Spray-dried nicotine for inclusion in oral products

Abstract

A method for preparing a nicotine-containing powder for inclusion in an oral product is provided. [Solution] A method for preparing a nicotine-containing powder (432) includes a step S410 of dissolving a carrier (402) including a biopolymer, a natural polymer, a synthetic polymer, a bulk sweetener, or any combination thereof, in a solvent (404) to form a first solution (408), a step S420 of contacting the first solution with nicotine, a nicotine complex, a nicotine salt, or any combination thereof to form a second mixture (428), and a step S430 of spray-drying the second mixture to form a plurality of particles defining the nicotine-containing powder.

Description

[Technical Field]

[0001] The present disclosure relates to spray-dried nicotine for inclusion in oral products and methods for its preparation. [Background technology]

[0002] Oral nicotine products are available in a variety of forms, such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, sticks (e.g., coated wooden dowels or single-use dissolvable sticks), pouches (e.g., containing fibers or granules), etc. Oral products can have nicotine strengths that provide a familiar experience for adult tobacco consumers. Summary of the Invention

[0003] At least some exemplary embodiments relate to methods for preparing nicotine-containing powders.

[0004] In at least one exemplary embodiment, a method of preparing a nicotine-containing powder comprises dissolving a carrier including a biopolymer, a natural polymer, a synthetic polymer, a bulk sweetener, or any combination thereof, in a solvent to form a first solution; contacting the first solution with nicotine, a nicotine complex, a nicotine salt, or any combination thereof to form a second mixture; and spray-drying the second mixture to form a plurality of particles defining the nicotine-containing powder.

[0005] In at least one exemplary embodiment, the biopolymer may include a polysaccharide, a bulk sweetener, or any combination thereof.

[0006] In at least one exemplary embodiment, the polysaccharide may comprise starch, methylcellulose, hydroxypropyl cellulose (HPC), hydroxymethylpropyl cellulose (HPMC), highly methylated pectin, under methylated pectin, amidated pectin, carboxymethylcellulose (CMC), dextrin, maltodextrin, xanthan gum, agar, carrageenan, guar gum, alginic acid, or any combination thereof.

[0007] In at least one exemplary embodiment, the bulk sweetener may include sucrose, dextrose, fructose, lactose, raffinose, trehalose, maltose, maltodextrin, isomalt, a sugar alcohol, or any combination thereof.

[0008] In at least one exemplary embodiment, the sugar alcohol may comprise sorbitol, mannitol, xylitol, maltitol, lactitol, isomalt, hydrogenated isomaltulose, hydrogenated starch hydrolysates, or any combination thereof.

[0009] In at least one exemplary embodiment, the biopolymer may comprise starch, methylcellulose, hydroxypropyl cellulose (HPC), hydroxymethylpropyl cellulose (HPMC), highly methylated pectin, under methylated pectin, amidated pectin, carboxymethylcellulose (CMC), dextrin, maltodextrin, xanthan gum, agar, carrageenan, guar gum, alginic acid, sucrose, dextrose, fructose, lactose, raffinose, trehalose, maltose, maltodextrin, or any combination thereof.

[0010] In at least one exemplary embodiment, the natural polymer may include pectin, starch, gum arabic, or any combination thereof.

[0011] In at least one exemplary embodiment, the nicotine salt may include citrate, monotartrate, bitartrate, bitartrate dihydrate, salicylate, sulfate or disulfate, phosphate or superphosphate, acetate, lactate, succinate, maleate, fumarate, gluconate, saccharate, benzoate, methanesulfonate, hydrochloride, hydrobromide, hydroiodide, or any combination thereof.

[0012] In at least one exemplary embodiment, the solvent may include water, where the inlet temperature setpoint ranges from 120°C to 210°C and the initial product temperature ranges from 25°C to 100°C.

[0013] In at least one exemplary embodiment, the solvent may include ethanol, where the inlet temperature setpoint ranges from 65°C to 180°C and the initial product temperature ranges from 25°C to 79°C.

[0014] In at least one exemplary embodiment, the average particle size of the plurality of particles may range from 5 μm to 200 μm.

[0015] In at least one exemplary embodiment, the plurality of particles may have a moisture content of 10% or less.

[0016] In at least one exemplary embodiment, the method may further comprise homogenizing the second mixture.

[0017] In at least one exemplary embodiment, the method may further comprise adding a pH adjuster to the second mixture.

[0018] In at least one exemplary embodiment, the method can further include adding an antioxidant to the second mixture. The antioxidant can include ascorbyl palmitate, butylhydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherol, propyl gallate, tert-butylhydroquinone (TBHQ), butylhydroxyanisole (BHA), vitamin E, derivatives thereof, or any combination thereof.

[0019] In at least one exemplary embodiment, a method of preparing a nicotine-containing granule is provided, which may include preparing a nicotine-containing powder as detailed above, and compressing a portion of a plurality of particles defining the nicotine-containing powder to form the nicotine-containing granule.

[0020] In at least one exemplary embodiment, a method for preparing a nicotine-containing powder comprising a plurality of particles having a uniform size may include dissolving a carrier in a solvent to form a first solution; contacting the first solution with nicotine, a nicotine complex, a nicotine salt, or any combination thereof to form a second mixture; homogenizing the second mixture to form a third mixture; and spray-drying the third mixture to form a plurality of particles defining the nicotine-containing powder, wherein the average particle size of the plurality of particles is in the range of 5 μm to 200 μm. The carrier may include starch, methylcellulose, hydroxypropyl cellulose (HPC), hydroxymethylpropyl cellulose (HPMC), highly methylated pectin, low methylated pectin, amidated pectin, carboxymethylcellulose (CMC), dextrin, maltodextrin, xanthan gum, agar, carrageenan, guar gum, alginic acid, sucrose, dextrose fructose, lactose, raffinose, trehalose, maltose, maltodextrin, sorbitol, mannitol, xylitol, maltitol, lactitol, isomalt, hydrogenated isomaltulose, hydrogenated starch hydrolysates, polyvinylpyrrolidone (PVP), copolymers of polyvinylpyrrolidone (PVP) and vinyl acetate, methacrylate copolymers, or any combination thereof. The solvent may include water, ethanol, or any combination thereof.

[0021] In at least one exemplary embodiment, the solvent can include water, where the inlet temperature setpoint ranges from 120°C to 210°C and the initial product temperature ranges from 25°C to 100°C.

[0022] In at least one exemplary embodiment, the solvent may include ethanol, the inlet temperature setpoint ranges from 65°C to 180°C, and the initial product temperature ranges from 25°C to 79°C.

[0023] In at least one exemplary embodiment, the method can further include adding at least one of a pH adjuster and an antioxidant to the second mixture. The antioxidant can include ascorbyl palmitate, butylhydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherol, propyl gallate, tert-butylhydroquinone (TBHQ), butylhydroxyanisole (BHA), vitamin E, derivatives thereof, or any combination thereof. [Brief explanation of the drawings]

[0024] Various features and advantages of the non-limiting embodiments herein will become more apparent from a consideration of the detailed description in conjunction with the accompanying drawings. The accompanying drawings are provided for illustrative purposes only and should not be construed as limiting the scope of the claims. The accompanying drawings are not to be considered as drawn to scale unless explicitly noted. Various dimensions of the drawings may be exaggerated for clarity.

[0025] [Figure 1] FIG. 1 is a flow diagram illustrating a method of forming a nicotine-containing powder, according to at least one exemplary embodiment.

[0026] [Figure 2] FIG. 1 is a flow diagram illustrating a method of forming a nicotine-containing powder, according to at least one exemplary embodiment.

[0027] [Figure 3] FIG. 1 is a flow diagram illustrating a method of forming a nicotine-containing powder, according to at least one exemplary embodiment.

[0028] [Figure 4] FIG. 1 is a flow diagram illustrating a method of forming a nicotine-containing powder, according to at least one exemplary embodiment.

[0029] [Figure 5]FIG. 1 is a cross-sectional view of an encapsulated nicotine granule according to at least one exemplary embodiment.

[0030] [Figure 6] FIG. 1 is a cross-sectional view of an encapsulated nicotine granule according to at least one exemplary embodiment.

[0031] [Figure 7] FIG. 1 is a flow diagram illustrating a method of forming encapsulated nicotine granules, according to at least one exemplary embodiment.

[0032] [Figure 8] FIG. 1 is a cross-sectional view of an encapsulated sweetener according to at least one exemplary embodiment.

[0033] [Figure 9] FIG. 1 is a cross-sectional view of an encapsulated sweetener granule according to at least one exemplary embodiment.

[0034] [Figure 10] FIG. 1 is a flow diagram illustrating a method of forming encapsulated sweetener granules, according to at least one exemplary embodiment.

[0035] [Figure 11] The chemical structures of different forms of nicotine are shown: free base nicotine (A), monoprotonated nicotine (B), and diprotonated nicotine (C).

[0036] [Figure 12] Graphs showing nicotine kinetics in the cheek for different nicotine solutions ((A)-(B)).

[0037] [Figure 13A] Figure 13A is a table showing partition coefficient data for nicotine in different oil and water phase combinations. [Figure 13B]FIG. 1 shows the chemical structure of triacetin (C2). [Figure 13C] FIG. 1 shows the chemical structure of MCT (C8-C10). [Figure 13D] FIG. 1 shows the chemical structure of triolein (C18).

[0038] [Figure 14] FIG. 1 is a perspective view of a pouch product according to at least one exemplary embodiment.

[0039] [Figure 15] FIG. 1 is a perspective view of a fusible film according to at least one exemplary embodiment.

[0040] [Figure 16A] 1 is a perspective view of an oral product having a circular cross-section according to at least one exemplary embodiment.

[0041] [Figure 16B] 1 is a perspective view of an oral product having an oval cross-section according to at least one exemplary embodiment.

[0042] [Figure 16C] 1 is a perspective view of an oral product having a rectangular cross-section according to at least one exemplary embodiment.

[0043] [Figure 16D] 1 is a perspective view of an oral product having an elongated rectangular cross-section according to at least one exemplary embodiment.

[0044] [Figure 16E] 1 is a perspective view of an oral product having a lenticular or football-shaped cross-section according to at least one exemplary embodiment.

[0045] [Figure 16F] 1 is a perspective view of an oral product having a boomerang-shaped cross-section according to at least one exemplary embodiment.

[0046] [Figure 16G] 1 is a perspective view of an oral product having a shield-shaped cross-section according to at least one exemplary embodiment.

[0047] [Figure 17] 1 is a perspective view of an oral product according to at least one exemplary embodiment.

[0048] [Figure 18] 1 is a perspective view of a chewing gum according to at least one exemplary embodiment;

[0049] [Figure 19A] 1 is a perspective view of a chewing gum having an oval cross section in accordance with at least one exemplary embodiment.

[0050] [Figure 19B] 1 is a perspective view of a chewing gum having a rectangular cross section in accordance with at least one exemplary embodiment.

[0051] [Figure 19C] 1 is a perspective view of a chewing gum having an elongated rectangular cross section in accordance with at least one exemplary embodiment.

[0052] [Figure 19D] 1 is a perspective view of a chewing gum having a lenticular or football-shaped cross section in accordance with at least one exemplary embodiment.

[0053] [Figure 19E] 1 is a perspective view of a chewing gum having a boomerang-shaped cross section in accordance with at least one exemplary embodiment.

[0054] [Figure 19F] 1 is a perspective view of a chewing gum having a shield-shaped cross section in accordance with at least one exemplary embodiment;

[0055] [Figure 20] 1 is a perspective view of a chewing gum according to at least one exemplary embodiment;

[0056] [Figure 21] 1 is a cross-sectional view of a coated chewing gum according to at least one exemplary embodiment.

[0057] [Figure 22] 1 is a perspective view of an oral pouch product according to at least one exemplary embodiment. FIG.

[0058] [Figure 23] 23 is a cross-sectional view of the oral pouch product taken along line II-II shown in FIG. 22 according to at least one exemplary embodiment.

[0059] [Figure 24] 23 is a cross-sectional view of the oral pouch product taken along line III-III shown in FIG. 22 according to at least one exemplary embodiment.

[0060] [Figure 25] FIG. 1 is a side view of an oral pouch product according to at least one exemplary embodiment.

[0061] [Figure 26] FIG. 7B is a cross-sectional view of the oral pouch product shown in FIG. 25 taken along line VII-VII according to at least one exemplary embodiment.

[0062] [Figure 27] 1 is a cross-sectional view of an oral pouch product according to at least one exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0063] Several detailed exemplary embodiments are disclosed herein. However, the specific structural and functional details disclosed herein are merely representative for purposes of describing the exemplary embodiments. The exemplary embodiments may be embodied in many alternative forms and should not be construed as being limited to only the exemplary embodiments described herein.

[0064] Thus, while exemplary embodiments are susceptible to various modifications and alternative forms, such exemplary embodiments are shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that there is no intention to limit the exemplary embodiments to the particular forms disclosed, but on the contrary, the exemplary embodiments are intended to encompass all modifications, equivalents, and alternatives falling within the scope of the exemplary embodiments. Like numbers refer to like elements throughout the description of the figures.

[0065] When an element or layer is referred to as being "on," "connected to," "coupled to," or "covering" another element or layer, it is understood that it may be directly on, connected to, coupled to, or covering the other element or layer, or that intervening elements or layers may be present. Conversely, when an element is referred to as being "directly on," "directly connected to," or "directly coupled to" another element or layer, there are no intervening elements or layers present. Like numbers refer to like elements throughout this specification. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0066] Terms such as first, second, and third may be used herein to describe various elements, regions, layers, and / or sections, but it should be understood that these elements, regions, layers, and / or sections are not limited by these terms. These terms are used only to distinguish one element, region, layer, or section from another region, layer, or section. Thus, a first element, component, region, layer, or section described below could be referred to as a second element, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0067] Spatially relative terms (e.g., "beneath," "below," "lower," "above," "upper," "inside," "upside," etc.) are used herein for ease of description and to describe the relationship of one element or feature to another element or feature, as shown in the figures. It should be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device were turned upside down in the figures, an element described as "below" or "beneath" another element or feature would be located "above" that other element or feature. Thus, the term "below" may encompass both upper and lower orientations. The device may be in other orientations (rotated 90 degrees or other orientations), and the spatially relative descriptors used herein would be interpreted accordingly.

[0068] The terminology used herein is for the purpose of describing various exemplary embodiments only and is not intended to limit the exemplary embodiments. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It will be further understood that the terms "includes," "including," "having," and / or "comprising" specify the presence of stated features, integers, steps, operations, and / or elements, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, and / or groups thereof.

[0069] Exemplary embodiments are described herein with reference to cross-sectional views that are schematic illustrations of exemplary embodiments. As such, variations from the shapes shown are to be expected. Accordingly, exemplary embodiments should not be construed as limited to the shapes of regions shown in this disclosure, but are intended to include deviations and variations in shapes. When the terms "about" or "substantially" are used in connection with numerical values, unless the context indicates otherwise, the associated numerical value is intended to include a tolerance of ±10% from the stated numerical value.

[0070] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments belong. Furthermore, terms, including those defined in commonly used dictionaries, should be interpreted as having a meaning consistent with the meaning in the context of the relevant technology, and will not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0071] In at least one exemplary embodiment, the present disclosure provides a method for enhancing the flavor and / or sensory effect of nicotine in an oral product. In at least one exemplary embodiment, the method includes spray-drying nicotine. In at least one exemplary embodiment, the method includes encapsulating nicotine. In at least one exemplary embodiment, the method includes encapsulating a sweetener such as may be included in an oral product that includes a nicotine-containing material.

[0072] In at least one exemplary embodiment, the oral product is an oral tobacco product, an oral non-tobacco product, an oral cannabis product, or any combination thereof. The oral product may be in the form of a loose material (e.g., loose cellulosic material), a shaped material (e.g., a plug or twist), a pouched material, a tablet, a lozenge, a chew, a gum, a film, other oral product, or any combination thereof.

[0073] Oral products may include chewing tobacco, snus, moist snuff, dry snuff, other smokeless tobacco, non-tobacco products for oral consumption, or any combination thereof.

[0074] When the oral product is an oral tobacco product, including a smokeless tobacco product, the smokeless tobacco product may include whole, shredded, cut, granulated, reconstituted, cured, aged, fermented, pasteurized, or other processed tobacco. The tobacco may be provided as a whole or a part thereof, such as the leaf, flower, root, stem, extract (e.g., nicotine), or any combination thereof.

[0075] In at least one exemplary embodiment, the oral product includes a tobacco extract, such as a tobacco-derived nicotine extract, and / or synthetic nicotine. The oral product may include nicotine alone or in combination with a carrier, such as a cellulosic material (e.g., white snus). The carrier may be a non-tobacco material (e.g., microcrystalline cellulose) or a tobacco material (e.g., tobacco fiber with reduced or removed nicotine content, which may be referred to as "exhausted tobacco plant tissue or fiber"). In some exemplary embodiments, the exhaused tobacco plant tissue or fiber can be processed to remove at least 25%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, or 95% of the nicotine. For example, the tobacco plant tissue can be washed with water or other solvents to remove the nicotine.

[0076] In other exemplary embodiments, the oral product may include cannabis, such as cannabis plant tissue and / or cannabis extract. In at least one exemplary embodiment, the cannabis material includes leaf and / or flower material from one or more species of cannabis plant, and / or extract from one or more species of cannabis plant. One or more species of cannabis plant may include Cannabis sativa, Cannabis indica, and / or Cannabis ruderalis. In at least one exemplary embodiment, the cannabis may be in the form of fiber. In at least one exemplary embodiment, the cannabis may include cannabinoids, terpenes, and / or flavonoids. In at least one exemplary embodiment, the cannabis material may be cannabis-derived cannabis material, such as cannabis-derived cannabinoids, cannabis-derived terpenes, and / or cannabis-derived flavonoids.

[0077] Oral products (e.g., oral tobacco products, oral non-tobacco products, or oral cannabis products) can contain a variety of moisture ranges. In at least one exemplary embodiment, the oral product is a dry oral product having a moisture content ranging from 5% to 10% by weight. In at least one exemplary embodiment, the oral product has a medium moisture content, such as a moisture content ranging from 20% to 35% by weight. In at least one exemplary embodiment, the oral product is a wet oral product having a moisture content ranging from 40% to 55% by weight.

[0078] In at least one exemplary embodiment, the oral product may further include one or more components such as a mouth-stable polymer, a mouth-soluble polymer, a sweetener (e.g., synthetic and / or natural sweeteners), a stimulant, a soothing agent, a concentration agent, a plasticizer, a mouth-soluble fiber, an alkaloid, a mineral, a vitamin, a dietary supplement, a nutraceutical, a colorant, an amino acid, a chemesthetic agent, an antioxidant, a food emulsifier, a pH adjuster, a botanical, a tooth whitening agent, a therapeutic agent, a processing aid, a stearate, a wax, a stabilizer, a disintegrant, a lubricant, a preservative, a filler, a flavoring agent, a flavor masking agent, a bitter receptor blocker, a receptor enhancer, other additives, or any combination thereof. <Spray-dried nicotine powder>

[0079] In at least one exemplary embodiment, nicotine-containing powders suitable for inclusion in oral products can be prepared using spray drying techniques. Such nicotine-containing powders can include a plurality of substantially uniform nicotine particles.

[0080] In at least some exemplary embodiments, the substantially uniform nicotine particles have an average particle size (90% distribution) ranging from about 5 μm to about 200 μm. For example, a plurality of substantially uniform nicotine particles can have an average particle size of about 5 μm or more (e.g., about 10 μm or more, about 20 μm or more, about 30 μm or more, about 40 μm or more, about 50 μm or more, about 60 μm or more, about 70 μm or more, about 80 μm or more, about 90 μm or more, about 100 μm or more, about 110 μm or more, about 120 μm or more, about 130 μm or more, about 140 μm or more, about 150 μm or more, about 160 μm or more, about 170 μm or more, about 180 μm or more, or about 190 μm or more). The plurality of substantially uniform nicotine particles can have an average particle size of about 200 μm or less (e.g., about 190 μm or less, about 180 μm or less, about 170 μm or less, about 160 μm or less, about 150 μm or less, about 140 μm or less, about 130 μm or less, about 120 μm or less, about 110 μm or less, about 100 μm or less, about 90 μm or less, about 80 μm or less, about 70 μm or less, about 60 μm or less, about 50 μm or less, about 40 μm or less, about 30 μm or less, about 20 μm or less, or about 10 μm or less).

[0081] In at least some exemplary embodiments, the substantially uniform nicotine particles have a moisture content of 10% or less. For example, the substantially uniform nicotine particles have a moisture content of 10% or less, 9% or less, 8% or less, 7% or less, 5% or less, 4% or less, 3% or less, 2% or less, or 1% or less.

[0082] In at least some exemplary embodiments, the nicotine content of the substantially uniform nicotine particles is 30% by weight or less. For example, the nicotine content of the substantially uniform nicotine particles can range from about 10% by weight to about 30% by weight. The nicotine content of the substantially uniform nicotine particles can be about 10% by weight or more (e.g., about 11% by weight or more, about 12% by weight or more, about 13% by weight or more, about 14% by weight or more, about 15% by weight or more, about 16% by weight or more, about 17% by weight or more, about 18% by weight or more, about 19% by weight or more, about 20% by weight or more, about 21% by weight or more, about 22% by weight or more, about 23% by weight or more, about 24% by weight or more, about 25% by weight or more, about 26% by weight or more, about 27% by weight or more, about 28% by weight or more, or about 29% by weight or more). The nicotine content of the substantially uniform nicotine particles can be about 30% by weight or less (e.g., about 29% by weight or less, about 28% by weight or less, about 27% by weight or less, about 26% by weight or less, about 25% by weight or less, about 24% by weight or less, about 23% by weight or less, about 22% by weight or less, about 21% by weight or less, about 20% by weight or less, about 19% by weight or less, about 18% by weight or less, about 17% by weight or less, about 16% by weight or less, about 15% by weight or less, about 14% by weight or less, about 13% by weight or less, about 12% by weight or less, or about 11% by weight or less).

[0083] 1 is a flow chart illustrating a method 400 for forming a nicotine-containing powder 432 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). The method 400 includes a step S410 of providing a first solution 408 (i.e., carrier solution). The first solution 408 may have a viscosity suitable for subsequent processing.

[0084] The first solution 408 may include a carrier 402 and a solvent 404. In at least some exemplary embodiments, the providing step S410 includes contacting the carrier 402 with the solvent 404 to form the first solution 408 (i.e., the carrier solution). In at least one exemplary embodiment, the contacting includes dissolving the carrier 402 in the solvent 404 to form the first solution 408 (i.e., the carrier solution). In each instance, the solvent 404 may include water, ethanol, or both water and ethanol. The carrier 402 may include a biopolymer, a natural polymer, a synthetic polymer, a bulk sweetener, a pyrrolidone polymer, a methacrylate copolymer, or any combination thereof.

[0085] The biopolymer may include, by way of example, a polysaccharide, a bulk sweetener, or both a polysaccharide and a bulk sweetener. In some exemplary embodiments, the polysaccharide may include, for example, starch, methylcellulose, hydroxypropyl cellulose (HPC), hydroxymethylpropyl cellulose (HPMC), highly methylated pectin, less methylated pectin, amidated pectin, carboxymethylcellulose (CMC), dextrin, maltodextrin, isomalt, xanthan gum, agar, carrageenan, guar gum, alginic acid, isomalt, or any combination thereof. In some exemplary embodiments, the bulk sweetener may include, for example, sucrose, dextrose, fructose, lactose, raffinose, trehalose, maltose, maltodextrin, isomalt, a sugar alcohol, or any combination thereof. In some exemplary embodiments, the biopolymer comprises, for example, starch, methylcellulose, hydroxypropyl cellulose (HPC), hydroxymethylpropyl cellulose (HPMC), highly methylated pectin, under methylated pectin, amidated pectin, carboxymethylcellulose (CMC), dextrin, xanthan gum, agar, carrageenan, guar gum, alginic acid, sucrose, dextrose, fructose, lactose, raffinose, trehalose, maltose, maltodextrin, isomalt, or any combination thereof.

[0086] In at least some exemplary embodiments, the natural polymer and synthetic polymer include, for example, pectin, starch, gum arabic, or any combination thereof. In some exemplary embodiments, the bulk sweetener includes, for example, a sugar alcohol, which may include, for example, sorbitol, mannitol, xylitol, maltitol, lactitol, isomalt, hydrogenated isomaltulose, hydrogenated starch hydrolysate, or any combination thereof. In some exemplary embodiments, the pyrrolidone polymer includes, for example, polyvinylpyrrolidone (PVP), a copolymer of polyvinylpyrrolidone (PVP) and vinyl acetate, or any combination thereof. In some exemplary embodiments, the methacrylate copolymer includes, for example, a copolymer of methacrylate and acrylic acid.

[0087] In at least some exemplary embodiments, the first solution 408 includes the carrier 402 in an amount ranging from about 3% to about 45% by weight. For example, the first solution 408 may include about 3% or more by weight of the carrier 402 (e.g., about 4% or more by weight, about 5% or more by weight, about 10% or more by weight, about 15% or more by weight, about 20% or more by weight, about 25% or more by weight, about 30% or more by weight, about 35% or more by weight, about 40% or more by weight, about 41% or more by weight, about 42% or more by weight, about 43% or more by weight, or about 44% or more by weight). The first solution 408 may include about 45% or less by weight of the carrier 402 (e.g., about 44% or less by weight, about 43% or less by weight, about 42% or less by weight, about 41% or less by weight, about 40% or less by weight, about 35% or less by weight, about 30% or less by weight, about 25% or less by weight, about 20% or less by weight, about 15% or less by weight, about 10% or less by weight). % or less by weight, about 5% or less by weight, or about 4% or less by weight. The amount of carrier 402 and the amount of solvent 404 in first solution 408 can be adjusted so that first solution 408 has a viscosity suitable for subsequent processing. In at least some exemplary embodiments, such as when carrier 402 includes pectin, first solution 508 can include about 5% by weight of carrier 402. In other exemplary embodiments, such as when carrier 402 includes maltodextrin, first solution 508 can include about 30% by weight of carrier 402.

[0088] In at least some exemplary embodiments, first solution 408 includes an amount ranging from about 55% to about 97% by weight of solvent 404. For example, first solution 408 can include about 55% or more by weight of solvent 404 (e.g., about 56% or more, about 57% or more, about 58% or more, about 59% or more, about 60% or more, about 65% or more, about 70% or more, about 75% or more, about 80% or more, about 85% or more, about 90% or more, about 95% or more, or about 96% or more by weight). The first solution 408 can include about 97% by weight or less of the solvent 404 (e.g., about 96% by weight or less, about 95% by weight or less, about 90% by weight or less, about 85% by weight or less, about 80% by weight or less, about 75% by weight or less, about 70% by weight or less, about 65% by weight or less, about 60% by weight or less, about 59% by weight or less, about 58% by weight or less, about 57% by weight or less, or about 56% by weight or less).

[0089] In at least one exemplary embodiment, the method 400 includes a step S420 of contacting the first solution 408 with a nicotine-containing formulation 422 to form a second mixture 428 (i.e., a feed solution). In some exemplary embodiments, the nicotine-containing formulation 422 includes nicotine, a nicotine conjugate (e.g., nicotine polacrilex), a nicotine salt, or any combination thereof. The nicotine salt may include a nitrate, monotartrate, bitartrate, bitartrate dihydrate, salicylate, sulfate or disulfate, phosphate or superphosphate, acetate, lactate, succinate, maleate, fumarate, gluconate, saccharate, benzoate, methanesulfonate, hydrochloride, hydrobromide, hydroiodide, or any combination thereof.

[0090] In at least some exemplary embodiments, second mixture 428 includes an amount ranging from about 85% to about 99% by weight of first solution 408. For example, second mixture 428 can include about 85% by weight or more of first solution 408 (e.g., about 86% by weight or more, about 87% by weight or more, about 88% by weight or more, about 89% by weight or more, about 90% by weight or more, about 91% by weight or more, about 92% by weight or more, about 93% by weight or more, about 94% by weight or more, about 95% by weight or more, about 96% by weight or more, about 97% by weight or more, or about 98% by weight or more). The second mixture 428 can comprise about 99% by weight or less (e.g., about 98% by weight or less, about 97% by weight or less, about 96% by weight or less, about 95% by weight or less, about 94% by weight or less, about 93% by weight or less, about 92% by weight or less, about 91% by weight or less, about 90% by weight or less, about 89% by weight or less, about 88% by weight or less, about 87% by weight or less, or about 86% by weight or less) of the first solution 408.

[0091] In at least some exemplary embodiments, such as when nicotine-containing formulation 422 includes pure nicotine, second mixture 428 includes nicotine-containing formulation 422 in an amount ranging from about 1% to about 10% by weight. For example, second mixture 428 may include about 1% by weight or more of nicotine-containing formulation 422 (e.g., about 2% by weight or more, about 3% by weight or more, about 4% by weight or more, about 5% by weight or more, about 6% by weight or more, about 7% by weight or more, about 8% by weight or more, or about 9% by weight or more) of nicotine-containing formulation 422. Second mixture 428 may include about 10% by weight or less of nicotine-containing formulation 422 (e.g., about 9% by weight or less, about 8% by weight or less, about 7% by weight or less, about 6% by weight or less, about 5% by weight or less, about 4% by weight or less, about 3% by weight or less, or about 2% by weight or less).

[0092] The second mixture 428 may have a viscosity that allows the second mixture 428 to be easily poured or pumped in a subsequent spray drying step. In at least one exemplary embodiment, the second mixture 428 may have a viscosity in the range of about 1 centipoise to about 700 centipoise at about 22°C. For example, the second mixture 428 can have a clay of about 1 centipoise or more (e.g., about 10 centipoise or more, about 20 centipoise or more, about 30 centipoise or more, about 40 centipoise or more, about 50 centipoise or more, about 100 centipoise or more, about 150 centipoise or more, about 200 centipoise or more, about 250 centipoise or more, about 300 centipoise or more, about 350 centipoise or more, about 400 centipoise or more, about 450 centipoise or more, about 500 centipoise or more, about 550 centipoise or more, about 600 centipoise or more, or about 650 centipoise or more) at about 22°C. The second mixture 428 can have a clay of about 700 centipoise or less (e.g., about 690 centipoise or less, about 680 centipoise or less, about 670 centipoise or less, about 660 centipoise or less, about 650 centipoise or less, about 600 centipoise or less, about 550 centipoise or less, about 500 centipoise or less, about 450 centipoise or less, about 400 centipoise or less, about 350 centipoise or less, about 300 centipoise or less, about 250 centipoise or less, about 200 centipoise or less, about 150 centipoise or less, about 100 centipoise or less, about 50 centipoise or less, about 40 centipoise or less, about 30 centipoise or less, about 20 centipoise or less, about 10 centipoise or less) at about 22°C. Such a viscosity is believed to be desirable to provide suitable rheological properties that allow the slurry to flow under applied pressure, as well as to allow the mixture 428 to remain stable.

[0093] In at least one exemplary embodiment, the method 400 includes a step S430 of spray-drying the second mixture 428 to form a plurality of particles defining a nicotine-containing powder 432 (i.e., a dry powder). The plurality of particles defining the nicotine-containing powder 432 may have an average particle size (90% distribution) in the range of about 5 μm to about 200 μm. For example, the plurality of particles defining the nicotine-containing powder 432 can have an average particle size of about 5 μm or more (e.g., about 10 μm or more, about 20 μm or more, about 30 μm or more, about 40 μm or more, about 50 μm or more, about 60 μm or more, about 70 μm or more, about 80 μm or more, about 90 μm or more, about 100 μm or more, about 110 μm or more, about 120 μm or more, about 130 μm or more, about 140 μm or more, about 150 μm or more, about 160 μm or more, about 170 μm or more, about 180 μm or more, about 190 μm or more). The plurality of particles defining the nicotine-containing powder 432 can have an average particle size of about 200 μm or less (e.g., about 190 μm or less, about 180 μm or less, about 170 μm or less, about 160 μm or less, about 150 μm or less, about 140 μm or less, about 130 μm or less, about 120 μm or less, about 110 μm or less, about 100 μm or less, about 90 μm or less, about 80 μm or less, about 70 μm or less, about 60 μm or less, about 50 μm or less, about 40 μm or less, about 30 μm or less, about 20 μm or less, or about 10 μm or less).

[0094] The moisture content of the plurality of particles defining the nicotine-containing powder 432 can be about 10% or less. For example, the moisture content of the nicotine-containing powder 432 can be about 10% or less, about 9% or less, about 8% or less, about 7% or less, about 5% or less, about 4% or less, about 3% or less, about 2% or less, or about 1% or less.

[0095] In at least some exemplary embodiments, the nicotine content of the nicotine-containing powder 432 is about 30% or less by weight. For example, the nicotine content of the nicotine-containing powder 432 can range from about 10% to about 30% by weight. The nicotine content of the nicotine-containing powder 432 can be about 10% or more by weight (e.g., about 11% or more by weight, about 12% or more by weight, about 13% or more by weight, about 14% or more by weight, about 15% or more by weight, about 16% or more by weight, about 17% or more by weight, about 18% or more by weight, about 19% or more by weight, about 20% or more by weight, about 21% or more by weight, about 22% or more by weight, about 23% or more by weight, about 24% or more by weight, about 25% or more by weight, about 26% or more by weight, about 27% or more by weight, about 28% or more by weight, or about 29% or more by weight). The nicotine content of the nicotine-containing powder 432 can be about 30% by weight or less (e.g., about 29% by weight or less, about 28% by weight or less, about 27% by weight or less, about 26% by weight or less, about 25% by weight or less, about 24% by weight or less, about 23% by weight or less, about 22% by weight or less, about 21% by weight or less, about 20% by weight or less, about 19% by weight or less, about 18% by weight or less, about 17% by weight or less, about 16% by weight or less, about 15% by weight or less, about 14% by weight or less, about 13% by weight or less, about 12% by weight or less, or about 11% by weight or less).

[0096] A variety of spray drying techniques and equipment known to those skilled in the art may be employed. Spray drying parameters may be used to tailor the dried final product (e.g., nicotine-containing powder 432) to precise quality standards and physical characteristics. These standards and characteristics include particle size distribution, residual moisture content, bulk density, and particle morphology.

[0097] In some exemplary embodiments, the nozzle air pressure for spray-drying step S430 ranges from about 30 psi to about 40 psi. For example, the nozzle air pressure can be about 30 psi or greater (e.g., about 31 psi or greater, about 32 psi or greater, about 33 psi or greater, about 34 psi or greater, about 35 psi or greater, about 36 psi or greater, about 37 psi or greater, about 38 psi or greater, or about 39 psi or greater). The nozzle air pressure can be about 40 psi or less (e.g., about 39 psi or less, about 38 psi or less, about 37 psi or less, about 36 psi or less, about 35 psi or less, about 34 psi or less, about 33 psi or less, about 32 psi or less, or about 31 psi or less).

[0098] In some exemplary embodiments, the solution pump revolutions per minute in the spray-drying step S430 ranges from about 15 rpm to about 35 rpm. For example, the solution pump revolutions per minute can be about 15 rpm or greater (e.g., about 16 rpm or greater, about 17 rpm or greater, about 18 rpm or greater, about 19 rpm or greater, about 20 rpm or greater, about 21 rpm or greater, about 22 rpm or greater, about 23 rpm or greater, about 24 rpm or greater, about 25 rpm or greater, about 26 rpm or greater, about 27 rpm or greater, about 28 rpm or greater, about 29 rpm or greater, about 30 rpm or greater, about 31 rpm or greater, about 32 rpm or greater, about 33 rpm or greater, or about 34 rpm or greater). The solution pump rotation speed can be about 35 rpm or less (e.g., about 35 rpm or less, about 34 rpm or less, about 33 rpm or less, about 32 rpm or less, about 31 rpm or less, about 30 rpm or less, about 29 rpm or less, about 28 rpm or less, about 27 rpm or less, about 26 rpm or less, about 25 rpm or less, about 24 rpm or less, about 23 rpm or less, about 22 rpm or less, about 21 rpm or less, about 20 rpm or less, about 19 rpm or less, about 18 rpm or less, about 17 rpm or less, or about 16 rpm or less).

[0099] In some exemplary embodiments, the solution spray rate in spray-drying step S430 ranges from about 9 g / min to about 15 g / min. For example, the solution spray can be about 9 g / min or more (e.g., about 10 g / min or more, about 11 g / min or more, about 12 g / min or more, about 13 g / min or more, or about 14 g / min or more). The solution spray can be about 15 g / min or less (e.g., about 14 g / min or less, about 13 g / min or less, about 12 g / min or less, about 11 g / min or less, or about 10 g / min or less).

[0100] In some exemplary embodiments, the spray time of the spray drying step S430 ranges from about 40 minutes to about 200 minutes. For example, the nebulization time can be about 40 minutes or more (e.g., about 45 minutes or more, about 50 minutes or more, about 55 minutes or more, about 60 minutes or more, about 65 minutes or more, about 70 minutes or more, about 75 minutes or more, about 80 minutes or more, about 85 minutes or more, about 90 minutes or more, about 95 minutes or more, about 100 minutes or more, about 105 minutes or more, about 110 minutes or more, about 115 minutes or more, about 120 minutes or more, about 125 minutes or more, about 130 minutes or more, about 135 minutes or more, about 140 minutes or more, about 145 minutes or more, about 150 minutes or more, about 155 minutes or more, about 160 minutes or more, about 165 minutes or more, about 170 minutes or more, about 175 minutes or more, about 180 minutes or more, about 185 minutes or more, about 190 minutes or more, or about 195 minutes or more). The nebulization time can be about 200 minutes or less (e.g., about 195 minutes or less, about 190 minutes or less, about 185 minutes or less, about 180 minutes or less, about 175 minutes or less, about 170 minutes or less, about 165 minutes or less, about 160 minutes or less, about 155 minutes or less, about 150 minutes or less, about 145 minutes or less, about 140 minutes or less, about 135 minutes or less, about 130 minutes or less, about 125 minutes or less, about 120 minutes or less, about 115 minutes or less, about 110 minutes or less, about 105 minutes or less, about 100 minutes or less, about 95 minutes or less, about 90 minutes or less, about 85 minutes or less, about 80 minutes or less, about 75 minutes or less, about 70 minutes or less, about 65 minutes or less, about 60 minutes or less, about 55 minutes or less, about 50 minutes or less, or about 45 minutes or less).

[0101] In some exemplary embodiments, such as when solvent 404 comprises water, the inlet temperature of spray-drying step S430 ranges from about 120° C. to about 210° C. For example, the inlet temperature can be about 120° C. or higher (e.g., about 125° C. or higher, about 130° C. or higher, about 135° C. or higher, about 140° C. or higher, about 145° C. or higher, about 150° C. or higher, about 155° C. or higher, about 160° C. or higher, about 165° C. or higher, about 170° C. or higher, about 175° C. or higher, about 180° C. or higher, about 185° C. or higher, about 190° C. or higher, about 195° C. or higher, about 200° C. or higher, or about 205° C. or higher). The inlet temperature can be about 210°C or less (e.g., about 205°C or less, about 200°C or less, about 195°C or less, about 190°C or less, about 185°C or less, about 180°C or less, about 175°C or less, about 170°C or less, about 165°C or less, about 160°C or less, about 155°C or less, about 150°C or less, about 145°C or less, about 140°C or less, about 135°C or less, or about 130°C or less).

[0102] In some exemplary embodiments, such as when solvent 404 comprises ethanol, the inlet temperature of spray-drying step S430 ranges from about 65° C. to about 180° C. For example, the inlet temperature can be about 65° C. or higher (e.g., about 70° C. or higher, about 75° C. or higher, about 80° C. or higher, about 85° C. or higher, about 90° C. or higher, about 95° C. or higher, about 100° C. or higher, about 105° C. or higher, about 110° C. or higher, about 115° C. or higher, about 120° C. or higher, about 125° C. or higher, about 130° C. or higher, about 135° C. or higher, about 140° C. or higher, about 145° C. or higher, about 150° C. or higher, about 155° C. or higher, about 160° C. or higher, about 165° C. or higher, about 170° C. or higher, or about 175° C. or higher). The inlet temperature can be about 180°C or less (e.g., about 175°C or less, about 170°C or less, about 165°C or less, about 160°C or less, about 155°C or less, about 150°C or less, about 145°C or less, about 140°C or less, about 135°C or less, about 130°C or less, about 125°C or less, about 120°C or less, about 115°C or less, about 110°C or less, about 105°C or less, about 100°C or less, about 95°C or less, about 90°C or less, about 85°C or less, about 80°C or less, about 75°C or less, or about 70°C or less).

[0103] In some exemplary embodiments, such as when solvent 404 comprises water, the initial product temperature in spray-drying step S430 ranges from about 25° C. to about 100° C. For example, the initial product temperature can be about 25° C. or higher (e.g., about 30° C. or higher, about 35° C. or higher, about 40° C. or higher, about 45° C. or higher, about 50° C. or higher, about 65° C. or higher, about 75° C. or higher, about 80° C. or higher, about 85° C. or higher, about 90° C. or higher, or about 95° C.). The initial product temperature can be about 100° C. or lower (e.g., about 95° C. or lower, about 90° C. or lower, about 85° C. or lower, about 80° C. or lower, about 75° C. or lower, about 70° C. or lower, about 65° C. or lower, about 60° C. or lower, about 55° C. or lower, about 50° C. or lower, about 45° C. or lower, about 40° C. or lower, about 35° C. or lower, or about 30° C. or lower).

[0104] In some exemplary embodiments, such as when solvent 404 comprises ethanol, the initial product temperature in spray-drying step S430 ranges from about 25° C. to about 79° C. For example, the initial product temperature can be about 25° C. or higher (e.g., about 30° C. or higher, about 35° C. or higher, about 40° C. or higher, about 45° C. or higher, about 50° C. or higher, about 55° C. or higher, about 60° C. or higher, about 65° C. or higher, or about 75° C. or higher). The initial product temperature can be about 79° C. or lower (e.g., about 78° C. or lower, about 77° C. or lower, about 76° C. or lower, about 75° C. or lower, about 70° C. or lower, about 65° C. or lower, about 60° C. or lower, about 55° C. or lower, about 50° C. or lower, about 45° C. or lower, about 40° C. or lower, about 35° C. or lower, or about 30° C. or lower).

[0105] After spray drying step S430, the nicotine-containing powder 432 may optionally be pressed into tablets, granules, pellets, cylinders, or other shapes to produce solid forms suitable for controllable release and inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules).

[0106] 2 is a flow diagram illustrating a method 500 for forming a nicotine-containing powder 542 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). Method 500 is similar to method 400, except that method 500 includes a step S530 of heating the second mixture (i.e., feed solution) 528 to a first temperature before the step S540 of spray drying.

[0107] For example, the method 500 includes a step S510 of contacting a carrier 502 with a solvent 504 to form a first solution 508 (i.e., a carrier solution), a step S520 of contacting the first solution 508 with a nicotine-containing formulation 522 to form a second mixture 528 (i.e., a feed solution), a step S530 of heating the second mixture 528, and a step S540 of spray-drying the heated second mixture 538 to form a plurality of particles defining a nicotine-containing powder 542 (i.e., a dry powder). Although not shown, the method 500 may include, after the spray drying step S540, pressing the nicotine-containing powder 542 into tablets, grains, pellets, cylinders, or other shapes to produce a solid form that is capable of sustained release and suitable for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules).

[0108] In at least some exemplary embodiments, the method 500 may include a step S530 of heating the second mixture to a first temperature.

[0109] In at least one exemplary embodiment, such as when the solvent 504 comprises water, the first temperature can range from about 120° C. to about 210° C. For example, the first temperature can be about 120° C. or higher (e.g., about 125° C. or higher, about 130° C. or higher, about 135° C. or higher, about 140° C. or higher, about 145° C. or higher, about 150° C. or higher, about 155° C. or higher, about 160° C. or higher, about 165° C. or higher, about 170° C. or higher, about 175° C. or higher, about 180° C. or higher, about 185° C. or higher, about 190° C. or higher, about 195° C. or higher, about 200° C. or higher, or about 205° C. or higher). The first temperature can be about 210°C or less (e.g., about 205°C or less, about 200°C or less, about 195°C or less, about 190°C or less, about 185°C or less, about 180°C or less, about 175°C or less, about 170°C or less, about 165°C or less, about 160°C or less, about 155°C or less, about 150°C or less, about 145°C or less, about 140°C or less, about 135°C or less, or about 130°C or less).

[0110] In some embodiments, such as when solvent 504 includes ethanol, the first temperature can range from about 65° C. to about 180° C. For example, the first temperature can be about 65° C. or higher (e.g., about 70° C. or higher, about 75° C. or higher, about 80° C. or higher, about 85° C. or higher, about 90° C. or higher, about 95° C. or higher, about 100° C. or higher, about 105° C. or higher, about 110° C. or higher, about 115° C. or higher, about 120° C. or higher, about 125° C. or higher, about 130° C. or higher, about 135° C. or higher, about 140° C. or higher, about 145° C. or higher, about 150° C. or higher, about 155° C. or higher, about 160° C. or higher, about 165° C. or higher, about 170° C. or higher, or about 175° C. or higher). The first temperature can be about 180°C or less (e.g., about 175°C or less, about 170°C or less, about 165°C or less, about 160°C or less, about 155°C or less, about 150°C or less, about 145°C or less, about 140°C or less, about 135°C or less, about 130°C or less, about 125°C or less, about 120°C or less, about 115°C or less, about 110°C or less, about 105°C or less, about 100°C or less, about 95°C or less, about 90°C or less, about 85°C or less, about 80°C or less, about 75°C or less, or about 70°C or less).

[0111] 3 is a flow diagram illustrating a method of forming a nicotine-containing powder 642 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). Method 500 is similar to methods 400 and / or 500, except that method 600 includes a step S630 of homogenizing second mixture 628 to form a third mixture 638 (i.e., feed solution) having a substantially uniform distribution. In some exemplary embodiments, the step S630 of homogenizing second mixture 628 may be performed using a paddle stirrer, a high-pressure stirrer, a high-shear stirrer, an ultrasonic homogenizer, or any combination thereof.

[0112] For example, the method 600 includes a step S610 of contacting a carrier 602 with a solvent 604 to form a first solution 508 (i.e., a carrier solution), a step S620 of contacting the first solution 608 with a nicotine-containing formulation 622 to form a second mixture 628, a step S630 of homogenizing the second mixture 628 to form a third mixture 638 (i.e., a feed solution), and a step S640 of spray-drying the third mixture 638 to form a plurality of particles defining a nicotine-containing powder 642 (i.e., a dry powder). After the spray drying step S640, although not shown, the method 600 may include a step of pressing the nicotine-containing powder 642 into tablets, grains, pellets, cylinders, or other shapes to produce a solid form that is capable of sustained release and suitable for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., including fibers or granules).

[0113] Although the homogenizing step S630 is illustrated as occurring after the contacting step S620, in at least one exemplary embodiment, the contacting step S620 and the homogenizing step S630 may occur simultaneously. Similarly, the method 600 may, in certain embodiments, include heating the second mixture 628 and / or the third mixture 638, as exemplified in method 500, and / or adding an additive, as exemplified in method 700.

[0114] 4 is a flow diagram illustrating a method 700 for forming a nicotine-containing powder 742 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). Method 700 is similar to methods 400 and / or 500 and / or 600, except that method 700 includes adding one or more additives 732 to a feed solution 738.

[0115] For example, the method 700 includes a step S710 of contacting a carrier 702 with a solvent 704 to form a first solution 708 (i.e., a carrier solution); a step S720 of contacting the first solution 708 with a nicotine-containing formulation 722 to form a second mixture 728; a step S730 of adding one or more additives 732 to the second mixture 728 to form a third mixture 738 (i.e., a feed solution); and a step S740 of spray-drying the third mixture 738 to form a plurality of particles defining a nicotine-containing powder 742 (i.e., a dry powder). After the spray drying step S740, although not shown, the method 700 may include a step of pressing the nicotine-containing powder 742 into tablets, grains, pellets, cylinders, or other shapes to produce a solid form that is capable of sustained release and suitable for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., including fibers or granules).

[0116] In some exemplary embodiments, the one or more additives include a pH adjuster, an antioxidant, or a combination of a pH adjuster and an antioxidant. The pH adjuster may include sodium carbonate / bicarbonate, potassium carbonate / bicarbonate, citric acid, or any combination thereof. The antioxidant may include ascorbyl palmitate, butylhydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherol, propyl gallate, tert-butylhydroquinone (TBHQ), butylhydroxyanisole (BHA), vitamin E, and any combination or derivative thereof. The presence of an antioxidant may help limit the formation of nicotine-N-oxides.

[0117] In at least some exemplary embodiments, third mixture 738 can have an amount ranging from about 0.1% to about 10% by weight of additive 732. For example, third mixture 738 can have about 0.1% by weight or more (e.g., about 0.5% by weight or more, about 1% by weight or more, about 1.5% by weight or more, about 2% by weight or more, about 2.5% by weight or more, about 3% by weight or more, about 3.5% by weight or more, about 4% by weight or more, about 4.5% by weight or more, about 5% by weight or more, about 5.5% by weight or more, about 6% by weight or more, about 6.5% by weight or more, about 7% by weight or more, about 7.5% by weight or more, about 8% by weight or more, about 8.5% by weight or more, about 9% by weight or more, or about 9.5% by weight or more). The third mixture 728 can have about 10% by weight or less (e.g., about 9.5% by weight or less, about 9% by weight or less, about 8.5% by weight or less, about 8% by weight or less, about 7.5% by weight or less, about 7% by weight or less, about 6.5% by weight or less, about 6% by weight or less, about 5.5% by weight or less, about 5% by weight or less, about 4.5% by weight or less, about 4% by weight or less, about 3.5% by weight or less, about 3% by weight or less, about 2.5% by weight or less, about 2% by weight or less, about 1% by weight or less, or about 0.5% by weight or less).

[0118] Although the step S730 of adding additive 731 is illustrated as a next step after the contacting step S720, in at least one exemplary embodiment, the contacting step S720 and the step S730 of adding additive may occur simultaneously. Similarly, method 700 may, in certain embodiments, include heating the second mixture 728 and / or the third mixture 738, as exemplified in method 500, and / or homogenizing the second mixture 728 and / or the third mixture 738, as exemplified in method 600.

[0119] In at least one exemplary embodiment, an exemplary feed solution for use in the spray-drying step, as shown in Figures 2 through 4, can be prepared to include pectin (a natural binder for nicotine) and nicotine oil in water. An exemplary feed solution can include about 6 wt. % pectin (i.e., carrier) and 1.5 wt. % nicotine oil in water as the solvent. The feed solution can be spray-dried, for example, using a VSD-200 spray dryer with a spray rate ranging from about 9 g / min to about 15 g / min and a spray time of about 150 minutes. The feed solution can have an initial product temperature ranging from about 86°C to about 90°C. The inlet temperature of the spray dryer can range from about 170°C to about 200°C. The exemplary feed solution can be spray-dried according to these listed parameters to produce a nicotine-containing powder having the properties listed in Table 1. [Table 1] Table 1. Examples of nicotine-containing powders prepared by spray drying step

[0120] In at least one exemplary embodiment, an exemplary feed solution for use in the spray-drying step as shown in Figures 2 through 4 can be prepared to include pectin (which is a natural binder for nicotine) and nicotine oil in water. An exemplary feed solution can include about 6 wt. % pectin (i.e., carrier) and 1.5 wt. % nicotine oil in water as the solvent. The feed solution can be spray-dried, for example, using a VSD-200 spray dryer with a spray rate ranging from about 9 g / min to about 10 g / min and a spray time of about 200 minutes. The feed solution can have an initial product temperature ranging from about 96°C to about 98°C. The inlet temperature of the spray dryer can be about 200°C. An exemplary feed solution can be spray-dried according to these recited parameters to produce a nicotine-containing powder having the properties set forth in Table 2. [Table 2] Table 2. Examples of nicotine-containing powders prepared by spray drying step

[0121] In at least one exemplary embodiment, an exemplary feed solution for use in the spray-drying step, as illustrated in Figures 2 to 4, can be prepared to include a mixture of gum arabic and maltodextrin and nicotine oil in water. The exemplary feed solution can include about 30% by weight of a mixture of gum arabic and maltodextrin (i.e., carrier) and 3.3% by weight of nicotine oil in water as a solvent. The ratio of gum arabic to maltodextrin can be about 2:3 by weight. The feed solution can be spray-dried, for example, using a VSD-200 spray dryer with a spray rate ranging from about 10 g / min to about 12 g / min and a spray time of about 100 minutes. The feed solution can have an initial product temperature ranging from about 92°C to about 96°C. The inlet temperature of the spray dryer can range from about 170°C to about 180°C. The exemplary feed solution can be spray-dried according to these recited parameters to produce a nicotine-containing powder having the properties set forth in Table 3. [Table 3] Table 3. Examples of nicotine-containing powders prepared by spray drying step

[0122] In at least one exemplary embodiment, an exemplary feed solution for use in the spray-drying step as illustrated in Figures 2 to 4 may be prepared to include a mixture of gum arabic and maltodextrin and nicotine oil in water. The exemplary feed solution may include about 30% by weight of a mixture of gum arabic and maltodextrin (i.e., carrier) and 7.5% by weight of nicotine oil in water as a solvent. The ratio of gum arabic to maltodextrin may be about 2:3 by weight. The feed solution may be spray-dried, for example, using a VSD-200 spray dryer with a spray rate ranging from about 9 g / min to about 12 g / min and a spray time of about 47.7 minutes. The feed solution may have an initial product temperature ranging from about 95°C to about 102°C. The inlet temperature of the spray dryer may be about 190°C. The exemplary feed solution may be spray-dried according to these recited parameters to produce a nicotine-containing powder having the properties listed in Table 4. [Table 4] Table 4. Examples of nicotine-containing powders prepared by spray drying step <Encapsulated nicotine granules>

[0123] In at least one exemplary embodiment, encapsulated nicotine granules (ENG) suitable for inclusion in oral products are provided.

[0124] 5 is a cross-sectional view of an example of an encapsulated nicotine granule 800 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, indissolvable chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). In at least one exemplary embodiment, the encapsulated nicotine granule 800 includes a nicotine-containing material 810 surrounded or encapsulated by a matrix 824. While the nicotine-containing material 810 is shown dispersed within the matrix 824, one skilled in the art will recognize that in various other examples, the matrix 824 can take on various other shapes or configurations. For example, in some exemplary embodiments, the matrix 824 can have the nicotine material 810 dispersed evenly throughout the encapsulated nicotine granule 800.

[0125] The encapsulated nicotine granules 800 may have an average particle size (D50) ranging from about 100 μm to about 5 mm. For example, the encapsulated nicotine granules 800 may have an average particle size of about 100 μm or greater (e.g., about 200 μm or greater, about 300 μm or greater, about 400 μm or greater, about 500 μm or greater, about 600 μm or greater, about 700 μm or greater, about 800 μm or greater, about 900 μm or greater, about 1 mm or greater, about 1.5 mm or greater, about 2.0 mm or greater, about 2.5 mm or greater, about 3.0 mm or greater, about 3.5 mm or greater, about 4.0 mm or greater, about 4.5 mm or greater, or about 5.0 mm or greater). The encapsulated nicotine granules 800 may have an average particle size of about 5 mm or less (e.g., 4.5 mm or less, about 4.0 mm or less, about 3.5 mm or less, about 3.0 mm or less, about 2.5 mm or less, about 2.0 mm or less, about 1.5 mm or less, about 1 mm or less, about 900 μm or less, about 800 μm or less, about 700 μm or less, about 600 μm or less, about 500 μm or less, about 400 μm or less, about 300 μm or less, about 200 μm or less, or about 150 μm or less).

[0126] In some exemplary embodiments, the nicotine-containing material 810 includes nicotine, a nicotine conjugate (such as nicotine polacrilex), a nicotine salt, or any combination thereof. The nicotine salt may include, for example, nitrate, monotartrate, bitartrate, bitartrate dihydrate, salicylate, sulfate or disulfate, phosphate or superphosphate, acetate, lactate, succinate, maleate, fumarate, gluconate, saccharate, benzoate, methanesulfonate, hydrochloride, hydrobromide, hydroiodide, or any combination thereof.

[0127] In at least one exemplary embodiment, matrix 824 includes a sugar alcohol, a humectant / oil, or a combination of a sugar alcohol and a humectant / oil. The sugar alcohol may include sorbitol, mannitol, xylitol, maltitol, lactitol, isomalt, hydrogenated isomaltulose, hydrogenated starch hydrolysates, or any combination thereof. The humectant / oil may help maintain the moisture level of matrix 824. In some exemplary embodiments, the humectant includes glycerol, propylene glycol, or a combination of glycerol and propylene glycol.

[0128] In at least one exemplary embodiment, matrix 824 can include sugar alcohol in an amount ranging from about 50% to about 99.5% by weight. For example, matrix 824 can include about 50% or more sugar alcohol (e.g., about 55% or more, about 60% or more, about 65% or more, about 70% or more, about 75% or more, about 80% or more, about 85% or more, about 90% or more, or about 95% or more by weight). Matrix 824 can include about 99.5% or less sugar alcohol (e.g., about 95% or less, about 90% or less, about 85% or less, about 80% or less, about 75% or less, about 70% or less, about 65% or less, about 60% or less, or about 55% or less by weight).

[0129] 6 is a cross-sectional view of an example of encapsulated nicotine granules 900 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). The encapsulated nicotine granules 900 are the same as the encapsulated nicotine granules 800, except that the encapsulated nicotine granules 900 include one or more additives 922.

[0130] In at least one exemplary embodiment, the encapsulated nicotine granules 900 include a nicotine-containing material 910 surrounded by or encapsulated in a matrix 920. The matrix 920 may include one or more additives 922. For example, the matrix 920 may include one or more additives 922 dispersed throughout the matrix 920. The one or more additives 922 may be substantially uniformly dispersed within the matrix 920 and around the nicotine-containing material 910. The encapsulated nicotine granules 900 may include one or more additives 922 in an amount ranging from greater than 0% to less than or equal to about 10% by weight. For example, the encapsulated nicotine granules 900 may include greater than 0% by weight of one or more additives 922 (e.g., about 0.1% by weight or more, about 0.5% by weight or more, about 1.0% by weight or more, about 1.5% by weight or more, about 2.0% by weight or more, about 2.5% by weight or more, about 3.0% by weight or more, about 3.5% by weight or more, about 4.0% by weight or more, about 4.5% by weight or more, about 5.0% by weight or more, about 5.5% by weight or more, about 6.0% by weight or more, about 6.5% by weight or more, about 7.0% by weight or more, about 7.5% by weight or more, about 8.0% by weight or more, about 8.5% by weight or more, about 9.0% by weight or more, or about 9.5% by weight or more). The encapsulated nicotine granules 900 may comprise about 10% by weight or less of one or more nicotine 922 (e.g., about 9.5% by weight or less, about 9.0% by weight or less, about 8.5% by weight or less, about 8.0% by weight or less, about 7.5% by weight or less, about 7.0% by weight or less, about 6.5% by weight or less, about 6.0% by weight or less, about 5.5% by weight or less, about 5.0% by weight or less, about 4.5% by weight or less, about 4.0% by weight or less, about 3.5% by weight or less, about 3.0% by weight or less, about 2.5% by weight or less, about 2.0% by weight or less, about 1.5% by weight or less, about 1.0% by weight or less, or about 0.5% by weight or less).

[0131] The one or more additives 922 may include, for example, an antioxidant, a sweetener, a pH adjuster, a polysaccharide, a flavoring agent, or any combination thereof. In at least one exemplary embodiment, the antioxidant additive includes ascorbyl palmitate, tert-butylhydroquinone (TBHQ), sodium ascorbate, or any combination thereof. In at least one exemplary embodiment, the sweetener includes acesulfame potassium, aspartame, sodium saccharin, sucralose, or any combination thereof. In at least one exemplary embodiment, the pH adjuster includes sodium carbonate / bicarbonate, potassium carbonate / bicarbonate, citric acid, or any combination thereof. In at least one exemplary embodiment, the polysaccharide includes guar gum, xanthan gum, gum arabic, or any combination thereof.

[0132] Flavoring agents may include spray dried, powdered, and / or liquid flavoring agents. In at least one exemplary embodiment, the flavoring agent is selected from the group consisting of peppermint, spearmint, wintergreen, menthol, cinnamon, chocolate, vanillin, licorice, clove, anise, sandalwood, geranium, rose oil, vanilla, lemon oil, cassia, fennel, ginger, ethyl acetate, isoamyl acetate, propyl isobutyrate, isobutyl butyrate, ethyl butyrate, ethyl valerate, benzyl formate, limonene, cymene, pinene, linalool, geraniol, citronellol, citral, orange oil, coriander oil, borneol, fruit extracts, coffee, tea, cocoa, mint, pomegranate, acai, raspberry, blueberry, strawberry, boysenberry, cranberry, bourbon, scotch, whiskey, cognac, hydrangea, lavender, apple, peach, pear, cherry, plum, orange, lime, lychee, grey The flavors include, but are not limited to, grapefruit, butter, rum, coconut, almond, pecan, walnut, hazelnut, French vanilla, macadamia, sugarcane, maple, blackcurrant, caramel, banana, malt, espresso, Kahlua, white chocolate, spice flavors (such as cinnamon, clove, coriander, basil, oregano, garlic, mustard, nutmeg, rosemary, thyme, tarragon, dill, sage, anise, fennel), methyl salicylate, linalool, jasmine, coffee, olive oil, sesame oil, sunflower oil, bergamot oil, geranium oil, lemon oil, ginger oil, balsamic vinegar, rice wine vinegar, red wine vinegar, allspice, pimento, mango, soursop, sugar apple, naseberry, sorrel, or any combination thereof.

[0133] Methods are provided for preparing encapsulated nicotine granules (ENG) as shown in Figures 5 and / or 6 that are suitable for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, indissolvable chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). In some exemplary embodiments, the method of forming such encapsulated nicotine granules comprises heating and cooling a first mixture, adding a nicotine-containing material to the cooled first mixture to form a second mixture, and cooling the second mixture to a further temperature to form one or more solidified structures, such as sheets. The one or more solidified structures can be fragmented to form encapsulated nicotine granules for inclusion in oral products and having desired organoleptic properties.

[0134] Figure 7 is a flow diagram illustrating a method 1000 for preparing a nicotine-containing powder 1052 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). The nicotine-containing powder 1052 may include a plurality of encapsulated nicotine granules, as illustrated in Figures 5 and / or 6. The method 1000 can be carried out using a batch process, a continuous process, or both batch and continuous processes (e.g., compound extrusion).

[0135] In at least one exemplary embodiment, the method 1000 for preparing a nicotine-containing powder 1052 includes a step S1010 of preparing a molten mixture 1012. In some exemplary embodiments, the step S1010 of preparing the molten mixture 1012 includes heating a first mixture 1006. For example, the first mixture 1006 may be heated to a first temperature.

[0136] In at least one exemplary embodiment, the first temperature ranges from about 120° C. to about 200° C. For example, the first temperature can be about 120° C. or higher (e.g., about 125° C. or higher, about 130° C. or higher, about 135° C. or higher, about 140° C. or higher, about 145° C. or higher, about 150° C. or higher, about 155° C. or higher, about 160° C. or higher, about 165° C. or higher, about 170° C. or higher, about 175° C. or higher, about 180° C. or higher, about 185° C. or higher, about 190° C. or higher, or about 195° C. or higher). The first temperature can be about 200°C or less (e.g., about 195°C or less, about 190°C or less, about 185°C or less, about 180°C or less, about 175°C or less, about 170°C or less, about 165°C or less, about 160°C or less, about 155°C or less, about 150°C or less, about 145°C or less, about 140°C or less, about 135°C or less, about 130°C or less, or about 125°C or less).

[0137] First mixture 1006 can include one or more polyols (e.g., sugars and / or sugar alcohols) 1002. In at least one exemplary embodiment, method 1000 includes a step S1005 of preparing first mixture 1006. In some exemplary embodiments, step S1005 of preparing first mixture 1006 includes contacting one or more polyols 1002 with an aqueous solvent 1004. For example, one or more polyols 1002 can be mixed with aqueous solvent 1004 to form first mixture 1006. Although not shown, in at least one exemplary embodiment, first mixture 1006 can further include one or more additives. The one or more additives can include, by way of example only, antioxidants, sweeteners, pH adjusters, polysaccharides, flavoring agents, or any combination thereof.

[0138] In at least one exemplary embodiment, the method 1000 includes forming a cooled molten mixture 1028. In some exemplary embodiments, forming the cooled molten mixture 1028 includes cooling S1020 the molten mixture 1012. For example, the molten mixture 1012 can be cooled to a second temperature to form the cooled molten mixture 1028.

[0139] In at least one exemplary embodiment, the second temperature ranges from about 65° C. to about 200° C. For example, the second temperature can be 65° C. or higher (e.g., about 70° C. or higher, about 75° C. or higher, about 80° C. or higher, about 85° C. or higher, about 90° C. or higher, about 95° C. or higher, about 100° C. or higher, about 105° C. or higher, about 110° C. or higher, about 115° C. or higher, about 120° C. or higher, about 125° C. or higher, about 130° C. or higher, about 135° C. or higher, about 140° C. or higher, about 145° C. or higher, about 150° C. or higher, about 155° C. or higher, about 160° C. or higher, about 165° C. or higher, about 170° C. or higher, about 175° C. or higher, about 180° C. or higher, about 185° C. or higher, about 190° C. or higher, or about 195° C. or higher). The second temperature can be about 200°C or less (e.g., about 195°C or less, about 190°C or less, about 185°C or less, about 180°C or less, about 175°C or less, about 170°C or less, about 165°C or less, about 160°C or less, about 155°C or less, about 150°C or less, about 145°C or less, about 140°C or less, about 135°C or less, about 130°C or less, about 125°C or less, about 120°C or less, about 115°C or less, about 110°C or less, about 105°C or less, about 100°C or less, about 95°C or less, about 90°C or less, about 85°C or less, about 80°C or less, about 75°C or less, or about 70°C or less).

[0140] In at least one exemplary embodiment, the method 1000 includes forming a second mixture 1038. In some exemplary embodiments, forming the second mixture 1038 includes adding S1030 one or more nicotine-containing materials 1032 to the cooled molten mixture 1028.

[0141] The second mixture 1038 can include an amount ranging from about 0.1% to about 50% by weight of the cooled melt mixture 1028. For example, the second mixture 1038 can include about 0.1% by weight or more of the cooled melt mixture 1028 (e.g., about 0.5% by weight or more, about 1% by weight or more, about 5% by weight or more, about 10% by weight or more, about 15% by weight or more, about 20% by weight or more, about 25% by weight or more, about 30% by weight or more, about 35% by weight or more, about 40% by weight or more, or about 45% by weight or more). The second mixture 1038 can include about 50% by weight or less of the cooled molten mixture 1028 (e.g., about 45% by weight or less, about 40% by weight or less, about 35% by weight or less, about 30% by weight or less, about 25% by weight or less, about 20% by weight or less, about 15% by weight or less, about 10% by weight or less, about 5% by weight or less, about 1% by weight or less, or about 0.5% by weight or less).

[0142] In at least one exemplary embodiment, second mixture 1038 can include an amount of cooled molten mixture 1028 ranging from about 60% to about 80% by weight. For example, second mixture 1038 can include about 60% or more by weight of cooled molten mixture 1028 (e.g., about 62% or more by weight, about 64% or more by weight, about 66% or more by weight, about 68% or more by weight, about 70% or more by weight, about 72% or more by weight, about 74% or more by weight, about 76% or more by weight, or about 78% or more by weight). Second mixture 1038 can include about 80% or less by weight (e.g., about 78% or less by weight, about 76% or less by weight, about 74% or less by weight, about 72% or less by weight, about 70% or less by weight, about 68% or less by weight, about 66% or less by weight, about 64% or less by weight, or about 62% or less by weight).

[0143] The second mixture 1038 can include one or more nicotine-containing materials 1032 in an amount ranging from about 0.1% to about 50% by weight. For example, the second mixture 1038 can include about 0.1% by weight or more of the nicotine-containing material 1032 (e.g., about 0.5% by weight or more, about 1% by weight or more, about 5% by weight or more, about 10% by weight or more, about 15% by weight or more, about 20% by weight or more, about 25% by weight or more, about 30% by weight or more, about 35% by weight or more, about 40% by weight or more, or about 45% by weight or more). The second mixture 1038 can include about 50% by weight or less of the nicotine-containing material 1032 (e.g., about 45% by weight or less, about 40% by weight or less, about 35% by weight or less, about 30% by weight or less, about 25% by weight or less, about 20% by weight or less, about 15% by weight or less, about 10% by weight or less, about 5% by weight or less, about 1% by weight or less, or about 0.5% by weight or less).

[0144] In at least one exemplary embodiment, the second mixture 1038 may include an amount of nicotine-containing material 1032 ranging from about 20% to about 40% by weight. For example, the second mixture 1038 may include about 20% or more by weight of the nicotine-containing material 1032 (e.g., about 22% or more by weight, about 24% or more by weight, about 26% or more by weight, about 28% or more by weight, about 30% or more by weight, about 32% or more by weight, about 34% or more by weight, about 36% or more by weight, or about 38% or more by weight). The second mixture may include about 40% or less by weight of the nicotine-containing material 1032 (e.g., about 38% or less by weight, about 36% or less by weight, about 34% or less by weight, about 32% or less by weight, about 30% or less by weight, about 28% or less by weight, about 26% or less by weight, about 24% or less by weight, or about 22% or less by weight).

[0145] Although not shown, in at least one exemplary embodiment, the second mixture 1038 may include one or more additives, and forming the second mixture may include adding the one or more additives to the cooled molten mixture 1028. The one or more additives may include, by way of example only, an antioxidant, a sweetener, a pH adjuster, a polysaccharide, a flavoring agent, or any combination thereof.

[0146] In some exemplary embodiments, the one or more nicotine-containing materials 1032 include nicotine, a nicotine conjugate (e.g., nicotine polacrilex), a nicotine salt, or any combination thereof. The nicotine salt may include, for example, a nitrate, a monotartrate, a bitartrate, a bitartrate dihydrate, a salicylate, a sulfate or disulfate, a phosphate or superphosphate, an acetate, a lactate, a succinate, a maleate, a fumarate, a gluconate, a saccharate, a benzoate, a methanesulfonate, a hydrochloride, a hydrobromide, a hydroiodide, or any combination thereof.

[0147] In at least one exemplary embodiment, such as when the one or more nicotine-containing materials 1032 include a solid nicotine salt, the second temperature ranges from about 120° C. to about 130° C. For example, the second temperature can be about 120° C. or higher (e.g., about 121° C. or higher, about 122° C. or higher, about 123° C. or higher, about 124° C. or higher, about 125° C. or higher, about 126° C. or higher, about 127° C. or higher, about 128° C. or higher, or about 129° C. or higher). The second temperature can be about 130° C. or lower (e.g., about 129° C. or lower, about 128° C. or lower, about 127° C. or lower, about 126° C. or lower, about 125° C. or lower, about 124° C. or lower, about 123° C. or lower, about 122° C. or lower, or about 121° C. or lower).

[0148] In at least one exemplary embodiment, such as when the one or more nicotine-containing materials 1032 include a liquid nicotine solution or a nicotine salt, the second temperature ranges from about 65° C. to about 100° C. For example, the second temperature can be about 65° C. or higher (e.g., about 70° C. or higher, about 75° C. or higher, about 80° C. or higher, about 85° C. or higher, about 90° C. or higher, or about 95° C. or higher). The second temperature can be about 100° C. or lower (e.g., about 95° C. or lower, about 90° C. or lower, about 85° C. or lower, about 80° C. or lower, about 75° C. or lower, or about 70° C. or lower).

[0149] In at least one exemplary embodiment, the method 1000 includes forming one or more solidified structures 1048. In some exemplary embodiments, forming the one or more solidified structures 1048 includes cooling S1040 the second mixture 1038. For example, the second mixture 1038 may be cooled to a third temperature to form a cooled molten mixture 1048. In some exemplary embodiments, forming the one or more solidified structures 1048 includes glassifying the second mixture 1038. For example, the third temperature may be a temperature above the glass transition temperature (T g ) may be less than

[0150] In at least one exemplary embodiment, the third temperature ranges from about 40° C. to about 45° C. For example, the third temperature can be about 40° C. or higher (e.g., about 40.5° C. or higher, about 41° C. or higher, about 41.5° C. or higher, about 42° C. or higher, about 42.5° C. or higher, about 43° C. or higher, about 43.5° C. or higher, about 44° C. or higher, or about 44.5° C. or higher). The third temperature can be about 45° C. or lower (e.g., about 44.5° C. or lower, about 44° C. or lower, about 43.5° C. or lower, about 43° C. or lower, about 42.5° C. or lower, about 42° C. or lower, about 41.5° C. or lower, about 41° C. or lower, or about 40.5° C. or lower).

[0151] The one or more solidification structures 1048 may have one or more sheets or one of a variety of other configurations as will be appreciated by those skilled in the art. For example, in at least one exemplary embodiment, the one or more solidification structures 1048 may include one or more brittle sheets at room temperature.

[0152] In at least one exemplary embodiment, the method 1000 includes a step S1050 of fragmenting the one or more solidified structures 1048 to form a nicotine-containing powder 1052.

[0153] Nicotine-containing materials, such as nicotine-containing powders, are often light- and air-sensitive under ambient conditions, and their various chemical and physical properties can present challenges during the preparation, processing, and storage of oral products containing the nicotine-containing materials.

[0154] Exemplary encapsulated nicotine granules prepared according to at least one exemplary embodiment and contained in oral products (e.g., gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules), etc.) may be gentle to consumers. <Encapsulated sweetener granules>

[0155] In at least one exemplary embodiment, an encapsulated sweetener granule (ESG) suitable for inclusion in an oral product is provided.

[0156] FIG. 8 is an exemplary cross-sectional view of an encapsulated sweetener granule 1200 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, indissolvable chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). In at least one exemplary embodiment, the encapsulated sweetener granule 1200 includes a sweetener-containing material 1210 surrounded or encapsulated by a matrix 1224. While the nicotine-containing material 1210 is shown dispersed within the matrix 1224, those skilled in the art will recognize that in various other examples, the matrix 1224 may take on various other shapes or configurations. For example, in some exemplary embodiments, the matrix 1224 includes the sweetener-containing material 1210 uniformly dispersed throughout the encapsulated sweetener granule 1200. In some other exemplary embodiments, the matrix 1224 may define a continuous coating that surrounds or encapsulates the sweetener-containing material 1210.

[0157] The encapsulated sweetener granules 1200 may have an average particle size (D50) ranging from about 100 μm to about 5 mm. For example, the encapsulated sweetener granules 1200 may have an average particle size of about 100 μm or greater (e.g., about 200 μm or greater, about 300 μm or greater, about 400 μm or greater, about 500 μm or greater, about 600 μm or greater, about 700 μm or greater, about 800 μm or greater, about 900 μm or greater, about 1 mm or greater, about 1.5 mm or greater, about 2.0 mm or greater, about 2.5 mm or greater, about 3.0 mm or greater, about 3.5 mm or greater, about 4.0 mm or greater, about 4.5 mm or greater, or about 5.0 mm or greater). The encapsulated sweetener granules 1200 can have an average particle size of about 5 mm or less (e.g., 4.5 mm or less, about 4.0 mm or less, about 3.5 mm or less, about 3.0 mm or less, about 2.5 mm or less, about 2.0 mm or less, about 1.5 mm or less, about 1 mm or less, about 900 μm or less, about 800 μm or less, about 700 μm or less, about 600 μm or less, about 500 μm or less, about 400 μm or less, about 300 μm or less, about 200 μm or less, or about 150 μm or less).

[0158] In some exemplary embodiments, the sweetener-containing material 1210 includes one or more high-intensity sweeteners. The one or more high-intensity sweeteners may include synthetic and / or natural sweeteners. In at least one exemplary embodiment, the natural sweetener includes a sugar (such as a monosaccharide, disaccharide, and / or polysaccharide). In at least one exemplary embodiment, the natural sweetener includes sucrose (e.g., table sugar), honey, a mixture of low-molecular-weight sugars excluding sucrose, glucose (e.g., glucose, corn sugar, dextrose), molasses, corn sweetener, high-fructose corn syrup (e.g., corn syrup), fructose (e.g., fruit sugar), lactose (e.g., milk sugar), maltose (e.g., maltobiose), sorghum syrup, concentrated fruit juice, or any combination thereof. In at least one exemplary embodiment, the sweetener-containing material 1210 includes a sugar alcohol. The sugar alcohol may include mannitol, sorbitol, xylitol, maltitol, or any combination thereof. In at least one exemplary embodiment, the sweetener-containing material 1210 includes a non-nutritive sweetener including stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof.

[0159] In at least one exemplary embodiment, matrix 1224 includes a sugar alcohol, a humectant / oil, or a combination of a sugar alcohol and a humectant / oil. The sugar alcohol may include sorbitol, mannitol, xylitol, maltitol, lactitol, isomalt, hydrogenated isomaltulose, hydrogenated starch hydrolysates, or any combination thereof. The humectant / oil may help maintain the moisture level of matrix 1224. In some exemplary embodiments, the humectant includes glycerol, propylene glycol, or a combination of glycerol and propylene glycol.

[0160] In at least one exemplary embodiment, matrix 1224 can include sugar alcohol in an amount ranging from about 50% to about 99.5% by weight. For example, matrix 824 can include about 50% or more sugar alcohol by weight (e.g., about 55% or more, about 60% or more, about 65% or more, about 70% or more, about 75% or more, about 80% or more, about 85% or more, about 90% or more, or about 95% or more). Matrix 824 can include about 99.5% or less sugar alcohol by weight (e.g., about 95% or less, about 90% or less, about 85% or less, about 80% or less, about 75% or less, about 70% or less, about 65% or less, about 60% or less, or about 55% or less).

[0161] 9 is a cross-sectional view of an example of an encapsulated sweetener granule 1300 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). The encapsulated sweetener granule 1300 is the same as the encapsulated sweetener granule 1200, except that the encapsulated sweetener granule 1300 includes one or more additives 1322.

[0162] In at least one exemplary embodiment, the encapsulated sweetener granule 1300 includes a sweetener-containing material 1310 surrounded or encapsulated by a matrix 1320. The matrix 1320 may include one or more additives 1322. For example, the matrix 1320 may include one or more additives 1322 dispersed throughout the matrix 1320. The one or more additives 1322 may be substantially uniformly dispersed within the matrix 1320 and around the sweetener-containing material 1310.

[0163] The encapsulated sweetener granules 1300 may contain one or more additives 1322 in an amount ranging from about 0.01% to about 45% by weight. For example, the encapsulated sweetener granules 1300 may contain about 0.01% by weight or more of the one or more additives 1322 (e.g., about 5% by weight or more, about 10% by weight or more, about 15% by weight or more, about 20% by weight or more, about 25% by weight or more, about 30% by weight or more, about 35% by weight or more, or about 40% by weight or more). The encapsulated sweetener granules 1300 may contain about 45% by weight or less of the one or more additives 1322 (e.g., about 40% by weight or less, about 35% by weight or less, about 30% by weight or less, about 25% by weight or less, about 20% by weight or less, about 15% by weight or less, about 10% by weight or less, or about 5% by weight or less).

[0164] The one or more additives 1322 may include, for example, an antioxidant, a sweetener, a pH adjuster, a polysaccharide, a flavoring agent, or any combination thereof. In at least one exemplary embodiment, the antioxidant additive includes ascorbyl palmitate, tert-butylhydroquinone (TBHQ), sodium ascorbate, or any combination thereof. In at least one exemplary embodiment, the sweetener includes acesulfame potassium, aspartame, sodium saccharin, sucralose, or any combination thereof. In at least one exemplary embodiment, the pH adjuster includes sodium carbonate / bicarbonate, potassium carbonate / bicarbonate, citric acid, or any combination thereof. In at least one exemplary embodiment, the polysaccharide includes guar gum, xanthan gum, gum arabic, or any combination thereof.

[0165] Flavoring agents may include spray dried, powdered, and / or liquid flavoring agents. In at least one exemplary embodiment, the flavoring agent is selected from the group consisting of peppermint, spearmint, wintergreen, menthol, cinnamon, chocolate, vanillin, licorice, clove, anise, sandalwood, geranium, rose oil, vanilla, lemon oil, cassia, fennel, ginger, ethyl acetate, isoamyl acetate, propyl isobutyrate, isobutyl butyrate, ethyl butyrate, ethyl valerate, benzyl formate, limonene, cymene, pinene, linalool, geraniol, citronellol, citral, orange oil, coriander oil, borneol, fruit extracts, coffee, tea, cocoa, mint, pomegranate, acai, raspberry, blueberry, strawberry, boysenberry, cranberry, bourbon, scotch, whiskey, cognac, hydrangea, lavender, apple, peach, pear, cherry, plum, orange, lime, lychee, grey The flavors include, but are not limited to, grapefruit, butter, rum, coconut, almond, pecan, walnut, hazelnut, French vanilla, macadamia, sugarcane, maple, blackcurrant, caramel, banana, malt, espresso, Kahlua, white chocolate, spice flavors (such as cinnamon, clove, coriander, basil, oregano, garlic, mustard, nutmeg, rosemary, thyme, tarragon, dill, sage, anise, fennel), methyl salicylate, linalool, jasmine, coffee, olive oil, sesame oil, sunflower oil, bergamot oil, geranium oil, lemon oil, ginger oil, balsamic vinegar, rice wine vinegar, red wine vinegar, allspice, pimento, mango, soursop, sugar apple, naseberry, sorrel, or any combination thereof.

[0166] Methods are provided for preparing encapsulated sweetener granules (ESGs) as shown in Figures 8 and / or 9, suitable for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). In some exemplary embodiments, the method for forming such encapsulated sweetener granules includes heating and cooling a first mixture, adding a sweetener-containing material to the cooled first mixture to form a second mixture, and cooling the second mixture to a further temperature to form one or more solidified structures, such as sheets. The one or more solidified structures can be fragmented to form encapsulated sweetener granules for inclusion in an oral product and for providing desired organoleptic properties.

[0167] Figure 10 is a flow diagram illustrating a method 1400 for preparing a sweetener-containing powder 1452 for inclusion in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). The sweetener-containing powder 1452 may include a plurality of encapsulated nicotine granules, as illustrated in Figure 8 and / or Figure 9. The method 1400 can be carried out using a batch process, a continuous process, or both a batch and a continuous process (e.g., compound extrusion).

[0168] In at least one exemplary embodiment, the method 1400 for preparing the sweetener-containing powder 1442 includes a step S1410 of preparing a molten mixture 1412. In some exemplary embodiments, the step S1410 of preparing the molten mixture 1412 includes heating the first mixture 1406. For example, the first mixture 1406 can be heated to a first temperature.

[0169] In at least one exemplary embodiment, the first temperature ranges from about 120° C. to about 200° C. For example, the first temperature can be about 120° C. or higher (e.g., about 125° C. or higher, about 130° C. or higher, about 135° C. or higher, about 140° C. or higher, about 145° C. or higher, about 150° C. or higher, about 155° C. or higher, about 160° C. or higher, about 165° C. or higher, about 170° C. or higher, about 175° C. or higher, about 180° C. or higher, about 185° C. or higher, about 190° C. or higher, or about 195° C. or higher). The first temperature can be about 200°C or less (e.g., about 195°C or less, about 190°C or less, about 185°C or less, about 180°C or less, about 175°C or less, about 170°C or less, about 165°C or less, about 160°C or less, about 155°C or less, about 150°C or less, about 145°C or less, about 140°C or less, about 135°C or less, about 130°C or less, or about 125°C or less).

[0170] First mixture 1406 may include one or more polyols 1402 and / or one or more hydrocolloids 1403. In at least one exemplary embodiment, one or more polyols 1402 may include isomalt, maltitol, mannitol, sorbitol, xylitol, or any combination thereof. In at least one exemplary embodiment, one or more hydrocolloids 1403 may include guar gum, gum arabic, or any combination thereof.

[0171] First mixture 1406 can include one or more polyols 1402 in an amount ranging from about 50% to about 99.5% by weight. For example, first mixture 1406 can include about 50% or more by weight of one or more polyols 1402 (e.g., about 55% or more, about 60% or more, about 65% or more, about 70% or more, about 75% or more, about 80% or more, about 85% or more, about 90% or more, or about 95% or more by weight). First mixture 1406 can include about 99.5% or less by weight of one or more polyols 1402 (e.g., about 95% or less, about 90% or less, about 85% or less, about 80% or less, about 75% or less, about 70% or less, about 65% or less, about 60% or less, or about 50% or less by weight).

[0172] First mixture 1406 can include one or more hydrocolloids 1403 in an amount ranging from about 0.01% to about 5% by weight. For example, first mixture 1406 can include about 0.01% by weight or more of one or more hydrocolloids (e.g., about 0.02% by weight or more, about 0.05% by weight or more, about 1.0% by weight or more, about 1.5% by weight or more, about 2.0% by weight or more, about 2.5% by weight or more, about 3.0% by weight or more, about 3.5% by weight or more, about 4.0% by weight or more, about 4.5% by weight or more, or about 4.9% by weight or more). The first mixture 1406 may include about 5% by weight or less of one or more hydrocolloids (e.g., about 4.9% by weight or less, about 4.5% by weight or less, about 4.0% by weight or less, about 3.5% by weight or less, about 3.0% by weight or less, about 3.5% by weight or less, about 3.0% by weight or less, about 2.5% by weight or less, about 2.0% by weight or less, about 1.5% by weight or less, about 1.0% by weight or less, or about 0.5% by weight or less).

[0173] In at least one exemplary embodiment, method 1400 includes a step S1405 of preparing a first mixture 1406. In some exemplary embodiments, the step S1405 of preparing the first mixture 1406 includes contacting one or more polyols 1402 and / or one or more hydrocolloids 1403 with an aqueous solvent 1404. For example, one or more polyols 1402 and / or one or more hydrocolloids 1403 may be mixed with the aqueous solvent 1404 to form the first mixture 1406. Although not shown, in at least one exemplary embodiment, first mixture 1406 may further include one or more additives. The one or more additives may include, by way of example only, an antioxidant, a sweetener, a pH adjuster, a polysaccharide, a flavoring agent, or any combination thereof.

[0174] In at least one exemplary embodiment, method 1400 includes forming a cooled molten mixture 1428. In some exemplary embodiments, forming the cooled molten mixture 1428 includes the step S1420 of cooling molten mixture 1412. For example, molten mixture 1412 can be cooled to a second temperature to form cooled molten mixture 1428.

[0175] In at least one exemplary embodiment, the second temperature ranges from about 65° C. to about 200° C. For example, the second temperature can be about 65° C. or higher (e.g., about 70° C. or higher, about 75° C. or higher, about 80° C. or higher, about 85° C. or higher, about 90° C. or higher, about 95° C. or higher, about 100° C. or higher, about 105° C. or higher, about 110° C. or higher, about 115° C. or higher, about 120° C. or higher, about 125° C. or higher, about 130° C. or higher, about 135° C. or higher, about 140° C. or higher, about 145° C. or higher, about 150° C. or higher, about 155° C. or higher, about 160° C. or higher, about 165° C. or higher, about 170° C. or higher, about 175° C. or higher, about 180° C. or higher, about 185° C. or higher, about 190° C. or higher, or about 195° C. or higher). The second temperature can be about 200°C or less (e.g., about 195°C or less, about 190°C or less, about 185°C or less, about 180°C or less, about 175°C or less, about 170°C or less, about 165°C or less, about 160°C or less, about 155°C or less, about 150°C or less, about 145°C or less, about 140°C or less, about 135°C or less, about 130°C or less, about 125°C or less, about 120°C or less, about 115°C or less, about 110°C or less, about 105°C or less, about 100°C or less, about 95°C or less, about 90°C or less, about 85°C or less, about 80°C or less, about 75°C or less, or about 70°C or less).

[0176] In at least one exemplary embodiment, the method 1400 includes forming a second mixture 1438. In some exemplary embodiments, forming the second mixture 1438 includes adding one or more sweetener-containing materials 1432 to the cooled, molten mixture 1428 in a step S1430. The second mixture 1438 may include one or more sweetener-containing materials 1432 in an amount ranging from about 0.01% to about 45% by weight. For example, the second mixture 1438 may include about 0.01% by weight or more of the one or more sweetener-containing materials 1432 (e.g., about 5% by weight or more, about 10% by weight or more, about 15% by weight or more, about 20% by weight or more, about 25% by weight or more, about 30% by weight or more, about 35% by weight or more, or about 40% by weight or more). The second mixture 1438 may include about 45% by weight or less of one or more sweetener-containing materials 1432 (e.g., about 40% by weight or less, about 35% by weight or less, about 30% by weight or less, about 25% by weight or less, about 20% by weight or less, about 15% by weight or less, about 10% by weight or less, or about 5% by weight or less).

[0177] Although not shown, in at least one embodiment, the second mixture 1438 can include one or more additives, and forming the second mixture can include adding the one or more additives to the cooled molten mixture 1428. The one or more additives can include, by way of example only, an antioxidant, a sweetener, a pH adjuster, a polysaccharide, a flavoring agent, or any combination thereof.

[0178] In some exemplary embodiments, sweetener-containing material 1432 includes one or more high-intensity sweeteners. The one or more high-intensity sweeteners may include synthetic and / or natural sweeteners. In at least one exemplary embodiment, the natural sweetener includes sucrose (e.g., table sugar), honey, a mixture of low-molecular-weight sugars other than sucrose, glucose (e.g., glucose, corn sugar, dextrose), molasses, corn sweetener, high-fructose corn syrup (e.g., corn syrup), fructose (e.g., fruit sugar), lactose (e.g., milk sugar), maltose (e.g., maltobiose), sorghum syrup, concentrated fruit juice, or any combination thereof. In at least one exemplary embodiment, sweetener-containing material 1432 includes a sugar alcohol. The sugar alcohol may include mannitol, sorbitol, xylitol, maltitol, or any combination thereof. In at least one exemplary embodiment, sweetener-containing material 1432 comprises a non-nutritive sweetener including stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof.

[0179] In at least one exemplary embodiment, method 1400 includes forming one or more solidified structures 1448. In some exemplary embodiments, forming one or more solidified structures 1448 includes cooling S1440 second mixture 1438. For example, second mixture 1438 may be cooled to a third temperature to form cooled molten mixture 1428. In some exemplary embodiments, forming one or more solidified structures 1448 may include vitrifying second mixture 1438. For example, the third temperature may be a temperature above a glass transition temperature (T g ) may be less than

[0180] In at least one exemplary embodiment, the third temperature ranges from about 40° C. to about 45° C. For example, the third temperature can be about 40° C. or higher (e.g., about 40.5° C. or higher, about 41° C. or higher, about 41.5° C. or higher, about 42° C. or higher, about 42.5° C. or higher, about 43° C. or higher, about 43.5° C. or higher, about 44° C. or higher, or about 44.5° C. or higher). The third temperature can be about 45° C. or lower (e.g., about 44.5° C. or lower, about 44° C. or lower, about 43.5° C. or lower, about 43° C. or lower, about 42.5° C. or lower, about 42° C. or lower, about 41.5° C. or lower, about 41° C. or lower, or about 40.5° C. or lower).

[0181] The one or more solidification structures 1448 may have one or more sheets or one of a variety of other configurations as will be appreciated by those skilled in the art. For example, in at least one exemplary embodiment, the one or more solidification structures 1448 may include one or more brittle sheets at room temperature.

[0182] In at least one exemplary embodiment, the method 1400 includes a step S1450 of fragmenting the one or more solidified structures 1448 to form a sweetener-containing powder 1452. <Liquid mixture of triglycerides and liquid nicotine>

[0183] Figures 11A to 11C show the chemical structures of different forms of nicotine.

[0184] Nicotine, or 3-(1-methyl-2-pyrrolidinyl)pyridine, is a tertiary amine. Under ambient conditions, nicotine is an oily, volatile, and hygroscopic liquid. In this state, nicotine is the free base (unprotonated state) and has the structure shown in Figure 11A. The pK of the free base nicotine is a The value is approximately 8.

[0185] Nicotine can also be in the form of a complex or salt. Nicotine complexes and salts can be provided in solid form, such as powders. An example of a nicotine complex used in oral products is nicotine polacrilex. In the salt form, nicotine is either monoprotonated, as shown in Figure 11B, or diprotonated, as shown in Figure 11C. Monoprotonated and diprotonated nicotine have a lower pK than free base nicotine. a The nicotine salt may include nitrate, monotartrate, bitartrate, bitartrate dihydrate, salicylate, sulfate or disulfate, phosphate or superphosphate, acetate, lactate, succinate, maleate, fumarate, gluconate, saccharate, benzoate, methanesulfonate, hydrochloride, hydrobromide, hydroiodide, or any combination thereof.

[0186] Oral products often contain nicotine in the form of a complex or salt for manufacturing, handling, and stability reasons. However, nicotine has a pK a It is believed that higher pH values ​​are more readily absorbed into the buccal mucosa. Therefore, oral products containing nicotine in a protonated state may also contain a pH adjuster to create a more basic environment in the oral product.

[0187] In at least one exemplary embodiment, the oral product comprises a liquid mixture of nicotine and a triglyceride. Oral products comprising the liquid mixture may be configured to increase buccal nicotine absorption compared to oral products comprising aqueous nicotine, nicotine complexes, and / or nicotine salts. The nicotine may be liquid nicotine. At least a portion of the liquid nicotine may be dissolved in the triglyceride to form a solution of the triglyceride and the liquid nicotine. In at least one exemplary embodiment, all of the liquid nicotine is dissolved in the triglyceride. In at least one exemplary embodiment, the liquid mixture may consist essentially of liquid nicotine and a triglyceride, such as a medium-chain triglyceride (MCT).

[0188] The weight ratio of triglyceride to nicotine in the liquid mixture can be about 1:1 or greater (e.g., about 3:2 or greater, about 2:1 or greater, about 3:1 or greater, about 4:1 or greater, about 5:1 or greater, about 6:1 or greater, about 7:1 or greater, about 8:1 or greater, about 9:1 or greater, or about 10:1 or greater). The weight ratio can be about 95:5 or less (e.g., about 9:1 or less, about 8:1 or less, about 7:1 or less, about 6:1 or less, about 5:1 or less, about 4:1 or less, about 3:1 or less, or about 3:2 or less). In at least one exemplary embodiment, the weight ratio ranges from about 1:1 to about 9:1 (e.g., about 3:2 to about 4:1, about 3:1 to about 5:1, or about 4:1).

[0189] In at least one exemplary embodiment, the oral product can include additional triglycerides beyond those present in the liquid mixture. The additional triglycerides can be used as a plasticizer in at least one exemplary embodiment. The ratio of triglycerides to liquid nicotine in the oral product (i.e., both the liquid mixture and any additional triglycerides) can be about 1:1 or greater (e.g., about 3:2 or greater, about 2:1 or greater, about 3:1 or greater, about 4:1 or greater, about 5:1 or greater, about 6:1 or greater, about 7:1 or greater, about 8:1 or greater, about 9:1 or greater, about 10:1, about 15:1 or greater, about 20:1 or greater, about 25:1 or greater, about 30:1 or greater, about 40:1 or greater, about 50:1 or greater, about 60:1 or greater, about 70:1 or greater, about 75:1 or greater, or about 80:1 or greater). The weight ratio of triglyceride to liquid nicotine can be about 100:1 or less (e.g., about 90:1 or less, about 80:1 or less, about 75:1 or less, about 70:1 or less, about 60:1 or less, about 50:1 or less, about 40:1 or less, about 30:1 or less, about 25:1 or less, about 20:1, about 15:1 or less, about 10:1 or less, about 9:1 or less, about 8:1 or less, about 7:1 or less, about 6:1 or less, about 5:1 or less, about 4:1 or less, about 3:1 or less, about 2:1 or less, or about 3:2 or less).

[0190] 12A-12B are graphs showing nicotine kinetics in the cheek for different nicotine solutions.

[0191] In at least one exemplary embodiment, providing nicotine dissolved in a triglyceride may enhance buccal absorption compared to nicotine in an aqueous phase. It is believed that providing nicotine dissolved in a triglyceride facilitates retention of at least a portion of the nicotine in a free base state, regardless of the presence of a pH adjuster.

[0192] As shown in Figures 12A-12B, three solutions are prepared according to Table 5 below. The amounts in Table 5 are in weight percent. Solution A contains 0.5 mg of liquid nicotine in water at pH 7. Solution B contains 0.5 mg of nicotine in water at pH 10. Solution C contains 0.5 mg of nicotine in MCT oil. [Table 5] Table 5. Solution composition by weight %

[0193] To determine the amount of nicotine absorbed and unabsorbed, each of Solutions A, B, and C was placed in the oral cavity of an adult tobacco consumer. Five adult tobacco consumers participated. Expectorant samples were collected from each of the five adult tobacco consumers at three time intervals: 0 to 1 minute, 1 to 5 minutes, and 5 to 10 minutes, for each of the three solutions. Each expectorant sample was analyzed to determine the weight of nicotine in the expectorant sample. The nicotine measured in the expectorant sample was necessarily not absorbed by the buccal mucosa. The amount of nicotine absorbed was calculated for each solution based on the difference between the known weight of nicotine in each solution and the measured amount of nicotine in each expectorant sample for each solution, as described in further detail below.

[0194] Solution A contains 0.5 mg of nicotine. The first Solution A expectorant sample 4200 is taken from 0 to 1 minute and contains 57% by weight of the 0.5 mg of nicotine. The second Solution A expectorant sample 4202 is taken from 1-5 minutes and contains 18% by weight of the 0.5 mg of nicotine. The third Solution A expectorant sample 4204 is taken from 5-10 minutes and contains 5% by weight of the 0.5 mg of nicotine. Therefore, the Solution A absorbed nicotine 4206 is calculated to be 20% by weight (100% - 57% - 18% - 5% = 20%).

[0195] Solution B contains 0.5 mg of nicotine. The first Solution B expectorant sample 4210 is taken between 0 and 1 minute and contains 50% by weight of the 0.5 mg of nicotine. The second Solution B expectorant sample 4212 is taken between 1 and 5 minutes and contains 19% by weight of the 0.5 mg of nicotine. The third Solution B expectorant sample 4214 is taken between 5 and 10 minutes and contains 6% by weight of the 0.5 mg of nicotine. Therefore, Solution B absorbed nicotine 4216 is calculated to be 25% by weight (100% - 50% - 19% - 6% = 25%).

[0196] Solution C contains 0.5 mg of nicotine. The first Solution C expectorant sample 4220 is taken between 0 and 1 minute and contains 38% by weight of the 0.5 mg of nicotine. The second Solution C expectorant sample 4222 is taken between 1 and 5 minutes and contains 22% by weight of the 0.5 mg of nicotine. The third Solution C expectorant sample 4224 is taken between 5 and 10 minutes and contains 5% by weight of the 0.5 mg of nicotine. Therefore, the Solution C absorbed nicotine 4226 is calculated to be 35% by weight (100% - 38% - 22% - 5% = 35%).

[0197] As shown by the difference in behavior between Solutions A and B, increasing the pH of an aqueous solution, such as Solution B, enhances buccal nicotine absorption. For example, increasing the pH of the aqueous environment can promote retention of nicotine in the free base phase. As shown by the difference in behavior between Solutions A / B and Solution C, providing nicotine in MCT, such as Solution C, enhances buccal nicotine absorption compared to providing nicotine in an aqueous phase. Furthermore, as shown by the difference in behavior between Solutions B and C, providing nicotine in MCT enhances buccal absorption compared to an aqueous phase containing a pH adjuster, such as Solution C. As shown in FIG. 12B, the amount of nicotine absorbed in Solution C is greater than the amount absorbed in each of Solutions A and B.

[0198] Figure 13A is a table showing partition coefficient data for nicotine in different oil and water phase combinations. Figure 13B shows the chemical structure of triacetin (C2). Figure 13C shows the chemical structures of MCT (C8-C10). Figure 13D shows the chemical structure of triolein (C18).

[0199] As shown in Figure 13A, nicotine is soluble in both oil and water. Each of Samples 1 to 8 is prepared and measured according to the following method: Liquid nicotine is added to a container containing an oil phase at a target nicotine concentration. The oil phase containing nicotine is mixed with the aqueous phase in a 1:1 volume ratio (v:v) using an orbital shaker at approximately 100 revolutions per minute (rpm) for approximately 5 minutes to prepare a nicotine oil:aqueous phase mixture. The nicotine oil:aqueous phase mixture is allowed to stand at room temperature (approximately 25°C) for approximately 24 hours. The nicotine concentrations in the oil phase and the nicotine phase are measured using a liquid chromatography method. A partition coefficient, which is the concentration ratio of a compound (i.e., nicotine) in two immiscible solvents (i.e., the oil phase and the aqueous phase) at equilibrium, is calculated for each sample. The partition coefficient is a comparison of the solubility of nicotine in the two liquid phases.

[0200] Samples 1 to 6 contain MCT oil (CAS No. 73398-61-5) as the oil phase. Sample 7 contains triacetin oil as the oil phase. Sample 8 contains triolein oil as the oil phase. Sample 1 contains deionized (DI) water as the aqueous phase. Sample 2 contains basified DI water with a pH of 7.4 as the aqueous phase. Sample 3 contains artificial saliva with a pH of 6.8 as the aqueous phase. The artificial saliva simulates mucus conditions. Sample 4 contains acidified DI water with a pH of 2 as the aqueous phase. Samples 5 to 8 contain a pH adjuster of 1 M acetic acid with a pH of 2 as the aqueous phase to simulate gastric conditions.

[0201] In each of Samples 5 through 8, the partition coefficient was less than 1, indicating a higher solubility of nicotine in the acetic acid pH adjuster than in the respective oil phase. This is likely due to the protonation of nicotine and a higher electrostatic interaction. In each of Samples 1 through 4, the partition coefficient was greater than 1, indicating a higher solubility in the MCT oil than in the respective aqueous phase. However, in each sample, at least a portion of the nicotine was dissolved in the aqueous phase. Therefore, when water is present in the liquid mixture, at least a portion of the nicotine was dissolved in the aqueous phase.

[0202] In at least one exemplary embodiment, the oral product includes water. The oral product may include water in an amount of about 8% by weight or less (e.g., about 5% by weight or less, about 3% by weight or less, about 2% by weight or less, about 1% by weight or less, about 0.5% by weight or less). In at least one exemplary embodiment, the oral product does not include water.

[0203] In at least one exemplary embodiment, the liquid mixture includes water in an amount of about 5% by weight or less (e.g., about 4% by weight or less, about 3% by weight or less, about 2% by weight or less, about 1% by weight or less, about 0.5% by weight or less, or about 0.25% by weight or less). In at least one exemplary embodiment, water is not intentionally added to the liquid mixture. However, small amounts of water may come into contact with the liquid mixture through other elements in the oral product. In at least one exemplary embodiment, the liquid mixture does not include water. Limiting the amount of water and / or omitting water may facilitate increasing the amount of nicotine dissolved in the triglycerides. Thus, oral products having a liquid mixture may be configured to promote increased buccal absorption of nicotine compared to oral products having all or part of the nicotine in the aqueous phase.

[0204] As described above, in at least one exemplary embodiment, the nicotine may be liquid nicotine. At least about 50% by weight of the nicotine may be free base nicotine (e.g., 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, at least about 90% by weight, at least about 95% by weight, at least about 98% by weight, at least about 99% by weight). In at least one exemplary embodiment, at least 80% by weight of the nicotine is free base nicotine. In at least one exemplary embodiment, all of the nicotine is free base nicotine.

[0205] In at least one exemplary embodiment, the nicotine is tobacco-derived nicotine, synthetic nicotine, or both tobacco-derived and synthetic nicotine. In at least one exemplary embodiment, the oral product includes nicotine in an amount of about 0.1 mg or more (e.g., about 1 mg or more, about 2 mg or more, about 4 mg or more, about 6 mg or more, about 8 mg or more, about 10 mg or more, about 12 mg or more). The oral product may include nicotine in an amount of about 14 mg or less (e.g., about 12 mg or less, about 10 mg or less, about 8 mg or less, about 6 mg or less, about 4 mg or less, about 2 mg or less, or about 1 mg or less). In at least one exemplary embodiment, the oral product includes liquid nicotine in an amount ranging from 0.1 mg to about 14 mg (e.g., in the range of about 4 mg to about 8 mg, in the range of about 8 mg to about 6 mg).

[0206] The triglyceride may include a long-chain triglyceride (LCT), an MCT, a short-chain triglyceride (STC), or any combination thereof. In at least one exemplary embodiment, the triglyceride includes an MCT. In at least one exemplary embodiment, the liquid mixture further includes triacetin, triolein, trilinolein, a vegetable oil, a partially hydrogenated oil, or any combination thereof. In at least one exemplary embodiment, the liquid mixture includes triacetin, triolein, trilinolein, a vegetable oil, a partially hydrogenated oil, or any combination thereof as a substitute for the triglyceride, in the same weight ratios and proportions as described herein for the triglyceride.

[0207] In at least one exemplary embodiment, the oral product comprises triglycerides in an amount of about 1% by weight or more (e.g., about 2% by weight or more, about 3% by weight or more, about 4% by weight or more, about 5% by weight or more, about 10% by weight or more, about 15% by weight or more, about 20% by weight or more, about 25% by weight or more to about 30% by weight or more, about 40% by weight or more, about 50% by weight or more, about 60% by weight or more, about 70% by weight or more, about 80% by weight or more, or about 90% by weight or more). In at least one exemplary embodiment, the oral product can comprise triglycerides in an amount of about 95% by weight or less (e.g., about 90% by weight or less, about 80% by weight or less, about 70% by weight or less, about 60% by weight or less, about 50% by weight or less, about 40% by weight or less, about 30% by weight or less, about 20% by weight or less, about 15% by weight or less, about 10% by weight or less, about 7% by weight or less, or about 5% by weight or less). In at least one exemplary embodiment, the oral product is in a solid form comprising about 50% or less triglycerides by weight, hi at least one exemplary embodiment, the oral product is in a gel, paste, or liquid form comprising about 75% or more triglycerides by weight (e.g., about 80% or more triglycerides by weight, about 85% or more triglycerides by weight, about 90% or more triglycerides by weight, about 95% or more triglycerides by weight).

[0208] In at least one exemplary embodiment, the oral product further comprises a carrier. At least a portion of the liquid mixture can be absorbed into the carrier. In at least one exemplary embodiment, all of the liquid mixture is absorbed into the carrier. In at least one exemplary embodiment, the weight ratio of carrier to liquid mixture can be in the range of about 75:25 or more (e.g., about 80:20 or more, about 85:15 or more, about 90:10 or more, or about 95:5 or more). In at least one other exemplary embodiment, the oral product does not comprise a carrier.

[0209] In at least one exemplary embodiment, the carrier can be a material that is insoluble in the mouth. In at least one exemplary embodiment, the carrier is a cellulosic material. The cellulosic material can include or be derived from sugar beet, wood pulp, cotton, bran, citrus pulp, grass (e.g., switchgrass), willow, poplar, or any combination thereof. The insoluble cellulosic material can be a processed cellulosic material such as microcrystalline cellulose (MCC), carboxymethyl cellulose (CMC), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), or any combination thereof. In at least one exemplary embodiment, the cellulosic material includes cellulosic fibers that are insoluble in the mouth.

[0210] In at least one exemplary embodiment, the oral product does not contain a pH adjuster. In at least one other exemplary embodiment, the oral product contains a pH adjuster. The pH adjuster may include ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, calcium carbonate, potassium carbonate, potassium bicarbonate, potassium hydroxide, sodium carbonate, sodium bicarbonate, sodium hydroxide, or any combination thereof. The pH adjuster may be included in an amount of about 0.01% by weight or more (e.g., about 0.05% by weight or more, about 0.1% by weight or more, about 0.5% by weight or more, or about 1% by weight or more). The pH adjuster may be included in an amount of about 2% by weight or less (e.g., about 1% by weight or less, about 0.5% by weight or less, about 0.1% by weight or less, or about 0.05% by weight or less). In at least one exemplary embodiment, the pH adjuster is present in an amount ranging from about 0.01% by weight to about 2% by weight.

[0211] In at least one exemplary embodiment, the oral product comprises a liquid mixture (optionally absorbed in a carrier) and additional ingredients such as a mouth-soluble polymer, a mouth-stable polymer, a plasticizer, a flavoring agent, a sweetener, a mouth-soluble fiber, an antioxidant, a stimulant, a soothing agent (e.g., theanine and / or melatonin), a concentration agent (e.g., ginkgo biloba), a stimulant (e.g., gingko ... biloba), alkaloids, minerals, vitamins, dietary supplements, functional foods, colorants, amino acids, chemical sensates, food emulsifiers, botanicals (e.g., green tea), tooth whitening agents (e.g., sodium hexametaphosphate (SHMP)), therapeutic agents, processing aids, stearates (e.g., magnesium and / or potassium), waxes (e.g., glyceryl monostearate, propylene glycol monostearate, and / or acetylated monoglycerides), stabilizers (e.g., ascorbic acid and monosterol citrate, butylhydroxytoluene (BHT), or butylhydroxyanisole (BHA)), lubricants (e.g., sodium lauryl sulfate (SLS)), preservatives (e.g., sodium benzoate), fillers, or any combination thereof. Oral products may contain multiple additional elements. Furthermore, a single element may belong to more than one of the above-mentioned categories.

[0212] In at least one exemplary embodiment, the additional element may be included in an amount of about 0.5% by weight or more (e.g., about 1% by weight or more, about 2% by weight or more, about 5% by weight or more, about 10% by weight or more, about 15% by weight or more, about 20% by weight or more, about 25% by weight or more, about 30% by weight or more, about 35% by weight or more, about 40% by weight or more, about 45% by weight or more, about 50% by weight or more, about 55% by weight or more, about 60% by weight or more, about 65% by weight or more, about 70% by weight or more, about 75% by weight or more, about 80% by weight or more, about 85% by weight or more, or about 90% by weight or more). The additional elements can be in an amount of about 95% by weight or less (e.g., about 90% by weight or less, about 85% by weight or less, about 80% by weight or less, about 75% by weight or less, about 70% by weight or less, about 65% by weight or less, about 60% by weight or less, about 55% by weight or less, about 50% by weight or less, about 45% by weight or less, about 40% by weight or less, about 35% by weight or less, about 30% by weight or less, about 25% by weight or less, about 20% by weight or less, about 15% by weight or less, about 10% by weight or less, or about 5% by weight or less).

[0213] In at least one exemplary embodiment, the oral product comprises a polymer that is soluble in the mouth. As used herein, "soluble in the mouth" means that the polymer significantly degrades when exposed to saliva in the oral cavity for more than about 4 hours. In at least one exemplary embodiment, the soluble in the mouth polymer disintegrates when exposed to saliva at normal human body temperature for a period of about 1 hour or less (e.g., about 30 minutes or less, about 15 minutes or less, about 10 minutes or less, or about 5 minutes or less). The soluble in the mouth polymer may be biocompatible.

[0214] In at least one exemplary embodiment, the mouth-soluble polymer is a cellulosic polymer (e.g., carboxymethyl cellulose (CMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methyl cellulose (HPMC), and / or methyl cellulose (MC)), a natural polymer (e.g., starch, modified starch, konjac, collagen, inulin, soy protein, whey protein, casein, and / or wheat gluten, etc.), a seaweed-derived polymer (e.g., carrageenan (e.g., kappa carrageenan, iota carrageenan, lambda carrageenan), alginate ( The composition may include, for example, a microbially derived polymer (e.g., xanthan, dextran, pullulan, curdlan, and / or gellan), an extract (e.g., locust bean gum, guar gum, tara gum, tragacanth gum, pectin (e.g., low methoxypectin and amidated pectin), agar, zein, karaya, gelatin, psyllium seed, chitin, and / or chitosan), an exudate (e.g., acacia gum (gum arabic) and / or shellac), a synthetic polymer (e.g., polyvinylpyrrolidone, polyethylene oxide, and / or polyvinyl alcohol), or any combination thereof. Other useful mouth-soluble polymers are known in the art (see, e.g., Krochta et al. Food Technology, 1997, 51:61-74; Glicksman Food Hydrocolloids CRC 1982; Krochta Edible Coatings and Films to Improve Food Quality Technomic 1994; Industrial Gums Academic 1993; Nussinovitch Water-Soluble Polymer Applications in Foods Blackwell Science 2003, the entire contents of which are incorporated herein by reference).

[0215] In at least one embodiment, the oral product comprises a mouth-stable polymer. As used herein, "mouth-stable" means that the polymer does not significantly dissolve or disintegrate when exposed to saliva at normal human body temperature (i.e., 98.6°F) for more than about one hour. In at least one exemplary embodiment, a mouth-stable polymer is a biodegradable polymer that is configured to degrade over a period of days, weeks, months, or years, but does not appreciably degrade when held in the oral cavity and exposed to saliva for a period of about one hour. In at least one exemplary embodiment, the mouth-stable polymer is stable in the oral cavity and exposed to saliva at normal human body temperature for a period of about two hours or more (e.g., about six hours or more, about twelve hours or more, about one day or more, or about two days or more). Thus, according to at least one exemplary embodiment, an oral product comprising a mouth-stable polymer is configured to remain intact when placed in the mouth of an adult consumer. After a period of time, the mouth-stable polymer and other mouth-stable components can be removed from the adult consumer's mouth and discarded.

[0216] Mouth-stable polymers may be biocompatible and biostable. Mouth-stable polymers may generally be recognized by appropriate regulatory agencies (e.g., the U.S. Food and Drug Administration (FDA)) as safe and in compliance with applicable food-contact regulations. In at least one exemplary embodiment, the mouth-stable polymer has a flexural modulus of 5 MPa or greater, or optionally a flexural modulus of 10 MPa or greater, when tested according to ASTM test method D790 or ISO 178 at 23°C.

[0217] In at least one exemplary embodiment, the mouth-stable polymer may include polyurethane, silicone, polyester, polyacrylate, polyethylene, polypropylene, polyetheramide, polystyrene, polyvinyl alcohol, polyvinyl acetate, polyvinyl chloride, polybutyl acetate, butyl rubber, poly(styrene-ethylene-butylene-styrene) (SEBS), poly(styrene-butadiene-styrene) (SBS), poly(styrene-isoprene-styrene) (SIS), any copolymer thereof, or any combination thereof. In at least one exemplary embodiment, the mouth-stable polymer includes polyurethane. In at least one exemplary embodiment, the mouth-stable polymer includes a food-grade or medical-grade polymer, such as a medical-grade polyurethane.

[0218] In at least one exemplary embodiment, the mouth-stable polymer is a thermoplastic polymer. The thermoplastic polymer can be a thermoplastic elastomer. In at least one exemplary embodiment, the mouth-stable polymer comprises a thermoplastic elastomer that meets the requirements of the FDA modified ISO 10993, Part 1 "Biological Evaluation of Medical Devices" test conducted for a human tissue contact time of 30 days or less. The mouth-stable polymer can have a Shore hardness of 50D or less, a melt flow index of 3 g / 10 min at 200°C / 10 kg, a tensile strength (using ISO 37) of 10 MPa or greater, and / or an ultimate elongation (using ISO 37) of less than 100%.

[0219] In at least one exemplary embodiment, the oral product includes a plasticizer. The plasticizer may include triglycerides (e.g., long-chain, medium-chain, and / or short-chain), triacetin, propylene glycol, glycerin, vegetable oils, phthalates, esters of polycarboxylic acids with moderate chain length linear or branched fatty alcohols, or any combination thereof. The plasticizer may be present in addition to the triglycerides and / or other fats and oils in the liquid mixture.

[0220] In at least one exemplary embodiment, the oral product includes a flavoring agent. The flavoring agent may be natural or artificial. In at least one exemplary embodiment, the flavoring agent is a fruit flavor (e.g., bergamot, berry, cherry, lemon, and / or orange), a liquor or liqueur flavor (e.g., bourbon, cognac, scotch, whiskey, and / or Drambuie brand liqueur), a mint flavor (e.g., Japanese mint, menthol, peppermint, spearmint, wintergreen, and / or mint oil from a Mentha species), a floral flavor (e.g., geranium, lavender, and / or rose), a spice, an herb, or another plant or plant-derived flavor (e.g., anise, apium graveolens, or the like). graveolens,), caraway, cardamom, cascarilla, cassia, cinnamon, chamomile, clove, cocoa, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pimenta, sage, sandalwood (vanilla, and / or ylang ylang), honey extract, or any combination thereof. In at least one exemplary embodiment, the flavoring agent comprises bergamot, berry, cherry, lemon, orange, bourbon, cognac, scotch, whiskey, Drambuie brand liqueur, peppermint, menthol, peppermint, spearmint, wintergreen, mint oil from a species of Mentha, geranium, lavender, rose, anise, apium graveolens, caraway, cardamom, cascarilla, cassia, cinnamon, chamomile, clove, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pimenta, sage, sandalwood vanilla, ylang ylang, honey extract, or any combination thereof. In at least one exemplary embodiment, the oral product comprises an encapsulated flavoring agent.

[0221] In at least one exemplary embodiment, the oral product includes a sweetener. The sweetener may include an artificial sweetener and / or a natural sweetener. The natural sweetener may include a sugar, such as a monosaccharide, a disaccharide, and / or a polysaccharide. In at least one exemplary embodiment, the sweetener includes a natural sweetener (including sucrose (i.e., table sugar), honey, a mixture of low molecular weight sugars other than sucrose, glucose (i.e., glucose, corn sugar, dextrose), molasses, corn sweetener, glucose syrup (i.e., corn syrup), fructose (i.e., fruit sugar), lactose (i.e., milk sugar), maltose (i.e., maltobiose), sorghum syrup, concentrated fruit juice, or any combination thereof). In at least one exemplary embodiment, the sweetener includes a sugar alcohol. The sugar alcohol may include ethylene glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt, maltitol, lactitol, maltotriitol, maltotetritoitol, polyglycitol, or any combination thereof. In at least one exemplary embodiment, the sweetener comprises a non-nutritive sweetener including stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof.

[0222] In at least one exemplary embodiment, the oral product comprises a mouth-soluble fiber. The mouth-soluble fiber may be configured to dissolve upon exposure to saliva in the mouth of an adult tobacco consumer at normal human body temperature. In at least one exemplary embodiment, the mouth-soluble fiber comprises maltodextrin, psyllium, starch, or any combination thereof. In at least one exemplary embodiment, the mouth-soluble fiber comprises soluble dietary fiber. In at least one exemplary embodiment, the oral product comprises a partially soluble fiber, such as sugar beet fiber.

[0223] In at least one exemplary embodiment, the oral product may include an energizing agent. In at least one exemplary embodiment, the energizing agent includes caffeine, taurine, glucuronolactone, or any combination thereof. The caffeine may include synthetic caffeine and / or natural caffeine (such as coffee bean extract caffeine). In at least one exemplary embodiment, the oral product includes about 10 mg or more (e.g., about 25 mg or more, about 50 mg or more, about 75 mg or more, about 100 mg or more, about 150 mg or more) of caffeine. The caffeine content may be about 200 mg or less (e.g., about 150 mg or less, about 100 mg or less, about 75 mg or less, about 50 mg or less, or about 25 mg or less).

[0224] In at least one exemplary embodiment, the oral product may include a colorant. The colorant may be a natural colorant and / or an artificial colorant. In at least one exemplary embodiment, the oral product does not include a colorant.

[0225] In at least one exemplary embodiment, the oral product includes a filler. The filler may be configured to provide a different texture or flexibility to the oral product compared to an oral product without the filler. The filler may include a mouth-soluble component, a mouth-insoluble component, or both a mouth-soluble component and a mouth-insoluble component. The mouth-soluble component may be configured to dissolve or disintegrate in an adult consumer's mouth to make the oral product softer. The filler may include dicalcium phosphate, calcium sulfate, clay, silica, glass particles, glyceryl palmitostearate, sodium stearyl fumarate, talc, or any combination thereof. Additionally, certain of the above-mentioned components, such as mouth-soluble fiber, sweeteners, minerals, or any combination thereof, may also be classified as fillers. In at least one exemplary embodiment, a cellulosic material may be present in the oral product as a filler in addition to, or as an alternative to, being a carrier for the liquid mixture.

[0226] In at least one exemplary embodiment, the oral product is a chewing gum, a spray, a lozenge, a dissolvable tablet, an insoluble chew, a film, a gel, a capsule, or a pouch (e.g., containing fibers or granules). In at least one exemplary embodiment, the oral product directly comprises the liquid mixture. In at least one exemplary embodiment, the oral product comprises the liquid mixture absorbed into a carrier (e.g., a cellulosic material such as MCC).

[0227] FIG. 14 is a perspective view of a pouch product according to at least one exemplary embodiment.

[0228] In at least one exemplary embodiment, the oral product may be a pouch product 4400, as shown in Figure 14. The pouch product may include a liquid mixture absorbed into a carrier, such as MCC, and contained within a pouch. The pouch may be formed from a permeable fabric. Pouch product 4400 may be a pouch product such as those described in any of U.S. Patent No. 9,066,540 issued June 30, 2015, U.S. Patent No. 8,978,661 issued March 17, 2015, U.S. Patent No. 10,039,309 issued August 7, 2018, U.S. Patent No. 9,414,624 issued August 16, 2016, U.S. Patent No. 9,693,582 issued July 4, 2017, or U.S. Patent No. 9,462,827 issued October 11, 2016 (each of which is incorporated herein by reference in its entirety), and may further be a pouch product containing a liquid mixture as described above, as a substitute for or in addition to tobacco and / or nicotine.

[0229] In at least one exemplary embodiment, the oral product is a mouth spray. The mouth spray comprises a liquid mixture. The mouth spray may further comprise a liquid carrier. The liquid carrier may comprise water, propylene glycol, glycerin, ethanol, or any combination thereof.

[0230] FIG. 15 is a perspective view of a soluble film in accordance with at least one exemplary embodiment.

[0231] In at least one exemplary embodiment, the oral product may be a dissolvable film 4500. The dissolvable film 4500 may be a film such as those described in U.S. Patent No. 8,469,036, issued June 25, 2013, the entire contents of which are incorporated herein by reference, and may further be a film that includes a liquid mixture, such as those described above, as a substitute for or in addition to tobacco.

[0232] In at least one exemplary embodiment, the oral product comprises a chewing gum, which comprises a gum base and a liquid mixture, at least a portion of which is absorbed into a carrier, such as MCC.

[0233] In at least one exemplary embodiment, the gum base includes an elastomer, a resin, a wax, a fat, an emulsifier, a filler, an antioxidant, or any combination thereof. The elastomer may include, by way of example, couma macrocarpa, loquat, tunu, jelutong, chicle, styrene butadiene rubber, butyl rubber, polyisobutylene, or any combination thereof. The resin may include, by way of example, a glycerin ester of gum, a terpene resin, polyvinyl acetate, or any combination thereof. The wax may include, by way of example, paraffin, microcrystalline wax, or both paraffin and microcrystalline wax. The fat may include, by way of example, hydrogenated vegetable oil. The emulsifier may include, by way of example, lecithin, glyceryl monostearate, or a combination of lecithin and glyceryl monostearate. The filler may include, by way of example, calcium carbonate, talc, or both calcium carbonate and talc. Antioxidants may include, by way of example only, butylhydroxytoluene (BHT), butylhydroxyanisole (BHA), tocopherol, ascorbyl palmitate, or any combination thereof. In at least one exemplary embodiment, the gum base includes natural latex, vegetable gum (e.g., chicle), spruce gum, mastic gum, or any combination thereof.

[0234] In at least one exemplary embodiment, the oral product is a troche. The troche can include a solid solution and a liquid mixture. The solid solution can include a soluble fiber and a sugar alcohol as described above. In at least one exemplary embodiment, the solid solution includes isomalt. In at least one exemplary embodiment, the liquid mixture is absorbed into a carrier (e.g., MCC). In at least one exemplary embodiment, the troche directly includes the liquid mixture without a carrier. In at least one exemplary embodiment, the troche can be a troche as described in U.S. Patent No. 9,351,936, issued May 31, 2016 (the entire contents of which are incorporated herein by reference), and can be a troche further including, as a general matter or in addition to nicotine, a liquid mixture as described above.

[0235] In at least one exemplary embodiment, the oral product is a dissolvable tablet. The dissolvable tablet may comprise the orally soluble polymer described above and a liquid mixture (optionally absorbed in a carrier). In at least one exemplary embodiment, the dissolvable tablet may be a tablet (or tab) as described in U.S. Patent Application No. 14 / 505,814, filed October 3, 2014, U.S. Patent No. 9,930,909, issued April 3, 2018, or U.S. Patent No. 8,469,036, issued June 25, 2013 (the entire contents of each of which are incorporated herein by reference), or may further comprise a liquid mixture as described above as a substitute for or in addition to tobacco.

[0236] In at least one exemplary embodiment, the oral product is an insoluble chew. The insoluble chew may include a mouth-stable polymer as described above and a liquid mixture (optionally absorbed in a carrier). The insoluble chew may be a chew as described in U.S. Patent No. 9,854,831 issued January 2, 2018, U.S. Patent No. 10,098,376 issued October 16, 2018, U.S. Patent No. 9,420,827 issued August 23, 2016, or U.S. Patent No. 9,185,931 issued November 17, 2015 (the entire contents of each of which are incorporated herein by reference), or may include a liquid mixture as described above as a substitute for or in addition to tobacco.

[0237] In at least one exemplary embodiment, the oral product can be a gel, such as those described in U.S. Patent No. 8,469,036, issued June 25, 2013, the entire contents of which are incorporated herein by reference, and can further include a liquid mixture as described above, either as a substitute for or in addition to tobacco.

[0238] An oral product according to at least one exemplary embodiment can be manufactured to have a variety of different sizes and shapes (as described in more detail below and shown in FIGS. 16A-17). In at least one exemplary embodiment, the size and / or shape of the oral product facilitates desired positioning of the oral product in the oral cavity and / or within the packaging. In at least one exemplary embodiment, the oral product can have dimensions ranging from about 0.25 mm to about 30 mm (e.g., from about 0.25 mm to about 1 mm, from about 1 mm to about 10 mm, from about 1 mm to about 5 mm, from about 5 mm to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from about 20 mm to about 30 mm, from about 20 mm to about 25 mm, or from about 25 mm to about 30 mm). In at least one exemplary embodiment, the oral product has a first dimension (e.g., a minimum dimension or thickness) ranging from about 0.25 mm to about 10 mm (e.g., about 2.5 mm). In at least one exemplary embodiment, the oral product has a maximum dimension (e.g., diameter, height, or width) ranging from about 5 mm to about 25 mm (e.g., about 12 mm). The oral product may have a weight ranging from about 1 g to about 10 g (e.g., from about 1 g to about 5 g, from about 2 g to about 4 g, or from about 5 g to about 10 g).

[0239] In at least one exemplary embodiment, an oral product, such as a chewing gum, dissolvable tablet, chewable tablet, and / or gel, can define a thickness and a cross-sectional shape perpendicular to the thickness. As used herein, "thickness" refers to the smallest dimension of the oral product. In at least one exemplary embodiment, the oral product can have a substantially uniform thickness. Figures 16A through 16G illustrate oral products having different cross-sectional shapes, according to at least one exemplary embodiment.

[0240] FIG. 16A is a perspective view of an oral product having a circular cross-section, according to at least one exemplary embodiment.

[0241] In at least one exemplary embodiment, an oral product 4600A is provided, as shown in Figure 16A. The oral product 4600A may have a circular cross-section. Although not shown, the oral product 4600A may have rounded ends.

[0242] FIG. 16B is a perspective view of an oral product having an oval cross-section according to at least one exemplary embodiment.

[0243] In at least one exemplary embodiment, an oral product 4600B is provided, as shown in FIG. 16B. The oral product 4600B can have a generally oval cross-section. In at least one exemplary embodiment, the generally oval cross-section is a generally elliptical cross-section. Although not shown, the oral product 4600B may have rounded edges.

[0244] FIG. 16C is a perspective view of an oral product having a rectangular cross-section according to at least one exemplary embodiment.

[0245] In at least one exemplary embodiment, an oral product 4600C is provided, as shown in FIG. 16C. The oral product 4600C can have a generally rectangular cross-section. In at least one exemplary embodiment, the generally rectangular cross-section is a generally square cross-section. In at least one exemplary embodiment, the rectangular cross-section may have rounded corners. Although not shown, the oral product 4600C may have rounded edges.

[0246] FIG. 16D is a perspective view of an oral product having an elongated rectangular cross-section according to at least one exemplary embodiment.

[0247] In at least one exemplary embodiment, an oral product 4600D is provided, as shown in FIG. 16D. The oral product 4600D may have an elongated rectangular cross-section. The elongated rectangular cross-section may have rounded corners. Although not shown, the oral product 4600D may have rounded edges.

[0248] FIG. 16E is a perspective view of an oral product having a lenticular or football-shaped cross-section according to at least one exemplary embodiment.

[0249] In at least one exemplary embodiment, an oral product 4600E is provided, as shown in FIG. 16E. The oral product 4600E may have a lenticular cross-section. In at least one exemplary embodiment, the lenticular cross-section may have rounded corners. Although not shown, the oral product 4600E may have rounded edges.

[0250] FIG. 16F is a perspective view of an oral product having a boomerang-shaped cross-section according to at least one exemplary embodiment.

[0251] In at least one exemplary embodiment, an oral product 4600F is provided, as shown in FIG. 16F. The oral product 4600F can have a boomerang-shaped cross-section. The boomerang-shaped cross-section can have rounded corners. Although not shown, the oral product 4600F can also have rounded ends.

[0252] FIG. 16G is a perspective view of an oral product having a shield-shaped cross-section according to at least one exemplary embodiment.

[0253] In at least one exemplary embodiment, an oral product 4600G is provided, as shown in FIG. 16G. The oral product 4600G may have a shield-shaped cross-section. The cross-section may be axisymmetric about a plane passing through its center. In at least one exemplary embodiment, the oral product 4600G has three rounded corners. In at least one exemplary embodiment, the oral product has a triangular cross-section. Although not shown, the oral product 4600G may have rounded edges.

[0254] In at least one other exemplary embodiment, the oral product defines another shape, for example, the oral product may have a semicircular cross-sectional shape, a comma-shaped cross-sectional shape, a bowtie-shaped cross-sectional shape, or a bean / kidney-shaped cross-sectional shape.

[0255] In at least one exemplary embodiment, the oral product may have a non-uniform thickness (e.g., pillow-shaped). In at least one exemplary embodiment, the oral product does not have a single minimum dimension, such as when the oral product has a spherical or cubic shape. In at least one exemplary embodiment, the oral product defines another three-dimensional shape.

[0256] FIG. 17 is a perspective view of an oral product according to at least one exemplary embodiment.

[0257] In at least one exemplary embodiment, an oral product 4700 is provided, as shown in Figure 17. The oral product 4700 may have a wedge shape with rounded ends. The rounded ends may be to avoid sharp corners that may cause discomfort when placed in the mouth of an adult consumer. In at least one other exemplary embodiment, the oral product may have a hemispherical shape, a semi-cylindrical shape, a twisted shape, a spiral shape, a cushion / pillow shape, a bar shape, or a pebble shape.

[0258] At least one exemplary embodiment relates to a method for increasing buccal absorption of nicotine in an oral product. The method may include preparing a liquid mixture as described above and incorporating the liquid mixture into the oral product. In at least one exemplary embodiment, the method includes preparing the liquid mixture before incorporating it into the oral product. In at least one exemplary embodiment, the method further includes absorbing the liquid mixture into a carrier before incorporating it into the oral product. In at least one exemplary embodiment, the method further includes forming the oral product.

[0259] In at least one exemplary embodiment, preparing the liquid mixture includes dissolving liquid nicotine in a triglyceride, such as MCT, wherein at least a portion of the liquid nicotine is in a free base form. In at least one exemplary embodiment, the weight ratio of triglyceride to liquid nicotine ranges from about 1:1 to about 9:1.

[0260] In at least one exemplary embodiment, allowing the liquid mixture to be absorbed into the carrier may include mixing the liquid mixture with the carrier. The method may include allowing the liquid mixture and the carrier to equilibrate for a desired (or alternatively, predetermined) period of time before incorporation into the oral product.

[0261] The incorporating step can include incorporating the liquid mixture into any of the oral products described herein, such as a chewing gum, spray, lozenge, dissolvable tablet, indissolvable chew, film, gel, capsule, or pouch (e.g., containing fibers or granules). In at least one exemplary embodiment, the incorporating step includes combining the liquid mixture and any carrier with one or more additional ingredients described herein. In at least one exemplary embodiment, the oral product can be formed simultaneously with the incorporation of the liquid mixture. In at least one exemplary embodiment, the oral product can be formed prior to incorporating the liquid mixture, such as by forming a tablet and allowing the formed tablet to absorb the liquid mixture.

[0262] In at least one exemplary embodiment, the incorporating step includes adding a carrier, such as a cellulosic material, to a gum base to absorb the liquid mixture to form a chewing gum. In at least one exemplary embodiment, the incorporating step includes combining the liquid mixture with a soluble fiber and a sugar alcohol to form a lozenge. In at least one exemplary embodiment, the incorporating step includes mixing the liquid mixture with a carrier liquid to form a mouth spray product. In at least one exemplary embodiment, the incorporating step includes mixing the liquid mixture with a mouth-soluble polymer to form a soluble oral product. In at least one exemplary embodiment, the incorporating step includes combining the liquid mixture with a mouth-stable polymer to form a chewable oral product.

[0263] In at least one exemplary embodiment, at least a portion of the nicotine remains dissolved in the triglyceride during and after the incorporation step. All of the nicotine can remain dissolved in the triglyceride during and after the incorporation step. In at least one exemplary embodiment, at least a portion of the nicotine remains in a free base state during and after the incorporation step. <Sustained-release chewing gum>

[0264] FIG. 18 is a perspective view of a chewing gum according to at least one exemplary embodiment.

[0265] In at least one exemplary embodiment, the present disclosure provides a controlled-release nicotine chewing gum 5100. The chewing gum 5100 includes a gum base polymer, an oil, and nicotine or a nicotine derivative. In at least one exemplary embodiment, the gum base polymer includes polyvinyl acetate (PVA) and the oil includes a triglyceride.

[0266] In at least one exemplary embodiment, a gum base polymer such as PVA is included in a higher amount compared to a typical gum base (e.g., a gum base including more than 10% by weight of a polymer, a sugar alcohol, and a filler such as calcium carbonate and / or talc), as described in more detail below. Increasing the amount of gum base polymer can promote a sustained release of nicotine. For example, the release rate of nicotine can decrease as the amount of gum base polymer increases.

[0267] In at least one exemplary embodiment, after about 10 minutes of chewing by an adult tobacco consumer, less than 95% of the nicotine by weight is released from the chewing gum (e.g., less than 90% of the nicotine by weight, less than 85% of the nicotine by weight, or less than 80% of the nicotine by weight). In at least one exemplary embodiment, after about 10 minutes of chewing by an adult tobacco consumer, an amount of nicotine in the range of about 75% to about 90% by weight is released from the oral product.

[0268] In at least one exemplary embodiment, the fat (which may be a blend of fats) may be included in a higher amount compared to typical chewing gum. The amount of fat may be selected to achieve a desired chewing gum texture and / or softness. More specifically, the softness of the chewing gum may increase as the amount of fat increases. In at least one exemplary embodiment, the fat includes triglycerides, triacetin, and flavor fats, as described in more detail below.

[0269] In at least one exemplary embodiment, the chewing gum 5100 is sized and shaped to be received in its entirety in the oral cavity of an adult tobacco consumer. The chewing gum 5100 may be uncoated as shown, or may be coated (as shown in FIG. 21). Coated chewing gum may include a body and a coating that partially or completely surrounds the body. The weight percentages of chewing gum described herein refer to the uncoated chewing gum or the coated chewing gum body.

[0270] In at least one exemplary embodiment, the gum base polymer comprises a resin, an elastomer, or any combination thereof. Resins may include, by way of example, polyvinyl acetate (PVA), glycerin esters of gum, terpene resins, or any combination thereof. Elastomers may include, by way of example, couma macrocarpa, loquat, chunu, jelutong, chicle, styrene butadiene rubber, butyl rubber, polyisobutylene, or any combination thereof. In at least one exemplary embodiment, the gum base polymer comprises natural latex, vegetable gum (e.g., chicle), spruce gum, mastic gum, or any combination thereof. The gum base polymer may comprise a single polymer or a combination of polymers. In at least one exemplary embodiment, the gum base polymer consists essentially of PVA.

[0271] In at least one exemplary embodiment, the amount of gum base polymer in the chewing gum 5100 (i.e., the uncoated chewing gum or the body of the coated chewing gum) is about 30% or more by weight of the chewing gum 5100. For example, the chewing gum 5100 may include gum base polymer in an amount of about 35% or more by weight (e.g., about 40% or more by weight, about 45% or more by weight, about 50% or more by weight, or about 55% or more by weight). The chewing gum 5100 may include chewing gum polymer in an amount of about 60% or less by weight (e.g., about 55% or less by weight, about 50% or less by weight, about 45% or less by weight, or about 40% or less by weight). In at least one exemplary embodiment, the gum base polymer is present in an amount ranging from about 35% to about 55% by weight of the chewing gum 5100 (e.g., from about 40% to about 50%, from about 43% to about 47%, from about 44% to about 46%, or about 45% by weight).

[0272] In at least one exemplary embodiment, the gum base polymer comprises PVA. The amount of PVA in the chewing gum 5100 (i.e., the uncoated chewing gum or the body of the coated chewing gum) may be about 30% or more by weight of the chewing gum 5100. For example, the chewing gum 5100 may comprise PVA in an amount of about 35% or more by weight (e.g., about 40% or more, about 45% or more, about 50% or more, or about 55% or more by weight). The chewing gum 5100 may comprise PVA in an amount of about 60% or less by weight (e.g., about 55% or less, about 50% or less, about 45% or less, or about 40% or less by weight). In at least one exemplary embodiment, the PVA is present in an amount ranging from about 35% to about 55% by weight of the chewing gum 5100 (e.g., from about 40% to about 50% by weight, from about 43% to about 47% by weight, from about 44% to about 46% by weight, or about 45% by weight).

[0273] In at least one exemplary embodiment, the chewing gum 5100 further comprises a polysaccharide to facilitate the sustained release of nicotine or a nicotine derivative. The polysaccharide facilitates the sustained release of nicotine by reducing the dissolution rate and corresponding nicotine release. The polysaccharide may include xanthan gum, guar gum, pullulan, locust bean gum, or any combination thereof. The chewing gum 5100 may include polysaccharides in an amount of about 0.01% by weight or greater (e.g., about 0.05% by weight or greater, about 0.1% by weight or greater, about 0.2% by weight or greater, about 0.5% by weight or greater, about 1% by weight or greater, about 2% by weight or greater, about 3% by weight or greater, or about 4% by weight or greater). The chewing gum 5100 may comprise polysaccharides in an amount of about 5% by weight or less (e.g., about 4% by weight or less, about 3% by weight or less, about 2% by weight or less, about 1% by weight or less, about 0.5% by weight or less, about 0.5% by weight or less, about 0.2% by weight or less, or about 0.05% by weight or less). The chewing gum 5100 may comprise polysaccharides in an amount ranging from 0.2% by weight to 1% by weight.

[0274] As noted above, in at least one exemplary embodiment, the chewing gum 5100 further comprises a fat. The fat can be a mixture of fats and oils. In at least one exemplary embodiment, the fat comprises a plasticizer, a flavor fat, or both a plasticizer and a flavor fat.

[0275] In at least one exemplary embodiment, the chewing gum 5100 (i.e., the uncoated chewing gum or the coated chewing gum body) comprises fat in an amount of about 5% by weight or more (e.g., about 8% by weight or more, about 9% by weight or more, about 10% by weight or more, about 11% by weight or more, about 12% by weight or more, about 13% by weight or more, or about 15% by weight or more). The chewing gum 5100 may comprise fat in an amount of about 20% by weight or less (e.g., about 15% by weight or less, about 14% by weight or less, about 13% by weight or less, about 12% by weight or less, about 11% by weight or less, about 10% by weight or less, or about 8% by weight or less). In at least one exemplary embodiment, the chewing gum 5100 comprises fat in an amount ranging from about 8% by weight to about 16% by weight (e.g., about 10% by weight to about 14% by weight, about 11% by weight to about 13% by weight, or about 12% by weight).

[0276] The plasticizer may include triglycerides (e.g., long-chain, medium-chain, and / or short-chain), triacetin, propylene glycol, glycerin, vegetable oils, phthalates, esters of polycarboxylic acids and moderate-chain linear or branched fatty alcohols, or any combination thereof. In at least one exemplary embodiment, the chewing gum 5100 includes a triglyceride including a long-chain triglyceride (LCT), a medium-chain triglyceride (MCT), or both LCT and MCT. In at least one exemplary embodiment, the plasticizer includes a triglyceride and another different plasticizer. In at least one exemplary embodiment, the plasticizer includes a triglyceride and triacetin. In at least one exemplary embodiment, the plasticizer includes an MCT and triacetin.

[0277] In at least one exemplary embodiment, the chewing gum 5100 (i.e., the uncoated chewing gum or the coated chewing gum body) comprises triglycerides (e.g., MCT) in an amount of about 4% by weight or greater (e.g., about 5% by weight or greater, about 6% by weight or greater, about 7% by weight or greater, or about 8% by weight or greater). The chewing gum 5100 may comprise triglycerides in an amount of about 12% by weight or less (e.g., about 10% by weight or less, about 8% by weight or less, about 7% by weight or less, about 6% by weight or less, or about 5% by weight or less). In at least one exemplary embodiment, the chewing gum 5100 comprises triglycerides in an amount ranging from about 4% by weight to about 8% by weight (e.g., from about 4% by weight to about 7% by weight, from about 4% by weight to about 6% by weight, from about 5% by weight to about 7% by weight, from about 5% by weight to about 6% by weight).

[0278] In at least one exemplary embodiment, the chewing gum 5100 (i.e., the uncoated chewing gum or the coated chewing gum body) comprises triacetin in an amount of about 1% by weight or greater (e.g., about 2% by weight or greater, about 3% by weight or greater, about 4% by weight or greater, or about 5% by weight or greater). The chewing gum 5100 may comprise triacetin in an amount of about 7% by weight or less (e.g., about 5% by weight or less, about 4% by weight or less, about 3% by weight or less, or about 2% by weight or less). In at least one exemplary embodiment, the chewing gum 5100 comprises triacetin in an amount ranging from about 1% to about 4% by weight (e.g., about 1% to about 3% by weight, about 2% to about 4% by weight, or about 2% to about 3% by weight).

[0279] As noted above, in at least one exemplary embodiment, the oil or fat further comprises a flavored oil or fat. The flavored oil or fat may be or include a flavoring agent. The flavoring agent may be natural or artificial. In at least one exemplary embodiment, the flavoring agent is a fruit flavor (e.g., bergamot, berry, cherry, lemon, and / or orange), a liquor or liqueur flavor (e.g., bourbon, cognac, scotch, whiskey, and / or Drambuie brand liqueur), a mint flavor (e.g., Japanese mint, menthol, peppermint, spearmint, wintergreen, and / or mint oil from a Mentha species), a floral flavor (e.g., geranium, lavender, and / or rose), a spice, herb, or another plant or plant-derived flavor (e.g., anise, apium graveolens, etc.). graveolens,), caraway, cardamom, cascarilla, cassia, cinnamon, chamomile, clove, cocoa, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pimenta, sage, sandalwood (vanilla, and / or ylang ylang), honey extract, or any combination thereof. In at least one exemplary embodiment, the flavoring agent comprises bergamot, berry, cherry, lemon, orange, bourbon, cognac, scotch, whiskey, Drambuie brand liqueur, peppermint, menthol, peppermint, spearmint, wintergreen, mint oil from a species of Mentha, geranium, lavender, rose, anise, apium graveolens, caraway, cardamom, cascarilla, cassia, cinnamon, chamomile, clove, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pimenta, sage, sandalwood vanilla, ylang ylang, honey extract, or any combination thereof.

[0280] In at least one exemplary embodiment, a flavoring agent (e.g., spearmint oil and / or peppermint oil) or another component of the flavor oil (e.g., propylene glycol, MCT, and / or triacetin in complex flavor compounds) may act as a plasticizer.

[0281] In at least one exemplary embodiment, in addition to or instead of the flavoring being present as a flavor oil or fat, the chewing gum 5100 may include a non-oil-based flavoring. In at least one exemplary embodiment, the chewing gum 5100 includes an encapsulated flavor oil or fat and / or an encapsulated non-oil-based flavoring. The non-oil-based flavoring, the encapsulated flavoring, and the flavoring oil or fat are not considered part of the nicotine and triglyceride-containing fat.

[0282] In at least one exemplary embodiment, the chewing gum 5100 comprises flavor oils or fats in an amount of about 0.001% by weight or more (e.g., about 0.01% by weight or more, about 0.1% by weight or more, about 1% by weight or more, about 2% by weight or more, about 3% by weight or more, about 4% by weight or more, or about 5% by weight or more). The chewing gum 5100 may comprise flavor oils or fats in an amount of about 10% by weight or less (e.g., about 7% by weight or less, about 5% by weight or less, about 4% by weight or less, about 3% by weight or less, about 2% by weight or less, about 1% by weight or less, about 0.1% by weight or less, or about 0.01% by weight or less). In at least one exemplary embodiment, the chewing gum 5100 comprises flavored fat in an amount ranging from about 0.001% to about 6% by weight (e.g., from about 1% to about 6% by weight, from about 1% to about 4% by weight, from about 1% to about 3% by weight, from about 2% to about 5% by weight, from about 2% to about 4% by weight, from about 3% to about 6% by weight, or from about 3% to about 4% by weight). In at least one exemplary embodiment, the fat does not comprise a flavored fat. In at least one exemplary embodiment, the chewing gum does not comprise a flavoring agent.

[0283] As mentioned above, in at least one exemplary embodiment, the chewing gum 5100 comprises nicotine or a nicotine derivative (e.g., a nicotine complex (e.g., nicotine polacrilex) or a nicotine salt (e.g., nitrate, monotartrate, bitartrate, bitartrate dihydrate, salicylate, sulfate or disulfate, phosphate or superphosphate, acetate, lactate, succinate, maleate, fumarate, gluconate, saccharate, benzoate, methanesulfonate, hydrochloride, hydrobromide, hydroiodide, or any combination thereof)). The nicotine or nicotine derivative may include tobacco-derived nicotine, synthetic nicotine, or both tobacco-derived and synthetic nicotine. In at least one exemplary embodiment, the chewing gum 5100 comprises liquid nicotine.

[0284] In at least one exemplary embodiment, tobacco-derived nicotine may include nicotine and one or more additional organoleptic components. In at least one exemplary embodiment, tobacco-derived nicotine may be extracted from raw (e.g., green leaf) tobacco and / or processed tobacco. Processed tobacco may include fermented and unfermented tobacco, dark air-cured, dark fire-cured, burley, flue-cured, and cigar filler or wrapper, as well as products obtained from whole leaf stemming operations. Tobacco may also be conditioned by heating, infusion, and / or pasteurization processes. For example, fermentation is typically characterized by a high initial moisture content, heat generation, and a dry weight loss of about 10% to about 20% by weight. By processing the tobacco prior to extraction of the nicotine and other organoleptic components, the tobacco-derived nicotine may include components that provide a favorable experience. In at least one exemplary embodiment, tobacco-derived nicotine can be obtained by mixing dried and fermented tobacco with water and / or another solvent (e.g., ethanol) and then removing insoluble tobacco material. The tobacco extract can be further concentrated or purified. In at least one exemplary embodiment, selected tobacco materials can be removed from the tobacco extract.

[0285] In at least one exemplary embodiment, the chewing gum 5100 comprises nicotine or a nicotine derivative in an amount greater than about 0.1 mg (e.g., greater than about 1 mg, greater than about 2 mg, greater than about 4 mg, greater than about 6 mg, greater than about 8 mg, greater than about 10 mg, or greater than about 12 mg). The chewing gum 5100 may comprise nicotine or a nicotine derivative in an amount of about 14 mg or less (e.g., about 12 mg or less, about 10 mg or less, about 8 mg or less, about 6 mg or less, about 4 mg or less, about 2 mg or less, or about 1 mg or less). In at least one exemplary embodiment, the chewing gum 5100 comprises nicotine or a nicotine derivative in an amount ranging from about 3 mg to about 8 mg.

[0286] In at least one exemplary embodiment, the chewing gum 5100 further comprises additives, which may include sweeteners, mouth-soluble fiber, insoluble cellulosic materials, antioxidants, energizing agents, soothing agents, concentration agents, alkaloids, minerals, vitamins, dietary supplements, functional foods, colorants, amino acids, chemical sensates, food emulsifiers, pH adjusters, botanicals (e.g., green tea), tooth whitening agents (e.g., sodium hexametaphosphate (SHMP)), therapeutic agents, processing aids, stearates (e.g., magnesium and / or potassium), waxes (e.g., glyceryl monostearate, propylene glycol monostearate, and / or acetylated monoglycerides), stabilizers (e.g., ascorbic acid and monosterol citrate, butylhydroxytoluene (BHT), or butylhydroxyanisole (BHA)), lubricants (e.g., sodium lauryl sulfate (SLS)), preservatives (e.g., sodium benzoate), or any combination thereof. An additive may include multiple additives, and furthermore, a single additive may belong to more than one of the above categories.

[0287] In at least one exemplary embodiment, the additive may be included in an amount of about 0.001% by weight or more (e.g., about 0.005% by weight or more, about 0.01% by weight or more, about 0.05% by weight or more, about 0.1% by weight or more, about 0.5% by weight, about 1% by weight or more, about 2% by weight or more, about 5% by weight or more, about 10% by weight or more, about 15% by weight or more, about 20% by weight or more, about 25% by weight or more, about 30% by weight or more, about 35% by weight or more, about 40% by weight or more). The additive may be included in an amount of about 65% by weight or less (e.g., about 60% by weight or less, about 55% by weight or less, about 50% by weight or less, about 45% by weight or less, about 40% by weight or less, about 35% by weight or less, about 30% by weight or less, about 25% by weight or less, about 20% by weight or less, about 15% by weight or less, about 10% by weight or less, about 5% by weight or less, about 1% by weight or less, about 0.5% by weight or less, about 0.1% by weight or less, or about 0.01% by weight or less).

[0288] In at least one exemplary embodiment, the additive comprises a sweetener. The sweetener may comprise an artificial sweetener and / or a natural sweetener. The natural sweetener may comprise a sugar such as a monosaccharide, a disaccharide, and / or a polysaccharide. In at least one exemplary embodiment, the sweetener comprises a natural sweetener (including sucrose (i.e., table sugar), honey, a mixture of low molecular weight sugars excluding sucrose, glucose (i.e., glucose, corn sugar, dextrose), molasses, corn sweetener, glucose syrup (i.e., corn syrup), fructose (i.e., fruit sugar), lactose (i.e., milk sugar), maltose (i.e., maltobiose), sorghum syrup, concentrated fruit juice, or any combination thereof). In at least one exemplary embodiment, the sweetener comprises a sugar alcohol. The sugar alcohol may include ethylene glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt, maltitol, lactitol, maltotriitol, maltotetritoitol, polyglycitol, or any combination thereof. In at least one exemplary embodiment, the sweetener comprises a non-nutritive sweetener including stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof.

[0289] In at least one exemplary embodiment, the additive comprises a mouth-soluble fiber. The mouth-soluble fiber may be configured to dissolve upon exposure to saliva in the mouth of an adult tobacco consumer at normal human body temperature. In at least one exemplary embodiment, the mouth-soluble fiber comprises maltodextrin, psyllium, starch, or any combination thereof. In at least one exemplary embodiment, the mouth-soluble fiber comprises soluble dietary fiber. In at least one exemplary embodiment, the additive comprises a partially soluble fiber, such as sugar beet fiber.

[0290] In at least one exemplary embodiment, the additive comprises a cellulosic material that is insoluble in the mouth. The cellulosic material may comprise or be derived from sugar beet, wood pulp, cotton, bran, citrus pulp, grass (e.g., switchgrass), willow, poplar, or any combination thereof. The insoluble cellulosic material may be a processed cellulosic material such as microcrystalline cellulose (MCC), carboxymethyl cellulose (CMC), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), or any combination thereof. In at least one exemplary embodiment, the cellulosic material that is insoluble in the mouth comprises cellulosic fiber that is insoluble in the mouth.

[0291] In at least one exemplary embodiment, the additive may include an energizing agent. In at least one exemplary embodiment, the energizing agent includes caffeine, taurine, glucuronolactone, or any combination thereof. The caffeine may include synthetic caffeine and / or natural caffeine (such as coffee bean extract caffeine). In at least one exemplary embodiment, the chewing gum 5100 includes about 10 mg or more (e.g., about 25 mg or more, about 50 mg or more, about 75 mg or more, about 100 mg or more, about 150 mg or more) of caffeine. The caffeine content may be about 200 mg or less (e.g., about 150 mg or less, about 100 mg or less, about 75 mg or less, about 50 mg or less, or about 25 mg or less).

[0292] In at least one exemplary embodiment, the additive may include a sedative, hi at least one exemplary embodiment, the sedative includes theanine, melatonin, or both theanine and melatonin.

[0293] In at least one exemplary embodiment, the additive may include a concentration agent, hi at least one exemplary embodiment, the concentration agent includes ginkgo biloba.

[0294] In at least one exemplary embodiment, the additive may include a colorant. The colorant may be a natural colorant and / or an artificial colorant. In at least one exemplary embodiment, the chewing gum 5100 does not include a colorant. In at least one exemplary embodiment, the chewing gum 5100 has a white or off-white color.

[0295] In at least one exemplary embodiment, the additive may include a pH adjuster. The pH adjuster may include ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, calcium carbonate, potassium carbonate, potassium bicarbonate, potassium hydroxide, sodium carbonate, sodium bicarbonate, sodium hydroxide, or any combination thereof. The pH adjuster may be included in an amount of about 0.01% by weight or more (e.g., about 0.05% by weight or more, about 0.1% by weight or more, about 0.5% by weight or more, or about 1% by weight or more). The pH adjuster may be included in an amount of about 2% by weight or less (e.g., about 1% by weight or less, about 0.5% by weight or less, about 0.1% by weight or less, or about 0.05% by weight or less). In at least one exemplary embodiment, the pH adjuster is present in an amount ranging from about 0.01% by weight to about 2% by weight. In at least one exemplary embodiment, the chewing gum 5100 does not include a pH adjuster.

[0296] In at least one exemplary embodiment, the chewing gum 5100 includes a filler. A filler can generally be described as an element that does not undergo a physical change before or after mixing. Certain additives mentioned above, such as insoluble fiber in the mouth, can be classified as a filler. The filler may additionally or alternatively include dicalcium phosphate, calcium sulfate, clay, silica, glass particles, glyceryl palmitostearate, sodium stearyl fumarate, talc, or any combination thereof. In at least one exemplary embodiment, the filler may include insoluble fiber in the mouth, dicalcium phosphate, calcium sulfate, clay, silica, glass particles, glyceryl palmitostearate, sodium stearyl fumarate, talc, or any combination thereof.

[0297] The chewing gum 5100 may include fillers in an amount of 20% by weight or less (e.g., 15% by weight or less, 10% by weight or less, 9% by weight or less, 8% by weight or less, 7% by weight or less, 6% by weight or less, 5% by weight or less, 4% by weight or less, 3% by weight or less, 2% by weight or less, or 1% by weight or less). The chewing gum 5100 may include fillers in an amount of about 0% by weight or more (e.g., about 1% by weight or more, about 2% by weight or more, about 3% by weight or more, about 4% by weight or more, or about 5% by weight or more). In at least one exemplary embodiment, fillers may be included in an amount ranging from about 0% by weight to about 8% by weight.

[0298] In the exemplary embodiment shown, the chewing gum 5100 has a uniform unitary structure. In at least one exemplary embodiment, the chewing gum has two or more layers. The layers may be separable or inseparable. The layers may have different compositions. For example, the layers may have different flavors, amounts of nicotine or nicotine derivatives (including no nicotine or nicotine derivatives), textures and / or softness, and / or may be configured to have different nicotine release rates. In at least one exemplary embodiment, to achieve layers with different textures or release rates, the layers may have different amounts of chewing gum polymers (e.g., PVA), polysaccharides, and / or oils (e.g., MCT and / or triacetin).

[0299] The chewing gum according to at least one exemplary embodiment can be manufactured to have a variety of different sizes and shapes (as described in more detail below and shown in FIGS. 18-21). In at least one exemplary embodiment, the size and / or shape of the chewing gum product facilitates desired positioning of the chewing gum in the oral cavity and / or within the package. In at least one exemplary embodiment, the chewing gum 5100 can have dimensions ranging from about 1 mm to about 25 mm (e.g., about 1 mm to about 10 mm, about 1 mm to about 5 mm, about 5 mm to about 25 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, or about 20 mm to about 25 mm). In at least one exemplary embodiment, the chewing gum 5100 has a first dimension (e.g., smallest dimension or thickness) ranging from about 1 mm to about 10 mm (e.g., about 2.5 mm). In at least one exemplary embodiment, the chewing gum 5100 has a maximum dimension (e.g., diameter, height, or width) ranging from about 5 mm to about 25 mm (e.g., about 12 mm). The chewing gum 5100 may have a weight ranging from about 1 g to about 10 g (e.g., from about 1 g to about 5 g, from about 2 g to about 4 g, or from about 5 g to about 10 g).

[0300] In at least one exemplary embodiment, a chewing gum can define a thickness and a cross-sectional shape perpendicular to the thickness. As used herein, "thickness" refers to the smallest dimension of a chewing gum. In at least one exemplary embodiment, a chewing gum can have a substantially uniform thickness. Although not shown, any of the chewing gums described herein may have rounded ends. In at least one exemplary embodiment, a chewing gum is substantially disc-shaped (e.g., chewing gum 5100 of FIG. 18 has a substantially circular cross-section perpendicular to the thickness). Figures 19A to 19F illustrate chewing gums having other cross-sectional shapes, according to at least one exemplary embodiment.

[0301] FIG. 19A is a perspective view of a chewing gum having an oval cross section according to at least one exemplary embodiment.

[0302] In at least one exemplary embodiment, a chewing gum 5200A is provided. The chewing gum 5200A may be the same as the chewing gum 5100, except that the chewing gum 5200A has a generally oval cross-section. In at least one exemplary embodiment, the generally oval cross-section is a generally elliptical cross-section.

[0303] FIG. 19B is a perspective view of a chewing gum having a rectangular cross section, according to at least one exemplary embodiment.

[0304] In at least one exemplary embodiment, a chewing gum 5200B is provided. The chewing gum 5200B may be the same as the chewing gum 5100, except that the chewing gum 5200B has a generally rectangular cross-section. In at least one exemplary embodiment, the generally rectangular cross-section is a generally square cross-section. In at least one exemplary embodiment, the rectangular cross-section may have rounded corners.

[0305] FIG. 19C is a perspective view of a chewing gum having an elongated rectangular cross section, according to at least one exemplary embodiment.

[0306] In at least one exemplary embodiment, a chewing gum 5200C is provided. The chewing gum 5200C may be the same as the chewing gum 5100, except that the chewing gum 5200C has an elongated rectangular cross-section. The elongated rectangular cross-section may have rounded corners.

[0307] FIG. 19D is a perspective view of a chewing gum having a lenticular or football-shaped cross-section according to at least one exemplary embodiment.

[0308] In at least one exemplary embodiment, a chewing gum 5200D is provided. The chewing gum 5200D may be the same as the chewing gum 5100, except that the chewing gum 5200D has a lenticular cross-section. In at least one exemplary embodiment, the lenticular cross-section may have rounded corners.

[0309] FIG. 19E is a perspective view of a chewing gum having a boomerang-shaped cross-section according to at least one exemplary embodiment.

[0310] In at least one exemplary embodiment, a chewing gum 5200E is provided. The chewing gum 5200E may be the same as the chewing gum 5100, except that the chewing gum 5200E has a boomerang-shaped cross-section. The boomerang-shaped cross-section may have rounded corners.

[0311] FIG. 19F is a perspective view of a chewing gum having a shield-shaped cross section in accordance with at least one exemplary embodiment.

[0312] In at least one exemplary embodiment, a chewing gum 5200F is provided. The chewing gum 5200F may be the same as the chewing gum 5100, except that the chewing gum 5200F has a shield-shaped cross section. The cross section may be symmetrical about a plane passing through the center. In at least one exemplary embodiment, the chewing gum 5200F has three rounded corners. In at least one exemplary embodiment, the chewing gum has a triangular cross section.

[0313] In at least one other exemplary embodiment, the chewing gum defines another shape, for example, the chewing gum may have a semicircular cross-sectional shape, a comma-shaped cross-sectional shape, a bowtie-shaped cross-sectional shape, or a bean / kidney-shaped cross-sectional shape.

[0314] In at least one exemplary embodiment, the chewing gum may have a non-uniform thickness (e.g., pillow-shaped). In at least one exemplary embodiment, the chewing gum does not have a single minimum dimension, such as when the chewing gum has a spherical or cubic shape. In at least one exemplary embodiment, the chewing gum defines another three-dimensional shape.

[0315] FIG. 20 is a perspective view of a chewing gum according to at least one exemplary embodiment.

[0316] In at least one exemplary embodiment, chewing gum 5300 is provided. Chewing gum 5300 may be the same as chewing gum 5100, except that chewing gum 5300 has a wedge shape with rounded ends. The rounded ends may be to avoid sharp corners that may cause discomfort when placed in the mouth. In at least one other exemplary embodiment, chewing gum may have a hemispherical shape, a semi-cylindrical shape, a twisted shape, a spiral shape, a cushion / pillow shape, a stick shape, or a pebble shape.

[0317] FIG. 21 is a cross-sectional view of a coated chewing gum according to at least one exemplary embodiment.

[0318] In at least one exemplary embodiment, a chewing gum 5400 is provided. The chewing gum 5400 may have any shape, such as those described above and shown in Figures 18-20. The chewing gum 5400 has a body 5402 and a coating 5404 on an outer surface 5406 of the body 5402. The coating 5404 may cover the entire outer surface 5406, as shown, or may cover only a portion of the outer surface 5406.

[0319] In at least one exemplary embodiment, coating 5404 may include any of the additives described above. In at least one exemplary embodiment, coating 5404 may include a mouth-soluble polymer and one or more additional additives. In at least one exemplary embodiment, coating 5404 may be configured to provide nicotine or a nicotine derivative and / or additives (e.g., flavoring and / or sweetening agents) over a period of time different from that of body 5402. For example, coating 5404 may be configured to provide an initial burst of nicotine or additives. The flavoring and / or sweetening agents may be the same as or different from the flavoring and / or sweetening agents in body 5402.

[0320] In at least one exemplary embodiment, the coating is in the form of a flavor strip, either uniformly or non-uniformly patterned on the body. In at least one exemplary embodiment, the coating includes flavorings and / or sweeteners on the exterior surface of the body, which may be in addition to or instead of flavorings (e.g., flavored oils and fats) and / or sweeteners within the body.

[0321] In at least one exemplary embodiment, the chewing gum may include functional and / or decorative indicia. In at least one exemplary embodiment, the indicia include a trademark, product name, image, flavor indicia, decoration, date, product identifier, manufacturer identifier, lot number, or any combination thereof. In at least one exemplary embodiment, the indicia is embossed or debossed on the exterior surface of the chewing gum. In at least one exemplary embodiment, the indicia is in the form of a dissolvable film on the exterior surface of the chewing gum.

[0322] At least one exemplary embodiment relates to a method for preparing a sustained-release nicotine chewing gum. The method includes providing a gum base polymer, a fat, and nicotine or a nicotine derivative. In at least one exemplary embodiment, the gum base polymer includes PVA, and the fat includes a triglyceride. In at least one exemplary embodiment, the triglyceride includes a medium-chain triglyceride. In at least one exemplary embodiment, the method further includes providing a flavor fat, a polysaccharide, an additive, and / or a filler, as described above.

[0323] In at least one exemplary embodiment, providing a gum base polymer comprises providing an amount of gum base polymer sufficient to achieve a desired nicotine release rate. In at least one exemplary embodiment, the method further comprises determining the amount of gum base polymer based on the desired nicotine release rate. In at least one exemplary embodiment, the method further comprises adjusting the amount of gum base polymer based on the desired nicotine release rate.

[0324] The gum base polymer may be configured to reduce the nicotine release rate, such that increasing the amount of gum base polymer increases the reduction in nicotine release rate. In at least one exemplary embodiment, the method comprises providing the gum base polymer in an amount ranging from about 35% to about 55% by weight of the total chewing gum weight (i.e., the total weight of the uncoated chewing gum or the weight of the coated chewing gum body).

[0325] In at least one exemplary embodiment, providing a fat comprises providing a sufficient amount of fat to achieve a desired texture and / or softness. In at least one exemplary embodiment, the method may further comprise determining the amount of fat based on the desired softness. In at least one exemplary embodiment, the method may further comprise adjusting the amount of fat based on the desired softness.

[0326] The fat may be configured to improve the softness of the chewing gum, whereby increasing the amount of fat promotes improved softness of the chewing gum. In at least one exemplary embodiment, the method comprises providing fat in an amount of about 8% or more by weight of the total weight of the chewing gum.

[0327] In at least one exemplary embodiment, the method further comprises forming a chewing gum from the gum base polymer, fat, nicotine or a nicotine derivative, and optional flavor fat, polysaccharide, additives, and / or fillers.

[0328] In at least one exemplary embodiment, the chewing gum is formed in a batch process. The batch process may include bringing a heated mixer to a temperature ranging from about 30°C to about 90°C (e.g., about 60°C). During mixing, the gum base is added to the heated mixture along with the plasticizer and allowed to melt. Additional ingredients, such as nicotine, fats and oils, sugar alcohols, fillers, flavors, sweeteners, and / or other ingredients described above, are added to the heated mixture. The ingredients may be added all at once, in multiple steps, in the order listed, or in a different order. A dough is formed and kneaded with a heated mixer to ensure uniform distribution of the ingredients throughout the dough. The dough is discharged, cooled, and then sheeted and cut or otherwise portioned. In at least one exemplary embodiment, alternative techniques for forming the chewing gum include extrusion through a rotary cutter and / or sheet extrusion, as well as rolling and scoring operations.

[0329] In at least one exemplary embodiment, the method may further comprise coating the chewing gum, which may comprise pan-coating the individual pieces with sugars, sugar alcohols, and / or other ingredients, as described above. <Example>

[0330] In at least one exemplary embodiment, the uncoated sustained-release nicotine chewing gum comprises a gum base polymer comprising 45% PVA by weight of the chewing gum. The chewing gum comprises 12% fat by weight. The fat comprises 5.8% MCT, 2.5% triacetin, and the balance flavor fat. The chewing gum further comprises 6% filler by weight. The filler comprises a fiber that is insoluble in the mouth. The chewing gum further comprises a pH adjuster, an antioxidant, and a bulking agent comprising a sugar alcohol.

[0331] The present disclosure provides methods for enhancing the flavor and / or sensory effects of nicotine in oral products such as gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, and pouches (e.g., containing fibers or granules). In at least one exemplary embodiment, a nicotine powder is formed, which includes a spray-drying step. In at least one exemplary embodiment, the nicotine may be encapsulated. In at least one exemplary embodiment, the nicotine powder formed using the spray-drying step may be encapsulated. In at least one exemplary embodiment, the oral product may include an encapsulated sweetener. The encapsulated sweetener may be included with the spray-dried nicotine powder and / or the encapsulated nicotine. <Oral pouch products>

[0332] FIG. 22 is a perspective view of an oral pouch product in accordance with at least one exemplary embodiment.

[0333] In at least one exemplary embodiment, as shown in FIG. 22 , the oral pouch product 6800 is configured to fit into the mouth of an adult consumer and has a fill material including a dry mix and a liquid mix absorbed by the dry mix, as further described with reference to FIG. 23 . For example, the adult consumer may suck, chew, or otherwise orally manipulate the oral pouch product 6800 to release the flavor and / or functional ingredients contained therein. The oral pouch product 6800 may be, by way of example only, an oral pouch product having a generally rectangular shape. In still other embodiments, the oral pouch product 6800 may have a pouch shape resembling a ravioli or pillow shape, a rectangular shape, or any other suitable shape.

[0334] A variety of shapes may be utilized, so long as the shape fits comfortably and unobtrusively in the mouth of an adult consumer. In at least one exemplary embodiment, the oral pouch product 6800 is substantially free of oral irritants, which, as used herein, means that the shape, configuration, and position of the oral pouch product 6800 do not irritate oral tissues (e.g., gums) via sharp edges or the like. Furthermore, "substantial" and "substantially free," as used in connection with oral irritants, mean that the shape, configuration, and position of the oral pouch product 6800 do not irritate oral tissues (e.g., gums) over a time frame or period of time having the same order of magnitude as the typical length of time that the oral pouch product 6800 may be enjoyed by an adult consumer. Generally, sharp corners are avoided because they can lead to discomfort in the oral cavity.

[0335] The oral pouch product 6800 can be sized and configured to fit comfortably in an adult consumer's mouth, such as between the cheek and gum. In at least one exemplary embodiment, the oral pouch product 6800 has a major dimension in the range of about 0.20 inches to about 2.0 inches (e.g., about 0.25 inches to about 1.75 inches, about 0.75 inches to about 1.5 inches) and a lateral dimension in the range of about 0.25 inches to about 1.5 inches (e.g., about 0.50 inches to about 1.25 inches, about 0.75 inches to about 1.0 inch). The oral pouch product 6800 can weigh from about 0.25 grams (g) to about 2.0 grams (e.g., about 0.3 grams to about 1.8 grams, about 0.4 grams to about 1.5 grams, about 0.5 grams to about 1.25 grams, or about 0.75 grams to about 1.0 gram).

[0336] The oral pouch product 6800 may be placed in the mouth of an adult consumer for about 1 minute to about 3 hours (e.g., about 1 minute to about 2 hours, about 5 minutes to about 90 minutes, about 10 minutes to about 60 minutes, about 20 minutes to about 40 minutes). The size of the oral pouch product 6800 may be selected based on the desired length of placement in the adult consumer's mouth. For example, a larger pouch containing a greater amount of filler material may provide for longer placement. In at least one exemplary embodiment, the oral pouch product 6800 is discarded after being placed in the adult consumer's mouth once.

[0337] In at least one exemplary embodiment, as shown in FIG. 22 , the oral pouch product 6800 can include a pouch package 6820. The pouch package 6820 can be sealed around one or more edges (e.g., at least one seam) to define an interior cavity 6900 configured to carry a fill material 6910 (as discussed below and shown in FIG. 23 ). For example, the pouch package 6820 can include at least one longitudinal seal 6830 and one or more fin seals 6840. The longitudinal seal 6830 extends between the fin seals 6840. In at least one exemplary embodiment, the oral pouch product 6800 is formed on a high-speed vertical fill-and-seal machine.

[0338] In at least one exemplary embodiment, the pouch wrapper 6820 includes an outer web 6850. The outer web 6850 can have a thickness of about 0.05 mm to about 0.25 mm (e.g., about 0.075 mm to about 0.100 mm or about 0.1 mm to about 0.20 mm). The outer web 6850 can be formed of a permeable or semi-permeable material, for example, to allow saliva, water, or both saliva and water to pass through the outer web 6850 and enter the interior cavity 6900 defined by the pouch wrapper 6820. Flavors and liquids formed by mixing of saliva and / or water with the fill material 6910 contained within the oral pouch product 6800 can be drawn from the oral pouch product 6800 through the outer web 6850.

[0339] In at least one exemplary embodiment, the outer web 6850 is formed from a material that is generally recognized as safe ("GRAS") for use and / or contact with food. This material may be stain-resistant, water-permeable, and / or porous. For example, in at least one exemplary embodiment, the outer web 6850 comprises paper. For example, the web may be formed from a cellulosic fibrous material, such as tea bag material or other material typically used to form snus pouches. In at least one exemplary embodiment, the outer web 6850 has a desired (or alternatively, predetermined) level of basis weight and / or wet strength to reduce the occurrence of breakage of the pouch wrapper 6820 during manufacturing operations, storage, and placement in the mouth of an adult consumer. For example, the outer web 6850 may have a weight of approximately 16.5 g / m 2 and a wet tensile CD strength of 68 N / m. In another exemplary embodiment, the outer web 58 may be formed of a paper having a wet MD tensile strength of about 45 N / mm to about 52 N / mm.

[0340] In at least one exemplary embodiment, the outer web 6850 is formed of a hydrophobic paper or material. The hydrophobic paper may be formed of a cellulosic material. The hydrophobic paper may be a nonwoven material and may include any hydrophobic material. The hydrophobic material may be a synthetic material and / or a semi-synthetic material. The hydrophobic material may include viscose, rayon, lyocell, polyester, polyurethane, polyethylene, polypropylene, and / or modal fibers. The outer web 6850 may be treated to render the outer web 6850 hydrophobic. In other exemplary embodiments, the hydrophobic material may be a woven material.

[0341] The material used to form the outer web 6850 may have a neutral or pleasant taste and / or aroma. Additionally, the outer web 6850 may be substantially white. However, in other exemplary embodiments, the outer web 6850 may be colored to indicate the flavor of the inner filler material 6910 contained therein.

[0342] In at least one exemplary embodiment, the outer web 6850 may be impregnated or coated with at least one flavoring agent, at least one cannabis material, at least one tobacco material, at least one binder, at least one sensate or chemosensate, at least one functional ingredient, at least one saliva-inducing component, or any combination thereof to enhance the flavor of the fill material 6910 (shown in FIG. 23 ) contained within the oral pouch product 6800. A substantially continuous coating comprising at least one flavoring agent and / or at least one cannabis material and / or at least one tobacco material and / or at least one binder and / or at least one sensate or chemosensate may be applied to the outer (appearance-facing) surface of the outer web 6850. In at least one exemplary embodiment, the coating may be formed on only a portion of the outer web 6850, such as only along a seam or only on one side of the pouch 6800. The coating can provide an initial burst of flavor upon placement of the oral pouch product 6800 in the oral cavity, and the inner fill material 6910 provides a later flavor release to extend the flavor release while placed in the mouth of an adult consumer.

[0343] The at least one flavoring agent can be any flavoring agent disclosed herein for inclusion in a liquid mixture comprising nicotine and a triglyceride. In at least one exemplary embodiment, the at least one flavoring agent can be coated on or impregnated into the outer web 6850 in an amount ranging from about 0.01% to about 5% by weight (e.g., from about 0.1% to about 4.5%, from about 1% to about 4%, from about 1.5% to about 3.5%, from about 2% to about 3% by weight) based on the weight of the oral pouch product 800.

[0344] In at least one exemplary embodiment, the at least one cannabis or tobacco material may be coated on or impregnated into the outer web 6850. The at least one cannabis or tobacco material may include, by way of example only, ground cannabis or tobacco material, cannabis or tobacco plant fiber, and / or extracts thereof. The at least one cannabis or tobacco material may coat or impregnate the outer web 6850 in an amount ranging from about 0.01% to about 5% by weight (e.g., about 0.1% to about 4.5%, about 1% to about 4%, about 1.5% to about 3.5%, about 2% to about 3% by weight) based on the weight of the oral pouch product 6800.

[0345] In at least one exemplary embodiment, at least one binder may coat or impregnate the outer web 6850. The at least one binder may be a food-grade adhesive, gum, or other binder. For example, in some exemplary embodiments, the at least one binder includes, but is not limited to, sodium alginate, sugar, agar, guar gum, or the like. The at least one binder may coat or impregnate the outer web in an amount ranging from about 0.01% to about 5% by weight (e.g., from about 0.1% to about 4.5%, from about 1% to about 4%, from about 1.5% to about 3.5%, from about 2% to about 3% by weight) based on the weight of the oral pouch product 6800.

[0346] At least one sensate or chemosensate agent may coat or impregnate the outer web 6850. The at least one sensate or chemosensate agent may include mint, menthol, cinnamon, pepper, jambu, or any combination thereof. In certain embodiments, the at least one sensate or chemosensate agent may include any soothing, cooling, and / or warming agent. For example, in some exemplary embodiments, the at least one sensate or chemosensate agent may include capsaicin, piperine, α-hydroxysanshool, and (8)-gingerol, which may be selected to provide a warming, tingling, or burning sensation. In other exemplary embodiments, the at least one sensate or chemosensate agent may include menthol, menthyl lactate, WS-3 (N-ethyl-p-menthane-3-carboxamide), WS-23 (2-isopropyl-N,2,3-trimethylbutyramide), and Evercool 180® (available from Givaudan SA), which may be selected to provide a cooling sensation. The at least one sensate or chemosensate agent may coat or impregnate the outer web 6850 in an amount ranging from about 0.01% to about 5% by weight (e.g., from about 0.1% to about 4.5%, from about 1% to about 4%, from about 1.5% to about 3.5%, from about 2% to about 3% by weight) based on the weight of the oral pouch product 6800.

[0347] In at least one exemplary embodiment, the at least one functional ingredient may include an antioxidant, a soothing agent, an energizing agent, an effervescent agent, or any combination thereof. The antioxidant may include, for example, vitamin C, vitamin B, magnesium, calcium, or any combination thereof. The soothing agent may include, by way of example only, chamomile, lavender, jasmine, theanine, melatonin, soursop, cannabidiol, or a combination thereof. The soothing agent may be added as a flavoring and / or fragrance embedded in the product and / or packaging. The energizing agent may include, by way of example only, caffeine, taurine, guarana, vitamin B6, vitamin B12, etc. The effervescent agent may include, for example, carbon dioxide embedded in a flavoring and / or fill material. In at least one exemplary embodiment, the at least one functional ingredient may coat or impregnate the outer web 6850 in an amount ranging from about 0.01% to about 5% by weight (e.g., from about 0.1% to about 4.5%, from about 1% to about 4%, from about 1.5% to about 3.5%, from about 2% to about 3% by weight) based on the weight of the oral pouch product 6800.

[0348] In at least one exemplary embodiment, the at least one soothing agent may coat or impregnate the outer web 6850 in an amount ranging from about 0.01% to about 5% by weight (e.g., from about 0.1% to about 4.5%, from about 1% to about 4%, from about 1.5% to about 3.5%, from about 2% to about 3% by weight) based on the weight of the oral pouch product 6800.

[0349] FIG. 23 is a cross-sectional view of the oral pouch product taken along line II-II of FIG. 22 according to at least one exemplary embodiment.

[0350] FIG. 24 is a cross-sectional view of the oral pouch product taken along line III-III of FIG. 22 according to at least one exemplary embodiment.

[0351] 23 , the opposing layers of the outer web 6850, the longitudinal seal 6830, and the fin seal 6840 define an interior cavity 6900 therebetween. An interior filler material 6910 may be retained within the interior cavity 6900. In at least one exemplary embodiment, the interior filler material 6910 completely fills the interior (e.g., cavity) 6900 of the oral pouch product 6800. In other exemplary embodiments, the interior filler material 6910 only partially fills the interior (e.g., cavity) 6900 of the oral pouch product 6800.

[0352] In at least one exemplary embodiment, the inner filling material 6910 has a moisture content ranging from about 4% by weight based on the weight of the oral pouch product to about 8% by weight based on the weight of the oral pouch product 6800 (e.g., from about 7% to about 90% by weight, from about 10% to about 90% by weight, from about 10% to about 50% by weight).

[0353] In at least one exemplary embodiment, the inner fill material 6910 includes a dry mix and a liquid mix, where the liquid mix includes liquid nicotine and a triglyceride, such as MCT. In at least one exemplary embodiment, the dry mix includes a non-tobacco cellulose material, and the liquid mix is ​​absorbed into the cellulose. In addition to the cellulose, the dry mix may further include a dry flavor enhancer, such as a salt, such as salt or sodium bicarbonate, or a pH adjuster. A high-intensity sweetener, such as sucralose, palatinose, stevia, acesulfame K, and any combination thereof, may be premixed with a liquid humectant (e.g., glycerin, propylene glycol, and any combination thereof). The premixed mixture may be mixed with the dry mix. The liquid mix including MCT and nicotine may be added last to the dry mix to reduce exposure to oxygen. An antioxidant may be further added to the liquid mix to extend shelf life and / or stabilize the nicotine.

[0354] For example, in at least one exemplary embodiment, the inner filling material 6910 includes about 20% to about 80% by weight (e.g., about 30% to about 70%, about 40% to about 60%, or about 45% to about 55%) non-dissolvable cellulose, about 0% to about 5% (e.g., about 1% to about 4%, or about 2% to about 3%) pH adjuster such as sodium bicarbonate, about 10% to about 30% (e.g., about 15% to about 25%, about 18% to about 23%, or about 20% to about 22%) triglyceride such as a medium-chain triglyceride, and a sweetener such as stevia or a combination of sucralose and palatinose.

[0355] By including high levels of triglycerides such as MCT, the oral pouch product 6800 maintains a relatively moist mouthfeel while maintaining a moisture content of about 4% to about 8% and a water activity level of less than about 0.6, which may help prevent and / or reduce microbial growth and enhance the stability of nicotine in the oral pouch product 6800. Additionally, when a hydrophobic pouch wrapper is used, because the inner fill material contains primarily oils and fats instead of water, flavors from the inner fill material 6910 penetrate the pouch wrapper more easily than when a hydrophilic pouch wrapper is used.

[0356] In at least one exemplary embodiment, the oral pouch product 6800 may further include cannabis. Cannabis may include any part of the cannabis plant and / or any extract therefrom. For example, in some exemplary embodiments, the plant material may include a mixture of Cannabis sativa and Cannabis indica, such as, by way of example only, a mixture of approximately 70% sativa and approximately 30% indica. In at least one exemplary embodiment, the oral pouch product 6800 may include a cannabis extract adhered to cellulose. In at least one exemplary embodiment, the oral pouch product 6800 may include cannabis in addition to other plant materials. The oral pouch product 6800 may also include other plant materials, such as herbs, vegetables, etc. In at least one exemplary embodiment, the inner fill material 6910 may also include tobacco material in addition to or in place of cannabis material.

[0357] In at least one exemplary embodiment, the cannabis (or other plant material) may be heated to a temperature sufficient to decarboxylate compounds within the cannabis (or other plant material) prior to placing the cannabis (or other plant material) in oral pouch product 6800. For example, the cannabis may be maintained at a heated temperature for a time sufficient to cause decarboxylation (i.e., conversion of tetrahydrocannabinolic acid ("THCA") present in cannabis to tetrahydrocannabinol ("THC"), and / or conversion of cannabidiolic acid ("CBDA") to cannabidiol ("CBD"). In some applications, maintaining the plant material at heated temperatures causes decarboxylation of cannabis according to the article by Dussy et al. entitled "Isolation of Delta9annabinol, et al., Isolation of Delta9-THCA-A from hemp and analytical aspects concerning the determination of Delta9-THC in cannabis products" (Forensic Sci. Int. 2005 Apr 20;149(1):3-10), the entire disclosure of which is incorporated herein by reference, and / or the article by Veress et al. entitled "Determination of cannabinoid acids by high-performance liquid chromatography of their neutral derivatives formed by thermal decarboxylation: I. Study of the decarboxylation process in open reactors" (Journal of Chromatography A 520:339-347, November 1990), the entire disclosure of which is incorporated herein by reference. For example, cannabis (or other plant material) may be maintained at about 225°C for about 35 to 45 minutes.

[0358] As shown in FIG. 23 , in at least one exemplary embodiment, the inner fill material 6910 includes a plant material (e.g., cannabis, tobacco, herbs, vegetables, or any combination thereof) and an additive. The additive may include at least one binder, at least one sensate or chemosensate agent, at least one functional ingredient, at least one saliva-inducing ingredient, at least one humectant, at least one sweetener, or any combination thereof (e.g., at least one flavoring agent and / or at least one sensate or chemosensate agent and / or at least one humectant and / or at least one sweetener). The color of the pouch package 6820 may be selected to identify its contents. For example, a green pouch package 6820 may be used to identify an oral pouch product 6800 containing a mint flavoring, and a red pouch package 6820 may be used to identify an oral pouch product 6800 containing cinnamon. In other exemplary embodiments, the pouch packaging 6820 may be white and may contain a liquid mixture absorbed in cellulose.

[0359] In at least one exemplary embodiment, the at least one flavoring agent may be any of the flavoring agents used in the coating of the pouch wrapper 6820, as described herein. The inner fill material 6910 may include the at least one flavoring agent in an amount of about 0.01% to about 25% by weight (e.g., about 0.1% to about 20% by weight, about 1% to about 15% by weight, about 5% to about 10% by weight) based on the weight of the oral pouch product 6800.

[0360] The inner fill material 6910 can include at least one sensate or chemosensate agent used in coating the pouch wrapper 6820, as described herein. The sensate and / or chemosensate agent can be included to provide a cooling sensation. The inner fill material 6910 can include at least one sensate or chemosensate agent in an amount of about 0.01% to about 25% by weight (e.g., about 0.1% to about 20% by weight, about 1% to about 15% by weight, about 5% to about 10% by weight) based on the weight of the oral pouch product 6800.

[0361] The inner filling material 6910 may include at least one humectant to help maintain the moisture level of the inner filling material 6910 of the oral pouch product 6800. Examples of humectants that may be used include glycerol and propylene glycol. The inner filling material 6910 may include at least one humectant in an amount of about 0.01% to about 15% by weight (e.g., about 1% to about 12%, about 5% to about 10%, about 7% to about 9%) based on the weight of the oral pouch product 6800.

[0362] As described above, in at least one exemplary embodiment, the inner fill material 6910 may include at least one sweetener. The at least one sweetener may include a natural sweetener or an artificial sweetener. In at least one embodiment, the sweetener includes a water-soluble sweetener such as, but not limited to, a monosaccharide, disaccharide, or polysaccharide (such as xylose, ribose, sucrose, maltose, fructose, glucose, and mannose). In other exemplary embodiments, the sweetener may include a sugar alcohol such as xylitol, mannitol, sorbitol, or maltitol. Non-nutritive artificial sweeteners such as sucralose may also be used. The inner fill material 6910 may include at least one sweetener in an amount ranging from about 0.01% to about 15% by weight (e.g., from about 1% to about 12%, from about 5% to about 10%, from about 7% to about 9% by weight) based on the weight of the oral pouch product 6800.

[0363] In at least one embodiment, the inner fill material 6910 of the oral pouch product 6800 can include at least one functional ingredient. The at least one functional ingredient can include an antioxidant, a soothing agent, a vitalizing agent, an effervescent agent, or any combination thereof. For example, the inner fill material 6910 can include the at least one functional ingredient in an amount of about 0.01% to about 15% by weight (e.g., about 1% to about 12%, about 5% to about 10%, about 7% to about 9%) based on the weight of the oral pouch product 6800. The antioxidant, soothing agent, vitalizing agent, and / or effervescent agent can be any of those used in the coatings of the pouch package 6820 described herein.

[0364] In at least one embodiment, by way of example only, the one or more materials disposed within cavity 6900 as inner fill material 6910, including one or more additives and / or one or more functional ingredients, may be provided in the form of a plurality of capsules, microcapsules, and / or beads of various sizes. The capsules, microcapsules, and / or beads may have a size determined by the desired size of the final product (e.g., oral pouch product 6800). For example, the capsules, microcapsules, and / or beads may have a size ranging from about 0.1 mm to about 8 mm, depending on the ingredients contained therein.

[0365] In each example, each capsule, microcapsule, and / or bead may include an outer shell and an inner core. Varying the shell thickness of the included capsules, microcapsules, and / or beads may allow the ingredients included in each capsule, microcapsule, and / or bead to be released at different rates to prolong the flavor and / or functional experience of the oral pouch product 6800. In some exemplary embodiments, the shell thickness ranges from about 0.1 mm to about 7 mm, depending on the size and desired dissolution rate of the capsule, microcapsule, and / or bead. Capsules, microcapsules, and / or beads with the thinnest shells dissolve first to release the encapsulated flavor and functional ingredients. Capsules, microcapsules, and / or beads with thicker shells dissolve at a slower rate to provide a continuous supply of flavor and functional ingredients.

[0366] In at least one exemplary embodiment, as shown in Figure 24, the pouch package 6820 can include at least one longitudinal seal 6830 and one or more fin seals 6840 (shown in Figures 22 and 23). As shown in Figure 24, the longitudinal seal 6830 can include overlapping edges of an outer web 6850 that are sealed together. The sealing function can be achieved by a food-grade adhesive or by sealing the overlapping edges to one another using heat or sonic techniques.

[0367] As shown in FIG. 23 , each fin seal 6840 is formed by overlapping the inner surface of the outer web 6850 of the pouch package 6820 with another portion of the inner surface of the outer web 6850 to form the fin seal. The fin seal can then be sealed using any method, such as those detailed above, to form the fin seal 6840. While not shown, in certain embodiments, an integrated fin seal and longitudinal seal may be used, as will be recognized by those skilled in the art. By overlapping the fin seal, the oral pouch product 6800 may be more comfortable for insertion into an adult consumer's mouth because it does not have loose, unsealed edges that could protrude and get caught in the consumer's mouth during consumption. Additionally, the integrated fin seal and longitudinal seal may be more robust to reduce and / or prevent breakage during manufacturing, packaging, shipping, placement, and / or use of the oral pouch product 6800.

[0368] A method for manufacturing the oral pouch product 6800 may generally include forming a package into an open pouch using a vertical fill machine or a horizontal fill machine, and filling the open pouch with the inner fill material 6910. The pouch may then be sealed to enclose the inner fill material 6910 and form the oral pouch product 6800. In at least one exemplary embodiment, a series of oral pouch products 6800 are formed with spaces between the seals of adjacent pouch products 6800, and then cut apart to form individual pouch products 6800. For example, the oral pouch products 6800 may be cut with a die at locations between adjacent seals to form soft edges on each pouch product 6800. Alternatively, a first strip of pouch package material can be advanced along a feed path, the fill material placed on the strip, a second strip placed on the first strip, the strips pressed together using a sealing die to form a seam, such as a heat seal or adhesive seal, around the fill material, and a punch die used to cut the first and second strips outside the seam to form the soft edge.

[0369] FIG. 25 is a side view of an oral pouch product according to at least one exemplary embodiment.

[0370] FIG. 26 is a cross-sectional view of the oral pouch product of FIG. 25 taken along line VII-VII, according to at least one exemplary embodiment.

[0371] 25 and 26, oral pouch product 7100 is the same as that of FIGS. 22-24, except that oral pouch product 7100 has a single seam or seal 7105 along wrapper 7120. In at least one exemplary embodiment, as shown, oral pouch product 7100 has a half-moon shape. In some exemplary embodiments, oral pouch product 7100 has a D-shape, a boomerang shape, a crescent shape, or other shape.

[0372] In at least one exemplary embodiment, the pouch package 7120 can be sealed along a seam or seal 7105 to define an interior cavity 7270 configured to accommodate or retain the fill material 7210, as described with reference to Figures 22-24. The single seam or seal 7105 can be formed by overlapping an inner surface of the outer web 7150 of the pouch package 7120 with another portion of the inner surface of the outer web 7150. The sealing function can be achieved by a food-grade adhesive or by sealing adjacent portions to each other using heat or sonic techniques.

[0373] FIG. 27 is a cross-sectional view of an oral pouch product according to at least one exemplary embodiment.

[0374] In another exemplary embodiment, the oral pouch product 8300 is similar to the pouch product 6800 of FIGS. 22-27, except that the outer web 8310 is a nonwoven material formed of a polymer, including synthetic or natural polymers. For example, the outer web 8310 may be formed of a mesh material formed of spun or meltblown fibers, such as polyurethane fibers, as described in U.S. Pat. Nos. 10,448,669, 10,463,070, and / or 9,414,624 (the entire contents of each of which are incorporated herein by reference). The mesh material may be at least partially elastomeric. Additionally, depending on the materials used to form the pouch product 8300, the pouch product 8300 may eliminate seams to provide a softer pouch. In at least one exemplary embodiment, the mesh material contains a filler material including cellulose and a liquid mixture including triglycerides and liquid nicotine.

[0375] While several exemplary embodiments have been disclosed herein, it should be understood that other variations may be possible. Such variations are not to be considered a departure from the spirit and scope of the present disclosure, and all such modifications that would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

[0376] Although described with reference to specific examples and figures, various modifications, additions, and substitutions of the exemplary embodiments may be made by one skilled in the art in light of the description. For example, the techniques described may be performed in an order different from that described, and / or the elements of the described systems, structures, devices, circuits, etc. may be connected or combined differently from that described, or the results may be achieved by other elements or equivalents, as appropriate.

Claims

1. 1. A method for preparing a nicotine-containing powder, said method comprising: dissolving a carrier comprising a biopolymer, a natural polymer, a synthetic polymer, a bulk sweetener, or any combination thereof, in a solvent to form a first solution; contacting the first solution with nicotine, a nicotine complex, a nicotine salt, or any combination thereof to form a second mixture; and spray drying the second mixture to form a plurality of particles defining a nicotine-containing powder. method.

2. 10. The method of claim 1, The biopolymer comprises a polysaccharide, a bulk sweetener, or any combination thereof. method.

3. 3. The method of claim 2, The polysaccharide comprises starch, methylcellulose, hydroxypropyl cellulose (HPC), hydroxymethylpropyl cellulose (HPMC), highly methylated pectin, low methylated pectin, amidated pectin, carboxymethylcellulose (CMC), dextrin, maltodextrin, xanthan gum, agar, carrageenan, guar gum, alginic acid, or any combination thereof; method.

4. 3. The method of claim 2, The bulk sweetener comprises sucrose, dextrose, fructose, lactose, raffinose, trehalose, maltose, maltodextrin, isomalt, a sugar alcohol, or any combination thereof. method.

5. 5. The method of claim 4, The sugar alcohol may include sorbitol, mannitol, xylitol, maltitol, lactitol, isomalt, hydrogenated isomaltulose, hydrogenated starch hydrolysates, or any combination thereof. method.

6. 10. The method of claim 1, The biopolymer may comprise starch, methylcellulose, hydroxypropyl cellulose (HPC), hydroxymethylpropyl cellulose (HPMC), highly methylated pectin, low methylated pectin, amidated pectin, carboxymethylcellulose (CMC), dextrin, maltodextrin, xanthan gum, agar, carrageenan, guar gum, alginic acid, sucrose, dextrose, fructose, lactose, raffinose, trehalose, maltose, maltodextrin, or any combination thereof; method.

7. 10. The method of claim 1, The natural polymer comprises pectin, starch, gum arabic, or any combination thereof. method.

8. 10. The method of claim 1, The nicotine salt comprises citrate, monotartrate, bitartrate, bitartrate dihydrate, salicylate, sulfate or disulfate, phosphate or superphosphate, acetate, lactate, succinate, maleate, fumarate, gluconate, saccharate, benzoate, methanesulfonate, hydrochloride, hydrobromide, hydroiodide, or any combination thereof; method.

9. 10. The method of claim 1, the solvent comprises water; The inlet temperature setpoint ranges from 120°C to 210°C, and the initial product temperature ranges from 25°C to 100°C. method.

10. 10. The method of claim 1, the solvent comprises ethanol; The inlet temperature setpoint ranges from 65°C to 180°C, and the initial product temperature ranges from 25°C to 79°C. method.

11. 10. The method of claim 1, The average particle size of the plurality of particles is in the range of 5 μm to 200 μm. method.

12. 。 10. The method of claim 1, The moisture content of the particles is 10% or less. method.

13. 。 10. The method of claim 1, The method further comprises homogenizing the second mixture. method.

14. 。 10. The method of claim 1, The method further comprises adding a pH adjuster to the second mixture. method.

15. 10. The method of claim 1, The method further comprises adding an antioxidant to the second mixture; The antioxidant comprises ascorbyl palmitate, butylhydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherol, propyl gallate, tert-butylhydroquinone (TBHQ), butylhydroxyanisole (BHA), vitamin E, derivatives thereof, or any combination thereof; method.

16. 1. A method for preparing nicotine-containing granules, said method comprising: Preparing a nicotine-containing powder by a method according to claim 1; and compressing a portion of the plurality of particles defining the nicotine-containing powder to form a nicotine-containing granule. method.

17. 1. A method for preparing a nicotine-containing powder comprising a plurality of particles having a uniform size, the method comprising: dissolving a carrier comprising starch, methylcellulose, hydroxypropyl cellulose (HPC), hydroxymethylpropyl cellulose (HPMC), highly methylated pectin, less methylated pectin, amidated pectin, carboxymethylcellulose (CMC), dextrin, maltodextrin, xanthan gum, agar, carrageenan, guar gum, alginic acid, sucrose, dextrose, fructose, lactose, raffinose, trehalose, maltose, maltodextrin, sorbitol, mannitol, xylitol, maltitol, lactitol, isomalt, hydrogenated isomaltulose, hydrogenated starch hydrolysates, polyvinylpyrrolidone (PVP), a copolymer of polyvinylpyrrolidone (PVP) and vinyl acetate, a methacrylate copolymer, or any combination thereof, in a solvent comprising water, ethanol, or any combination thereof to form a first solution; contacting the first solution with nicotine, a nicotine complex, a nicotine salt, or any combination thereof to form a second mixture; homogenizing the second mixture to form a third mixture; and spray drying the third mixture to form a plurality of particles defining the nicotine-containing powder; The average particle size of the plurality of particles is in the range of 5 μm to 200 μm. method.

18. 18. The method of claim 17, the solvent comprises water; The inlet temperature setpoint ranges from 120°C to 210°C, and the initial product temperature ranges from 25°C to 100°C. method.

19. 18. The method of claim 17, the solvent comprises ethanol; The inlet temperature setpoint ranges from 65°C to 180°C, and the initial product temperature ranges from 25°C to 79°C. method.

20. 18. The method of claim 17, The method further comprises adding at least one of a pH adjuster and an antioxidant to the second mixture; The antioxidant comprises ascorbyl palmitate, butylhydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherol, propyl gallate, tert-butylhydroquinone (TBHQ), butylhydroxyanisole (BHA), vitamin E, derivatives thereof, or any combination thereof; method.

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