt% or less, 50 wt% or less, 45 wt% or less, 40 wt% or less, 35 wt% or less, 30 wt% or less, or 25 wt% or less.
In some examples, the fibres of the fibrous material have a particle size of about 100 µm, 150 µm, 175 µm, 200 µm, 225 µm, 250 µm, 275 µm, 300 µm, 325 µm, 350 µm, 375 µm, or 400 µm. In some examples, the fibres have a particle size of about 200 µm. In some examples, the fibres have a particle size of about 250 µm. In some examples, the fibres have a particle size of about 300 µm.
In some examples, the particle size of the fibrous material is greater than the particle size of the particles. In some examples, the particle size of the fibrous material is less than the particle size of the particles. In some examples, the particle size of the fibrous material is similar to (e.g. within 10% of, or within 5% of) the particle size of the particles.
The content of the pouch may comprise additional fillers. Suitable additional fillers include calcium carbonate, calcium phosphate, corn starch, grains, lactose, polysaccharides (e.g. maltodextrin), polyols, sugars (e.g. dextrose, manitol, xylitol, sorbitol) and combinations thereof. In some cases, the additional filler content is 5 to 10 wt% of the content e.g. around 6 to 9 wt%.
In some examples, the content is substantially free from nicotinic compounds. By "substantially free from" it is meant that nicotinic compounds may be present in the content in an amount of about 0.1 wt.% or less, such as 0.01 wt.% or less based on the total weight of the content. In some examples, the content is free from nicotinic compounds. That is, in some examples, the content does not contain any nicotinic compounds.
In some examples, the content comprises a nicotinic compound (e.g., nicotine).
In some examples, the nicotinic compound is one selected from the group consisting of nicotine, nicotine salt(s), nicotine complex(es), and nicotine solvate(s), optionally wherein the nicotinic compound is nicotine. In some examples, the nicotine is freebase nicotine.
In some examples, the content comprises a nicotinic compound in an amount of from 0.5 to 5 wt% based on the total weight of the content.
In some examples the smokeless article comprises a nicotinic compound in an amount of from 0.5 to 5 wt% based on the total weight of the content and any flavourant and/or nicotinic compound (taking into account that all or a portion of the flavourant and/or nicotinic compound may be present in or on the pouch material rather than included in the content). In some examples the smokeless article comprises a nicotinic compound in an amount of from 0.7 to 2.4 wt%, preferably 1.6 wt% based on the total weight of the content and flavourant and/or nicotinic compound.
In some examples, the content has a bulk density above about 0.3 g/mL, such as above about 0.35 g/mL, such as above about 0.38 g/mL, such as above about 0.40 g/mL, or above about 0.41 g/mL.
In some examples, the content has a bulk density up to about 0.50 g/mL, such as up to about 0.45 g/mL, such as up to about 0.44 g/mL, such as up to about 0.43 g/mL, or up to about 0.425 g/mL.
In some examples the content has a bulk density of 0.30-0.50 g/mL, 0.35-0.50 g/mL, 0.38-0.45 g/mL, 0.40-0.45 g/mL, 0.41-0.44 g/mL, 0.41-0.43 g/mL, or 0.411-0.421 g/mL. In some examples, the content has a bulk density of 0.30-0.40 g/mL, such as 0.35-0.40 g/mL.

Additional Substances

When the nicotinic compound is applied to the pouch as a nicotinic stock solution, in some examples the stock solution comprises one or more additional substances. In some examples, the content may comprise one or more additional substances. In some examples, additional substances may be present in both the nicotinic stock solution and in the content.
Each additional substance may individually be a biologically/pharmacologically active compound, humectants, flavourants, fillers, preservatives, aqueous/non-aqueous solvents, particles and binders. Each additional substance may be provided for more than one purpose. That is, in some examples the content further comprises at least one of a flavourant, humectant, sweetener, colourant, pH adjuster and solvent.
In some examples, the stock solution and/or content comprises a flavourant. Flavourants (also known as flavour components) may be provided in solid or liquid form, for example an extract, oil, butter, powder, gel, or concentrate. As used herein, the term "flavourant" denotes a compound having a desirable taste, aroma or both. Suitable flavourants include aloe vera extract, menthol, rosemary, chamomile, citrus, coconut, peppermint, frankincense, spearmint, wintergreen, tea tree oil, oregano, lavender, eucalyptus, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour. Other suitable flavourants include apple, apricot, banana, citrus peel oil, citrus peel juice, berries, guava, melon, papaya, peach, pear, peas, clove, ginger, mustard, spearmint oil, nuts, honey, soybean, coconut, passion fruit, olive, avocado, plum, rose apple, starfruit, sesame seed, tamarind, fig, cardamom, coriander seed and leaf, quince, lychee, dill, lovage, kiwi, loquat, sage, Chinese quince. The flavourant may be evenly dispersed throughout the contents or may be provided in isolated locations and/or varying concentrations throughout the contents. In some examples, the first flavourant may be loaded onto fibres and/or particles contained in the content. For example, the first flavourant may be loaded onto fibres and/or particles prior to forming the content. In some examples, the first flavourant may be mixed evenly within the content.
In some examples, the flavourant is bound to or loaded onto particles. In some examples, the flavourant is bound to or loaded onto the surface of the particles. In some examples, the flavourant is associated with the particles. In some examples, the flavourant is associated with pores of the particles. In some examples, the flavourant is loaded onto the particles before they are added to the content.
In some examples, the pouch comprises a flavourant. In some examples, the flavourant is applied to the pouch by spraying. In some examples, the pouch comprises at least 5% of the total flavourant content of the smokeless article, such as at least 10%, such as at least 20%, such as at least 30%, such as at least 40%, such as at least 50%, such as at least 60%, such as at least 70%, such as at least 80%, such as at least 90%, such as at least 95%, such as at least 98%, such as at least 99%.
In some examples the pouch comprises 100% of the total flavourant content of the smokeless article, i.e. no flavourant is present in the pouch content. In some examples the pouch content comprises 100% of the total flavourant content of the smokeless article, i.e. no flavourant is present in and/or applied to the pouch material. In some examples, the pouch comprises 95% or less of the total flavourant content of the smokeless article, such as 90% or less, such as 80% or less, such as 70% or less, such as 60% of less, such as 50% or less, such as 40% or less, such as 30% or less, such as 20% or less. The amount of flavourant comprised by the pouch may be selected from a range with upper and lower amounts selected from the values given above. For example, the pouch may comprise 10 to 90% of the total flavourant content of the smokeless article, such as 10 to 80%, such as 10 to 70%, such as 10 to 60%, such as 10 to 50%, such as 10 to 40%, such as 10 to 30%. In some examples, the pouch may comprise 10 to 40% of the total flavourant content of the smokeless article, such as 10 to 35%, such as 10 to 30%, such as 10 to 25%. In some examples, the pouch may comprise 10 to 25% of the total flavourant content of the smokeless article.
In some examples the smokeless article comprises a flavourant in an amount of from 0.5 to 20 wt% based on the total weight of the content and flavourant and/or nicotinic compound (taking into account that all or a portion of the flavourant and/or nicotinic compound may be present in or on the pouch material rather than included in the content). In some examples the smokeless article comprises a flavourant in an amount of from 2 to 6 wt% based on the total weight of the content and flavourant and/or nicotinic compound.
In some examples, the stock solution and/or content comprises a further biologically active or pharmacologically active compound in addition to the nicotinic compound. Biologically/pharmacologically active compounds are provided to produce a pharmacological effect in the user. Suitable further biologically/pharmacologically active compounds include the group consisting of: caffeine, 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 examples, the stock solution and/or content comprises a solvent. Solvents may be provided 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. In some examples, the solvent is water.
In some examples, the stock solution and/or content comprises particles. That is, in some examples, the stock solution and/or content comprises a plurality of particles. The particles referred to herein are distinct from the filler material contained in the content. For example, the particles described herein may form a particulate component of the content, which is distinct from, though may be intimately mixed with, other components (e.g. the at least one filler material) of the content. In some examples, the particles may also be referred to as grains, granules, beads, microbeads, etc. In some examples, the nature of the particles may have an effect on the blend/powder characteristics of the content, and/or on the user experience of the product. In some examples, the particles may be wax particles, i.e. particles made from a wax, or including a wax.
In some examples, the particles may be coloured particles, e.g. particles which have been coloured using one or more dyes or pigments. Such coloured particles may appear coloured to the human eye, reflecting a wavelength in the visible part of the electromagnetic spectrum. In some examples, the particles may be coloured wax particles, for example they may comprise one or more, typically one, selected from the group consisting of paraffin wax, Montan wax, carnauba wax, candelilla wax, beeswax, cottonseed wax, animal wax, microcrystalline wax, mineral wax, palm wax, rapeseed wax, and soy wax. In some examples, the particles are paraffin wax particles
In some examples, the reflected light has a wavelength of between 380-750 nm. In some examples, the reflected light has a colour selected from red, yellow, green and blue. In some examples, the colour of the coloured particles is selected from: red, orange, yellow, green, blue, indigo, violet, pink, brown, and grey. In some examples, all of the coloured particles have the same colour. In some examples, some of the particles have a different colour to other particles.
In some examples, a suitable colour for the coloured particles is selected based on the intended experience of the user, such as flavour enhancement. In some examples, the particles comprise a flavourant loaded thereon. In this way, the flavour can be associated with the particles and can alter the flavour release profile.
In some examples, the particles have an average particle size (d50) of between 200 and 2500 µm. In some examples, the particles have an average particle size (d50) of 400 µm or more. In some examples, the particles have an average particle size (d50) of 900 µm or less. In some examples, the particles have a melting point of 40 °C or greater. In some examples, the particles have a melting point of 100 °C or greater. In some examples, the particles have a density, as measured at 25 °C, of 0.4 g/cm³ or greater. In some examples, the particles have a density, as measured at 25 °C, of 0.9 g/cm³ or greater.
In some examples, the particles are contained in an amount by weight, based on the total weight of the content, of from 0.1 wt% to 10 wt%. In some examples, the particles are contained in an amount of from 1 wt% to 3 wt%. In this way, there may be a sufficient quantity of particles in the content to provide a content with beneficial characteristics. When coloured as described herein, the particles may provide a desirable speckled effect which may improve the user's experience.
In some examples, the stock solution and/or content comprises a salt (in addition to any metallic stearate). 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.
In some examples, the content comprises a humectant. 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 triacetate). The humectant component may consist of a single humectant compound or may consist of two or more different humectant compounds.
When the content comprises a humectant, the humectant may have a lower limit of at least 1 wt% based on the total weight of the content, 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 70 wt% based on the total weight of the content, such as at most 65 wt%, such as at most 60 wt%, or such as at most 20 wt%, such as at most 10 wt%, such as at most 5 wt%, such as at most 2 wt%.
In some examples, the amount of humectant in the content is 1 to 70 wt% based on the total weight of the content, such as 10 to 60 wt%, such as 50 to 60 wt%.
In some examples, the content has an overall amount of water of between 5 and 60 wt% based on the total weight of the content, such as from 30 to 60 wt%, such as from 35 to 60 wt%, such as from 40 to 60 wt%, such as from 50 to 60 wt%. In some examples, the content has an overall amount of water from 40 to 55 wt%, such as from 40 to 50 wt% or from 42 to 50 wt%, such as from 42 to 28 wt%, based on the total weight of the content. In other examples, the content has an overall amount of water from 52 to 60 wt% based on the total weight of the content.
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'.
The humectant in the content (e.g. OND formulation) may comprise or consist of water and one or more polyhydric alcohols, for example water and glycerol. In some examples, the humectant may comprise propylene glycol.
In some examples, the stock solution and/or content comprises a sweetener. 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.
When the content comprises a sweetener, the content may comprise the sweetener (e.g. acesulfame K) in an amount of from 0 to 1 wt%, for example from 0.01 to 1 wt%, from 0.01 to 0.5 wt%, from 0.01 to 0.2 wt%, from 0.01 to 0.1 wt%, from 0.05 to 0.2 wt%, or from 0.05 to 0.15 wt% based on the total weight of the content.
The amount of sweetener in the content may have a lower limit of at least 0.01 % by weight of the content such as at least 0.02 wt%, such as at least 0.03 wt%, such as at least 0.04 wt%, such as at least 0.05 wt%, or such as least 0.06 wt%.
In some examples, the stock solution and/or content comprises a stabiliser. 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.
In some examples, the stock solution and/or content comprises a pH stabiliser or adjuster. pH stabilisers or adjusters (pH modifiers) 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. These components may have a buffering action, which helps to maintain the pH at the desired level. In some examples, the overall pH of the smokeless article is pH 7 to pH 9, such as pH 7.25 to pH 8.75 or pH 7.5 to pH 8.5, for example around pH 8.
The pH may be stable for at least 4 months, at least 5 months, at least 6 months, at least 7 months, or at least 8 months. The content (e.g., OND formulation) may have a shelf-life of at least 4 months, at least 5 months, at least 6 months, at least 7 months, or at least 8 months.
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.
When the content comprises a pH modifier, the pH modifier (e.g. sodium carbonate) may be in an amount from 0 to 1 wt%, for example from 0.01 to 1 wt%, from 0.01 to 0.5 wt%, from 0.01 to 0.2 wt%, from 0.01 to 0.1 wt%, from 0.01 to 0.08 wt%, or from 0.01 to 0.06 wt% based on the total weight of the content.
When present in the content, the pH modifier may have a lower limit of at least 0.01 % by weight of the content such as at least 0.02 wt%, such as at least 0.03 wt%, such as at least 0.04 wt%, such as at least 0.05 wt%, or such as least 0.06 wt%.
In some examples, the content comprises a binder. 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 examples the binder content is 5 to 10 wt% based on the total weight of the content, such as around 6 to 9 wt%, such as 7 to 8 wt%.
In some examples, the stock solution and/or content comprises a colourant. Colourants may be provided to modify the user impression of the smokeless article. Colourants may 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 (E1619), 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, separately to any colourant associated with the particles described above, 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%.
In some examples, the nicotinic compound is applied to the pouch as a nicotinic stock solution, the stock solution comprising the nicotinic compound and a solvent. In some examples, the stock solution comprises the nicotinic compound, a solvent, and at least one additional substance such as a flavourant, pH adjuster or sweetener. In some examples, the components of the stock solution are present in amounts as described above.
In some examples, the content comprises a metallic stearate and a filler material. In some examples, the content comprises a metallic stearate, a filler material and at least one additional substance such as a flavourant, pH adjuster or sweetener. In some examples, the content comprises a metallic stearate, a filler material, a flavourant, a pH adjuster, a sweetener and a solvent. In some examples, the components of the content are present in amounts as described above.

Pouch

The smokeless article comprises a pouch enclosing a content, wherein the content 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 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 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.
In some examples, 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. 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. In some examples, at least 50% of the pores have a diameter of from 50 µm to 200 µm, such as from 100 µm to 175 µm or from 125 µm or 150 µm. In some examples, at least 50% of the pores have a diameter of at least 100 µm. For example, in some examples 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.
In some examples, 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 examples, the total nicotinic compound (e.g. nicotine) content per pouch is from 4 to 15 mg. In some examples, the nicotinic compound content per pouch is about 7 to10 mg, for example the nicotinic compound content per pouch is about 8 mg.
In some examples, a flavourant may be applied to the pouch. This may be instead of or in addition to any flavourant contained by the content of the pouch. In some examples, the pouch comprises 10 to 40% of the total flavourant content of the smokeless article, such as 10 to 30%, such as 10 to 25%.
In examples where the pouch comprises a nicotinic compound spray coating, a flavourant may also be applied to the pouch by spraying.
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.
As described herein, the pouch of the smokeless article comprises a nicotinic compound. The nicotinic compound may be absorbed into the material of the pouch (either before forming the pouch or after forming the pouch). Additionally, or alternatively, the nicotinic compound may be provided on the surface of the pouch material, e.g. all or part of the internal or external surface of the pouch.
In some examples, the pouch material and/or structure may be selected to enhance absorption or retention of the nicotinic compound. For example, the pouch material may have regions that are absorbent, e.g. hydrophilic, or may be formed entirely from absorbent, e.g. hydrophilic, material.

Nicotine and Flavour Release

In some examples, in use, at least 10% of the total nicotine content of the smokeless article is released within the first 30 seconds, such as at least 15%, such as at least 20%. In some examples, in use, 10 to 20% of the total nicotine content of the smokeless article is released within the first 30 seconds, such as 10 to 15%. Additionally or alternatively, in some cases, in use, at least 50% of the total nicotine content of the smokeless article is released within the first 5 minutes, such as at least 55%, such as 50% to less than 80%. Further additionally or alternatively, in some cases, in use, at least 80% of the total nicotine content of the smokeless article is released within the first 10 minutes, such as at least 90%. In some examples, in use, 80 to 90% of the total nicotine content of the smokeless article is released within the first 10 minutes.
In some examples, in use, at least 10% of the total flavourant content is released within the first 30 seconds, such as at least 15%, such as at least 20%. In some examples, in use, 10 to 20% of the total flavourant content of the smokeless article is released within the first 30 seconds, such as 10 to 15%. Additionally or alternatively, in some cases, in use, at least 50% of the total flavourant content of the smokeless article is released within the first 5 minutes, such as at least 55%, such as50% to less than 80%. Further additionally or alternatively, in some cases, in use, at least 80% of the total flavourant content of the smokeless article is released within the first 10 minutes, such as at least 90%. In some examples, in use, 80 to 90% of the total flavourant content of the smokeless article is released within the first 10 minutes.
Release of nicotine and/or flavour components may be assessed by known procedures. For example, insertion of the smokeless article into artificial saliva and detection of the relevant nicotine and/or flavourant component by standard analytical techniques. Such assessment may be performed at physiological temperature and pH, e.g. 37°C and pH 6.8. Artificial saliva is known and may be prepared by (1) Prepare 1000 mL of distilled water; (2) Add 2 mL of concentrated sulfuric acid to lower the pH to 2.5 or less; (3) Measure out a predetermined amount of the following reagents and dissolve in the above solution. K₂HPO₄.H₂O 0.68 g NaCl (anhydrous) 0.33 g CaCl₂.2H₂O 0.15 g KCI (anhydrous) 0.75 g K₂CO₃ (anhydrous) 0.53 g MgCl₂.6H₂O 0.17 g; (4) Using 5N NaOH, adjust the pH of the solution (25° C) to 6.8±0.1. In some cases the assessment of release may be performed with stirring, e.g. at 60 rpm.
In a second aspect, the present disclosure provides a method of manufacturing a smokeless article for oral delivery. The smokeless article comprising a pouch enclosing a content.
In some examples, the method comprises: (i) providing a hydrophobic content; (ii) enclosing the content in a pouch; and (iii) sealing the pouch. In some examples, the pouch comprises a nicotinic compound. In some examples, after sealing the pouch (step (iii)), the method comprises a step (iv) of applying a nicotinic compound to the pouch. In some examples, the method comprises a step of applying a nicotinic compound to the pouch material before enclosing the content in a pouch (step (ii)).
In this way, a smokeless article in which the transfer of a nicotinic compound from the pouch to the content of the pouch is restricted/prevents is provided. This leads to enhanced user experience as a result of quicker release and greater uptake of the nicotinic compound by the user. Furthermore, the shelf-life of the smokeless article may be improved by restricting migration of the nicotinic compound within the article over time.
In some examples, the content comprises a metallic stearate. In some examples, providing a hydrophobic content comprises blending a metallic stearate with one or more selected from the group of a filler material, flavourant, humectant, sweetener, colourant, pH adjuster and solvent. In some examples, the content resulting from step (i) is isotropic. That is, the components of the content are evenly dispersed (e.g. they may appear to be homogeneously mixed on the macroscopic scale). In some examples, the metallic stearate and the other content components are mixed using a blender or a food processor or similar. In some examples, the metallic stearate and the other content components are mixed in a high-shear mixing apparatus. Suitable mixing apparatus is known to the skilled person. In some examples, the metallic stearate and the other content components are first roughly mixed to disperse the metallic stearate in the other content components, before being blended until the components are thoroughly mixed. In some examples, the components are mixed at high speed to ensure thorough mixing.
In this way, the amount of the content components coated by the metallic stearate is maximised. This leads to greater hydrophobicity of the pouch content, and thus improved restriction/prevention of transfer of the nicotinic compound from the pouch to the content enclosed by the pouch. Therefore, this ultimately leads to enhanced user experience.
Sealing the pouch (step (iii)) may comprise thermally or chemically sealing the pouch material to enclose said contents.
In some examples, the step of applying a nicotinic compound to the pouch comprises spraying the pouch with a nicotinic compound. In this way, a nicotinic compound coating may be provided on the pouch. In some examples, a nicotinic stock solution comprising the nicotinic compound is sprayed on the pouch. Therefore, in some examples, the method also comprises a step of obtaining a nicotinic stock solution. In some examples, the nicotinic stock solution comprises a nicotinic compound and a solvent, such as water. In some examples, the nicotinic stock solution comprises a nicotinic compound, a solvent, and at least one additional substance such as a flavourant, pH adjuster, or sweetener.
Beneficially, spray coating the nicotinic compound on the pouch may provide a more even distribution of the nicotinic compound over the surface of the pouch. This can lead to a more consistent uptake of nicotinic compound by the user, and also a greater and quicker transfer of the nicotinic compound to the user. This results in an improved user experience. Additionally, spray coating may allow for the amount of nicotinic compound applied to the pouch to be more accurately controlled.
Other methods of applying a nicotinic compound to the pouch are known to the skilled person.
In some examples, the method further comprises a step of applying a flavourant to the pouch. In some examples, the step of applying a flavourant to the pouch occurs after sealing the pouch (step (iii)). In some examples, the step of applying a flavourant to the pouch comprises spraying the pouch with a flavourant.
In some examples, the method further comprises a step of modifying the colour of the content by providing coloured particles. In some examples, uncoloured particles are mixed with a colourant to form coloured particles. In some examples, coloured particles having a first colour are mixed with a colourant to provide coloured particles having a second, different colour to the first colour. In some examples, the particles are formed from a coloured material (such as a material which has already been combined with a colourant, or a material which is intrinsically coloured) to form coloured particles directly. For example, the material of the particles may be mixed with a colourant, and the mixture then extruded to form coloured particles.
In some examples, the smokeless article produced by the method is a smokeless article according to the first aspect. Accordingly, in step (i), in some examples, the metallic stearate may be added in an amount of from 0.5 to 10 wt% based on the total weight of the content, such as from 5 to 10 wt%. In some examples, in step (i), a filler material may be added in an amount from 90 to 99.5 wt% based on the total weight of the content.
Other alternatives and optional features described with reference to the first aspect are equally applicable to the second aspect.
In a third aspect, the present disclosure provides a use of a hydrophobic content to restrict transfer of a nicotinic compound from a pouch of a smokeless article for oral delivery to a content enclosed by the pouch.
In other words, the invention provides a use of a hydrophobic content for restricting the migration of a nicotinic compound from a pouch of a smokeless article for oral delivery to a content enclosed by the pouch.
In some examples, the hydrophobic content comprises a metallic stearate. That is, in some examples, the third aspect provides a use of a metallic stearate to restrict transfer of a nicotinic compound from a pouch of a smokeless article for oral delivery to a content enclosed by the pouch, by incorporation of the metallic stearate into the content.
In some examples, the smokeless article for oral delivery is a smokeless article according to the first aspect and/or made by the second aspect. Therefore, any alternatives and optional features described with reference to the first and second aspect are equally applicable to the third aspect.
In a fourth aspect, the present disclosure provides a smokeless article for oral delivery obtained or obtainable by the method of the second aspect.
Any alternatives and optional features described with reference to the first and second aspect are equally applicable to the fourth aspect.
In a fifth aspect, the present disclosure provides a kit comprising a plurality of smokeless articles according to the first aspect, or a plurality of smokeless articles produced according to the second aspect.
In some examples, the kit further comprises a container, wherein the container removably encloses said plurality of smokeless articles.
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.
The preceding summary is provided for purposes of summarizing some examples to provide a basic understanding of aspects of the subject matter described herein. Accordingly, the above-described features should not be construed to narrow the scope or spirit of the subject matter described herein in any way. Moreover, the above and/or proceeding examples may be combined in any suitable combination to provide further examples, except where such a combination is clearly impermissible or expressly avoided. Other features, aspects, and advantages of the subject matter described herein will become apparent from the following text and the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

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

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.

DETAILED DESCRIPTION OF EMBODIMENTS

Before describing several examples implementing the present disclosure, it is to be understood that the present disclosure is not limited by specific construction details or process steps set forth in the following description and accompanying drawings. Rather, it will be apparent to those skilled in the art having the benefit of the present disclosure that the systems, apparatuses and/or methods described herein could be embodied differently and/or be practiced or carried out in various alternative ways.
Unless otherwise defined herein, scientific and technical terms used in connection with the presently disclosed inventive concept(s) shall have the meanings that are commonly understood by those of ordinary skill in the art, and known techniques and procedures may be performed according to conventional methods well known in the art and as described in various general and more specific references that may be cited and discussed in the present specification.
Any patents, published patent applications, and non-patent publications mentioned in the specification are hereby incorporated by reference in their entirety.
All examples implementing the present disclosure can be made and executed without undue experimentation in light of the present disclosure. While particular examples have been described, it will be apparent to those of skill in the art that variations may be applied to the systems, apparatus, and/or methods and in the steps or in the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the inventive concept(s). All such similar substitutions and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the inventive concept(s) as defined by the appended claims.
The use of the term "a" or "an" in the claims and/or the specification may mean "one," as well as "one or more," "at least one," and "one or more than one." As such, the terms "a," "an," and "the," as well as all singular terms, include plural referents unless the context clearly indicates otherwise. Likewise, plural terms shall include the singular unless otherwise required by context.
The use of the term "or" in the present disclosure (including the claims) is used to mean an inclusive "and/or" unless explicitly indicated to refer to alternatives only or unless the alternatives are mutually exclusive. For example, a condition "A or B" is satisfied by any of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).
As used in this specification and claim(s), the words "comprising, "having," "including," or "containing" (and any forms thereof, such as "comprise" and "comprises," "have" and "has," "includes" and "include," or "contains" and "contain," respectively) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.
Unless otherwise explicitly stated as incompatible, or the physics or otherwise of the embodiments, examples, or claims prevent such a combination, the features of examples disclosed herein, and of the claims, may be integrated together in any suitable arrangement, especially ones where there is a beneficial effect in doing so. This is not limited to only any specified benefit, and instead may arise from an "ex post facto" benefit. This is to say that the combination of features is not limited by the described forms, particularly the form (e.g. numbering) of example(s), embodiment(s), or dependency of claim(s). Moreover, this also applies to the phrase "in one embodiment," "according to an embodiment," and the like, which are merely a stylistic form of wording and are not to be construed as limiting the following features to a separate embodiment to all other instances of the same or similar wording. This is to say, a reference to 'an,' 'one,' or 'some' embodiment(s) may be a reference to any one or more, and/or all embodiments, or combination(s) thereof, disclosed. Also, similarly, the reference to "the" embodiment may not be limited to the immediately preceding embodiment. Further, all references to one or more embodiments or examples are to be construed as non-limiting to the claims.
As shown in Figure 1 there is provided a first embodiment of a smokeless article 10 having a pouch 12 containing a content 14. The pouch 12 comprises a nicotinic compound and the content 14 comprises a metallic stearate. The pouch 12 is substantially rectangular. The pouch 12 is formed from a single sheet of material and is substantially filled by the content 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 a content 14. The pouch 12 comprises a nicotinic compound and the content 14 comprises a metallic stearate. The pouch 12 is substantially circular. The pouch 12 is formed from two opposing sheets of material and is substantially filled by the content 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.

Preparation of content formulations

The example formulations were prepared according to the following method.

1. The materials (i.e., the metallic stearate and filler material) were dispensed into appropriately sized beakers using a 2 d.p. balance to determine the weights.
2. The filler material was transferred to a mixer.
3. The metallic stearate was added to the mixer, and all the materials were gently mixed with a spatula to disperse the metallic stearate.
4. The mixture was blended at full speed for approximately 5 minutes.
5. The mixture was removed from the mixer.

Preparation of the nicotinic stock solution for spraying

The example nicotinic stock solution was prepared according to the following method.

1. All the materials described in the table below were dispensed into appropriately sized beakers using a 2 d.p. balance to determine the weights. A larger beaker was used for the nicotine in water since the other materials were transferred into this beaker in the following steps.
2. The nicotine in water was placed on to a magnetic stirrer, and stirred to generate a vortex.
3. The other materials were added to the beaker containing the nicotine in water in the following order: sodium carbonate solution, water, salt, sucralose.
4. The solution was stirred for a further approximately 5 mins (or until the salt had dissolved).

Method for Pouch Spraying

1. Pouches were filled with the content and sealed, before being placed into a can.
2. The nicotinic stock solution, prepared according to the method above, was dispensed into a spray bottle and 1.2g of stock solution sprayed onto the pouch.
3. The can containing the pouch was then sealed and left in a fridge overnight to allow the solution to evenly distribute over the pouch before use.

Example formulations

The example formulations contained the following components.

Formulation 1

Overall Formulation

Material	%w/w
Nicotine	0.50-2.0
Solvent(s)	15-30
Sodium Chloride	0.1-1.0
pH modifier(s)	0.02-0.5
Sweetener(s)	0.01-0.5
Fibrous material(s)	60-80
Magnesium stearate	1-10
TOTAL	100

It should be noted that the overall formulation of Formulation 1 does not contain any flavourant. However, as described above, the smokeless article may comprise a flavourant which may be provided in solid or liquid form.

Pouch Content Composition

Material	Content wt%
Fibrous material(s)	90
Magnesium stearate	10
	100

Nicotinic stock Solution Composition

Material	Stock solution wt%
Nicotine	3-10
Solvent(s)	83-96
Sodium Chloride	0.5-5.0
pH modifier(s)	0.05-1.0
Sweetener(s)	0.01-1.0
	100

In a test where a first set of users were given a smokeless article comprising a pouch filled with Formulation 1 and a second set of users were given a comparative smokeless article comprising a pouch filled with a formulation differing only in the absence of the metallic stearate, the first set of users rated the user experience more positively. In particular, the first set of users experienced increased nicotine perception in terms of speed and strength of delivery.

Comparative Examples

For comparison, other OND compositions comprising other materials as a replacement for the metallic stearate were tested.
The alternative materials that were investigated were stearic acid, sodium stearyl fumarate and fumed silica. However, it was found that none of these materials were able to perform a similar function to the metallic stearate when included in the content (i.e., imparting hydrophobicity).

Example Comparative Pouch Content Composition

Material	Content wt%
Fibrous material(s)	90
Fumed silica	10
	100

Therefore, it was found that stearic acid, sodium stearyl fumarate and fumed silica are not suitable alternatives to metallic stearate and therefore do not result in improved nicotine perception when included in the content of a smokeless article.

Claims

A smokeless article for oral delivery, the article comprising a pouch enclosing a content, wherein the content contains a component which renders the content hydrophobic, and the pouch comprises a nicotinic compound.
A smokeless article according to claim 1, wherein the content which renders the content hydrophobic comprises a metallic stearate.
A smokeless article according to claim 2, wherein the metallic stearate is present in an amount of from 0.5 to 10 wt% based on the total weight of the content,
preferably in an amount of from 5 to 10 wt% based on the total weight of the content.
A smokeless article according to claim 2 or 3, wherein the metallic stearate comprises one or more selected from the group consisting of magnesium stearate, calcium stearate, sodium stearate, and potassium stearate,
preferably wherein the metallic stearate consists of magnesium stearate.
A smokeless article according to any one of claims 1 to 4, wherein the pouch comprises at least 10% of the total nicotine content of the smokeless article.
A smokeless article according to any one of claims 1 to 5, wherein the pouch comprises a nicotinic compound coating.
A smokeless article according to any one of claims 1 to 6, wherein the content is substantially free from nicotine.
A smokeless article according to any one of claims 1 to 7, wherein the pouch comprises a flavourant.
A smokeless article according to claim 8, wherein the pouch comprises at least 10% of the total content of the said flavourant in the smokeless article.
A smokeless article according to any one of claims 1 to 9, wherein in use at least 10% of the total nicotine and/or flavourant content of the smokeless article is released within the first 30 seconds.
A method for manufacturing a smokeless article for oral delivery, the method comprising:
(i) providing a hydrophobic content;

(ii) enclosing the content in a pouch; and

(iii) sealing the pouch;
wherein
a. the pouch comprises a nicotinic compound; or

b. after sealing, the method comprises a step of applying a nicotinic compound to the pouch.
The method of claim 11, wherein the content comprises a metallic stearate as a hydrophobic component.
A method of manufacturing a smokeless article according to claim 11 or 12, wherein the step of applying a nicotinic compound to the pouch comprises spraying the pouch with a nicotinic compound solution.
A method of manufacturing a smokeless article according to any one of claims 11 to 13, further comprising, after sealing, a step of applying a flavourant to the pouch,
optionally wherein the flavourant is applied by spraying the pouch with a flavourant.
Use of a hydrophobic content to restrict transfer of a nicotinic compound from a pouch of a smokeless article for oral delivery to the content enclosed by the pouch.