EP4661701A1

EP4661701A1 - Aerosol-generating material comprising a water-insoluble active substance and methods for manufacturing the same

Info

Publication number: EP4661701A1
Application number: EP24704753.3A
Authority: EP
Inventors: Walid Abi Aoun; Barry DIMMICK; Oriol STROPHAIR
Original assignee: Nicoventures Trading Ltd
Current assignee: Nicoventures Trading Ltd
Priority date: 2023-02-10
Filing date: 2024-02-09
Publication date: 2025-12-17
Also published as: GB202301944D0; WO2024165717A1; TW202510756A

Abstract

The present invention relates to aerosol-generating materials comprising a water-insoluble active substance and to methods for manufacturing the same. The aerosol-generating materials are in the form of one or more beads.

Description

Aerosol-generating material comprising a water-insoluble active substance and methods for manufacturing the same

Technical Field

The present invention relates to aerosol-generating materials comprising a waterinsoluble active substance and to methods for manufacturing the same. The aerosolgenerating materials are in the form of one or more beads.

Background

Aerosol generating materials comprising water-soluble active agents, such as nicotine and tobacco extracts, are known. However, frequently the conventional manufacturing methods for such aerosol-generating materials are not appropriate for water-insoluble active agents.

Summary

According to a first aspect of the present invention, there is provided an aerosolgenerating composition comprising one or more beads comprising an aerosolgenerating material comprising a water-insoluble active substance, a filler and an aerosol-former material.

In some embodiments, the water-insoluble active substance is a constituent, derivative or extract of cannabis.

In some embodiments, the constituent, derivative or extract of cannabis is a cannabinoid.

In some embodiments, the cannabinoid is selected from cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A). In some embodiments, the cannabinoid is cannabidiol.

In some embodiments, the aerosol-generating composition comprises from about 0.1 to about 50 wt% of the active substance calculated on a dry weight basis. In some embodiments, the aerosol-former material comprises, or is, one or more of glycerol, propylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, 1,3-butylene glycol, erythritol, meso-Erythritol, ethyl vanillate, ethyl laurate, a diethyl suberate, triethyl citrate, triacetin, a diacetin mixture, benzyl benzoate, benzyl phenyl acetate, tributyrin, lauryl acetate, lauric acid, myristic acid, and propylene carbonate.

In some embodiments, the aerosol-former material comprises or is glycerol or a combination of glycerol and propylene glycol.

In some embodiments, the aerosol-generating composition comprises from about 10 to about 50 wt% aerosol-former material calculated on a dry weight basis.

In some embodiments, the filler is one or more selected from the group consisting of: inorganic filler materials, such as calcium carbonate, perlite, vermiculite, diatomaceous earth, colloidal silica, magnesium oxide, magnesium sulphate, magnesium carbonate, and suitable inorganic sorbents, such as molecular sieves; and organic filler materials such as wood pulp; tobacco pulp; hemp fibre; starch and starch derivatives, such as maltodextrin; chitosan; and cellulose and cellulose derivatives, such as ground cellulose, microcrystalline cellulose and nanocrystalline cellulose.

In some embodiments, the aerosol-generating composition comprises from about 5 to about 75 wt% filler calculated in a dry weight basis.

In some embodiments, the aerosol-generating material further comprises a binder.

In some embodiments, the binder comprises or is one or more compounds selected from: polysaccharide binders, such as alginates, pectins, starches or derivatives thereof, cellulose or derivatives thereof, pullulan, carrageenan, agar and agarose; gelatin; gums, such as xanthan gum, guar gum and acacia gum; silica or silicone compounds, such as PDMS and sodium silicate; clays, such as kaolin; and polyvinyl alcohol. In some embodiments, the polysaccharide binder is selected from the group consisting of alginate and a cellulose derivative, and/or wherein the cellulose derivative is selected from hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethylcellulose (CMC), hydroxypropyl methylcellulose (HPMC), methyl cellulose, ethyl cellulose, cellulose acetate (CA), cellulose acetate butyrate (CAB), and cellulose acetate propionate (CAP). In some embodiments, the aerosol-generating composition comprises from about 0.1 to about 12 wt% binder calculated in a dry weight basis.

In some embodiments, the aerosol-generating composition comprises one or more beads comprising a second aerosol-generating material. In some embodiments, the second aerosol-generating material comprises one or more active substance selected from the group consisting of: nutraceuticals; nootropics; psychoactives; and constituents, derivatives or extracts of tobacco or another botanical, such as nicotine, caffeine, taurine, theine, vitamins such as B6 or B12 or C, melatonin, and constituents or derivatives thereof.

In some embodiments, the aerosol-generating composition further comprises a flavour or sensate.

In some embodiments, the beads comprising the aerosol-generating materials have the same or substantially the same diameters.

In some embodiments, the beads comprising the aerosol-generating materials have different diameters.

According to a second aspect of the present invention, there is provided a consumable for use in a non-combustible aerosol provision device, the consumable comprising the aerosol-generating composition according to the first aspect.

In some embodiments, the consumable comprises a cartridge or chamber comprising the aerosol-generating composition.

According to a third aspect of the present invention, there is provided a noncombustible aerosol provision system comprising a consumable according to the second aspect and a non-combustible aerosol provision device.

According to a fourth aspect of the present invention, there is provided a method for preparing an aerosol-generating composition according to the first aspect, wherein the beads comprising aerosol-generating material are formed by extrusion.

In some embodiments, the method comprises dissolving the water-insoluble active substance in the aerosol-former material prior to extrusion. In some embodiments, the extruded material is dried and broken into beads.

In some embodiments, the extruded material is spheronised.

In some embodiments, the extruded material is dried at a temperature of no higher than 65°C.

Brief Description of the Drawings

Embodiments of the invention will now be described, by way of example only, with reference to accompanying drawing, in which:

Figure 1 is a side-on cross-sectional view of a consumable comprising aerosol generating material according to the invention; and

Figure 2 is a perspective illustration of a non-combustible aerosol provision device for generating aerosol from the aerosol-generating material of the consumable shown in Figure 1.

Detailed Description

The present invention seeks to provide an aerosol-generating composition comprising one or more beads comprising an aerosol-generating material comprising a waterinsoluble active substance, a filler and an aerosol-former material.

Conventional manufacturing methods used to generate aerosol-generating materials have been developed to include water-soluble active substances, such as nicotine or tobacco extracts. Therefore, the methods often include the formulation of waterbased compositions and this causes issues when water-insoluble active substances are included. Specifically, the water-insoluble active substance does not mix uniformly with the other components of the material, leading to an inconsistent product with varying amounts of the active substance. This, in turn, will produce an inconsistent and unpredictable aerosol or vapour when heated. This is unacceptable.

To ensure that the water insoluble active agent is incorporated into the aerosol generating material in a uniform and predictable matter, the aerosol generating material must comprise components that are compatible with the water-insoluble active substance and may be combined to form a stable and coherent composition in which the active substance is uniformly distributed.

Properties of the beads In some embodiments, the that may be generally spheroid in shape. In some embodiments, the beads have a substantially smooth surface morphology.

In some embodiments, at least about 90% of the beads have a diameter in the range of from about 0.3 mm to about 5 mm. Optionally, the diameter may be at least about 0.3 mm, at least 0.4 mm, at least about 0.5 mm, at least about 0.7 mm, at least about 1 mm, at least about 1.5 mm, at least about 2 mm, at least about 2.5 mm, at least about 3 mm, at least about 3.5 mm, at least about 4 mm or at least about 4.5 mm. Alternatively or additionally, the diameter is no greater than about 5 mm, no greater than about 4.5 mm, no greater than about 4 mm, no greater than about 3.5 mm, no greater than about 3 mm, no greater than about 2.5 mm, no greater than about 2 mm, no greater than about 1.5 mm, no greater than about 1 mm, or no greater than about 0.5 mm. In some embodiments, the beads have a mean diameter of from about 2.5 to about 3 mm.

Beads with a smaller diameter have a greater surface area to volume ratio and they may therefore exhibit more rapid release of components upon heating compared to beads with a larger diameter.

In some embodiments, the size of the beads is selected to provide a desired release profile of one of more components upon heating. In general, beads with a smaller diameter or size will release components more quickly upon use and for a shorter period of time. Beads with a larger diameter or particle size will release components more gradually and for a longer period. In some embodiments, beads of different sizes may be selected and combined to provide a release profile that starts rapidly upon commencement of use and continues over an extended period of use.

In some embodiments, it may be desirable for the beads to have an average particle size or diameter of no greater than about 5 mm, of no greater than 4 mm, of no greater than about 3 mm, or of no greater than about 2 mm, when measured by sieving. In some embodiments, the beads have a diameter of from about 2 to about 3 mm. This may be assessed by sieving or by measurement using a QuickScope™ instrument for approximating the diameter of a roughly spherical form.

In some embodiments, the beads have a volume in the range of from about 0.015 to about 66 mm³. In some embodiments, the beads have a mean volume of at least about 0.015 mm³, at least about 0.02 mm³, at least about 0.1 mm³, at least about 0.5 mm³, at least about 1 mm³, at least about 5 mm³, at least about 10 mm³, at least about 20 mm³, at least about 30 mm³, at least about 40 mm³, at least about 50 mm³, or at least about 60 mm³. Additionally or alternatively, the beads have a mean volume of no greater than about 66 mm³, no greater than about 60 mm³, no greater than about 50 mm³, no greater than about 40 mm³, no greater than about 30 mm³, no greater than about 20 mm³, no greater than about 10 mm³, no greater than about 5 mm³, no greater than about 1 mm³, no greater than about 0.5 mm³, no greater than about 0.2 mm³, no greater than about 0.1 mm³, or no greater than about 0.05 mm³.

In some embodiments, the beads have a bulk density in the range of from about 0.5 to about 1.5 g/cm³. In some embodiments, the shaped particles have a bulk density of at least about 0.5 g/cm³, at least about 0.6 g/cm³, at least about 0.7 g/cm³, and/or a bulk density of no greater than about 1.5 g/cm³, no greater than about 1.4 g/cm³, no greater than about 1.3 g/ cm³, no greater than about 1.2 g/ cm³, or no greater than about 1.1 g/cm³. In some embodiments, the beads have a bulk density of from about 0.5 to about 1 g/cm³, or from about 0.7 to about 0.8 g/cm³.

The chemical makeup of the beads will be controlled by the chemical makeup of the formulation used to form them. The selection of compatible components and combining them in a suitable process will allow the components to be homogenously distributed with the resultant beads. In particular, the beads of the present invention will include the water-insoluble active substance evenly distributed throughout each bead.

In some embodiments, the beads have a residual moisture content of greater than 7% and no more than 12%. In some embodiments, the residual moisture may be from about 8% to about 10%.

The water content of the shaped particles described herein may vary according to, for example, the temperature, pressure and humidity conditions at which the particles are maintained. The water content can be determined by Karl-Fisher analysis or by gas chromatography-thermal conductivity detector (GC-TCD), as known to those skilled in the art.

Active Substance

In some embodiments, the insoluble active substance is a constituent, derivative or extract of cannabis. In some embodiments, the constituent, derivative or extract of cannabis is a cannabinoid. Cannabinoids are lipid-soluble, hydrophilic molecules that are insoluble or poorly soluble in water. As such, inclusion of cannabinoids in conventional aerosol generating materials can be challenging as it is difficult to solubilise them into a form suitable for incorporation into material. Cannabinoids are quick to recrystallize when in an aqueous environment and so the aerosol-generating material must be formulated and prepared in the absence of any significant amount of water.

As used herein, any compound or mixture of compounds which may be obtained from cannabis may be a constituent, derivative or extract thereof, including synthetic versions of such compound(s) or such compound(s) derived from other natural sources.

In some embodiments the constituent, derivative or extract of cannabis comprises, or is, one or more compounds selected from: cannabinoids (such as phytocannabinoids that may optionally be THC and/or CBD); terpenes (such as triterpenes); alkaloids; and flavonoids.

In some embodiments the constituent, derivative or extract of cannabis comprises one or more compounds selected from: cannabinoids (such as phytocannabinoids) and terpenes (such as triterpenes).

In some embodiments the constituent, derivative or extract of cannabis comprises one or more cannabinoids, such as phytocannabinoids.

Cannabinoids are a class of natural or synthetic chemical compounds which act on cannabinoid receptors (i.e., CB1 and CB2) in cells that repress neurotransmitter release in the brain. Cannabinoids may be naturally occurring (phytocannabinoids) from plants such as cannabis, from animals (endocannabinoids), or artificially manufactured (synthetic cannabinoids). Cannabis species express at least 85 different phytocannabinoids, and are divided into subclasses, including cannabigerols, cannabichromenes, cannabidiols, tetrahydrocannabinols, cannabinols and cannabinodiols, and other cannabinoids. Cannabinoids found in cannabis include, without limitation: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetra hydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A).

In some embodiments, the cannabinoids are phytocannabinoids.

In some embodiments, the terpenes are triterpenes.

In particular embodiments, the constituent, derivative or extract of cannabis comprises, or is, tetrahydrocannabinol (THC) and/or cannabidiol (CBD).

In some embodiments, the constituent, derivative or extract of cannabis comprises, or is, THC.

In particular embodiments, the constituent, derivative or extract of cannabis comprises, or is, CBD.

In some embodiments, the constituent, derivative or extract of cannabis is present in the precursor composition and/or the extruded composition in an amount of from about 0.1 to about 50% by weight, based on the total weight of the composition. In some embodiments, the constituent, derivative or extract of cannabis is present in the composition in an amount of at least about 0.1%, at least about 0.2%, at least about 0.3%, at least about 0.4%, at least about 0.5%, at least about 0.6%, at least about 0.7%, at least about 0.8%, at least about 0.9%, at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 10%, at least about 15%, at least about 20%, of at least about 25%, at least about 30%, at least about 35%, at least about 40%, or at least about 45% by weight of the total composition. Alternatively or additionally, the constituent, derivative or extract of cannabis is present in the precursor composition and/or the extruded composition in an amount of no more than about 50%, no more than about 45%, no more than about 40%, no more than about 35%, no more than about 30%, no more than about 25%, no more than about 20%, no more than about 15%, no more than about 10%, no more than about 5%, no more than about 1%, no more than about 0.5%, or no more than about 0.1% by weight, based on the total weight of the composition.

Aerosol-former material

The aerosol-former material may comprise one or more constituents capable of forming an aerosol. The aerosol-former material may be, for instance, a polyol aerosol generator or a non-polyol aerosol generator. It may be a solid or liquid at room temperature, but preferably is a liquid at room temperature. In some embodiments, the aerosol-former material may comprise one or more of glycerine, glycerol, propylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, 1,3-butylene glycol, erythritol, meso-Erythritol, ethyl vanillate, ethyl laurate, a diethyl suberate, triethyl citrate, triacetin, a diacetin mixture, benzyl benzoate, benzyl phenyl acetate, tributyrin, lauryl acetate, lauric acid, myristic acid, and propylene carbonate.

In some embodiments, the aerosol-former material comprises one or more polyhydric alcohols, such as propylene glycol, triethylene glycol, 1,3-butanediol and glycerin; esters of polyhydric alcohols, such as glycerol mono-, di- or triacetate; and/or aliphatic esters of mono-, di- or polycarboxylic acids, such as dimethyl dodecanedioate and dimethyl tetradecanedioate. In some embodiments, the aerosol-former material comprises one or more compounds selected from erythritol, propylene glycol, glycerol, vegetable glycerine (VG), triacetin, sorbitol and xylitol. In some embodiments, the aerosol-former material comprises, consists essentially of, or consists of, glycerol. In a preferred embodiment, the aerosol-former material consists of glycerol.

A combination of aerosol-former materials may be used, in equal or differing proportions.

At least one of the aerosol-former materials is a liquid within which the water-soluble active substance is miscible or soluble. This means that the water-insoluble active substance may be uniformly distributed in the aerosol-generating material.

In some embodiments, the aerosol-generating material comprises from about 10 to about 50 wt% aerosol-former material calculated on a dry weight basis. In some embodiments, the aerosol-generating material comprises aerosol-former material in an amount of at least about 10 wt%, at least about 15 wt%, at least about 20 wt%, at least about 25 wt%, at least about 30 wt%, at least about 35 wt%, at least about 40 wt%, or at least about 45 wt% on a dry weight basis. Additionally or alternatively, the aerosol-generating material comprises aerosol-former material in an amount of up to about 50 wt%, up to about 45 wt%, up to about 40 wt%, up to about 35 wt%, up to about 30 wt%, up to about 25 wt%, or up to about 20 wt% on a dry weight basis. In some embodiments, the aerosol-generating material comprises from about 20 to about 40 wt% aerosol-former material on a dry weight basis.

Filler The aerosol-generating material further comprises a filler. This will generally be a solid material having an appropriate particle size. In some embodiments, the filler is in the form of a fine powder, optionally having a mean particle size within the range of from about 0.3 to about 2 mm.

In some embodiments, the filler is one or more selected from the group consisting of: inorganic filler materials, such as calcium carbonate, perlite, vermiculite, diatomaceous earth, colloidal silica, magnesium oxide, magnesium sulphate, magnesium carbonate, and suitable inorganic sorbents, such as molecular sieves; and organic filler materials such as wood pulp; tobacco pulp; hemp fibre; starch and starch derivatives, such as maltodextrin; chitosan; and cellulose and cellulose derivatives, such as ground cellulose, microcrystalline cellulose and nanocrystalline cellulose. In some embodiments, the filler is one or more selected from wood pulp and ground cellulose.

In some embodiments, the aerosol-generating material comprises from about 5 to about 75 wt% filler calculated in a dry weight basis. In some embodiments, the aerosol-generating material comprises filler in an amount of at least about 5 wt%, at least about 10 wt%, at least about 15 wt%, at least about 20 wt%, at least about 25 wt%, at least about 30 wt%, at least about 35 wt%, at least about 40 wt%, or at least about 45 wt%, at least about 50 wt%, at least about 55 wt%, at least about 60 wt%, or at least about 65 wt%, or at least about 70 wt% on a dry weight basis. Additionally or alternatively, the aerosol-generating material comprises filler in an amount of up to about 75 wt%, up to about 70 wt%, up to about 65 wt%, up to about 60 wt%, up to about 55 wt%, up to about 50 wt%, up to about 45 wt%, up to about 40 wt%, up to about 35 wt%, up to about 30 wt%, up to about 25 wt%, up to about 20 wt%, up to about 15 wt%, or up to about 10 wt% on a dry weight basis. In some embodiments, the aerosol-generating material comprises from about 10 to about 60 wt% or from about 20 to about 40 wt% filler on a dry weight basis.

Binder

In some embodiments, the aerosol-generating material does not comprise a binder. In such embodiments, the manufacturing process may be sufficient to bind or fuse together the components of the aerosol-generating material, including the liquid and solid components discussed above.

In other embodiments, the aerosol-generating material comprises a binder. The binder may be one or more compounds selected from: polysaccharide binders, such as alginates, pectins, starches or derivatives thereof, cellulose or derivatives thereof, pullulan, carrageenan, agar and agarose; gelatin; gums, such as xanthan gum, guar gum and acacia gum; silica or silicone compounds, such as PDMS and sodium silicate; clays, such as kaolin; and polyvinyl alcohol.

In some embodiments, the polysaccharide binder is selected from the group consisting of alginate and a cellulose derivative, and/or wherein the cellulose derivative is selected from hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethylcellulose (CMC), hydroxypropyl methylcellulose (HPMC), methyl cellulose, ethyl cellulose, cellulose acetate (CA), cellulose acetate butyrate (CAB), and cellulose acetate propionate (CAP).

In some embodiments, the aerosol-generating material comprises from about 0.1 to about 12 wt% binder calculated in a dry weight basis. In some embodiments, the aerosol-generating material comprises binder in an amount of at least about 0.1 wt%, at least about 0.5 wt%, at least about 1 wt%, at least about 1.5 wt%, at least about 2 wt%, at least about 3 wt%, at least about 4 wt% on a dry weight basis, at least about 5 wt%, at least about 6 wt%, at least about 7 wt%, at least about 8 wt%, at least about 9 wt%, at least about 10 wt%, at least about 11 wt%, or at least about 12 wt%,. Additionally or alternatively, the aerosol-generating material comprises binder in an amount of up to about 12 wt%, up to about 11 wt%, up to about 10 wt%, up to about 9 wt%, up to about 8 wt%, up to about 7 wt%, up to about 6 wt%, up to about 5 wt%, up to about 4.5 wt%, up to about 4 wt%, up to about 3.5 wt%, up to about 3 wt%, up to about 2.5 wt%, up to about 2 wt%, up to about 1.5 wt%, up to about 1 wt%, up to about 0.5 wt%, or up to about 0.2 wt% on a dry weight basis. In some embodiments, the aerosol-generating material comprises from about 1 to about 8 wt% binder on a dry weight basis.

Flavours

In some embodiments, the beads and/or the precursor composition further comprise one or more flavours.

As used herein, the terms "flavour" and "flavourant" refer to materials which, where local regulations permit, may be used to create a desired taste, aroma or other somatosensorial sensation in a product for adult consumers. They may include naturally occurring flavour materials, botanicals, extracts of botanicals, synthetically obtained materials, or combinations thereof (e.g., tobacco, cannabis, licorice (liquorice), hydrangea, eugenol, Japanese white bark magnolia leaf, chamomile, fenugreek, clove, maple, matcha, menthol, Japanese mint, aniseed (anise), cinnamon, turmeric, Indian spices, Asian spices, herb, Wintergreen, cherry, berry, red berry, cranberry, peach, apple, orange, mango, clementine, lemon, lime, tropical fruit, papaya, rhubarb, grape, durian, dragon fruit, cucumber, blueberry, mulberry, citrus fruits, Drambuie, bourbon, scotch, whiskey, gin, tequila, rum, spearmint, peppermint, lavender, aloe vera, cardamom, celery, cascarilla, nutmeg, sandalwood, bergamot, geranium, khat, naswar, betel, shisha, pine, honey essence, rose oil, vanilla, lemon oil, orange oil, orange blossom, cherry blossom, cassia, caraway, cognac, jasmine, ylang-ylang, sage, fennel, wasabi, piment, ginger, coriander, coffee, hemp, a mint oil from any species of the genus Mentha, eucalyptus, star anise, cocoa, lemongrass, rooibos, flax, ginkgo biloba, hazel, hibiscus, laurel, mate, orange skin, rose, tea such as green tea or black tea, thyme, juniper, elderflower, basil, bay leaves, cumin, oregano, paprika, rosemary, saffron, lemon peel, mint, beefsteak plant, curcuma, cilantro, myrtle, cassis, valerian, pimento, mace, damien, marjoram, olive, lemon balm, lemon basil, chive, carvi, verbena, tarragon, limonene, thymol, camphene), flavour enhancers, bitterness receptor site blockers, sensorial receptor site activators or stimulators, sugars and/or sugar substitutes (e.g., sucralose, acesulfame potassium, aspartame, saccharine, cyclamates, lactose, sucrose, glucose, fructose, sorbitol, or mannitol), and other additives such as charcoal, chlorophyll, minerals, botanicals, or breath freshening agents. They may be imitation, synthetic or natural ingredients or blends thereof. They may be in any suitable form, for example, liquid such as an oil, solid such as a powder.

In some embodiments, the flavour comprises menthol, spearmint and/or peppermint. In some embodiments, the flavour comprises flavour components of cucumber, blueberry, citrus fruits and/or redberry. In some embodiments, the flavour comprises eugenol. In some embodiments, the flavour comprises flavour components extracted from tobacco. In some embodiments, the flavour comprises flavour components extracted from cannabis.

In some embodiments, the flavour may comprise a sensate, which is intended to achieve a somatosensorial sensation which are usually chemically induced and perceived by the stimulation of the fifth cranial nerve (trigeminal nerve), in addition to or in place of aroma or taste nerves, and these may include agents providing heating, cooling, tingling, numbing effect. A suitable heat effect agent may be, but is not limited to, vanillyl ethyl ether and a suitable cooling agent may be, but not limited to eucalyptol, WS-3. In some embodiments, the flavour is included in an amount of from about 0.1 to about 5 wt%, or from about 1 to about 2 wt% on a wet weight basis.

Where a hydrophilic flavour is included in the precursor composition, it may be necessary to also include a surfactant or emulsifier to allow the formation of a stable water-in-oil emulsion.

Extrusion

According to some embodiments of the present invention, the one or more beads comprising an aerosol-generating material are formed by extrusion. This method of manufacturing is particularly useful as it does not require the addition of significant amounts of water in order to combine the components. By avoiding the inclusion of large amounts of water during the preparation of the beads of aerosol-generating material, the distribution of the water-insoluble active substance can be better controlled to provide a homogenous distribution of the active substance in the beads and a predictable and consistent content of active substance.

In some embodiments, the water-insoluble active substance is pre-mixed with a compatible liquid component in which the active substance is miscible or soluble. Preferably, this compatible liquid component does not comprise water. In some embodiments, the liquid component comprises a liquid aerosol-former material, such as glycerol. Alternatively or additionally, the liquid component comprises a solvent within which the water-insoluble active substance is soluble, such as a lipid-based solvent.

Such embodiments may be particularly suitable where the water-insoluble active substance is a liquid at room temperature or where the water-insoluble active substance is readily dissolved in an aerosol-former material.

The uniform liquid mixture comprising the water-insoluble active substance is then blended with the solid components of the aerosol-generating material to form a precursor composition which is extruded. The precursor composition may further include a small amount of water, for example to assist the extrusion and or to activate any binders present. In some embodiments, the water content of the precursor composition may be as high as about 30% or about 20%.

In an alternative approach, the water-insoluble active substance is in solid form and particles of the active substance are mixed with the other solid components of the aerosol-generating material to form a blend that is then mixed with any liquid component, such as any liquid aerosol-forming material, to form a precursor composition which is extruded. The precursor composition may further include a small amount of water, for example to assist the extrusion and or to activate any binders present. In some embodiments, the water content of the precursor composition may be as low as about 10% or even about 4%.

Extrusion involves the feeding of the precursor composition through an orifice to produce an extruded agglomerate. The process applies pressure to the precursor composition combined with shear forces. In some embodiments, the extrusion process also involves elevated temperatures.

Extrusion may be performed using one of the main classes of extruders: screw, sieve and basket, roll, ram and pin barrel extruders. A single screw or twin-screw extruder may be used.

The solid components of the precursor composition may be pre-mixed. In some embodiments, the size of the particles of the solid components prior to extrusion is no greater than about 1000 pm, or no greater than about 800 pm.

The homogenously mixed liquid components are added to the precursor composition to be extruded. The solid and liquid components may be mixed thoroughly before being extruded. The liquid component, in addition to including the active substance, may act as a processing aid to assist dissolution or solubilisation of components of the precursor composition, to improve the homogeneity of the resultant extruded composition or to aid binding or agglomeration.

The extrusion of the precursor composition will disperse the water-insoluble active substance and liquid aerosol former material within the composition. Such dispersion may provide a homogenous mixture of the components within the extruded product, thereby ensuring that the beads formed have a consistent make-up and produce a predictable and consistent aerosol upon heating.

The temperature and pressure exerted on the composition as it is extruded may also cause some solid components, including any solid water-insoluble active substance, to become molten, thus helping to distribute these components and to fuse the particulate material together. Fusion of solid particles in the precursor composition as a result of the extrusion may be enhanced by any binder that is present in the precursor composition. Liquid components may also contribute to fusion.

In some embodiments, during extrusion the precursor composition is exposed to elevated pressure and temperature and is forced though an orifice, such as a shaping nozzle or die, to form an extruded composition. In some embodiments, the extruded composition has a string, strand or rod-like form and/or may be cut into segments of a desired length as it exits the orifice or later to provide segments of desired length.

In some embodiments, the precursor composition is exposed to temperatures from about 40°C to about 200°C, or from about 80°C to about 130°C, or from about 60°C to about 95°C within the extruder. In some embodiments, including those using double extrusion, the precursor composition is exposed to temperatures from about 70°C to about 95°C within the extruder. In some embodiments, including those using single extrusion, the precursor composition is exposed to temperatures from about 60°C to about 80°C within the extruder. Individuals skilled in the art carefully balance component stability and temperature. It is often desirable to heat components to a molten state but for less stable components this is sometimes avoided.

The precursor composition may be exposed to pressures (immediately before the die or nozzle) ranging from about 2 bar to about 100 bar, or from about 5 bar to about 60 bar, depending on the design of the die or nozzle being used. Pressures significantly higher than 100 bar may also be used in some embodiments.

In some embodiments, the extrusion process is a hot melt extrusion process. The process involves the application of heat, pressure and agitation to mix materials together and force them through a die. High shear hot melt extruders blend materials and break up particles.

The extruded agglomerate will be shaped by the nozzle or die through which it is forced. In some embodiments, the extruded agglomerate is cut into pieces of desired length. The pieces formed in this way may be used directly as an aerosol generating material. Alternatively, the pieces may undergo further processing, such as spheronisation.

In some embodiments, the nozzle or die is shaped to provide a solid strand of extruded composition. For example, the extruded composition may have the form of a solid cylindrical rod. Alternatively, the extruded composition may have different cross-sectional shapes, including oval, polygonal (such as triangular, square, etc.), and stars.

In some embodiments, the extruded composition is formed into a desired shape selected to enhance or promote the release of the one or more constituent, derivative or extract of cannabis, for example by providing a form having a large surface area per unit volume. This large surface area may be provided on the outer surface of the extruded composition, for example by selecting cross-sectional shapes with large perimeter. Alternatively or in addition, the large surface area may be provided through the creation of channels within the extruded composition.

In some embodiments, the nozzle is shaped to provide an extruded agglomerate with inner channels. These inner channels provide further surface area and can enhance release of the one or more constituent, derivative or extract of cannabis, and other component of the composition.

By means of various nozzle or die designs and/or different process parameters within the extruder, including the temperature, pressure and shear forces, extruded compositions with different physical properties may be prepared, including different dissolution and release properties.

In some embodiments, the extruded composition is shaped upon discharge from the extruder. In some embodiments, the extruded composition is cut to an initial length, for example 1 metre, and allowed to cool before then being cut into sections of the desired length to provide pieces or particles of the desired dimensions.

In some embodiments, the extruded composition may be cooled just before or just as it leaves the extruder. In some embodiments, the cooling is intensive and involves exposing the extruded composition, which will be at an elevated temperature, for example from about 30°C to about 100°C, or from about 40°C to about 70°C, to a cooling means that will reduce the temperature to within a range of from about 0°C to about 70°C, from about 0°C to about 50°C, from about 5°C to about 25°C or from about 5°C to about 15°C. This rapid cooling of the extruded composition may enhance the internal and external stability of the extruded composition. In some embodiments, it is the nozzle or die that is cooled to achieve this effect. In some embodiments, it may be desirable to control the temperature of the precursor composition during extrusion, including before feeding the composition through the nozzle or die. This is especially the case where the precursor composition includes temperature sensitive components. Thus, in some embodiments, extrusion of the precursor composition includes reducing the temperature of the precursor composition before it reaches the nozzle or die. Such cooling of the precursor composition may result in the formation of an extruded composition with beneficial properties, or may improve the strand-shaping process, for example where channels are to be formed within the extruded strand.

In some embodiments, spheronisation is used to further process extruded segments or pellets. These segments are typically cylindrically-shaped and are cut or broken into uniform lengths following extrusion. They are then gradually transformed into spherical shapes by spheronisation. This shaping occurs as a result of plastic deformation and spheronisation can lead to spherical agglomerated structures, often with a nearly uniform diameter.

In some embodiments, the extruded composition will be milled and/or spheronised to produce particles that will flow freely, for example to allow them to be fed into a pouch. The optimal particle size distribution for good flowability has an approximate D90 of 500 pm or 200 pm.

Aerosol generating material

The beads of the present invention may be used as an aerosol-generating material. An aerosol-generating material is a material that is capable of generating aerosol, for example when heated, irradiated or energized in any other way.

In some embodiments, the aerosol-generating material is for use in a "noncombustible" aerosol provision system. According to the present disclosure, a "non-combustible" aerosol provision system is one where a constituent aerosolgenerating material of the aerosol provision system (or component thereof) is not combusted or burned in order to facilitate delivery of at least one substance to a user.

In some embodiments, the delivery system is a non-combustible aerosol provision system, such as a powered non-combustible aerosol provision system. In some embodiments, the non-combustible aerosol provision system is an electronic cigarette, also known as a vaping device or electronic nicotine delivery system (END), although it is noted that the presence of nicotine in the aerosolgenerating material is not a requirement.

In some embodiments, the non-combustible aerosol provision system is an aerosol-generating material heating system, also known as a heat-not-burn system. An example of such a system is a tobacco heating system.

In some embodiments, the non-combustible aerosol provision system is a hybrid system to generate aerosol using a combination of aerosol-generating materials, one or a plurality of which may be heated. Each of the aerosol-generating materials may be, for example, in the form of a solid, liquid or gel and may or may not contain nicotine. In some embodiments, the hybrid system comprises a liquid or gel aerosol-generating material and a solid aerosol-generating material. The solid aerosol-generating material may comprise, for example, tobacco or a non-tobacco product.

Typically, the non-combustible aerosol provision system may comprise a non- combustible aerosol provision device and a consumable for use with the non- combustible aerosol provision device.

In some embodiments, the disclosure relates to consumables comprising aerosolgenerating material and configured to be used with non-combustible aerosol provision devices. These consumables are sometimes referred to as articles throughout the disclosure.

In some embodiments, the non-combustible aerosol provision system, such as a non-combustible aerosol provision device thereof, may comprise a power source and a controller. The power source may, for example, be an electric power source or an exothermic power source. In some embodiments, the exothermic power source comprises a carbon substrate which may be energised so as to distribute power in the form of heat to an aerosol-generating material or to a heat transfer material in proximity to the exothermic power source.

In some embodiments, the non-combustible aerosol provision system may comprise an area for receiving the consumable, an aerosol generator, an aerosol generation area, a housing, a mouthpiece, a filter and/or an aerosol-modifying agent.

In some embodiments, the consumable for use with the non-combustible aerosol provision device may comprise aerosol-generating material, an aerosol-generating material storage area, an aerosol-generating material transfer component, an aerosol generator, an aerosol generation area, a housing, a wrapper, a filter, a mouthpiece, and/or an aerosol-modifying agent.

In other embodiments, the aerosol-generating compositions of the present invention may include one or more other aerosol-generating materials, in addition to the beads. For example, the beads may be combined with aerosol-generating material comprising tobacco material, or other plant or botanical material. The different aerosolgenerating materials may be provided separately or together, for example as a mixture or blend.

Incorporation into an aerosol-generating device

In some embodiments, the beads of the invention are provided in a consumable.

A consumable is an article comprising aerosol-generating material, part or all of which is intended to be consumed during use by a user. A consumable may comprise one or more other components, such as an aerosol-generating material storage area, an aerosol-generating material transfer component, an aerosol generation area, a housing, a wrapper, a mouthpiece, a filter and/or an aerosol-modifying agent. A consumable may also comprise an aerosol generator, such as a heater, that emits heat to cause the aerosol-generating material to generate aerosol in use. The heater may, for example, comprise combustible material, a material heatable by electrical conduction, or a susceptor. The consumable may be any shape or size that is appropriate to the aerosol provision device. In some embodiments, the consumable is a rod shape.

In some embodiments, one or mor bead is provided in an aerosol-generating device such as a heating product (akin to a tobacco heating product or THP), or hybrid product (including both solid and liquid aerosol sources). Advantageously, the bead may be used directly as a solid substrate and are directly heated without burning to provide an inhalable aerosol. Heating the bead may aerosolise components of the bead, for example, the active substance and the aerosol-former material. Figure 1 is a side-on cross-sectional view of a consumable or article 1 for use in an aerosol delivery system. The article 1 comprises a mouthpiece segment 2, and an aerosol generating segment 3.

The aerosol generating segment 3 is in the form of a cylindrical rod and comprises an aerosol-generating material 4 comprising a population of beads as disclosed herein. For example, the beads can be any of the beads discussed herein.

Although described above in rod form, the aerosol-generating segment 3 can be provided in other forms, for instance a plug, pouch, or packet of material within an article.

The mouthpiece segment 2, in the illustrated embodiment, includes a body of material 5 such as a fibrous or filamentary tow.

The rod-shaped consumable 1 further comprises a wrapper 6 circumscribing the mouthpiece segment 2 and aerosol generating segment 3, such as a paper wrapper.

Figure 2 shows an example of a non-combustible aerosol provision device 100 for generating aerosol from an aerosol-generating medium such as the aerosol-generating material of a consumable 110, as described herein. In broad outline, the device 100 may be used to heat a replaceable article 110 comprising the aerosol-generating medium, for instance an article 1 as illustrated in Figure 1 or as described elsewhere herein, to generate an aerosol or other inhalable medium which is inhaled by a user of the device 100. The device 100 and replaceable article 110 together form a system.

The device 100 comprises a housing 102 (in the form of an outer cover) which surrounds and houses various components of the device 100. The device 100 has an opening 104 in one end, through which the article 110 may be inserted for heating by a heating assembly. In use, the article 110 may be fully or partially inserted into the heating assembly where it may be heated by one or more components of the heater assembly.

The device 100 of this example comprises a first end member 106 which comprises a lid 108 which is moveable relative to the first end member 106 to close the opening 104 when no article 110 is in place. In Figure 2, the lid 108 is shown in an open configuration, however the lid 108 may move into a closed configuration. For example, a user may cause the lid 108 to slide in the direction of arrow "B". The device 100 may also include a user-operable control element 112, such as a button or switch, which operates the device 100 when pressed. For example, a user may turn on the device 100 by operating the switch 112.

The device 100 may also comprise an electrical component, such as a socket/port 114, which can receive a cable to charge a battery of the device 100. For example, the socket 114 may be a charging port, such as a USB charging port.

Examples

The following are illustrative examples of the compositions and processes described herein.

Beads of aerosol-generating material are formed by extruding a precursor composition comprising the following:

Formulation 1

Formulation 2

The CBD used was in isolate form (> 98% pure). Both plant-derived and synthetically-derived CBD isolates are used. The formulations are prepared for extrusion by combining the components to form the precursor composition. Next, the precursor composition is extruded using a screw extruder with a die to produce extruded material in the form of a string. The string is cut into sections and these are spheronised to form substantially spherical beads.

The various embodiments described herein are presented only to assist in understanding and teaching the claimed features. These embodiments are provided as a representative sample of embodiments only, and are not exhaustive and/or exclusive. It is to be understood that advantages, embodiments, examples, functions, features, structures, and/or other aspects described herein are not to be considered limitations on the scope of the invention as defined by the claims or limitations on equivalents to the claims, and that other embodiments may be utilised and modifications may be made without departing from the scope of the claimed invention. Various embodiments of the invention may suitably comprise, consist of, or consist essentially of, appropriate combinations of the disclosed elements, components, features, parts, steps, means, etc., other than those specifically described herein. In addition, this disclosure may include other inventions not presently claimed, but which may be claimed in future.

Claims

1. An aerosol-generating composition comprising one or more beads comprising an aerosol-generating material comprising a water-insoluble active substance, a filler and an aerosol-former material.

2. An aerosol-generating composition as claimed in claim 1, wherein the waterinsoluble active substance is a constituent, derivative or extract of cannabis.

3. An aerosol-generating composition as claimed in claim 1 or claim 2, wherein the constituent, derivative or extract of cannabis is a cannabinoid.

4. An aerosol-generating composition as claimed in claim 3, wherein the cannabinoid is selected from cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A).

5. An aerosol-generating composition as claimed in any one of claims 1 to 4, comprising from about 0.1 to about 50 wt% of the active substance calculated on a dry weight basis.

6. An aerosol-generating composition as claimed in any one of claims 1 to 5, wherein the aerosol-former material comprises (or is) one or more of glycerol, propylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, 1,3- butylene glycol, erythritol, meso-Erythritol, ethyl vanillate, ethyl laurate, a diethyl suberate, triethyl citrate, triacetin, a diacetin mixture, benzyl benzoate, benzyl phenyl acetate, tributyrin, lauryl acetate, lauric acid, myristic acid, and propylene carbonate.

7. An aerosol-generating composition as claimed in any one of claims 1 to 6, comprising from about 10 to about 50 wt% aerosol-former material calculated on a dry weight basis.

8. An aerosol-generating composition as claimed in any one of claims 1 to 7, wherein the filler is one or more selected from the group consisting of: inorganic filler materials, such as calcium carbonate, perlite, vermiculite, diatomaceous earth, colloidal silica, magnesium oxide, magnesium sulphate, magnesium carbonate, and suitable inorganic sorbents, such as molecular sieves; and organic filler materials such as wood pulp; tobacco pulp; hemp fibre; starch and starch derivatives, such as maltodextrin; chitosan; and cellulose and cellulose derivatives, such as ground cellulose, microcrystalline cellulose and nanocrystalline cellulose.

9. An aerosol-generating composition as claimed in any one of claims 1 to 8, comprising from about 5 to about 75 wt% filler calculated in a dry weight basis.

10. An aerosol-generating composition as claimed in any one of claims 1 to 9, the aerosol-generating material further comprising a binder.

11. An aerosol-generating composition as claimed in claim 10, wherein the binder comprises or is one or more compounds selected from: polysaccharide binders, such as alginates, pectins, starches or derivatives thereof, cellulose or derivatives thereof, pullulan, carrageenan, agar and agarose; gelatin; gums, such as xanthan gum, guar gum and acacia gum; silica or silicone compounds, such as PDMS and sodium silicate; clays, such as kaolin; and polyvinyl alcohol.

12. An aerosol-generating composition as claimed in claim 11, wherein the polysaccharide binder is selected from the group consisting of alginate and a cellulose derivative, and/or wherein the cellulose derivative is selected from hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethylcellulose (CMC), hydroxypropyl methylcellulose (HPMC), methyl cellulose, ethyl cellulose, cellulose acetate (CA), cellulose acetate butyrate (CAB), and cellulose acetate propionate (CAP).

13. An aerosol-generating composition as claimed in any one of claims 10 to 12, comprising from about 0.1 to about 12 wt% binder calculated in a dry weight basis.

14. An aerosol-generating composition as claimed in any one of claims 1 to 13, comprising one or more beads comprising a second aerosol-generating material.

15. An aerosol-generating composition as claimed in claim 14, wherein the second aerosol-generating material comprises one or more active substance selected from the group consisting of: nutraceuticals; nootropics; psychoactives; and constituents, derivatives or extracts of tobacco or another botanical, such as nicotine, caffeine, taurine, theine, vitamins such as B6 or B12 or C, melatonin, and constituents or derivatives thereof.

16. An aerosol-generating composition as claimed in any one of claims 1 to 15, further comprising a flavour or sensate.

17. An aerosol-generating composition as claimed in any one of claims 1 to 16, wherein the beads comprising the aerosol-generating materials have the same or substantially the same diameters.

18. An aerosol-generating composition as claimed in any one of claims 1 to 16, wherein the beads comprising the aerosol-generating materials have different diameters.

19. A consumable for use in a non-combustible aerosol provision device, the consumable comprising the aerosol-generating composition as claimed in any one of claims 1 to 18.

20. A consumable as claimed in claim 19, comprising a cartridge or chamber comprising the aerosol-generating composition.

21. A non-combustible aerosol provision system comprising a consumable of claim 19 or claim 20 and a non-combustible aerosol provision device.

22. A method for preparing an aerosol-generating composition as claimed in any one of claims 1 to 18, wherein the beads comprising aerosol-generating material are formed by extrusion.

23. A method as claimed in claim 22, comprising dissolving the water-insoluble active substance in the aerosol-former material prior to extrusion.

24. A method as claimed in claim 22 or claim 23, wherein the extruded material is dried and broken into beads, and optionally spheronised.

25. A method as claimed in any one of claims 22 to 24, wherein the extruded material is dried at a temperature of no higher than 65°C.