EP4670519A1

EP4670519A1 - SMOKE-FREE ITEM

Info

Publication number: EP4670519A1
Application number: EP24185528.7A
Authority: EP
Inventors: designation of the inventor has not yet been filed The
Original assignee: Imperial Tobacco Ltd United Kingdom
Current assignee: Imperial Tobacco Ltd United Kingdom
Priority date: 2024-06-28
Filing date: 2024-06-28
Publication date: 2025-12-31
Also published as: WO2026003335A1

Abstract

The present invention relates to a smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising a nicotinic compound, a first filler material, and a second filler material, the first filler material consisting of polymeric and/or wax microspheres, the second filler material consisting of a fibrous powder, and the ratio by weight of the first filler material to the second filler material being between 1:1 and 6:1. A method of manufacturing the article and kits comprising the article are also described.

Description

FIELD

The present disclosure relates to a smokeless article. In particular, the disclosure relates to a smokeless article for oral consumption comprising a pouch enclosing a content which comprises a nicotinic compound for oral delivery. This disclosure also relates to methods of manufacturing the smokeless article.

BACKGROUND

Smokeless articles are a suitable alternative to conventional cigarettes because they do not require heating for substance delivery to the user. Instead, smokeless articles rely on saliva to extract soluble substances, typically nicotine and/or flavours, from the content contained within the smokeless article.
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.
The above-described extraction and delivery process continues until the soluble element is depleted from the smokeless article. The smokeless article is then removed from the mouth and disposed of.
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 consumption.
The present disclosure provides, in a first aspect, a smokeless article for oral consumption comprising a pouch enclosing a content, e.g., an oral nicotine delivery (OND) formulation.
The content comprises a nicotinic compound, a first filler material, and a second filler material.
The first filler material consists of microspheres. The microspheres are polymeric and/or wax microspheres. That is, the microspheres may comprise or consist of a polymer, a wax, or a polymeric wax.
The second filler material consists of a fibrous powder.
The ratio by weight of the first filler material to the second filler material is between 1:1 and 6:1.
Without being bound by any theory, it is thought that the polymeric and/or wax microspheres improve nicotine perception due to their morphology and the features associated with such a morphology. For example, microspheres often possess a high specific surface area and a generally smooth surface, and they may have a low water holding capacity. However, using polymeric and/or wax microspheres as the sole filler material may result in a less desirable mouth-feel due to a grainy texture. Inclusion of a fibrous powder as a second filler material may improve the mouth-feel, e.g. by filling spaces surrounding the microspheres whilst maintaining the positive effect of improved nicotine perception. The present inventors have found that a ratio of between 1:1 and 6:1 by weight of the polymeric and/or wax microspheres to the fibrous powder results in a good balance between nicotine perception and mouthfeel.
In a second aspect, the present disclosure provides a method of manufacturing a smokeless article for oral consumption comprising a pouch enclosing a content.
The method comprises the steps: (i) mixing a first filler material and a second filler material in a ratio by weight of between 1:1 and 6:1, to form a premixture; (ii) adding a nicotinic compound to the premixture to form the content; (iii) adding the content to the pouch or forming the pouch around the content. The first filler material consists of polymeric and/or wax microspheres and the second filler material consists of a fibrous powder.
The smokeless article in the above method may be a smokeless article according to the first aspect.
In a third aspect, the present disclosure provides a use of a combination of polymeric and/or wax microspheres and a fibrous powder, in a ratio by weight of between 1:1 and 6:1, in a smokeless article for oral consumption to improve nicotine perception, and/or improve mouthfeel.
In a fourth aspect, the present disclosure provides a kit comprising a plurality of smokeless articles according to the first aspect and a container.
As used herein, the term "oral consumption" is intended to refer to any oral administration route achieved by placing the smokeless article into the oral cavity. This includes, but is not limited to, buccal, sub-lingual, periodontal, gingival and ingestion.
The smokeless article may be an oral nicotine delivery (OND) article when the active agent within the content comprises a nicotinic compound.
In some examples, the active agent comprises or consists of an active compound. In some examples the active agent comprises or consists of a nicotinic compound.
The smokeless article comprises a pouch enclosing a content, wherein the content (including e.g. a nicotinic compound and first and second filler materials) 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 60 minutes, such as about 25 minutes to 50 minutes or about 30 minutes to about 45 minutes, after being placed in the mouth. As used herein, the term "active lifetime" is intended to refer to the amount of time after being placed in the mouth that the smokeless article provides the user with a perceptible taste and/or physiological experience. For example, for an article containing an active ingredient such as nicotine or other pharmacologically active ingredient the active lifetime may be defined as the in use period of time in which 90%wt of the available pharmacologically active is released. In other words, the active lifetime may be the duration of time from insertion into the oral cavity for 90%wt of the total amount of nicotine pharmacologically active ingredient that is capable of being released during normal use to dissolve into the user's saliva and /or enter the user's bloodstream. It will therefore be appreciated that the active lifetime of a product may vary from user to user and for a user based on oral conditions, in particular extent of salivation. Nonetheless, the skilled person is able to mimic oral conditions to determine the active lifetime in one instance, which can be used as a comparison or analysis point.
The pouch may be formed from one or more materials. The pouch material may be formed from fiber, paper, cloth and fabric. The pouch material may be formed from one or more polymeric materials. The polymeric material may be selected from one or more of hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol (PVOH), polyvinylpyrrolidone (PVP), polyethylene oxide (PEO), hydroxyethyl cellulose (HEC), polyethylene glycol (PEG), pullulan, sodium alginate, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, maltodextrin, methylmethacrylate copolymer, carboxyvinyl copolymers, starch, and gelatin.
The pouch is typically completely insoluble in saliva. Suitable insoluble pouch materials include, but are not limited to, fiber, paper, water-insoluble polymers, cloth, and fabric. Suitable soluble pouch materials include, but are not limited to, water-soluble polymers such as polyethylene oxide (PEO), hydroxypropyl cellulose (HPC), and hydroxypropyl methylcellulose (HPMC).
The pouch may be formed by, for example, folding a single sheet on itself or bringing two or more sheets together and sealing the edges. The edges may initially be partially sealed to provide an open pouch in which the content (e.g. 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 50 µm to 200 µm, such as 100 µm to 175 µm, or 125 µm to 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 active agent comprises or consists of a nicotinic compound.
The nicotinic compound may be selected from nicotine, nicotine salt(s), nicotine complex(es); and nicotine solvate(s).
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 content comprises a nicotinic compound (e.g. nicotine) in an amount of from 0.3 wt% to 2 wt%, for example from 0.4 wt% to 2 wt%, from 0.5 wt% to 2 wt%, from 0.5 wt% to 1.9 wt%, from 0.8 wt% to 1.8 wt%, from 1 wt% to 1.6 wt%, from 1.2 wt% to 1.6 wt%, or from 1.3 wt% to 1.5 wt%, based on the total weight of the content.
In some examples, the total nicotinic compound (e.g. nicotine) content per pouch is from 4 to 15 mg. In some examples, the nicotinic compound content per pouch is about 7-10 mg, for example the nicotinic compound content per pouch is about 8 mg.
In some examples, the amount of water in the content is from 30 wt% to 60 wt%, for example from 35 wt% to 60 wt%, from 40 wt% to 60 wt%, from 40 wt% to 55 wt%, from 40 wt% to 50 wt%, or from 42 wt% to 50 wt% based on the total weight of the content. In some examples, the amount of water in the content is from 42 wt% to 48 wt%, based on the total weight of the content.
The content may comprise one or more additional substance. Each additional substance may individually be a biologically/pharmacologically active compound, humectants, flavourants, fillers, preservatives, aqueous/non-aqueous solvents and binders. Each additional substance may be provided for more than one purpose.
The contents of the pouch (i.e. the ingredients, material and/or substances enclosed within the pouch) preferably occupies substantially all of the internal volume of the pouch. The contents may occupy 80%, 85%, 90%, 95% or 100% of the internal volume of the pouch. The contents may comprise a solid material to provide physical integrity, such as an organic material (e.g. plant material) or an inorganic material. Such solid materials may naturally or inherently contain one or more biologically/pharmacologically active compounds and/or additives.
Biologically/pharmacologically active compounds are provided to produce a pharmacological effect in the user. Suitable biologically/pharmacologically active compounds include the group consisting of: nicotine, cocaine, caffeine, opiates and opioids, cathine and cathinone, kavalactones, mysticin, beta-carboline alkaloids, salvinorin A, together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing. Biologically/pharmacologically active compounds may also have additive properties.
In some embodiments the content includes an active compound comprising nicotine and wherein the form of nicotine is selected from the group consisting of nicotine salts, nicotine base, stabilized nicotine and mixtures thereof. For example, the content may include at least one nicotine salt selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine ditartrate, nicotine ditartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate and mixtures thereof.
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. Preferably the solvent is water.
Filler materials are included in the content of smokeless articles according to the present disclosure. 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 also impacts 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".
Specifically, the content according to the present disclosure comprises a first filler material and a second filler material in a ratio by weight of between 1:1 and 6:1. The first filler material consists of polymeric and/or wax microspheres. The second filler material consists of a fibrous powder.
The ratio by weight of the first filler material to the second filler material is between 1:1 and 6:1. For example, the ratio is between 1:1 and 5:1, between 2:1 and 6:1, between 2:1 and 5:1, between 2:1 and 4:1, between 2.5:1 and 4.5:1, between 2:1 and 3:1, or between 3:1 and 4:1. In some examples, the ratio is between 2:1 and 4:1. In some examples, the ratio is about 2:1. In some examples, the ratio is about 3:1. In some examples, the ratio is about 4:1. In some examples, the ratio is about 5:1.
For example, the ratio by weight of the first filler material to the second filler material is 1:1 or more, 1.5:1 or more, 2:1 or more, 2.25:1 or more, 2.5:1 or more, 2.75:1 or more, 3:1 or more, 3.25:1 or more, 3.5:1 or more, 3.75:1 or more, 4:1 or more, 4.5:1 or more, or 5:1 or more.
For example, the ratio by weight of the first filler material to the second filler material is 6:1 or less, 5:1 or less, 5.5:1 or less, 4.5:1 or less, 4:1 or less, 3.75:1 or less, 3.5:1 or less, 3.25:1 or less, 3:1 or less, 2.75:1 or less, 2.5:1 or less, 2.25:1 or less, or 2:1 or less.
In some examples, the average aspect ratio of the second filler material is larger than the average aspect ratio of the first filler material. The average aspect ratio is the median aspect ratio of a projection image of a sample of the particles.
In some examples, the content comprises a third filler material consisting of a plant fibre. For example, the plant fibre may be bamboo fibre or wheat fibre.
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%.
The first filler material consists of microspheres. The microspheres are polymeric and/or wax microspheres. In some examples, the microspheres are polymeric microspheres or wax microspheres. In some examples, the microspheres are polymeric microspheres. In some examples, the microspheres are wax microspheres. Microspheres are approximately spherical particles with diameters ranging from about 1 µm to about 1000 µm. The microspheres may be insoluble in water. The microspheres are food-grade and/or biocompatible. The microspheres may be relatively smooth on their surface, i.e. they have a low surface roughness.
The microspheres may be polymeric microspheres, for example they comprise or consist of a polymer. For example, the microspheres are made from a polymer. The polymer may be a synthetic polymer, a biopolymer, or a bio-derived polymer. For example, the polymer may be a biopolymer or a bio-derived polymer. For example, a biopolymer may be collagen, actin, fibrin, starch (e.g., corn starch), cellulose, alginate, gelatin, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, or polyhydroxyalkanoate (PHA), for example cellulose. For example, a bio-derived polymer may be microcrystalline cellulose (MCC), hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), hydroxyethyl cellulose (HEC), poly(lactic acid) (PLA), maltodextrin, poly(glycolic acid) (PGA), poly(ε-caprolactone), or polybutylene succinate (PBS), for example MCC. For example, a synthetic polymer may be a polymeric wax, polyvinylpyrrolidone (PVP), polyethylene oxide (PEO), or polyethylene glycol (PEG), for example a polymeric wax. In some examples, the microspheres are cellulosic, i.e. the microspheres are made of cellulose or derived from cellulose (e.g. to form MCC). The polymer may be a copolymer, such as a block copolymer, a graft copolymer, an alternating copolymer, a periodic copolymer, or a statistical copolymer. The polymer may be branched or linear.
In some examples, the polymer is cellulosic. Cellulosic means the polymer is cellulose or cellulose-derived (e.g. made by processing or modifying cellulose). In some examples, the polymer is microcrystalline cellulose (MCC). In some examples, the first filler material consists of MCC microspheres. Suitable MCC microspheres include "VIVAPUR^® MCC SPHERES" manufactured by JRS Pharma, in particular those of Grade 100, Grade 200, Grade 350, Grade 500 and Grade 700.
MCC microspheres have a low water holding capacity (WHC) due to their high specific surface area and surface smoothness. This contributes to improved release of nicotine, and hence improved nicotine perception in the user of the smokeless article. A "low water holding capacity" may be, for example, 140 %WHC or lower, where WHC is measured as the mass of water held by a material (for 10 minutes) divided by the mass of the dry material, expressed as a percentage.
MCC may be prepared by processing cellulose (e.g. wood pulp) with a strong acid (i.e., acid hydrolysis). MCC is also known as "refined cellulose" since it is obtained by refining wood pulp. The terms "microcrystalline cellulose" and "cellulose powder" or "powdered cellulose" are often used interchangeably in the art since they are both processed cellulose. In some cases, MCC refers to chemically processed cellulose whereas powdered cellulose or cellulose powder refers to mechanically processed cellulose. In some cases, powdered cellulose or cellulose powder refers to MCC powder.
The microspheres may be wax microspheres, for example they may comprise or consist of a wax. For example, the microspheres may be made from a wax. The wax may be natural or synthetic. In some examples, the wax is 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, and combinations thereof. In some examples, the wax is or comprises paraffin wax. In some examples, the wax is a polymeric wax.
The first filler material may consist of a combination of two or more types of microspheres.
The microspheres may have a coating. The coating may be a sugar (e.g. sucrose). For example, the microspheres may made of a starch (e.g. corn starch) with a sugar (e.g. sucrose) coating.
When the microspheres consist of polymeric microspheres and wax microspheres, they may consist of a mixture of polymeric microspheres and wax microspheres where the polymeric and wax microspheres are distinct. Alternatively, the polymeric and wax microspheres may be the same in the case of a polymeric wax.
IThe microspheres may have a monodisperse size distribution. For example, a monodisperse diameter distribution. In some examples, the first filler material has a monomodal diameter distribution.
In some examples, the microspheres have an average diameter (d50) of 50 µm to 1000 µm, for example 50 µm to 700 µm. In some examples, the average diameter (d50) is 100 µm or more, 125 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, 355 µm or more, 400 µm or more, 450 µm or more, 500 µm or more, 550 µm or more, 600 µm or more, 700 µm or more, 800 µm or more, or 900 µm or more. In some examples, the average diameter (d50) is 1000 µm or less, 900 µm or less, 800 µm or less, 750 µm or less, 715 µm or less, 710 µm or less, 700 µm or less, 600 µm or less, 500 µm or less, 450 µm or less, 400 µm or less, 375 µm or less, 355 µm or less, 350 µm or less, 325 µm 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, or 150 µm or less.
In some examples, the microspheres have an average diameter (d50) of 200 µm or more. In some examples, the microspheres have an average diameter (d50) of 355 µm or less.
In some examples, the microspheres have an average diameter (d50) of 100 µm to 750 µm. In some examples, the average diameter (d50) is 100 µm to 600 µm. In some examples, the average diameter (d50) is 100 µm to 500 µm. In some examples, the average diameter (d50) is 100 µm to 400 µm. In some examples, the average diameter (d50) is 100 µm to 300 µm. In some examples, the average diameter (d50) is 100 µm to 200 µm. In some examples, the average diameter (d50) is 150 µm to 350 µm. In some examples, the average diameter (d50) is 200 µm to 400 µm. In some examples, the average diameter (d50) is 200 µm to 355 µm. In some examples, the average diameter (d50) is 200 µm to 350 µm. In some examples, the average diameter (d50) is 200 µm to 300 µm.
In some examples, the microspheres have an average diameter (d50) of about 100 µm, 150 µm, 200 µm, 250 µm, 300 µm, 350 µm, or 400 µm. For example, about 200 µm or about 250 µm.
In some examples, the microspheres have a specific surface area of between 0.01 m²/g and 0.50 m²/g. In some examples, the specific surface area is between 0.01 m²/g and 0.40 m²/g. In some examples, the specific surface area is between 0.01 m²/g and 0.30 m²/g. In some examples, the specific surface area is between 0.03 m²/g and 0.30 m²/g. In some examples, the specific surface area is between 0.05 m²/g and 0.30 m²/g. In some examples, the specific surface area is between 0.05 m²/g and 0.20 m²/g. In some examples, the specific surface area is between 0.10 m²/g and 0.20 m²/g. In some examples, the specific surface area is between 0.05 m²/g and 0.15 m²/g. In some examples, the specific surface area is between 0.08 m²/g and 0.13 m²/g. In some examples, the specific surface area is about 0.08 m²/g, 0.09 m²/g, 0.10 m²/g, 0.11 m²/g, 0.12 m²/g, or 0.13 m²/g, for example about 0.11 m²/g.
As noted above, the microspheres may not be perfectly spherical. In some examples, the microspheres have a sphericity of between 0.70 and 1. For example, the microspheres may have a sphericity of between 0.75 and 1, between 0.80 and 1, between 0.85 and 1, or between 0.90 and 1. In some examples, the microspheres have a sphericity of between 0.70 and 0.95. For example, the microspheres may have a sphericity of between 0.75 and 0.95, between 0.80 and 0.95, between 0.85 and 0.95, or between 0.90 and 0.95. In some examples, the microspheres have a sphericity of about 0.80 ± 0.05, 0.85 ± 0.05, 0.90 ± 0.05, or 0.95 ± 0.05, for example about 0.90 ± 0.05.
Reference to "sphericity" herein refers to the volume-based sphericity of all measured particles (SPHT₃) as known to the skilled person. SPHT₃ is given by SPHT₃ = 4πA/P², where P is the measured circumference of a particle projection and A is the measured area covered by a particle projection, where the particle projection is obtained using scanning electron microscopy or optical microscopy.
In some examples, the first filler material is contained in an amount by weight, based on the total weight of the content, of between 5 wt% and 75 wt%. In some examples, the amount of the first filler material is 5 wt% or more, 10 wt% or more, 15 wt% or more, 20 wt% or more, 25 wt% or more, 30 wt% or more, 35 wt% or more, 40 wt% or more, or 45 wt% or more. In some examples, the amount of the first filler material is 26 wt% or more, 27 wt% or more, 28 wt% or more, 29 wt% or more, 30 wt% or more, 31 wt% or more, 32 wt% or more, 33 wt% or more, 34 wt% or more, or 35 wt% or more.
In some examples, the amount of the first filler material is 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 amount of the first filler material is 39 wt% or less, 38 wt% or less, 37 wt% or less, 36 wt% or less, 35 wt% or less, 34 wt% or less, 33 wt% or less, or 32 wt% or less.
In some examples, the first filler material is contained in an amount by weight, based on the total weight of the content, of between 10 wt% and 65 wt%, between 10 wt% and 50 wt%, between 15 wt% and 45 wt%, between 15 wt% and 40 wt%, between 20 wt% and 45 wt%, between 20 wt% and 40 wt%, between 25 wt% and 40 wt%, between 25 wt% and 35 wt%, between 30 wt% and 40 wt%, or between 35 wt% and 40 wt%. In some examples, the amount of the first filer material by weight, based on the total weight of the content, is between 28 wt% and 38 wt%, for example between 30 wt% and 38 wt%, between 30 wt% and 36 wt%, between 31 wt% and 36 wt%, between 32 wt% and 38 wt%, between 33 wt% and 38 wt%, between 34 wt% and 38 wt%, between 34 wt% and 37 wt%, or between 35 wt% and 37 wt%.
In some examples, the first filler material is contained in an amount by weight, based on the total weight of the content, of about 31 wt%, about 32 wt%, about 33 wt%, about 34 wt%, about 35 wt%, about 36 wt%, about 37 wt%, about 38 wt%, about 39 wt% or about 40 wt%, for example about 36 wt%.
The second filler material consists of a fibrous powder. A fibrous powder is a powdered material composed essentially or completely of fibres. The fibrous powder may comprise or consist of particles made of a fibrous material. For example, the particles may be fibres, pellets, grains or granules. The fibrous powder may be insoluble in water. The fibrous powder is food-grade and/or biocompatible.
The fibrous powder may be naturally-occurring (e.g., a powdered plant fibre), bio-derived, or synthetic. In some examples, it is naturally-occurring or bio-derived, for example bio-derived. For example, a naturally-occurring fibrous powder 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 second filler material may consist of a combination of two or more fibrous powders.
In some examples, the fibrous powder is cellulosic. Cellulosic fibres means fibres made of cellulose (e.g. powdered cellulose) or derived from cellulose (e.g. to form MCC). In some examples, the second filler material comprises or consists of MCC powder and/or powdered cellulose. Suitable cellulosic powder includes MMC powder "VIVAPUR^® MCC" manufactured by JRS Pharma, or powdered cellulose "VlTACEL^® EPG70" manufactured by JRS Pharma.
As used herein, the term "particle size" when referring to particles such as 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.
In some examples, the second filler material has a monomodal particle size distribution.
In some examples, the second filler material has a particle size of 50 µm or more and 700 µm or less. In some examples, the particle size is 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, 375 µm or more, 400 µm or more, 450 µm or more, 500 µm or more, or 600 µm or more. In some examples, the particle size is 600 µm or less, 500 µm or less, 450 µm or less, 425 µm or less, 400 µm or less, 375 µm or less, 350 µm or less, 325 µm 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, or 150 µm or less.
In some examples, the second filler material has a particle size of 100 µm to 600 µm. In some examples, the second filler material has a particle size of 100 µm to 500 µm. In some examples, the second filler material has a particle size of 100 µm to 400 µm. In some examples, the second filler material has a particle size of 100 µm to 300 µm. In some examples, the second filler material has a particle size of 100 µm to 200 µm. In some examples, the second filler material has a particle size of 200 µm to 400 µm. In some examples, the second filler material has a particle size of 200 µm to 300 µm. In some examples, the second filler material has a particle size of 225 µm to 275 µm. In some examples, the second filler material has a particle size of 175 µm to 225 µm. In some examples, the second filler material has a particle size of 150 µm to 250 µm. In some examples, the second filler material has a particle size of 300 µm to 400 µm.
In some examples, the second filler material has 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 second filler material has a particle size of about 200 µm. In some examples, the second filler material has a particle size of about 250 µm. In some examples, the second filler material has a particle size of about 300 µm.
In some examples, the second filler material has a monomodal particle size distribution.
In some examples, the second filler material has a particle size which is smaller than the average diameter (d50) of the first filler material. In some examples, the second filler material has a particle size which is similar to the average diameter (d50) of the first filler material. In some examples, the second filler material has a particle size which is larger than the average diameter (d50) of the first filler material.
In some examples, the second filler material has a broader size distribution than the first filler material. In some examples, the particles of the second filler material are less uniform than the microspheres of the first filler material. The particles which make up the fibrous powder are generally less spherical than the microspheres of the first filler material. In some examples, the particles of the second filler material are not spherical. In some examples, the fibrous powder comprises irregularly shaped particles. In some examples, the fibrous powder comprises elongate particles. In some examples, the particles of the second filler material do not have smooth surfaces.
In some examples, the first filler material consists of MCC microspheres, and the second filler material consists of MCC powder and/or powdered cellulose.
In some examples, the fibrous powder comprises nicotine-dosed fibres. 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 glycerine. In some embodiments, 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%.
In some examples, the second filler material is contained in an amount by weight, based on the total weight of the content, of between 0.5 wt% and 50 wt%. In some examples, the amount of the second filler material is 1 wt% or more, 2 wt% or more, 5 wt% or more, 10 wt% or more, 15 wt% or more, 20 wt% or more, 25 wt% or more, 30 wt% or more, 35 wt% or more, or 40 wt% or more. In some examples, the amount of the second filler material is 4 wt% or more, 5 wt% or more, 6 wt% or more, 7 wt% or more, 8 wt% or more, 9 wt% or more, 10 wt% or more, 11 wt% or more, 12 wt% or more, 13 wt% or more, 14 wt% or more, 15 wt% or more, 16 wt% or more, 17 wt% or more, 18 wt% or more, 19 wt% or more, or 20 wt% or more.
In some examples, the amount of the second filler material is 45 wt% or less, 40 wt% or less, 35 wt% or less, 30 wt% or less, 25 wt% or less, 20 wt% or less, 15 wt% or less, 10 wt% or less, 5 wt% or less, or 2 wt% or less. In some examples, the amount of the second filler material is 19 wt% or less, 18 wt% or less, 17 wt% or less, 16 wt% or less, 15 wt% or less, 14 wt% or less, 13 wt% or less, 12 wt% or less, 11 wt% or less, 9 wt% or less, or 8 wt% or less.
In some examples, the second filler material is contained in an amount by weight, based on the total weight of the content, of about 10 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt% or about 20 wt%, for example about 12 wt%.
The third filler material consists 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. The plant fibre is essentially or completely water-insoluble. In some examples, the plant fibre comprises elongate fibres. The third filler material 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, and 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.
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 such as JELUCEL^® BF fibres sold by Jelu-werk, 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" refers 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, or may be prepared by grinding or milling plant material until fibres of the required particle size are obtained.
In some examples, the third filler material consists of one or more non-tobacco plant fibres. In some examples, the third filler 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 smokeless article is free of tobacco. The presence of tobacco may affect the considerations relating to shelf-life and nicotine absorption so for some properties, behaviour relating to non-tobacco formulations may differ from that for formulations containing tobacco, or containing tobacco at a level greater than 5 wt%.
In some examples, the plant fibre 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 embodiments, 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%.
In some examples, the plant fibre is powdered. In some examples, the plant fibre is not powdered.
The plant fibres 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 450 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 plant fibres have a particle size of about 30 µm. In some examples, the plant fibres have a particle size of about 40 µm. In some examples, the plant fibres have a particle size of about 50 µm.
In some examples, the plant fibres 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 plant fibres have a particle size of about 300 µm. In some examples, the plant fibres have a particle size of about 250 µm. In some examples, the plant fibres have a particle size of about 200 µm.
In some examples, the plant fibres 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 plant 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 embodiments, the plant fibres have a particle size of 30 to 300 µm.
In some embodiments, the plant fibres have a larger particle size than the fibrous powder of the second filler material. In some embodiments, the plant fibres have a larger particle size than the average diameter (d50) of the microspheres of the first filler material. In some embodiments, the plant fibres have a smaller particle size than the fibrous powder of the second filler material. In some embodiments, the plant fibres have a smaller particle size than the average diameter (d50) of the microspheres of the first filler material.
In some examples, the amount of the third filler material is 10 wt% or less based on the total weight of the content of the pouch. By containing the third filler material in this amount, it is possible to achieve a more desirable balance between nicotine perception and mouthfeel. For example, the amount of the third filler material is 8 wt% or less, 7 wt% or less, 6 wt% or less, 5 wt% or less, 4 wt% or less, 3 wt% or less, 2 wt% or less, or 1 wt% or less. In some examples, the amount is 5 wt% or less.
In some examples, the amount of the third filler material is 0.1 wt% or more based on the total weight of the content of the pouch. For example, the amount of the third filler material is 0.2 wt% or more, 0.25 wt% or more, 0.5 wt% or more, 0.75 wt% or more, 1 wt% or more, 1.5 wt% or more, 2 wt% or more, 2.5 wt% or more, 3 wt% or more, or 4 wt% or more. In some examples, the amount is 0.25 wt% or more. In some examples, the amount is 1 wt% or more.
In some examples, the amount of the third filler material is between 0.1 wt% and 5 wt% based on the total weight of the content of the pouch. In some examples, the amount is between 0.25 wt% and 4 wt%. In some examples, the amount is between 0.25 wt% and 3 wt%. In some examples, the amount is between 0.5 wt% and 2 wt%.
In some examples, the amount of the third filler material is about 0.25 wt% based on the total weight of the content of the pouch. In some examples, the amount of the third filler material is about 0.5 wt%. In some examples, the amount of the third filler material is about 1 wt%. In some examples, the amount of the third filler material is about 1.5 wt%. In some examples, the amount of the third filler material is about 2 wt%.
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.
In some examples, 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.
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.
Flavourants may be provided in solid or liquid form. Suitable flavourants include coffee, eucalyptus, menthol, liquorice, peppermint, spearmint, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour. The flavourant may be evenly dispersed throughout the contents or may be provided in isolated locations and/or varying concentrations throughout the contents.
As used herein, the term "flavourant" denotes a compound having a desirable taste, aroma or both.
In some examples, the content comprises one or more flavourants (e.g. peppermint flavour) in an amount of from above 0 wt% to 10 wt%, for example from 1 wt% to 10 wt%, from 1 wt% to 8 wt%, from 1 wt% to 6 wt%, from 2 w% to 8 wt%, from 2 wt% to 7 wt%, or from 3 wt% to 7 wt% based on the total weight of the content.
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 70% by weight of the contents, such as at most 65 wt%, such as at most 60 wt%, or such as at most 20 wt%, such as at most 10 wt%, such as at most 5 wt%, such as at most 2 wt%.
In some examples, the amount of humectant is 1 to 70 wt% of the contents, such as 10 to 60 wt% or 50 to 60 wt%.
In some examples, the content has an overall amount of water of between 5 and 60 wt% based on the weight of the contents such as between 40 and 60 wt%, or between 50 and 60 wt%, for example between 52 and 60 wt%.
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.
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.
In some examples, the content comprises a sweetener (e.g. acesulfame K) in an amount of from 0 wt% to 1 wt%, for example from 0.01 wt% to 1 wt%, from 0.01 wt% to 0.5 wt%, from 0.01 wt% to 0.2 wt%, from 0.01 wt% to 0.1 wt%, from 0.05 wt% to 0.2 wt%, or from 0.05 wt% to 0.15 wt% based on the total weight of the content.
The amount of sweetener may have a lower limit of at least 0.01 % by weight of the content such as at least 0.02 wt%, such as at least 0.03 wt%, such as at least 0.04 wt%, such as at least 0.05 wt%, or such as least 0.06 wt%.
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.
Binders may be provided. Suitable binders include starches and/or cellulosic binders such as methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose and carboxymethyl cellulose, gums such as xanthan, guar, arabic and/or locust bean gum, organic acids and their salts such as alginic acid (sodium alginate), agar and pectins. In some embodiments the binder content is 5 to 10 wt% of the contents, e.g. around 6 to 9 wt% or 7 to 8 wt%.
Colourants may be provided to modify the user impression of the smokeless article. Colourants include whitening agents. Colourants may be selected from one or more of common colourants such as curcumin (E100), turmeric (E100(ii)), riboflavin (E101), riboflavin-5'-phosphate (E101(ii)), tartrazine (E102), quinoline yellow (E104), riboflavin-5-sodium phosphate (E106), yellow 2G (E107), sunset yellow FCF (E110), carmine, cochineal (E120), azorubine (E122), amaranth (E123), ponceau 4R (E124), erythrosine (E127), red 2G (E128), allura red AC (E129), patent blue V (E131), indigotine (E132), brilliant blue FCF (E133) chlorophylls (E140), copper complexes of chlorophyll (E141), green S (E142), caramel (E150a-d), brilliant black BN (E151), carbon (E153), brown FK (E154), brown HT (E155), alfa-, beta- and gamma- carotene (E160a), annatto, bixin, norbixin (E160b), bell pepper (Paprika) extract (E160c), lycopene (E160d), beta- apo-8'-carotenal (E160e), ethyl ester of beta-apo-8'-carotenic acid (E160f), flavoxanthin (E161a), lutein (E161b), cryptoxanthin (E161c), rubixanthin (E161d), violaxanthin (E161e), rhodoxanthin (E161f), canthaxanthin (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 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%.
A second aspect of the disclosure is a process of manufacturing the smokeless article according to the first aspect, comprising the steps of:

(i) mixing a first filler material and a second filler material in a ratio by weight of between 1:1 and 6:1, to form a premixture;
(ii) adding a nicotinic compound to the premixture to form the content; and
(iii) adding the content to the pouch or forming the pouch around the content.

The first filler material and the second filler material are as described in the first aspect.
Optionally, the method may include adding further additives to the premixture and/or the content. The additives may include, but are not limited to, one or more selected from: a third filler material, pH modifiers, flavourants, humectants, sweeteners, stabilisers, binders, and colourants.
A third aspect of the disclosure is the use of a combination of microspheres and a fibrous powder, in a ratio by weight of between 1:1 and 6:1, in a smokeless article for oral consumption to improve nicotine perception, and/or improve mouthfeel; optionally wherein the smokeless article is according to first aspect.
A fourth aspect of the disclosure is a kit comprising a plurality of smokeless articles according to the first aspect and a container.
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.
Figure 4 shows a cross sectional view of a fourth embodiment of a smokeless article.

DETAILED DESCRIPTION OF EMBODIMENTS

As shown in Figure 1 there is provided a first embodiment of a smokeless article 10 having a pouch 12 containing contents 14. The pouch 12 is substantially rectangular. The pouch 12 is formed from a single sheet of material and is substantially filled by the contents 14. The pouch 12 has a seal 16 along each of the three edges where the inner face of the single sheet meets itself to seal the contents 14 in the pouch 12.
Figure 2 shows a second embodiment of a smokeless article 10' having a pouch 12 containing contents 14. The pouch 12 is substantially circular. The pouch 12 is formed from two opposing sheets of material and is substantially filled by the contents 14. The pouch has a circumferential seal 16 along the edges where the two opposing sheets of material meet to seal the contents 14 in the pouch 12.
Figure 3 shows a third embodiment of a smokeless article 10" that, like the first embodiment, has a pouch 12 made from a single sheet of material. However, one of the three seals 16' is formed by an overlap of the inner face and the outer face of the single sheet meet to seal the contents 14 in the pouch 12. The remaining two seals at opposing ends of the pouch 12 are formed where the inner face of the single sheet meets itself.
Figure 4 shows a fourth embodiment of a smokeless article 10‴ that comprises the third embodiment enclosed by outer pouch 12" having an outer contents 14" positioned in the space between the inner pouch 12' and the outer pouch 12". The outer pouch 12" also has a circumferential seal 16‴ to seal the outer contents 14" and inner pouch 12' in the outer pouch 12".
Use of the fourth embodiment begins when the smokeless article 10‴ is placed in the user's mouth where it is exposed to saliva. Saliva first permeates outer pouch 12" and dissolves and extracts the saliva soluble substances of outer contents 14". Upon leaving the outer pouch 12", the saliva soluble substances of outer contents 14" therefore provide the user with a first experience. Saliva subsequently further permeates the inner pouch 12' where it dissolves and extracts the saliva soluble substances of inner contents 14'. The saliva soluble substances of inner contents 14' therefore provide the user with a complimentary and secondary experience. When the extractable amount of saliva soluble substances in the inner contents 14' and outer contents 14" drops below perceivable levels the active lifetime of the smokeless article 10‴ has ended.
Before describing 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.

EXAMPLES

Preparation of formulations

The example formulations were prepared according to the following method.

1. All the materials were dispensed into appropriately sized beakers using a 2 d.p. balance to determine the weights.
2. All the powdered materials were added into a food processor and mixed for approximately 1-2 mins at full speed.
3. The sodium carbonate was premixed with the flavourant and sweetener premix and gently swirled by hand for approx. 1 min.
4. The food processor was started at full speed again, then the solution prepared in step 3 above was added over the course of 2-3 mins.
5. The food processor was stopped and the nicotine in water was added.
6. The food processor was started at full speed again for 2-3 mins.
7. The sample was then removed from the food processor.

Example formulations

The example formulations contained the following components.

Formulation 1

Material	Purpose	%w/w
Nicotine (Active premix)	Active agent	1.40
Water (Active premix)	Solvent for nicotine	6.38
Water	Solvent	33.00
MCC microspheres (MCC 200 Spheres)	First filler material	31.60
cellulose powder (VITACEL EPG 70)	Second filler material	17.02
Bamboo fibre (BF-300)	Third filler material	0.25
Sodium Chloride	Buffer	2.00
Sodium Carbonate (premix)	pH regulator	0.06
Water (premix)	Solvent for sodium carbonate	0.29
Xylitol	Cooling sensate	4.00
Flavourant	Flavour extract	3.50
Sweetener (premix)	Sweetener	0.10
Water (premix)	Solvent for sweetener	0.40
	Total	100.00

The MCC microspheres were obtained from JRS Pharma, sold as VIVAPUR^® MCC SPHERES Grade 200 ("MCC200 Spheres"). The microspheres have a diameter between 200 µm and 355 µm (> 85%).
The cellulose powder was obtained from JRS Pharma, sold as VITACEL^® EPG 70. The powder has a particle size of approximately 300 µm.
The bamboo fibre was obtained from Jelu-werk, sold as JELUCEL^® BF-300 ("BF-300"). The fibre has a median particle size between 32 and 100 µm, and a maximum fibre length of approximately 300 µm.
A smokeless article comprising a pouch filled with Formulation 1 provided excellent nicotine perception and a desirable mouthfeel.

Claims

A smokeless article for oral consumption comprising a pouch enclosing a content, the content comprising a nicotinic compound, a first filler material, and a second filler material, wherein
the first filler material consists of polymeric and/or wax microspheres,

the second filler material consists of a fibrous powder, and

the ratio by weight of the first filler material to the second filler material is between 1:1 and 6:1.
The smokeless article according to claim 1, wherein the microspheres are cellulosic microspheres.
The smokeless article according to claim 1 or 2, wherein the microspheres are microcrystalline cellulose (MCC) microspheres.
The smokeless article according to any preceding claim, wherein the microspheres have an average diameter (d50) of 50 µm or more and 700 µm or less.
The smokeless article according to any preceding claim, wherein the average diameter (d50) of microspheres is 200 µm or more.
The smokeless article according to any preceding claim, wherein the average diameter (d50) of the microspheres is 400 µm or less.
The smokeless article according to any preceding claim, wherein the microspheres have a specific surface area of between 0.05 m²/g and 0.30 m²/g.
The smokeless article according to any preceding claim, wherein the first filler material is contained in an amount by weight, based on the total weight of the content, of between 20 wt% and 45 wt%.
The smokeless article according to any preceding claim, wherein the ratio by weight of the first filler material to the second filler material is between 1:1 and 3:1.
The smokeless article according to any preceding claim, wherein the fibrous powder is a cellulosic powder, optionally selected from MCC powder and powdered cellulose.
The smokeless article according to any preceding claim, wherein the fibrous powder has a particle size between 100 µm and 600 µm.
The smokeless article according to any preceding claim, wherein the content further comprises a third filler material consisting of a plant fibre, optionally wherein the plant fibre is wheat fibre or bamboo fibre.
The smokeless article according to claim 12, wherein the third filler material is contained in an amount of up to 5 wt% based on the total weight of the content.
A method of manufacturing a smokeless article for oral consumption comprising a pouch enclosing a content, the method comprising the steps:
(i) mixing a first filler material and a second filler material in a ratio by weight of between 1:1 and 6:1, to form a premixture;

(ii) adding a nicotinic compound to the premixture to form the content;

(iii) adding the content to the pouch or forming the pouch around the content;
wherein the first filler material consists of polymeric and/or wax microspheres and the second filler material consists of a fibrous powder; and

optionally wherein the smokeless article is according to any one of claims 1 to 13.
Use of a combination of polymeric and/or wax microspheres and a fibrous powder, in a ratio by weight of between 1:1 and 6:1, in a smokeless article for oral consumption to improve nicotine perception, and/or improve mouthfeel; optionally wherein the smokeless article is according to any one of claims 1 to 13.
A kit comprising a plurality of smokeless articles according to any one of claims 1 to 13 and a container.