Controlled release nicotine chewing gum

Abstract

A chewing gum comprises a body and a coating. The body comprises a gum-based polymer, an oil, an active ingredient, an insoluble cellulosic material, and a buffer system. The gum-based polymer includes polyvinyl acetate (PVA) in an amount of 35 to 55 weight percent of the host. The oil includes triglyceride in an amount of 3 to 11 weight percent of the body. The buffer system is present in an amount of 0.1 to 8 weight percent of the body. The coating at least partially surrounds the body.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 528,214, filed July 21, 2023, the disclosure of which is incorporated herein by reference in its entirety. Background Technology

[0002] At least one example implementation involves controlled-release nicotine chewing gum.

[0003] Related fields description

[0004] Oral nicotine products are available in a variety of forms, such as chewing gum, sprays, lozenges, soluble tablets, non-soluble chewables, films, gels, capsules, and pouches (e.g., containing fiber or granules). The nicotine levels in oral products can create a familiar experience for adult tobacco consumers. Summary of the Invention

[0005] At least one example implementation involves chewing gum.

[0006] In at least one example embodiment, the chewing gum comprises a body and a coating. The body comprises a gum-based polymer, an oil, an active ingredient, an insoluble cellulose material, and a cushioning system. The gum-based polymer comprises polyvinyl acetate (PVA) in an amount of 35 to 55 wt% of the body. The oil comprises medium-chain triglycerides in an amount of 3 to 11 wt% of the body. The cushioning system is present in an amount of 0.1 to 8 wt% of the body. The coating at least partially surrounds the body.

[0007] In at least one example embodiment, the buffer system comprises a weak base and a conjugate acid.

[0008] In at least one example implementation, the buffer system comprises sodium carbonate and sodium bicarbonate.

[0009] In at least one example embodiment, sodium carbonate is present in an amount of 0.2 to 1 wt% of the main body. Sodium bicarbonate is present in an amount of 0.1 to 0.7 wt% of the main body.

[0010] In at least one example embodiment, the chewing gum has a size greater than or equal to 8 × 10⁻⁶. -4 The acid buffering capacity of chewing gum is greater than or equal to approximately 25 × 10⁻⁶. -4 Its alkaline buffering capacity.

[0011] In at least one example embodiment, the chewing gum has a thickness greater than or equal to 15 × 10⁻⁶. -4 The acid buffering capacity of chewing gum is greater than or equal to approximately 50 × 10⁻⁶. -4The alkaline buffering capacity. In at least one example embodiment, the body is configured to maintain a pH greater than or equal to 9 during a 5-minute contact period with saliva.

[0012] In at least one example embodiment, the active ingredient comprises nicotine or a nicotine derivative.

[0013] In at least one example embodiment, the nicotine or nicotine derivative comprises liquid nicotine. The liquid nicotine is dissolved in MCT.

[0014] In at least one example embodiment, liquid nicotine and MCT are adsorbed onto an insoluble cellulose material, absorbed onto an insoluble cellulose material, or simultaneously adsorbed onto and absorbed onto an insoluble cellulose material.

[0015] In at least one example embodiment, the insoluble cellulose material comprises MCC. The bulk composition includes 2 to 15% by weight of MCC.

[0016] In at least one example embodiment, 90% or more by weight of nicotine or a nicotine derivative is configured to be in free alkali form during a 5-minute contact period with saliva.

[0017] In at least one example embodiment, the nicotine or nicotine derivative comprises tobacco-derived nicotine.

[0018] In at least one example implementation, the body has a uniform unit structure.

[0019] In at least one example embodiment, the body contains 40 to 50 percent PVA by weight.

[0020] In at least one example embodiment, the adhesive polymer is essentially composed of PVA.

[0021] In at least one example embodiment, the PVA comprises a first PVA having a first weight average molecular weight and a second PVA having a second weight average molecular weight, the second weight average molecular weight being different from the first weight average molecular weight.

[0022] In at least one example embodiment, the oil further comprises triacetin.

[0023] In at least one example embodiment, the body further comprises an antioxidant.

[0024] In at least one example embodiment, the antioxidant comprises vitamin E and ascorbyl palmitate.

[0025] In at least one example embodiment, the body further comprises a sweetener.

[0026] In at least one example embodiment, the sweetener comprises a variety of sugar alcohols.

[0027] In at least one example embodiment, a variety of sugar alcohols include maltitol and sorbitol.

[0028] In at least one example embodiment, the coating comprises sugar alcohol, pH adjuster and gum arabic.

[0029] At least one example embodiment relates to chewing gum. The chewing gum comprises a body and a coating. The body comprises a gum-based polymer, a liquid mixture, microcrystalline cellulose, sodium carbonate, and sodium bicarbonate. The body includes the gum-based polymer in an amount of 35 to 55 weight percent. The gum-based polymer comprises a first polyvinyl acetate (PVA) having a first weight-average molecular weight and a second PVA having a second weight-average molecular weight, the second weight-average molecular weight being different from the first weight-average molecular weight. The liquid mixture comprises medium-chain triglycerides (MCTs) and liquid nicotine. The MCTs are present in an amount of 3 to 11 weight percent of the body. The liquid nicotine is dissolved in the MCTs. At least a portion of the liquid mixture is adsorbed onto, absorbed into, or simultaneously adsorbed onto and absorbed into the MCTs. The coating at least partially surrounds the body.

[0030] At least one example embodiment relates to a method of manufacturing chewing gum. The method includes preparing diluted nicotine by dissolving liquid nicotine in oil. The method further includes preparing a cellulose mixture by adsorbing diluted nicotine onto a cellulose material, absorbing diluted nicotine into a cellulose material, or simultaneously adsorbing diluted nicotine onto and absorbing diluted nicotine into a cellulose material. The method further includes preparing a gum base comprising a gum base polymer and a cellulose mixture, the gum base polymer comprising polyvinyl acetate. The method further includes preparing a chewing gum core comprising the gum base. The method also includes preparing chewing gum by coating a chewing gum core. Attached Figure Description

[0031] The various features and advantages of the non-limiting embodiments described herein will become more apparent upon review of the detailed description in conjunction with the accompanying drawings. The drawings are provided for illustrative purposes only and should not be construed as limiting the scope of the claims. Unless otherwise expressly stated, the drawings are not to be considered as drawn to scale. Various dimensions in the drawings may have been enlarged for clarity.

[0032] Figure 1 It is a flowchart illustrating a method for forming nicotine-containing powder according to at least one example embodiment.

[0033] Figure 2 It is a flowchart illustrating a method for forming nicotine-containing powder according to at least one example embodiment.

[0034] Figure 3 It is a flowchart illustrating a method for forming nicotine-containing powder according to at least one example embodiment.

[0035] Figure 4 It is a flowchart illustrating a method for forming nicotine-containing powder according to at least one example embodiment.

[0036] Figure 5 This is a cross-sectional view of an encapsulated nicotine particle according to at least one exemplary embodiment.

[0037] Figure 6 This is a cross-sectional view of an encapsulated nicotine particle according to at least one exemplary embodiment.

[0038] Figure 7 This is a flowchart illustrating a method for forming encapsulated nicotine particles according to at least one example embodiment.

[0039] Figure 8 This is a cross-sectional view of an encapsulated sweetener according to at least one example embodiment.

[0040] Figure 9 This is a cross-sectional view of encapsulated sweetener particles according to at least one example embodiment.

[0041] Figure 10 This is a flowchart illustrating a method for forming encapsulated sweetener particles according to at least one example embodiment.

[0042] Figure 11A-11C The chemical structures of different forms of nicotine were described. Figure 11A It is the chemical structure of free nicotine. Figure 11B It is the chemical structure of monoprotonated nicotine. Figure 11C It is the chemical structure of diprotonated nicotine.

[0043] Figure 12A-12B It is a diagram depicting the distribution of oral nicotine in different nicotine solutions.

[0044] Figure 13A It is a table depicting the distribution coefficient data of nicotine in different oil and water phases. Figure 13A It is a table depicting the distribution coefficient data of nicotine in different oil and water phase combinations. Figure 13B The chemical structure of triacetin (C2) was described. Figure 13C The chemical structure of MCT (C8–C10) was described. Figure 13D The chemical structure of triolein (C18) was described.

[0045] Figure 14 It is a perspective view of a bag according to at least one example embodiment.

[0046] Figure 15 This is a perspective view of a soluble film agent according to at least one example embodiment.

[0047] Figure 16A This is a perspective view of an oral product having a circular cross-section according to at least one example embodiment.

[0048] Figure 16B It is a perspective view of an oral product having an elliptical cross-section according to at least one example embodiment.

[0049] Figure 16C It is a perspective view of an oral product having a rectangular cross-section according to at least one example embodiment.

[0050] Figure 16D It is a perspective view of an oral product having an elongated rectangular cross-section according to at least one example embodiment.

[0051] Figure 16E It is a perspective view of an oral product having a lens or a soccer ball-shaped cross-section according to at least one example embodiment.

[0052] Figure 16F It is a perspective view of an oral product having a boomerang-shaped cross-section according to at least one example embodiment.

[0053] Figure 16G This is a perspective view of an oral product having a shield-shaped cross-section according to at least one example embodiment.

[0054] Figure 17 It is a perspective view of an oral product according to at least one example embodiment.

[0055] Figure 18 This is a perspective view of chewing gum according to at least one example embodiment.

[0056] Figure 19A It is a perspective view of a chewing gum having an elliptical cross-section according to at least one example embodiment.

[0057] Figure 19B It is a perspective view of a chewing gum having a rectangular cross-section according to at least one example embodiment.

[0058] Figure 19C It is a perspective view of a chewing gum having an elongated rectangular cross-section according to at least one example embodiment.

[0059] Figure 19DIt is a perspective view of a chewing gum having a lens or a football-shaped cross-section according to at least one example embodiment.

[0060] Figure 19E It is a perspective view of a chewing gum having a boomerang-shaped cross-section according to at least one example embodiment.

[0061] Figure 19F It is a perspective view of a chewing gum having a shield-shaped cross-section according to at least one example embodiment.

[0062] Figure 20A It is a perspective view of a chewing gum having the shape of a pillow or cushion according to at least one example embodiment.

[0063] Figure 20B This is a perspective view of a wedge-shaped chewing gum according to at least one example embodiment.

[0064] Figure 20C This is a cross-sectional view of coated chewing gum according to at least one example embodiment.

[0065] Figure 20D This is a cross-sectional view of another chewing gum with a coating according to at least one example embodiment.

[0066] Figure 21 It is a flowchart depicting a method for making chewing gum according to at least one example embodiment.

[0067] Figure 22 This is a perspective view of an oral pouch product according to at least one example embodiment.

[0068] Figure 23 It is based on at least one example implementation along Figure 22 A cross-sectional view of the oral pouch product, line II-II.

[0069] Figure 24 It is based on at least one example implementation along Figure 22 A cross-sectional view of the oral pouch product, line III-III.

[0070] Figure 25 This is a side view of an oral pouch product according to at least one example embodiment.

[0071] Figure 26 It is based on at least one example implementation along Figure 25 A cross-sectional view of line VII-VII of the oral bagged product.

[0072] Figure 27 This is a cross-sectional view of an oral pouch product according to at least one example embodiment. Detailed Implementation

[0073] This document discloses several detailed example implementations. However, the specific structural and functional details disclosed herein are for illustrative purposes only. These example implementations may take many alternative forms and should not be construed as being limited to only the example implementations presented herein.

[0074] Accordingly, although the exemplary embodiments can take many modifications and alternatives, the accompanying drawings illustrate exemplary embodiments only by way of example, and these will be described in detail herein. However, it should be understood that this document is not intended to limit the exemplary embodiments to the specific forms disclosed; rather, the exemplary embodiments will cover all modifications, equivalents, and alternatives falling within the scope of the exemplary embodiments. Throughout the description of the accompanying drawings, the same numbers refer to the same elements.

[0075] It should be understood that when an element or layer is described as "located in," "connected to," "coupled to," or "covers" another element or layer, it may be directly located in, connected to, coupled to, or cover the other element or layer, or there may be an intermediate element or layer. Conversely, when an element is described as "directly located in," "directly connected to," or "directly coupled to" another element or layer, there are no intermediate elements or layers. The same numbering throughout the specification represents the same element. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0076] It should be understood that although terms such as first, second, third, etc., may be used herein to describe various elements, regions, layers, and / or portions, these elements, regions, layers, and / or portions should not be limited by these terms. These terms are used only to distinguish different elements, regions, layers, or portions. Therefore, the first element, component, region, layer, or portion discussed below may also be referred to as the second element, region, layer, or portion without departing from the teachings of the exemplary embodiments.

[0077] For ease of description, spatially relative terms (such as "below," "below," "lower," "above," "higher," "inner," "outer," etc.) are used to describe the relationship between one element or feature illustrated in the figures and another. It should be understood that spatially relative terms are intended to cover different orientations of the device other than those depicted in the figures during use or operation. For example, if the device in the figure is flipped over, the element described as "below" or "below" to another element or feature will be facing "above" to that element or feature. Therefore, the term "below" can encompass both above and below orientations. The device may be oriented in other directions (rotated 90 degrees or in other orientations), and the spatially relative descriptive terms used herein should reflect this accordingly.

[0078] The terminology used herein is for the purpose of describing a number of exemplary embodiments only and is not intended to limit the exemplary embodiments. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” as used herein are intended to include the plural forms. It will be further understood that the terms “comprising,” “including,” and / or “containing” specify the presence of the stated features, integers, steps, operations, and / or elements, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, and / or combinations thereof.

[0079] This document describes exemplary embodiments with reference to cross-sectional illustrations (which are schematic diagrams of exemplary embodiments). Therefore, variations from the illustrated shapes are to be expected. Thus, exemplary embodiments should not be construed as limited to the shape of the area illustrated herein, but will include deviations and variations in shape. Unless the context otherwise requires, when “about” or “substantially” is used with numerical values, the relevant numerical values ​​are intended to include tolerances around ±10% of the stated value.

[0080] Unless otherwise defined, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments pertain. It will be further understood that terms (including those as defined in common dictionaries) shall be interpreted as having a meaning consistent with the meaning in the context of the relevant field, and shall not be interpreted in an idealized or overly formal sense unless so defined herein.

[0081] This disclosure provides methods for enhancing the flavor and / or sensory effects of nicotine in oral products such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules). In at least one example embodiment, a nicotine powder comprising a spray-drying process is formed. In at least one example embodiment, nicotine may be encapsulated. In at least one example embodiment, nicotine powder formed using a spray-drying process may be encapsulated. In at least one example embodiment, the oral product may contain an encapsulated sweetener. The encapsulated sweetener may be included together with the spray-dried nicotine powder and / or the encapsulated nicotine.

[0082] In at least one example embodiment, the oral product is an oral tobacco product, an oral non-tobacco product, or any combination thereof. The oral product may be in the form of a loose material (e.g., loose cellulose material), a molding material (e.g., a plug or twist), a pouch material, a tablet, a lozenge, a chewable substance, a gel, a film, any other oral product, or any combination thereof.

[0083] Oral products may include chewing tobacco, snuff, wet snuff, dry snuff, other smokeless tobacco products, and non-tobacco products for oral inhalation, or any combination thereof.

[0084] If the oral product is an oral tobacco product containing smokeless tobacco products, then smokeless tobacco products may include whole tobacco, shredded tobacco, cut tobacco, pellet tobacco, reconstituted tobacco, flue-cured tobacco, aged tobacco, fermented tobacco, pasteurized tobacco, or other processed tobacco. Tobacco may be present in whole or in part as leaves, flowers, roots, stems, extracts (such as nicotine), or in any combination thereof.

[0085] In at least one example embodiment, the oral product comprises a tobacco extract, such as a tobacco-derived nicotine extract, and / or synthetic nicotine. The oral product may contain nicotine alone, or a combination of nicotine and a carrier such as a cellulose material (e.g., white snuff). The carrier may be a tobacco-free material (e.g., microcrystalline cellulose) or a tobacco material (e.g., tobacco fiber with reduced or eliminated nicotine content, which may be referred to as “depleted tobacco plant tissue or fiber”). In some example embodiments, the waste tobacco plant tissue or fiber may be treated to remove at least 25%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, or 95% of the nicotine. For example, the tobacco plant tissue may be washed with water or another solvent to remove nicotine.

[0086] Oral products (such as oral tobacco products or oral non-tobacco products) can have a variety of moisture contents. In at least one example embodiment, the oral product is a dry oral product with a moisture content ranging from 5% to 10% by weight. In at least one example embodiment, the oral product has a moderate moisture content, such as 20% to 35% by weight. In at least one example embodiment, the oral product is a wet oral product with a moisture content ranging from 40% to 55% by weight.

[0087] In at least one example embodiment, the oral product may also contain one or more elements such as orally stabilized polymers, orally soluble polymers, sweeteners (e.g., synthetic and / or natural sweeteners), fortifiers, soothing agents, synergists, plasticizers, orally soluble fibers, alkaloids, minerals, vitamins, dietary supplements, nutritional foods, colorants, amino acids, chemesthetic agents, antioxidants, food-grade emulsifiers, pH adjusters, herbal preparations, teeth whitening agents, therapeutic agents, processing aids, stearates, waxes, stabilizers, disintegrants, lubricants, preservatives, fillers, flavoring agents, masking agents, bitter taste receptor blockers, receptor enhancers, other additives, or any combination thereof.

[0088] Spray-dried nicotine powder

[0089] In at least one example embodiment, nicotine-containing powder suitable for inclusion in oral products can be prepared using a spray drying technique. Such nicotine-containing powder can contain a variety of substantially uniform nicotine particles.

[0090] In at least one example embodiment, the substantially uniform nicotine particles have an average particle size (90% distribution) of about 5 μm to about 200 μm. For example, a plurality of substantially uniform nicotine particles may have an average particle size greater than or equal to about 5 μm (e.g., greater than or equal to about 10 μm, greater than or equal to about 20 μm, greater than or equal to about 30 μm, greater than or equal to about 40 μm, greater than or equal to about 50 μm, greater than or equal to about 60 μm, greater than or equal to about 70 μm, greater than or equal to about 80 μm, greater than or equal to about 90 μm, greater than or equal to about 100 μm, greater than or equal to about 110 μm, greater than or equal to about 120 μm, greater than or equal to about 130 μm, greater than or equal to about 140 μm, greater than or equal to about 150 μm, greater than or equal to about 160 μm, greater than or equal to about 170 μm, greater than or equal to about 180 μm, or greater than or equal to about 190 μm). Multiple substantially uniform nicotine particles may have an average particle size of less than or equal to about 200 μm (e.g., less than or equal to about 190 μm, less than or equal to about 180 μm, less than or equal to about 170 μm, less than or equal to about 160 μm, less than or equal to about 150 μm, less than or equal to about 140 μm, less than or equal to about 130 μm, less than or equal to about 120 μm, less than or equal to about 110 μm, less than or equal to about 100 μm, less than or equal to about 90 μm, less than or equal to about 80 μm, less than or equal to about 70 μm, less than or equal to about 60 μm, less than or equal to about 50 μm, less than or equal to about 40 μm, less than or equal to about 30 μm, less than or equal to about 20 μm, or less than or equal to about 10 μm).

[0091] In at least some example embodiments, the substantially uniform nicotine particles have a water content of less than or equal to 10%. For example, the substantially uniform nicotine particles have a water content of less than or equal to 10%, less than or equal to 9%, less than or equal to 8%, less than or equal to 7%, less than or equal to 5%, less than or equal to 4%, less than or equal to 3%, less than or equal to 2%, or less than or equal to 1%.

[0092] In at least some example embodiments, the substantially uniform nicotine particles have a nicotine content of less than or equal to 30 wt.%. For example, substantially uniform nicotine particles may have a nicotine content of about 10 wt.% to about 30 wt.%. Substantially homogeneous nicotine particles can have a nicotine content of greater than or equal to about 10 wt.% (e.g., greater than or equal to about 11 wt.%, greater than or equal to about 12 wt.%, greater than or equal to about 13 wt.%, greater than or equal to about 14 wt.%, greater than or equal to about 15 wt.%, greater than or equal to about 16 wt.%, greater than or equal to about 17 wt.%, greater than or equal to about 18 wt.%, greater than or equal to about 19 wt.%, greater than or equal to about 20 wt.%, greater than or equal to about 21 wt.%, greater than or equal to about 22 wt.%, greater than or equal to about 23 wt.%, greater than or equal to about 24 wt.%, greater than or equal to about 25 wt.%, greater than or equal to about 26 wt.%, greater than or equal to about 27 wt.%, greater than or equal to about 28 wt.%, or greater than or equal to about 29 wt.%). Substantially homogeneous nicotine particles may have a nicotine content of less than or equal to about 30 wt.% (e.g., less than or equal to about 29 wt.%, less than or equal to about 28 wt.%, less than or equal to about 27 wt.%, less than or equal to about 26 wt.%, less than or equal to about 25 wt.%, less than or equal to about 24 wt.%, less than or equal to about 23 wt.%, less than or equal to about 22 wt.%, less than or equal to about 21 wt.%, less than or equal to about 20 wt.%, less than or equal to about 19 wt.%, less than or equal to about 18 wt.%, less than or equal to about 17 wt.%, less than or equal to about 16 wt.%, less than or equal to about 15 wt.%, less than or equal to about 14 wt.%, less than or equal to about 13 wt.%, less than or equal to about 12 wt.%, or less than or equal to about 11 wt.%).

[0093] Figure 1 This is a flowchart illustrating a method 400 for forming a nicotine-containing powder 432 for inclusion in an oral product, such as chewing gum, spray, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules). Method 400 includes providing S410 a first solution 408 (i.e., a carrier solution). The first solution 408 may have a viscosity suitable for subsequent processing.

[0094] The first solution 408 may comprise a carrier 402 and a solvent 404. In at least some example embodiments, providing S410 includes contacting the carrier 402 and the solvent 404 to form the first solution 408 (i.e., the carrier solution). In at least one example embodiment, contacting includes dissolving the carrier 402 in the solvent 404 to form the first solution 408 (i.e., the carrier solution). In each case, the solvent 404 may comprise water, ethanol, or both water and ethanol. The carrier 402 may comprise a biopolymer, a natural polymer, a synthetic polymer, a bulk sweetener, a pyrrolidone polymer, a methacrylate copolymer, or any combination thereof.

[0095] For example, the biopolymer may comprise a polysaccharide, a bulk sweetener, or both a polysaccharide and a bulk sweetener. In some example embodiments, the polysaccharide includes, for example, starch, methylcellulose, hydroxypropylcellulose (HPC), hydroxymethylpropylcellulose (HPMC), highly methylated pectin, low-methylated pectin, amidated pectin, carboxymethyl cellulose (CMC), dextrin, maltodextrin, isomaltitol, xanthan gum, agar, carrageenan, cardamom, alginate, isomaltitol, or any combination thereof. In some example embodiments, the bulk sweetener includes, for example, sucrose, glucose, fructose, lactose, raffinose, trehalose, maltose, maltodextrin, isomaltitol, sugar alcohols, or any combination thereof. In some example embodiments, the biopolymer includes, for example, starch, methylcellulose, hydroxypropylcellulose (HPC), hydroxymethylpropylcellulose (HPMC), highly methylated pectin, low-methylated pectin, amidated pectin, carboxymethyl cellulose (CMC), dextrin, xanthan gum, agar, carrageenan, nutmeg, alginate, sucrose, glucose, fructose, lactose, raffinose, trehalose, maltose, maltodextrin, isomaltitol, or any combination thereof.

[0096] In at least some example embodiments, the natural and synthetic polymers include, for example, pectin, starch, gum arabic, or any combination thereof. In some example embodiments, the bulk sweeteners include, for example, sugar alcohols, which may include sorbitol, mannitol, xylitol, maltitol, lactitol, isomaltulose, hydrogenated isomaltulose, hydrogenated starch hydrolysate, or any combination thereof. In some example embodiments, the pyrrolidone polymers include, for example, polyvinylpyrrolidone (PVP), copolymers of polyvinylpyrrolidone (PVP) and vinyl acetate, or any combination thereof. In some example embodiments, the methacrylate copolymers include, for example, copolymers of methacrylate and acrylic acid.

[0097] In at least some example embodiments, the first solution 408 includes a carrier 402 in an amount of about 3 wt.% to about 45 wt.%. For example, the first solution 408 may contain a carrier 402 in an amount of greater than or equal to about 3 wt.% (e.g., greater than or equal to about 4 wt.%, greater than or equal to about 5 wt.%, greater than or equal to about 10 wt.%, greater than or equal to about 15 wt.%, greater than or equal to about 20 wt.%, greater than or equal to about 25 wt.%, greater than or equal to about 30 wt.%, greater than or equal to about 35 wt.%, greater than or equal to about 40 wt.%, greater than or equal to about 41 wt.%, greater than or equal to about 42 wt.%, greater than or equal to about 43 wt.%, or greater than or equal to about 44 wt.%). The first solution 408 may contain less than or equal to about 45 wt.% (e.g., less than or equal to about 44 wt.%, less than or equal to about 43 wt.%, less than or equal to about 42 wt.%, less than or equal to about 41 wt.%, less than or equal to about 40 wt.%, less than or equal to about 35 wt.%, less than or equal to about 30 wt.%, less than or equal to about 25 wt.%, less than or equal to about 20 wt.%, less than or equal to about 15 wt.%, less than or equal to about 10 wt.%, less than or equal to about 5 wt.%, or less than or equal to about 4 wt.%) of carrier 402. The amount of carrier 402 and solvent 404 in the first solution 408 can be adjusted so that the first solution 408 has a viscosity suitable for subsequent processing. For example, in at least some example embodiments, such as when carrier 402 contains pectin, the first solution 508 may contain about 5 wt.% of carrier 402. In other example embodiments, such as when carrier 403 contains maltodextrin, the first solution 508 may contain about 30 wt.% of carrier 402.

[0098] In at least some example embodiments, the first solution 408 contains about 55 wt.% to about 97 wt.% of solvent 404. For example, the first solution 408 may contain greater than or equal to about 55 wt.% (e.g., greater than or equal to about 56 wt.%, greater than or equal to about 57 wt.%, greater than or equal to about 58 wt.%, greater than or equal to about 59 wt.%, greater than or equal to about 60 wt.%, greater than or equal to about 65 wt.%, greater than or equal to about 70 wt.%, greater than or equal to about 75 wt.%, greater than or equal to about 80 wt.%, greater than or equal to about 85 wt.%, greater than or equal to about 90 wt.%, greater than or equal to about 95 wt.%, or greater than or equal to about 96 wt.%) of solvent 404. The first solution 408 may contain less than or equal to about 97 wt.% (e.g., less than or equal to about 96 wt.%, less than or equal to about 95 wt.%, less than or equal to about 90 wt.%, less than or equal to about 85 wt.%, less than or equal to about 80 wt.%, less than or equal to about 75 wt.%, less than or equal to about 70 wt.%, less than or equal to about 65 wt.%, less than or equal to about 60 wt.%, less than or equal to about 59 wt.%, less than or equal to about 58 wt.%, less than or equal to about 57 wt.%, or less than or equal to about 56 wt.%) of solvent 404.

[0099] In at least one example embodiment, method 400 includes contacting a first solution 408 with a nicotine-containing formulation 422 (S420) to form a second mixture 428 (i.e., a feed solution). In some example embodiments, the nicotine-containing formulation 422 comprises nicotine, a nicotine complex (e.g., nicotine polacrilex), a nicotine salt, or any combination thereof. Nicotine salts may include nitrates, monotartrates, bitartrates, bitartrate dihydrates, salicylates, sulfates or bisulfates, phosphates or acid phosphates, acetates, lactates, succinates, maleates, fumarates, gluconates, sucrose, benzoates, methanesulfonates, hydrochlorides, hydrobromides, hydroiodates, or any combination thereof.

[0100] In at least some example embodiments, the second mixture 428 contains about 85 wt.% to about 99 wt.% of the first solution 408. For example, the second mixture 428 may contain more than or equal to about 85 wt.% (e.g., more than or equal to about 86 wt.%, more than or equal to about 87 wt.%, more than or equal to about 88 wt.%, more than or equal to about 89 wt.%, more than or equal to about 90 wt.%, more than or equal to about 91 wt.%, more than or equal to about 92 wt.%, more than or equal to about 93 wt.%, more than or equal to about 94 wt.%, more than or equal to about 95 wt.%, more than or equal to about 96 wt.%, more than or equal to about 97 wt.%, or more than or equal to about 98 wt.%) of the first solution 408. The second mixture 428 may contain less than or equal to about 99 wt.% (e.g., less than or equal to about 98 wt.%, less than or equal to about 97 wt.%, less than or equal to about 96 wt.%, less than or equal to about 95 wt.%, less than or equal to about 94 wt.%, less than or equal to about 93 wt.%, less than or equal to about 92 wt.%, less than or equal to about 91 wt.%, less than or equal to about 90 wt.%, less than or equal to about 89 wt.%, less than or equal to about 88 wt.%, less than or equal to about 87 wt.%, or less than or equal to about 86 wt.%) of the first solution 408.

[0101] In at least some example embodiments, such as when the nicotine-containing formulation 422 contains pure nicotine, the second mixture 428 contains about 1 wt.% to about 10 wt.% of the nicotine-containing formulation 422. For example, the second mixture 428 may contain greater than or equal to about 1 wt.% (e.g., greater than or equal to about 2 wt.%, greater than or equal to about 3 wt.%, greater than or equal to about 4 wt.%, greater than or equal to about 5 wt.%, greater than or equal to about 6 wt.%, greater than or equal to about 7 wt.%, greater than or equal to about 8 wt.%, or greater than or equal to about 9 wt.%) of the nicotine-containing formulation 422. The second mixture 428 may contain less than or equal to about 10 wt.% (e.g., less than or equal to about 9 wt.%, less than or equal to about 8 wt.%, less than or equal to about 7 wt.%, less than or equal to about 6 wt.%, less than or equal to about 5 wt.%, less than or equal to about 4 wt.%, less than or equal to about 3 wt.%, or less than or equal to about 2 wt.%) of the nicotine-containing formulation 422.

[0102] The viscosity of the second mixture 428 allows it to be easily injected or pumped during subsequent spray drying. In at least one example embodiment, the second mixture 428 may have a viscosity of about 1 centipoise to about 700 centipoise at about 22°C. For example, the second mixture 428 may have a viscosity greater than or equal to about 1 centipoise at about 22°C (e.g., greater than or equal to about 10 centipoise, greater than or equal to about 20 centipoise, greater than or equal to about 30 centipoise, greater than or equal to about 40 centipoise, greater than or equal to about 50 centipoise, greater than or equal to about 100 centipoise, greater than or equal to about 150 centipoise, greater than or equal to about 200 centipoise, greater than or equal to about 250 centipoise, greater than or equal to about 300 centipoise, greater than or equal to about 350 centipoise, greater than or equal to about 400 centipoise, greater than or equal to about 450 centipoise, greater than or equal to about 500 centipoise, greater than or equal to about 550 centipoise, greater than or equal to about 600 centipoise, or greater than or equal to about 650 centipoise). The second mixture 428 may have a viscosity of less than or equal to about 700 centipoise at about 22°C (e.g., less than or equal to about 690 centipoise, less than or equal to about 680 centipoise, less than or equal to about 670 centipoise, less than or equal to about 660 centipoise, less than or equal to about 650 centipoise, less than or equal to about 600 centipoise, less than or equal to about 550 centipoise, less than or equal to about 500 centipoise, less than or equal to about 450 centipoise, less than or equal to about 400 centipoise, less than or equal to about 350 centipoise, less than or equal to about 300 centipoise, less than or equal to about 250 centipoise, less than or equal to about 200 centipoise, less than or equal to about 150 centipoise, less than or equal to about 100 centipoise, less than or equal to about 50 centipoise, less than or equal to about 40 centipoise, less than or equal to about 30 centipoise, less than or equal to about 20 centipoise, less than or equal to about 10 centipoise). This type of viscosity is believed to provide suitable rheological properties, allowing the slurry to flow under applied pressure, but also allowing mixture 428 to remain stable.

[0103] In at least one example embodiment, method 400 includes spray drying S430 of a second mixture 428 to form a plurality of particles that define a nicotine-containing powder 432 (i.e., dry powder). The plurality of particles defining the nicotine-containing powder 432 may have an average particle size (90% distribution) of about 5 μm to about 200 μm. For example, multiple particles of nicotine-containing powder 432 are defined to have an average particle size greater than or equal to about 5 μm (e.g., greater than or equal to about 10 μm, greater than or equal to about 20 μm, greater than or equal to about 30 μm, greater than or equal to about 40 μm, greater than or equal to about 50 μm, greater than or equal to about 60 μm, greater than or equal to about 70 μm, greater than or equal to about 80 μm, greater than or equal to about 90 μm, greater than or equal to about 100 μm, greater than or equal to about 110 μm, greater than or equal to about 120 μm, greater than or equal to about 130 μm, greater than or equal to about 140 μm, greater than or equal to about 150 μm, greater than or equal to about 160 μm, greater than or equal to about 170 μm, greater than or equal to about 180 μm, or greater than or equal to about 190 μm). The multiple particles of the nicotine-containing powder 432 are defined to have an average particle size of less than or equal to about 200 μm (e.g., less than or equal to about 190 μm, less than or equal to about 180 μm, less than or equal to about 170 μm, less than or equal to about 160 μm, less than or equal to about 150 μm, less than or equal to about 140 μm, less than or equal to about 130 μm, less than or equal to about 120 μm, less than or equal to about 110 μm, less than or equal to about 100 μm, less than or equal to about 90 μm, less than or equal to about 80 μm, less than or equal to about 70 μm, less than or equal to about 60 μm, less than or equal to about 50 μm, less than or equal to about 40 μm, less than or equal to about 30 μm, less than or equal to about 20 μm, or less than or equal to about 10 μm).

[0104] The plurality of particles of the nicotine-containing powder 432 are defined to have a water content of less than or equal to about 10%. For example, the plurality of particles of the nicotine-containing powder 432 are defined to have a water content of less than or equal to about 10%, less than or equal to about 9%, less than or equal to about 8%, less than or equal to about 7%, less than or equal to about 5%, less than or equal to about 4%, less than or equal to about 3%, less than or equal to about 2%, or less than or equal to about 1%.

[0105] In at least some example embodiments, the nicotine content of the nicotine-containing powder 432 is less than or equal to about 30 wt.%. For example, the nicotine-containing powder 432 may have a nicotine content of about 10 wt.% to about 30 wt.%. The nicotine-containing powder 432 may have a nicotine content of greater than or equal to about 10 wt.% (e.g., greater than or equal to about 11 wt.%, greater than or equal to about 12 wt.%, greater than or equal to about 13 wt.%, greater than or equal to about 14 wt.%, greater than or equal to about 15 wt.%, greater than or equal to about 16 wt.%, greater than or equal to about 17 wt.%, greater than or equal to about 18 wt.%, greater than or equal to about 19 wt.%, greater than or equal to about 20 wt.%, greater than or equal to about 21 wt.%, greater than or equal to about 22 wt.%, greater than or equal to about 23 wt.%, greater than or equal to about 24 wt.%, greater than or equal to about 25 wt.%, greater than or equal to about 26 wt.%, greater than or equal to about 27 wt.%, greater than or equal to about 28 wt.%, or greater than or equal to about 29 wt.%). Nicotine-containing powder 432 may have a nicotine content of less than or equal to about 30 wt.% (e.g., less than or equal to about 29 wt.%, less than or equal to about 28 wt.%, less than or equal to about 27 wt.%, less than or equal to about 26 wt.%, less than or equal to about 25 wt.%, less than or equal to about 24 wt.%, less than or equal to about 23 wt.%, less than or equal to about 22 wt.%, less than or equal to about 21 wt.%, less than or equal to about 20 wt.%, less than or equal to about 19 wt.%, less than or equal to about 18 wt.%, less than or equal to about 17 wt.%, less than or equal to about 16 wt.%, less than or equal to about 15 wt.%, less than or equal to about 14 wt.%, less than or equal to about 13 wt.%, less than or equal to about 12 wt.%, or less than or equal to about 11 wt.%).

[0106] A variety of spray drying technologies and equipment known to those skilled in the art can be employed. Spray drying parameters can be used to tailor the dried end product (e.g., nicotine-containing powder 432) to ensure precise quality standards and physical properties. These standards and properties include particle size distribution, residual moisture, bulk density, and particle morphology.

[0107] In some example implementations, the nozzle pressure for the spray drying process S430 is from about 30 psi to about 40 psi. For example, the nozzle pressure may be greater than or equal to about 30 psi (e.g., greater than or equal to about 31 psi, greater than or equal to about 32 psi, greater than or equal to about 33 psi, greater than or equal to about 34 psi, greater than or equal to about 35 psi, greater than or equal to about 36 psi, greater than or equal to about 37 psi, greater than or equal to about 38 psi, or greater than or equal to about 39 psi). The nozzle pressure may be less than or equal to about 40 psi (e.g., less than or equal to about 39 psi, less than or equal to about 38 psi, less than or equal to about 37 psi, less than or equal to about 36 psi, less than or equal to about 35 psi, less than or equal to about 34 psi, less than or equal to about 33 psi, less than or equal to about 32 psi, or less than or equal to about 31 psi).

[0108] In some example embodiments, the solution pump speed for the spray drying process S430 is from about 15 rpm to about 35 rpm per minute. For example, the solution pump speed may be greater than or equal to about 15 rpm (e.g., greater than or equal to about 16 rpm, greater than or equal to about 17 rpm, greater than or equal to about 18 rpm, greater than or equal to about 19 rpm, greater than or equal to about 20 rpm, greater than or equal to about 21 rpm, greater than or equal to about 22 rpm, greater than or equal to about 23 rpm, greater than or equal to about 24 rpm, greater than or equal to about 25 rpm, greater than or equal to about 26 rpm, greater than or equal to about 27 rpm, greater than or equal to about 28 rpm, greater than or equal to about 29 rpm, greater than or equal to about 30 rpm, greater than or equal to about 31 rpm, greater than or equal to about 32 rpm, greater than or equal to about 33 rpm, or greater than or equal to about 34 rpm). The solution pump speed can be less than or equal to about 35 rpm (e.g., less than or equal to about 35 rpm, less than or equal to about 34 rpm, less than or equal to about 33 rpm, less than or equal to about 32 rpm, less than or equal to about 31 rpm, less than or equal to about 30 rpm, less than or equal to about 29 rpm, less than or equal to about 28 rpm, less than or equal to about 27 rpm, less than or equal to about 26 rpm, less than or equal to about 25 rpm, less than or equal to about 24 rpm, less than or equal to about 23 rpm, less than or equal to about 22 rpm, less than or equal to about 21 rpm, less than or equal to about 20 rpm, less than or equal to about 19 rpm, less than or equal to about 18 rpm, less than or equal to about 17 rpm, less than or equal to about 16 rpm).

[0109] In some example embodiments, the solution spraying rate for the spray drying process S430 is from about 9 g / min to about 15 g / min. For example, the solution spraying rate may be greater than or equal to about 9 g / min (e.g., greater than or equal to about 10 g / min, greater than or equal to about 11 g / min, greater than or equal to about 12 g / min, greater than or equal to about 13 g / min, or greater than or equal to about 14 g / min). The solution spraying rate may be less than or equal to about 15 g / min (e.g., less than or equal to about 14 g / min, less than or equal to about 13 g / min, less than or equal to about 12 g / min, less than or equal to about 11 g / min, or less than or equal to about 10 g / min).

[0110] In some example embodiments, the spraying time for the spray drying process S430 ranges from about 40 minutes to about 200 minutes. For example, the spraying time can be greater than or equal to about 40 minutes (e.g., greater than or equal to about 45 minutes, greater than or equal to about 50 minutes, greater than or equal to about 55 minutes, greater than or equal to about 60 minutes, greater than or equal to about 65 minutes, greater than or equal to about 70 minutes, greater than or equal to about 75 minutes, greater than or equal to about 80 minutes, greater than or equal to about 85 minutes, greater than or equal to about 90 minutes, greater than or equal to about 95 minutes, greater than or equal to about 100 minutes, greater than or equal to about 105 minutes, greater than or equal to about 110 minutes, greater than or equal to about 115 minutes, etc.). (Approximately 120 minutes or more, approximately 125 minutes or more, approximately 130 minutes or more, approximately 135 minutes or more, approximately 140 minutes or more, approximately 145 minutes or more, approximately 150 minutes or more, approximately 155 minutes or more, approximately 160 minutes or more, approximately 165 minutes or more, approximately 170 minutes or more, approximately 175 minutes or more, approximately 180 minutes or more, approximately 185 minutes or more, approximately 190 minutes or more, or approximately 195 minutes or more). The spray time can be less than or equal to approximately 200 minutes (e.g., less than or equal to approximately 195 minutes, less than or equal to approximately 190 minutes, less than or equal to approximately 185 minutes, less than or equal to approximately 180 minutes, less than or equal to approximately 175 minutes, less than or equal to approximately 170 minutes, less than or equal to approximately 165 minutes, less than or equal to approximately 160 minutes, less than or equal to approximately 155 minutes, less than or equal to approximately 150 minutes, less than or equal to approximately 145 minutes, less than or equal to approximately 140 minutes, less than or equal to approximately 135 minutes, less than or equal to approximately 130 minutes, less than or equal to, etc.). The timeframes are approximately 125 minutes, less than or equal to approximately 120 minutes, less than or equal to approximately 115 minutes, less than or equal to approximately 110 minutes, less than or equal to approximately 105 minutes, less than or equal to approximately 100 minutes, less than or equal to approximately 95 minutes, less than or equal to approximately 90 minutes, less than or equal to approximately 85 minutes, less than or equal to approximately 80 minutes, less than or equal to approximately 75 minutes, less than or equal to approximately 70 minutes, less than or equal to approximately 65 minutes, less than or equal to approximately 60 minutes, less than or equal to approximately 55 minutes, less than or equal to approximately 50 minutes, or less than or equal to approximately 45 minutes.

[0111] In some example embodiments, for example, when solvent 404 contains water, the inlet temperature for spray drying process S430 is from about 120°C to about 210°C. For example, the inlet temperature may be greater than or equal to about 120°C (e.g., greater than or equal to about 125°C, greater than or equal to about 130°C, greater than or equal to about 135°C, greater than or equal to about 140°C, greater than or equal to about 145°C, greater than or equal to about 150°C, greater than or equal to about 155°C, greater than or equal to about 160°C, greater than or equal to about 165°C, greater than or equal to about 170°C, greater than or equal to about 175°C, greater than or equal to about 180°C, greater than or equal to about 185°C, greater than or equal to about 190°C, greater than or equal to about 195°C, greater than or equal to about 200°C, or greater than or equal to about 205°C). The inlet temperature may be less than or equal to about 210°C (e.g., less than or equal to about 205°C, less than or equal to about 200°C, less than or equal to about 195°C, less than or equal to about 190°C, less than or equal to about 185°C, less than or equal to about 180°C, less than or equal to about 175°C, less than or equal to about 170°C, less than or equal to about 165°C, less than or equal to about 160°C, less than or equal to about 155°C, less than or equal to about 150°C, less than or equal to about 145°C, less than or equal to about 140°C, less than or equal to about 135°C, or less than or equal to about 130°C).

[0112] In some example embodiments, for example, when solvent 404 contains ethanol, the inlet temperature for spray drying process S430 is from about 65°C to about 180°C. For example, the inlet temperature may be greater than or equal to about 65°C (e.g., greater than or equal to about 70°C, greater than or equal to about 75°C, greater than or equal to about 80°C, greater than or equal to about 85°C, greater than or equal to about 90°C, greater than or equal to about 95°C, greater than or equal to about 100°C, greater than or equal to about 105°C, greater than or equal to about 110°C, greater than or equal to about 115°C, greater than or equal to about 120°C, greater than or equal to about 125°C, greater than or equal to about 130°C, greater than or equal to about 135°C, greater than or equal to about 140°C, greater than or equal to about 145°C, greater than or equal to about 150°C, greater than or equal to about 155°C, greater than or equal to about 160°C, greater than or equal to about 165°C, greater than or equal to about 170°C, or greater than or equal to about 175°C). The inlet temperature may be less than or equal to about 180°C (e.g., less than or equal to about 175°C, less than or equal to about 170°C, less than or equal to about 165°C, less than or equal to about 160°C, less than or equal to about 155°C, less than or equal to about 150°C, less than or equal to about 145°C, less than or equal to about 140°C, less than or equal to about 135°C, less than or equal to about 130°C, less than or equal to about 125°C, less than or equal to about 120°C, less than or equal to about 115°C, less than or equal to about 110°C, less than or equal to about 105°C, less than or equal to about 100°C, less than or equal to about 95°C, less than or equal to about 90°C, less than or equal to about 85°C, less than or equal to about 80°C, less than or equal to about 75°C, or less than or equal to about 70°C).

[0113] In some example embodiments, for instance, when solvent 404 contains water, the initial product temperature for spray drying process S430 is from about 25°C to about 100°C. For example, the initial product temperature may be greater than or equal to about 25°C (e.g., greater than or equal to about 30°C, greater than or equal to about 35°C, greater than or equal to about 40°C, greater than or equal to about 45°C, greater than or equal to about 50°C, greater than or equal to about 65°C, greater than or equal to about 75°C, greater than or equal to about 80°C, greater than or equal to about 85°C, greater than or equal to about 90°C, or greater than or equal to about 95°C). The initial product temperature can be less than or equal to about 100°C (e.g., less than or equal to about 95°C, less than or equal to about 90°C, less than or equal to about 85°C, less than or equal to about 80°C, less than or equal to about 75°C, less than or equal to about 70°C, less than or equal to about 65°C, less than or equal to about 60°C, less than or equal to about 55°C, less than or equal to about 50°C, less than or equal to about 45°C, less than or equal to about 40°C, less than or equal to about 35°C, or less than or equal to about 30°C).

[0114] In some example embodiments, for instance, when solvent 404 contains ethanol, the initial product temperature for spray drying process S430 is in the range of about 25°C to about 79°C. For example, the initial product temperature may be greater than or equal to about 25°C (e.g., greater than or equal to about 30°C, greater than or equal to about 35°C, greater than or equal to about 40°C, greater than or equal to about 45°C, greater than or equal to about 50°C, greater than or equal to about 55°C, greater than or equal to about 60°C, greater than or equal to about 65°C, or greater than or equal to about 75°C). The initial product temperature may be less than or equal to about 79°C (e.g., less than or equal to about 78°C, less than or equal to about 77°C, less than or equal to about 76°C, less than or equal to about 75°C, less than or equal to about 70°C, less than or equal to about 65°C, less than or equal to about 60°C, less than or equal to about 55°C, less than or equal to about 50°C, less than or equal to about 45°C, less than or equal to about 40°C, less than or equal to about 35°C, or less than or equal to about 30°C).

[0115] After spray drying S430, the nicotine-containing powder 432 can be optionally compressed into tablets, granules, pills, cylinders or other geometric shapes to produce a controlled-release solid suitable for inclusion in oral products such as chewing gum, sprays, lozenges, soluble tablets, non-soluble chewables, films, gels, capsules and pouches (e.g. containing fibers or granules).

[0116] Figure 2 This diagram illustrates a flowchart of method 500 for forming a nicotine-containing powder 542 for inclusion in oral products such as chewing gum, sprays, lozenges, soluble tablets, non-soluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules)). Method 500 is similar to method 400, except that method 500 includes heating a second mixture (i.e., the feed solution) 528 to a first temperature (S530) prior to spray drying S540.

[0117] For example, method 500 includes: contacting a carrier 502 and a solvent 504 (S510) to form a first solution 508 (i.e., a carrier solution); contacting the first solution 508 with a nicotine-containing formulation 522 (S520) to form a second mixture 528 (i.e., a feed solution); heating the second mixture 528 (S530); and spray-drying the heated second mixture 528 S540 to form a plurality of particles defining a nicotine-containing powder 542 (i.e., a dried powder). After spray drying S540, although not illustrated, method 500 may include compressing the nicotine-containing powder 542 into tablets, granules, pills, tubular or other geometries to produce a controlled-release solid suitable for inclusion in oral products such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules).

[0118] In at least some example implementations, method 500 may include heating the second mixture to a first temperature (S530).

[0119] In at least some example embodiments, such as when solvent 504 contains water, the first temperature may be from about 120°C to about 210°C. For example, the first temperature may be greater than or equal to about 120°C (e.g., greater than or equal to about 125°C, greater than or equal to about 130°C, greater than or equal to about 135°C, greater than or equal to about 140°C, greater than or equal to about 145°C, greater than or equal to about 150°C, greater than or equal to about 155°C, greater than or equal to about 160°C, greater than or equal to about 165°C, greater than or equal to about 170°C, greater than or equal to about 175°C, greater than or equal to about 180°C, greater than or equal to about 185°C, greater than or equal to about 190°C, greater than or equal to about 195°C, greater than or equal to about 200°C, or greater than or equal to about 205°C). The first temperature may be less than or equal to about 210°C (e.g., less than or equal to about 205°C, less than or equal to about 200°C, less than or equal to about 195°C, less than or equal to about 190°C, less than or equal to about 185°C, less than or equal to about 180°C, less than or equal to about 175°C, less than or equal to about 170°C, less than or equal to about 165°C, less than or equal to about 160°C, less than or equal to about 155°C, less than or equal to about 150°C, less than or equal to about 145°C, less than or equal to about 140°C, less than or equal to about 135°C, or less than or equal to about 130°C).

[0120] In some embodiments, for example when solvent 504 contains ethanol, the first temperature may be from about 65°C to about 180°C. For example, the first temperature may be greater than or equal to about 65°C (e.g., greater than or equal to about 70°C, greater than or equal to about 75°C, greater than or equal to about 80°C, greater than or equal to about 85°C, greater than or equal to about 90°C, greater than or equal to about 95°C, greater than or equal to about 100°C, greater than or equal to about 105°C, greater than or equal to about 110°C, greater than or equal to about 115°C, greater than or equal to about 120°C, greater than or equal to about 125°C, greater than or equal to about 130°C, greater than or equal to about 135°C, greater than or equal to about 140°C, greater than or equal to about 145°C, greater than or equal to about 150°C, greater than or equal to about 155°C, greater than or equal to about 160°C, greater than or equal to about 165°C, greater than or equal to about 170°C, or greater than or equal to about 175°C). The first temperature may be less than or equal to about 180°C (e.g., less than or equal to about 175°C, less than or equal to about 170°C, less than or equal to about 165°C, less than or equal to about 160°C, less than or equal to about 155°C, less than or equal to about 150°C, less than or equal to about 145°C, less than or equal to about 140°C, less than or equal to about 135°C, less than or equal to about 130°C, less than or equal to about 125°C, less than or equal to about 120°C, less than or equal to about 115°C, less than or equal to about 110°C, less than or equal to about 105°C, less than or equal to about 100°C, less than or equal to about 95°C, less than or equal to about 90°C, less than or equal to about 85°C, less than or equal to about 80°C, less than or equal to about 75°C, or less than or equal to about 70°C).

[0121] Figure 3 This is a flowchart illustrating a method for forming a nicotine-containing powder 642 for inclusion in oral products such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules)). Method 500 is similar to method 400 and / or method 500, except that method 600 includes homogenizing a second mixture 628 for S630 to form a third mixture 638 (i.e., a feed solution), said third mixture having a substantially uniform distribution. In some example embodiments, a paddle mixer, a high-pressure mixer, a high-shear mixer, an ultrasonic homogenizer, or any combination thereof may be used to homogenize the second mixture 628 for S630.

[0122] For example, method 600 includes: contacting a carrier 602 and a solvent 604 (S610) to form a first solution 508 (i.e., a carrier solution); contacting the first solution 608 with a nicotine-containing formulation 622 (S620) to form a second mixture 628; homogenizing the second mixture 628 (S630) to form a third mixture 638 (i.e., a feed solution); and spray-drying the third mixture 638 (S640) to form a plurality of particles defining a nicotine-containing powder 642 (i.e., a dried powder). After spray drying S640, although not illustrated, method 600 may include compressing the nicotine-containing powder 642 into tablets, granules, pills, tubular or other geometries to produce a controlled-release solid suitable for inclusion in oral products such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules and pouches (e.g., containing fibers or granules).

[0123] Although homogenization S630 is illustrated as occurring after contact S620, in at least one example embodiment, contact S620 and homogenization S630 may occur simultaneously. Similarly, in some embodiments, method 600 may include heating a second mixture 628 and / or a third mixture 638 (as illustrated in method 500), and / or adding additives (as illustrated in method 700).

[0124] Figure 4 This illustration shows a flowchart of a method 700 for forming a nicotine-containing powder 742 for inclusion in an oral product, such as chewing gum, spray, lozenges, soluble tablets, insoluble chewables, 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.

[0125] For example, method 700 includes: contacting a carrier 702 and a solvent 704 (S710) to form a first solution 708 (i.e., a carrier solution); contacting the first solution 708 with a nicotine-containing formulation 722 (S720) to form a second mixture 728; adding one or more additives 732 to the second mixture 728 (S730) to form a third mixture 738 (i.e., a feed solution); and spray-drying the third mixture 738 (S740) to form a plurality of particles defining a nicotine-containing powder 742 (i.e., a dried powder). After spray drying S740, although not illustrated, method 700 may include compressing the nicotine-containing powder 742 into tablets, granules, pills, tubular or other geometries to produce a controlled-release solid suitable for inclusion in oral products such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules and pouches (e.g., containing fibers or granules).

[0126] In some example embodiments, 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 carbonates / bicarbonates, potassium carbonate / potassium bicarbonate, citric acid, or any combination thereof. The antioxidant may include ascorbyl palmitate, butylated hydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherol, propyl gallate, tert-butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA), vitamin E, or any combination or derivative thereof. The presence of antioxidants can help limit the formation of nicotine N-oxides.

[0127] In at least some example embodiments, the third solution 738 may have an additive 732 in an amount of about 0.1 wt.% to about 10 wt.%. For example, the third mixture 738 may include more than or equal to about 0.1 wt.% (e.g., more than or equal to about 0.5 wt.%, more than or equal to about 1 wt.%, more than or equal to about 1.5 wt.%, more than or equal to about 2 wt.%, more than or equal to about 2.5 wt.%, more than or equal to about 3 wt.%, more than or equal to about 3.5 wt.%, more than or equal to about 4 wt.%, more than or equal to about 4.5 wt.%, more than or equal to about 5 wt.%, more than or equal to about 5.5 wt.%, more than or equal to about 6 wt.%, more than or equal to about 6.5 wt.%, more than or equal to about 7 wt.%, more than or equal to about 7.5 wt.%, more than or equal to about 8 wt.%, more than or equal to about 8.5 wt.%, more than or equal to about 9 wt.%, or more than or equal to about 9.5 wt.%). The third mixture 728 may include less than or equal to about 10 wt.% (e.g., less than or equal to about 9.5 wt.%, less than or equal to about 9 wt.%, less than or equal to about 8.5 wt.%, less than or equal to about 8 wt.%, less than or equal to about 7.5 wt.%, less than or equal to about 7 wt.%, less than or equal to about 6.5 wt.%, less than or equal to about 6 wt.%, less than or equal to about 5.5 wt.%, less than or equal to about 5 wt.%, less than or equal to about 4.5 wt.%, less than or equal to about 4 wt.%, less than or equal to about 3.5 wt.%, less than or equal to about 3 wt.%, less than or equal to about 2.5 wt.%, less than or equal to about 2 wt.%, less than or equal to about 1 wt.%, or less than or equal to about 0.5 wt.%).

[0128] Although the addition of additive 731 in S730 is illustrated as occurring after contact in S720, in at least one example embodiment, contact in S720 and addition of additive in S730 may occur simultaneously. Similarly, in some embodiments, method 700 may include heating the second mixture 728 and / or the third mixture 738 (as illustrated in method 500), and / or homogenizing the second mixture 728 and / or the third mixture 738 (as illustrated in method 600).

[0129] In at least one example embodiment, an example feed solution for a spray drying process can be prepared, such as... Figure 2-4 As illustrated, the feed solution contains nicotine oil and pectin (a natural binder of nicotine) in water. An example feed solution may contain 1.5 wt.% nicotine oil and approximately 6 wt.% pectin (i.e., a carrier) in an aqueous solvent. The feed solution may be spray-dried, for example, using a VSD-200 spray dryer with a spray rate ranging from approximately 9 g / min to approximately 15 g / min and a spray time of approximately 150 minutes. The feed solution may have an initial product temperature of approximately 86°C to approximately 90°C. The inlet temperature of the spray dryer may be in the range of approximately 170°C to approximately 200°C. The example feed solution can be spray-dried according to these listed parameters to produce a nicotine-containing powder having the properties listed in Table 1.

[0130]

[0131] Table 1. Examples of nicotine-containing powders prepared using spray drying process

[0132] In at least one example embodiment, an example feed solution for a spray drying process can be prepared, such as... Figure 2-4 As illustrated, the feed solution contains nicotine oil and pectin (a natural binder of nicotine) in water. An example feed solution may contain 1.5 wt.% nicotine oil and approximately 6 wt.% pectin (i.e., a carrier) in an aqueous solvent. The feed solution may be spray-dried, for example, using a VSD-200 spray dryer with a spray rate ranging from approximately 9 g / min to approximately 10 g / min and a spray time of approximately 200 minutes. The feed solution may have an initial product temperature of approximately 96°C to approximately 98°C. The inlet temperature of the spray dryer may be approximately 200°C. The example feed solution can be spray-dried according to these listed parameters to produce a nicotine-containing powder having the properties listed in Table 2.

[0133]

[0134] Table 2. Examples of nicotine-containing powders prepared using spray drying process

[0135] In at least one example embodiment, an example feed solution for a spray drying process can be prepared, such as... Figure 2-4 The illustrated feed solution comprises nicotine oil in water and a mixture of gum arabic and maltodextrin. An example feed solution may contain 3.3 wt.% nicotine oil in an aqueous solvent and approximately 30 wt.% a mixture of gum arabic and maltodextrin (i.e., the carrier). The ratio of gum arabic to maltodextrin may be approximately 2:3 w / w. The feed solution may be spray-dried, for example, using a VSD-200 spray dryer with a spray rate ranging from approximately 10 g / min to approximately 12 g / min and a spray time of approximately 100 minutes. The feed solution may have an initial product temperature of approximately 92°C to approximately 96°C. The inlet temperature of the spray dryer may be in the range of approximately 170°C to approximately 180°C. The example feed solution may be spray-dried according to these listed parameters to produce a nicotine-containing powder having the properties listed in Table 3.

[0136]

[0137] Table 3. Examples of nicotine-containing powders prepared using spray drying process

[0138] In at least one example embodiment, an example feed solution for a spray drying process can be prepared, such as... Figure 2-4 The illustrated feed solution comprises nicotine oil in water and a mixture of gum arabic and maltodextrin. An example feed solution may contain 7.5 wt.% nicotine oil in an aqueous solvent and approximately 30 wt.% a mixture of gum arabic and maltodextrin (i.e., the carrier). The ratio of gum arabic to maltodextrin may be approximately 2:3 w / w. The feed solution may be spray-dried, for example, using a VSD-200 spray dryer with a spray rate ranging from approximately 9 g / min to approximately 12 g / min and a spray time of approximately 47.7 minutes. The feed solution may have an initial product temperature of approximately 95°C to approximately 102°C. The inlet temperature of the spray dryer may be approximately 190°C. The example feed solution may be spray-dried according to these listed parameters to produce a nicotine-containing powder having the properties listed in Table 4.

[0139]

[0140] Table 4. Examples of nicotine-containing powders prepared using spray drying process

[0141] Encapsulated nicotine particles

[0142] In at least one example implementation, encapsulated nicotine granules (ENG) suitable for inclusion in oral products are provided.

[0143] Figure 5This illustration shows a cross-sectional view of an encapsulated nicotine particle 800, used for inclusion in oral products such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules)). In at least one example embodiment, the encapsulated nicotine particle 800 comprises nicotine-containing material 810 surrounded or encapsulated by a matrix 824. While the illustration shows nicotine-containing material 810 dispersed within the matrix 824, those skilled in the art will recognize that the matrix 824 may take various other shapes or configurations in a variety of other cases. For example, in some example embodiments, the matrix 824 may have nicotine material 810 uniformly dispersed throughout the encapsulated nicotine particle 800.

[0144] The encapsulated nicotine particles 800 may have an average particle size (D50) of about 100 µm to about 5 mm. For example, the encapsulated nicotine particles 800 may have an average particle size greater than or equal to about 100 µm (e.g., greater than or equal to about 200 µm, greater than or equal to about 300 µm, greater than or equal to about 400 µm, greater than or equal to about 500 µm, greater than or equal to about 600 µm, greater than or equal to about 700 µm, greater than or equal to about 800 µm, greater than or equal to about 900 µm, greater than or equal to about 1 mm, greater than or equal to about 1.5 mm, greater than or equal to about 2.0 mm, greater than or equal to about 2.5 mm, greater than or equal to about 3.0 mm, greater than or equal to about 3.5 mm, greater than or equal to about 4.0 mm, greater than or equal to about 4.5 mm, or greater than or equal to about 5.0 mm). The encapsulated nicotine particles 800 may have an average particle size of less than or equal to about 5 mm (e.g., less than or equal to about 4.5 mm, less than or equal to about 4.0 mm, less than or equal to about 3.5 mm, less than or equal to about 3.0 mm, less than or equal to about 2.5 mm, less than or equal to about 2.0 mm, less than or equal to about 1.5 mm, less than or equal to about 1 mm, less than or equal to about 900 µm, less than or equal to about 800 µm, less than or equal to about 700 µm, less than or equal to about 600 µm, less than or equal to about 500 µm, less than or equal to about 400 µm, less than or equal to about 300 µm, less than or equal to about 200 µm, or less than or equal to about 150 µm).

[0145] In some example embodiments, the nicotine-containing material 810 comprises nicotine, a nicotine complex (e.g., nicotine polacrilex), nicotine salts, or any combination thereof. Nicotine salts may include, for example, nitrates, monotartrates, bitartrate, bitartrate dihydrate, salicylates, sulfates or bisulfates, phosphates or acid phosphates, acetates, lactates, succinates, maleates, fumarates, gluconates, glycosides, benzoates, methanesulfonates, hydrochlorides, hydrobromide, hydroiodates, or any combination thereof.

[0146] In at least one example embodiment, matrix 824 comprises 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, isomaltulose, hydrogenated isomaltulose, hydrogenated starch hydrolysate, or any combination thereof. The humectant / oil may help maintain the moisture level of matrix 824. In some example embodiments, the humectant comprises glycerin, propylene glycol, or a combination of glycerin and propylene glycol.

[0147] In at least one example embodiment, matrix 824 may include sugar alcohol in an amount of about 50 wt.% to about 99.5 wt.%. For example, matrix 824 may contain more than or equal to about 50 wt.% (e.g., more than or equal to about 55 wt.%, more than or equal to about 60 wt.%, more than or equal to about 65 wt.%, more than or equal to about 70 wt.%, more than or equal to about 75 wt.%, more than or equal to about 80 wt.%, more than or equal to about 85 wt.%, more than or equal to about 90 wt.%, or more than or equal to about 95 wt.%) of sugar alcohol. Matrix 824 may contain less than or equal to about 99.5 wt.% (e.g., less than or equal to about 95 wt.%, less than or equal to about 90 wt.%, less than or equal to about 85 wt.%, less than or equal to about 80 wt.%, less than or equal to about 75 wt.%, less than or equal to about 70 wt.%, less than or equal to about 65 wt.%, less than or equal to about 60 wt.%, or less than or equal to about 55 wt.%) of sugar alcohol.

[0148] Figure 6 This is a cross-sectional illustration of an example encapsulated nicotine granule 900 for inclusion in oral products such as chewing gum, sprays, lozenges, soluble tablets, non-soluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules)). The encapsulated nicotine granule 900 is identical to the encapsulated nicotine granule 800, except that the encapsulated nicotine granule 900 contains one or more additives 922.

[0149] In at least one example embodiment, the encapsulated nicotine particles 900 comprise nicotine-containing material 910 surrounded or encapsulated by a matrix 920. The matrix 920 may comprise one or more additives 922. For example, the matrix 920 may comprise 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 particles 900 may comprise one or more additives 922 in an amount greater than 0 wt.% to less than or equal to about 10 wt.%. For example, the encapsulated nicotine particles 900 may contain one or more additives 922 in greater than or equal to 0 wt.% (e.g., greater than or equal to about 0.1 wt.%, greater than or equal to about 0.5 wt.%, greater than or equal to about 1.0 wt.%, greater than or equal to about 1.5 wt.%, greater than or equal to about 2.0 wt.%, greater than or equal to about 2.5 wt.%, greater than or equal to about 3.0 wt.%, greater than or equal to about 3.5 wt.%, greater than or equal to about 4.0 wt.%, greater than or equal to about 4.5 wt.%, greater than or equal to about 5.0 wt.%, greater than or equal to about 5.5 wt.%, greater than or equal to about 6.0 wt.%, greater than or equal to about 6.5 wt.%, greater than or equal to about 7.0 wt.%, greater than or equal to about 7.5 wt.%, greater than or equal to about 8.0 wt.%, greater than or equal to about 8.5 wt.%, greater than or equal to about 9.0 wt.%, or greater than or equal to about 9.5 wt.%). The encapsulated nicotine particles 900 may contain less than or equal to about 10 wt.% (e.g., less than or equal to about 9.5 wt.%, less than or equal to about 9.0 wt.%, less than or equal to about 8.5 wt.%, less than or equal to about 8.0 wt.%, less than or equal to about 7.5 wt.%, less than or equal to about 7.0 wt.%, less than or equal to about 6.5 wt.%, less than or equal to about 6.0 wt.%, less than or equal to about 5.5 wt.%, less than or equal to about 5.0 wt.%, less than or equal to about 4.5 wt.%, less than or equal to about 4.0 wt.%, less than or equal to about 3.5 wt.%, less than or equal to about 3.0 wt.%, less than or equal to about 2.5 wt.%, less than or equal to about 2.0 wt.%, less than or equal to about 1.5 wt.%, less than or equal to about 1.0 wt.%, or less than or equal to about 0.5 wt.%) of one or more additives 922.

[0150] One or more additives 922 may comprise, for example, antioxidants, sweeteners, pH adjusters, polysaccharides, flavoring agents, or any combination thereof. In at least one example embodiment, the antioxidant additive includes ascorbyl palmitate, tert-butylhydroquinone (TBHQ), sodium ascorbate, or any combination thereof. In at least one example embodiment, the sweetener includes acesulfame potassium, aspartame, sodium saccharin, sucralose, or any combination thereof. In at least one example embodiment, the pH adjuster includes sodium carbonate / sodium bicarbonate, potassium carbonate / potassium bicarbonate, citric acid, or any combination thereof. In at least one example embodiment, the polysaccharide includes cardamom, xanthan gum, gum arabic, or any combination thereof.

[0151] Flavoring agents may include spray-dried, powdered, and / or liquid flavoring agents. In at least one example embodiment, the flavoring agents include peppermint, spearmint, wintergreen, menthol, cinnamon, chocolate, vanillin, licorice, clove, anise, sandalwood, geranium, rose oil, vanilla, lemon oil, cinnamon, fennel, ginger, ethyl acetate, isoamyl acetate, propyl isobutyrate, isobutyl isobutyrate, ethyl butyrate, ethyl valerate, benzyl formate, limonene, umbelliferone, pinene, linalool, geraniol, citronellol, citral, orange oil, coriander oil, borneol, fruit extracts, coffee, tea, cocoa, peppermint, pomegranate, acai, raspberry, blueberry, strawberry, boysonberry, cranberry, bourbon whiskey, Scotch whiskey, whiskey, cognac, hydrangea, lavender, apple, peach, and pear. Cherry, plum, orange, lime, lychee, grape, grapefruit, butter, rum, coconut, almond, pecan, walnut, hazelnut, French vanilla, macadamia nut, sugarcane, maple syrup, blackcurrant, caramel, banana, malt, espresso, coffee liqueur, white chocolate, spices (such as cinnamon, cloves, coriander, basil, oregano, garlic, mustard, nutmeg, rosemary, thyme, tarragon, dill, sage, fennel, and anise), methyl salicylate, linalool, jasmine, coffee, olive oil, sesame oil, sunflower seed oil, bergamot oil, bay leaf oil, lemon oil, ginger oil, balsamic vinegar, rice wine vinegar, and red wine vinegar, five-spice powder, bell pepper, mango, soursop, custard apple, sapodilla, oxalis, or any combination thereof.

[0152] Provided are provided the preparation of nicotine granules (ENGs) suitable for encapsulation in oral products such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules)). Figure 5 and Figure 6(The methods illustrated in the figures). In some example embodiments, the method for forming such encapsulated nicotine particles includes: 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 a cured structure such as one or more sheets. One or more cured structures may be fragmented to form encapsulated nicotine particles with desired sensory properties for inclusion in oral products.

[0153] Figure 7 This is a flowchart illustrating a method 1000 for preparing nicotine powder 1052 for inclusion in oral products (such as chewing gum, sprays, lozenges, soluble tablets, non-soluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules)). Figure 5 and / or Figure 6 As illustrated in the figure, the nicotine powder 1052 may include multiple encapsulated nicotine particles. Method 1000 may be carried out using a batch process, a continuous process, or a combination of batch and continuous processes (e.g., compound extrusion).

[0154] In at least one example embodiment, the method 1000 for preparing nicotine powder 1052 includes preparing a molten mixture 1012 (S1010). In some example embodiments, preparing the molten mixture 1012 (S1010) includes heating a first mixture 1006. For example, the first mixture 1006 may be heated to a first temperature.

[0155] In at least one example embodiment, the first temperature is in the range of about 120°C to about 200°C. For example, the first temperature may be greater than or equal to about 120°C (e.g., greater than or equal to about 125°C, greater than or equal to about 130°C, greater than or equal to about 135°C, greater than or equal to about 140°C, greater than or equal to about 145°C, greater than or equal to about 150°C, greater than or equal to about 155°C, greater than or equal to about 160°C, greater than or equal to about 165°C, greater than or equal to about 170°C, greater than or equal to about 175°C, greater than or equal to about 180°C, greater than or equal to about 185°C, greater than or equal to about 190°C, or greater than or equal to about 195°C). The first temperature may be less than or equal to about 200°C (e.g., less than or equal to about 195°C, less than or equal to about 190°C, less than or equal to about 185°C, less than or equal to about 180°C, less than or equal to about 175°C, less than or equal to about 170°C, less than or equal to about 165°C, less than or equal to about 160°C, less than or equal to about 155°C, less than or equal to about 150°C, less than or equal to about 145°C, less than or equal to about 140°C, less than or equal to about 135°C, less than or equal to about 130°C, or less than or equal to about 125°C).

[0156] The first mixture 1006 may comprise one or more polyols (e.g., sugars and / or sugar alcohols) 1002. In at least one example embodiment, method 1000 includes preparing the first mixture 1006 (S1005). In some example embodiments, preparing the first mixture 1006 (S1005) includes contacting one or more polyols 1002 with an aqueous solvent 1004. For example, one or more polyols 1002 may be mixed with an aqueous solvent 1004 to form the first mixture 1006. Although not illustrated, in at least one example embodiment, the first mixture 1006 may further comprise one or more additives. By way of example only, one or more additives may include antioxidants, sweeteners, pH adjusters, polysaccharides, flavoring agents, or any combination thereof.

[0157] In at least one example embodiment, method 1000 includes forming a cooled molten mixture 1028. In some example embodiments, forming a cooled molten mixture 1028 includes cooling a molten mixture 1012 (S1020). For example, the molten mixture 1012 may be cooled to a second temperature to form the cooled molten mixture 1028.

[0158] In at least one example embodiment, the second temperature is in the range of about 65°C to about 200°C. For example, the second temperature may be greater than or equal to 65°C (e.g., greater than or equal to about 70°C, greater than or equal to about 75°C, greater than or equal to about 80°C, greater than or equal to about 85°C, greater than or equal to about 90°C, greater than or equal to about 95°C, greater than or equal to about 100°C, greater than or equal to about 105°C, greater than or equal to about 110°C, greater than or equal to about 115°C, greater than or equal to about 120°C, greater than or equal to about 125°C, greater than or equal to about 130°C, greater than or equal to about 135°C, greater than or equal to about 140°C, greater than or equal to about 145°C, greater than or equal to about 150°C, greater than or equal to about 155°C, greater than or equal to about 160°C, greater than or equal to about 165°C, greater than or equal to about 170°C, greater than or equal to about 175°C, greater than or equal to about 180°C, greater than or equal to about 185°C, greater than or equal to about 190°C, or greater than or equal to about 195°C). The second temperature may be less than or equal to about 200°C (e.g., less than or equal to about 195°C, less than or equal to about 190°C, less than or equal to about 185°C, less than or equal to about 180°C, less than or equal to about 175°C, less than or equal to about 170°C, less than or equal to about 165°C, less than or equal to about 160°C, less than or equal to about 155°C, less than or equal to about 150°C, less than or equal to about 145°C, less than or equal to about 140°C, less than or equal to about 135°C, less than or equal to about 130°C, less than or equal to about 125°C, less than or equal to about 120°C, less than or equal to about 115°C, less than or equal to 110°C, less than or equal to about 105°C, less than or equal to about 100°C, less than or equal to about 95°C, less than or equal to about 90°C, less than or equal to about 85°C, less than or equal to about 80°C, less than or equal to about 75°C, or less than or equal to about 70°C).

[0159] In at least one example embodiment, method 1000 includes forming a second mixture 1038. In some example embodiments, forming the second mixture 1038 includes adding one or more nicotine-containing materials 1032 to a cooled molten mixture 1028 (S1030).

[0160] The second mixture 1038 may include a cooled molten mixture 1028 in an amount of about 0.1 wt.% to about 50 wt.%. For example, the second mixture 1038 may contain more than or equal to about 0.1 wt.% (e.g., more than or equal to about 0.5 wt.%, more than or equal to about 1 wt.%, more than or equal to about 5 wt.%, more than or equal to about 10 wt.%, more than or equal to about 15 wt.%, more than or equal to about 20 wt.%, more than or equal to about 25 wt.%, more than or equal to about 30 wt.%, more than or equal to about 35 wt.%, more than or equal to about 40 wt.%, or more than or equal to about 45 wt.%) of cooled molten mixture 1028. The second mixture 1038 may contain less than or equal to about 50 wt.% (e.g., less than or equal to about 45 wt.%, less than or equal to about 40 wt.%, less than or equal to about 35 wt.%, less than or equal to about 30 wt.%, less than or equal to about 25 wt.%, less than or equal to about 20 wt.%, less than or equal to about 15 wt.%, less than or equal to about 10 wt.%, less than or equal to about 5 wt.%, less than or equal to about 1 wt.%, or less than or equal to about 0.5 wt.%) of cooled molten mixture 1028.

[0161] In at least one example embodiment, the second mixture 1038 may contain about 60 wt.% to about 80 wt.% of cooled molten mixture 1028. For example, the second mixture 1038 may contain greater than or equal to about 60 wt.% (e.g., greater than or equal to about 62 wt.%, greater than or equal to about 64 wt.%, greater than or equal to about 66 wt.%, greater than or equal to about 68 wt.%, greater than or equal to about 70 wt.%, greater than or equal to about 72 wt.%, greater than or equal to about 74 wt.%, greater than or equal to about 76 wt.%, or greater than or equal to about 78 wt.%) of cooled molten mixture 1028. The second mixture 1038 may contain less than or equal to about 80 wt.% (e.g., less than or equal to about 78 wt.%, less than or equal to about 76 wt.%, less than or equal to about 74 wt.%, less than or equal to about 72 wt.%, less than or equal to about 70 wt.%, less than or equal to about 68 wt.%, less than or equal to about 66 wt.%, less than or equal to about 64 wt.%, or less than or equal to about 62 wt.%).

[0162] The second mixture 1038 may contain one or more nicotine-containing materials 1032 in an amount of about 0.1 wt.% to about 50 wt.%. For example, the second mixture 1038 may contain greater than or equal to about 0.1 wt.% (e.g., greater than or equal to about 0.5 wt.%, greater than or equal to about 1 wt.%, greater than or equal to about 5 wt.%, greater than or equal to about 10 wt.%, greater than or equal to about 15 wt.%, greater than or equal to about 20 wt.%, greater than or equal to about 25 wt.%, greater than or equal to about 30 wt.%, greater than or equal to about 35 wt.%, greater than or equal to about 40 wt.%, or greater than or equal to about 45 wt.%) of nicotine-containing materials 1032. The second mixture 1038 may contain less than or equal to about 50 wt.% (e.g., less than or equal to about 45 wt.%, less than or equal to about 40 wt.%, less than or equal to about 35 wt.%, less than or equal to about 30 wt.%, less than or equal to about 25 wt.%, less than or equal to about 20 wt.%, less than or equal to about 15 wt.%, less than or equal to about 10 wt.%, less than or equal to about 5 wt.%, less than or equal to about 1 wt.%, or less than or equal to about 0.5 wt.%) of nicotine-containing material 1032.

[0163] In at least one example embodiment, the second mixture 1038 may contain about 20 wt.% to about 40 wt.% of nicotine-containing material 1032. For example, the second mixture 1038 may contain greater than or equal to about 20 wt.% (e.g., greater than or equal to about 22 wt.%, greater than or equal to about 24 wt.%, greater than or equal to about 26 wt.%, greater than or equal to about 28 wt.%, greater than or equal to about 30 wt.%, greater than or equal to about 32 wt.%, greater than or equal to about 34 wt.%, greater than or equal to about 36 wt.%, or greater than or equal to about 38 wt.%) of nicotine-containing material 1032. The second mixture may contain less than or equal to about 40 wt.% (e.g., less than or equal to about 38 wt.%, less than or equal to about 36 wt.%, less than or equal to about 34 wt.%, less than or equal to about 32 wt.%, less than or equal to about 30 wt.%, less than or equal to about 28 wt.%, less than or equal to about 26 wt.%, less than or equal to about 24 wt.%, or less than or equal to about 22 wt.%) of nicotine-containing material 1032.

[0164] Although not illustrated, in at least one example embodiment, the second mixture 1038 may contain one or more additives, and forming the second mixture may involve adding one or more additives to a cooled molten mixture 1028. By way of example only, one or more additives may include antioxidants, sweeteners, pH adjusters, polysaccharides, flavoring agents, or any combination thereof.

[0165] In some example embodiments, one or more nicotine-containing materials 1032 comprise nicotine, nicotine complexes (e.g., nicotine polacrilex), nicotine salts, or any combination thereof. Nicotine salts may include, for example, nitrates, monotartrates, bitartrate, bitartrate dihydrate, salicylates, sulfates or bisulfates, phosphates or acid phosphates, acetates, lactates, succinates, maleates, fumarates, gluconates, glycosides, benzoates, methanesulfonates, hydrochlorides, hydrobromide, hydroiodates, or any combination thereof.

[0166] In at least one example embodiment, when one or more nicotine-containing materials 1032 comprise solid nicotine salts, the second temperature is in the range of about 120°C to about 130°C. For example, the second temperature may be greater than or equal to about 120°C (e.g., greater than or equal to about 121°C, greater than or equal to about 122°C, greater than or equal to about 123°C, greater than or equal to about 124°C, greater than or equal to about 125°C, greater than or equal to about 126°C, greater than or equal to about 127°C, greater than or equal to about 128°C, or greater than or equal to about 129°C). The second temperature may be less than or equal to about 130°C (e.g., less than or equal to about 129°C, less than or equal to about 128°C, less than or equal to about 127°C, less than or equal to about 126°C, less than or equal to about 125°C, less than or equal to about 124°C, less than or equal to about 123°C, less than or equal to about 122°C, or less than or equal to about 121°C).

[0167] In at least one example embodiment, when one or more nicotine-containing materials 1032 comprise a liquid nicotine solution or nicotine salt, the second temperature is in the range of about 65°C to about 100°C. For example, the second temperature may be greater than or equal to about 65°C (e.g., greater than or equal to about 70°C, greater than or equal to about 75°C, greater than or equal to about 80°C, greater than or equal to about 85°C, greater than or equal to about 90°C, or greater than or equal to about 95°C). The second temperature may be less than or equal to about 100°C (e.g., less than or equal to about 95°C, less than or equal to about 90°C, less than or equal to about 85°C, less than or equal to about 80°C, less than or equal to about 75°C, or less than or equal to about 70°C).

[0168] In at least one example embodiment, method 1000 includes forming one or more cured structures 1048. In some example embodiments, forming one or more cured structures 1048 includes cooling a second mixture 1038 (S1040). For example, the second mixture 1038 may be cooled to a third temperature to form a cooled molten mixture 1048. In some example embodiments, forming one or more cured structures 1048 includes vitrifying the second mixture 1038. For example, the third temperature may be below the glass transition temperature (T0) of one or more polyols 1002. g ).

[0169] In at least one example embodiment, the third temperature is in the range of about 40°C to about 45°C. For example, the third temperature may be greater than or equal to about 40°C (e.g., greater than or equal to about 40.5°C, greater than or equal to about 41°C, greater than or equal to about 41.5°C, greater than or equal to about 42°C, greater than or equal to about 42.5°C, greater than or equal to about 43°C, greater than or equal to about 43.5°C, greater than or equal to about 44°C, or greater than or equal to about 44.5°C). The third temperature may be less than or equal to about 45°C (e.g., less than or equal to about 44.5°C, less than or equal to about 44°C, less than or equal to about 43.5°C, less than or equal to about 43°C, less than or equal to about 42.5°C, less than or equal to about 42°C, less than or equal to about 41.5°C, less than or equal to about 41°C, or less than or equal to about 40.5°C).

[0170] One or more cured structures 1048 may comprise one or more sheets, or various other configurations recognized by those skilled in the art. For example, in at least one example embodiment, one or more cured structures 1048 may comprise one or more flake-forming sheets at room temperature.

[0171] In at least one example embodiment, method 1000 includes breaking one or more solidified structures 1048 (S1050) to form nicotine-containing powder 1052.

[0172] Nicotine-containing materials (such as nicotine-containing powders) are generally sensitive to light and air under environmental conditions, and due to their diverse chemical and physical properties, there may be a variety of difficulties in the preparation, processing, and storage of oral products containing nicotine-containing materials.

[0173] For example, encapsulated nicotine particles prepared according to at least one embodiment and included in oral products (such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g. containing fibers or particles), by way of example only) may be less irritating to consumers than insoluble chewables.

[0174] Encapsulated sweetener granules

[0175] In at least one example implementation, sweetener particles (ESG) suitable for encapsulation in oral products are provided.

[0176] Figure 8 This illustration shows a cross-sectional view of an encapsulated sweetener particle 1200, exemplified for inclusion in oral products such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fibers or granules). In at least one example embodiment, the encapsulated sweetener particle 1200 comprises a sweetener-containing material 1210 surrounded or encapsulated by a matrix 1224. While the illustration shows the nicotine-containing material 1210 dispersed within the matrix 1224, those skilled in the art will recognize that the matrix 1224 may take on a variety of other shapes or configurations in a variety of other cases. For example, in some example embodiments, the matrix 1224 has the sweetener-containing material 1210 uniformly dispersed throughout the encapsulated sweetener particle 1200. In some other embodiments, the matrix 112 may define a continuous coating surrounding or encapsulating the sweetener-containing material 1210.

[0177] The encapsulated sweetener particles 1200 may have an average particle size (D50) of about 100 µm to about 5 mm. For example, the encapsulated sweetener particles 1200 may have an average particle size greater than or equal to about 100 µm (e.g., greater than or equal to about 200 µm, greater than or equal to about 300 µm, greater than or equal to about 400 µm, greater than or equal to about 500 µm, greater than or equal to about 600 µm, greater than or equal to about 700 µm, greater than or equal to about 800 µm, greater than or equal to about 900 µm, greater than or equal to about 1 mm, greater than or equal to about 1.5 mm, greater than or equal to about 2.0 mm, greater than or equal to about 2.5 mm, greater than or equal to about 3.0 mm, greater than or equal to about 3.5 mm, greater than or equal to about 4.0 mm, greater than or equal to about 4.5 mm, or greater than or equal to about 5.0 mm). The encapsulated sweetener particles 1200 may have an average particle size of less than or equal to about 5 mm (e.g., less than or equal to about 4.5 mm, less than or equal to about 4.0 mm, less than or equal to about 3.5 mm, less than or equal to about 3.0 mm, less than or equal to about 2.5 mm, less than or equal to about 2.0 mm, less than or equal to about 1.5 mm, less than or equal to about 1 mm, less than or equal to about 900 µm, less than or equal to about 800 µm, less than or equal to about 700 µm, less than or equal to about 600 µm, less than or equal to about 500 µm, less than or equal to about 400 µm, less than or equal to about 300 µm, less than or equal to about 200 µm, or less than or equal to about 150 µm).

[0178] In some example embodiments, the sweetener-containing material 1210 comprises one or more high-intensity sweeteners. The one or more high-intensity sweeteners may include synthetic sweeteners and / or natural sweeteners. In at least one example embodiment, the natural sweetener includes sugars (e.g., monosaccharides, disaccharides, and / or polysaccharides). In at least one example embodiment, the natural sweetener includes sucrose (e.g., castor sugar), honey, a mixture of low molecular weight sugars other than sucrose, glucose (e.g., glucose, corn sugar, dextrose), molasses, corn sweetener, glucose syrup (e.g., corn syrup), fructose (e.g., fructose), lactose (e.g., milk sugar), maltose (e.g., malt sugar, maltobiose), sorghum syrup, fruit juice concentrate, or any combination thereof. In one example embodiment, the sweetener-containing material 1210 comprises sugar alcohols. Sugar alcohols may include mannitol, sorbitol, xylitol, maltitol, or any combination thereof. In at least one example embodiment, the sweetener-containing material 1210 comprises a non-nutritive sweetener, including stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof.

[0179] In at least one example embodiment, matrix 1224 comprises 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, isomaltulose, hydrogenated isomaltulose, hydrogenated starch hydrolysate, or any combination thereof. The humectant / oil may help maintain the moisture level of matrix 1224. In some example embodiments, the humectant includes glycerin, propylene glycol, or a combination of glycerin and propylene glycol.

[0180] In at least one example embodiment, matrix 1224 may contain sugar alcohol in an amount of about 50 wt.% to about 99.5 wt.%. For example, matrix 824 may contain more than or equal to about 50 wt.% (e.g., more than or equal to about 55 wt.%, more than or equal to about 60 wt.%, more than or equal to about 65 wt.%, more than or equal to about 70 wt.%, more than or equal to about 75 wt.%, more than or equal to about 80 wt.%, more than or equal to about 85 wt.%, more than or equal to about 90 wt.%, or more than or equal to about 95 wt.%) of sugar alcohol. Matrix 824 may contain less than or equal to about 99.5 wt.% (e.g., less than or equal to about 95 wt.%, less than or equal to about 90 wt.%, less than or equal to about 85 wt.%, less than or equal to about 80 wt.%, less than or equal to about 75 wt.%, less than or equal to about 70 wt.%, less than or equal to about 65 wt.%, less than or equal to about 60 wt.%, or less than or equal to about 55 wt.%) of sugar alcohol.

[0181] Figure 9 This is a cross-sectional illustration of an example of encapsulated sweetener particles 1300 contained in oral products (such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fiber or granules)). The encapsulated sweetener particles 1300 are identical to encapsulated sweetener particles 1200, except that the encapsulated sweetener particles 1300 contain one or more additives 1322.

[0182] In at least one example embodiment, the encapsulated sweetener particles 1300 comprise sweetener-containing material 1310 surrounded or encapsulated by a matrix 1320. The matrix 1320 may comprise one or more additives 1322. For example, the matrix 1320 may comprise 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.

[0183] The encapsulated sweetener particles 1300 may contain one or more additives 1322 in an amount of about 0.01 wt.% to about 45 wt.%. For example, the encapsulated sweetener particles 1300 may contain one or more additives 1322 in an amount of greater than or equal to about 0.01 wt.% (e.g., greater than or equal to about 5 wt.%, greater than or equal to about 10 wt.%, greater than or equal to about 15 wt.%, greater than or equal to about 20 wt.%, greater than or equal to about 25 wt.%, greater than or equal to about 30 wt.%, greater than or equal to about 35 wt.%, or greater than or equal to about 40 wt.%). The encapsulated sweetener granules 1300 may contain one or more additives 1322 in less than or equal to about 45 wt.% (e.g., less than or equal to about 40 wt.%, less than or equal to about 35 wt.%, less than or equal to about 30 wt.%, less than or equal to about 25 wt.%, less than or equal to about 20 wt.%, less than or equal to about 15 wt.%, less than or equal to about 10 wt.%, or less than or equal to about 5 wt.%).

[0184] One or more additives 1322 may comprise, for example, antioxidants, sweeteners, pH adjusters, polysaccharides, flavoring agents, or any combination thereof. In at least one example embodiment, the antioxidant additive includes ascorbyl palmitate, tert-butylhydroquinone (TBHQ), sodium ascorbate, or any combination thereof. In at least one example embodiment, the sweetener includes acesulfame potassium, aspartame, sodium saccharin, sucralose, or any combination thereof. In at least one example embodiment, the pH adjuster includes sodium carbonate / sodium bicarbonate, potassium carbonate / potassium bicarbonate, citric acid, or any combination thereof. In at least one example embodiment, the polysaccharide includes cardamom, xanthan gum, gum arabic, or any combination thereof.

[0185] Flavoring agents may include spray-dried, powdered, and / or liquid flavoring agents. In at least one example embodiment, the flavoring agents include peppermint, spearmint, wintergreen, menthol, cinnamon, chocolate, vanillin, licorice, clove, anise, sandalwood, geranium, rose oil, vanilla, lemon oil, cinnamon, fennel, ginger, ethyl acetate, isoamyl acetate, propyl isobutyrate, isobutyl isobutyrate, ethyl butyrate, ethyl valerate, benzyl formate, limonene, umbelliferone, pinene, linalool, geraniol, citronellol, citral, orange oil, coriander oil, borneol, fruit extracts, coffee, tea, cocoa, peppermint, pomegranate, acai, raspberry, blueberry, strawberry, boysonberry, cranberry, bourbon whiskey, Scotch whiskey, whiskey, cognac, hydrangea, lavender, apple, peach, and pear. Cherries, plums, oranges, limes, lychees, grapes, grapefruits, butter, rum, coconuts, almonds, pecans, walnuts, hazelnuts, French vanilla, macadamia nuts, sugarcane, maple syrup, blackcurrants, caramel, bananas, malt, espresso, coffee liqueur, white chocolate, spices (such as cinnamon, cloves, coriander, basil, oregano, garlic, mustard, nutmeg, rosemary, thyme, tarragon, dill, sage, fennel, and anise), methyl salicylate, linalool, jasmine, coffee, olive oil, sesame oil, sunflower seed oil, bergamot oil, bay leaf oil, lemon oil, ginger oil, balsamic vinegar, rice vinegar, and red wine vinegar, five-spice powder, bell peppers, mangoes, custard apples, sweet potato, sapodilla, oxalis, or any combination thereof.

[0186] Provided are sweetener particles (ESGs) suitable for encapsulation in oral products such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fiber or granules)). Figure 8 and Figure 9 The methods illustrated in the diagram are for non-soluble chewable substances. In some example embodiments, methods for forming such encapsulated sweetener particles include: 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 a cured structure such as one or more sheets. One or more cured structures may be fragmented to form encapsulated sweetener particles with desired sensory properties for inclusion in oral products.

[0187] Figure 10 This is a flowchart illustrating a method 1400 for preparing a sweetener-containing powder 1452 for inclusion in oral products (such as chewing gum, sprays, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, and pouches (e.g., containing fiber or granules)). For example, in insoluble chewables... Figure 8 and / or Figure 9As illustrated in the figure, the sweetener-containing powder 1452 may include multiple encapsulated nicotine particles. Method 1400 may be carried out using a batch process, a continuous process, or both (e.g., combined extrusion).

[0188] In at least one example embodiment, method 1400 for preparing sweetener-containing powder 1442 includes preparing a melt mixture 1412 (S1410). In some example embodiments, preparing the melt mixture 1412 (S1410) includes heating a first mixture 1406. For example, the first mixture 1406 may be heated to a first temperature.

[0189] In at least one example embodiment, the first temperature is in the range of about 120°C to about 200°C. For example, the first temperature may be greater than or equal to about 120°C (e.g., greater than or equal to about 125°C, greater than or equal to about 130°C, greater than or equal to about 135°C, greater than or equal to about 140°C, greater than or equal to about 145°C, greater than or equal to about 150°C, greater than or equal to about 155°C, greater than or equal to about 160°C, greater than or equal to about 165°C, greater than or equal to about 170°C, greater than or equal to about 175°C, greater than or equal to about 180°C, greater than or equal to about 185°C, greater than or equal to about 190°C, or greater than or equal to about 195°C). The first temperature can be less than or equal to about 200°C (e.g., less than or equal to about 195°C, less than or equal to about 190°C, less than or equal to about 185°C, less than or equal to about 180°C, less than or equal to about 175°C, less than or equal to about 170°C, less than or equal to about 165°C, less than or equal to about 160°C, less than or equal to about 155°C, less than or equal to about 150°C, less than or equal to about 145°C, less than or equal to about 140°C, less than or equal to about 135°C, less than or equal to about 130°C, or less than or equal to about 125°C).

[0190] The first mixture 1406 may comprise one or more polyols 1402 and / or one or more aqueous colloids 1403. In at least one example embodiment, the one or more polyols 1402 may include isomaltitol, maltitol, mannitol, sorbitol, xylitol, or any combination thereof. In at least one example embodiment, the one or more aqueous colloids 1403 may include guar gum, gum arabic, or any combination thereof.

[0191] The first mixture 1406 may include one or more polyols 1402 in an amount of about 50 wt.% to about 99.5 wt.%. For example, the first mixture 1406 may contain one or more polyols 1402 in an amount of greater than or equal to about 50 wt.% (e.g., greater than or equal to about 55 wt.%, greater than or equal to about 60 wt.%, greater than or equal to about 65 wt.%, greater than or equal to about 70 wt.%, greater than or equal to about 75 wt.%, greater than or equal to about 80 wt.%, greater than or equal to about 85 wt.%, greater than or equal to about 90 wt.%, or greater than or equal to about 95 wt.%). The first mixture 1406 may contain less than or equal to about 99.5 wt.% (e.g., less than or equal to about 95 wt.%, less than or equal to about 90 wt.%, less than or equal to about 85 wt.%, less than or equal to about 80 wt.%, less than or equal to about 75 wt.%, less than or equal to about 70 wt.%, less than or equal to about 65 wt.%, less than or equal to about 60 wt.%, or less than or equal to about 50 wt.%) of one or more polyols 1402.

[0192] The first mixture 1406 may include one or more aqueous colloids 1403 in an amount of about 0.01 wt.% to about 5 wt.%. For example, the first mixture 1406 may contain one or more aqueous colloids in an amount of greater than or equal to about 0.01 wt.% (e.g., greater than or equal to about 0.02 wt.%, greater than or equal to about 0.05 wt.%, greater than or equal to about 1.0 wt.%, greater than or equal to about 1.5 wt.%, greater than or equal to about 2.0 wt.%, greater than or equal to about 2.5 wt.%, greater than or equal to about 3.0 wt.%, greater than or equal to about 3.5 wt.%, greater than or equal to about 4.0 wt.%, greater than or equal to about 4.5 wt.%, or greater than or equal to about 4.9 wt.%). The first mixture 1406 may contain less than or equal to about 5 wt.% (e.g., less than or equal to about 4.9 wt.%, less than or equal to about 4.5 wt.%, less than or equal to about 4.0 wt.%, less than or equal to about 3.5 wt.%, less than or equal to about 3.0 wt.%, less than or equal to about 2.5 wt.%, less than or equal to about 2.0 wt.%, less than or equal to about 1.5 wt.%, less than or equal to about 1.0 wt.%, or less than or equal to about 0.5 wt.%) of one or more aqueous colloids.

[0193] In at least one example embodiment, method 1400 includes preparing a first mixture 1406 (S1405). In some example embodiments, preparing the first mixture 1406 (S1405) includes contacting one or more polyols 1402 and / or one or more aqueous colloids 1403 with an aqueous solvent 1404. For example, one or more polyols 1402 and / or one or more aqueous colloids 1403 may be mixed with an aqueous solvent 1404 to form the first mixture 1406. Although not illustrated, in at least one example embodiment, the first mixture 1406 may further comprise one or more additives. By way of example only, one or more additives may include antioxidants, sweeteners, pH adjusters, polysaccharides, flavoring agents, or any combination thereof.

[0194] In at least one example embodiment, method 1400 includes forming a cooled molten mixture 1428. In some example embodiments, forming a cooled molten mixture 1428 includes cooling the molten mixture 1412. For example, the molten mixture 1412 may be cooled to a second temperature to form the cooled molten mixture 1428.

[0195] In at least one example embodiment, the second temperature is in the range of about 65°C to about 200°C. For example, the second temperature may be greater than or equal to about 65°C (e.g., greater than or equal to about 70°C, greater than or equal to about 75°C, greater than or equal to about 80°C, greater than or equal to about 85°C, greater than or equal to about 90°C, greater than or equal to about 95°C, greater than or equal to about 100°C, greater than or equal to about 105°C, greater than or equal to about 110°C, greater than or equal to about 115°C, greater than or equal to about 120°C, greater than or equal to about 125°C, greater than or equal to about 130°C, greater than or equal to about 135°C, greater than or equal to about 140°C, greater than or equal to about 145°C, greater than or equal to about 150°C, greater than or equal to about 155°C, greater than or equal to about 160°C, greater than or equal to about 165°C, greater than or equal to about 170°C, greater than or equal to about 175°C, greater than or equal to about 180°C, greater than or equal to about 185°C, greater than or equal to about 190°C, or greater than or equal to about 195°C). The second temperature may be less than or equal to about 200°C (e.g., less than or equal to about 195°C, less than or equal to about 190°C, less than or equal to about 185°C, less than or equal to about 180°C, less than or equal to about 175°C, less than or equal to about 170°C, less than or equal to about 165°C, less than or equal to about 160°C, less than or equal to about 155°C, less than or equal to about 150°C, less than or equal to about 145°C, less than or equal to about 140°C, less than or equal to about 135°C, less than or equal to about 130°C, less than or equal to about 125°C, less than or equal to about 120°C, less than or equal to about 115°C, less than or equal to about 110°C, less than or equal to about 105°C, less than or equal to about 100°C, less than or equal to about 95°C, less than or equal to about 90°C, less than or equal to about 85°C, less than or equal to about 80°C, less than or equal to about 75°C, or less than or equal to about 70°C).

[0196] In at least one example embodiment, method 1400 includes forming a second mixture 1438. In some example embodiments, forming the second mixture 1438 includes adding one or more sweetener-containing materials 1432 to a cooled molten mixture 1428 (S1430). The second mixture 1438 may include one or more sweetener-containing materials 1432 in an amount from about 0.01 wt.% to about 45 wt.%. For example, the second mixture 1438 may contain more than or equal to about 0.01 wt.% (e.g., more than or equal to about 5 wt.%, more than or equal to about 10 wt.%, more than or equal to about 15 wt.%, more than or equal to about 20 wt.%, more than or equal to about 25 wt.%, more than or equal to about 30 wt.%, more than or equal to about 35 wt.%, or more than or equal to about 40 wt.%) of one or more sweetener-containing materials 1432. The second mixture 1438 may contain less than or equal to about 45 wt.% (e.g., less than or equal to about 40 wt.%, less than or equal to about 35 wt.%, less than or equal to about 30 wt.%, less than or equal to about 25 wt.%, less than or equal to about 20 wt.%, less than or equal to about 15 wt.%, less than or equal to about 10 wt.%, or less than or equal to about 5 wt.%) of one or more sweetener-containing materials 1432.

[0197] Although not illustrated, in at least one embodiment, the second mixture 1438 may contain one or more additives, and forming the second mixture may include adding one or more additives to a cooled molten mixture 1428. By way of example only, one or more additives may include antioxidants, sweeteners, pH adjusters, polysaccharides, flavoring agents, or any combination thereof.

[0198] In some example embodiments, the sweetener-containing material 1432 comprises one or more high-intensity sweeteners. The one or more high-intensity sweeteners may include synthetic sweeteners and / or natural sweeteners. In at least one example embodiment, the natural sweetener includes sugars (e.g., monosaccharides, disaccharides, and / or polysaccharides). In at least one example embodiment, the natural sweetener includes sucrose (e.g., castor sugar), honey, a mixture of low molecular weight sugars other than sucrose, glucose (e.g., glucose, corn sugar, dextrose), molasses, corn sweetener, glucose syrup (e.g., corn syrup), fructose (e.g., fructose), lactose (e.g., milk sugar), maltose (e.g., malt sugar, maltobiose), sorghum syrup, concentrated fruit juice, or any combination thereof. In one example embodiment, the sweetener-containing material 1432 includes sugar alcohols. Sugar alcohols may include mannitol, sorbitol, xylitol, maltitol, or any combination thereof. In at least one example embodiment, the sweetener-containing material 1432 comprises a non-nutritive sweetener, including stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof.

[0199] In at least one example embodiment, method 1400 includes forming one or more cured structures 1448. In some example embodiments, forming one or more cured structures 1448 includes cooling a second mixture 1438 (S1440). For example, the second mixture 1438 may be cooled to a third temperature to form a cooled molten mixture 1428. In some example embodiments, forming one or more cured structures 1448 may include vitrifying the second mixture 1438. For example, the third temperature may be below the glass transition temperature (T0) of one or more polyols 1402 and / or 1403. g ).

[0200] In at least one example embodiment, the third temperature is in the range of about 40°C to about 45°C. For example, the third temperature may be greater than or equal to about 40°C (e.g., greater than or equal to about 40.5°C, greater than or equal to about 41°C, greater than or equal to about 41.5°C, greater than or equal to about 42°C, greater than or equal to about 42.5°C, greater than or equal to about 43°C, greater than or equal to about 43.5°C, greater than or equal to about 44°C, or greater than or equal to about 44.5°C). The third temperature may be less than or equal to about 45°C (e.g., less than or equal to about 44.5°C, less than or equal to about 44°C, less than or equal to about 43.5°C, less than or equal to about 43°C, less than or equal to about 42.5°C, less than or equal to about 42°C, less than or equal to about 41.5°C, less than or equal to about 41°C, or less than or equal to about 40.5°C).

[0201] One or more cured structures 1448 may comprise one or more sheets, or various other configurations recognized by those skilled in the art. For example, in at least one example embodiment, one or more cured structures 1448 may comprise one or more flake-forming sheets at room temperature.

[0202] In at least one example embodiment, method 1400 includes fragmenting one or more solidified structures 1448 (S1450) to form a sweetener-containing powder 1452.

[0203] A liquid mixture of triglycerides and liquid nicotine

[0204] Figure 11A-11C The chemical structures of different forms of nicotine were described.

[0205] Nicotine, or 3-(1-methyl-2-pyrrolyl)pyridine, is a tertiary amine. At room temperature and pressure, nicotine is an oily, volatile, hygroscopic liquid. In this state, nicotine is a free base (unprotonated) and its structure is as follows: Figure 11A As shown. Free nicotine base has a pK value of approximately 8. a value.

[0206] Nicotine can also be in the form of complexes or salts. Nicotine complexes or salts can be provided in solid form such as powder. An example of a nicotine complex used in oral products is nicotine polacrilex. In the salt, nicotine is unprotonated, as... Figure 11B As shown, or diprotonated, such as Figure 11C As shown. Monoprotonated and diprotonated nicotine have lower pK values ​​than free base nicotine. a Value. Nicotine salts may include nitrates, monotartrates, bitartrates, bitartrate dihydrates, salicylates, sulfates or bisulfates, phosphates or acid phosphates, acetates, lactates, succinates, maleates, fumarates, gluconates, glycosides, benzoates, methanesulfonates, hydrochlorides, hydrobromide, hydroiodates, or any combination thereof.

[0207] Oral products typically contain nicotine in the form of compounds or salts for manufacturing, processing, and stability reasons. However, nicotine is believed to have higher pK values. a Nicotine is more easily absorbed by the oral mucosa at a lower pH. Therefore, oral products containing protonated nicotine may also contain pH adjusters to create a more alkaline environment in the oral product.

[0208] In at least one embodiment, the oral product comprises a liquid mixture of nicotine and triglycerides. Compared to oral products comprising aqueous nicotine, nicotine complexes, and / or nicotine salts, the oral product comprising this liquid mixture can be configured to have higher oral nicotine absorption. The nicotine may be liquid nicotine. At least a portion of the liquid nicotine may be soluble in the triglycerides to form a solution of triglycerides and liquid nicotine. In at least one example embodiment, all of the liquid nicotine solution is soluble in the triglycerides. In at least one example embodiment, the liquid mixture may consist substantially of liquid nicotine and triglycerides such as medium-chain triglycerides (MCTs).

[0209] The weight ratio of triglycerides to nicotine in the liquid mixture can be greater than or equal to about 1:1 (e.g., greater than or equal to about 3:2, greater than or equal to about 2:1, greater than or equal to about 3:1, greater than or equal to about 4:1, greater than or equal to about 5:1, greater than or equal to about 6:1, greater than or equal to about 7:1, greater than or equal to about 8:1, greater than or equal to about 9:1, or greater than or equal to about 10:1). This weight ratio can be less than or equal to about 95:5 (e.g., less than or equal to about 9:1, less than or equal to about 8:1, less than or equal to about 7:1, less than or equal to about 6:1, less than or equal to about 5:1, less than or equal to about 4:1, less than or equal to about 3:1, or less than or equal to about 3:2). In at least one example 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).

[0210] In at least one example embodiment, the oral product may contain additional triglycerides in addition to those present in the liquid mixture. In at least one example embodiment, the additional triglycerides may be used as plasticizers. In oral products (i.e., both the liquid mixture and any additional triglycerides), the ratio of triglycerides to liquid nicotine may be greater than or equal to about 1:1 (e.g., greater than or equal to 3:2, greater than or equal to 2:1, greater than or equal to 3:1, greater than or equal to 4:1, greater than or equal to 5:1, greater than or equal to 6:1, greater than or equal to 7:1, greater than or equal to 8:1, greater than or equal to 9:1, greater than or equal to 10:1, greater than or equal to 15:1, greater than or equal to 20:1, greater than or equal to 25:1, greater than or equal to 30:1, greater than or equal to 40:1, greater than or equal to 50:1, greater than or equal to 60:1, greater than or equal to 70:1, greater than or equal to 75:1, or greater than or equal to 80:1). The weight ratio of triglycerides to liquid nicotine can be less than or equal to about 100:1 (e.g., less than or equal to about 90:1, less than or equal to about 80:1, less than or equal to about 75:1, less than or equal to about 70:1, less than or equal to about 60:1, less than or equal to about 50:1, less than or equal to about 40:1, less than or equal to about 30:1, less than or equal to about 25:1, less than or equal to about 20:1, less than or equal to about 15:1, less than or equal to about 10:1, less than or equal to about 9:1, less than or equal to about 8:1, less than or equal to about 7:1, less than or equal to about 6:1, less than or equal to about 5:1, less than or equal to about 4:1, less than or equal to about 3:1, less than or equal to about 2:1, or less than or equal to about 3:2).

[0211] Figure 12A-12B It is a graph depicting the distribution of oral nicotine for different nicotine solutions.

[0212] In at least one example embodiment, dissolving nicotine in triglycerides promotes absorption through the oral mucosa compared to nicotine in the aqueous phase. It is believed that, regardless of the presence of a pH adjuster, dissolving nicotine in triglycerides promotes the retention of at least a portion of the nicotine in its free, alkaline state.

[0213] like Figure 12A-12B As shown, three solutions were prepared according to Table 5 below. The amounts in Table 5 are by weight percentage. 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.

[0214] Solution A Solution B Solution C nicotine 0.050% 0.050% 0.050% Propylene glycol 0.200% 0.200% -- MCT -- -- 99.950% water 99.732% 99.746% --- Citric acid 0.018% -- --- Sodium carbonate -- 0.004% ---

[0215] Table 5. Solution composition by wt.%

[0216] To determine the amount of nicotine absorbed and unabsorbed, solutions A, B, and C were placed in the oral cavity of adult tobacco consumers. Five adult tobacco consumers participated. For each of the three solutions, sputum samples were collected from each of the five adult tobacco consumers at three time intervals: 0–1 minute, 1–5 minutes, and 5–10 minutes. Each sputum sample was analyzed to measure the weight of nicotine contained therein. The nicotine measured in the sputum sample does not necessarily indicate absorption in the oral mucosa. As described in more detail below, the amount of nicotine absorbed by each solution was calculated based on the difference between the known weight of nicotine in each solution and the amount of nicotine measured in each sputum sample for each solution.

[0217] Solution A contains 0.5 mg of nicotine. First solution A sputum sample 4200 was collected over 0–1 minute and contained 57% by weight of 0.5 mg nicotine. Second solution A sputum sample 4202 was collected over 1–5 minutes and contained 18% by weight of 0.5 mg nicotine. Third solution A sputum sample 4204 was collected over 5–10 minutes and contained 5% by weight of 0.5 mg nicotine. Accordingly, the nicotine absorbed by solution A 4206 was calculated to be 20% by weight (100% - 57% - 18% - 5% = 20%).

[0218] Solution B contains 0.5 mg of nicotine. Sputum sample 4210 of Solution B was collected over 0–1 minute and contained 50% by weight of 0.5 mg nicotine. Sputum sample 4212 of Solution B was collected over 1–5 minutes and contained 19% by weight of 0.5 mg nicotine. Sputum sample 4214 of Solution B was collected over 5–10 minutes and contained 6% by weight of 0.5 mg nicotine. Accordingly, the nicotine absorbed by Solution B 4216 was calculated to be 25% by weight (100% - 50% - 19% - 6% = 25%).

[0219] Solution C contains 0.5 mg of nicotine. Sputum sample 4220 of solution C was collected over 0–1 minute and contained 38% by weight of 0.5 mg nicotine. Sputum sample 4222 of solution C was collected over 1–5 minutes and contained 22% by weight of 0.5 mg nicotine. Sputum sample 4224 of solution C was collected over 5–10 minutes and contained 5% by weight of 0.5 mg nicotine. Accordingly, the nicotine absorbed by solution C 4226 was calculated to be 35% by weight (100% - 38% - 22% - 5% = 35%).

[0220] As the behavioral differences between solutions A and B demonstrate, increasing the pH of an aqueous solution (as in solution B) helps increase oral nicotine absorption. For example, increasing the pH of an aqueous environment can help retain nicotine in a free alkaline phase. As the behavioral differences between solutions A / B and solution C demonstrate, providing nicotine in the MCT (as shown in solution C) helps increase oral nicotine absorption compared to providing nicotine in an aqueous phase. Furthermore, as the behavioral differences between solutions B and C demonstrate, providing nicotine in the MCT (as in solution C) helps increase oral absorption compared to an aqueous phase containing a pH adjuster. Figure 12B As shown, solution C absorbs a higher amount of nicotine than solutions A and B.

[0221] Figure 13A It is a table depicting the distribution coefficient data of nicotine in different oil and water phase combinations. Figure 13B The chemical structure of triacetin (C2) was described. Figure 13C The chemical structure of MCT (C8–C10) was described. Figure 13D The chemical structure of triolein (C18) was described.

[0222] like Figure 13A As shown, nicotine is soluble in both oil and water. Samples 1-8 were each prepared and measured according to the following method: Liquid nicotine of the target concentration was added to a container containing the oil phase. The oil phase containing nicotine was mixed with the water phase at a 1:1 volume ratio (v:v) using a track shaker at approximately 100 rpm for approximately 5 minutes to prepare a nicotine oil:water mixture. The nicotine oil:water mixture was allowed to stand at room temperature (approximately 25°C) for approximately 24 hours. The concentration of nicotine in each of the oil and nicotine phases was measured using liquid chromatography. The partition coefficient for each sample was calculated; this coefficient represents the specific concentration of a compound (e.g., nicotine) at equilibrium in two immiscible solvents (e.g., oil and water phases). The partition coefficient is a comparison of the solubility of nicotine in the two liquid phases.

[0223] Solutions 1-6 contain MCT oil (CAS No. 73398-61-5) as the oil phase. Sample 7 contains triacetate oil as the oil phase. Sample 8 contains triacetate oil as the oil phase. Sample 1 contains deionized water (DI) as the aqueous phase. Sample 2 contains alkaline DI water with pH 7.4 as the aqueous phase. Sample 3 contains artificial saliva with pH 6.8 as the aqueous phase. Artificial saliva simulates mucosal conditions. Sample 4 contains acidic DI water with pH 2 as the aqueous phase. Samples 5-8 contain 1M acetic acid pH adjuster with pH 2 as the aqueous phase, which simulates gastric conditions.

[0224] In each of samples 5-8, the partition coefficient is less than 1, indicating that nicotine is more soluble in the acetic acid pH adjuster than in the corresponding oil phase. This is attributed to the protonation of nicotine and stronger electrostatic interactions. In each of samples 1-4, the partition coefficient is greater than 1, indicating that nicotine is more soluble in the MCT oil than in the corresponding aqueous phase. However, in each sample, at least some nicotine is dissolved in the aqueous phase. Therefore, if water is present in the liquid mixture, at least some nicotine will dissolve in the aqueous phase.

[0225] In at least one example embodiment, the oral product contains water. The oral product may contain water in an amount less than or equal to about 8% by weight (e.g., less than or equal to about 5% by weight, less than or equal to about 3% by weight, less than or equal to about 2% by weight, less than or equal to about 1% by weight, less than or equal to about 0.5% by weight). In at least one example embodiment, the oral product does not contain water.

[0226] In at least one example embodiment, the liquid mixture contains water in an amount less than or equal to about 5% by weight (e.g., less than or equal to about 4% by weight, less than or equal to about 3% by weight, less than or equal to about 2% by weight, less than or equal to about 1% by weight, less than or equal to about 0.5% by weight, or less than or equal to about 0.25% by weight). In at least one example embodiment, water is not intentionally added to the liquid mixture. However, a small amount of water may come into contact with the liquid mixture via other elements in the oral product. In at least one example embodiment, the liquid mixture is water-free. Limiting the amount of water and / or omitting water can promote an increase in the amount of nicotine dissolved in the triglycerides. Therefore, an oral product containing this liquid mixture can be formulated to promote oral absorption of nicotine compared to an oral product in which all or part of the nicotine is in the aqueous phase.

[0227] As described above, in at least one example embodiment, the nicotine may be liquid nicotine. Nicotine at or above about 50% by weight may be free base nicotine (e.g., at or above about 55% by weight, at or above about 60% by weight, at or above about 65% by weight, at or above about 70% by weight, at or above about 75% by weight, at or above about 80% by weight, at or above about 85% by weight, at or above about 90% by weight, at or above about 95% by weight, at or above about 98% by weight, at or above about 99% by weight). In at least one example embodiment, more than 80% by weight of the nicotine is free base nicotine. In at least one example embodiment, all nicotine is free base nicotine.

[0228] In at least one example embodiment, the nicotine is tobacco-derived nicotine, synthetic nicotine, or both tobacco-derived and synthetic nicotine. In at least one example embodiment, the oral product contains a nicotine amount greater than or equal to about 0.1 mg (e.g., greater than or equal to about 1 mg, greater than or equal to about 2 mg, greater than or equal to about 4 mg, greater than or equal to about 6 mg, greater than or equal to about 8 mg, greater than or equal to about 10 mg, or greater than or equal to about 12 mg). The oral product may contain a nicotine amount less than or equal to about 14 mg (e.g., less than or equal to about 12 mg, less than or equal to about 10 mg, less than or equal to about 8 mg, less than or equal to about 6 mg, less than or equal to about 4 mg, less than or equal to about 2 mg, or less than or equal to about 1 mg). In at least one example embodiment, the oral product contains a nicotine amount from 0.1 mg to about 14 mg (e.g., about 4 mg to about 8 mg, about 8 mg to about 6 mg).

[0229] Triglycerides may include long-chain triglycerides (LCT), medium-chain triglycerides (MCT), short-chain triglycerides (STC), or any combination thereof. In at least one example embodiment, the triglyceride comprises MCT. In at least one example embodiment, the liquid mixture further comprises triacetin, triolein, trilinoleic acid glyceride, vegetable oil, partially hydrogenated oil, or any combination thereof. In at least one example embodiment, the liquid mixture comprises triacetin, triolein, trilinoleic acid glyceride, vegetable oil, partially hydrogenated oil, or any combination thereof as alternatives to the triglycerides described herein, in the same weight ratio and percentage relative to the triglycerides.

[0230] In at least one example embodiment, the oral product contains triglycerides in an amount greater than or equal to about 1% by weight (e.g., greater than or equal to about 2% by weight, greater than or equal to about 3% by weight, greater than or equal to about 4% by weight, greater than or equal to about 5% by weight, greater than or equal to about 10% by weight, greater than or equal to about 15% by weight, greater than or equal to about 20% by weight, greater than or equal to about 25% by weight, greater than or equal to about 30% by weight, greater than or equal to about 40% by weight, greater than or equal to about 50% by weight, greater than or equal to about 60% by weight, greater than or equal to about 70% by weight, greater than or equal to about 80% by weight, or greater than or equal to about 90% by weight). In at least one example embodiment, the oral product may contain triglycerides in an amount less than or equal to about 95% by weight (e.g., less than or equal to about 90% by weight, less than or equal to about 80% by weight, less than or equal to about 70% by weight, less than or equal to about 60% by weight, less than or equal to about 50% by weight, less than or equal to about 40% by weight, less than or equal to about 30% by weight, less than or equal to about 20% by weight, less than or equal to about 15% by weight, less than or equal to about 10% by weight, less than or equal to about 7% by weight, or less than or equal to about 5% by weight). In at least one example embodiment, the oral product is in a solid form containing less than or equal to about 50% by weight of triglycerides. In at least one example embodiment, the oral product is in a gel, paste, or liquid form containing more than or equal to about 75% by weight (e.g., more than or equal to about 80% by weight, more than or equal to about 85% by weight, more than or equal to about 90% by weight, more than or equal to about 95% by weight of triglycerides).

[0231] In at least one example embodiment, the oral product further comprises a carrier. At least a portion of the liquid mixture is absorbable in the carrier. In at least one example embodiment, all of the liquid mixture is absorbed in the carrier. In at least one example embodiment, the weight ratio of the carrier to the liquid mixture is in the range of about 75:25 (e.g., about 80:20, about 85:15, about 90:10, or about 95:5). In at least one other example embodiment, the oral product does not contain a carrier.

[0232] In at least one exemplary embodiment, the carrier may be an orally insoluble material. In at least one exemplary embodiment, the carrier is a cellulose material. Cellulose materials may include or be derived from beets, wood pulp, cotton, bran, citrus pomace, grass (e.g., switchgrass), willow, poplar, or any combination thereof. Insoluble cellulose materials may be treated cellulose materials, such as microcrystalline cellulose (MCC), carboxymethyl cellulose (CMC), hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), or any combination thereof. In at least one exemplary embodiment, the cellulose material comprises orally insoluble cellulose fibers.

[0233] In at least one example embodiment, the oral product does not contain a pH adjuster. In at least one other example 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 amount of the pH adjuster contained may be greater than or equal to about 0.01 weight percent (e.g., greater than or equal to about 0.05 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.5 weight percent, or greater than or equal to about 1 weight percent). The amount of the pH adjuster contained may be less than or equal to about 2 weight percent (e.g., less than or equal to about 1 weight percent, less than or equal to about 0.5 weight percent, less than or equal to about 0.1 weight percent, or less than or equal to about 0.05 weight percent). In at least one example embodiment, the pH adjuster is present in an amount from about 0.01 weight percent to 2 weight percent.

[0234] In at least one example embodiment, the oral product comprises a liquid mixture (optionally absorbed in a carrier) and other elements. These other elements may include: oral soluble polymers, oral stabilized polymers, plasticizers, flavoring agents, sweeteners, oral soluble fibers, antioxidants, stimulants, soothing agents (e.g., theanine and / or melatonin), synergists (e.g., ginkgo), alkaloids, minerals, vitamins, dietary supplements, nutritional foods, coloring agents, amino acids, chemical somatosensory agents, food-grade emulsifiers, plant extracts (e.g., green tea), teeth 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 glyceryl monostearate), stabilizers (e.g., ascorbic acid and monosterol citrate, butylated hydroxytoluene (BHT) or butylated hydroxyanisole (BHA)), lubricants (e.g., sodium lauryl sulfate (SLS)), preservatives (e.g., sodium benzoate), fillers, or any combination thereof. Oral products may contain a variety of additional elements. In addition, a single element may belong to more than one category.

[0235] In at least one example embodiment, the amount of the additional elements included may be greater than or equal to about 0.5% by weight (e.g., greater than or equal to about 1% by weight, greater than or equal to about 2% by weight, greater than or equal to about 5% by weight, greater than or equal to about 10% by weight, greater than or equal to about 15% by weight, greater than or equal to about 20% by weight, greater than or equal to about 25% by weight, greater than or equal to about 30% by weight, greater than or equal to about 35% by weight, greater than or equal to about 40% by weight, greater than or equal to about 45% by weight, greater than or equal to about 50% by weight, greater than or equal to about 55% by weight, greater than or equal to about 60% by weight, greater than or equal to about 65% by weight, greater than or equal to about 70% by weight, greater than or equal to about 75% by weight, greater than or equal to about 80% by weight, greater than or equal to about 85% by weight, or greater than or equal to about 90% by weight). The additional element may be present in an amount less than or equal to about 95% by weight (e.g., less than or equal to about 90% by weight, less than or equal to about 85% by weight, less than or equal to about 80% by weight, less than or equal to about 75% by weight, less than or equal to about 70% by weight, less than or equal to about 65% by weight, less than or equal to about 60% by weight, less than or equal to about 55% by weight, less than or equal to about 50% by weight, less than or equal to about 45% by weight, less than or equal to about 40% by weight, less than or equal to about 35% by weight, less than or equal to about 30% by weight, less than or equal to about 25% by weight, less than or equal to about 20% by weight, less than or equal to about 15% by weight, less than or equal to about 10% by weight, or less than or equal to about 5% by weight).

[0236] In at least one example embodiment, the oral product comprises an orally soluble polymer. As used herein, "orally soluble" means that the polymer undergoes significant degradation during an oral exposure to saliva for approximately four hours. In at least one example embodiment, the orally soluble polymer disintegrates upon exposure to saliva at normal human temperature for less than or equal to about one hour (e.g., less than or equal to about 30 minutes, less than or equal to about 15 minutes, less than or equal to about 10 minutes, or less than or equal to about 5 minutes). The orally soluble polymer may be biocompatible.

[0237] In at least one example embodiment, the orally soluble polymer may comprise cellulose polymers such as carboxymethyl cellulose (CMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methyl cellulose (HPMC), and / or methyl cellulose (MC); natural polymers such as starch, modified starch, konjac, collagen, inulin, soy protein, whey protein, casein, and / or wheat bran; and seaweed-derived polymers such as carrageenan (e.g., κ-carrageenan, ι-carrageenan, λ-carrageenan). Alginate (e.g., propylene glycol alginate); microbial-derived polymers such as xanthan gum, dextran, pullulan, gelatin, and / or gellan gum; extracts such as tamarind gum, cardamom gum, tara gum, tragacanth gum, pectin (e.g., low-methoxylated and amidated), agar, corn gluten, carrageenan, gelatin, psyllium husk, chitin, and / or chitosan; exudates such as gum arabic and / or shellac; synthetic polymers such as polyvinylpyrrolidone, polyethylene oxide, and / or polyvinyl alcohol, or any combination thereof. Other useful oral soluble polymers are known in the art, for example, see 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, all of which are incorporated herein by reference.

[0238] In at least one example, the oral product comprises an orally stable polymer. As used herein, "orally stable" means that the polymer does not significantly dissolve or disintegrate during a period of approximately one hour of exposure to saliva at normal human body temperature (i.e., 98.6°F). In at least one example embodiment, the orally stable polymer is a biodegradable polymer configured to decompose over periods of days, weeks, months, or years, but does not significantly decompose during a period of approximately one hour of residence in the oral cavity and exposure to saliva. In at least one example embodiment, the orally stable polymer is stable when exposed to saliva in the oral cavity at normal human body temperature for at least two hours (e.g., at least six hours, at least 12 hours, at least one day, or at least two days). Accordingly, the oral product comprising an orally stable polymer according to at least one example embodiment is configured to remain intact when placed in the mouth of an adult consumer. After a period of time, the orally stable polymer and any other orally stable elements can be removed from the adult consumer's mouth and discarded.

[0239] Mouth-stabilized polymers can be biocompatible and biostable. Mouth-stabilized polymers are generally recognized by relevant regulatory agencies (such as the U.S. Food and Drug Administration (FDA)) as safe and compliant with applicable food contact regulations. In at least one example embodiment, when the mouth-stabilized polymer is tested at 23°C according to ASTM D790 or ISO 178, it has a flexural modulus greater than or equal to 5 MPa, or optionally greater than or equal to 10 MPa.

[0240] In at least one example embodiment, the β-stabilized polymer includes polyurethane, silicone, polyester, polyacrylate, polyethylene, polypropylene, polyetheramide, polystyrene, polyvinyl alcohol, polyvinyl acetate, polyvinyl chloride, polybutyl acetate, butyl rubber, poly(styrene-ethylene-butene-styrene) (SEBS), poly(styrene-butadiene-styrene) (SBS), poly(styrene-isoprene-styrene) (SIS), any copolymers thereof, or any combination thereof. In at least one example embodiment, the β-stabilized polymer comprises polyurethane. In at least one example embodiment, the β-stabilized polymer includes food-grade or medical-grade polymers, such as medical-grade polyurethane.

[0241] In at least one example embodiment, the mouth-stabilized polymer is a thermoplastic polymer. The thermoplastic polymer may be a thermoplastic elastomer. In at least one example embodiment, the mouth-stabilized polymer comprises a thermoplastic elastomer that meets the requirements of the FDA-modified ISO 10993 Part 1, "Biological evaluation of medical devices," when its human tissue contact time is 30 days or less. The mouth-stabilized polymer may have a Shore hardness of 50D or lower, a melt flow rate of 3 g / 10 min (at 200°C / 10 kg), a tensile strength greater than or equal to 10 MPa (using ISO 37), and / or a final elongation of less than 100% (using ISO 37).

[0242] In at least one example embodiment, the oral product contains 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 and medium-chain linear or branched fatty alcohols, or any combination thereof. In addition to triglycerides and / or other oils, the plasticizer may also be present in the liquid mixture.

[0243] In at least one example embodiment, the oral product comprises a flavoring agent. The flavoring agent may be natural or artificial. In at least one example embodiment, the flavoring agent includes fruit flavoring agents (e.g., bergamot, berry, cherry, lemon, and / or orange), alcoholic or liqueur flavoring agents (e.g., bourbon, cognac, Scotch whisky, whiskey, and / or DRAMBUIE brand liqueurs), mint flavoring agents (e.g., Japanese mint, menthol, peppermint, spearmint, wintergreen, and / or peppermint oil from species of the genus *Mentha*), floral flavoring agents (e.g., geranium, lavender, and / or rose), spices, herbs, or other botanical or plant-derived flavoring agents (e.g., anise, celery, coriander, cardamom, bitter bark, cinnamon, cassia, chamomile, clove, cocoa, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pepper, sage, sandalwood, vanilla, and / or ylang-ylang), honey flavoring, or any combination thereof. In at least one example embodiment, the flavoring agent includes bergamot, berries, cherry, lemon, orange, bourbon, cognac, Scotch whisky, whiskey, DRAMBUIE brand liqueur, Japanese mint, menthol, peppermint, spearmint, wintergreen, peppermint oil from species of the genus *Mentha*, geranium, lavender, rose, anise, celery, coriander, cardamom, bitter bark, cinnamon, cassia, chamomile, clove, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pepper, sage, sandalwood, vanilla, ylang-ylang, honey flavoring, or any combination thereof. In at least one example embodiment, the oral product comprises an encapsulated flavoring agent.

[0244] In at least one example embodiment, the oral product comprises a sweetener. The sweetener may include synthetic sweeteners and / or natural sweeteners. Natural sweeteners may include sugars such as monosaccharides, disaccharides, and / or polysaccharides. In at least one example embodiment, the sweetener includes natural sweeteners, including sucrose (i.e., castor 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., malt sugar, maltobiose), sorghum syrup, fruit juice concentrate, or any combination thereof. In one example embodiment, the sweetener includes sugar alcohols. Sugar alcohols may include ethylene glycol, glycerol, erythritol, threitol, arabinitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, idoteol, inositol, heptetol, isomaltitol, maltitol, lactitol, maltotriol, maltotetratitol, polyglycerol, or any combination thereof. In at least one example embodiment, the sweetener includes non-nutritive sweeteners, including stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof.

[0245] In at least one example embodiment, the oral product comprises orally soluble fiber. The orally 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 example embodiment, the orally soluble fiber comprises maltodextrin, psyllium husk, starch, or any combination thereof. In at least one example embodiment, the orally soluble fiber comprises soluble dietary fiber. In at least one example embodiment, the oral product comprises partially soluble fiber, such as beet fiber.

[0246] In at least one example embodiment, the oral product may contain a stimulant. In at least one example embodiment, the stimulant includes caffeine, taurine, glucuronide, or any combination thereof. Caffeine may include synthetic caffeine and / or natural caffeine, such as caffeine extracted from coffee beans. In at least one example embodiment, the oral product contains a caffeine amount greater than or equal to about 10 mg (e.g., greater than or equal to about 25 mg, greater than or equal to about 50 mg, greater than or equal to about 75 mg, greater than or equal to about 100 mg, or greater than or equal to about 150 mg). The amount of caffeine contained may be less than or equal to about 200 mg (e.g., less than or equal to about 150 mg, less than or equal to about 100 mg, less than or equal to about 75 mg, less than or equal to about 50 mg, or less than or equal to about 25 mg).

[0247] In at least one example embodiment, the oral product may contain a colorant. The colorant may be a natural colorant and / or an artificial colorant. In at least one example embodiment, the oral product does not contain a colorant.

[0248] In at least one example embodiment, the oral product comprises a filler. The filler may be configured to alter the texture or flexibility of the oral product compared to an oral product without the filler. The filler may include orally soluble elements, orally insoluble elements, or both. Orally soluble elements may be configured to dissolve or disintegrate in the mouth of an adult consumer, thereby making the oral product more flexible. Fillers may include dicalcium phosphate, calcium sulfate, clay, silica, glass particles, glyceryl palmitate, sodium stearoyl fumarate, talc, or any combination thereof. Furthermore, some of the elements described above may also be classified as fillers, such as orally soluble fiber, sweeteners, minerals, or any combination thereof. In at least one example embodiment, cellulose materials may be present in the oral product as a filler, in addition to serving as a carrier of a liquid mixture or as an alternative to a carrier of a liquid mixture.

[0249] In at least one example embodiment, the oral product is chewing gum, spray, lozenge, soluble tablet, insoluble chewable substance, film, gel, capsule, or pouch (e.g., containing fiber or granules). In at least one example embodiment, the oral product directly comprises a liquid mixture. In at least one example embodiment, the oral product comprises a liquid mixture absorbed on a carrier (e.g., a cellulose material such as MCC).

[0250] Figure 14 It is a perspective view of a bag-shaped product according to at least one example embodiment.

[0251] In at least one example implementation, such as Figure 14 As shown, the oral product may be a pouch 4400. The pouch may contain a liquid mixture absorbed on a carrier such as an MCC and contained in a sachet. The sachet may be formed of a permeable fabric. The pouch product 4400 may be as described in any of the following: 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, the entire contents of each of which are incorporated herein by reference, and further include the liquid mixture described herein as an alternative or supplement to tobacco and / or nicotine.

[0252] In at least one example 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 include water, propylene glycol, glycerin, ethanol, or any combination thereof.

[0253] Figure 15 This is a perspective view of a soluble film agent according to at least one example embodiment.

[0254] In at least one example embodiment, the oral product may be a soluble film formulation 4500. The soluble film formulation 4500 may be a film formulation as described in U.S. Patent No. 8,469,036, issued June 25, 2013, the entire contents of which are incorporated herein by reference, and further includes liquid mixtures as described above as an alternative to or supplement to tobacco.

[0255] In at least one example embodiment, the oral product includes chewing gum. The chewing gum comprises a gum base and a liquid mixture. In at least one example embodiment, at least a portion of the liquid mixture is absorbed in a carrier such as an MCC.

[0256] In at least one example embodiment, the gum base includes elastomers, resins, waxes, fats, emulsifiers, fillers, antioxidants, or any combination thereof. For example, the elastomer may include milkwood, loquat, tunu, jeluton gum, gum, styrene-butadiene rubber, butyl rubber, polyisobutylene, or any combination thereof. For example, the resin may include glyceryl esters of gums, terpene resins, polyvinyl acetate, or any combination thereof. For example, the wax may include paraffin wax, microcrystalline wax, or both paraffin wax and microcrystalline wax. For example, the fat may include hydrogenated vegetable oil. For example, the emulsifier may include lecithin, glyceryl monostearate, or both lecithin and glyceryl monostearate. For example, the filler may include calcium carbonate, talc, or both calcium carbonate and talc. For example, the antioxidant may include butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), tocopherol, ascorbyl palmitate, or any combination thereof. In at least one example embodiment, the gum base includes natural latex, plant gums (e.g., gum arabic), spruce gum, mastic gum, or any combination thereof.

[0257] In at least one example embodiment, the oral product is a tablet. The tablet may comprise a solid solution and a liquid mixture. The solid solution may include soluble fiber and sugar alcohols, as described above. In at least one example embodiment, the solid solution comprises isomaltitol. In at least one example embodiment, the liquid mixture is absorbed in a carrier (e.g., MCC). In at least one example embodiment, the tablet directly comprises the liquid mixture without a carrier. In at least one example embodiment, the tablet may be a tablet 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 further comprises the liquid mixture described above as a supplement or alternative to nicotine.

[0258] In at least one example embodiment, the oral product is a soluble tablet. The soluble tablet may comprise an orally soluble polymer, such as those described above, and optionally a liquid mixture absorbed in a carrier. In at least one example embodiment, the soluble tablet may be a tablet (or sheet) as described in U.S. Application Serial No. 14 / 505,814, issued 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 which are incorporated herein by reference), and further comprises the liquid mixture described above as an alternative to or supplement to tobacco.

[0259] In at least one example embodiment, the oral product is a non-soluble chewable. The non-soluble chewable may comprise orally stabilized polymers, such as those described above, and optionally a liquid mixture absorbed in a carrier. The non-soluble chewable may be a chewable 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, and further include the liquid mixtures described above as alternatives to or supplements to tobacco.

[0260] In at least one example embodiment, the oral product may be a gel. The gel may be as described in U.S. Patent No. 8,469,036, issued June 25, 2013, the entire contents of which are incorporated herein by reference, and further includes the liquid mixture described above as an alternative to or supplement to tobacco.

[0261] The oral product according to at least one example embodiment can be formulated to have a variety of different sizes and shapes (as described in more detail below and as shown in the example). Figure 16A–17 shown). In at least one example embodiment, the size and / or shape of the oral product facilitates its desired positioning within oral administration and / or packaging. In at least one example embodiment, the oral product may have a size of about 0.25 mm to about 30 mm (e.g., about 0.25 to about 1 mm, 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, about 20 mm to about 30 mm, about 20 mm to about 25 mm, or about 25 mm to 30 mm). In at least one example embodiment, the oral product has a first dimension (e.g., minimum dimension or thickness) of about 0.25 mm to about 10 mm (e.g., about 2.5 mm). In at least one example embodiment, the oral product has a maximum dimension (e.g., diameter, height, or width) of about 5 mm to about 25 mm (e.g., about 12 mm). Oral products may have a weight of about 1 g to about 10 g (e.g., about 1 g to about 5 g, about 2 g to about 4 g, or about 5 g to about 10 g).

[0262] In at least one example embodiment, the oral product (such as chewing gum, soluble tablets, chewable tablets, and / or gels) may define a thickness and a cross-sectional shape perpendicular to that thickness. As used herein, “thickness” refers to the minimum dimension of the oral product. In at least one example embodiment, the oral product may have a substantially uniform thickness. Figure 16A –16G describes an oral product with a different cross-sectional shape according to at least one example embodiment.

[0263] Figure 16A This is a perspective view of an oral product having a circular cross-section according to at least one example embodiment.

[0264] In at least one example implementation, such as Figure 16A As shown, oral product 4600A is provided. Oral product 4600A may have a circular cross-section. Although not shown, oral product 4600A may have circular edges.

[0265] Figure 16B It is a perspective view of an oral product having an elliptical cross-section according to at least one example embodiment.

[0266] In at least one example implementation, such as Figure 16B The illustration shows an oral product 4600B. The oral product 4600B may have a substantially elliptical cross-section. In at least one example embodiment, the substantially elliptical cross-section is a substantially elliptical cross-section. Although not shown, the oral product 4600B may have rounded edges.

[0267] Figure 16C It is a perspective view of an oral product having a rectangular cross-section according to at least one example embodiment.

[0268] In at least one example implementation, such as Figure 16C As shown, an oral product 4600C is provided. The oral product 4600C may have a substantially rectangular cross-section. In at least one example embodiment, the substantially rectangular cross-section is a substantially square cross-section. In at least one example embodiment, the rectangular cross-section may have rounded corners. Although not shown, the oral product 4600C may have rounded edges.

[0269] Figure 16D It is a perspective view of an oral product having an elongated rectangular cross-section according to at least one example embodiment.

[0270] In at least one example implementation, such as Figure 16D As shown, oral product 4600D is provided. Oral product 4600D may have a substantially elongated rectangular cross-section. The elongated rectangular cross-section may have rounded corners. Although not shown, oral product 4600D may have rounded edges.

[0271] Figure 16E It is a perspective view of an oral product having a lens or a soccer ball-shaped cross-section according to at least one example embodiment.

[0272] In at least one example implementation, such as Figure 16E The illustration shows an oral product 4600E. The oral product 4600E may have a lens-shaped cross-section. In at least one example embodiment, the lens-shaped cross-section may have rounded corners. Although not shown, the oral product 4600E may have rounded edges.

[0273] Figure 16F It is a perspective view of an oral product having a boomerang-shaped cross-section according to at least one example embodiment.

[0274] In at least one example implementation, such as Figure 16F As shown, oral product 4600F is provided. Oral product 4600F may have a boomerang-shaped cross-section. The boomerang-shaped cross-section may have rounded corners. Although not shown, oral product 4600F may have rounded edges.

[0275] Figure 16G This is a perspective view of an oral product having a shield-shaped cross-section according to at least one example embodiment.

[0276] In at least one example implementation, such as Figure 16GAs shown, an oral product 4600G is provided. The oral product 4600G may have a shield-shaped cross-section. The cross-section may have reflective symmetry about a central plane. In at least one example embodiment, the oral product 4600G includes three rounded corners. In at least one example embodiment, the oral product includes a triangular cross-section. Although not shown, the oral product 4600G may have rounded edges.

[0277] In at least one other example embodiment, the oral product is defined by an additional shape. For example, the oral product may have a semi-circular cross-sectional shape, a comma-shaped cross-sectional shape, a bowtie-shaped cross-sectional shape, or a bean / kidney-shaped cross-sectional shape.

[0278] In at least one example embodiment, the oral product may have a non-uniform thickness (e.g., a pillow shape). In at least one example embodiment, the oral product does not have a single minimum size, such as when the oral product has a spherical or cubic shape. In at least one example embodiment, the oral product defines other three-dimensional shapes.

[0279] Figure 17 It is a perspective view of an oral product according to at least one example embodiment.

[0280] In at least one example implementation, such as Figure 17 As shown, an oral product 4700 is provided. The oral product 4700 may have a wedge shape with rounded edges. The rounded edges may be included to avoid sharp corners that could cause discomfort when placed in the mouth of an adult consumer. In at least one other example embodiment, the oral product may have a hemispherical, semi-cylindrical, twisted, spiral, pad / pillow-shaped, rod-shaped, or pebble-shaped form.

[0281] At least one example embodiment relates to a method for improving oral 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 example embodiment, the method includes preparing the liquid mixture prior to incorporation into the oral product. In at least one example embodiment, the method further includes absorbing the liquid mixture onto a carrier prior to incorporation into the oral product. In at least one example embodiment, the method further includes forming the oral product.

[0282] In at least one example embodiment, preparing the liquid mixture involves dissolving liquid nicotine in a triglyceride (such as MCT). At least a portion of the liquid nicotine is in a free alkaline state. In at least one example embodiment, the weight ratio of glycerol to liquid nicotine is in the range of about 1:1 to about 9:1.

[0283] In at least one example embodiment, absorbing a liquid mixture onto a carrier may include mixing the liquid mixture with the carrier. The method may include allowing the liquid mixture and carrier to equilibrate for a desired (or alternatively predetermined) time period prior to incorporation into an oral product.

[0284] Incorporation may include incorporating a liquid mixture into any oral product described herein, such as chewing gum, spray, lozenges, soluble tablets, insoluble chewables, films, gels, capsules, or pouches (e.g., containing fibers or granules). In at least one example embodiment, incorporation includes combining the liquid mixture and optionally a carrier with one or more additional elements described herein. In at least one example embodiment, the oral product may be formed simultaneously with the incorporation of the liquid mixture. In at least one example embodiment, the oral product may be formed prior to the incorporation of the liquid mixture, such as by forming a tablet and absorbing the liquid mixture into the formed tablet.

[0285] In at least one example embodiment, the invention includes adding a carrier, such as a cellulose material, to a gum base with a liquid mixture therein to form chewing gum. In at least one example embodiment, the invention includes combining the liquid mixture with soluble fiber and sugar alcohol to form an tablet. In at least one example embodiment, the invention includes mixing the liquid mixture with a carrier liquid to form an oral spray product. In at least one example embodiment, the invention includes mixing the liquid mixture with an orally soluble polymer to form a soluble oral product. In at least one example embodiment, the invention includes mixing the liquid mixture with an orally stable polymer to form a chewable oral product.

[0286] In at least one example embodiment, at least a portion of the nicotine remains dissolved in the triglycerides during and after incorporation. All nicotine may remain dissolved in the triglycerides during and after incorporation. In at least one example embodiment, at least a portion of the nicotine remains in a free base state during and after incorporation.

[0287] Controlled-release chewing gum

[0288] In at least one example embodiment, this disclosure provides controlled-release nicotine chewing gum. The chewing gum comprises a gum base polymer, an oil, nicotine or a nicotine derivative, and a buffering system. In at least one example embodiment, the gum base polymer comprises polyvinyl acetate (PVA), and the oil comprises triglycerides.

[0289] In at least one example embodiment, the size and shape of the chewing gum 5100 are perfectly acceptable to the oral cavity of an adult tobacco consumer. The chewing gum 5100 may be uncoated or coated (e.g., ...). Figure 20C-20D(As shown). Coated chewing gum may consist of a body or core, and a coating that partially or completely surrounds the body.

[0290] In at least one example embodiment, the chewing gum contains a higher amount of buffering system compared to other chewing gums, and / or has a higher buffering capacity compared to other chewing gums. Contact between the chewing gum 5100 and saliva lowers the pH value of the chewing gum. In at least one example embodiment, the increased amount of buffering system in the chewing gum retains the gum at a higher pH in the presence of saliva. Maintaining the pH of the chewing gum at a level higher than the pKa of nicotine helps retain a higher amount of nicotine in its free base form.

[0291] The buffer system comprises a base and an acid. In at least one example embodiment, the buffer system comprises a weak base and its conjugate acid. In at least one example embodiment, the buffer system comprises sodium carbonate / sodium bicarbonate, potassium carbonate / potassium bicarbonate, calcium carbonate / calcium bicarbonate, potassium phosphate-based buffer systems (e.g., including monopotassium phosphate, dipotassium phosphate, and / or tripotassium phosphate) or any combination thereof.

[0292] In at least one example embodiment, the chewing gum contains an alkali (e.g., a weak alkali) in an amount greater than or equal to about 0.025 weight percent (e.g., greater than or equal to about 0.05 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.25 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.75 weight percent, greater than or equal to about 0.8 weight percent, greater than or equal to about 0.9 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 1.25 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 1.75 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.25 weight percent, greater than or equal to about 2.5 weight percent, or greater than or equal to about 2.75 weight percent). Chewing gum 5100 may contain alkali in an amount less than or equal to about 3% by weight (e.g., less than or equal to about 2.75% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2.25% by weight, less than or equal to about 2% by weight, less than or equal to about 1.75% by weight, less than or equal to about 1.5% by weight, less than or equal to about 1.25% by weight, less than or equal to about 1% by weight, less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.75% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.25% by weight, less than or equal to about 0.2% by weight, less than or equal to about 0.1% by weight, or less than or equal to about 0.05% by weight).

[0293] In at least one example embodiment, alkali is present in the body or core of the chewing gum 5100, while the coating, if present, is alkali-free. The main body may contain an alkali in an amount greater than or equal to about 0.025 weight percent (e.g., greater than or equal to about 0.05 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.25 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.75 weight percent, greater than or equal to about 0.8 weight percent, greater than or equal to about 0.9 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 1.25 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 1.75 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.25 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 2.75 weight percent, or greater than or equal to about 3 weight percent). The main body may contain an alkali in an amount less than or equal to about 5% by weight (e.g., less than or equal to about 3% by weight, less than or equal to about 2.75% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2.25% by weight, less than or equal to about 2% by weight, less than or equal to about 1.75% by weight, less than or equal to about 1.5% by weight, less than or equal to about 1.25% by weight, less than or equal to about 1% by weight, less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.75% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.25% by weight, less than or equal to about 0.2% by weight, less than or equal to about 0.1% by weight, or less than or equal to about 0.05% by weight). In other example embodiments, the alkali is present in both the body and the coating of the chewing gum 5100, or only in the coating of the chewing gum 5100, such that the body is alkali-free.

[0294] In at least one example embodiment, the chewing gum 5100 contains an acid (e.g., the conjugate acid of a weak base) in an amount greater than or equal to about 0.05 weight percent (e.g., greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.25 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.75 weight percent, greater than or equal to about 0.8 weight percent). (The weight percentages are approximately 0.9% by weight, approximately 1% by weight, approximately 1.25% by weight, approximately 1.5% by weight, approximately 1.75% by weight, approximately 2% by weight, approximately 2.25% by weight, approximately 2.5% by weight, approximately 2.75% by weight, approximately 3% by weight, approximately 3.25% by weight, approximately 3.5% by weight, or approximately 3.75% by weight). Gum 5100 may contain acid in an amount less than or equal to about 3% by weight (e.g., less than or equal to about 4% by weight, less than or equal to about 3.75% by weight, less than or equal to about 3.5% by weight, less than or equal to about 3.25% by weight, less than or equal to about 3% by weight, less than or equal to about 2.75% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2.25% by weight, less than or equal to about 2% by weight, less than or equal to about 1.75% by weight, less than or equal to about 1.5%). (by weight, less than or equal to about 1% by weight, less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.75% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.25% by weight, less than or equal to about 0.2% by weight, or less than or equal to about 0.1% by weight).

[0295] In at least one example embodiment, the acid is present in both the body and the coating of the coated chewing gum. The acid in the body and the coating may be the same. The body may contain the acid in an amount greater than or equal to about 0.05 weight percent (e.g., greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.25 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.75 weight percent, greater than or equal to about 0.8 weight percent, greater than or equal to about 0.9 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 1.25 weight percent). (The weight percentages are approximately 1.5% by weight, approximately 1.75% by weight, approximately 2% by weight, approximately 2.25% by weight, approximately 2.5% by weight, approximately 2.75% by weight, approximately 3% by weight, approximately 3.25% by weight, approximately 3.5% by weight, approximately 3.75% by weight, approximately 4% by weight, approximately 4.25% by weight, approximately 4.5% by weight, or approximately 4.75% by weight). The main body may contain acid in an amount less than or equal to about 5% by weight (e.g., less than or equal to about 4.75% by weight, less than or equal to about 4.5% by weight, less than or equal to about 4.25% by weight, less than or equal to about 4% by weight, less than or equal to about 3.75% by weight, less than or equal to about 3.5% by weight, less than or equal to about 3.25% by weight, less than or equal to about 3% by weight, less than or equal to about 2.75% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2.25% by weight, less than or equal to about 2% by weight, less than or equal to...). The coating is present in approximately 1.75% by weight, less than or equal to approximately 1.5% by weight, less than or equal to approximately 1% by weight, less than or equal to approximately 0.9% by weight, less than or equal to approximately 0.8% by weight, less than or equal to approximately 0.75% by weight, less than or equal to approximately 0.7% by weight, less than or equal to approximately 0.6% by weight, less than or equal to approximately 0.5% by weight, less than or equal to approximately 0.4% by weight, less than or equal to approximately 0.3% by weight, less than or equal to approximately 0.25% by weight, less than or equal to approximately 0.2% by weight, or less than or equal to approximately 0.1% by weight. In at least one example embodiment, the coating (e.g.) Figure 20DThe primary coating shown may contain acid in an amount greater than or equal to about 0.05 weight percent (e.g., greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.25 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.75 weight percent, greater than or equal to about 0.8 weight percent, greater than or equal to about 0.9 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 1.25 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 1.75 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.25 weight percent, greater than or equal to about 2.5 weight percent, or greater than or equal to about 2.75 weight percent). The coating may contain acid in an amount less than or equal to about 3% by weight (e.g., less than or equal to about 2.75% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2.25% by weight, less than or equal to about 2% by weight, less than or equal to about 1.75% by weight, less than or equal to about 1.5% by weight, less than or equal to about 1% by weight, less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.75% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.25% by weight, less than or equal to about 0.2% by weight, or less than or equal to about 0.1% by weight). In other embodiments, the acid is present only in the body of the coated chewing gum such that the coating is substantially acid-free; or the acid is present only in the coating such that the body is substantially acid-free.

[0296] In at least one example embodiment, the chewing gum may contain a buffer system in an amount greater than or equal to about 0.1% by weight (e.g., greater than or equal to about 0.2% by weight, greater than or equal to about 0.3% by weight, greater than or equal to about 0.4% by weight, greater than or equal to about 0.5% by weight, greater than or equal to about 0.6% by weight, greater than or equal to about 0.7% by weight, greater than or equal to about 0.8% by weight, greater than or equal to about 0.9% by weight, greater than or equal to about 1% by weight, greater than or equal to about 1.25% by weight, greater than or equal to about 1.5% by weight, greater than or equal to about 1.75% by weight, greater than or equal to about 2% by weight, greater than or equal to about 2.5% by weight, greater than or equal to about 3% by weight, greater than or equal to about 3.5% by weight, greater than or equal to about 4% by weight, greater than or equal to about 4.5% by weight, greater than or equal to about 5% by weight, greater than or equal to about 6% by weight, or greater than or equal to about 7% by weight). The amount of the included buffer system can be less than or equal to about 8% by weight (e.g., less than or equal to about 7% by weight, less than or equal to about 6% by weight, less than or equal to about 5% by weight, less than or equal to about 4.5% by weight, less than or equal to about 4% by weight, less than or equal to about 3.5% by weight, less than or equal to about 3% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2% by weight, less than or equal to about 1.75% by weight, less than or equal to about 1.5% by weight, less than or equal to about 1.25% by weight, less than or equal to about 1% by weight, less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, or less than or equal to about 0.2% by weight).

[0297] The buffering capacity used in this article is the buffering capacity of a single piece of chewing gum. In at least one example embodiment, the buffering system may have a buffering capacity greater than or equal to about 8 × 10⁻⁶. -4 (For example, greater than or equal to approximately 9 × 10) -4 Greater than or equal to approximately 10 × 10 -4 Greater than or equal to approximately 12 × 10 -4 Greater than or equal to approximately 15 × 10 -4 Greater than or equal to approximately 18 × 10 -4 or greater than or equal to approximately 20 × 10 -4 The buffer system has an acid buffering capacity of approximately 20 × 10⁻⁶. -4 (For example, greater than or equal to approximately 25 × 10) -4 Greater than or equal to approximately 30 × 10-4 Greater than or equal to approximately 35 × 10 -4 Greater than or equal to approximately 40 × 10 -4 Greater than or equal to approximately 45 × 10 -4 Greater than or equal to approximately 50 × 10 -4 Greater than or equal to approximately 55 × 10 -4 Greater than or equal to approximately 60 × 10 -4 or greater than or equal to approximately 65 × 10 -4 Its alkaline buffering capacity.

[0298] In at least one example embodiment, the acid and alkali buffering capacity of the chewing gum is higher than that of other chewing gums (e.g., chewing gums without a buffering system, chewing gums with different buffering systems, and / or chewing gums with a lower amount of buffering system). In at least one example embodiment, the acid buffering capacity may be greater than or equal to about 1.25 times (e.g., greater than or equal to about 1.5 times, greater than or equal to about 1.75 times, greater than or equal to about 2 times, greater than or equal to about 3 times, or greater than or equal to about 4 times) of the acid buffering capacity of other chewing gums. In at least one example embodiment, the alkali buffering capacity may be greater than or equal to about 2 times (e.g., greater than or equal to about 3 times, greater than or equal to about 4 times, greater than or equal to about 5 times, greater than or equal to about 6 times, greater than or equal to about 7 times, greater than or equal to about 8 times, greater than or equal to about 9 times, or greater than or equal to about 10 times) of the alkali buffering capacity of other chewing gums.

[0299] In at least one example embodiment, the chewing gum is configured to maintain a desired (or alternatively predetermined) pH during a desired (or alternatively predetermined) period of contact with saliva. In at least one example embodiment, the desired pH is greater than or equal to about 8.0 (e.g., greater than or equal to about 8.1, greater than or equal to about 8.2, greater than or equal to about 8.3, greater than or equal to about 8.4, greater than or equal to about 8.5, greater than or equal to about 8.6, greater than or equal to about 8.7, greater than or equal to about 8.8, greater than or equal to about 8.9, greater than or equal to about 9.0, greater than or equal to about 9.1, greater than or equal to about 9.2, greater than or equal to about 9.3). (greater than or equal to about 9.4, greater than or equal to about 9.5, greater than or equal to about 9.6, greater than or equal to about 9.7, greater than or equal to about 9.8, greater than or equal to about 9.9, greater than or equal to about 10, greater than or equal to about 10.1, greater than or equal to about 10.2, greater than or equal to about 10.3, greater than or equal to about 10.4, greater than or equal to about 10.5, greater than or equal to about 10.6, greater than or equal to about 10.7, or greater than or equal to about 10.9). In at least one example implementation, the desired pH is less than or equal to about 11 (e.g., less than or equal to about 10.9, less than or equal to about 10.8, less than or equal to about 10.7, less than or equal to about 10.6, less than or equal to about 10.5, less than or equal to about 10.4, less than or equal to about 10.3, less than or equal to about 10.2, less than or equal to about 10.1, less than or equal to about 10, less than or equal to about 9.9, less than or equal to about 9.8, less than or equal to about...). 9.7, less than or equal to about 9.6, less than or equal to about 9.5, less than or equal to about 9.4, less than or equal to about 9.3, less than or equal to about 9.2, less than or equal to about 9.1, less than or equal to about 9, less than or equal to about 8.9, less than or equal to about 8.8, less than or equal to about 8.7, less than or equal to about 8.6, less than or equal to about 8.5, less than or equal to about 8.4, less than or equal to about 8.3, less than or equal to about 8.2, or less than or equal to about 8.1. In at least one example embodiment, the desired duration of contact with saliva is greater than or equal to about 2 minutes (e.g., greater than or equal to about 3 minutes, greater than or equal to about 5 minutes, greater than or equal to about 10 minutes, greater than or equal to about 15 minutes, greater than or equal to about 20 minutes, or greater than or equal to about 25 minutes). In at least one example implementation, the desired time of contact with saliva is less than or equal to about 30 minutes (e.g., less than or equal to about 25 minutes, less than or equal to about 20 minutes, less than or equal to about 15 minutes, or greater than or equal to about 10 minutes).

[0300] In at least one example embodiment, the chewing gum is configured to have a peak pH upon contact with saliva. In at least one example embodiment, the peak pH is greater than or equal to about 8.2 (e.g., greater than or equal to about 8.1, greater than or equal to about 8.2, greater than or equal to about 8.3, greater than or equal to about 8.4, greater than or equal to about 8.5, greater than or equal to about 8.6, greater than or equal to about 8.7, greater than or equal to about 8.8, greater than or equal to about 8.9, greater than or equal to about 9.0, greater than or equal to about 9.1, greater than or equal to about 9.2, greater than or equal to about 9.3). Greater than or equal to about 9.4, greater than or equal to about 9.5, greater than or equal to about 9.6, greater than or equal to about 9.7, greater than or equal to about 9.8, greater than or equal to about 9.9, greater than or equal to about 10, greater than or equal to about 10.1, greater than or equal to about 10.2, greater than or equal to about 10.3, greater than or equal to about 10.4, greater than or equal to about 10.5, greater than or equal to about 10.6, greater than or equal to about 10.7, or greater than or equal to about 10.9). In at least one example embodiment, the peak pH is less than or equal to about 11 (e.g., less than or equal to about 10.9, less than or equal to about 10.8, less than or equal to about 10.7, less than or equal to about 10.6, less than or equal to about 10.5, less than or equal to about 10.4, less than or equal to about 10.3, less than or equal to about 10.2, less than or equal to about 10.1, less than or equal to about 10, less than or equal to about 9.9, less than or equal to about 9.8, less than or equal to about 9.7, less than or equal to about 9.6, less than or equal to about 9.5, less than or equal to about 9.4, less than or equal to about 9.3, less than or equal to about 9.2, less than or equal to about 9.1, or less than or equal to about 9).

[0301] In at least one example embodiment, during the desired period of saliva contact, the chewing gum is configured to retain 60% or more by weight (e.g., 65% or more by weight, 70% or more by weight, 75% or more by weight, 80% or more by weight, 85% or more by weight, 90% or more by weight, or 95% or more by weight) of nicotine in a free alkaline form. In at least one example embodiment, the desired period of saliva contact is greater than or equal to about 2 minutes (e.g., 3 minutes or more, 5 minutes or more, 10 minutes or more, 15 minutes or more, 20 minutes or more, or 25 minutes or more). In at least one example embodiment, the desired period of saliva contact is less than or equal to about 30 minutes (e.g., 25 minutes or more, 20 minutes or more, 15 minutes or more, or 10 minutes or more).

[0302] In at least one example embodiment, the gel-based polymer, such as PVA, is present in a higher amount compared to a typical gel-based base (e.g., a gel-based base containing more than 10% by weight of polymer, sugar alcohol, and fillers such as calcium carbonate and / or talc), as described in more detail below. Increasing the amount of the gel-based polymer can promote the controlled release of nicotine or other active ingredients. For example, as the amount of the gel-based polymer increases, the nicotine release rate can decrease.

[0303] In at least one example embodiment, after an adult tobacco consumer chews the gum for approximately 10 minutes, less than approximately 95% by weight of nicotine is released from the gum (e.g., less than approximately 90% by weight of nicotine, less than approximately 85% by weight of nicotine, less than approximately 80% by weight of nicotine, less than approximately 70% by weight of nicotine, less than approximately 65% ​​by weight of nicotine, less than approximately 60% by weight of nicotine, less than approximately 55% by weight of nicotine, or less than approximately 50% by weight of nicotine). In at least one example embodiment, after an adult tobacco consumer chews the gum for approximately 10 minutes, an amount of nicotine from approximately 45% by weight to approximately 95% by weight (e.g., approximately 45% by weight to approximately 75% by weight, approximately 50% by weight to approximately 70% by weight, or approximately 55% by weight to approximately 65% ​​by weight of nicotine) is released from the oral product.

[0304] In at least one example embodiment, the amount of oil (which may be a mixture of oils) present can be higher than in typical chewing gum. The amount of oil can be selected to achieve a desired chewing gum texture and / or softness. More specifically, the softness of the chewing gum increases with increasing oil content. In at least one example embodiment, the oil includes triglycerides, triacetin, and flavoring oils, as described in more detail below.

[0305] In at least one example embodiment, the gum-based polymer comprises a resin, an elastomer, or any combination thereof. For example, the resin may include PVA, glyceryl esters of gums, terpene resins, or any combination thereof. For example, the elastomer may include milkwood, loquat, tunu, jeluton gum, gum, styrene-butadiene rubber, butyl rubber, polyisobutylene, or any combination thereof. In at least one example embodiment, the gum-based polymer comprises natural latex, plant gums (e.g., resins), spruce gum, mastic gum, or any combination thereof. The gum-based polymer may comprise a single polymer or a combination of polymers. In at least one example embodiment, the gum-based polymer is substantially composed of PVA (e.g., a single PVA or multiple PVAs, as discussed in more detail below).

[0306] In at least one example embodiment, the gel-based polymer comprises a plurality of polymers having different molecular weights (e.g., a first polymer and a second polymer). In at least one example embodiment, the gel-based polymer comprises a plurality of PVAs, each PVA having a different molecular weight. In at least one example embodiment, the PVA comprises a first PVA having a first molecular weight (e.g., a first weight-average molecular weight measured by gel permeation chromatography (GPC)) and a second PVA having a second molecular weight different from the first molecular weight (e.g., a second weight-average molecular weight measured by GPC). The first weight-average molecular weight may be greater than or equal to about 9,000 amu (e.g., greater than or equal to about 10,000 amu, greater than or equal to about 11,000 amu, greater than or equal to about 12,000 amu, greater than or equal to about 13,000 amu, or greater than or equal to about 14,000 amu). The first weight-average molecular weight may be less than or equal to about 15,000 amu (e.g., less than or equal to about 14,000 amu, less than or equal to about 13,000 amu, less than or equal to about 12,000 amu, less than or equal to about 11,000 amu, or less than or equal to about 10,000 amu). The K value of the first PVA may be greater than or equal to about 17 (e.g., greater than or equal to about 18, greater than or equal to about 19, greater than or equal to about 20, or greater than or equal to about 21). The K value of the first PVA may be less than or equal to about 21 (e.g., less than or equal to about 20, less than or equal to about 19, or less than or equal to about 18). The second-weighted average molecular weight can be greater than or equal to about 45,000 amu (e.g., greater than or equal to about 47,500 amu, greater than or equal to about 50,000 amu, greater than or equal to about 52,500 amu, greater than or equal to about 55,000 amu, greater than or equal to about 57,500 amu, greater than or equal to about 60,000 amu, or greater than or equal to about 62,500 amu). The second-weighted average molecular weight can be less than or equal to about 65,000 amu (e.g., less than or equal to about 62,500 amu, less than or equal to about 60,000 amu, less than or equal to about 57,500 amu, less than or equal to about 55,000 amu, less than or equal to about 52,500 amu, less than or equal to about 50,000 amu, or less than or equal to about 47,500 amu). The K value of the second PVA may be greater than or equal to about 31 (e.g., greater than or equal to about 32, greater than or equal to about 33, greater than or equal to about 34, or greater than or equal to about 35). The K value of the second PVA may be less than or equal to about 36 (e.g., less than or equal to about 35, less than or equal to about 34, less than or equal to about 33, or less than or equal to about 32).In at least one example embodiment, the first polymer comprises VINAVIL RAVIFLEX BL 0,5–A, VINAVILRAVIFLEX SL 1A–A, or a combination thereof, and the second polymer comprises VINAVIL RAVIFLEX BL 7S–A, VINAVILRAVIFLEX BL 7,5S–A, or a combination thereof.

[0307] In at least one example embodiment, the weight-average molecular weight of the first polymer (e.g., the first PVA) is lower than that of the second polymer (e.g., the second PVA). The weight ratio of the first polymer to the second polymer may be greater than or equal to about 1:1 (e.g., greater than or equal to about 2:1, greater than or equal to about 3:1, greater than or equal to about 4:1, greater than or equal to about 5:1, greater than or equal to about 6:1, greater than or equal to about 7:1, greater than or equal to about 8:1, greater than or equal to about 9:1, greater than or equal to about 10:1, greater than or equal to about 11:1, greater than or equal to about 12:1, or greater than or equal to about 15:1). The weight ratio may be less than or equal to about 20:1 (e.g., less than or equal to about 12:1, less than or equal to about 11:1, less than or equal to about 10:1, less than or equal to about 9:1, less than or equal to about 8:1, less than or equal to about 7:1, less than or equal to about 6:1, less than or equal to about 5:1, less than or equal to about 4:1, less than or equal to about 3:1, or less than or equal to about 2:1).

[0308] In at least one example embodiment, a certain amount of a first polymer and a second polymer may be provided to achieve the desired hardness. Hardness can generally be influenced, at least in part, by the molecular weight of the polymers and the presence and composition of plasticizers and oils. The hardness of the coated chewing gum can be determined using a texture analyzer, such as the XT-Plus texture analyzer from STABLE MICRO SYSTEM GODALMINGGU71YL, UK, equipped with a TA15–45° stainless steel conical probe and a TA-90 heavy-duty platform. The test can be run under the following conditions: pre-test speed 1.00 mm / s, test speed 1.0 mm / s, post-test speed 10.00 mm / s, distance from the chewing gum surface or penetration depth 5.00 mm, run time 5.0 s, ambient measurement temperature, and calibration weight 1 kg. The test can be performed in "Measure Force in Compression" mode with automatic triggering, automatic tare mode, and a data acquisition rate of 400 pps. Before testing, the chewing gum is placed directly under the probe. Texture analysis typically involves measuring the gum's response to stress. Peak normal force is the maximum force that penetrates the gum's core or body.

[0309] In at least one example embodiment, the peak positive force of the chewing gum (i.e., uncoated chewing gum or the core of coated chewing gum) measured as described above is greater than or equal to about 1500 g (e.g., greater than or equal to about 1600 g, greater than or equal to about 1700 g, greater than or equal to about 1800 g, greater than or equal to about 1900 g, greater than or equal to about 2000 g, greater than or equal to about 2100 g, greater than or equal to about 2200 g, greater than or equal to about 2300 g, greater than or equal to about 2400 g, greater than or equal to about 2500 g, greater than or equal to about 2600 g, greater than or equal to about 2700 g, greater than or equal to about 2800 g, greater than or equal to about 2900 g, greater than or equal to about 3000 g, greater than or equal to about 3000 g, greater than or equal to about 3100 g, greater than or equal to about 3200 g, greater than or equal to about 3300 g, greater than or equal to about 3400 g). g, greater than or equal to about 3,500 g, or greater than or equal to about 3,600 g). The peak normal force can be less than or equal to about 4,000 g (e.g., less than or equal to about 3,800 g, less than or equal to about 3,700 g, less than or equal to about 3,600 g, less than or equal to about 3,500 g, less than or equal to about 3,400 g, less than or equal to about 3,300 g, less than or equal to about 3,200 g, less than or equal to about 3,100 g, less than or equal to about 3,000 g, less than or equal to about 2,900 g, less than or equal to about 2,800 g, less than or equal to about 2,700 g, less than or equal to about 2,600 g, less than or equal to about 2,500 g, less than or equal to about 2,400 g, less than or equal to about 2,300 g, less than or equal to about 2,200 g, less than or equal to about 2,100 g, less than or equal to about 2,000 g, less than or equal to about 1,900 g, less than or equal to about 1,800 g). g, less than or equal to about 1,700 g, or less than or equal to about 1,600 g).

[0310] In at least one example embodiment, the amount of the gum base polymer present in the chewing gum is greater than or equal to about 15% by weight of the chewing gum (e.g., greater than or equal to about 20% by weight, greater than or equal to about 25% by weight, greater than or equal to about 30% by weight, greater than or equal to about 35% by weight, greater than or equal to about 40% by weight, greater than or equal to about 45% by weight, greater than or equal to about 50% by weight, or greater than or equal to about 55% by weight). The amount of the gum base polymer contained in the chewing gum may be less than or equal to about 60% by weight (e.g., less than or equal to about 55% by weight, less than or equal to about 50% by weight, less than or equal to about 45% by weight, less than or equal to about 40% by weight, less than or equal to about 35% by weight, less than or equal to about 30% by weight, less than or equal to about 25% by weight, or less than or equal to about 20% by weight).

[0311] In at least one example embodiment, the gum base polymer is present in the body or core of the chewing gum, and the coating, if present, does not contain the gum base polymer. In at least one example embodiment, the amount of the gum base polymer present in the body is from about 25% to about 65% by weight (e.g., from about 30% to about 60% by weight, from about 35% to about 60% by weight, from about 40% to about 55% by weight, 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 from about 45% by weight).

[0312] In at least one example embodiment, the gum polymer comprises PVA (e.g., a combination of various PVAs with different molecular weights described above) in an amount greater than or equal to about 15% by weight of the chewing gum (e.g., greater than or equal to about 20% by weight, greater than or equal to about 25% by weight, greater than or equal to about 30% by weight, greater than or equal to about 35% by weight, greater than or equal to about 40% by weight, greater than or equal to about 45% by weight, greater than or equal to about 50% by weight, or greater than or equal to about 55% by weight). The amount of PVA contained in the chewing gum may be less than or equal to about 60% by weight (e.g., less than or equal to about 55% by weight, less than or equal to about 50% by weight, less than or equal to about 45% by weight, less than or equal to about 40% by weight, less than or equal to about 35% by weight, less than or equal to about 30% by weight, less than or equal to about 25% by weight, or less than or equal to about 20% by weight).

[0313] In at least one example embodiment, PVA is present in the body or core of the chewing gum, while the coating, if present, does not contain PVA. In at least one example embodiment, the amount of PVA present in the body is from about 25% to about 65% by weight (e.g., from about 30% to about 60% by weight, from about 35% to about 60% by weight, from about 40% to about 55% by weight, 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 from about 45% by weight).

[0314] In at least one example embodiment, the chewing gum further comprises a polysaccharide to facilitate the controlled release of nicotine or a nicotine derivative. The polysaccharide can facilitate the controlled release of nicotine by reducing the dissolution rate and the corresponding nicotine release. The polysaccharide may include xanthan gum, cardamom, pullulan, tamarind gum, gum arabic, or any combination thereof. The chewing gum may contain a polysaccharide in an amount greater than or equal to about 0.01 weight percent (e.g., greater than or equal to about 0.02 weight percent, greater than or equal to about 0.05 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.15 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.8 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 3 weight percent, or greater than or equal to about 4 weight percent). Chewing gum may contain polysaccharides in amounts less than or equal to about 5% by weight (e.g., less than or equal to about 4% by weight, less than or equal to about 3% by weight, less than or equal to about 2% by weight, less than or equal to about 1% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.2% by weight, less than or equal to about 0.15% by weight, less than or equal to about 0.1% by weight, less than or equal to about 0.05% by weight, or less than or equal to about 0.02% by weight).

[0315] In at least one example embodiment, the uncoated gum or the body or core of the gum contains polysaccharides. The body may contain polysaccharides in an amount greater than or equal to about 0.05 weight percent (e.g., greater than or equal to about 0.1 weight percent, greater than or equal to about 0.15 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.8 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 3 weight percent, or greater than or equal to about 4 weight percent). The main body may contain polysaccharides in an amount less than or equal to about 5% by weight (e.g., less than or equal to about 4% by weight, less than or equal to about 3% by weight, less than or equal to about 2% by weight, less than or equal to about 1% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.2% by weight, less than or equal to about 0.15% by weight, or less than or equal to about 0.1% by weight).

[0316] In at least one example embodiment, the chewing gum includes a coating adhesive. The coating adhesive may be present in an inner coating layer, which will contribute to the following bonding... Figure 20D The discussion elaborates on this further. In at least one example embodiment, the inner coating layer is substantially composed of a coating adhesive. The coating adhesive may include gum arabic, cardamom, xanthan gum, hydroxypropyl methylcellulose, or any combination thereof. The chewing gum may contain a coating adhesive in an amount greater than or equal to about 0.25% by weight (e.g., greater than or equal to about 0.5% by weight, greater than or equal to about 0.75% by weight, greater than or equal to about 1% by weight, greater than or equal to about 1.25% by weight, greater than or equal to about 1.5% by weight, greater than or equal to about 1.75% by weight, greater than or equal to about 2% by weight, greater than or equal to about 2.25% by weight, greater than or equal to about 2.5% by weight, greater than or equal to about 2.75% by weight, greater than or equal to about 3% by weight, or greater than or equal to about 4% by weight). Chewing gum may contain a coating release agent in an amount less than or equal to about 5% by weight (e.g., less than or equal to about 4% by weight, less than or equal to about 3% by weight, less than or equal to about 2.75% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2.25% by weight, less than or equal to about 2% by weight, less than or equal to about 1.75% by weight, less than or equal to about 1.5% by weight, less than or equal to about 1.25% by weight, less than or equal to about 1% by weight, less than or equal to about 0.75% by weight, or less than or equal to about 0.5% by weight).

[0317] As described above, in at least one example embodiment, the chewing gum also contains oil. The oil may be a mixture of oils. In at least one example embodiment, the oil includes a plasticizer, a flavoring oil, or both a plasticizer and a flavoring oil.

[0318] In at least one example embodiment, the chewing gum contains oil in an amount greater than or equal to about 2% by weight (e.g., greater than or equal to about 3% by weight, greater than or equal to about 4% by weight, greater than or equal to about 5% by weight, greater than or equal to about 6% by weight, greater than or equal to about 7% by weight, greater than or equal to about 8% by weight, greater than or equal to about 9% by weight, greater than or equal to about 10% by weight, greater than or equal to about 11% by weight, greater than or equal to about 12% by weight, greater than or equal to about 13% by weight, or greater than or equal to about 15% by weight). Chewing gum may contain oil in an amount less than or equal to about 20 percent by weight (e.g., less than or equal to about 15 percent by weight, less than or equal to about 14 percent by weight, less than or equal to about 13 percent by weight, less than or equal to about 12 percent by weight, less than or equal to about 11 percent by weight, less than or equal to about 10 percent by weight, less than or equal to about 9 percent by weight, less than or equal to about 8 percent by weight, less than or equal to about 7 percent by weight, less than or equal to about 6 percent by weight, less than or equal to about 5 percent by weight, less than or equal to about 4 percent by weight, or less than or equal to about 3 percent by weight).

[0319] In at least one example embodiment, the oil is present in the body or core of the chewing gum, and the coating, if present, is substantially oil-free. The body may contain oil in an amount greater than or equal to about 3% by weight (e.g., greater than or equal to about 4%, greater than or equal to about 5%, greater than or equal to about 6%, greater than or equal to about 7%, greater than or equal to about 8%, greater than or equal to about 9%, greater than or equal to about 10%, greater than or equal to about 11%, greater than or equal to about 12%, greater than or equal to about 13%, greater than or equal to about 15%, greater than or equal to about 17.5%, or greater than or equal to about 20%). The body may contain oil in an amount less than or equal to about 25% by weight (e.g., less than or equal to about 20% by weight, less than or equal to about 17.5% by weight, less than or equal to about 15% by weight, less than or equal to about 14% by weight, less than or equal to about 13% by weight, less than or equal to about 12% by weight, less than or equal to about 11% by weight, less than or equal to about 10% by weight, less than or equal to about 9% by weight, less than or equal to about 8% by weight, less than or equal to about 7% by weight, less than or equal to about 6% by weight, less than or equal to about 5% by weight, or less than or equal to about 4% by weight). In at least one example embodiment, the uncoated gum or the body of the gum contains oil in an amount from about 5% by weight to about 20% by weight (e.g., 8% by weight to about 16% by weight, about 10% by weight to about 14% by weight, about 11% by weight to about 13% by weight, or about 12% by weight).

[0320] Plasticizers may include triglycerides (e.g., long-chain, medium-chain, and / or short-chain triglycerides), diglycerides, monoglycerides, triacetin, propylene glycol, glycerol, vegetable oils, phthalates, esters of polycarboxylic acids and medium-chain linear or branched fatty alcohols, or any combination thereof. In at least one example embodiment, the chewing gum contains triglycerides, including long-chain triglycerides (LCT), medium-chain triglycerides (MCT), or both LCT and MCT. In at least one example embodiment, the plasticizer comprises a triglyceride and another different plasticizer. In at least one example embodiment, the plasticizer comprises a triglyceride and triacetin. In at least one example embodiment, the plasticizer comprises MCT and triacetin.

[0321] In at least one example embodiment, the chewing gum contains triglycerides (e.g., MCT) in an amount greater than or equal to about 0.5% by weight (e.g., greater than or equal to about 1% by weight, greater than or equal to about 2% by weight, greater than or equal to about 3% by weight, greater than or equal to about 4% by weight, greater than or equal to about 5% by weight, greater than or equal to about 6% by weight, greater than or equal to about 7% by weight, greater than or equal to about 8% by weight, greater than or equal to about 9% by weight, greater than or equal to about 10% by weight, greater than or equal to about 11% by weight, greater than or equal to about 12% by weight, greater than or equal to about 13% by weight, or greater than or equal to about 14% by weight). Chewing gum may contain triglycerides in amounts less than or equal to about 15 percent by weight (e.g., less than or equal to about 14 percent by weight, less than or equal to about 13 percent by weight, less than or equal to about 12 percent by weight, less than or equal to about 11 percent by weight, less than or equal to about 10 percent by weight, less than or equal to about 9 percent by weight, less than or equal to about 8 percent by weight, less than or equal to about 7 percent by weight, less than or equal to about 6 percent by weight, less than or equal to about 5 percent by weight, less than or equal to about 4 percent by weight, less than or equal to about 3 percent by weight, less than or equal to about 2 percent by weight, or less than or equal to about 1 percent by weight).

[0322] In at least one example embodiment, triglycerides are present in the body or core of the chewing gum, and the coating, if present, is substantially triglyceride-free. In at least one example embodiment, the uncoated chewing gum or the body of the coated chewing gum contains triglycerides in an amount greater than or equal to about 2% by weight (e.g., greater than or equal to about 3%, greater than or equal to about 4%, greater than or equal to about 5%, greater than or equal to about 6%, greater than or equal to about 7%, greater than or equal to about 8%, greater than or equal to about 9%, greater than or equal to about 10%, greater than or equal to about 11%, greater than or equal to about 12%, greater than or equal to about 13%, greater than or equal to about 14%, greater than or equal to about 15%, or greater than or equal to about 17%). The main body may contain triglycerides in an amount less than or equal to about 20% by weight (e.g., less than or equal to about 17% by weight, less than or equal to about 15% by weight, less than or equal to about 14% by weight, less than or equal to about 13% by weight, less than or equal to about 12% by weight, less than or equal to about 11% by weight, less than or equal to about 10% by weight, less than or equal to about 9% by weight, less than or equal to about 8% by weight, less than or equal to about 7% by weight, less than or equal to about 6% by weight, less than or equal to about 5% by weight, less than or equal to about 4% by weight, or less than or equal to about 3% by weight).

[0323] In at least one example embodiment, the chewing gum contains triacetin in an amount greater than or equal to about 0.5% by weight (e.g., greater than or equal to about 0.75% by weight, greater than or equal to about 1% by weight, greater than or equal to about 1.25% by weight, greater than or equal to about 1.5% by weight, greater than or equal to about 1.75% by weight, greater than or equal to about 2% by weight, greater than or equal to about 2.25% by weight, greater than or equal to about 2.5% by weight, greater than or equal to about 3% by weight, greater than or equal to about 4% by weight, or greater than or equal to about 5% by weight). The chewing gum may contain triacetin in an amount less than or equal to about 7% by weight (e.g., less than or equal to about 5% by weight, less than or equal to about 4% by weight, less than or equal to about 3% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2.25% by weight, less than or equal to about 2% by weight, less than or equal to about 1.75% by weight, less than or equal to about 1.5% by weight, less than or equal to about 1.25% by weight, less than or equal to about 1% by weight, or less than or equal to about 0.75% by weight). In at least one example embodiment, the chewing gum contains triacetin in an amount from about 0.75% by weight to about 3% by weight (e.g., 1% by weight to about 4% by weight, about 1% by weight to about 3% by weight, about 1.25% by weight to about 2.5% by weight, about 2% by weight to about 4% by weight, or about 2% by weight to about 3% by weight).

[0324] In at least one example embodiment, triacetin is present in the body of the chewing gum, and the coating, if present, is substantially free of triacetin. In at least one example embodiment, the body contains triacetin in an amount greater than or equal to about 1% by weight (e.g., greater than or equal to about 1.25% by weight, greater than or equal to about 1.5% by weight, greater than or equal to about 1.75% by weight, greater than or equal to about 2% by weight, greater than or equal to about 2.25% by weight, greater than or equal to about 2.5% by weight, greater than or equal to about 2.75% by weight, greater than or equal to about 3% by weight, greater than or equal to about 3.25% by weight, greater than or equal to about 3.5% by weight, greater than or equal to about 3.75% by weight, greater than or equal to about 4% by weight, greater than or equal to about 5% by weight, or greater than or equal to about 7% by weight). The main body may contain triacetin in an amount less than or equal to about 10% by weight (e.g., less than or equal to about 7% by weight, less than or equal to about 5% by weight, less than or equal to about 4% by weight, less than or equal to about 3.75% by weight, less than or equal to about 3.5% by weight, less than or equal to about 3.25% by weight, less than or equal to about 3% by weight, less than or equal to about 2.75% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2.25% by weight, less than or equal to about 2% by weight, less than or equal to about 1.75% by weight, less than or equal to about 1.5% by weight, or less than or equal to about 1.25% by weight).

[0325] As described above, in at least one example embodiment, the oil further comprises a flavoring oil. The flavoring oil may be a flavoring agent or may contain a flavoring agent. In at least one example embodiment, the flavoring agent (e.g., spearmint oil and / or peppermint oil) or another component of the flavoring oil (e.g., propylene glycol, MCT, and / or triacetin in a compound flavoring compound) may act as a plasticizer.

[0326] In at least one example embodiment, the chewing gum contains a flavoring oil in an amount greater than or equal to about 0.001 weight percent (e.g., greater than or equal to about 0.01 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.25 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.75 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 5 weight percent). The chewing gum may contain a flavoring oil in an amount less than or equal to about 10 weight percent (e.g., less than or equal to about 7 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2 weight percent, less than or equal to about 1 weight percent, less than or equal to about 0.75 weight percent, less than or equal to about 0.5 weight percent, less than or equal to about 0.25 weight percent, less than or equal to about 0.1 weight percent, or less than or equal to about 0.01 weight percent). In at least one example embodiment, the chewing gum comprises a flavoring oil in an amount from about 0.001 weight percent to about 6 weight percent (e.g., about 0.75 weight percent to about 3 weight percent, about 0.75 to about 2 weight percent, about 1 weight percent to about 6 weight percent, about 1 weight percent to about 4 weight percent, about 1 weight percent to about 3 weight percent, about 2 weight percent to about 5 weight percent, about 2 weight percent to about 4 weight percent, about 3 weight percent to about 6 weight percent, or about 3 weight percent to about 4 weight percent). In at least one example embodiment, the oil does not contain flavoring oil. In at least one example embodiment, the chewing gum does not contain flavoring agents.

[0327] In at least one example embodiment, the flavoring oil is present in the body of the chewing gum, and the coating, if present, is substantially free of flavoring oil. The amount of flavoring oil present in the body may be greater than or equal to about 0.1% by weight (e.g., greater than or equal to about 0.25% by weight, greater than or equal to about 0.5% by weight, greater than or equal to about 0.75% by weight, greater than or equal to about 1% by weight, greater than or equal to about 2% by weight, greater than or equal to about 3% by weight, greater than or equal to about 4% by weight, or greater than or equal to about 5% by weight). The amount of flavoring oil contained in the body may be less than or equal to about 10% by weight (e.g., less than or equal to about 7% by weight, less than or equal to about 5% by weight, less than or equal to about 4% by weight, less than or equal to about 3% by weight, less than or equal to about 2% by weight, less than or equal to about 1% by weight, less than or equal to about 0.75% by weight, less than or equal to about 0.5% by weight, or less than or equal to about 0.25% by weight). In at least some other embodiments, the flavoring oil is present in both the body and the coating, or only in the coating such that the body is substantially free of flavoring oil.

[0328] In at least one example embodiment, in addition to the flavoring agent being present as a flavoring oil, or as an alternative to the flavoring agent being present as a flavoring oil, the chewing gum may also contain a non-oil-based flavoring agent (e.g., a powdered flavoring agent). In at least one example embodiment, the chewing gum contains encapsulated flavoring oil and / or encapsulated non-oil-based flavoring agent. The non-oil-based flavoring agent, the encapsulated flavoring agent, and the flavoring oil are not considered part of an oil containing nicotine and triglycerides.

[0329] In at least one example embodiment, the chewing gum contains a non-oil-based flavoring agent in an amount greater than or equal to about 0.001 weight percent (e.g., greater than or equal to about 0.01 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.25 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.75 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 5 weight percent). Chewing gum may contain non-oil-based flavorings in an amount less than or equal to about 10 percent by weight (e.g., less than or equal to about 7 percent by weight, less than or equal to about 5 percent by weight, less than or equal to about 4 percent by weight, less than or equal to about 3 percent by weight, less than or equal to about 2 percent by weight, less than or equal to about 1 percent by weight, less than or equal to about 0.75 percent by weight, less than or equal to about 0.5 percent by weight, less than or equal to about 0.25 percent by weight, less than or equal to about 0.1 percent by weight, or less than or equal to about 0.01 percent by weight).

[0330] In at least one example embodiment, a non-oil-based flavoring agent is present in the body of the chewing gum, and the coating, if present, is substantially free of non-oil-based flavoring agents. The amount of non-oil-based flavoring agent present in the body may be greater than or equal to about 0.1% by weight (e.g., greater than or equal to about 0.25% by weight, greater than or equal to about 0.5% by weight, greater than or equal to about 0.75% by weight, greater than or equal to about 1% by weight, greater than or equal to about 2% by weight, greater than or equal to about 3% by weight, greater than or equal to about 4% by weight, or greater than or equal to about 5% by weight). The amount of non-oil-based flavoring agent contained in the body may be less than or equal to about 10% by weight (e.g., less than or equal to about 7% by weight, less than or equal to about 5% by weight, less than or equal to about 4% by weight, less than or equal to about 3% by weight, less than or equal to about 2% by weight, less than or equal to about 1% by weight, less than or equal to about 0.75% by weight, less than or equal to about 0.5% by weight, or less than or equal to about 0.25% by weight). In at least some other embodiments, the non-oil-based flavoring agent is present in both the body and the coating, or only in the coating such that the body is substantially free of the non-oil-based flavoring agent.

[0331] Flavoring oils and non-oil-based flavoring agents may be natural or artificial. In at least one example embodiment, flavoring oils and / or non-oil-based flavoring agents include fruit flavoring agents (e.g., bergamot, berry, cherry, lemon, and / or orange), alcoholic or liqueur flavoring agents (e.g., bourbon, cognac, Scotch whisky, whiskey, and / or DRAMBUIE brand liqueurs), mint flavoring agents (e.g., Japanese mint, menthol, peppermint, spearmint, wintergreen, and / or peppermint oil from species of the genus *Mentha*), floral flavoring agents (e.g., geranium, lavender, and / or rose), spices, herbs, or other plant or plant-derived flavoring agents (e.g., anise, celery, coriander, cardamom, bitter bark, cinnamon, cassia, chamomile, clove, cocoa, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pepper, sage, sandalwood, vanilla, and / or ylang-ylang), honey flavoring, or any combination thereof.

[0332] As described above, in at least one example embodiment, the chewing gum contains nicotine or a nicotine derivative, such as a nicotine complex (e.g., nicotine polacrilex) or a salt of nicotine (e.g., nitrate, monotartrate, bitartrate, bitartrate dihydrate, salicylate, sulfate or bisulfate, phosphate or acid phosphate, acetate, lactate, succinate, maleate, fumarate, gluconate, glycoside, 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 example embodiment, the chewing gum contains liquid nicotine.

[0333] In at least one example embodiment, tobacco-derived nicotine may comprise nicotine and one or more additional sensory elements. In at least one example embodiment, tobacco-derived nicotine may be extracted from raw tobacco (e.g., green tobacco) and / or processed tobacco. Processed tobacco may include fermented and unfermented tobacco, dark-dried tobacco, dark-fired tobacco, burley tobacco, flue-cured tobacco, and cigar filler or wrapper, as well as products processed by whole-leaf destemming. Tobacco may also be treated by, for example, heating, sweating, and / or pasteurization steps. Fermentation is typically characterized by high initial moisture content, heat generation, and a dry weight loss of approximately 10 to 20 percent by weight. By processing the tobacco prior to the extraction of nicotine and other sensory elements, tobacco-derived nicotine may contain components that provide a pleasant experience. In at least one example embodiment, tobacco-derived nicotine may 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 may be further concentrated or purified. In at least one example implementation, selected tobacco materials can be removed from the tobacco extract.

[0334] In at least one example embodiment, the chewing gum contains nicotine or a nicotine derivative in an amount greater than or equal to about 0.1 mg (e.g., greater than or equal to about 1 mg, greater than or equal to about 2 mg, greater than or equal to about 4 mg, or greater than or equal to about 6 mg, greater than or equal to about 8 mg, greater than or equal to about 10 mg, or greater than or equal to about 12 mg). The chewing gum may contain nicotine or a nicotine derivative in an amount less than or equal to about 14 mg (e.g., less than or equal to about 12 mg, less than or equal to about 10 mg, less than or equal to about 8 mg, less than or equal to about 6 mg, less than or equal to about 4 mg, less than or equal to about 2 mg, or less than or equal to about 1 mg). In at least one example embodiment, the chewing gum contains nicotine or a nicotine derivative in an amount from about 3 mg to about 8 mg.

[0335] In at least one example embodiment, the chewing gum contains nicotine or a nicotine derivative in an amount greater than or equal to about 0.01 weight percent (e.g., greater than or equal to about 0.02 weight percent, greater than or equal to about 0.03 weight percent, greater than or equal to about 0.04 weight percent, greater than or equal to about 0.05 weight percent, greater than or equal to about 0.06 weight percent, greater than or equal to about 0.08 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.8 weight percent, or greater than or equal to about 0.9 weight percent). Chewing gum may contain nicotine or nicotine derivatives in an amount less than or equal to about 1% by weight (e.g., less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.2% by weight, less than or equal to about 0.1% by weight, less than or equal to about 0.08% by weight, less than or equal to about 0.06% by weight, less than or equal to about 0.05% by weight, less than or equal to about 0.04% by weight, less than or equal to about 0.03% by weight, or less than or equal to about 0.02% by weight).

[0336] In at least one example embodiment, nicotine or a nicotine derivative is present in the body or core of the chewing gum, and the coating, if present, is substantially free of nicotine or a nicotine derivative. The body of the chewing gum contains nicotine or a nicotine derivative in an amount greater than or equal to about 0.03 weight percent (e.g., greater than or equal to about 0.04 weight percent, greater than or equal to about 0.05 weight percent, greater than or equal to about 0.06 weight percent, greater than or equal to about 0.08 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.8 weight percent, greater than or equal to about 0.9 weight percent, or greater than or equal to about 1 weight percent). The body of the chewing gum may contain nicotine or nicotine derivatives in an amount less than or equal to about 1.5% by weight (e.g., less than or equal to about 1% by weight, less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.2% by weight, less than or equal to about 0.1% by weight, less than or equal to about 0.08% by weight, less than or equal to about 0.06% by weight, less than or equal to about 0.05% by weight, or less than or equal to about 0.04% by weight). In other example embodiments, nicotine or nicotine derivatives are present in both the body and coating of the chewing gum.

[0337] In at least one exemplary embodiment, the chewing gum comprises a solid carrier material, such as an oral insoluble cellulose material. The oral insoluble cellulose material described below can be used as a carrier for oil and / or nicotine. The oral insoluble cellulose material may include or be derived from beets, wood pulp, cotton, bran, citrus pulp, grasses (e.g., switchgrass), willow, poplar, or any combination thereof. The insoluble cellulose material may be a treated cellulose material, such as microcrystalline cellulose (MCC), carboxymethyl cellulose (CMC), hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), or any combination thereof. In at least one exemplary embodiment, the oral insoluble cellulose material comprises oral insoluble cellulose fibers. Chewing gum may contain oral insoluble cellulose material in an amount greater than or equal to about 0.5% by weight (e.g., greater than or equal to about 1% by weight, greater than or equal to about 2% by weight, greater than or equal to about 3% by weight, greater than or equal to about 4% by weight, greater than or equal to about 5% by weight, greater than or equal to about 6% by weight, greater than or equal to about 7% by weight, greater than or equal to about 8% by weight, greater than or equal to about 9% by weight, greater than or equal to about 10% by weight, greater than or equal to about 11% by weight, or greater than or equal to about 12% by weight). Chewing gum may contain oral insoluble cellulose material in an amount of less than or equal to about 15 percent by weight (e.g., less than or equal to about 12 percent by weight, less than or equal to about 11 percent by weight, less than or equal to about 10 percent by weight, less than or equal to about 9 percent by weight, less than or equal to about 8 percent by weight, less than or equal to about 7 percent by weight, less than or equal to about 6 percent by weight, less than or equal to about 5 percent by weight, less than or equal to about 4 percent by weight, less than or equal to about 3 percent by weight, less than or equal to about 2 percent by weight, or less than or equal to about 1 percent by weight).

[0338] In at least one example embodiment, the oral insoluble cellulose material is present in the body, and the coating, if present, is substantially free of the oral insoluble cellulose material. The body of the uncoated or coated chewing gum may contain oral insoluble cellulose material in an amount greater than or equal to about 1% by weight (e.g., greater than or equal to about 2%, greater than or equal to about 3%, greater than or equal to about 4%, greater than or equal to about 5%, greater than or equal to about 6%, greater than or equal to about 7%, greater than or equal to about 8%, greater than or equal to about 9%, greater than or equal to about 10%, greater than or equal to about 11%, greater than or equal to about 12%, greater than or equal to about 15%, or greater than or equal to about 17%). The main body may contain oral insoluble cellulose material in an amount of less than or equal to about 20% by weight (e.g., less than or equal to about 17% by weight, less than or equal to about 15% by weight, less than or equal to about 12% by weight, less than or equal to about 11% by weight, less than or equal to about 10% by weight, less than or equal to about 9% by weight, less than or equal to about 8% by weight, less than or equal to about 7% by weight, less than or equal to about 6% by weight, less than or equal to about 5% by weight, less than or equal to about 4% by weight, less than or equal to about 3% by weight, or less than or equal to about 2% by weight).

[0339] In at least one example embodiment, the chewing gum contains an antioxidant. In at least one example embodiment, the antioxidant includes ascorbyl palmitate, butylated hydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherol, propyl gallate, tert-butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA), vitamin E, vitamin C, vitamin B, magnesium, or any combination or derivative thereof. In at least one example embodiment, the chewing gum contains a first antioxidant and a second antioxidant. The first and second antioxidants may be present in different amounts. In at least one example embodiment, the first antioxidant includes vitamin E, and the second antioxidant includes ascorbyl palmitate.

[0340] In at least one example embodiment, the chewing gum contains an antioxidant in an amount greater than or equal to about 0.0001 weight percent (e.g., greater than or equal to about 0.0005 weight percent, greater than or equal to about 0.001 weight percent, greater than or equal to about 0.005 weight percent, greater than or equal to about 0.01 weight percent, greater than or equal to about 0.025 weight percent, greater than or equal to about 0.05 weight percent, greater than or equal to about 0.075 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.25 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.75 weight percent, greater than or equal to about 0.8 weight percent, or greater than or equal to about 0.9 weight percent). The chewing gum contains antioxidants in an amount less than or equal to about 1% by weight (e.g., less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.75% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.25% by weight, less than or equal to about 0.2% by weight, less than or equal to about 0.1% by weight, less than or equal to about 0.075% by weight, less than or equal to about 0.05% by weight, less than or equal to about 0.025% by weight, less than or equal to about 0.01% by weight, less than or equal to about 0.005% by weight, less than or equal to about 0.001% by weight, or less than or equal to about 0.0005% by weight). In at least one example embodiment, the antioxidants are present in the body or core of the chewing gum, and the coating, if present, does not contain antioxidants. In other example embodiments, the antioxidant is present in both the body and the coating of the chewing gum, or only in the coating of the chewing gum, such that the body does not contain the antioxidant.

[0341] In at least one example embodiment, the chewing gum contains a sweetener. The sweetener may include synthetic sweeteners and / or natural sweeteners. Natural sweeteners may include sugars such as monosaccharides, disaccharides, and / or polysaccharides. In at least one example embodiment, the sweetener includes natural sweeteners, including sucrose (i.e., castor 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., maltose, maltobiose), sorghum syrup, fruit juice concentrate, or any combination thereof. In at least one example embodiment, the sweetener includes sugar alcohols. Sugar alcohols may include ethylene glycol, glycerol, erythritol, threitol, arabinitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, idutol, inositol, heptaheptaol, isomaltitol, maltitol, lactitol, maltotriol, maltotetratitol, polyglycerol, or any combination thereof. In at least one example embodiment, the sweetener includes non-nutritive sweeteners, including stevia, saccharin, aspartame, sucralose, acesulfame potassium (“Ace K”), or any combination thereof.

[0342] In at least one example embodiment, the chewing gum contains a sweetener in an amount greater than or equal to about 20 percent by weight (e.g., greater than or equal to about 25 percent by weight, greater than or equal to about 30 percent by weight, greater than or equal to about 35 percent by weight, greater than or equal to about 40 percent by weight, greater than or equal to about 45 percent by weight, greater than or equal to about 50 percent by weight, greater than or equal to about 55 percent by weight, greater than or equal to about 60 percent by weight, greater than or equal to about 65 percent by weight, greater than or equal to about 70 percent by weight, or greater than or equal to about 75 percent by weight). Chewing gum may contain sweeteners in an amount less than or equal to about 80 percent by weight (e.g., less than or equal to about 75 percent by weight, less than or equal to about 70 percent by weight, less than or equal to about 65 percent by weight, less than or equal to about 60 percent by weight, less than or equal to about 55 percent by weight, less than or equal to about 50 percent by weight, less than or equal to about 45 percent by weight, less than or equal to about 40 percent by weight, less than or equal to about 35 percent by weight, less than or equal to about 30 percent by weight, or less than or equal to about 25 percent by weight).

[0343] In at least one example embodiment, the coated chewing gum contains a sweetener in both the body and the coating. The body may contain a sweetener in an amount greater than or equal to about 15% by weight (e.g., greater than or equal to about 20% by weight, greater than or equal to about 25% by weight, greater than or equal to about 30% by weight, greater than or equal to about 35% by weight, greater than or equal to about 40% by weight, greater than or equal to about 45% by weight, greater than or equal to about 50% by weight, greater than or equal to about 55% by weight, greater than or equal to about 60% by weight, or greater than or equal to 65% by weight). The body may contain a sweetener in an amount less than or equal to about 70% by weight (e.g., less than or equal to about 65% by weight, less than or equal to about 60% by weight, less than or equal to about 55% by weight, less than or equal to about 50% by weight, to about less than or equal to 45% by weight, less than or equal to 40% by weight, less than or equal to 35% by weight, less than or equal to 30% by weight, less than or equal to 25% by weight, or less than or equal to 20% by weight). The coating may contain sweeteners in an amount greater than or equal to about 65% by weight (e.g., greater than or equal to about 70% by weight, greater than or equal to about 75% by weight, greater than or equal to about 80% by weight, greater than or equal to about 85% by weight, greater than or equal to about 90% by weight, greater than or equal to about 93% by weight, greater than or equal to about 95% by weight, greater than or equal to about 97% by weight, greater than or equal to about 98% by weight, or greater than or equal to about 99% by weight). The coating may contain sweeteners in an amount less than or equal to 100% by weight (e.g., less than or equal to about 99% by weight, less than or equal to about 98% by weight, less than or equal to about 97% by weight, less than or equal to about 95% by weight, less than or equal to about 93% by weight, less than or equal to about 90% by weight, less than or equal to about 85% by weight, less than or equal to about 80% by weight, less than or equal to about 75% by weight, or less than or equal to about 70% by weight).

[0344] In at least one example embodiment, the body comprises a first sweetener, and the coating comprises a second sweetener. The first sweetener and the second sweetener may be different. In other example embodiments, the first sweetener and the second sweetener may be the same.

[0345] In at least one example embodiment, the sweetener comprises a sugar alcohol. The sugar alcohol can be a variety of sugar alcohols, such as four sugar alcohols. In at least one example embodiment, the body of the chewing gum comprises a first sugar alcohol, and the coating of the chewing gum comprises a second sugar alcohol. For example, the body may comprise maltitol and sorbitol, and the coating may comprise xylitol and mannitol. In at least one example embodiment, the body further comprises another sweetener, such as a non-nutritive sweetener.

[0346] In at least one example embodiment, the chewing gum contains a coloring agent. The chewing gum may contain a coloring agent in an amount greater than or equal to about 0.01 weight percent (e.g., greater than or equal to about 0.02 weight percent, greater than or equal to about 0.025 weight percent, greater than or equal to about 0.05 weight percent, greater than or equal to about 0.075 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.125 weight percent, greater than or equal to about 0.15 weight percent, or greater than or equal to about 0.175 weight percent). The chewing gum may contain a colorant in an amount less than or equal to about 0.25% by weight (e.g., less than or equal to about 0.2% by weight, less than or equal to about 0.175% by weight, less than or equal to about 0.15% by weight, less than or equal to about 0.125% by weight, less than or equal to about 0.1% by weight, less than or equal to about 0.075% by weight, less than or equal to about 0.05% by weight, less than or equal to about 0.025% by weight, or less than or equal to about 0.02% by weight). In at least one example embodiment, the colorant comprises a white or off-white colorant. In at least one example embodiment, the colorant comprises titanium dioxide.

[0347] In at least one example embodiment, the colorant is present in the coating, and the body is substantially free of the colorant. (e.g., the coating of chewing gum) Figure 20D The primary coating shown may contain a colorant in an amount greater than or equal to about 0.05% by weight (e.g., greater than or equal to about 0.1% by weight, greater than or equal to about 0.2% by weight, greater than or equal to about 0.3% by weight, greater than or equal to about 0.4% by weight, greater than or equal to about 0.5% by weight, greater than or equal to about 0.6% by weight, greater than or equal to about 0.7% by weight, greater than or equal to about 0.8% by weight, or greater than or equal to about 0.9% by weight). The coating may contain a colorant in an amount less than or equal to about 1% by weight (e.g., less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, or less than or equal to about 0.2% by weight). In at least some other embodiments, the colorant is present in both the substrate and the coating, or only in the substrate such that the coating is substantially free of colorant.

[0348] In at least one example embodiment, the chewing gum contains a coolant. The chewing gum may contain a coolant in an amount greater than or equal to about 0.01 weight percent (e.g., greater than or equal to about 0.02 weight percent, greater than or equal to about 0.05 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.8 weight percent, or greater than or equal to about 0.9 weight percent). The chewing gum may contain a coolant in an amount less than or equal to about 1% by weight (e.g., less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.2% by weight, less than or equal to about 0.1% by weight, less than or equal to about 0.05% by weight, or less than or equal to about 0.025% by weight). In at least one example embodiment, the coolant comprises methanol.

[0349] In at least one example embodiment, the coated chewing gum contains a coolant in the body such that the coating is substantially coolant-free. The body may contain a coolant in an amount greater than or equal to about 0.01 weight percent (e.g., greater than or equal to about 0.025 weight percent, greater than or equal to about 0.05 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.2 weight percent, greater than or equal to about 0.3 weight percent, greater than or equal to about 0.4 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 0.6 weight percent, greater than or equal to about 0.7 weight percent, greater than or equal to about 0.8 weight percent, or greater than or equal to about 0.9 weight percent). The main body contains a coolant in an amount less than or equal to about 1% by weight (e.g., less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.2% by weight, less than or equal to about 0.1% by weight, less than or equal to about 0.05% by weight, or less than or equal to about 0.025% by weight).

[0350] In at least one example embodiment, the chewing gum contains an emulsifier. The chewing gum may contain an emulsifier in an amount greater than or equal to about 0.05% by weight (e.g., greater than or equal to about 0.1% by weight, greater than or equal to about 0.2% by weight, greater than or equal to about 0.3% by weight, greater than or equal to about 0.4% by weight, greater than or equal to about 0.5% by weight, greater than or equal to about 0.6% by weight, greater than or equal to about 0.7% by weight, greater than or equal to about 0.8% by weight, or greater than or equal to about 0.9% by weight). The chewing gum may contain an emulsifier in an amount less than or equal to about 1% by weight (e.g., less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, less than or equal to about 0.2% by weight, or less than or equal to about 0.1% by weight). In at least one example embodiment, the emulsifier comprises polysorbate.

[0351] Emulsifiers may be present in the body of the chewing gum such that the coating, if present, is substantially emulsifier-free. The body of the chewing gum may contain emulsifiers in an amount greater than or equal to about 0.1% by weight (e.g., greater than or equal to about 0.2% by weight, greater than or equal to about 0.3% by weight, greater than or equal to about 0.4% by weight, greater than or equal to about 0.5% by weight, greater than or equal to about 0.6% by weight, greater than or equal to about 0.7% by weight, greater than or equal to about 0.8% by weight, greater than or equal to about 0.9% by weight, greater than or equal to about 1% by weight, or greater than or equal to about 1.5% by weight). The main body contains an emulsifier in an amount less than or equal to about 2% by weight (e.g., less than or equal to about 1.5% by weight, less than or equal to about 1% by weight, less than or equal to about 0.9% by weight, less than or equal to about 0.8% by weight, less than or equal to about 0.7% by weight, less than or equal to about 0.6% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.4% by weight, less than or equal to about 0.3% by weight, or less than or equal to about 0.2% by weight).

[0352] In at least one example embodiment, the chewing gum contains wax. The amount of wax present may be greater than or equal to about 0.01 weight percent (e.g., greater than or equal to about 0.02 weight percent, greater than or equal to about 0.03 weight percent, greater than or equal to about 0.04 weight percent, greater than or equal to about 0.05 weight percent, greater than or equal to about 0.06 weight percent, greater than or equal to about 0.07 weight percent, greater than or equal to about 0.08 weight percent, greater than or equal to about 0.09 weight percent, greater than or equal to about 0.1 weight percent, or greater than or equal to about 0.15 weight percent). Chewing gum may contain wax in an amount less than or equal to about 0.2% by weight (e.g., less than or equal to about 0.15% by weight, less than or equal to about 0.1% by weight, less than or equal to about 0.09% by weight, less than or equal to about 0.08% by weight, less than or equal to about 0.07% by weight, less than or equal to about 0.06% by weight, less than or equal to about 0.05% by weight, less than or equal to about 0.04% by weight, less than or equal to about 0.03% by weight, or less than or equal to about 0.02% by weight). In at least one example embodiment, the wax comprises carnauba wax. In at least one example embodiment, the wax is in the coating of the chewing gum and the body is substantially wax-free. In at least one example embodiment, the outer coating (e.g., Figure 20D (As shown) It is basically composed of wax.

[0353] In at least one example embodiment, the chewing gum further comprises additives. Additives may include orally stabilized polymers, orally soluble polymers, stimulants, soothing agents, synergists, orally soluble or partially soluble fibers (e.g., beet fiber), alkaloids, minerals, vitamins, dietary supplements, nutritional foods, amino acids, chemical somatosensory agents, plant extracts (e.g., green tea), teeth 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, butylated hydroxytoluene (BHT) or butylated hydroxyanisole (BHA)), lubricants (e.g., sodium lauryl sulfate (SLS)), preservatives (e.g., sodium benzoate), fillers, flavoring agents, effervescent agents (e.g., carbon dioxide embedded in flavoring agents or filler materials), other additives, or any combination thereof. The chewing gum may contain a variety of additional elements. Furthermore, a single element may belong to more than one category. An additive may contain multiple additives. Additionally, a single additive may belong to more than one category. Each of these additives may be present in the body of the chewing gum such that the coating of the chewing gum is free of that particular additive. In other embodiments, the additive may be present in both the body and the coating of the chewing gum, or only in the coating such that the body is free of that particular additive.

[0354] In at least one example embodiment, the amount of additive included may be greater than or equal to about 0.001 weight percent (e.g., greater than or equal to about 0.005 weight percent, greater than or equal to about 0.01 weight percent, greater than or equal to about 0.05 weight percent, greater than or equal to about 0.1 weight percent, greater than or equal to about 0.5 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 5 weight percent, greater than or equal to about 10 weight percent, greater than or equal to about 15 weight percent, greater than or equal to about 20 weight percent, greater than or equal to about 25 weight percent, greater than or equal to about 30 weight percent, greater than or equal to about 35 weight percent, or greater than or equal to about 40 weight percent). The additive may be present in an amount less than or equal to about 65% by weight (e.g., less than or equal to about 60% by weight, less than or equal to about 55% by weight, less than or equal to about 50% by weight, less than or equal to about 45% by weight, less than or equal to about 40% by weight, less than or equal to about 35% by weight, less than or equal to about 30% by weight, less than or equal to about 25% by weight, less than or equal to about 20% by weight, less than or equal to about 15% by weight, less than or equal to about 10% by weight, less than or equal to about 5% by weight, less than or equal to about 1% by weight, less than or equal to about 0.5% by weight, less than or equal to about 0.1% by weight, or less than or equal to about 0.01% by weight).

[0355] In at least one example embodiment, the additive comprises orally soluble fiber. The orally 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 example embodiment, the orally soluble fiber comprises maltodextrin, psyllium husk, starch, or any combination thereof. In at least one example embodiment, the orally soluble fiber comprises soluble dietary fiber. In at least one example embodiment, the additive comprises partially soluble fiber, such as beet fiber.

[0356] In at least one example embodiment, the additive may contain a stimulant. In at least one example embodiment, the stimulant includes caffeine, taurine, glucuronide, guarana, vitamin B6, vitamin B12, or any combination thereof.

[0357] Caffeine, also known as 1,3,7-trimethylxanthine, is a white, odorless, and bitter-tasting substance. Caffeine is naturally found in tea, coffee, and chocolate, and is commonly added to soft drinks, energy drinks, and some foods. However, due to its bitterness, beverages or foods with high caffeine content may not taste appealing. Caffeine can include synthetic caffeine and / or natural caffeine, such as caffeine extracted from coffee beans. In at least one example embodiment, the oral product contains a caffeine amount greater than or equal to about 10 mg (e.g., greater than or equal to about 25 mg, greater than or equal to about 150 mg). The amount of caffeine contained may be less than or equal to about 200 mg (e.g., less than or equal to about 150 mg, less than or equal to about 100 mg, less than or equal to about 75 mg, less than or equal to about 50 mg, or less than or equal to about 25 mg).

[0358] In at least one example embodiment, the additive may contain a soothing agent. In at least one example embodiment, the soothing agent includes theanine, melatonin, or both theanine and melatonin. Further or alternatively, by way of example only, the soothing agent may include chamomile, lavender, jasmine, soursop, or any combination thereof. The soothing agent may be added as a flavoring and / or fragrance embedded in the chewing gum (e.g., the body and / or coating) and / or packaging. In at least one example embodiment, the chewing gum contains a soothing agent in an amount greater than or equal to about 0.1% by weight (e.g., greater than or equal to about 0.5% by weight, greater than or equal to about 1% by weight, greater than or equal to about 1.5% by weight, greater than or equal to about 2% by weight, greater than or equal to about 2.5% by weight, greater than or equal to about 3% by weight, greater than or equal to about 3.5% by weight, greater than or equal to about 4% by weight, or greater than or equal to about 4.5% by weight). In at least one example embodiment, the chewing gum contains a soothing agent in an amount less than or equal to about 5% by weight (e.g., less than or equal to about 4.5% by weight, less than or equal to about 4% by weight, less than or equal to about 3.5% by weight, less than or equal to about 3% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2% by weight, less than or equal to about 1.5% by weight, less than or equal to about 1% by weight, or less than or equal to about 0.5% by weight).

[0359] In at least one example embodiment, the additive may contain a synergist. In at least one example embodiment, the synergist includes ginkgo leaf extract.

[0360] In at least one example embodiment, the chewing gum includes a filler. A filler can generally be described as an element that does not undergo physical change before or after mixing. Certain additives described herein, such as insoluble fibers, can be classified as fillers. Fillers may further or alternatively include dicalcium phosphate, calcium sulfate, clay, silica, glass particles, glyceryl palmitate, sodium stearoyl fumarate, talc, or any combination thereof.

[0361] The chewing gum may contain filler in an amount less than or equal to 20% by weight (e.g., less than or equal to 15% by weight, less than or equal to 10% by weight, less than or equal to 9% by weight, less than or equal to 8% by weight, less than or equal to 7% by weight, less than or equal to 6% by weight, less than or equal to 5% by weight, less than or equal to 4% by weight, less than or equal to 3% by weight, less than or equal to 2% by weight, or less than or equal to 1% by weight). The chewing gum may contain filler in an amount greater than or equal to about 0% by weight (e.g., greater than or equal to about 1% by weight, greater than or equal to about 2% by weight, greater than or equal to about 3% by weight, greater than or equal to about 4% by weight, or greater than or equal to about 5% by weight). In at least one example embodiment, filler may be included in an amount from about 0% by weight to about 8% by weight. In at least one example embodiment, the chewing gum is substantially free of filler.

[0362] In at least one example embodiment, the chewing gum does not contain an orally soluble polymer. In at least one example embodiment, the additive contains an orally soluble polymer. As used herein, "orally soluble" means that the polymer undergoes significant degradation during a period of approximately four hours of exposure to saliva in the oral cavity of an adult consumer. In at least one example embodiment, the orally soluble polymer disintegrates during a period of less than or equal to about one hour (e.g., less than or equal to about 30 minutes, less than or equal to about 15 minutes, less than or equal to about 10 minutes, or less than or equal to about 5 minutes) of exposure to saliva at normal human body temperature (i.e., 98.6°F).

[0363] Orally soluble polymers may include, for example, cellulose polymers, natural polymers, seaweed-derived polymers, microbial-derived polymers, extracts, exudates, synthetic polymers, or any combination thereof. Other useful orally soluble polymers are known in the art, see, for example, 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, and / or Nussinovitch Water-Soluble Polymer Applications in Foods Blackwell Science 2003, the entire contents of which are incorporated herein by reference.

[0364] In at least one example embodiment, the cellulose polymer may include, for example, carboxymethyl cellulose (CMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methyl cellulose (HPMC), methyl cellulose (MC), or any combination thereof. In at least one example embodiment, the natural polymer may include, for example, starch, modified starch, konjac, collagen, inulin, soy protein, whey protein, casein, wheat bran, or any combination thereof. In at least one example embodiment, the seaweed-derived polymer may include, for example, carrageenan, alginate, or a combination of carrageenan and alginate. In at least one example embodiment, the carrageenan may include, for example, κ carrageenan, ι carrageenan, λ carrageenan, or any combination thereof. In at least one example embodiment, the alginate may include, for example, propylene glycol alginate. In at least one example embodiment, the microbial-derived polymer may include, for example, xanthan gum, dextran, pullulan, gelatin, gellan gum, or any combination thereof. In at least one example embodiment, the extract may include, for example, tamarind gum, cardamom gum, tara gum, tragacanth gum, pectin (e.g., low-methoxyl and amidated pectin), agar, corn gluten, sycamore gum, gelatin, plantain seed, chitin, chitosan, or any combination thereof. In at least one example embodiment, the exudate may include, for example, gum arabic, shellac, or any combination thereof. In at least one example embodiment, the synthesized polymer may include, for example, polyvinylpyrrolidone, polyethylene oxide, polyvinyl alcohol, or any combination thereof.

[0365] In at least one example embodiment, the chewing gum does not contain a mouth-stabilized polymer. In at least one example embodiment, the chewing gum additive contains a mouth-stabilized polymer. As used herein, "mouth-stabilized" means that the polymer does not significantly dissolve or disintegrate during a period of approximately one hour of exposure to saliva at normal human body temperature (i.e., 98.6°F). In at least one example embodiment, the mouth-stabilized polymer is a biodegradable polymer configured to decompose over a period of days, weeks, months, or years, but does not significantly decompose during a period of approximately one hour of exposure to saliva in the oral cavity. In at least one example embodiment, the mouth-stabilized polymer is stable when exposed to saliva at normal human body temperature in the oral cavity for more than or equal to about 2 hours (e.g., more than or equal to about 6 hours, more than or equal to about 12 hours, more than or equal to about 1 day, or more than or equal to about 2 days). Accordingly, the oral product containing a mouth-stabilized polymer according to at least one example embodiment is configured to remain intact when placed in the mouth of an adult consumer. After a period of time, the mouth-stabilized polymer and any other mouth-stabilizing elements can be removed from the adult consumer's mouth and discarded.

[0366] Mouth-stable polymers can be biocompatible and biostable. Mouth-stable polymers are generally recognized by relevant regulatory agencies (such as the U.S. Food and Drug Administration (FDA)) as safe and compliant with applicable food contact regulations. In at least one example embodiment, when tested at 23°C according to ASTM test method D790 or ISO 178, the flexural modulus of the mouth-stable polymer is greater than or equal to about 5 MPa (c is greater than or equal to about 10 MPa).

[0367] In at least one example embodiment, the octane-stabilized polymer may include, for example, polyurethane, silicone, polyester, polyacrylate, polyethylene, polypropylene, polyetheramide, polystyrene, polyvinyl alcohol, polyvinyl acetate, polyvinyl chloride, polybutyl acetate, butyl rubber, poly(styrene-ethylene-butene-styrene) (SEBS), poly(styrene-butadiene-styrene) (SBS), poly(styrene-isoprene-styrene) (SIS), any copolymers thereof, or any combination thereof. In at least one example embodiment, the octane-stabilized polymer includes food-grade or medical-grade polymers such as medical-grade polyurethane.

[0368] In at least one example embodiment, the mouth-stabilized polymer comprises, for example, a thermoplastic polymer. The thermoplastic polymer may include a thermoplastic elastomer. In at least one example embodiment, the mouth-stabilized polymer comprises a thermoplastic elastomer that meets the requirements of the FDA-modified ISO 10993 Part 1, "Biological evaluation of medical devices," when its human tissue contact time is 30 days or less. The mouth-stabilized polymer may have a Shore hardness of 50D or lower, a melt flow rate of 3 g / 10 min (at 200°C / 10 kg), a tensile strength greater than or equal to 10 MPa (using ISO 37), and / or a final elongation of less than 100% (using ISO 37).

[0369] In at least one example embodiment, the chewing gum additive contains a nutritional food. As used herein, the term "nutritional food" refers to any food ingredient that has beneficial effects on human health. Nutritional foods include specific compounds and / or compositions isolated from natural food sources and genetically modified food sources. Suitable nutritional foods include, but are not limited to, a variety of phytonutrients derived from natural plants and genetically modified plants. The amount of nutritional food included may be from about 0.1% to about 5% by weight of the composition. In at least one example embodiment, the chewing gum does not contain a nutritional food.

[0370] In at least one example embodiment, the chewing gum contains minerals other than those present in, for example, fruits and / or vegetables. Minerals may include, for example, calcium, magnesium, phosphorus, iron, zinc, iodine, selenium, potassium, copper, manganese, molybdenum, chromium, and any combination thereof. The amount of minerals incorporated into oral products intended for adult consumption may vary depending on the type of mineral and the intended adult consumer. The amount of minerals may be formulated to be less than or equal to the USDA's recommended daily allowance.

[0371] In at least one example embodiment, the chewing gum contains a sensory active agent or a chemopreservative. The sensory active agent or chemopreservative may include peppermint, menthol, cinnamon, pepper, jambu, or any combination thereof. The sensory active agent or chemopreservative may include any soothing, cooling, and / or warming agent. For example, in some example embodiments, the sensory active agent or chemopreservative may include capsaicin, pipeline, α-hydroxy-sanshool, and (8)-gingerole, which may be selected to provide a warming, tingling, or burning sensation. In other example embodiments, the sensory active agent or chemopreservative 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 amount of sensory active agent or chemical sensation agent contained in the chewing gum is from about 0.01% to about 5% by weight, based on the weight of the chewing gum. In at least one example embodiment, the chewing gum does not contain sensory active agents or chemical sensation agents.

[0372] In at least one example embodiment, the chewing gum additive contains amino acids. Suitable amino acids include, but are not limited to, the eight essential amino acids that the human body cannot biosynthesize, including valine, leucine, isoleucine, lysine, threonine, tryptophan, methionine, and phenylalanine. Examples of suitable amino acids include non-essential amino acids, including alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, proline, serine, and tyrosine. The amount of amino acids contained may be from about 0.1% to about 5% of the weight of the chewing gum. In at least one example embodiment, the chewing gum does not contain amino acids.

[0373] In at least one example embodiment, the chewing gum contains amino acids in an amount greater than or equal to about 0.1% by weight (e.g., greater than or equal to about 0.5% by weight, greater than or equal to about 1% by weight, greater than or equal to about 1.5% by weight, greater than or equal to about 2% by weight, greater than or equal to about 2.5% by weight, greater than or equal to about 3% by weight, greater than or equal to about 3.5% by weight, greater than or equal to about 4% by weight, or greater than or equal to about 4.5% by weight). In at least one example embodiment, the chewing gum contains amino acids in an amount less than or equal to about 5% by weight (e.g., less than or equal to about 4.5% by weight, less than or equal to about 4% by weight, less than or equal to about 3.5% by weight, less than or equal to about 3% by weight, less than or equal to about 2.5% by weight, less than or equal to about 2% by weight, less than or equal to about 1.5% by weight, less than or equal to about 1% by weight, or less than or equal to about 0.5% by weight).

[0374] In at least one example embodiment, the chewing gum contains wax. For example, the wax may include paraffin wax, microcrystalline wax, or both paraffin wax and microcrystalline wax. In at least one example embodiment, the chewing gum does not contain wax.

[0375] In at least one example embodiment, the chewing gum comprises a uniform unit structure. In at least one example embodiment, the chewing gum comprises two or more layers. The layers may be separable or non-separable. The layers may have different compositions. For example, the layers may have different flavors, amounts of nicotine or nicotine derivatives (including those without nicotine or nicotine derivatives), textures and / or softness, and / or be configured to have different nicotine release rates. In at least one example 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). In at least one example embodiment, the chewing gum is coated to have a body or core and a coating, as will be described in more detail below. The body may have a uniform unit structure.

[0376] In at least one example embodiment, at least a portion of the nicotine is dissolved in at least a portion of the oil (e.g., triglycerides) to form a liquid mixture. For example, substantially all of the nicotine is dissolved in the oil. In at least one example embodiment, at least a portion of the liquid mixture may be absorbed and / or adsorbed by an insoluble cellulose material (e.g., MCC).

[0377] The chewing gum according to at least one example embodiment can be made into a variety of different sizes and shapes (as described in more detail below and as shown in the example). Figure 18– As shown in –20D). In at least one example embodiment, the size and / or shape of the chewing gum product facilitates its ideal positioning within the mouth and / or packaging. In at least one example embodiment, the chewing gum may have a size of 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 example embodiment, the chewing gum has a first dimension (e.g., minimum size or thickness) of about 1 mm to about 15 mm (e.g., about 6 mm to about 14 mm, or about 8 mm to about 12 mm). The chewing gum may have a second dimension (e.g., width) of about 5 mm to about 20 mm (e.g., about 9 mm to about 13 mm, or about 11 mm to about 15 mm). In at least one example embodiment, the chewing gum has a maximum size (e.g., length) of about 5 mm to about 30 mm (e.g., about 10 mm to about 26 mm, about 15 mm to about 23 mm, or about 17 mm to about 21 mm).

[0378] In at least one example embodiment, the chewing gum has a total weight of about 1 g to about 10 g (e.g., about 1 g to about 3 g, about 1 g to about 5 g, about 2 g to about 4 g, or about 5 g to about 10 g). The body of the coated chewing gum may have a weight of about 0.7 g to about 8 g (e.g., about 0.7 g to about 3 g, about 1 g to about 2.5 g, about 1.5 g to about 2 g, or about 2 g to about 4 g). The coating of the coated chewing gum may have a weight of about 0.2 g to about 3 g (e.g., about 0.2 g to about 1 g, about 0.4 g to about 0.8 g, about 1 g to about 2 g, or about 2 g to about 3 g).

[0379] In at least one example embodiment, the chewing gum may define a thickness and a cross-sectional shape perpendicular to that thickness. As used herein, "thickness" refers to the minimum dimension of the chewing gum. In at least one example embodiment, the chewing gum may have a substantially uniform thickness. Although not illustrated in the figures, any chewing gum described herein may include rounded edges. In at least one example embodiment, the chewing gum is substantially disc-shaped (e.g., Figure 18 The chewing gum 5100 has a substantially circular cross-section perpendicular to its thickness. Figure 19A –19F depicts chewing gum with other cross-sectional shapes according to at least one example embodiment.

[0380] Figure 18 This is a perspective view of chewing gum according to at least one example embodiment.

[0381] In at least one example embodiment, this disclosure provides controlled-release nicotine gum 5100. Gum 5100 may have the composition described above. Gum 5100 may have a substantially cylindrical shape and a substantially circular cross-section. Gum 5100 may be coated or uncoated. In at least one example embodiment, the body or core of gum 5100 may be substantially homogeneous.

[0382] Figure 19A It is a perspective view of a chewing gum having an elliptical cross-section according to at least one example embodiment.

[0383] In at least one example embodiment, chewing gum 5200A is provided. Chewing gum 5200A may be identical to chewing gum 5100, except that the cross-section of chewing gum 5200A is substantially elliptical. In at least one example embodiment, the substantially elliptical cross-section is a substantially elliptical cross-section.

[0384] Figure 19B It is a perspective view of a chewing gum having a rectangular cross-section according to at least one example embodiment.

[0385] In at least one example embodiment, chewing gum 5200B is provided. Chewing gum 5200B may be identical to chewing gum 5100, except that the cross-section of chewing gum 5200B is substantially square. In at least one example embodiment, the substantially rectangular cross-section is a substantially square cross-section. In at least one example embodiment, the rectangular cross-section may have rounded corners.

[0386] Figure 19C It is a perspective view of a chewing gum with an elongated rectangular cross-section according to at least one example embodiment.

[0387] In at least one example embodiment, chewing gum 5200C is provided. Chewing gum 5200C may be the same as chewing gum 5100, except that chewing gum 5200C has an elongated rectangular cross-section. The elongated rectangular cross-section may have rounded corners.

[0388] Figure 19D It is a perspective view of a chewing gum having a lens or a football-shaped cross-section according to at least one example embodiment.

[0389] In at least one example embodiment, chewing gum 5200D is provided. Chewing gum 5200D may be the same as chewing gum 5100, except that chewing gum 5200D has a lens-shaped cross-section. In at least one example embodiment, the lens-shaped cross-section may have rounded corners.

[0390] Figure 19EIt is a perspective view of a chewing gum having a boomerang-shaped cross-section according to at least one example embodiment.

[0391] In at least one example embodiment, chewing gum 5200E is provided. Chewing gum 5200E may be the same as chewing gum 5100, except that chewing gum 5200E has a boomerang-shaped cross-section. The boomerang-shaped cross-section may have rounded corners.

[0392] Figure 19F It is a perspective view of a chewing gum having a shield-shaped cross-section according to at least one example embodiment.

[0393] In at least one example embodiment, chewing gum 5200F is provided. Chewing gum 5200F may be identical to chewing gum 5100, except that chewing gum 5200F has a shield-shaped cross-section. The cross-section may have reflective symmetry about a central plane. In at least one example embodiment, chewing gum 5200F includes three rounded corners. In at least one example embodiment, the chewing gum includes a triangular cross-section.

[0394] In at least one other example embodiment, the chewing gum is defined by an additional shape. For example, the chewing gum may have a semi-circular cross-sectional shape, a comma-shaped cross-sectional shape, a bowtie-shaped cross-sectional shape, or a bean-shaped / kidney-shaped cross-sectional shape.

[0395] In at least one example embodiment, the chewing gum may have a non-uniform thickness. In at least one example embodiment, the chewing gum does not have a single minimum size, such as when the chewing gum is spherical or cubic in shape. In at least one example embodiment, the chewing gum defines an additional three-dimensional shape. In at least one other example embodiment, the chewing gum may be hemispherical, semi-cylindrical, twisted, spiral, or cushion / pillow shaped (e.g., Figure 20A As shown), wedge-shaped (such as) Figure 20B (As shown), rod-shaped or pebble-shaped.

[0396] Figure 20A It is a perspective view of chewing gum in the shape of a pillow or cushion according to at least one example embodiment.

[0397] In at least one example embodiment, chewing gum 5300A is provided. Chewing gum 5300A may be identical to chewing gum 5100, except that chewing gum 5300A is pillow-shaped, cushion-shaped, drage-shaped, or round. It may include rounded corners to avoid sharp edges that cause discomfort when placed in the mouth. In at least one example embodiment, chewing gum 5300A may be an elongated rectangle.

[0398] Figure 20B It is a perspective view of a wedge-shaped chewing gum according to at least one example embodiment.

[0399] In at least one example embodiment, chewing gum 5300B is provided. Chewing gum 5300B may be the same as chewing gum 5100A, except that chewing gum 5300B has a wedge shape with a rounded edge.

[0400] Figure 20C This is a cross-sectional view of coated chewing gum according to at least one example embodiment.

[0401] In at least one example embodiment, chewing gum 5400 is provided. Chewing gum 5400 may have any shape, as described above, and Figure 18-20B The shape shown is that of a chewing gum 5400, comprising a body 5402 and a coating 5404 on the outer surface 5406 of the body 5402. The coating 5404 may cover the entire outer surface 5406 (as shown) or a portion of the outer surface 5406. The composition of the body 5402 may be consistent with... Figure 18 The main components of Zhongkou gum 5100 are the same.

[0402] In at least one example embodiment, coating 5404 may contain any of the additives described above. In at least one example embodiment, coating 5404 may contain an orally soluble polymer and one or more other additives. In at least one example embodiment, coating 5404 may be configured to provide nicotine or nicotine derivatives and / or additives (e.g., flavoring agents and / or sweeteners) at a time period different from that of body 5402. For example, coating 5404 may be configured to provide an initial burst of nicotine or additives. The flavoring agents and / or sweeteners may be the same as or different from those in body 5402.

[0403] Figure 20D This is a cross-sectional view of another chewing gum with a coating according to at least one example embodiment.

[0404] In at least one example embodiment, chewing gum 5450 includes a body or core 5425 and a multi-layer coating. In addition to the coating structure, chewing gum 5450 may be combined with… Figure 20C The same as the chewing gum 5400 in the text. A multilayer coating may comprise a primary or intermediate coating 5454, an inner coating or layer 5456, and an outer coating or layer 5458. The inner coating 5456 is located between the primary coating and the body 5452. The inner coating 5456 may include a coating adhesive. The outer coating 5458 may be located on at least a portion of the outer surface of the primary coating 5454. The outer coating 5458 may contain wax.

[0405] In at least one example embodiment, the coating exists in the form of seasoning strips that are uniformly or non-uniformly distributed on the body. In at least one example embodiment, the coating includes flavoring agents and / or sweeteners on the outer surface of the body, which may serve as a complement or alternative to flavoring agents (e.g., seasoning oils) and / or sweeteners within the body.

[0406] In at least one example embodiment, the chewing gum may include functional and / or decorative markings. In at least one example embodiment, the markings include trademarks, product names, images, flavor indicators, decorations, dates, product identifiers, manufacturer identifiers, batch numbers, or any combination thereof. In at least one example embodiment, the markings are embossed or debossed on the outer surface of the chewing gum. In at least one example embodiment, the markings are present on the outer surface of the chewing gum in the form of a soluble film.

[0407] Figure 21 It is a flowchart depicting a method for making chewing gum according to at least one example embodiment.

[0408] At least one example implementation relates to a method of making chewing gum, such as Figure 21 As shown, the method typically includes: preparing a liquid mixture (S5500); preparing a cellulose mixture (S5502); preparing a gum base (S5504); preparing a gum core (S5506); and optionally coating the gum core (S5508).

[0409] In step S5500, the method includes preparing a liquid mixture. Preparing the liquid mixture may include preparing a diluted active ingredient. In at least one example embodiment, S5500 is performed in two steps. The first step may include preparing a diluted active precursor by blending the active ingredient and a diluent. For example, at least a portion of the active ingredient may be soluble in the diluent, such that the diluent acts as a solvent. The second step may include preparing the liquid mixture by adding an additional diluent to the diluted active precursor. The second step may also include combining the additional diluent and the diluted active precursor with a first antioxidant (e.g., a liquid antioxidant) and / or a flavoring oil. In at least one example embodiment, S5500 includes preparing a diluted nicotine precursor by dissolving liquid nicotine in MCT, and then preparing the liquid mixture (also referred to as "diluted nicotine") by blending or combining the liquid mixture with a first antioxidant (e.g., a liquid antioxidant such as vitamin E). In at least one example embodiment, S550 may further include adding an additional diluent and / or active ingredient.

[0410] In step S5502, the method includes preparing a carrier blend. S5502 may include blending and / or stirring a liquid mixture with a solid carrier. The solid carrier may be an insoluble cellulose material. S5502 may further include blending the solid carrier and the liquid mixture with one or more additional elements (such as a second antioxidant). In at least one example embodiment, at least a portion of the liquid mixture is adsorbed and / or absorbed onto the solid carrier. In at least one example embodiment, S5502 includes mixing the liquid mixture (e.g., liquid nicotine, MCT, and a first antioxidant) with MCC and a second antioxidant (e.g., a solid antioxidant such as ascorbyl palmitate). In at least one example embodiment, S5502 may further include adding an additional diluent or oil.

[0411] In step S5504, the method includes preparing a gum base. Preparing the gum base may include blending a gum base polymer, a plasticizer, and a sweetener. S2204 may further include blending one or more additional additives (such as those described above) with the gum base polymer, plasticizer, and sweetener. Blending may be carried out in a heated mixer. Blending may be carried out at a temperature of about 80°C to about 100°C (e.g., about 85°C to about 95°C, or about 87°C to about 93°C) for a duration of about 15 minutes to about 25 minutes (e.g., about 17 minutes to about 23 minutes, or about 20 minutes). In at least one example embodiment, S5504 includes blending two polyvinyl alcohols (PVA) of different molecular weights, a plasticizer (e.g., triacetin), and a sweetener comprising sugar alcohols (e.g., maltitol and sorbitol). Step S5504 may be performed before, after, or simultaneously with steps S5502 and S5504.

[0412] In step S5506, the method includes preparing a gum core or body. Preparing the gum core may generally include mixing the carrier blend prepared in step S5502 with the gum base prepared in step S5504, and preparing individual components or units of the blend. Step S5506 may further include blending in additional elements such as a pH adjuster. In at least one example embodiment, step S5506 includes: combining the carrier blend and the gum base in an extruder; forming a strip by extruding the carrier blend and the gum base; forming one or more sheets from the strip; rolling the sheets to a desired thickness; scoring the rolled sheets to desired dimensions; cooling the scored sheets; and dividing or separating the cooled sheets to form a plurality of gum cores.

[0413] In step S5508, the method optionally includes coating the gum core. The coating may include pancoating. In at least one example embodiment, S5508 further includes polishing the coated gum core.

[0414] At least one example embodiment relates to a method for preparing controlled-release nicotine chewing gum. The method includes providing a gum base polymer, an oil, nicotine or a nicotine derivative, and a buffer system. In at least one example embodiment, the gum base polymer comprises PVA, and the oil comprises triglycerides. In at least one example embodiment, the triglycerides comprise medium-chain triglycerides. In at least one example embodiment, the method further includes providing flavoring oils, polysaccharides, additives, and / or fillers, as described above.

[0415] In at least one example embodiment, providing the gel-based polymer includes providing a gel-based polymer sufficient to achieve the desired nicotine release rate. In at least one example embodiment, the method further includes determining the amount of the gel-based polymer based on the desired nicotine release rate. In at least one example embodiment, the method further includes adjusting the amount of the gel-based polymer based ...

Claims

1. A type of chewing gum, comprising: The main body, the main body comprising: The adhesive polymer comprises: Polyvinyl acetate (PVA), in an amount of 35 to 55% by weight of the main component. The oil contains medium-chain triglycerides in an amount of 3 to 11% by weight of the main component. Active ingredients Insoluble cellulose materials, and A buffer system, wherein the amount of the buffer system is from 0.1 weight percent to 8 weight percent of the main body; and A coating that at least partially surrounds the body.

2. The chewing gum of claim 1, wherein the buffer system comprises a weak base and a conjugate acid.

3. The chewing gum of claim 1, wherein the buffering system comprises: Sodium carbonate, and Sodium bicarbonate.

4. The chewing gum according to claim 3, wherein The sodium carbonate is present in an amount of 0.2 to 1% by weight of the main component, and The sodium bicarbonate is present in an amount of 0.1 to 0.7% by weight of the main body.

5. The chewing gum according to claim 1, wherein... The chewing gum has an acid buffering capacity greater than or equal to 8 x 10 -4 and also has a buffering capacity greater than or equal to 8 x 10 The chewing gum has a basic buffering capacity greater than or equal to about 25 x 10 -4 -2.

6. The chewing gum of claim 1, wherein... The chewing gum has a density greater than or equal to 15 × 10 -4 Its acid buffering capacity, and The chewing gum has a size greater than or equal to approximately 50 × 10 -4 Its alkaline buffering capacity.

7. The chewing gum of claim 1, wherein the body is configured to maintain a pH greater than or equal to 9 during a 5-minute contact period with saliva.

8. The chewing gum of claim 1, wherein the active ingredient comprises nicotine or a nicotine derivative.

9. The chewing gum of claim 8, wherein... The nicotine or nicotine derivative comprises liquid nicotine, and The liquid nicotine is dissolved in MCT.

10. The chewing gum of claim 9, wherein the liquid nicotine and the MCT are adsorbed onto the insoluble cellulose material, absorbed onto the insoluble cellulose material, or simultaneously adsorbed onto and absorbed onto the insoluble cellulose material.

11. The chewing gum of claim 10, wherein... The insoluble cellulose material contains MCC, and The main body contains 2% to 15% by weight of the MCC.

12. The chewing gum of claim 9, wherein greater than or equal to 90% by weight of the nicotine or nicotine derivative is configured to be in the form of a free base during a 5-minute contact period with saliva.

13. The chewing gum of claim 9, wherein the nicotine or nicotine derivative comprises tobacco-derived nicotine.

14. The chewing gum of claim 1, wherein the body has a uniform unit structure.

15. The chewing gum of claim 1, wherein the body comprises 40 to 50 percent by weight of the PVA.

16. The chewing gum of claim 1, wherein the gum base polymer is substantially composed of the PVA.

17. The chewing gum of claim 1, wherein the PVA comprises a first PVA having a first weight average molecular weight and a second PVA having a second weight average molecular weight, the second weight average molecular weight being different from the first weight average molecular weight.

18. The chewing gum of claim 1, wherein the oil further comprises triacetin.

19. The chewing gum of claim 1, wherein the body further comprises an antioxidant.

20. The chewing gum of claim 19, wherein the antioxidant comprises vitamin E and ascorbyl palmitate.

21. The chewing gum of claim 1, wherein the body further comprises: Sweeteners.

22. The chewing gum of claim 21, wherein the sweetener comprises a variety of sugar alcohols.

23. The chewing gum of claim 22, wherein the plurality of sugar alcohols includes maltitol and sorbitol.

24. The chewing gum of claim 1, wherein the coating comprises sugar alcohol, pH adjuster and gum arabic.

25. A type of chewing gum, comprising: The main body, the main body comprising: A gel-based polymer, wherein the amount of the gel-based polymer is from 35% to 55% by weight of the main component, the gel-based polymer comprising: First polyvinyl acetate (PVA), the first PVA having a first weight-average molecular weight, and A second PVA, having a second weight-average molecular weight, which differs from the first weight-average molecular weight. A liquid mixture comprising: Medium-chain triglycerides (MCTs), wherein the amount of MCTs is 3 to 11% by weight of the main component, and Liquid nicotine, dissolved in the MCT. Microcrystalline cellulose (MCC), wherein at least a portion of the liquid mixture is adsorbed onto the MCC, absorbed within the MCC, or simultaneously adsorbed and absorbed within the MCC. Sodium carbonate, and Sodium bicarbonate; and A coating that at least partially surrounds the body.

26. A method for manufacturing chewing gum, the method comprising: Diluted nicotine is prepared by dissolving liquid nicotine in oil; Cellulose blends are prepared by adsorbing the diluted nicotine onto a cellulose material, absorbing the diluted nicotine into the cellulose material, or simultaneously adsorbing the diluted nicotine onto a cellulose material and absorbing the diluted nicotine into the cellulose material. A gel base is prepared, the gel base comprising a gel polymer and the cellulose blend, wherein the gel polymer comprises polyvinyl acetate; Preparation of a chewing gum core comprising the gum base; and The chewing gum is prepared by coating the chewing gum core.

Images