Dried molded particles, their manufacturing method and use

Abstract

This invention relates to molded particles comprising a dry liquid composition containing a plant extract such as tobacco extract. The invention also relates to a method for producing these dry molded particles and their use.

Description

[Technical Field]

[0001] This invention relates to molded particles comprising a dry liquid composition containing a plant extract such as tobacco extract. The invention also relates to a method for producing these dry molded particles and their use. [Background technology]

[0002] It is difficult to prepare a dried solid material from a liquid composition containing tobacco extract while retaining desirable components, including volatile or semi-volatile components. Dried materials formed by conventional freeze-drying or refrigeration methods generally form as solid masses or cakes, which are then broken down into particles of the desired size. [Overview of the project]

[0003] According to a first aspect of the present invention, molded particles are provided, each comprising a freeze-dried molded portion of a liquid composition containing a plant extract.

[0004] In some embodiments, the molded particles contain volatile and semi-volatile components of a plant extract.

[0005] In some embodiments, the plant extract is tobacco extract and optionally aqueous tobacco extract.

[0006] In some embodiments, the liquid composition further comprises an aerosol-forming agent material. In some embodiments, the aerosol-forming agent material is glycerol.

[0007] In some embodiments, the liquid composition further comprises an excipient. In some embodiments, the excipient is dextran.

[0008] In some embodiments, the molded particles contain about 45 to about 100% by weight (on a dry weight basis) of dried plant extract.

[0009] In some embodiments, the molded particles contain about 1 to about 20% by weight (on a dry weight basis) of aerosol-forming agent material.

[0010] In some embodiments, the molded particles contain about 0.1 to about 20% by weight (on a dry weight basis) of excipients.

[0011] In some embodiments, the molded particles are lyophilized droplets of a liquid composition containing a plant extract.

[0012] In some embodiments, the molded particles are spherical beads.

[0013] In some embodiments, at least 90% of the beads have a diameter that varies by no more than 5% from the mass median diameter of the group.

[0014] In some embodiments, the beads have a diameter ranging from about 2 mm to about 5 mm.

[0015] In some embodiments, the beads are approximately 0.005 to 0.02 cm in diameter. 3 It has the volume of .

[0016] In some embodiments, the molded particles are approximately 0.5 to 1.5 g / cm³. 3 It has a density within that range.

[0017] In some embodiments, the molded particles are flat in shape, such as thin strips or discs.

[0018] In some embodiments, the molded particles have a thickness of about 0.05 mm to about 1 mm.

[0019] In some embodiments, the molded particles have a residual moisture content of about 12% or less, or about 10% or less, as measured by Karl Fischer analysis.

[0020] In some embodiments, the residual moisture content is at least 7% as measured by Karl Fischer analysis.

[0021] According to a second aspect of the present invention, there is provided a method of providing shaped particles, the method comprising: supplying a portion of a liquid composition containing a plant extract into a mold; lyophilizing the liquid composition in the mold.

[0022] <00×0092>In some embodiments, the method comprises: pre-freezing droplets of a liquid composition containing a plant extract; lyophilizing the frozen droplets to form beads.

[0023] In some embodiments, the droplets of the liquid composition containing a plant extract have a volume of from about 1 μl to about 50 μl.

[0024] <× In some embodiments, the droplets are pre-frozen by dispensing droplets of the liquid composition into liquid nitrogen.

[0025] In some embodiments, the droplets are pre-frozen at atmospheric pressure.

[0026] In some embodiments, the droplets freeze instantaneously upon contact with liquid nitrogen.

[0027] In some embodiments, the lyophilization is carried out at a temperature of from about -35 to about -50 °C.

[0028] In some embodiments, the lyophilization is carried out at a pressure of from about 30 to about 40 μbar.

[0029] In some embodiments, the lyophilization is carried out for from about 48 to about 120 hours.

[0030] In some embodiments, the method includes a secondary drying step.

[0031] In some embodiments, the secondary drying step includes raising the temperature of the lyophilized shaped particles to a secondary drying temperature of 20 °C or less.

[0032] In some embodiments, the freeze-dried molded particles are held at a secondary drying temperature for a period of about 9 to 24 hours.

[0033] In some embodiments, the secondary drying step is performed at a pressure of about 20 to about 30 μbar.

[0034] According to a third aspect of the present invention, a non-combustible aerosol supply system containing molded particles according to the first aspect is provided.

[0035] In some embodiments, the system is configured to heat molded particles to form vapor and / or aerosol.

[0036] In some embodiments, the non-combustible aerosol supply system includes a further aerosol-generating material that is heated to form an aerosol and / or vapor. In some embodiments, the further aerosol-generating material is a liquid.

[0037] According to a fourth aspect of the present invention, an article for use in a non-combustible aerosol supply system is provided, comprising molded particles according to the first aspect.

[0038] According to a fifth aspect of the present invention, an oral product is provided which includes a permeable container surrounding molded particles according to the first aspect.

[0039] According to the sixth aspect, a method is provided for providing an article according to the fourth aspect or an oral product according to the fifth aspect, the method comprising the steps of forming one or more molded particles according to the method of the second aspect, and placing one or more molded particles in a container.

[0040] According to the seventh aspect, the use of molded particles according to any one of claims 1 to 20 is provided for generating an inhalable medium.

[0041] According to the eighth aspect, molded particles are provided that are obtained or can be obtained by the method according to the second aspect for generating an inhalable medium for use in an aerosol supply system.

[0042] Next, embodiments of the present invention will be described as merely examples with reference to the attached drawings. [Brief explanation of the drawing]

[0043] [Figure 1] This is a side cross-sectional view of a first embodiment of a consumable product comprising an aerosol generating material containing dried molded particles according to the present invention. [Figure 2] Figure 1 is a perspective view of a non-combustion aerosol supply device for generating aerosols from consumable aerosol-generating materials. [Figure 3] This is a schematic diagram of a permeable container or pouch for holding a collection of dried molded particles according to the present invention. [Modes for carrying out the invention]

[0044] The present invention relates to a plurality or group of molded particles, such as beads, each comprising a dried or dehydrated molded portion of a liquid composition containing a plant extract. For example, the plant extract may be a tobacco extract.

[0045] As used herein, the term “molded” means that the particles have a controlled, predetermined shape. These particles are not formed, for example, by creating a larger dry mass and crushing it into particles. Such a process does not provide particles with a controlled, predetermined shape. Instead, the liquid composition is dried in a predetermined shape to form molded particles. There are various methods to achieve this, as will be described below.

[0046] Since each molded particle contains a dry molded portion of the liquid composition, a group or collection of these molded particles has several beneficial properties. Firstly, the composition of each molded particle can be precisely controlled. Secondly, the size and shape or form of each particle can be precisely controlled. Thirdly, in some embodiments, the molded particles can be free-flowing, making them easy to handle, store, and process.

[0047] Importantly, the ability to manufacture molded particles with predictable composition, size, and shape means that the particles can be used to provide accurate and predictable delivery of ingredients when in use. Furthermore, a population of particles containing mixtures of different particles (i.e., mixtures of particles with different properties) can be used to provide a desired delivery profile over a period of time.

[0048] The molded particles according to the present invention can be produced by freeze-drying a portion of a liquid composition that has a desired shape.

[0049] Particles of dried or dehydrated liquid compositions can be produced using conventional freeze-drying or refrigeration processes. This involves drying a larger volume of liquid composition rather than individual droplets. Thus, conventional methods result in the formation of solid clumps or cakes, which can then be broken down into particles within a desired size range. However, there are drawbacks associated with particles formed in this way. For example, cakes formed by drying a liquid composition may not be uniformly dried, and particles formed by breaking down clumps may also lack a consistent composition, particularly with respect to water content. Furthermore, when a cake is divided into particles, it can result in particles of different shapes and sizes. While it is possible to select particles within a specific size range, at least some of the dried material will be discarded, which is undesirable.

[0050] Furthermore, conventional freeze-drying or refurbishment methods used to form dried cakes can take several days, and in some cases up to two weeks. Faster, more efficient freeze-drying or refurbishment processes are advantageous because they can significantly reduce the required drying time by drying droplets to form molded particles, for example, to less than a week, and in some cases as little as four days.

[0051] Different liquid compositions have different critical temperatures and must be freeze-dried below the critical temperature to avoid undesirable "swelling" as a result of structural changes and formulation collapse. Therefore, careful formulation of liquid compositions dramatically affects the freeze-drying time. The higher the freeze-drying temperature, the shorter the drying time.

[0052] Since the material of dried molded particles can be highly hygroscopic, it is desirable that the particles be available without further processing steps. Further processing steps may expose the particles to moisture, thus increasing their moisture content, which can lead to a decrease in handling, stability, and shelf life.

[0053] In fact, the molded particles disclosed herein exhibit excellent physical stability and shelf life and can be easily transported and stored. In some embodiments, the particles can be stored at a storage temperature range of 0 to 35°C. In some embodiments, the particles can be stored at a relative humidity of up to about 30%.

[0054] Another advantage of dried molded particles is that they can be used directly in a variety of products without requiring further processing after drying. For example, molded particles can be used as solid aerosol generating materials in combustion or non-combustion aerosol delivery systems such as heated tobacco products (THPs) or hybrid systems. Molded particles may also be used in aerosol-free delivery systems, such as systems that deliver at least one substance to a user orally, nasally, transdermally, or otherwise without forming an aerosol.

[0055] Each molded particle according to one aspect of the present invention comprises a dried molded portion of a liquid composition containing a plant extract, such as a tobacco extract. Therefore, the particles may contain one or more active substances and / or flavorings, and in at least some embodiments, these active substances and / or flavorings are derived from the plant extract. For example, in some embodiments, the particles contain one or more volatile or semi-volatile components derived from the plant extract. These may be derived from plant materials used to prepare the plant extract. In other embodiments, these components may be added to the liquid plant extract.

[0056] liquid composition The liquid composition contains a plant extract. In some embodiments, the liquid composition consists of a plant extract.

[0057] In some embodiments, the plant extract is a liquid plant extract. Such an extract is formed by contacting the plant material with a solvent, and then separating the solvent and any dissolved components from the solid plant material (also called a solid plant residue). The appropriate solvent should be selected based on the components to be extracted from the plant material.

[0058] As used herein, the term “plant matter” includes, but is not limited to, any material derived from a plant, including, extracts, leaves, bark, fibers, stems, roots, seeds, flowers, fruits, pollen, exoskeletons, or shells. Alternatively, the material may include naturally occurring active compounds in the plant matter, obtained by synthesis. The material may be in the form of a liquid, solid, powder, dust, crushed particles, granules, pellets, flakes, strips, or sheets. Examples of plant-based substances include tobacco, eucalyptus, star anise, hemp, cocoa, cannabis, fennel, lemongrass, peppermint, spearmint, rooibos, chamomile, flax, ginger, ginkgo, hazelnut, hibiscus, bay leaf, licorice, matcha, mate, orange peel, papaya, rose, sage, tea (such as green or black tea), thyme, clove, cinnamon, coffee, aniseed, basil, bay leaf, cardamom, coriander, cumin, nutmeg, oregano, paprika, rosemary, saffron, and laurel. Vander, lemon peel, mint, juniper, elderflower, vanilla, wintergreen, perilla, curcuma, turmeric, sandalwood, cilantro, bergamot, orange blossom, myrtle, blackcurrant, valerian, pimento, mace, damian, marjoram, olive, lemon balm, lemon basil, chives, calvi, verbena, tarragon, geranium, mulberry, ginseng, theanine, theacrine, maca, ashwagandha, damiana, guarana, chlorophyll, baobab, or any combination thereof. The mint may be selected from the following mint varieties: American mint, mint cv, Egyptian mint, European mint, eau de cologne mint, candy mint, curly mint, Kentucky colonel mint, horse mint, pineapple mint, pennyroyal mint, green mint, and apple mint.

[0059] In some embodiments, the liquid composition includes tobacco extract. In some embodiments, the liquid composition consists of tobacco extract.

[0060] In some embodiments, the tobacco extract is a liquid tobacco extract. Such an extract is formed by contacting tobacco material with a solvent and then separating the solvent and any dissolved tobacco components from the solid tobacco material (also called solid tobacco residue).

[0061] In some embodiments, the liquid tobacco extract is an aqueous extract. That is, the extract is formed by contacting the tobacco material with an aqueous solvent. This creates a liquid extract and extracted solid tobacco material. The liquid extract may be at least partially separated from the solid tobacco material before the formation of the liquid composition. In some embodiments, the tobacco extract is used as a liquid composition or directly in a liquid composition.

[0062] Liquid tobacco extracts may be extracts from any type of tobacco and any part of the tobacco plant, including tobacco leaf blades, stems, stalks, ribs, scraps and fragments, or mixtures of two or more thereof. Suitable tobacco extracts or materials include blends of tobacco materials, including, optionally, Virginia or yellow tobacco, Burley tobacco, Oriental tobacco, or any of those listed herein. Tobacco may be expanded, such as dry ice expanded tobacco (DIET), or processed by any other method. In some embodiments, tobacco materials may be reconstituted tobacco materials. Tobacco may be pretreated or untreated, for example, solid stems (SS), shredded dried stems (SDS), steam-treated stems (STS), or any combination thereof. Tobacco materials may be pretreated by fermentation, hardening, unhardening, roasting, or other methods.

[0063] In some embodiments, the tobacco extract has a solid content of about 40 to about 65% by weight, about 45 to about 65% by weight, or about 40 to about 60% by weight (calculated on a wet weight basis). In some embodiments, the water content of the tobacco extract is about 35% to about 65% by weight, or about 35 to about 55% by weight (calculated on a wet weight basis). In some embodiments, the nicotine content of the tobacco extract is about 1% to about 5% by weight (calculated on a wet weight basis).

[0064] The liquid composition may be in the form of a slurry, suspension, emulsion, or solution. The liquid composition may contain a plant extract and further solvent components. The solvent component may include water. If other components are present in the dry material, these further components may be added separately or together with water. In some embodiments, the liquid composition may contain about 30 to about 70% v / v of plant extract, about 40 to about 60% v / v of plant extract, or about 50% v / v of plant extract.

[0065] The water content of the liquid composition may be at least about 20% by weight, at least about 30% by weight, at least about 40% by weight, at least about 50% by weight, at least about 60% by weight, at least about 70% by weight, at least about 80% by weight, or at least about 90% by weight on a wet weight basis. Additionally or alternatively, the water content of the liquid composition may be up to about 95% by weight, up to about 90% by weight, up to about 85% by weight, up to about 80% by weight, up to about 75% by weight, up to about 70% by weight, up to about 65% by weight, up to about 60% by weight, up to about 55% by weight, or up to about 50% by weight, on a wet weight basis. In some embodiments, the water content of the liquid composition may be about 45 to about 90% by weight, or about 55 to about 85% by weight, on a wet weight basis.

[0066] The liquid composition may contain at least about 10% by weight, at least about 20% by weight, at least about 30% by weight, at least about 35% by weight, at least about 40% by weight, at least about 45% by weight, at least about 50% by weight, or at least about 55% by weight of tobacco solid (calculated on a wet weight basis). Alternatively or additionally, the liquid composition may contain up to about 70% by weight, up to about 65% by weight, up to about 60% by weight, up to about 55% by weight, or up to about 50% by weight of tobacco solid (calculated on a wet weight basis). In some embodiments, the liquid tobacco extract and / or liquid composition contains tobacco solid (calculated on a wet weight basis) in amounts of about 10% to about 65% by weight, or about 25% to about 45% by weight.

[0067] In some embodiments, the liquid composition contains at least about 10% by weight, about 20% by weight, at least about 30% by weight, at least about 40% by weight, at least about 50% by weight, at least about 60% by weight, at least about 70% by weight, at least about 80% by weight, or at least about 90% by weight of tobacco extract (calculated on a wet weight basis). Alternatively or additionally, the liquid composition may contain up to about 99% by weight, up to about 90% by weight, up to about 80% by weight, up to about 70% by weight, or up to about 60% by weight of tobacco extract (calculated on a wet weight basis). In some embodiments, the liquid composition contains about 40 to about 60% by weight of tobacco extract, or about 50% by weight of tobacco extract (calculated on a wet weight basis).

[0068] In some embodiments, the liquid composition contains an active substance. As used herein, the active substance may be a physiologically active material, which is a material intended to achieve or enhance a physiological reaction.

[0069] In some embodiments, the active substance is derived from a plant extract. For example, in some embodiments, the active substance is nicotine derived from tobacco extract.

[0070] Alternatively or additionally, the liquid composition may contain active substances not derived from plant extracts. Suitable active substances may be selected from dietary supplements, nootropics, and psychostimulants. Active substances may be naturally occurring or obtained by synthesis. Active substances may include, for example, caffeine, taurine, theine, vitamins such as B6 or B12 or C, melatonin, cannabinoids, or their components, derivatives, or combinations. Active substances may also include one or more components, derivatives, or extracts of tobacco, cannabis, or other plant substances.

[0071] In some embodiments, the active substance may include nicotine derived from tobacco extract and additional nicotine or other active substances as referred herein. In some embodiments, the active substance may include caffeine, melatonin, or vitamin B12.

[0072] In some embodiments, the liquid composition includes, in addition to tobacco extract, extracts from other plant sources.

[0073] In some embodiments, the plant extract is concentrated before being incorporated into the liquid composition. This can make the drying step more efficient, for example, by reducing the energy required. It can also help provide the liquid composition in a form suitable for processes involving the formation of liquid molded portions and their drying to form molded particles.

[0074] In some embodiments, the liquid composition comprises one or more aerosol-forming agent materials.

[0075] The aerosol-forming agent material may contain one or more components capable of forming an aerosol. The aerosol-forming agent material may be, for example, a polyol aerosol-forming agent or a non-polyol aerosol-forming agent. The aerosol-forming agent material may be solid or liquid at room temperature, but is preferably liquid at room temperature. In some embodiments, the aerosol-forming agent material may contain one or more of the following: glycerin, glycerol, propylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, 1,3-butylene glycol, erythritol, mesoerythritol, ethyl vanillate, ethyl laurate, diethyl suberate, triethyl citrate, triacetin, diacetin mixture, benzyl benzoate, benzyl phenylacetate, tributyline, lauryl acetate, lauric acid, myristic acid, and propylene carbonate.

[0076] In some embodiments, the aerosol-forming agent 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 dodecanediate and dimethyl tetradecanediate. In some embodiments, the aerosol-forming agent material comprises one or more compounds selected from erythritol, propylene glycol, glycerol, vegetable glycerin (VG), triacetin, sorbitol, and xylitol. In some embodiments, the aerosol-forming agent material comprises glycerol, is essentially composed of glycerol, or is composed of glycerol. In preferred embodiments, the aerosol-forming agent material is composed of glycerol.

[0077] The aerosol-forming agent materials may be used in equal or different proportions. The aerosol-forming agent materials may act as plasticizers.

[0078] In some embodiments, the liquid composition contains at least about 1% v / v, at least about 5% v / v, or at least about 10% v / v of aerosol-forming agent material. Alternatively or additionally, the liquid composition may contain up to about 20% v / v, up to about 15% v / v, up to about 10% v / v, or up to about 5% v / v of aerosol-forming agent material.

[0079] In embodiments of the present invention in which the aerosol-forming agent material is glycerol, the dry molded particles may contain at least about 5% by weight, at least about 10% by weight, or at least about 12% by weight of the aerosol-forming agent material (on a dry weight basis). Alternatively or additionally, the aerosol-forming agent material may contain up to about 20% by weight, up to about 15% by weight, or up to about 20% by weight of glycerol (on a dry weight basis).

[0080] The amount of glycerol in the liquid composition, and therefore in the dried molded particles, is important because it acts as both an aerosol-forming agent and a plasticizer. It is also important to remember that glycerol has freeze-resistant properties.

[0081] It is desirable to include enough glycerol to provide consumers with a sufficient and pleasant aerosol, but a balance must be struck, as too much glycerol will negatively affect the freeze-drying process. If the concentration of glycerol in the liquid composition is too high, the disintegration temperature of the formulation will decrease, which means that freeze-drying must be carried out at a lower temperature, adding processing time required for drying and increasing energy costs. If the disintegration temperature of the formulation is low, the formulation will undergo structural changes. This is accompanied, for example, by so-called "boiling" of the formulation, leading to the disintegration of the product and significant expansion of the dried particles. Therefore, freeze-drying should be carried out at a temperature lower than the disintegration temperature of the formulation, preferably about 2-7°C lower than the disintegration temperature.

[0082] In some embodiments, the amount of glycerol contained in the liquid composition is 5% v / v or less, and may be as low as 0%.

[0083] In some embodiments, the liquid composition further comprises one or more excipients.

[0084] The inventors have found that the inclusion of excipients can be important for the stability of the liquid composition during the freeze-drying process, particularly when the liquid composition contains glycerol as an aerosol-forming agent. This may result from the excipients raising the disintegration temperature of the formulation. In fact, experiments have shown that drying a liquid composition containing tobacco extract and glycerol but without excipients can lead to the undesirable structural changes described above during freeze-drying. Some "swelling" or significant expansion of the droplets was observed during drying, indicating "boiling" of the liquid composition. In contrast, when an excipient such as dextran (e.g., dextran 70K) was added, no such changes were observed when the droplets were dried. Instead, beads of uniform size were formed, showing only slight shrinkage compared to the size of the frozen droplets before freeze-drying.

[0085] Suitable excipients include mannitol, sucrose, trehalose, lactose, sorbitol, raffinose, maltose, dextran 10, dextran 70, dextran 90, maltodextrin, gelatin, agar, cyclodextrin, PEG2000-6000, and (PVP10k).

[0086] In some embodiments, the liquid composition contains one or more excipients in an amount of about 1 to about 20% by weight on a wet weight basis. In some embodiments, the liquid composition may contain at least about 1% by weight, at least about 2% by weight, at least about 5% by weight, at least about 8% by weight, or at least about 10% by weight of excipients on a wet weight basis. Alternatively or additionally, the liquid composition may contain up to about 20% by weight, up to about 15% by weight, or up to about 10% by weight of excipients on a wet weight basis.

[0087] In some embodiments, the liquid composition comprises about 50% by weight of tobacco extract, about 0 to about 10% v / v of glycerol, and about 10% by weight of excipients. The tobacco extract may contain about 55 to about 62% by weight of tobacco solids.

[0088] In some embodiments, the liquid composition may contain an acid. The acid may be an organic acid. In some of these embodiments, the acid may be at least one of a monoprotonic acid, a diprotonic acid, and a triprotonic acid. In some such embodiments, the acid may contain at least one carboxyl functional group. In some such embodiments, the acid may be at least one of an α-hydroxy acid, a carboxylic acid, a dicarboxylic acid, a tricarboxylic acid, and a keto acid. In some such embodiments, the acid may be an α-keto acid.

[0089] In some such embodiments, the acid may be at least one of succinic acid, lactic acid, benzoic acid, citric acid, tartaric acid, fumaric acid, levulinic acid, acetic acid, malic acid, formic acid, sorbic acid, benzoic acid, propanoic acid, and pyruvic acid.

[0090] In other embodiments, the acid may be an inorganic acid. In some of these embodiments, the acid may be a mineral acid. In some such embodiments, the acid may be at least one of sulfuric acid, hydrochloric acid, boric acid, and phosphoric acid.

[0091] In some embodiments, the preferred acid is lactic acid and / or levulinic acid.

[0092] The presence of an acid can be beneficial because it can stabilize the dissolved species in the tobacco extract. For example, the presence of an acid can reduce or substantially prevent the evaporation of nicotine from the liquid composition before or during freeze-drying, thereby reducing nicotine loss during production.

[0093] In some embodiments, the liquid composition contains one or more acids in an amount of about 1 to about 5% by weight on a wet weight basis.

[0094] In some embodiments, the liquid composition further comprises one or more flavorings.

[0095] As used herein, the terms “flavoring” and “flavoring agent” refer to materials that may be used to create a desired taste, aroma, or other somatosensory effect in products intended for adult consumers, where permitted by local regulations.These are naturally occurring flavorings, plant substances, extracts of plant substances, synthetically obtained materials, or combinations thereof (e.g., tobacco, cannabis, licorice, hydrangea, eugenol, magnolia leaves, chamomile, fenugreek, clove, maple, matcha, menthol, Japanese mint, anise, cinnamon, turmeric, Indian spices, Asian spices, herbs, wintergreen, cherry, berries, red berries, cranberries, peaches, apples, oranges, mangoes, clementines, lemons, limes, toro). Fruits, papaya, rhubarb, grapes, 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 nut, shisha, pine, honey essence, rose oil, vanilla, lemon oil, orange oil, orange blossom, cherry blossom, cassia, caraway, cognac, jasmine, ylang Iran, sage, fennel, wasabi, bell pepper, ginger, coriander, coffee, hemp, peppermint oil from any of the Mentha species, eucalyptus, star anise, cocoa, lemongrass, rooibos, flax, ginkgo, hazelnut, hibiscus, bay leaf, mate, orange peel, rose, tea such as green or black tea, thyme, juniper, elderflower, basil, bay leaf, cumin, oregano, paprika, rosemary, saffron, lemon peel, mint, shiso, curcuma, cilantro, myrtle, blackcurrant, valerian, pimento, mace, Damien, It may contain other additives such as marjoram, olive, lemon balm, lemon basil, chives, calvi, verbena, tarragon, limonene, thymol, camphene), flavor enhancers, bitter taste receptor site blockers, sensory receptor site activators or stimulants, sugars and / or sugar substitutes (e.g., sucralose, acesulfame potassium, aspartame, saccharin, cyclamate, lactose, sucrose, glucose, fructose, sorbitol, or mannitol), as well as charcoal, chlorophyll, minerals, plant-based substances, or breath fresheners.The materials may be imitations, synthetics, natural raw materials, or blends thereof. The materials may be in any suitable form, such as a liquid like oil or a solid like a powder.

[0096] In some embodiments, the flavorings include menthol, spearmint, and / or peppermint. In some embodiments, the flavorings include flavor components of cucumber, blueberry, citrus, and / or red berry. In some embodiments, the flavorings include eugenol. In some embodiments, the flavorings include flavor components extracted from tobacco. In some embodiments, the flavorings include flavor components extracted from cannabis.

[0097] In some embodiments, the flavoring agent may include a sensory stimulant, which is intended to achieve somatosensory effects that are normally chemically induced and perceived by stimulation of the fifth cranial nerve (trigeminal nerve), in addition to or instead of the aroma or taste nerves, and may include components that produce heating, cooling, tingling, or numbing effects. A suitable heat-producing agent may be, but is not limited to, vanillyl ethyl ether, and a suitable coolant may be, but is not limited to, eucalyptol or WS-3.

[0098] In some embodiments, the liquid composition contains one or more flavorings in an amount of about 0.1 to about 5% by weight, or about 1 to about 2% by weight, on a wet weight basis.

[0099] When hydrophobic flavorings are included in a liquid composition, it may be necessary to include a surfactant or emulsifier to enable the formation of a stable oil-in-water emulsion. Suitable surfactants include, for example, fatty acid esters of polyoxyethylene sorbitan (Tweens) or sorbitan (Spans), or those containing lecithin. Manufacturing of molded particles in the form of beads To form the molded particles of the present invention in the form of beads, droplets of a liquid composition containing a plant extract are freeze-dried. To enable the freeze-drying of the liquid in the form of droplets, the liquid composition is first dispensed as a series of droplets, which are rapidly pre-frozen by exposure to extremely low temperatures (also referred to herein as "instantaneous freezing").

[0100] In some embodiments, droplets of the liquid composition are dispensed into liquid nitrogen. The droplets of the liquid composition freeze very rapidly when exposed to temperatures in the range of -196°C.

[0101] The size of the beads can be adjusted by changing the size of the droplets being dispensed.

[0102] In some embodiments, droplets are formed with a volume of about 1 to about 50 μl. In some embodiments, the volume or average (intermediate) volume of the droplet is at least about 1 μl, at least about 5 μl, at least about 10 μl, at least about 15 μl, at least about 20 μl, at least about 25 μl, at least about 30 μl, at least about 35 μl, or at least about 40 μl. Additionally or alternatively, in some embodiments, the volume or average (intermediate) volume of the droplet is about 50 μl or less, about 45 μl or less, about 40 μl or less, about 35 μl or less, about 30 μl or less, about 25 μl or less, about 20 μl or less, or about 15 μl or less.

[0103] In some embodiments, the droplets are pre-frozen at atmospheric pressure.

[0104] Droplets of liquid compositions tend to expand during pre-freezing. Their size can increase by approximately 5-10%. Some crystallization may also be observed within the frozen droplets.

[0105] Once formed, the pre-frozen droplets of the liquid composition are freeze-dried. Freeze drying process The molded portion of the liquid composition is dried by freeze-drying. In the above embodiment, the molded portion may be a spherical body formed as a frozen droplet.

[0106] In other embodiments, the molded portion of the liquid composition may be created using a mold. In such embodiments, at least one surface of the created shape will be flat. The liquid composition can be added to the mold, and then the mold can be freeze-dried directly in a freeze-dryer. In other embodiments, the liquid in the mold may be frozen, for example, by flash freezing, and then the frozen portion may be freeze-dried.

[0107] The drying method used to dry the molded portion of the liquid composition may be any suitable freeze-drying process using known small-scale or large-scale freeze-drying apparatus.

[0108] Freeze-drying, also known as lyophilization or cryodesication, is a process that involves freezing a liquid composition, lowering the temperature, and removing water by sublimation under reduced pressure. While not wishing to be bound by any particular theory, the low processing temperature and rapid water loss by sublimation are considered to avoid changes in the structure, appearance, and properties of the liquid composition. This process preserves the structure of the liquid composition and reduces the loss and decomposition of volatile components such as nicotine and flavor compounds.

[0109] Freeze-drying may be carried out at a temperature of approximately -35 to -50°C. Freeze-drying may also be carried out at a pressure of approximately 30 to 40 μbar.

[0110] Dry molded particles formed by freeze-drying have a lower water content than the molded portion of the liquid composition. The residual water content of the dry molded particles may be reduced to less than about 15%, or to about 5-14% or 7-12%, as measured by gas chromatography-tectonics (GC-TCD) or Karl Fischer measurement. Low water content helps to avoid or control a phenomenon called "hot puffing" that can occur in aerosol-generating systems such as tobacco heating products.

[0111] Drying of a liquid composition for forming dry molded particles can result in a reduction of water content of at least about 50% by weight, about 60% by weight, about 70% by weight, about 80% by weight, about 90% by weight, about 95% by weight, or at least about 98% by weight.

[0112] In some embodiments, the molded portion of the liquid composition is freeze-dried for about 48 to about 120 hours. In some embodiments, freeze-drying is carried out for at least about 48, 50, 55, 60, 65, 70, 75, 80, 85, 90, or at least about 95 hours. Additionally or alternatively, freeze-drying is carried out for a period of about 120, 110, 100, 95, 90, 85, 80, 75, 70, 65 hours or less, or about 60 hours or less.

[0113] Secondary drying In some embodiments, the freeze-dried molded portion undergoes a secondary drying step.

[0114] In the first drying step, in which the liquid composition is dried by freeze-drying, unbound water in the liquid composition is removed. An optional secondary drying step may be performed to remove chemically bound water, thereby further reducing the moisture content of the dried particles.

[0115] In some embodiments, the secondary drying step may include gradually raising the temperature of the freeze-dried molded particles to a temperature of about +15°C to about +25°C, for example, about +20°C, and then holding the molded particles at that temperature for a certain period of time. To avoid displacing desired volatile components from the liquid composition held as a result of the pre-freezing and freeze-drying steps, the temperature of the freeze-dried molded particles held during the secondary drying step should not be higher than room temperature.

[0116] In some embodiments, the endpoint of secondary drying may be determined by a vacuum gauge, which is used to determine when no more water is being removed (i.e., a water release plateau). In some embodiments, this may be when the moisture content is less than about 10%, as measured by Karl Fischer analysis.

[0117] In some embodiments, the molded particles may be held at a high temperature for about 10 to about 25 hours.

[0118] dry shaped particles The molded particles formed by drying the molded portion of a liquid composition containing plant extracts have a size, shape, and composition that can be easily controlled as a result of the manufacturing process described above.

[0119] The geometric shape of the molded particles is influenced by the geometric shape of the molded portion of the liquid composition to be dried. This can be controlled by the method used to form the molded portion, for example, by using pre-frozen droplets or molds.

[0120] Furthermore, the freeze-drying process results in some shrinkage of the molded parts. Since the observed shrinkage is a result of the removal of water from the freeze droplets, the higher the water content in the liquid composition (and freeze droplets), the greater the shrinkage observed after drying. This shrinkage can result in a size or volume reduction of approximately 5–10%. The specific degree of shrinkage depends on the shape and size of the part.

[0121] If the molded portion has been pre-frozen, this step may result in initial expansion, as described above. Subsequent shrinkage during freeze-drying may cause it to return to approximately its pre-frozen size.

[0122] In some embodiments, the molded particles are beads, which may be substantially spherical in shape. In some embodiments, the beads may have a slightly contracted spherical shape, i.e., the beads may have a slightly non-uniform surface morphology.

[0123] The diameter of the beads is influenced by the volume of the droplets formed from the liquid composition and the solid content in the liquid composition. During drying, some shrinkage is observed relative to the size of the frozen droplets.

[0124] The manufacturing process means that the size of the dried beads can be very consistent. In some embodiments, at least about 90% of the dried beads have a diameter that varies by no more than 5% from the mass median diameter of the group. In some embodiments, at least about 95%, at least about 97%, at least about 98%, or at least about 99% of the dried beads have a diameter that varies by no more than 5% from the mass median diameter of the group.

[0125] In some embodiments, the dried beads are free-flowing and non-sticky, which helps in handling the beads.

[0126] In some embodiments, the dried beads have a diameter in the range of about 2 mm to about 5 mm. Optionally, the diameter may be 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 may be about 5 mm or less, about 4.5 mm or less, about 4 mm or less, about 3.5 mm or less, about 3 mm or less, or about 2.5 mm or less. In some embodiments, the average diameter of the dried beads is about 2.5 mm to about 3 mm.

[0127] Beads with smaller diameters have a larger surface area-to-volume ratio and therefore may exhibit a more rapid release of components compared to beads with larger diameters.

[0128] In some embodiments, the size of the dry beads is selected to provide a desired release profile for one or more components. Generally, smaller diameter or size beads release components more quickly and over a shorter period of time during use. Beads with larger diameter or particle size release components more gradually and over a longer period of time. In some embodiments, beads of different sizes can be selected and combined to provide a release profile that starts rapidly at the beginning of use and continues over a longer period of use.

[0129] In some embodiments, the beads may desirably have an average particle size or diameter of about 5 mm or less, 4 mm or less, about 3 mm or less, or about 2 mm or less when measured by sieving. In some embodiments, the beads have a diameter of about 2 to about 3 mm. This can be evaluated by sieving or by measurement using a QuickScope™ instrument to approximate the diameter of a nearly spherical shape.

[0130] In some embodiments, the dry beads have a volume in the range of about 0.005 to about 0.02 cm 3 . In some embodiments, the dry beads have a volume of at least about 0.008 cm 3 , at least about 0.009 cm 3 , at least about 0.01 cm 3 average volume, and / or about 0.015 cm 3 or less, about 0.014 cm 3 or less, about 0.013 cm 3 or less, or about 0.012 cm 3 or less average volume.

[0131] In some embodiments, the dry formed particles have a density in the range of about 0.5 to about 1.5 g / cm 3 . In some embodiments, the formed particles have an average density of at least about 0.5 g / cm 3 , at least about 0.6 g / cm 3 , at least about 0.7 g / cm 3 and / or about 1.5 g / cm 3 or less, about 1.4 g / cm 3 or less, about 1.3 g / cm 3 or less, or about 1.2 g / cm 3 or less, or about 1.1 g / cm 3 or less average density.

[0132] In some embodiments, the dried molded particles have a flat shape, such as a thin strip or disc. In some embodiments, the flat shape has a thickness of about 0.05 mm to about 1 mm. In some embodiments, the thickness of the flat shape is at least about 0.05 mm, at least about 0.06 mm, at least about 0.07 mm, at least about 0.08 mm, at least about 0.09 mm, at least about 0.1 mm, at least about 0.15 mm, at least about 0.2 mm, at least about 0.25 mm, at least about 0.3 mm, at least about 0.4 mm, at least about 0.5 mm, at least about 0.6 mm, at least about 0.7 mm, at least about 0.8 mm, or at least about 0.9 mm. Alternatively or additionally, the thickness of the flat shape is approximately 1 mm or less, approximately 0.9 mm or less, approximately 0.8 mm or less, approximately 0.7 mm or less, approximately 0.6 mm or less, approximately 0.5 mm or less, approximately 0.45 mm or less, approximately 0.4 mm or less, approximately 0.35 mm or less, approximately 0.3 mm or less, approximately 0.25 mm or less, approximately 0.2 mm or less, approximately 0.15 mm or less, approximately 0.1 mm or less, approximately 0.09 mm or less, approximately 0.08 mm or less, approximately 0.07 mm or less, or approximately 0.06 mm or less.

[0133] In some embodiments, the flat shape corresponds to the shape of a cut rag tobacco having, for example, a width of about 0.8 to about 1.2 mm, a length of about 10 to about 40 mm, and a thickness of about 0.06 to about 0.2 mm.

[0134] The chemical composition of the dried molded particles is controlled by the chemical composition of the liquid composition. The drying process is selected to mitigate or prevent the loss of desirable components from the liquid composition, particularly the loss of components of the plant extract. If the plant extract is a tobacco extract, it is desirable to retain tobacco components such as nicotine and volatile or semi-volatile flavors and aromas. In some embodiments, the drying process removes essentially only water from the liquid composition. In other embodiments, some nicotine and / or glycerol are also lost during the drying process, as both are soluble in water.

[0135] In some embodiments, the dried molded particles include a dried plant extract, such as dried tobacco extract. Optionally, the molded particles may further include an aerosol-forming agent material. In some embodiments, the molded particles also include an excipient.

[0136] In some embodiments, the dry molded particles contain about 45 to about 100% (by weight) of dry tobacco extract. For example, the molded particles contain at least about 50% by weight, at least about 55% by weight, at least about 60% by weight, at least about 65% by weight, at least about 70% by weight, at least about 75% by weight, at least about 80% by weight, at least about 85% by weight, or at least about 90% by weight of tobacco extract (calculated on a dry weight basis). Alternatively or additionally, the dry particles contain up to about 99% by weight, up to about 95% by weight, up to about 90% by weight, up to about 85% by weight, or up to about 80% by weight of tobacco extract (calculated on a dry weight basis). In some embodiments, the dry particles contain about 55 to about 85% by weight, or about 50 to about 80% by weight of dry tobacco extract (calculated on a dry weight basis).

[0137] In some embodiments, the amount of tobacco extract contained in the dried molded particles is as high as possible to provide as much nicotine and tobacco-derived flavor and aroma as possible per unit weight of the material. This high concentration of tobacco components affects the weight and volume of the material that needs to be shipped, stored, and incorporated into the final product.

[0138] In some embodiments, the dried molded particles may contain approximately 3–6% by weight of nicotine (calculated based on dry weight) derived from tobacco extract. If additional nicotine is added, the total nicotine content of the particles may increase to, for example, up to approximately 10% by weight.

[0139] In some embodiments, the residual moisture content of the dried molded particles is greater than 7%, but 12% or less, or 10% or less.

[0140] The water content of the molded particles described herein may vary, for example, depending on the temperature, pressure, and humidity conditions under which the particles are maintained. The water content can be determined by Karl Fischer analysis or gas chromatography-thermal conductivity detection (GC-TCD), as is known to those skilled in the art.

[0141] After the manufacture of dried molded particles, it may be desirable to store the particles in a controlled, dry environment to reduce the possibility of them absorbing moisture from their immediate surroundings. Ideally, the dried particles should be protected from moisture until they are used by the consumer.

[0142] In some embodiments, the dry molded particles contain about 0.1 to about 30% (by weight) of aerosol-forming agent material. In some embodiments, the amount of aerosol-forming agent material in the dry particles is about 1 to about 25% by weight (by dry weight), about 5 to about 20%, or about 5 to about 15%.

[0143] Aerosol-forming agents may be included in dry molded particles intended for use as aerosol-generating materials. When dry particles containing aerosol-forming agent materials are heated, vapors and / or aerosols can be formed with desirable properties. Furthermore, aerosol-forming agent materials can promote and control the release of plant components from the dry particles.

[0144] Aerosol-forming materials, such as glycerol and others mentioned herein, are humectants and can therefore promote the retention and absorption of moisture by the dry molded particles. High moisture content in the dry particles can make them sticky or tacky, making them more difficult to handle. The performance of the dry particles in delivering components may be impaired by the additional moisture content and poor handling. Furthermore, allowing moisture to be absorbed before use wastes the time and energy spent drying the molded particles.

[0145] Furthermore, as discussed above and in the examples, it was found that the amount of aerosol-forming agent material also affects the outcome of the drying process and the optimal freeze-drying conditions. When a larger amount of aerosol-forming agent material was included in the liquid composition, fragmentation of the dried particles was observed more frequently, resulting in particles of unpredictable size and shape.

[0146] Finally, at least some of the aerosol-forming materials proposed for inclusion in the molded particles, such as glycerol, act as freeze-resistant agents. Consequently, these materials influence how the liquid composition behaves when exposed to freezing temperatures during the pre-freezing and freeze-drying steps. Therefore, the amount of such components must be carefully selected to ensure that the drying process is not adversely affected. In particular, it is crucial that the process produces a consistent and predictable product.

[0147] In some embodiments, the dry molded particles contain about 0.1 to about 25% (by weight) of excipients. In some embodiments, the amount of excipients in the dry particles is about 5 to about 20% (by dry weight).

[0148] Excipients are included in the dried molded particles to stabilize the liquid composition when it is freeze-dried. As discussed in the examples, the presence and amount of excipients are known to affect the outcome of the drying process. The liquid composition must be freeze-dried below its decay temperature. The presence of excipients can raise the decay temperature of the liquid composition, thereby allowing freeze-drying at higher temperatures without increasing the risk of product decay. Product decay can result in "swelling," where large, swollen particles are produced with properties very different from non-swelled particles, resulting in a significantly inferior product.

[0149] The dried molded particles disclosed herein can be used in a variety of different delivery systems to deliver tobacco extract components to users. As used herein, the term “delivery system” is intended to encompass a system for delivering at least one substance to a user. Combustion aerosol supply systems for cigarettes, cigarillos, cigars, and tobacco for pipes, hand-rolled cigarettes, or homemade cigarettes (whether based on tobacco, tobacco derivatives, expanded tobacco, recombined tobacco, tobacco substitutes, or other smokeable materials), Non-combustion aerosol supply systems that release compounds from aerosol-generating materials without burning the materials, such as hybrid systems that generate aerosols using a combination of electronic cigarettes, tobacco heating products, and aerosol-generating materials, and Aerosol-free delivery system for delivering at least one substance to a user orally, nasally, transdermally, or by another method that does not form an aerosol, including but not limited to oral products such as lozenges, gums, patches, articles containing inhalable powders, and oral tobacco containing snus or wet snuff, wherein at least one substance may or may not contain nicotine. Includes.

[0150] In some embodiments, the dry-form particles are used in the delivery system without significant further processing. For example, it may not be necessary to adjust or select the particle size. Aerosol generating materials The dried molded particles of the present invention can be used as an aerosol generating material. An aerosol generating material is a material that can generate an aerosol when energy is supplied, for example, by heating, irradiation, or any other method.

[0151] In some embodiments, the aerosol-generating material is intended for use in a “non-combustible” aerosol-delivery system. According to this disclosure, a “non-combustible” aerosol-delivery system is a system in which the constituent aerosol-generating material (or its components) of the aerosol-delivery system is not burned or incinerated in order to facilitate the delivery of at least one substance to the user.

[0152] In some embodiments, the delivery system is a non-combustible aerosol supply system, such as a powered non-combustible aerosol supply system.

[0153] In some embodiments, the non-combustion aerosol delivery system is an electronic cigarette, also known as a vaping device or electronic nicotine delivery system (END), but it should be noted that the presence of nicotine in the aerosol-generating material is not a requirement.

[0154] In some embodiments, the non-combustion aerosol supply system is an aerosol-generating material heating system, also known as a non-combustion heating system. An example of such a system is a cigarette heating system.

[0155] In some embodiments, the non-combustible aerosol supply system is a hybrid system that generates aerosols using a combination of aerosol-generating materials, one or more 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 includes a liquid or gel aerosol-generating material and a solid aerosol-generating material. The solid aerosol-generating material may include, for example, tobacco or a non-tobacco product.

[0156] Typically, a non-combustible aerosol supply system may comprise a non-combustible aerosol supply device and consumables for use with the non-combustible aerosol supply device.

[0157] In some embodiments, the disclosure relates to consumables comprising aerosol-generating materials and configured for use with non-combustible aerosol supply devices. These consumables may be referred to as articles throughout the disclosure.

[0158] In some embodiments, a non-combustible aerosol supply system, for example, the non-combustible aerosol supply device, may include a power source and a controller. The power source may be, for example, an electrical power source or a heat-generating power source. In some embodiments, the heat-generating power source includes a carbon substrate that can be energized to distribute power in the form of heat to an aerosol-generating material or heat-transferring material adjacent to the heat-generating power source.

[0159] In some embodiments, the non-combustion aerosol supply system may include a consumable receiving area, an aerosol generator, an aerosol generating area, a housing, a suction port, a filter, and / or an aerosol modifier.

[0160] In some embodiments, consumables for use with a non-combustible aerosol supply device may include aerosol generating material, an aerosol generating material storage area, an aerosol generating material transfer component, an aerosol generator, an aerosol generating area, a housing, packaging material, a filter, a suction nozzle, and / or an aerosol modifier.

[0161] The dried molded particles of this disclosure provide an aerosol-generating material that is stable at a certain temperature range, and as a result can be stored and / or transported for much longer periods without degrading the properties of the aerosol. The low water content also inhibits microbial growth.

[0162] In some embodiments, the consumables include about 50 to about 250 mg of molded particles, about 50 to about 200 mg, about 50 to about 150 mg, or about 100 mg of molded particles.

[0163] In some embodiments, the dried molded particles are either the only aerosol-generating material used, or the only solid aerosol-generating material used to generate aerosols.

[0164] In other embodiments, the dried molded particles of the present invention may be combined with one or more other aerosol-generating materials. For example, the dried molded particles can be combined with an aerosol-generating material comprising tobacco material or other plant or plant-based material. Different aerosol-generating materials may be supplied separately or together, for example, as a mixture or blend.

[0165] In some embodiments, the aerosol-generating material includes one or more cannabinoid compounds selected from the group consisting of cannabidiol (CBD), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabiclomevalin (CBCV), cannabigerovalin (CBGV), cannabigerol monomethyl ether (CBGM), and cannabiersoin (CBE) and cannabicitran (CBT).

[0166] The aerosol-generating material may contain one or more cannabinoid compounds selected from the group consisting of cannabidiol (CBD) and THC (tetrahydrocannabinol).

[0167] The aerosol-generating material may contain cannabidiol (CBD).

[0168] The aerosol-generating material may contain nicotine and cannabidiol (CBD).

[0169] The aerosol-generating material may contain nicotine, cannabidiol (CBD), and THC (tetrahydrocannabinol).

[0170] Integration into aerosol generators In some embodiments, the dried molded particles are provided as consumables.

[0171] A consumable is an article containing aerosol-generating material, some or all of which is intended to be consumed by the user during use. The consumable may comprise one or more other components, such as an aerosol-generating material storage area, an aerosol-generating material transfer component, an aerosol-generating area, a housing, packaging material, a mouthpiece, a filter, and / or an aerosol modifier. The consumable may also include an aerosol generator, such as a heater, which generates heat during use to cause the aerosol-generating material to produce an aerosol. The heater may comprise, for example, a flammable material, an electrically conductive material, or a susceptor. The consumable may be any shape or size suitable for the aerosol supply device. In some embodiments, the consumable is rod-shaped.

[0172] In some embodiments, a collection of dry molded particles is provided in an aerosol generating device such as a heated tobacco product (THP) or a hybrid e-cigarette product. Preferably, the dry molded particles may be used directly as a solid substrate, and the dry molded particles are directly heated without combustion to provide an inhalable aerosol. By heating the particles, the components of the dry particles, such as glycerol, nicotine, and / or tobacco flavor, can be aerosolized. The dry molded particles and / or consumables may be stored under low humidity conditions, for example, less than 30% humidity, before use.

[0173] A further advantage of dry molded particles used directly as a solid substrate is that their low water content reduces the problems associated with "hot puffing" known in the art.

[0174] Figure 1 is a side cross-sectional view of a consumable or article 1 for use in an aerosol delivery system. Article 1 comprises a mouthpiece segment 2 and an aerosol generation segment 3.

[0175] The aerosol-generating segment 3 is in the form of a cylindrical rod and comprises an aerosol-generating material 4 containing a collection of dry-molded particles disclosed herein. For example, the dry-molded particles may be either particles or beads as discussed herein.

[0176] Although described above in rod form, the aerosol-generating segment 3 may be provided in other forms, such as a plug in an article, a pouch, or a packet of material.

[0177] In the illustrated embodiment, the suction nozzle segment 2 includes a material body 5 such as a fibrous or filamentous tow.

[0178] The rod-shaped consumable 1 further comprises a packaging material 6, such as a rolling paper, that surrounds the mouthpiece segment 2 and the aerosol generating segment 3.

[0179] Figure 2 shows an example of a non-combustible aerosol supply device 100 for generating aerosols from an aerosol-generating medium, such as an aerosol-generating material of the consumables 110 described herein. Schematically, the device 100 may be used to heat a replaceable article 110 containing an aerosol-generating medium, such as the article 1 illustrated in Figure 1 or described elsewhere herein, to generate an aerosol or other inhalable medium to be inhaled by the user of the device 100. The device 100 and the replaceable article 110 together form a system.

[0180] Device 100 comprises a housing 102 (in the form of an outer cover) that surrounds and accommodates various components of device 100. Device 100 has an opening 104 in one end, through which an article 110 can be inserted for heating by a heating assembly. When 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 heating assembly.

[0181] The device 100 in this example includes a first end member 106, the first end member 106 having a lid 108 that is movable relative to the first end member 106 to close the opening 104 when the article 110 is not in place. In Figure 2, the lid 108 is shown in an open configuration, but the lid 108 can be moved to a closed configuration. For example, the user may slide the lid 108 in the direction of arrow "B".

[0182] Device 100 may also include a user-operable control element 112, such as a button or switch, which operates device 100 when pressed. For example, a user may turn on device 100 by operating the switch 112.

[0183] Device 100 may also include electrical components such as a socket / port 114 that can receive a cable for charging the device 100's battery. For example, the socket 114 may be a charging port, such as a USB charging port. Aerosol-free delivery In some embodiments, the delivery system is an aerosol-free delivery system that delivers at least one substance to a user orally, nasally, transdermally, or by another means that does not form an aerosol, and includes, but is not limited to, articles containing lozenges, gums, patches, inhalable powders, and oral products such as oral tobacco containing snus or wet snuff, wherein at least one substance may or may not contain nicotine.

[0184] In some embodiments, the dried molded particles are incorporated into a pouch for oral use. The dried molded particles may be the sole material in the pouch, or they may be combined with other materials, including other sources of active and / or flavoring substances.

[0185] An example of a permeable pouch is shown in Figure 3. The pouch 21 comprises two sheets 22 of a porous material. These sheets are fused or bonded along their edges to form a chamber in which a flavor delivery composition and / or active substance delivery composition 23 is sealed. This flavor delivery composition and / or active substance delivery composition comprises dried molded particles disclosed herein.

[0186] Because dried molded particles provide plant-based substances, such as tobacco extracts, in a highly concentrated form, oral pouches can be very small while still delivering the same physiological and sensory stimulating effects as much larger conventional oral pouches. This can be beneficial to the user in terms of comfort during use or the product being less noticeable.

[0187] In some embodiments, the use of polysaccharides such as dextran as an excipient means that the dried molded particles may have a sweet taste when placed in the mouth. This can reduce the need to include further or optional additional sweeteners or flavorings.

[0188] Other possible aerosol-free delivery systems, including the dried molded particles disclosed herein, deliver the ingredients to the user orally, nasally, transdermally, or by any other suitable route of administration. In some embodiments, the molded particles are incorporated into products selected from the group consisting of lozenges, gums, patches, and inhalable powders. [Examples]

[0189] Example 1 - Nicotine retention The nicotine content of the liquid composition and dried beads after the freeze-drying process is calculated and indicates the amount of nicotine retained after processing. Compared to the original tobacco extract, the nicotine recovery rate of the dried aerosol-producing material is at least about 50% by weight on a dry weight basis. Compared to the original tobacco extract, the nicotine recovery rate of the dried aerosol-producing material may be at least about 55%, at least about 60%, at least about 75%, at least about 80%, or at least about 90% on a dry weight basis.

[0190] Example 2 - Glycerol retention The glycerol content of the precursor and dried aerosol-generating materials after the freeze-drying process has been calculated and indicates the amount of glycerol retained after processing. Compared to the precursor material, the glycerol recovery rate of the dried aerosol-generating material is at least about 50%. Compared to the precursor material, the glycerol recovery rate of the dried aerosol-generating material may be at least about 60%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, and at least about 95% on a dry weight basis.

[0191] Example 3 1.Liquid composition A series of liquid composition samples were prepared according to the configurations shown in Table 1 below.

[0192] Liquid aqueous tobacco extract was combined with an equal volume of solvent containing an aqueous solution of an excipient and / or aerosol-forming agent material. The excipient used was dextran 70. The aerosol-forming agent material used was glycerol. The effects of this component on the process and product were investigated using three different aqueous tobacco extracts.

[0193] [Table 1]

[0194] 2. Flash frozen droplets Droplets with a volume of approximately 20 μl were dispensed into a vacuum flask (Dewar flask) containing liquid nitrogen. Next, the frozen droplets formed from each sample were transferred to another vial at a temperature of -50°C and atmospheric pressure. The size and shape of the frozen droplets were uniform, but there was some variation in color. The frozen droplets were substantially spherical.

[0195] 3. Primary (freeze-drying) stage The frozen droplets were freeze-dried at a temperature of -50°C and a pressure of 30 μbar for 5380 minutes.

[0196] 4. Secondary drying stage Next, the temperature of the freeze-dried beads was adjusted to 20°C over a period of 140 minutes. The pressure was maintained at 30 μbar. Once the target temperature of 20°C was reached, the beads were held at this temperature and pressure of 30 μbar for a further 1250 minutes.

[0197] The properties of the obtained dried beads are summarized in Table 2.

[0198] [Table 2]

[0199] From the above comments, we can draw the following conclusions.

[0200] The excipient dextran 70 was found to stabilize the liquid composition during the drying process, appearing to prevent the observed undesirable swelling (expansion). While not all beads in the batch experienced this phenomenon, the absence of the excipient in the liquid composition resulted in some of the dried material being unsuitable for use. Incomplete drying also occurred in sample number 1 in the absence of the excipient.

[0201] The amount of glycerol present appeared to have only a slight effect on the product's appearance and, despite its freeze-resistant properties, did not seem to adversely affect the drying process at -50°C.

[0202] Example 4 The effects of glycerol and excipients (in this case, dextran 70) on the disintegration temperature of the formulation were evaluated, and the results are shown in Table 3.

[0203] [Table 3]

[0204] As this data shows, the inclusion of glycerol lowered the decay temperature. This means that formulations containing glycerol need to be freeze-dried at lower temperatures (and for longer periods).

[0205] The data also shows that the inclusion of dextran as an excipient increased the disintegration temperature. This means that some of the effects of including glycerol in the liquid composition can be compensated for by including an excipient. Furthermore, including an excipient raises the temperature at which the process can be carried out without the risk of disintegration of the formulation and the unacceptable effects of that disintegration on the resulting dried composition, thus making the freeze-drying process cheaper and faster.

[0206] The various embodiments described herein are presented solely to aid in understanding and teaching the claimed features. These embodiments are provided only as representative examples of embodiments and are not exhaustive or exclusive. The advantages, embodiments, examples, functions, features, structures, and / or other aspects described herein should not be considered limitations to the scope of the invention as defined by the claims or to equivalents of the claims, and it should be understood that other embodiments may be used and modified without departing from the scope of the claimed invention. Various embodiments of the invention may suitably include, consist of, or essentially consist of, appropriate combinations of disclosed elements, components, features, parts, steps, means, etc., other than those specifically described herein. In addition, this disclosure may include other inventions that are not currently claimed but may be claimed in the future.

Claims

1. Molded particles each containing a freeze-dried molded portion of a liquid composition containing a plant extract.

2. The molded particles according to claim 1, wherein the molded particles contain volatile and semi-volatile components of the plant extract.

3. The molded particle according to claim 1 or 2, wherein the plant extract is tobacco extract and optionally aqueous tobacco extract.

4. The molded particle according to any one of claims 1 to 3, wherein the liquid composition further comprises an aerosol-forming agent material.

5. The molded particle according to claim 4, wherein the aerosol-forming agent material is glycerol.

6. The molded particle according to any one of claims 1 to 5, wherein the liquid composition further comprises an excipient.

7. The molded particle according to any one of claims 1 to 6, wherein the excipient is dextran.

8. Molded particles according to any one of claims 1 to 7, comprising approximately 45 to approximately 100% by weight (based on dry weight) of dried plant extract.

9. A molded particle according to any one of claims 1 to 8, comprising approximately 1 to approximately 20% by weight (on a dry weight basis) of an aerosol-forming agent material.

10. A molded particle according to any one of claims 1 to 9, comprising approximately 0.1 to approximately 20% by weight (on a dry weight basis) of an excipient.

11. The molded particle according to any one of claims 1 to 10, wherein the molded particle is a freeze-dried droplet of the liquid composition containing a plant extract.

12. The molded particle according to any one of claims 1 to 11, wherein the molded particle is a spherical bead.

13. The molded particle according to claim 12, wherein at least 90% of the beads have a diameter that varies by 5% or less from the mass median diameter of the group.

14. The molded particle according to claim 12 or 13, wherein the beads have a diameter in the range of about 2 mm to about 5 mm.

15. The aforementioned beads are approximately 0.005 to 0.02 cm in diameter. ３ A molded particle according to any one of claims 12 to 14, having the volume of the specified amount.

16. The molded particles are approximately 0.5 to approximately 1.5 g / cm³ ３ A molded particle according to any one of claims 1 to 15, having a density in the range of [value].

17. The molded particle according to any one of claims 1 to 11, wherein the molded particle has a flat shape such as a thin strip or a disc.

18. Molded particles according to claim 17, having a thickness of approximately 0.05 mm to approximately 1 mm.

19. Molded particles according to any one of claims 1 to 18, having a residual moisture content of about 12% or less, or about 10% or less, as measured by Karl Fischer analysis.

20. The molded particles according to claim 19, having a residual moisture content of at least 7% as measured by Karl Fischer analysis.

21. A method for providing molded particles, The steps include supplying a portion of the liquid composition containing plant extracts into a mold, The steps include freeze-drying the liquid composition within the mold, A method that includes this.

22. A method for providing molded particles, A step of pre-freezing droplets of a liquid composition containing a plant extract, The steps include freeze-drying the aforementioned frozen droplets to form beads, A method that includes this.

23. The method according to claim 22, wherein the droplet of the liquid composition containing the plant extract has a volume of about 1 μl to about 50 μl.

24. The method according to claim 22 or 23, wherein the droplets are pre-frozen by dispensing droplets of the liquid composition into liquid nitrogen.

25. The method according to claim 24, wherein the droplets are pre-frozen at atmospheric pressure.

26. The method according to claim 24 or 25, wherein the droplet freezes instantaneously upon contact with the liquid nitrogen.

27. The method according to any one of claims 21 to 26, wherein the freeze-drying is carried out at a temperature of about -35 to about -50°C.

28. The method according to any one of claims 21 to 27, wherein the freeze-drying is performed at a pressure of about 30 to about 40 μbar.

29. The method according to any one of claims 21 to 28, wherein the freeze-drying is carried out for about 48 hours to about 120 hours.

30. The method according to any one of claims 21 to 29, comprising a secondary drying step.

31. The method according to claim 30, wherein the secondary drying step includes raising the temperature of the freeze-dried molded particles to a secondary drying temperature of 20°C or less.

32. The method according to claim 31, wherein the freeze-dried molded particles are held at a secondary drying temperature for a period of about 9 hours to about 24 hours.

33. The method according to any one of claims 30 to 32, wherein the secondary drying step is performed at a pressure of about 20 to about 30 μbar.

34. A non-combustion aerosol supply system comprising molded particles according to any one of claims 1 to 20.

35. The non-combustion aerosol supply system according to claim 34, wherein the system is configured to heat the molded particles to form steam and / or aerosol.

36. A non-combustible aerosol supply system according to claim 34 or 35, further comprising a further aerosol-generating material that is heated to form an aerosol and / or vapor, wherein the further aerosol-generating material is optionally a liquid.

37. An article for use in a non-combustible aerosol supply system, comprising molded particles according to any one of claims 1 to 20.

38. An oral product comprising a permeable container surrounding molded particles according to any one of claims 1 to 20.

39. A method for providing the article described in claim 37 or the oral product described in claim 38, A step of forming one or more molded particles according to the method described in any one of claims 21 to 33, The steps include placing one or more molded particles inside a container, A method that includes this.

40. Use of molded particles according to any one of claims 1 to 20 for generating an inhalable medium.

41. Molded particles obtained or obtainable by the method of any one of claims 21 to 33 for generating an inhalable medium for use in an aerosol supply system.

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