Oral Pouch Products

Abstract

The oral pouch product includes a wrapper and a fill material. The wrapper defines a cavity. The fill material is within the cavity. The fill material includes a dry mix and a liquid mix. The dry mix includes a cellulosic material and a water soluble filler. The liquid mix includes an oil and liquid nicotine. The oil includes a triglyceride, a diglyceride, a monoglyceride, or any combination thereof. The liquid nicotine is dissolved in the oil. The fill material is water-free or includes water in an amount of 5 weight percent or less.

Description

[Technical field]

[0001] The present disclosure relates to nicotine-containing oral pouch products. [Background technology]

[0002] Oral nicotine products are available in a variety of forms, including gums, sprays, lozenges, dissolvable tablets, insoluble chews, films, gels, capsules, sticks (e.g., coated wooden dowels or single dissolvable sticks) and pouches (e.g., containing fibers or granules). Oral products may contain levels of nicotine that provide an experience familiar to adult smokers. Summary of the Invention [Means for solving the problem]

[0003] At least one exemplary embodiment relates to an oral pouch product.

[0004] In at least one exemplary embodiment, an oral pouch product includes a wrapper and a fill material. The wrapper defines a cavity. The fill material is within the cavity. The fill material includes a dry mix and a liquid mix. The dry mix includes a cellulosic material and a water soluble filler. The liquid mix includes an oil and liquid nicotine. The oil includes a triglyceride, a diglyceride, a monoglyceride, or any combination thereof. The liquid nicotine is dissolved in the oil. The fill material is water-free or includes water in an amount of 5 weight percent or less.

[0005] In at least one exemplary embodiment, the fill material is glycerin-free and propylene glycol-free.

[0006] In at least one exemplary embodiment, the cellulosic material comprises microcrystalline cellulose (MCC).

[0007] In at least one exemplary embodiment, the MCC includes particles having a size ranging from 100 microns to 300 microns.

[0008] In at least one exemplary embodiment, the MCC is wood pulp derived MCC.

[0009] In at least one exemplary embodiment, the filler material comprises cellulosic material in an amount ranging from 10 weight percent to 70 weight percent.

[0010] In at least one exemplary embodiment, the filler material includes cellulosic material in an amount ranging from 30 weight percent to 60 weight percent.

[0011] In at least one exemplary embodiment, the fill material includes oil in an amount ranging from 10 percent to 50 percent by weight.

[0012] In at least one exemplary embodiment, the fill material includes oil in an amount ranging from 15 weight percent to 25 weight percent.

[0013] In at least one exemplary embodiment, the oil consists essentially of triglycerides, diglycerides, monoglycerides, or any combination thereof.

[0014] In at least one exemplary embodiment, the oil comprises a triglyceride.

[0015] In at least one exemplary embodiment, the triglyceride comprises a medium chain triglyceride.

[0016] In at least one exemplary embodiment, the loading material includes a water-soluble filler in an amount ranging from 10 weight percent to 50 weight percent.

[0017] In at least one exemplary embodiment, the water soluble filler comprises a sugar alcohol, a sugar, a maltodextrin, a starch, a polysaccharide, or any combination thereof.

[0018] In at least one exemplary embodiment, the water soluble filler comprises a sugar alcohol.

[0019] In at least one exemplary embodiment, the fill material comprises sugar alcohol in an amount ranging from 15 percent to 25 percent by weight.

[0020] In at least one exemplary embodiment, the sugar alcohol comprises xylitol.

[0021] In at least one exemplary embodiment, the fill material further comprises a pH adjuster.

[0022] pH adjusters include sodium bicarbonate.

[0023] In at least one exemplary embodiment, the filler material further comprises an antioxidant.

[0024] In at least one exemplary embodiment, the antioxidant comprises tocopherol or a tocopherol derivative, ascorbic acid, an ascorbic acid derivative, tert-butylhydroquinone, or any combination thereof.

[0025] In at least one exemplary embodiment, the filler material includes an antioxidant in an amount less than 2 weight percent.

[0026] In at least one exemplary embodiment, the fill material further comprises a fragrance.

[0027] In at least one exemplary embodiment, the fill material comprises a flavoring in an amount less than 10 weight percent.

[0028] In at least one exemplary embodiment, the fill material includes flavoring in an amount ranging from 0.1 percent to 5 percent by weight.

[0029] In at least one exemplary embodiment, the fill material includes liquid nicotine in an amount ranging from 0.1 percent to 10 percent by weight.

[0030] In at least one exemplary embodiment, the liquid nicotine comprises nicotine derived from tobacco.

[0031] In at least one exemplary embodiment, the liquid nicotine comprises synthetic nicotine.

[0032] In at least one exemplary embodiment, the wrapper comprises an elastomer.

[0033] In at least one exemplary embodiment, the elastomer is white in color.

[0034] In at least one exemplary embodiment, the elastomer comprises a polyurethane.

[0035] In at least one exemplary embodiment, the wrapper has a basis weight in the range of 20 grams per meter (gsm) to 30 gsm.

[0036] At least one exemplary embodiment relates to an oral pouch product.

[0037] In at least one exemplary embodiment, an oral pouch product includes a wrapper and a fill material. The wrapper defines a cavity. The wrapper includes an elastomer. The fill material is within the cavity. The fill material includes a dry mix and a liquid mix. The dry mix includes a cellulosic material and a water soluble filler. The liquid mix includes an oil and liquid nicotine. The oil includes a triglyceride, a diglyceride, a monoglyceride, or any combination thereof.

[0038] At least one exemplary embodiment relates to an oral pouch product.

[0039] In at least one exemplary embodiment, the oral pouch product includes a wrapper and a fill material. The wrapper defines a cavity. The fill material is within the cavity. The fill material includes a dry mix and a liquid mix. The dry mix includes microcrystalline cellulose and a water soluble filler. The microcrystalline cellulose is present in an amount ranging from 10 weight percent to 70 weight percent. The water soluble filler is present in an amount ranging from 10 weight percent to 50 weight percent. The water soluble filler includes a sugar alcohol. The liquid mix includes a triglyceride. The triglyceride is present in an amount ranging from 10 weight percent to 30 weight percent. The liquid nicotine is dissolved in the triglyceride. The fill material is free of glycerin and free of propylene glycol. The fill material is free of water or includes water in an amount less than 5 weight percent of the fill material.

[0040] In at least one exemplary embodiment, the wrapper comprises an elastomer.

[0041] In at least one exemplary embodiment, the elastomer comprises a polyurethane.

[0042] At least one exemplary embodiment relates to a method of manufacturing an oral pouch product.

[0043] In at least one exemplary embodiment, the method includes preparing a liquid mixture including liquid nicotine and an oil. The oil includes a triglyceride, a diglyceride, a monoglyceride, or any combination thereof. At least a portion of the nicotine is dissolved in the oil. The method further includes preparing a dry mixture including a cellulosic material and a water-soluble filler. The method further includes forming a fill material by mixing the liquid mixture with the dry mixture. The method further includes forming an oral pouch product by enclosing the fill material within a cavity defined by a wrapper.

[0044] Various features and advantages of non-limiting embodiments of the present disclosure may become more apparent upon reading the detailed description in conjunction with the accompanying drawings, which are for illustrative purposes only and should not be understood as limiting the scope of the claims. The accompanying drawings should not be considered as drawn to scale unless explicitly stated. Various dimensions of the drawings may be exaggerated for clarity. [Brief description of the drawings]

[0045] FIG. 1A is a perspective view of an oral pouch product in accordance with at least one exemplary embodiment.

[0046] FIG. 1B is a cross-sectional view of an oral pouch product taken along line II of FIG. 1A in accordance with at least one exemplary embodiment.

[0047] FIG. 2A is a perspective view of an oral pouch product in accordance with at least one exemplary embodiment.

[0048] FIG. 2B is a cross-sectional view of an oral pouch product taken along line II-II of FIG. 2A in accordance with at least one exemplary embodiment.

[0049] FIG. 2C is a cross-sectional view of an oral pouch product taken along line III-III of FIG. 2A in accordance with at least one exemplary embodiment.

[0050] FIG. 3A is a side view of an oral pouch product in accordance with at least one exemplary embodiment.

[0051] FIG. 3B is a cross-sectional view of an oral pouch product taken along line VIII-VIII of FIG. 3A in accordance with at least one exemplary embodiment.

[0052] FIG. 4A is the chemical structure of free base nicotine.

[0053] FIG. 4B is the chemical structure of monoprotonated nicotine.

[0054] FIG. 4C is the chemical structure of diprotonated nicotine.

[0055] 5A and 5B are graphs showing how various nicotine solutions are disposed inside the cheek.

[0056] FIG. 6A is a table showing partition coefficient data for nicotine in various combinations of oil and water phases.

[0057] FIG. 6B is a formula showing the chemical structure of triacetin (C2).

[0058] FIG. 6C is a formula showing the chemical structure of MCT (C8-C10).

[0059] FIG. 6D is a formula showing the chemical structure of triolein (C18).

[0060] FIG. 7 is a flow chart illustrating a method of preparing an oral pouch product in accordance with at least one exemplary embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0061] Several detailed exemplary embodiments are disclosed herein. However, the specific structural and functional details disclosed herein are provided merely to describe the exemplary embodiments. The exemplary embodiments may be embodied in many different forms and should not be construed as being limited to only the exemplary embodiments described herein.

[0062] Thus, the exemplary embodiments are susceptible to various modifications and variations, examples of which are shown in the drawings and described in detail herein. However, there is no intention to limit the exemplary embodiments to the particular forms disclosed, but rather the exemplary embodiments encompass all modifications, equivalents and alterations falling within the scope of the exemplary embodiments. Like reference numerals refer to like elements throughout the description of the drawings.

[0063] When an element or layer is described as "on," "connected to," "coupled to," or "overlying" another element or layer, the element or layer may be directly on, connected to, coupled to, or overlying the other element or layer, or there may be intervening elements or layers. Conversely, when an element is described as "directly on," "directly connected to," or "directly coupled to" another element or layer, there are no intervening elements or layers. Like reference numerals refer to like elements throughout the specification. As used herein, the word "and / or" includes any and all combinations of one or more of the items listed with this word.

[0064] Although the terms "first", "second", "third" and the like are used herein to describe various components, regions, layers and / or portions, it should be understood that these components, regions, layers and / or portions are not limited to these terms. These terms are merely used to distinguish one component, region, layer or portion from another region, layer or portion. Thus, a first component, component, region, layer or portion described below may also be referred to as a second component, region, layer or portion without departing from the teachings of the exemplary embodiments.

[0065] Spatial relative terms (e.g., "below," "lower," "lower," "above," "upper," "inside," "outside," etc.) are used herein for convenience to describe the illustrated relationship of one member or members or feature to another member or feature or features. It should be understood that the spatial relative terms are intended to include various orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures is turned over, a member described as being "below" or "below" another member or feature would then be "above" the other member or feature. Thus, the term "below" can include both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or otherwise) and the spatial relative terms used herein can be interpreted accordingly.

[0066] The terminology used herein is merely for the purpose of describing various exemplary embodiments and is not intended to limit the exemplary embodiments. As used herein, the singular forms "a," "an," and "the" are intended to include the plural unless expressly specified otherwise. Furthermore, it is to be understood that the words "comprise," "including," "comprises," and / or "comprising" specify the presence of stated features, integers, steps, operations, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, components, and / or groups thereof.

[0067] Exemplary embodiments are described herein with reference to cross-sectional views. These cross-sectional views are schematic views of exemplary embodiments. Variations from the shapes of the drawings are therefore expected. As such, the exemplary embodiments should not be construed as being limited to the shapes of the regions illustrated herein, but should also be construed to include variations and modifications of shapes. When the terms "about" and "substantially" are used in connection with numerical values, the numerical values ​​with which they are used are intended to include a tolerance of ±10% of the stated numerical values, unless otherwise indicated by the context.

[0068] All terms used herein (including technical and scientific terms) have the same meaning as commonly understood by those skilled in the art to which the exemplary embodiments pertain, unless otherwise specified. Furthermore, these terms should be interpreted to have a meaning consistent with the meaning in the corresponding field, including words defined in commonly used dictionaries, and should not be interpreted in an idealized or overly formal sense, unless otherwise specified herein.

[0069] In at least one exemplary embodiment, a method is provided for enhancing the flavor and / or sensory effects of nicotine in an oral product, such as an oral pouch product that includes nicotine and cellulose within a pouch wrapper.

[0070] In at least one exemplary embodiment, the oral pouch product includes a tobacco extract, such as a tobacco-derived nicotine extract, and / or synthetic nicotine. The oral pouch product may include nicotine alone or in combination with a carrier, such as a cellulose material (e.g., white snus). The carrier may be a non-tobacco material (e.g., microcrystalline cellulose). In some exemplary embodiments, the carrier may further include a tobacco material (e.g., tobacco fiber with reduced or no nicotine content, which may be referred to as "exhausted tobacco plant tissue or fiber"). In some exemplary embodiments, the exhausted 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 nicotine may be removed by washing the tobacco plant tissue with water or another solvent.

[0071] In another exemplary embodiment, the oral pouch product may include cannabis, such as cannabis plant tissue and / or cannabis extract. In at least one exemplary embodiment, the cannabis material includes leaf and / or flower material from one or more species of cannabis plant, and / or extract from one or more species of cannabis plant. The one or more species of cannabis plant may include Cannabis sativa, Cannabis indica, and / or Cannabis ruderalis. In at least one exemplary embodiment, the cannabis may be in the form of fiber. In at least one exemplary embodiment, the cannabis may include cannabinoids, terpenes, and / or flavonoids. In at least one exemplary embodiment, the cannabis material may be cannabis-derived cannabis material, such as cannabis-derived cannabinoids, cannabis-derived terpenes, and / or cannabis-derived flavonoids.

[0072] The oral pouch product may have a variety of oven volatiles. In at least one exemplary embodiment, the oral pouch product is a dry oral pouch product having a moisture content of less than 10 weight percent (e.g., 0.5 weight percent to 10 weight percent, or about 2 weight percent to about 4 weight percent). In at least one exemplary embodiment, the oral pouch product has a medium moisture content, e.g., a moisture content in the range of 20 weight percent to 35 weight percent. In at least one exemplary embodiment, the oral pouch product is a moist oral pouch product having a moisture content in the range of 40 weight percent to 55 weight percent.

[0073] In at least one exemplary embodiment, the oral pouch product further comprises one or more elements, such as, for example, a mouth-stable polymer, a mouth-dissolving polymer, a sweetener (e.g., synthetic and / or natural sweeteners), an activator, a soothing agent, a bulking agent, a plasticizer, a mouth-dissolving fiber, an alkaloid, a mineral, a vitamin, a food supplement, a nutraceutical, a colorant (natural and / or artificial), an amino acid, a chemesthetic agent, an antioxidant, a food grade emulsifier and / or surfactant, a pH modifier, a botanical, a tooth whitening agent, a therapeutic agent, a processing aid, a stearate, a wax, a stabilizer, a disintegrant, a lubricant, a preservative, a filler, a flavor, a flavor masking agent, a bitter receptor site blocker, a receptor site enhancer, other additives, or any combination thereof.

[0074] Oral Pouch Products FIG. 1A is a perspective view of an oral pouch product in accordance with at least one exemplary embodiment.

[0075] FIG. 1B is a cross-sectional view of an oral pouch product taken along line II of FIG. 1A in accordance with at least one exemplary embodiment.

[0076] 1A and 1B, oral pouch product 100 is configured to fit in the mouth of an adult consumer. Oral pouch product 100 includes a pouch wrapper 102 and an interior fill material 104. Fill material 104 is within an interior cavity 106 that is at least partially defined by pouch wrapper 102. For example, an adult consumer can suck, chew, or otherwise manipulate oral pouch product 100 to extract the internal flavor and / or functional ingredients.

[0077] The filler material 104 includes a dry mix and a liquid mix as described herein with reference to Figures 4A-6D. At least a portion of the liquid mix is ​​absorbed into the dry mix. In at least one exemplary embodiment, the entire liquid mix is ​​absorbed into the dry mix. The liquid mix includes an oil and an active pharmaceutical ingredient (API), such as nicotine. The dry mix includes an insoluble material or carrier, such as a cellulosic material.

[0078] In at least one exemplary embodiment, the API includes nicotine, and the oral pouch product 100 includes oil and nicotine in the amounts and ratios described below with reference to Figures 4A-6D. In at least one exemplary embodiment, the API includes one or more tobacco extracts, nicotine, one or more cannabis extracts, and / or one or more cannabinoids. The nicotine may include tobacco-derived nicotine and / or synthetic nicotine. In at least one exemplary embodiment, the API includes liquid nicotine. The cannabinoids may include tetrahydrocannabinol ("THC") and / or cannabidiol ("CBD").

[0079] The oral pouch product 100 may include an API in an amount of about 0.1 weight percent or more (e.g., about 0.5 weight percent or more, about 1 weight percent or more, about 2 weight percent or more, about 3 weight percent or more, about 4 weight percent or more, about 5 weight percent or more, about 6 weight percent or more, about 7 weight percent or more, about 8 weight percent or more, or about 9 weight percent or more). The oral pouch product 100 may include an API in an amount of about 10 weight percent or less (e.g., about 9 weight percent or less, about 8 weight percent or less, about 7 weight percent or less, about 6 weight percent or less, about 5 weight percent or less, about 4 weight percent or less, about 3 weight percent or less, about 2 weight percent or less, about 1 weight percent or less, or about 0.5 weight percent or less).

[0080] In at least one exemplary embodiment, the oil of the liquid mixture comprises one or more triglycerides, one or more diglycerides, one or more monoglycerides, triacetin, triolein, trilinolein, vegetable oil, one or more partially hydrogenated oils, or any combination thereof. In at least one exemplary embodiment, the oil consists essentially of one or more triglycerides, one or more diglycerides, one or more monoglycerides, or any combination thereof. In at least one exemplary embodiment, the oil consists essentially of triglycerides. The triglycerides may include LCT, MCT, SCT, or any combination thereof. In at least one exemplary embodiment, the triglycerides consist essentially of MCT. In at least one exemplary embodiment, the filler material 104 includes oil in an amount of about 0.5 weight percent or more (e.g., about 1 weight percent or more, about 5 weight percent or more, about 10 weight percent or more, about 15 weight percent or more, about 20 weight percent or more, about 25 weight percent or more, about 30 weight percent or more, about 35 weight percent or more, about 40 weight percent or more, or about 45 weight percent or more). The filler material 104 can include oil in an amount of about 50 weight percent or less (e.g., about 45 weight percent or less, about 40 weight percent or less, about 35 weight percent or less, about 30 weight percent or less, about 25 weight percent or less, about 20 weight percent or less, about 15 weight percent or less, about 10 weight percent or less, about 5 weight percent or less, or about 1 weight percent or less). In at least one exemplary embodiment, the oral pouch product 100 includes oil in an amount ranging from 10 weight percent to 50 weight percent (e.g., from about 10 weight percent to about 25 weight percent, or from about 15 weight percent to about 25 weight percent).

[0081] In at least one exemplary embodiment, the fill material 104 includes water, but in an amount of about 5 weight percent or less (e.g., about 4 weight percent or less, about 3 weight percent or less, about 2 weight percent or less, about 1 weight percent or less, about 0.5 weight percent or less, or about 0.25 weight percent or less). In at least one exemplary embodiment, water is not intentionally added to the liquid mixture. However, small amounts of water may contact the liquid mixture through other elements within the oral pouch product. In at least one exemplary embodiment, a low water content may slow the decomposition and oxidation of nicotine compared to oral pouch products with a high water content. In at least one exemplary embodiment, the fill material 104 does not include water.

[0082] The oral pouch product 100 maintains a relatively moist mouth feel by including higher levels of oils such as MCT while maintaining a low water content and water activity level of less than about 0.7. This can help prevent and / or reduce microbial growth and improve nicotine stability in the oral pouch product 100. When the wrapper 102 is hydrophobic because the fill material is predominantly oil rather than water, flavors from the fill material 104 pass through the pouch wrapper 102 more easily than when a hydrophilic pouch wrapper is used.

[0083] In at least one exemplary embodiment, the weight ratio of dry mix to liquid mix can be about 60:40 or greater (e.g., about 65:35 or greater, about 70:30 or greater, about 75:25 or greater, about 80:20 or greater, about 85:15 or greater, about 90:10 or greater, or about 95:5 or greater).

[0084] In at least one exemplary embodiment, the dry mixture includes an insoluble material. At least a portion of the liquid mixture may be absorbed into the insoluble material, as described below with reference to Figures 1A-3D. In at least one exemplary embodiment, the entire liquid mixture is absorbed into the insoluble material.

[0085] In at least one exemplary embodiment, the insoluble material is a cellulosic material. The cellulosic material may include or be derived from sugar beet, wood pulp, cotton, bran, citrus pulp, grass (e.g., switchgrass), willow, poplar, or any combination thereof. The insoluble cellulosic material may be a processed cellulosic material, such as microcrystalline cellulose ("MCC"), carboxymethyl cellulose ("CMC"), hydroxypropyl methylcellulose ("HPMC"), hydroxypropyl cellulose ("HPC"), or any combination thereof. In at least one exemplary embodiment, the cellulosic material comprises cellulose fibers that dissolve in the mouth. In at least one exemplary embodiment, the cellulosic material comprises MCC. In at least one exemplary embodiment, the MCC comprises MCC derived from wood pulp.

[0086] In at least one exemplary embodiment, the insoluble material includes water insoluble fibers. The water insoluble fibers may include water insoluble polymer fibers. The water insoluble polymer fibers may include polypropylene, polyester, polyethylene, polyurethane, or any combination thereof.

[0087] In at least one exemplary embodiment, the filler material 104 includes insoluble material in an amount of about 10 weight percent or more (e.g., about 15 weight percent or more, about 20 weight percent or more, about 25 weight percent or more, about 30 weight percent or more, about 35 weight percent or more, about 40 weight percent or more, about 45 weight percent or more, about 50 weight percent or more, about 55 weight percent or more, about 60 weight percent or more, about 65 weight percent or more, about 70 weight percent or more, or about 75 weight percent or more). Filler material 104 can include insoluble material in an amount of about 80 weight percent or less (e.g., about 75 weight percent or less, about 70 weight percent or less, about 65 weight percent or less, about 60 weight percent or less, about 55 weight percent or less, about 50 weight percent or less, about 45 weight percent or less, about 40 weight percent or less, about 35 weight percent or less, about 30 weight percent or less, about 25 weight percent or less, about 20 weight percent or less, or about 15 weight percent or less). In at least one exemplary embodiment, filler material 104 includes insoluble material in an amount ranging from 10 weight percent to 70 weight percent (e.g., from about 30 weight percent to about 60 weight percent).

[0088] In at least one exemplary embodiment, the particle size of the insoluble material is about 50 microns or more (e.g., about 100 microns or more, about 150 microns or more, about 200 microns or more, about 250 microns or more, about 300 microns or more, about 350 microns or more, about 400 microns or more, or about 450 microns or more). The particle size can be about 500 microns or less (e.g., about 450 microns or less, about 400 microns or less, about 350 microns or less, about 300 microns or less, about 250 microns or less, about 200 microns or less, about 150 microns or less, or about 100 microns or less).

[0089] In at least one exemplary embodiment, the dry mix further comprises a water-soluble filler. The water-soluble filler may comprise one or more sweeteners, maltodextrin, psyllium, starch, one or more polysaccharides, one or more salts, one or more synthetic polymers, dietary fiber, or any combination thereof. The filling material 104 may comprise a water-soluble filler in an amount of about 10 weight percent or more (e.g., about 15 weight percent or more, about 20 weight percent or more, about 25 weight percent or more, about 30 weight percent or more, about 35 weight percent or more, about 40 weight percent or more, or about 45 weight percent or more). The filling material 104 may comprise a water-soluble filler in an amount of about 50 weight percent or less (e.g., about 45 weight percent or less, about 40 weight percent or less, about 35 weight percent or less, about 30 weight percent or less, about 25 weight percent or less, about 20 weight percent or less, or about 15 weight percent or less).

[0090] In at least one exemplary embodiment, the filler material 104 includes at least one sweetener. The sweetener may include synthetic and / or natural sweeteners. The natural sweetener may include one or more sugars, the sugars being monosaccharides, disaccharides, and / or polysaccharides (e.g., xylose, ribose, mannose). In at least one exemplary embodiment, the sweetener includes natural sweeteners, the natural sweeteners including sucrose (i.e., table sugar), honey, sugars with low atomic weight other than sucrose, glucose (i.e., glucose, corn sugar, dextrose), molasses, corn sweeteners, glucose syrup (i.e., corn syrup), fructose (i.e., fruit sugar), lactose (i.e., milk sugar), maltose (i.e., maltose, maltobiose), sorghum syrup, concentrated fruit juice, or any combination thereof. In at least one exemplary embodiment, the sweetener comprises a non-nutritive sweetener, the non-nutritive sweetener comprises stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof. The sweetener may comprise a high-intensity sweetener. The high-intensity sweetener may be sucralose, palatinose, stevia, acesulfame potassium, glycyrrhizic acid, or any combination thereof.

[0091] In at least one exemplary embodiment, the sweetener comprises one or more sugar alcohols. The sugar alcohols may include ethylene glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt, maltitol, lactitol, maltotriitol, maltotetraitol, polyglycitol, or any combination thereof. The filler material 404 may include sugar alcohols in an amount of about 10 weight percent or more (e.g., about 15 weight percent or more, about 20 weight percent or more, about 25 weight percent or more, about 30 weight percent or more, about 35 weight percent or more, about 40 weight percent or more, or about 45 weight percent or more). Filling material 104 can include sugar alcohol in an amount of about 50 weight percent or less (e.g., about 45 weight percent or less, about 40 weight percent or less, about 35 weight percent or less, about 30 weight percent or less, about 25 weight percent or less, about 20 weight percent or less, or about 15 weight percent or less). In at least one exemplary embodiment, filling material 104 includes sugar alcohol in an amount ranging from about 15 weight percent to about 25 weight percent (e.g., about 18 weight percent to about 22 weight percent).

[0092] In at least one exemplary embodiment, the filler material 104 includes a pH adjuster. The pH adjuster may be included in the dry mix, such as a water-soluble filler. The pH adjuster may include ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, calcium carbonate, potassium carbonate, potassium bicarbonate, potassium hydroxide, sodium carbonate, sodium bicarbonate, sodium hydroxide, or any combination thereof. The pH adjuster may be included in an amount of about 0.01 weight percent or more (e.g., about 0.05 weight percent or more, about 0.1 weight percent or more, about 0.5 weight percent or more, about 1 weight percent or more, about 2 weight percent or more, about 3 weight percent or more, about 4 weight percent or more, about 5 weight percent or more, about 6 weight percent or more, about 7 weight percent or more, about 8 weight percent or more, or about 9 weight percent or more). The pH adjuster may be present in an amount of about 2 weight percent or less (e.g., about 10 weight percent or less, about 9 weight percent or less, about 8 weight percent or less, about 7 weight percent or less, about 6 weight percent or less, about 5 weight percent or less, about 4 weight percent or less, about 3 weight percent or less, about 2 weight percent or less, about 1 weight percent or less, about 0.5 weight percent or less, about 0.1 weight percent or less, or about 0.05 weight percent or less). In at least one exemplary embodiment, the pH adjuster is present in an amount ranging from about 4 weight percent to about 6 weight percent. In at least one other exemplary embodiment, the pH adjuster is present in an amount ranging from about 0.01 weight percent to about 2 weight percent. In at least one other exemplary embodiment, the oral pouch product does not include a pH adjuster.

[0093] In at least one exemplary embodiment, the oral pouch product does not include a moisturizer.In at least one exemplary embodiment, the oral pouch product does not include glycerin and / or propylene glycol.

[0094] In at least one exemplary embodiment, the filling material 104 includes an antioxidant. The antioxidant can be one or more oil-phase antioxidants, one or more water-phase antioxidants, one or more dry antioxidants, or any combination thereof. The antioxidant can include, for example, tocopherol, tocopherol derivatives, ascorbic acid, ascorbic acid derivatives (e.g., ascorbyl palmitate, sodium ascorbate), tert-butylhydroquinone (TBHQ), butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), vitamin C, vitamin B, magnesium, calcium, or any combination thereof. The filling material 104 can include an antioxidant in an amount of about 5 weight percent or less (e.g., about 4 weight percent or less, about 3 weight percent or less, about 2 weight percent or less, about 1 weight percent or less, or about 0.5 weight percent or less).

[0095] In at least one exemplary embodiment, the fill material 104 includes one or more flavorings. The flavorings may be provided in the liquid or dry mix, or may be provided separately (e.g., water-based flavors, as described below with reference to FIG. 7). The flavorings may include oil-phase flavorings and / or water-phase flavorings. The flavorings may be natural or artificial. In at least one exemplary embodiment, the flavorings may be fruit flavorings (e.g., bergamot, berry, cherry, lemon, and / or orange), liqueur or liqueur flavorings (e.g., bourbon, cognac, scotch, whiskey, and / or DRAMBUIE brand liqueurs), mint flavorings (e.g., peppermint, menthol, peppermint, spearmint, wintergreen, and / or mint oil from certain species of the genus Mentha), floral flavorings (e.g., citrus ... geranium, lavender, and / or rose), spices, herbs, other plants or plant-derived flavorings (e.g., anise, Dutch honeysuckle, graveolens, caraway, cardamom, cascarilla, cassia, cinnamon, chamomile, clove, cocoa, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pimenta, sage, sandalwood, vanilla, and / or ylang-ylang), honey essence, or any combination thereof. In at least one exemplary embodiment, the flavoring comprises bergamot, berry, cherry, lemon, orange, bourbon, cognac, scotch, whiskey, DRAMBUIE brand liqueur, mint, menthol, peppermint, spearmint, wintergreen, mint oil from a species of the genus Mentha, geranium, lavender, rose, anise, Dutch honeywort, graveolens, caraway, cardamom, cascarilla, cassia, cinnamon, chamomile, clove, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pimenta, sage, sandalwood, vanilla, ylang ylang, honey essence, or any combination thereof. In at least one exemplary embodiment, the oral pouch product comprises an encapsulated flavoring.In at least one exemplary embodiment, the filling material 104 includes a fragrance in an amount of about 0.01 weight percent or more (e.g., about 0.1 weight percent or more, about 0.5 weight percent or more, about 1 weight percent or more, about 2 weight percent or more, about 4 weight percent or more, about 5 weight percent or more, about 8 weight percent or more, about 10 weight percent or more, about 15 weight percent or more, or about 20 weight percent or more). The filling material 104 can include one of the fragrances in an amount of about 25 weight percent or less (e.g., about 20 weight percent or less, about 15 weight percent or less, about 10 weight percent or less, about 8 weight percent or more, about 5 weight percent or less, about 4 weight percent or less, about 2 weight percent or more, about 1 weight percent or less, about 0.5 weight percent or less, 0.1 weight percent or less). In at least one exemplary embodiment, fill material 104 includes a flavoring in an amount ranging from about 0.1 weight percent to about 10 weight percent (eg, from about 0.1 weight percent to about 4 weight percent).

[0096] In at least one exemplary embodiment, the filler material 104 includes an emulsifier and / or surfactant. The emulsifier and / or surfactant may include lecithin, glycerol monostearate, polysorbic acid, poloxamer, or a combination of lecithin and glycerol monostearate. The emulsifier and / or surfactant may be present in an amount greater than 0 weight percent (e.g., about 0.5 weight percent or more, about 0.75 weight percent or more, about 1 weight percent or more, about 2 weight percent or more, about 3 weight percent or more, or about 4 weight percent or more). The emulsifier and / or surfactant may be present in an amount less than or equal to about 5 weight percent (e.g., about 4 weight percent or less, about 3 weight percent or less, about 2 weight percent or less, about 1 weight percent or less, about 0.75 weight percent or less, or about 0.5 weight percent or less). In at least one exemplary embodiment, the emulsifier and / or surfactant is present in an amount ranging from 0.1 weight percent to about 2 weight percent.

[0097] In at least one exemplary embodiment, the dry mixture may additionally or alternatively include cannabis. Cannabis may include portions of the cannabis plant and / or any extracts thereof. For example, in some exemplary embodiments, the plant material may include a mixture of Cannabis sativa and Cannabis indica, by way of example only, about 70% sativa and about 30% indica. In at least one exemplary embodiment, the oral pouch product 100 may include a cannabis extract applied to an insoluble filler, such as cellulose. In at least one exemplary embodiment, the oral pouch product 100 may include cannabis in addition to other plant materials. Alternatively, the oral pouch product 100 may include other plant materials, such as herbs, vegetables, and the like.

[0098] In at least one exemplary embodiment, the cannabis (or other plant material) may be heated to a temperature sufficient to decarboxylate the composition therein prior to placing the cannabis (or other plant material) within the oral pouch product 100. For example, the cannabis may be maintained at the heated temperature for a period of time sufficient to cause decarboxylation (i.e., converting tetrahydrocannabinolic acid ("THCA") present in the cannabis to THC and / or converting cannabidiolic acid ("CBDA") to CBD). In some applications, maintaining the plant material at the heated temperature causes decarboxylation of the cannabis. This is demonstrated by Dussy et al., entitled "Isolation of Delta9-THCA-A from hemp and analytical aspects concerning the determination of Delta)-THC in cannabis products" (Forensic Sce. Int. April 2005, 20:149(1):3-10), and / or Veress et al., entitled "Determination of cannabinoid acids by high-performance liquid chromatography of their natural derivatives formed by thermal decarboxylation: I. Study of the decarboxylation process in open reactors" (Journal of Chromatography A 520:339-347, November 1990). and the above two articles are incorporated herein by reference in their entireties. For example, cannabis (or other plant material) may be maintained at about 225 degrees Celsius for about 35 to 45 minutes.

[0099] In at least one exemplary embodiment, the dry mix can further include tobacco material (in addition to or instead of cannabis material and / or cellulose). In at least one other exemplary embodiment, the filler material 104 includes tobacco plant material in an amount of about 5 weight percent or less (e.g., about 4 weight percent or less, about 3 weight percent or less, about 2 weight percent or less, or about 1 weight percent or less). In at least one other exemplary embodiment, the filler material 104 does not include tobacco plant material.

[0100] In at least one exemplary embodiment, the filler material 104 includes one or more additives, such as one or more mouth-soluble polymers, partially soluble fibers (e.g., sugar beet fibers), one or more plasticizers, one or more activators, one or more sizing agents (e.g., ginkgo), one or more alkaloids, one or more minerals, one or more vitamins, one or more dietary supplements, one or more nutraceuticals, one or more colorants, one or more amino acids, one or more sensates or chemesthetic agents. The oral pouch product may include one or more additional elements, one or more soothing agents, one or more botanicals (e.g., green tea), one or more tooth whitening agents (e.g., sodium hexametaphosphate (SHMP)), therapeutic agents, processing aids, stearates (e.g., magnesium and / or potassium), one or more waxes (e.g., glycerol monostearate, propylene glycol monostearate, and / or acetylated monoglycerides), one or more lubricants (e.g., sodium lauryl sulfate (SLS)), one or more preservatives (e.g., sodium benzoate), one or more fillers, one or more effervescent agents (e.g., flavors or carbon dioxide embedded within the fill material 104), or any combination thereof. The oral pouch product may include multiple additional elements. Additionally, a single element may belong to more than one of the above categories. In at least one exemplary embodiment, the filler material 104 includes one or more additives in an amount of about 0.01 weight percent or more (e.g., about 0.5 weight percent or more, about 1 weight percent or more, about 5 weight percent or more, about 10 weight percent or more, about 15 weight percent or more, about 20 weight percent or more, or about 25 weight percent or more). The filler material 104 can include one or more additives in an amount of about 30 weight percent or less (e.g., about 25 weight percent or less, about 20 weight percent or less, about 15 weight percent or less, about 10 weight percent or less, about 5 weight percent or less, about 1 weight percent or less, or about 0.5 weight percent or less).

[0101] In at least one exemplary embodiment, by way of example only, the one or more materials located within the internal cavity 106 as the fill material 104, including the one or more additives and / or one or more functional ingredients, may be provided in the form of a plurality of capsules, microcapsules, and / or beads of various sizes. The capsules, microcapsules, and / or beads may have a size determined by the desired size of the final product (e.g., oral pouch product 400). For example, the size of the capsules, microcapsules, and / or beads may range from about 0.1 mm to about 8 mm, depending on the ingredients included.

[0102] In each example, each capsule, microcapsule, and / or bead may include an outer shell and an inner core. Varying the thickness of the outer shell of the included capsules, microcapsules, and / or beads allows the ingredients included in each capsule, microcapsule, and / or bead to be released at different rates, thereby prolonging the flavor and / or functional experience of the oral pouch product 100. In some exemplary embodiments, the shell thickness ranges from about 0.1 mm to about 7 mm, depending on the size of the capsule, microcapsule, and / or bead and the desired dissolution rate. The capsules, microcapsules, and / or beads with the thinnest shells dissolve first, thereby releasing the encapsulated flavor and functional ingredients. Capsules, microcapsules, and / or beads with thicker shells dissolve at a slower rate, thereby providing longer flavor and functional ingredients.

[0103] In at least one exemplary embodiment, one or more of the ingredients in the fill material 104 may be provided as granules, such as encapsulated nicotine granules and / or encapsulated sweetener granules, as described in U.S. Patent Application Serial No. 17 / 223,773, which is incorporated herein by reference in its entirety.

[0104] In at least one exemplary embodiment, the additive comprises one or more mouth-dissolving polymers. As used herein, the term "mouth-dissolving" means that the polymer significantly degrades when exposed to saliva in the oral cavity for about 4 hours. In at least one exemplary embodiment, the mouth-dissolving polymer degrades when exposed to saliva for about 1 hour or less (e.g., about 30 minutes or less, about 15 minutes or less, about 10 minutes or less, or about 5 minutes or less) at normal human body temperature. The mouth-dissolving polymer may be biocompatible.

[0105] In at least one exemplary embodiment, the mouth-dissolving polymer is a cellulose polymer, such as carboxymethylcellulose ("CMC"), hydroxypropylcellulose ("HPC"), hydroxyethylcellulose ("HEC"), hydroxypropylmethylcellulose ("HPMC"), and / or methylcellulose ("MC"); a natural polymer, such as starch, modified starch, konjac, collagen, inulin, soy protein, whey protein, casein, and / or wheat gluten; a polymer derived from seaweed, such as carrageenan (e.g., kappa carrageenan, iota carrageenan, lambda carrageenan), alginate, glycerin, glyceryl stearate ... The composition may include, for example, glyceryl alginate, propylene glycol alginate, microbial polymers such as xanthan, dextran, pullulan, curdlan, and / or gellan, extracts such as locust bean gum, guar gum, tara gum, tragacanth gum, pectins (e.g., low methoxy and amidated), agar, zein, karaya, gelatin, psyllium seed, chitin, and / or chitosan, exudates such as acacia gum (gum arabic) and / or shellac, synthetic polymers such as polyvinylpyrrolidone, polyethylene oxide, and / or polyvinyl alcohol, or any combination thereof. Other useful mouth-soluble polymers are known in the art. See, e.g., Krochta et al., Food Technology 1997, 51:61-74. Glicksman, Food Hydrocolloids, CRC 1982, Korchta, 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 by reference in their entireties.

[0106] In at least one exemplary embodiment, the filler material 104 includes a plasticizer. The plasticizer may include one or more triglycerides (e.g., long chain, medium chain, and / or short chain), triacetin, propylene glycol, glycerin, vegetable oils, phthalates, one or more polycarboxylic acid esters with moderate chain length linear or branched aliphatic alcohols, or any combination thereof. The plasticizer may be present in addition to the triglycerides and / or other oils in the liquid mixture.

[0107] In at least one exemplary embodiment, the fill material 104 includes one or more activators. In at least one exemplary embodiment, the activators include caffeine, taurine, glucuronolactone, guarana, vitamin B6, vitamin B12, and the like. The caffeine may include synthetic caffeine and / or natural caffeine, such as caffeine extracted from coffee beans. In at least one exemplary embodiment, the oral pouch product includes caffeine in an amount of about 10 mg or more (e.g., about 25 mg or more, about 50 mg or more, about 75 mg or more, about 100 mg or more, about 150 mg or more). The amount of caffeine included may be about 200 mg or less (e.g., about 150 mg or less, about 100 mg or less, about 75 mg or less, about 50 mg or less, or about 25 mg or less).

[0108] In at least one exemplary embodiment, the filling material 104 includes a filler. The filler may be configured to change the texture or flexibility of the oral pouch product 100 as compared to an oral pouch product that does not include the filler. The filler may include elements that dissolve in the mouth, elements that do not dissolve in the mouth, or both elements that dissolve in the mouth and elements that do not dissolve in the mouth. The elements that dissolve in the mouth may be configured to dissolve or disintegrate when in the mouth of an adult consumer to make the oral pouch product more flexible. The filler may include dicalcium phosphate, calcium sulfate, one or more clays, silica, glass particles, glyceryl palmitostearate, sodium stearyl fumarate, talc, or any combination thereof. Additionally, some of the elements may also be classified as fillers, such as, for example, mouth-dissolving fiber, sweeteners, minerals, or any combination thereof. In at least one exemplary embodiment, a cellulosic material may be present as a filler in the oral pouch product 100 in addition to or instead of being present as a carrier for the liquid mixture.

[0109] The at least one sensate or chemesthetic agent may include mint, menthol, cinnamon, pepper, jambu, or any combination thereof. In some embodiments, the at least one sensate or chemesthetic agent may include any soothing, cooling, and / or warming agent. For example, the at least one sensate or chemesthetic agent may include capsaicin, pipelin, alpha hydroxy sanshool, and (8)-gingerol, which may be selected to provide a warm, tingling, or burning sensation. In other exemplary embodiments, the at least one sensate or chemesthetic agent may include menthol, menthyl lactate, WS-3 (N-ethyl-p-menthane-3-carboxamide), WS-23 (2-isopropyl-N-2,3-trimethylbutyramide), and Evercool 180® (available from Givaudan SA), which may be selected to provide a cooling sensation.

[0110] The at least one soothing agent may include, by way of example only, chamomile, lavender, jasmine, theanine, melatonin, soursop, cannabidiol, or any combination thereof.

[0111] In at least one exemplary embodiment, the pouch wrapper 102 includes an outer web 108. The outer web 108 may be formed from a material that is generally recognized as safe for use with and / or in contact with food ("GRAS"). The material may be stain resistant, water permeable, and / or porous. The outer web 108 may have a thickness of about 0.05 mm to about 0.25 mm (e.g., about 0.075 mm to about 0.100 mm, or about 0.1 mm to about 0.20 mm). The outer web 108 may be formed from a permeable or semi-permeable material, such as a material that allows saliva, water, or both saliva and water to pass through the outer web 108 and into the interior cavity 406 defined by the pouch wrapper 108. Flavors and juices formed by mixing saliva and / or water with the fill material 104 contained within the oral pouch product 100 can be drawn from the oral pouch product 100 via the exterior web 108 .

[0112] In at least one exemplary embodiment, the wrapper 102 comprises a nonwoven material. The nonwoven material may be formed of a polymer, including one or more synthetic and / or natural polymers. For example, the wrapper 402 may be formed of a mesh material formed of spun or meltblown fibers, such as polyurethane fibers as described in U.S. Pat. Nos. 10,448,669, 10,463,070, and / or 9,414,624, all of which are incorporated herein by reference in their entirety. The mesh material may be at least partially elastomeric. The mesh material may be white and may exclude any adhesive agent. In other exemplary embodiments, the mesh material may include a colorant. Additionally, due to the material used to form the wrapper 102, the oral pouch product 100 may eliminate seams to provide a softer pouch.

[0113] In at least one exemplary embodiment, the basis weight of the mesh material is about 10 grams per square meter ("gsm") or more (e.g., about 15 gsm or more, about 20 gsm or more, about 25 gsm or more, about 30 gsm or more, about 35 gsm or more, about 40 gsm or more, or about 45 gsm or more). The basis weight can be about 50 gsm or less (e.g., about 45 gsm or less, about 40 gsm or less, about 35 gsm or less, about 30 gsm or less, about 25 gsm or less, about 20 gsm or less, or about 15 gsm or less). In at least one exemplary embodiment, the basis weight ranges from about 20 gsm to about 30 gsm.

[0114] In at least one other exemplary embodiment, the outer web 108 comprises paper. For example, the outer web 108 can be formed of a cellulose fiber material, such as a tea bag material or other material typically used to form snus pouches. In at least one exemplary embodiment, the outer web 408 has a desired (or predetermined) level of basis weight and / or wet strength to reduce breakage of the pouch wrapper 102 during manufacturing, storage, and in the mouth of an adult consumer. For example, the outer web 108 can include a tea bag material having a basis weight of about 16.5 gsm and a wet tensile CD strength of 68 N / m. In another exemplary embodiment, the outer web 108 can be formed of a paper having a wet MD tensile strength of about 45 N / mm to about 52 N / mm.

[0115] In at least one exemplary embodiment, the outer web 108 is formed of a hydrophobic paper or material. The hydrophobic paper may be formed of a cellulosic material. The hydrophobic paper may be a nonwoven material and may include any hydrophobic material. The hydrophobic material may be a synthetic material and / or a semi-synthetic material. The hydrophobic material may include viscose, rayon, lyocell, and / or modal fibers. The outer web 108 may be treated to be hydrophobic. In another exemplary embodiment, the hydrophobic material may be a woven material.

[0116] In at least one exemplary embodiment, the wrapper 102 does not include added coloring agents. In at least one exemplary embodiment, the wrapper 102 is white due to the natural color of the polymer used to form it. However, in other exemplary embodiments, the wrapper 402 may be colored to indicate the flavor of the fill material 404 contained therein. The color of the wrapper 402 may be selected to identify its contents. For example, a green pouch wrapper may be used to identify an oral pouch product that includes a mint flavoring, and a red pouch wrapper may be used to identify an oral pouch product that includes cinnamon.

[0117] The materials used to form the outer web 108 may have a neutral or pleasant taste and / or aroma. In at least one exemplary embodiment, the outer web 108 may be impregnated or coated with at least one flavoring, at least one cannabis material, at least one tobacco material, at least one binder, at least one sensate or chemesthetic agent, at least one functional ingredient, at least one saliva-inducing ingredient, or any combination thereof, to enhance the flavor of the fill material 104 contained within the oral pouch product 100. A substantially continuous coating including the at least one flavoring, and / or the at least one cannabis material, and / or the at least one tobacco material, and / or the at least one binder, and / or the at least one sensate or chemesthetic agent may be coated on the outer (outwardly facing) surface of the outer web 108. In at least one exemplary embodiment, the coating may be formed on only a portion of the outer web 108, such as only along the seams or only on one side of the oral pouch product 100. The coating may provide a strong initial flavor upon placement of the oral pouch product 100 in the oral cavity, while the inner fill material 104 may release flavor later, thereby providing a longer release of flavor while the oral pouch product is in the mouth of an adult consumer.

[0118] The at least one flavor can be any of the flavors disclosed herein for inclusion in the fill material 102. In at least one exemplary embodiment, the at least one flavor can be coated or impregnated into the outer web 408 in an amount ranging from about 0.01 weight percent to about weight percent (e.g., 0.1 weight percent to about 4.5 weight percent, about 1 weight percent to about 4 weight percent, about 1.5 weight percent to about 3.5 weight percent, about 2 weight percent to about 3 weight percent) based on the weight of the oral pouch product 100.

[0119] In at least one exemplary embodiment, the at least one cannabis or tobacco material may be coated or impregnated into the outer web 108. The at least one cannabis or tobacco material may include, by way of example only, ground cannabis or tobacco material, cannabis or tobacco plant fiber, and / or any extract thereof. The at least one cannabis or tobacco material may be coated or impregnated into the outer web 108 in an amount ranging from about 0.01 weight percent to about 5 weight percent (e.g., from about 0.1 weight percent to about 4.5 weight percent, from about 1 weight percent to about 4 weight percent, from about 1.5 weight percent to about 3.5 weight percent, or from about 2 weight percent to about 3 weight percent) based on the weight of the oral pouch product 100.

[0120] In at least one exemplary embodiment, the at least one binder may be coated or impregnated into the outer web 108. The at least one binder may be a food grade adhesive, gum, or other binder. For example, in some exemplary embodiments, the at least one binder may include, but is not limited to, sodium alginate, sugar, agar, guar gum, and the like. The at least one binder may be coated or impregnated into the outer web in an amount ranging from about 0.01 weight percent to about 5 weight percent (e.g., 0.1 weight percent to about 4.5 weight percent, about 1 weight percent to about 4 weight percent, about 1.5 weight percent to about 3.5 weight percent, about 2 weight percent to about 3 weight percent) based on the weight of the oral pouch product 100.

[0121] The at least one sensate or chemesthetic agent can be any of those described above with respect to the filling material 104. The at least one sensate or chemesthetic agent can be coated or impregnated into the outer web 108 in an amount ranging from about 0.01 weight percent to about 5 weight percent (e.g., 0.1 weight percent to about 4.5 weight percent, about 1 weight percent to about 4 weight percent, about 1.5 weight percent to about 3.5 weight percent, or about 2 weight percent to about 3 weight percent) based on the weight of the oral pouch product 100.

[0122] In at least one exemplary embodiment, the at least one functional ingredient may include an antioxidant, a soothing agent, an activator, an effervescent agent, or any combination thereof, such as those described above with respect to the fill material 102. In at least one exemplary embodiment, the at least one functional ingredient may be coated or impregnated into the outer web 108 in an amount ranging from about 0.01 weight percent to about 5 weight percent (e.g., 0.1 weight percent to about 4.5 weight percent, about 1 weight percent to about 4 weight percent, about 1.5 weight percent to about 3.5 weight percent, or about 2 weight percent to about 3 weight percent) based on the weight of the oral pouch product 100.

[0123] The oral pouch product 100 may be, by way of example only, a generally rectangular shape, a ravioli or pillow shape, an oval shape, or any other suitable shape. A variety of shapes may be used so long as they fit comfortably and unobtrusively in the mouth of an adult consumer. In at least one exemplary embodiment, the oral pouch product 100 is substantially free of oral irritants. As used herein, oral irritants means that none of the shapes, structures, and locations of the oral pouch product 100 will irritate tissues in the oral cavity (e.g., gums) with sharp edges or the like. Additionally, the terms "substantial" and "substantially free" used with respect to oral irritants means that none of the shapes, structures, and locations of the oral pouch product 100 will irritate tissues in the oral cavity (e.g., gums) for a length of time comparable to the typical length of time an adult consumer may enjoy the oral pouch product 100. Generally, sharp corners are avoided as they may cause discomfort in the mouth.

[0124] The oral pouch product 100 may be sized and configured to fit comfortably in an adult consumer's mouth, e.g., between the cheek and gums. In at least one exemplary embodiment, the major dimension of the oral pouch product 100 ranges from about 0.20 inches to about 2.0 inches (e.g., about 0.25 inches to 1.75 inches, about 0.75 inches to about 1.5 inches) and the lateral dimension ranges from about 0.25 inches to about 1.5 inches (e.g., about 0.50 inches to 1.25 inches, about 0.75 inches to about 1.0 inches). The weight of the oral pouch product 100 may range from about 0.25 grams (g) to about 2.0 grams (e.g., about 0.3 grams to about 1.8 grams, about 0.4 grams to about 1.5 grams, about 0.5 grams to about 1.25 grams, or about 0.75 grams to about 1.0 grams).

[0125] The oral pouch product 100 can remain in the mouth of an adult consumer for about 1 minute to about 3 hours (e.g., about 1 minute to about 2 hours, about 5 minutes to about 90 minutes, about 10 minutes to about 60 minutes, about 20 minutes to about 40 minutes). The size of the oral pouch product 100 can be selected based on the length of time it is desired to remain in the mouth of an adult consumer. For example, a larger pouch containing a larger amount of fill material can remain in for a longer period of time. In at least one exemplary embodiment, the oral pouch product 100 is discarded after being placed in the mouth of an adult consumer once.

[0126] FIG. 2A is a perspective view of an oral pouch product in accordance with at least one exemplary embodiment.

[0127] FIG. 2B is a cross-sectional view of an oral pouch product taken along line II-II of FIG. 2A in accordance with at least one exemplary embodiment.

[0128] FIG. 2C is a cross-sectional view of an oral pouch product taken along line III-III of FIG. 2A in accordance with at least one exemplary embodiment.

[0129] In at least one exemplary embodiment, as shown in Figures 2A-2C, an oral pouch product 200 is the same as that shown in Figures 1A and 1B, except that the pouch wrapper 202 includes one or more seals or seams, such as a longitudinal seal 204 and a fin seal 206. The longitudinal seal 204 extends between the fin seal 206. In at least one exemplary embodiment, as shown in Figure 2C, the longitudinal seal 204 includes overlapping edges of an outer web 208 that are bonded together. In at least one exemplary embodiment, the dimensions of the seals 204 and 206 are less than about 1 mm. The sealing function can be achieved by bonding the overlapping edges together with a food grade adhesive or using heat or sonic techniques.

[0130] In at least one exemplary embodiment, as shown in FIG. 2B, the opposing layers of exterior web 208, longitudinal seal 204, and fin seal 206 define an interior cavity 210 therebetween. The filler material 212 may be the same as that shown in FIGS. 1A and 1B, but may be retained within interior cavity 210. In at least one exemplary embodiment, filler material 212 completely fills interior cavity 210 of oral pouch product 200. In other exemplary embodiments, filler material 210 only partially fills interior cavity 210 of oral pouch product 200.

[0131] As shown in FIG. 2B, each fin seal 206 is formed by overlapping an inner surface of the outer web 208 of the pouch wrapper 202 with another portion of the inner surface of the outer web 208 into a fin seal. The fin seal can then be sealed using any of the methods detailed above, thereby forming the fin seal 206. Although not shown, in some embodiments, an integrated fin and longitudinal seal can be used, as one skilled in the art would recognize. By overlapping the fin seal, the oral pouch product 200 can be more comfortable when inserted into the mouth of an adult consumer because there are no loose, unattached edges that can protrude out and catch in the consumer's mouth during enjoyment. Additionally, the integrated fin and longitudinal seal can be stronger, thereby reducing and / or preventing collapse of the oral pouch product 200 during manufacturing, packaging, shipping, placement in the mouth, and / or use.

[0132] FIG. 3A is a side view of an oral pouch product in accordance with at least one exemplary embodiment.

[0133] FIG. 3B is a side view of the oral pouch product taken along line VIII-VIII of FIG. 3A in accordance with at least one exemplary embodiment.

[0134] In at least one exemplary embodiment, as shown in Figures 3A and 3B, the oral pouch product 300 is the same as that shown in Figures 1A and 1B, except that the oral pouch product 300 has a single seam or seal 302 along the pouch wrapper 304. In at least one exemplary embodiment, as shown, the oral pouch product 300 has a half-moon shape. In some exemplary embodiments, the oral pouch product 300 has a D-shape, a boomerang shape, a crescent shape, or other shape.

[0135] In at least one exemplary embodiment, the pouch wrapper 304 can be sealed along a seam or seal 302 to define an interior cavity 306 configured to contain or retain a fill material 308, as described with reference to Figures 1A and 1B. The single seam or seal 302 can be formed by overlapping an inner surface of an outer web 310 of the pouch wrapper 304 with another portion of the inner surface of the outer web 310. The sealing function can be achieved by a food grade adhesive or by bonding adjacent portions together using heat or sonic techniques.

[0136] A liquid mixture of oil and nicotine In at least one exemplary embodiment, the oral pouch product of Figures 1-3 includes a liquid mixture that includes oil and nicotine, as described below.

[0137] 4A to 4C show the chemical structures of the various forms.

[0138] Nicotine, or 3-(1-methyl-2-pyrrolidinyl)pyridine, is a tertiary amine. Under ambient conditions, nicotine is an oily, volatile, and hygroscopic liquid. In this state, nicotine is the free base (unprotonated) and has the structure shown in Figure 4A. Free base nicotine has a pK of approximately 8. a It has a value.

[0139] Nicotine can also be in the form of a complex or salt. Nicotine complexes and salts can be provided in a solid form, such as a powder. One example of a nicotine complex used in oral pouch products is nicotine polacrilex. In the salt form, nicotine is monoprotonated, as shown in FIG. 4B, or diprotonated, as shown in FIG. 4C. Monoprotonated and diprotonated nicotine have a higher pK than free base nicotine. aThe nicotine salts may include nitrate, tartrate, bitartrate, bitartrate dihydrate, salicylate, sulfate or bisulfate, phosphate or acid phosphate, acetate, lactate, succinate, maleate, fumarate, gluconate, saccharate, benzoate, methanesulfonate, hydrochloride, hydrobromide, hydroiodide, or any combination thereof.

[0140] Oral pouch products such as those described with reference to Figures 1 to 3 often contain nicotine in a complex or salt form, for manufacturing, handling and stability reasons. However, nicotine has a higher pK a It is believed that nicotine is more readily absorbed by the buccal mucosa at these protonated values. Thus, an oral pouch product containing nicotine in a protonated state may further include a pH adjuster to provide a more basic environment within the oral pouch product.

[0141] In at least one exemplary embodiment, the oral pouch product includes a liquid mixture of nicotine and oil. The oil may include one or more triglycerides, one or more diglycerides, one or more monoglycerides, triacetin, triolein, trilinolein, vegetable oil, one or more partially hydrogenated oils, or any combination thereof. The triglycerides may include one or more short chain triglycerides ("SCT"), one or more medium chain triglycerides ("MCT"), one or more long chain triglycerides ("LCT"), or any combination thereof.

[0142] Oral pouch products containing a liquid mixture may be configured to provide increased buccal mucosal absorption as compared to oral pouch products containing aqueous nicotine, nicotine complexes, and / or nicotine salts. The nicotine may be liquid nicotine. At least a portion of the liquid nicotine may dissolve in the oil, thereby forming a solution of the oil and the liquid nicotine. In at least one exemplary embodiment, the entirety of the liquid nicotine dissolves in the oil. In at least one exemplary embodiment, the liquid mixture may consist essentially of liquid nicotine and oil (e.g., a triglyceride such as medium chain triglyceride (MCT)).

[0143] The weight ratio of oil (e.g., triglyceride) to nicotine in the liquid mixture can be about 1:1 or more (e.g., about 3:2 or more, about 2:1 or more, about 3:1 or more, about 4:1 or more, about 5:1 or more, about 6:1 or more, about 7:1 or more, about 8:1 or more, about 9:1 or more, or about 10:1 or more). The weight ratio can be about 95:5 or less (e.g., about 9:1 or less, about 8:1 or less, about 7:1 or less, about 6:1 or less, about 5:1 or less, about 4:1 or less, about 3:1 or less, or about 3:2 or less). In at least one exemplary embodiment, the weight ratio ranges from about 1:1 to about 9:1 (e.g., about 3:2 to about 4:1, about 3:1 to about 5:1, or 4:1).

[0144] In at least one exemplary embodiment, the oral pouch product may include additional oils other than those present in the liquid mixture. In at least one exemplary embodiment, the additional oils may be used as plasticizers. The ratio of oil to liquid nicotine (i.e., both the liquid mixture and the additional oils) in the oral pouch product may be about 1:1 or more (e.g., about 3:2 or more, about 2:1 or more, about 3:1 or more, about 4:1 or more, about 5:1 or more, about 6:1 or more, about 7:1 or more, about 8:1 or more, about 9:1 or more, about 10:1 or more, about 15:1 or more, about 20:1 or more, about 25:1 or more, about 30:1 or more, about 40:1 or more, about 50:1 or more, about 60:1 or more, about 70:1 or more, about 75:1 or more, or about 80:1 or more). The weight ratio of oil to liquid nicotine can be about 100:1 or less (e.g., about 90:1 or less, about 80:1 or less, about 75:1 or less, about 70:1 or less, about 60:1 or less, about 50:1 or less, about 40:1 or less, about 30:1 or less, about 25:1 or less, about 20:1 or less, about 15:1 or less, about 10:1 or less, about 9:1 or less, about 8:1 or less, about 7:1 or less, about 6:1 or less, about 5:1 or less, about 4:1 or less, about 3:1 or less, about 2:1 or less, or about 3:2 or less).

[0145] 5A and 5B are graphs showing how various nicotine solutions are disposed inside the cheek.

[0146] In at least one exemplary embodiment, providing nicotine dissolved in an oil, such as a triglyceride, may facilitate easier absorption into the inner cheek compared to nicotine in an aqueous phase. Providing nicotine dissolved in a triglyceride, with or without a pH modifier, is believed to facilitate retaining at least a portion of the nicotine in a free base state.

[0147] As shown in Figures 5A and 5B, three solutions are prepared according to Table 1 below. The amounts in Table 1 are weight percent. Solution A contains 0.5 mg of liquid nicotine in water at pH 7. Solution B contains 0.5 mg of liquid nicotine in water at pH 10. Solution C contains 0.5 mg of liquid nicotine in MCT oil. [Table 1]

[0148] To determine the amount of nicotine absorbed relative to the amount of nicotine not absorbed, each of solutions A, B and C is held in the oral cavity of an adult smoker. Five adult smokers participate. Expectorant samples are collected from each of the five adult smokers for each of the three solutions at three time intervals. The time intervals are 0-1 min, 1-5 min and 5-10 min. Each expectorant sample is analyzed to determine the weight of nicotine in the expectorant sample. The nicotine measured in the expectorant sample is necessarily not absorbed by the buccal mucosa. The amount of nicotine absorbed is calculated for each solution based on the difference between the known amount of nicotine in each solution and the measured amount of nicotine in each expectorant sample. This is described in more detail below.

[0149] Solution A contains 0.5 mg of nicotine. A first expectorant sample 500 of solution A is collected from 0 to 1 minute and contains 57 weight percent of 0.5 mg of nicotine. A second expectorant sample 502 of solution A is collected from 1 to 5 minutes and contains 18 weight percent of 0.5 mg of nicotine. A third expectorant sample 504 of solution A is collected from 5 to 10 minutes and contains 5 weight percent of 0.5 mg of nicotine. Thus, the nicotine absorbed 506 from solution A is calculated to be 20 weight percent (100%-57%-18%-5%=20%).

[0150] Solution B contains 0.5 mg of nicotine. A first expectorant sample 510 of Solution B was collected from 0 to 1 minute and contains 50 weight percent of 0.5 mg of nicotine. A second expectorant sample 512 of Solution B was collected from 1 to 5 minutes and contains 19 weight percent of 0.5 mg of nicotine. A third expectorant sample 514 of Solution B was collected from 5 to 10 minutes and contains 6 weight percent of 0.5 mg of nicotine. Thus, the nicotine absorbed 516 from Solution B is calculated to be 25 weight percent (100%-50%-19%-6%=25%).

[0151] Solution C contains 0.5 mg of nicotine. A first expectorant sample 520 of Solution C was collected from 0 to 1 minute and contains 38 weight percent of 0.5 mg of nicotine. A second expectorant sample 522 of Solution C was collected from 1 to 5 minutes and contains 22 weight percent of 0.5 mg of nicotine. A third expectorant sample 524 of Solution C was collected from 5 to 10 minutes and contains 5 weight percent of 0.5 mg of nicotine. Thus, the nicotine absorbed 56 from Solution C is calculated to be 35 weight percent (100%-38%-22%-5%=35%).

[0152] As shown by the difference in behavior between solutions A and B, increasing the pH of the aqueous solution, such as solution B, allows nicotine to be more easily absorbed into the inner cheek. For example, increasing the pH of the aqueous environment may facilitate retention of nicotine in the free base phase. As shown by the difference in behavior between solutions A / B and C, providing nicotine in MCT, such as solution C, allows nicotine to be more easily absorbed into the inner cheek than providing nicotine in an aqueous phase. Furthermore, as shown by the difference in behavior between solutions B and C, providing nicotine in MCT, such as solution C, allows nicotine to be more easily absorbed into the inner cheek than providing nicotine in an aqueous phase containing a pH modifier. As shown in FIG. 5B, the amount of nicotine absorbed from solution C is greater than the amount of nicotine absorbed from each of solutions A and B.

[0153] Figure 6A is a table showing partition coefficient data for nicotine in various combinations of oil and water phases. Figure 6B shows the chemical structure of triacetin (C2). Figure 6C shows the chemical structure of MCT (C8-C10). Figure 6D shows the chemical structure of triolein (C18).

[0154] As shown in FIG. 6A, nicotine has solubility in both oil and water. Each of Samples 1 to 8 is prepared and measured according to the following method: Liquid nicotine is added to a container containing an oil phase at a target nicotine concentration. The oil phase containing nicotine is mixed with the water phase. Mixing is performed using an orbital shaker at 100 revolutions per minute (rpm) in a 1:1 volume ratio (v:v) for about 5 minutes. This prepares a nicotine oil:water phase mixture. The nicotine oil:water phase mixture is allowed to stand at room temperature (about 25° C.) for about 24 hours. The concentration of nicotine in each of the oil and nicotine phases is measured using a liquid chromatography method. The partition coefficient, which is the ratio of the concentrations of a compound (i.e., nicotine) in two immiscible solvents (i.e., oil and water phases) at equilibrium, is calculated for each sample. The partition coefficient compares the solubility of nicotine in the two liquid phases.

[0155] Samples 1 to 6 contain MCT oil (CAS No. 73398-61-5) as the oil phase. Sample 7 contains triacetin oil as the oil phase. Sample 8 contains triolein as the oil phase. Sample 1 contains deionized (DI) water as the aqueous phase. Sample 2 contains basified DI with pH 7.4 as the aqueous phase. Sample 3 contains artificial saliva with pH 6.8 as the aqueous phase. The artificial saliva stimulates mucosal conditions. Sample 4 contains acidified DI water with pH 2 as the aqueous phase. Samples 5 to 8 contain 1M acetic acid pH adjuster with pH 2 as the aqueous phase. The acetic acid pH adjuster stimulates gastric conditions.

[0156] For each of samples 5 to 8, the partition coefficient is less than 1, indicating that the solubility of nicotine in the acetic acid pH adjuster is higher than that in the respective oil phase. This is believed to be caused by the protonation of nicotine and higher electrostatic interactions. For each of samples 1 to 4, the partition coefficient is greater than 1, indicating that the solubility in MCT oil is higher than that in the respective aqueous phase. However, in all samples, at least a portion of the nicotine is dissolved in the aqueous phase. Therefore, if water is present in the liquid mixture, at least a portion of the nicotine will be dissolved in the aqueous phase.

[0157] In at least one exemplary embodiment, the oral pouch product includes water. The oral pouch product includes water in an amount of about 10 weight percent or less (e.g., about 8 weight percent or less, about 5 weight percent or less, about 3 weight percent or less, about 2 weight percent or less, about 1 weight percent or less, about 0.5 weight percent or less). In at least one exemplary embodiment, the oral pouch product does not include water.

[0158] In at least one exemplary embodiment, the liquid mixture includes water, but in an amount of about 5 weight percent or less (e.g., about 4 weight percent or less, about 3 weight percent or less, about 2 weight percent or less, about 1 weight percent or less, about 0.5 weight percent or less, or about 0.25 weight percent or less). In at least one exemplary embodiment, water is not intentionally added to the liquid mixture. However, small amounts of water may contact the liquid mixture through other elements of the oral pouch product. In at least one exemplary embodiment, the liquid mixture does not include water. By limiting the amount of water and / or eliminating water, the amount of nicotine dissolved in the triglycerides may be easily increased. Thus, oral pouch products having a liquid mixture may be configured to be more easily absorbed into the inside of the cheek than oral pouch products that include all or part of the nicotine in the aqueous phase.

[0159] As mentioned above, in at least one exemplary embodiment, the nicotine can be liquid nicotine. The free base nicotine can be about 50 weight percent or more (e.g., about 55 weight percent or more, about 60 weight percent or more, about 65 weight percent or more, about 70 weight percent or more, about 75 weight percent or more, about 80 weight percent or more, about 85 weight percent or more, about 90 weight percent or more, about 95 weight percent or more, about 98 weight percent or more, or about 99 weight percent or more). In at least one exemplary embodiment, more than 80 weight percent of the nicotine is free base nicotine. In at least one exemplary embodiment, the entire nicotine is free base nicotine.

[0160] In at least one exemplary embodiment, the nicotine is tobacco-derived nicotine, synthetic nicotine, or both tobacco-derived nicotine and synthetic nicotine. In at least one exemplary embodiment, the oral pouch product contains nicotine in an amount of about 0.1 mg or more (e.g., about 1 mg or more, about 2 mg or more, about 4 mg or more, about 6 mg or more, about 8 mg or more, about 10 mg or more, about 12 mg or more). The oral pouch product may contain nicotine in an amount of about 14 mg or less (e.g., about 12 mg or less, about 10 mg or less, about 8 mg or less, about 6 mg or less, about 4 mg or less, about 2 mg or less, or about 1 mg or less). In at least one exemplary embodiment, the oral pouch product contains liquid nicotine in an amount ranging from 0.1 mg to about 14 mg (e.g., about 2 mg to about 10 mg, about 4 mg to about 8 mg, or about 5 mg to about 6 mg).

[0161] As described above, the oil may include one or more monoglycerides, one or more diglycerides, one or more triglycerides, triacetin, triolein, trilinolein, vegetable oil, one or more partially hydrogenated oils, or any combination thereof. The triglycerides may include one or more LCTs, one or more MCTs, one or more SCTs, or any combination thereof. In at least one exemplary embodiment, the oil includes one or more monoglycerides, one or more diglycerides, one or more triglycerides, or any combination thereof. In at least one exemplary embodiment, the oil includes one or more triglycerides. In at least one exemplary embodiment, the triglycerides include MCTs. In at least one exemplary embodiment, the liquid mixture further includes triacetin, triolein, trilinolein, vegetable oil, partially hydrogenated oils, or any combination thereof.

[0162] In at least one exemplary embodiment, the oral pouch product includes an oil (e.g., a triglyceride) in an amount by weight of about 1 percent or more (e.g., about 2 percent or more, about 3 percent or more, about 4 percent or more, about 5 percent or more, about 10 percent or more, about 15 percent or more, about 20 percent or more, about 25 percent or more, about 30 percent or more, about 40 percent or more, about 50 percent or more, about 60 percent or more, about 70 percent or more, about 80 percent or more, or about 90 percent or more). In at least one exemplary embodiment, the oral pouch product may include oil (e.g., triglycerides) in an amount of about 95 weight percent or less (e.g., about 90 weight percent or less, about 80 weight percent or less, about 70 weight percent or less, about 60 weight percent or less, about 50 weight percent or less, about 40 weight percent or less, about 30 weight percent or less, about 20 weight percent or less, about 15 weight percent or less, about 10 weight percent or less, about 7 weight percent or less, or about 5 weight percent or less). In at least one exemplary embodiment, the oral pouch product includes oil (e.g., triglycerides) in an amount ranging from 10 weight percent to 50 weight percent. In at least one exemplary embodiment, the oral pouch product is a solid form that includes oil (e.g., triglycerides) in an amount of about 50 weight percent or less.

[0163] Method for manufacturing oral pouch products FIG. 7 is a flowchart illustrating a method for making a pouch product in accordance with at least one exemplary embodiment.

[0164] As shown in Figure 7, the method of preparing the fill material optionally includes, in S700, preparing a standard API solution. The standard API solution includes an API, such as liquid nicotine, dissolved in an oil, such as MCT, in a desired (or predetermined) weight ratio. In at least one exemplary embodiment, the desired weight ratio is about 20:80 (1:4) or more (e.g., about 25:75 or more, about 30:70 or more, about 35:65 or more, about 40:60 (2:3) or more, about 45:55 or more, about 50:50 or more, about 55:45 or more, about 60:40 or more, about 65:35 or more, about 70:30 or more, or about 75:25 or more). Desirable weight ratios are about 80:20 or less (e.g., about 75:25 or less, about 70:30 or less, about 65:35 or less, about 60:40 or less, about 55:45 or less, about 50:50 or less, about 45:50 or less, about 40:60 or less, about 35:65 or less, about 30:70 or less, or about 25:75 or less).

[0165] At S704, the method may include preparing a liquid preblend. In at least one exemplary embodiment, the liquid preblend includes an API, an oil, and an antioxidant. In at least one exemplary embodiment, the liquid preblend may be prepared by providing a standard API solution in an amount suitable to achieve a desired API content in the pouch product (i.e., to prepare a product with a higher API dose, more standard API solution is provided). Additional oil may be added to the standard API solution to achieve a desired liquid content in the fill material. An antioxidant, e.g., a liquid antioxidant, may also be added to the oil and API. The amount of antioxidant may be selected based on the amount of API.

[0166] At S708, the method may include preparing a dry preblend. In at least one exemplary embodiment, preparing the dry preblend includes mixing insoluble materials, water soluble fillers, pH adjusters, dry flavors, dry antioxidants, plant materials (e.g., cannabis and / or tobacco plant materials), emulsifiers, and / or surfactants, and / or other dry additives.

[0167] At S712, the method may include mixing the liquid preblend with the dry preblend. In at least one exemplary embodiment, one or more of water activity, pH, oven volatility, bulk density, solubility, flowability, and API content are monitored at one or more points during the preparation of the oral pouch product. Mixing the liquid preblend with the dry preblend may include delivering the liquid preblend with an atomized spray. The ingredients may be mixed in a ribbon blender, or the like. The weight ratio of dry ingredients to liquid ingredients may be as described above with reference to Figures 1A and 1B.

[0168] At S716, the method may optionally include adding water-based additives, such as flavorings, which may be added by spraying and / or pouring, as appropriate, while mixing, such as in a ribbon blender. In at least one exemplary embodiment, the dry pre-blend is continuously agitated while the liquid pre-blend is added at S712 and the water-based additives are added at S716.

[0169] At S720, the method may include pouching the fill material. Pouching the fill material may generally include forming a wrapper in an open pouch using a vertical or horizontal filling machine and filling the open pouch with the fill material. The pouch may then be sealed to contain the fill material and form an oral pouch product. In at least one exemplary embodiment, a series of oral pouch products are formed with spaces between adjacent pouch product seals and then cut into individual pouch products. For example, the oral pouch products may be cut by a die at locations between adjacent seals to form soft edges on each pouch product. Alternatively, a first strip of pouch wrapper may be advanced along the feed path, the fill material may be placed on the strip, and a second strip may be placed on the first strip. A sealing die may be used to press the two strips together to form a seam, such as a heat seal or adhesive seal, around the fill material. A cuffing die can be used to cut the first and second strips outboard of the seam to create a soft edge.

[0170] Although certain illustrative embodiments have been described herein, it should be understood that other variations are possible, and such variations should not be considered a departure from the spirit and scope of the present disclosure, and it is intended that all modifications obvious to those skilled in the art be included within the scope of the following claims.

[0171] Although described with reference to specific examples and drawings, various modifications, additions, and substitutions of the exemplary embodiments may be made as described by those skilled in the art, for example, the techniques described above may be performed in a different order than described above, and / or the components of the systems, structures, devices, circuits, etc. described above may be connected or combined in a different manner than described above, or other elements or equivalents may be used to achieve results as appropriate.

Claims

1. An oral pouch product, comprising: a wrapper defining a cavity; a filler material in the cavity; the fill material comprises a dry mix and a liquid mix; The dry mixture comprises: a cellulose material; and a water-soluble filler, The liquid mixture an oil comprising a triglyceride, a diglyceride, a monoglyceride, or any combination thereof; and liquid nicotine dissolved in said oil, the filler material is free of water or contains water in an amount of 5 weight percent or less; the filler material is free of propylene glycol or contains propylene glycol in an amount of 1 weight percent or less; Oral pouch products.

2. 10. The oral pouch product of claim 1, wherein the fill material is glycerin-free and propylene glycol-free.

3. 10. The oral pouch product of claim 1, wherein the cellulosic material comprises microcrystalline cellulose (MCC).

4. 4. The oral pouch product of claim 3, wherein the MCC comprises particles having a size ranging from 100 microns to 300 microns.

5. 4. The oral pouch product of claim 3, wherein the MCC is wood pulp-derived MCC.

6. 10. The oral pouch product of claim 1, wherein the filler material comprises the cellulosic material in an amount ranging from 10 weight percent to 70 weight percent.

7. 7. The oral pouch product of claim 6, wherein the filler material comprises the cellulosic material in an amount ranging from 30 weight percent to 60 weight percent.

8. 10. The oral pouch product of claim 1, wherein the fill material comprises the oil in an amount ranging from 10 percent to 50 percent by weight.

9. 9. The oral pouch product of claim 8, wherein the fill material comprises the oil in an amount ranging from 15 weight percent to 25 weight percent.

10. 10. The oral pouch product of claim 1, wherein the oil consists essentially of triglycerides, diglycerides, monoglycerides, or any combination thereof.

11. 10. The oral pouch product of claim 1, wherein the oil comprises the triglyceride.

12. 12. The oral pouch product of claim 11, wherein the triglyceride comprises a medium chain triglyceride.

13. 10. The oral pouch product of claim 1, wherein the filling material comprises the water-soluble filler in an amount ranging from 10 weight percent to 50 weight percent.

14. 10. The oral pouch product of claim 1, wherein the water-soluble filler comprises a sugar alcohol, a sugar, a maltodextrin, a starch, a polysaccharide, or any combination thereof.

15. 15. The oral pouch product of claim 14, wherein the water-soluble filler comprises the sugar alcohol.

16. 16. The oral pouch product of claim 15, wherein the fill material comprises the sugar alcohol in an amount ranging from 15 weight percent to 25 weight percent.

17. 16. The oral pouch product of claim 15, wherein the sugar alcohol comprises xylitol.

18. 10. The oral pouch product of claim 1, wherein the fill material further comprises a pH adjuster.

19. 20. The oral pouch product of claim 18, wherein the pH adjuster comprises sodium bicarbonate.

20. 10. The oral pouch product of claim 1, wherein the fill material further comprises an antioxidant.

21. 21. The oral pouch product of claim 20, wherein the antioxidant comprises tocopherol or a tocopherol derivative, ascorbic acid, an ascorbic acid derivative, tert-butylhydroquinone, or any combination thereof.

22. 21. The oral pouch product of claim 20, wherein the fill material comprises the antioxidant in an amount less than 2 weight percent.

23. 10. The oral pouch product of claim 1, wherein the fill material further comprises a flavoring.

24. 24. The oral pouch product of claim 23, wherein the fill material comprises the flavoring agent in an amount less than 10 percent by weight.

25. 25. The oral pouch product of claim 24, wherein the fill material comprises the flavoring agent in an amount ranging from 0.1 weight percent to 5 weight percent.

26. 10. The oral pouch product of claim 1, wherein the fill material comprises the liquid nicotine in an amount ranging from 0.1 weight percent to 10 weight percent.

27. 10. The oral pouch product of claim 1, wherein the liquid nicotine comprises nicotine derived from tobacco.

28. 10. The oral pouch product of claim 1, wherein the liquid nicotine comprises synthetic nicotine.

29. 10. The oral pouch product of claim 1, wherein the wrapper comprises an elastomer.

30. 30. The oral pouch product of claim 29, wherein the elastomer is white.

31. 30. The oral pouch product of claim 29, wherein the elastomer comprises polyurethane.

32. 30. The oral pouch product of claim 29, wherein the wrapper has a basis weight in the range of 20 grams per meter (gsm) to 30 gsm.

33. An oral pouch product, comprising: a wrapper defining a cavity and a filler material within the cavity; the wrapper comprises an elastomer; the fill material comprises a dry mix and a liquid mix; The dry mixture comprises: a cellulose material; and a water-soluble filler, The liquid mixture an oil comprising a triglyceride, a diglyceride, a monoglyceride, or any combination thereof; and liquid nicotine dissolved in said oil, the filler material is free of water or contains water in an amount of 5 weight percent or less; the filler material is free of propylene glycol or contains propylene glycol in an amount of 1 weight percent or less; Oral pouch products.

34. An oral pouch product, comprising: a wrapper defining a cavity; a filler material in the cavity; the fill material comprises a dry mix and a liquid mix; The dry mixture comprises: microcrystalline cellulose in an amount ranging from 10 weight percent to 70 weight percent; a water soluble filler in an amount ranging from 10 weight percent to 50 weight percent, the water soluble filler comprising a sugar alcohol; The liquid mixture triglycerides in an amount ranging from 10 weight percent to 30 weight percent; and liquid nicotine dissolved in said triglyceride, the filler material is glycerin-free and propylene glycol-free; the filler material is free of water or contains water in an amount less than 5 weight percent of the filler material; Oral pouch products.

35. 35. The oral pouch product of claim 34, wherein the wrapper comprises an elastomer.

36. 36. The oral pouch product of claim 35, wherein the elastomer comprises polyurethane.

37. 1. A method of manufacturing an oral pouch product, comprising: preparing a liquid mixture comprising liquid nicotine and oil, wherein the oil comprises a triglyceride, a diglyceride, a monoglyceride, or any combination thereof, and wherein at least a portion of the nicotine is dissolved in the oil; preparing a dry mixture comprising a cellulosic material and a water-soluble filler; forming a filler material by mixing the liquid mixture with the dry mixture; forming an oral pouch product by enclosing the fill material within a cavity defined by a wrapper; Including, the filler material is free of water or contains water in an amount of 5 weight percent or less of the filler material; The method wherein the filler material is free of propylene glycol or contains propylene glycol in an amount of 1 weight percent or less.

38. The oral pouch product of claim 1, wherein substantially all of the liquid nicotine is dissolved in the oil.

39. The oral pouch product of claim 1, wherein the filling material does not contain water.

40. The oral pouch product of claim 1, wherein the liquid mixture consists essentially of the triglyceride and the liquid nicotine.

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