Oral products having tailored performance

Abstract

A method of manufacturing an oral product includes preparing a wet granulation. The wet granulation includes a binder, a flavorant, and a solvent. The solvent is present in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation. The method further includes forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder. The forming includes removing at least a portion of the solvent. The method further includes incorporating the physical hydrogel into an oral product including an active ingredient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims the benefit of U.S. Provisional Application No. 63 / 729,539, filed on Dec. 9, 2024, the entire disclosure of which is incorporated herein by reference thereto in its entirety.BACKGROUNDField

[0002] The present disclosure relates to oral products having tailored performance.Description of Related Art

[0003] Oral products are available in a variety of formats, such as chewing gums, sprays, lozenges, dissolvable tablets, non-dissolvable chews, films, gels, capsules, and pouches (e.g., containing fibers and / or granules). Oral products may include oral tobacco products, oral non-tobacco products, and oral cannabis products.SUMMARY

[0004] At least one example embodiment relates to a method of manufacturing an oral product.

[0005] In at least one example embodiment, the method includes preparing a wet granulation. The wet granulation includes a binder, a flavorant, and a solvent. The solvent is present in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation. The method further includes forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder. The forming includes removing at least a portion of the solvent. The method further includes incorporating the physical hydrogel into an oral product including an active ingredient.

[0006] In at least one example embodiment, the method further includes tuning a dissolution profile of the oral product. The tuning includes providing the flavorant having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

[0007] In at least one example embodiment, the tuning further includes providing the binder having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

[0008] In at least one example embodiment, the desired dipole moment magnitude of the flavorant ranges from 2 to 4.

[0009] In at least one example embodiment, the flavorant further includes a first hydrogen bonding site including a donor site and a second hydrogen bonding site including an acceptor site.

[0010] In at least one example embodiment, the flavorant further includes a third hydrogen bonding site. Each of the first hydrogen bonding site, the second hydrogen bonding site, and the third hydrogen bonding site has a dipole moment magnitude of greater than or equal to 0.3.

[0011] In at least one example embodiment, the flavorant includes one or more hydrogen bonding sites. Either: (i) all of the one or more hydrogen bonding sites are donor sites, or (ii) all of the one or more hydrogen bonding sites are acceptor sites.

[0012] In at least one example embodiment, the binder includes acrylic acid, methacrylic acid, poly(vinylpyrollidone), hydroxypropylmethyl cellulose, ethyl cellulose, poly(vinyl alcohol), poly(lactic acid), poly(ethylene glycol, or any combination thereof.

[0013] In at least one example embodiment, the preparing further includes admixing a first binder and a second binder.

[0014] In at least one example embodiment, the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof.

[0015] In at least one example embodiment, the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof.

[0016] In at least one example embodiment, the preparing includes, admixing the binder and the solvent, and after the admixing, adding the flavorant to the binder and the solvent.

[0017] In at least one example embodiment, the solvent includes water, ethanol, or both water and ethanol.

[0018] In at least one example embodiment, the preparing includes preparing a wet granulation consisting essentially of the binder, the flavorant, and the solvent.

[0019] In at least one example embodiment, the preparing is performed at a temperature ranging from 20° C. to 30° C.

[0020] In at least one example embodiment, the preparing is performed for a duration of less than or equal to 60 minutes.

[0021] In at least one example embodiment, the preparing includes stirring, gravity tumbling, or a combination of stirring and gravity tumbling.

[0022] In at least one example embodiment, the forming is performed at a temperature ranging from 30° C. to 50° C.

[0023] In at least one example embodiment, the forming is performed for a duration ranging from 1 hour to 24 hours.

[0024] In at least one example embodiment, the forming includes vacuum drying, fluidized bed drying, laminar airflow drying, or any combination thereof.

[0025] In at least one example embodiment, the active ingredient includes nicotine.

[0026] At least one example embodiment relates to a method of manufacturing a prolonged release oral product.

[0027] In at least one example embodiment, the method includes preparing a wet granulation. The wet granulation includes a binder, a flavorant, and a solvent. The flavorant includes a hydrogen bonding donor site having a dipole moment magnitude of greater than or equal to about 2 D and a hydrogen bonding acceptor site having a dipole moment magnitude of greater than or equal to about 2 D. The solvent is present in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation. The method further includes forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder. The forming includes removing at least a portion of the solvent. The method further includes incorporating the physical hydrogel into an oral product including an active ingredient.

[0028] At least one example embodiment relates to a method of manufacturing a delayed release oral product.

[0029] In at least one example embodiment, the method includes preparing a wet granulation. The wet granulation includes a binder, a flavorant, and a solvent. The flavorant includes or more hydrogen bonding sites. All of the one or more hydrogen bonding sites are hydrogen bond donor sites or all of the one or more hydrogen bonding sites are hydrogen bond acceptor sites. The solvent is present in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation. The method further includes forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder. The forming includes removing at least a portion of the solvent. The method further includes incorporating the physical hydrogel into an oral product including an active ingredient.

[0030] At least one example embodiment relates to an oral product.

[0031] In at least one example embodiment, the oral product includes a physical hydrogel and an active ingredient. The physical hydrogel includes a binder and a flavorant. The binder is present in an amount less than 5 weight percent of the oral product. At least a portion of the flavorant is hydrogen bonded to at least a portion of the binder. The active ingredient is configured to be released from the oral product when the physical hydrogel is exposed to saliva. The oral product is free of an antioxidant.

[0032] In at least one example embodiment, the binder is present in an amount ranging from 2 weight percent to 4 weight percent of the oral product.

[0033] In at least one example embodiment, the binder includes a first hydrogen bonding site and a second hydrogen bonding site. The first hydrogen bonding site is a proton donor. The second hydrogen bonding site is a proton acceptor. The flavorant includes a third hydrogen bonding site.

[0034] In at least one example embodiment, each of the first hydrogen bonding site, the second hydrogen bonding site, and the third hydrogen bonding site has a dipole moment magnitude of greater than or equal to 0.3 D.

[0035] In at least one example embodiment, the flavorant includes one or more hydrogen bonding sites including the third hydrogen bonding site. Either (i) all of the one or more hydrogen bonding sites are donor sites, or (ii) all of the one or more hydrogen bonding sites are acceptor sites.

[0036] In at least one example embodiment, the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof.

[0037] In at least one example embodiment, the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof.

[0038] In at least one example embodiment, the oral product has a water content of less than or equal to about 10 weight percent.

[0039] In at least one example embodiment, the water content ranges from 1 weight percent to 10 weight percent.

[0040] In at least one example embodiment, the oral product has a water content ranging from 10 weight percent to 20 weight percent.

[0041] In at least one example embodiment, the oral product has a water content of greater than 20 weight percent.

[0042] In at least one example embodiment, the oral product has a water content of greater than 30 weight percent.

[0043] In at least one example embodiment, the oral product includes a first region and a second region. The first region includes a first physical hydrogel. The first physical hydrogel includes the physical hydrogel. The second region includes a second physical hydrogel having a different composition than the first physical hydrogel.

[0044] In at least one example embodiment, the active ingredient includes nicotine.

[0045] At least one example embodiment relates to an oral pouch product.

[0046] In at least one example embodiment, the oral pouch product includes a pouch and a filling material. The pouch defines an interior region. The filling material is in the interior region. The filling material includes a physical hydrogel and an active ingredient. The physical hydrogel includes a binder and a flavorant. The binder is present in an amount less than 5 weight percent of the oral pouch product. At least a portion of the flavorant is hydrogen bonded to at least a portion of the binder. The active ingredient is configured to be released from the oral pouch product when the physical hydrogel is exposed to saliva. The oral pouch product is free of an antioxidant.

[0047] In at least one example embodiment, the pouch is formed from an elastomeric material.

[0048] In at least one example embodiment, the elastomeric material includes a plurality of non-woven fibers.

[0049] In at least one example embodiment, the pouch includes polyurethane fibers.

[0050] In at least one example embodiment, the pouch includes paper.

[0051] In at least one example embodiment, the active ingredient includes nicotine.

[0052] In at least one example embodiment, the filling material further includes tobacco.

[0053] In at least one example embodiment, the filling material includes the tobacco in an amount less than 5 weight percent.

[0054] At least one example embodiment relates to a physical hydrogel.

[0055] In at least one example embodiment, the physical hydrogel includes a plurality of binder molecules and a plurality of flavorant molecules. Each of the plurality of binder molecules has a plurality of hydrogen bonding sites including a binder hydrogen bond donor site and a binder hydrogen bond acceptor site. At least a portion of the plurality of polar flavorant molecules hydrogen bonded to at least a portion of the binder molecules.

[0056] In at least one example embodiment, each of the plurality of polar flavorant molecules includes a flavorant hydrogen bond donor site and a flavorant hydrogen bond acceptor site. The flavorant hydrogen bond donor site has a dipole moment magnitude of greater than or equal to about 2 D. The flavorant hydrogen bond acceptor site has a dipole moment magnitude of greater than or equal to about 2 D.

[0057] In at least one example embodiment, each of the plurality of polar flavorant molecules includes one or more hydrogen bonding sites. All of the one or more hydrogen bonding sites are flavorant hydrogen bond donor sites or all of the one or more hydrogen bonding sites are flavorant hydrogen bond acceptor sites.

[0058] In at least one example embodiment, the plurality of binder molecules includes plurality of first binder molecules and a plurality of second binder molecules different from the plurality of first binder molecules.

[0059] In at least one example embodiment, the plurality of polar flavorant molecules includes plurality of first polar flavorant molecules and a plurality of second polar flavorant molecules different from the plurality of first polar flavorant molecules.BRIEF DESCRIPTION OF THE DRAWINGS

[0060] The various features and advantages of the non-limiting embodiments herein may become more apparent upon review of the detailed description in conjunction with the accompanying drawings. The accompanying drawings are merely provided for illustrative purposes and should not be interpreted to limit the scope of the claims. The accompanying drawings are not to be considered as drawn to scale unless explicitly noted. For purposes of clarity, various dimensions of the drawings may have been exaggerated.

[0061] FIG. 1 is a schematic illustration of a physical hydrogel according to at least one example embodiment.

[0062] FIG. 2 is a schematic illustration of another physical hydrogel according to at least one example embodiment.

[0063] FIG. 3 is a schematic illustration of another physical hydrogel according to at least one example embodiment.

[0064] FIG. 4 is a flowchart illustrating a method of making an oral product including a physical hydrogel according to at least one example embodiment.

[0065] FIG. 5 is a perspective view of an oral pouch product according to at least one example embodiment.

[0066] FIG. 6 is a sectional view of the oral pouch product of FIG. 5 taken at line VI-VI of FIG. 5 according to at least one example embodiment.

[0067] FIG. 7 is a perspective view of another oral pouch product according to at least one example embodiment.

[0068] FIG. 8 is a perspective view of a chewing gum according to at least one example embodiment.

[0069] FIG. 9 is a perspective view of a lozenge according to at least one example embodiment.

[0070] FIG. 10 is a perspective view of an oral tablet according to at least one example embodiment.

[0071] FIG. 11 is a perspective view of a dissolvable film according to at least one example embodiment.

[0072] FIG. 12 illustrates a chemical structure of a physical hydrogel according to at least one example embodiment.DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0073] Some detailed example embodiments are disclosed herein. However, specific structural and functional details disclosed herein are merely representative for purposes of describing example embodiments. Example embodiments may, however, be embodied in many alternate forms and should not be construed as limited to only the example embodiments set forth herein.

[0074] Accordingly, while example embodiments are capable of various modifications and alternative forms, example embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit example embodiments to the particular forms disclosed, but to the contrary, example embodiments are to cover all modifications, equivalents, and alternatives thereof. Like numbers refer to like elements throughout the description of the figures.

[0075] It should be understood that when an element or layer is referred to as being “on,”“connected to,”“coupled to,”“attached to,”“adjacent to,” or “covering” another element or layer, it may be directly on, connected to, coupled to, attached to, adjacent to or covering the other element or layer or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,”“directly connected to,” or “directly coupled to” another element or layer, there are no intervening elements or layers present. Like numbers refer to like elements throughout the specification. As used herein, the term “and / or” includes any and all combinations or sub-combinations of one or more of the associated listed items.

[0076] It should be understood that, although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer, or section from another region, layer, or section. Thus, a first element, component, region, layer, or section discussed below could be termed a second element, component, region, layer, or section without departing from the teachings of example embodiments.

[0077] Spatially relative terms (e.g., “beneath,”“below,”“lower,”“above,”“upper,” and the like) may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It should be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the term “below” may encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0078] The terminology used herein is for the purpose of describing various example embodiments only and is not intended to be limiting of example embodiments. As used herein, the singular forms “a,”“an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “includes,”“including,”“comprises,” and / or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0079] While the term “same” or “identical” is used in description of example embodiments, it should be understood that some imprecisions may exist. Thus, when one element is referred to as being the same as another element, it should be understood that an element or a value is the same as another element within a desired manufacturing or operational tolerance range (e.g., ±10%).

[0080] When the terms “about” or “substantially” are used in this specification in connection with a numerical value, it is intended that the associated numerical value includes a manufacturing or operational tolerance (e.g., ±10%) around the stated numerical value. Moreover, when the words “generally” and “substantially” are used in connection with geometric shapes, it is intended that precision of the geometric shape is not required but that latitude for the shape is within the scope of the disclosure. Further, regardless of whether numerical values or shapes are modified as “about” or “substantially,” it will be understood that these values and shapes should be construed as including a manufacturing or operational tolerance (e.g., ±10%) around the stated numerical values or shapes.

[0081] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiments belong. It will be further understood that terms, including those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0082] FIG. 1 is a schematic illustration of a physical hydrogel according to at least one example embodiment.

[0083] At least one example embodiment relates to a physical hydrogel 100, as shown in FIG. 1. The physical hydrogel 100 includes a plurality of binder molecules 102. Each of the binder molecules 102 includes a plurality of hydrogen bonding sites. The hydrogen bonding sites include donors 106 and acceptors 108. A hydrogen bonding site that is a donor 106 has a partial positive charge, as indicated by δ+. A hydrogen bonding site that is an acceptor 108 has a partial negative charge, as indicated by δ−. A molecule having only a single hydrogen bonding site may form a hydrogen bond with a network to effectively terminate the chain, since it has no additional hydrogen bonding sites to continue the network. A molecule having two hydrogen bonding sites may be capable of forming a linear chain hydrogen bonding network. A molecule having three or more hydrogen bonding sites may be capable of forming a strong, branched hydrogen bonding network.

[0084] The binder molecules 102 are linked by a plurality of hydrogen bonds 110 so as to form a hydrogen bonding network. Each hydrogen bond 110 is formed between a donor 106 and an acceptor 108, such as a donor 106 on one of the binder molecules 102 and an acceptor 108 the other of the binder molecules 102.

[0085] The hydrogen bonding network exists until the hydrogen bonds 110 are broken. Thus, the hydrogen bonding network may be considered to be reversible and / or made of up quasi-linkages. In at least one example embodiment, the hydrogen bonds 110 are configured to be broken in the presence of saliva, water, or another solvent.

[0086] In at least one example embodiment, as will be described in greater detail below, the physical hydrogel 100 may be part of an oral product. The oral product may include other elements, such as an active ingredient (e.g., nicotine). The physical hydrogel 100 may bind all or portions of the oral product together and facilitate retention of elements, such as the active ingredient, until the hydrogen bonds 110 are broken, such as in the presence of saliva.

[0087] In at least one example embodiment, one or flavorants are part of a physical hydrogel (see, e.g., FIGS. 2-3). That is, flavorants may participate in a hydrogen bonding network. Flavorants may be used to tune characteristics of an oral product containing the physical hydrogel. In at least one example embodiment, flavorant is used to strengthen a hydrogen bonding network (see, e.g., FIG. 2). In at least one other example embodiments, flavorant is used to interfere with a hydrogen bonding network so as to weaken the hydrogen bonding network (see, e.g., FIG. 3). Strength of hydrogen bonding network can affect dissolution rate and release of flavorant and / or other elements of the oral product.

[0088] Both flavorant molecule characteristics and method of making an oral product including a binder and flavorant affect a participation of the flavorant in a hydrogen bonding network. Flavorant characteristics may include whether the flavorant is polar or nonpolar. In at least one example embodiment, the flavorant is a nonpolar flavorant that cannot form hydrogen bonds, does not participate in the hydrogen bonding network, and is not part of a physical hydrogel formed by the binder. In at least one other example embodiment, the flavorant is a polar flavorant that may be capable of forming hydrogen bonds, participating in the hydrogen bonding network, and being part of the physical hydrogel, depending on a method of manufacturing.

[0089] A polar flavorant may participate in the hydrogen bonding network with the binder to either strengthen the network or, alternatively, interfere with the network. Whether the flavorant strengthens or interferes with the network depends on quantity of hydrogen bonding sides, polarity of hydrogen bonding sides (i.e., whether the hydrogen bonding sites are donor sites or acceptor sites), and overall dipole moment of the individual hydrogen bonding sites, as will be described in greater detail below.

[0090] Flavorants may be natural or artificial. In at least one example embodiment, the flavorant may include a fruit flavorant (e.g., bergamot, berry, cherry, lemon, and / or orange), a liquor or liqueur flavorant (e.g., bourbon, cognac, scotch, whiskey, and / or DRAMBUIE brand liqueur), a mint flavorant (e.g., Japanese mint, menthol, peppermint, spearmint, wintergreen, and / or mint oils from a species of the genus Mentha), a floral flavorant (e.g., geranium, lavender, and / or rose), a spice, an herb, or another botanical or botanical-derived flavorant (e.g., anise, apium 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.

[0091] In at least one example embodiments, a binder for use in a physical hydrogel may have a desired quantity of hydrogen bonding sites, polarity of hydrogen bonding sites, and / or dipole moments of hydrogen bonding sites. In at least one example embodiment, the binder includes acrylic acid, methacrylic acid, poly(vinylpyrollidone), hydroxypropylmethyl cellulose, ethyl cellulose, poly(vinyl alcohol), poly(lactic acid), poly(ethylene glycol, or any combination thereof.

[0092] FIG. 2 is a schematic illustration of another physical hydrogel according to at least one example embodiment.

[0093] In at least one example embodiment, a physical hydrogel 200 includes binder molecules 202 and flavorant molecules 204. At least a portion of the flavorant molecules 202 are linked to at least a portion of the binder molecules 202 via hydrogen bonds 206. A hydrogen bonding network of the physical hydrogel 200 including the binder molecules 202 and the flavorant molecules 204 may generally be stronger than a hydrogen bonding network formed from only the binder molecules 202 or primarily the binder molecules 202. The flavorant molecules 204 participate in the hydrogen bonding network by forming additional hydrogen bonds 206 with the binder molecules 202 such that a quantity of hydrogen bonds, size of the hydrogen bonding network, and / or total strength of the hydrogen bonds is increased compared to the hydrogen bonding network having only binder molecules 202.

[0094] In at least one example embodiment, when used in an oral product, the physical hydrogel 200 may facilitate retention of the flavorant molecules 204 in the oral product until contact with a solvent, such as saliva. For example, the large network of hydrogen bonds may reduce or prevent direct paths to an external surface, thereby acting as a net to trap flavorant molecules 202 therein. The trapped flavorant molecules 202 would need to take a tortuous path to reach a surface and volatilize. Thus, loss of the flavorant molecules 204 prior to contact with saliva may be reduced or prevented. Additionally, larger hydrogen bonding networks are less soluble in water than smaller networks. As a result, during use, the physical hydrogel 200 having the strong hydrogen bonding network may be configured to have a prolonged release of elements, such as an active ingredient, during a period of use by an adult consumer (i.e., contact with saliva). In at least one example embodiment, a physical hydrogel includes greater than or equal to 1 binder (e.g., greater than or equal to 2 binders, or greater than or equal to 3 binders).

[0095] The flavorant molecule 204 may have greater than or equal to 2 hydrogen bonding sites (e.g., greater than or equal to 3 hydrogen bonding sites, greater than or equal to 4 hydrogen bonding sites, greater than or equal to 5 hydrogen bonding sites, or greater than or equal to about 6 hydrogen bonding sites). Accordingly, the flavorant molecule 204 can form a hydrogen bond with the binder molecule 202 and still have remaining hydrogen bonding sites available to form additional hydrogen bonds with binder molecules 202 and / or flavorant molecules 204 so as to strengthen the hydrogen bonding network. In at least one example embodiment, the flavorant molecule 204 may be a difunctional molecule. In at least one example embodiment, the binder molecules 202 and flavorant molecules 204 form a branched network.

[0096] At least a portion of the hydrogen bonding sites on the flavorant molecule 204 are hydrogen bond donors 208 and at least a portion of the bonding sites are hydrogen bond acceptors 210. The flavorant molecule 204 includes greater than or equal to 1 hydrogen bond donor 208 (e.g., greater than or equal to 2, or greater than or equal to 3). The flavorant molecule 204 includes greater than or equal to 1 hydrogen bond acceptor 210 (e.g., greater than or equal to 2, or greater than or equal to 3).

[0097] In at least one example embodiment, all or a portion of the hydrogen bonding sites have dipole moments within a desired range. In at least one example embodiment, greater than or equal to 1 of the hydrogen bonding sites has a dipole moment within the desired range (e.g., greater than or equal to 2, greater than or equal to 3, greater than or equal to 4, greater than or equal to 5, or greater than or equal to 6). In at least one example embodiment, all of the hydrogen bonding sites of the flavorant molecule 204 have dipole moments within the desired range. In at least one example embodiment, the desired range is greater than or equal to about 0.3 Debye (D) (e.g., greater than or equal to about 0.5 D, greater than or equal to about 1 D, greater than or equal to about 1.25 D, greater than or equal to about 1.5 D, greater than or equal to about 1.75 D, greater than or equal to about 2 D, greater than or equal to about 2.25 D, greater than or equal to about 2.5 D, greater than or equal to about 2.75 D, greater than or equal to about 3 D, greater than or equal to about 3.25 D, greater than or equal to about 3.5 D, greater than or equal to about 3.75 D, greater than or equal to about 4 D, or greater than or equal to about 4.25 D). The desired range may be less than or equal to about 4.5 D (e.g., less than or equal to about 4.25 D, less than or equal to about 4 D, less than or equal to about 3.75 D, less than or equal to about 3.5 D, less than or equal to about 3.25 D, less than or equal to about 3 D, less than or equal to about 2.75 D, less than or equal to about 2.5 D, less than or equal to about 2.25 D, less than or equal to about 2 D, less than or equal to about 1.75 D, less than or equal to about 1.5 D, or less than or equal to about 1.25 D). In at least one example embodiment, the dipole moment may have a strong dipole moment ranging from about 1 D to about 4.5 D.

[0098] In at least one example embodiment, the flavorant may be generally recognized as safe (GRAS) by the Flavor and Extract Manufacturers Association of the United States (FEMA). For example, the flavorant may be a FEMA GRAS flavorant that has at one hydrogen bond donor site and at least one hydrogen bond acceptor site, each having the dipole moments within the desired range. In at least one example embodiment, the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof. In at least one example embodiment, the physical hydrogel 200 includes a single flavorant. In other example embodiments, the physical hydrogel 200 includes multiple flavorants (e.g., 2 flavorants or 3 flavorants).

[0099] In at least one example embodiment, an oral product including the physical hydrogel 200 may have less binder than an oral product including the physical hydrogel 100 without a flavorant. That is, the increased strength of the hydrogen bonding network when the flavorant molecule 204 forms hydrogen bonds with the binder molecule 202 may facilitate the use of less binder while achieving desired characteristics of the oral product. In at least one example embodiment, an oral product including the physical hydrogel 200 includes binder in amount greater than or equal to about 0.25 weight percent (e.g., greater than or equal to about 0.5 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 5 weight percent). The oral product may include the binder in an amount less than or equal to about 10 weight percent (e.g., less than or equal to about 9 weight percent, less than or equal to about 8 weight percent, less than or equal to about 7 weight percent, less than or equal to about 6 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3 weight percent, or less than or equal to about 2 weight percent).

[0100] In at least one example embodiment, use of the physical hydrogel 200 in an oral product including the active ingredient (e.g., nicotine) may facilitate the use of less antioxidant or no antioxidant compared to an oral product including the physical hydrogel 100. The oral product including the physical hydrogel 200 may include an active ingredient (e.g., nicotine) and be substantially free of an antioxidant. In at least one example embodiment, the oral product including the physical hydrogel 200 further includes nicotine and is free of ascorbyl palmitate, butylated hydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA), and Vitamin E.

[0101] FIG. 3 is a schematic illustration of another physical hydrogel according to at least one example embodiment.

[0102] In at least one example embodiment, a physical hydrogel 300 includes binder molecules 302 and flavorant molecules 304. At least a portion of the flavorant molecules 304 are linked to at least a portion of the binder molecules 302 via hydrogen bonds 306. The flavorant molecules 304 may inhibit the hydrogen bonding network such that the hydrogen bonding network including the binder molecules 302 and the flavorant molecules 304 is generally weaker than a hydrogen bonding network formed from only the binder molecules 302 or primarily the binder molecules 302. The flavorant molecules 304 participate in the hydrogen bonding network by blocking hydrogen bonding sites so as to reduce hydrogen bonding between binder molecules 302 and / or additional flavorant molecules304.

[0103] In at least one example embodiment, the physical hydrogel 300 includes a smaller and / or weaker hydrogen bonding network than the physical hydrogel 100 of FIG. 1 or the physical hydrogel 200 of FIG. 2. Smaller hydrogen bonding networks may be more soluble in water than larger networks. As a result, during use, the physical hydrogel 300 having the smaller and / or weaker hydrogen bonding network may be configured to have a rapid release of elements, such as an active ingredient, during a period of use by an adult consumer (i.e., contact with saliva). In at least one example embodiment, a physical hydrogel 300 includes greater than or equal to 1 binder (e.g., greater than or equal to 2 binders, or greater than or equal to 3 binders).

[0104] The flavorant molecule 304 may have greater than or equal to 1 hydrogen bonding sites (e.g., greater than or equal to 2 hydrogen bonding sites, greater than or equal to 3 hydrogen bonding sites, or greater than or equal to 4 hydrogen bonding sites). In at least one example embodiment, the flavorant molecule 304 has only a small quantity of hydrogen bonding sites (e.g., a single hydrogen bonding site) so as to create a cap or stop in the hydrogen bonding network and reduce or prevent the formation of additional hydrogen bonds with the flavorant molecule 304. The flavorant molecule 304 may have a single hydrogen bonding site. In at least one example embodiment, an oral product including the physical hydrogel 300 may further include a nonpolar flavorant having zero hydrogen bonding sites, which does not directly interact with the hydrogen bonding network, but may passively inhibit chain formation. In at least one example embodiment, the flavorant molecule 304 has greater than 1 hydrogen bonding site, but weak dipole moments, as will be described in greater detail below.

[0105] In at least one example embodiment, all of the hydrogen bonding sites on the flavorant molecule 304 have the same polarity so as to reduce or prevent hydrogen bonding. For example, all or a majority of hydrogen bonding sites on the flavorant molecule 304 may hydrogen bond donors 308. In another example, all or a majority of hydrogen bonding sites on the flavorant molecule 304 may be hydrogen bond acceptors 310.

[0106] In at least one example embodiment, all or a portion of the hydrogen bonding sites have dipole moments within a desired range. In at least one example embodiment, greater than or equal to 1 of the hydrogen bonding sites has a dipole moment within the desired range (e.g., greater than or equal to 2, greater than or equal to 3, greater than or equal to 4, greater than or equal to 5, or greater than or equal to 6). In at least one example embodiment, all of the hydrogen bonding sites of the flavorant molecule 304 have dipole moments within the desired range. In at least one example embodiment, the desired range is greater than or equal to about 0.1 D (e.g., greater than or equal to about 0.2 D, greater than or equal to about 0.3 D, greater than or equal to about 0.4 D, greater than or equal to about 0.5 D, greater than or equal to about 1 D, greater than or equal to about 1.25 D, greater than or equal to about 1.5 D, greater than or equal to about 1.75 D, greater than or equal to about 2 D, greater than or equal to about 2.25 D, greater than or equal to about 2.5 D, greater than or equal to about 2.75 D, greater than or equal to about 3 D, greater than or equal to about 3.25 D, greater than or equal to about 3.5 D, or greater than or equal to about 3.75 D). The desired range may be less than or equal to about 4.5 D (e.g., less than or equal to about 4.25 D, less than or equal to about 4 D, less than or equal to about 3.75 D, less than or equal to about 3.5 D, less than or equal to about 3.25 D, less than or equal to about 3 D, less than or equal to about 2.75 D, less than or equal to about 2.5 D, less than or equal to about 2.25 D, less than or equal to about 2 D, less than or equal to about 1.75 D, less than or equal to about 1.5 D, less than or equal to about 1.25 D, less than or equal to about 1 D, less than or equal to about 0.75 D, less than or equal to about 0.5 D, less than or equal to about 0.4 D, less than or equal to about 0.3 D, or less than or equal to about 0.2 D).

[0107] In at least one example embodiment, the flavorant molecule 304 has a single hydrogen bonding site having a strong dipole moment ranging from about 1 D to about 4.5 D. Thus, the flavorant molecule 304 may form relatively strong hydrogen bonds with the binder 302 and cap or terminate the network. In at least one other example embodiment, the flavorant molecule 304 has greater than or equal to 2 hydrogen bonding sites and a weak dipole moment of less than or equal to about 1 D. Thus, the flavorant molecule 304 may form a relatively weak network with the binder molecule 302.

[0108] In at least one example embodiment, the flavorant may be generally recognized as safe (GRAS) by the FEMA. For example, the flavorant may be a FEMA GRAS flavorant having the above characteristics. In at least one example embodiment, the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof. In at least one example embodiment, the flavorant is a natural flavorant. Natural flavorants may inhibit network formation because they contain many different compounds (e.g., hundreds of different compounds), such that there may be too much interference from poor dipole and / or single reactive site molecules to achieve strong hydrogen bonding network formation.

[0109] In at least one example embodiment, an oral product including the physical hydrogel 300 includes greater than or equal to about 3 weight percent of binder (e.g., greater than or equal to about 5 weight percent, greater than or equal to about 6 weight percent, greater than or equal to about 7 weight percent, greater than or equal to about 7.5 weight percent, greater than or equal to about 8 weight percent, greater than or equal to about 8.5 weight percent, greater than or equal to about 9 weight percent, greater than or equal to about 9.5 weight percent, greater than or equal to about 10 weight percent, greater than or equal to about 10.5 weight percent, greater than or equal to about 11 weight percent, greater than or equal to about 11.5 weight percent, greater than or equal to about 12 weight percent, greater than or equal to about 13 weight percent, greater than or equal to about 14 weight percent, or greater than or equal to about 15 weight percent). The oral product including the physical hydrogel 300 may include less than or equal to about 20 weight percent of binder (e.g., less than or equal to about 15 weight percent, less than or equal to about 14 weight percent, less than or equal to about 13 weight percent, less than or equal to about 12 weight percent, less than or equal to about 11.5 weight percent, less than or equal to about 11 weight percent, less than or equal to about 10.5 weight percent, less than or equal to about 10 weight percent, less than or equal to about 9.5 weight percent, less than or equal to about 9 weight percent, less than or equal to about 8.5 weight percent, less than or equal to about 8 weight percent, less than or equal to about 7.5 weight percent, less than or equal to about 7 weight percent, less than or equal to about 6 weight percent, or less than or equal to about 5 weight percent).

[0110] At least one example embodiment relates to a method of making an oral product including a physical hydrogel. The physical hydrogel includes a binder and a flavorant, with at least a portion of the flavorant hydrogen bonded to at least a portion of the binder. The method may include tuning the oral product to have desired properties, such as desired dissolution characteristics, active ingredient release, flavorant retention, and / or moisture resistance.

[0111] The mere presence of binder and flavorant in an oral product does not necessarily lead to formation of a hydrogen bonding network or physical hydrogel including both the binder and the flavorant. Whether a physical hydrogel is formed between the binder and flavorant may depend at least upon flavorant characteristics, as described above, and method of making the oral product. For example, a physical hydrogel may be formed by providing and retaining a suitable flavorant (e.g., a polar flavorant) and a suitable binder in close proximity to one another, with limited or nointerference from other elements, while the binder is available for hydrogen bonding, so as to create hydrogen bonds between the binder and the flavorant instead of only the binder. In one example, adding a nonpolar flavorant to an oral product at any time during manufacturing, and at any proximity to a solvated binder, will not form a physical hydrogel including the binder and the flavorant because the nonpolar flavorant is not capable of forming hydrogen bonds. In another example, adding flavorant to the oral product when the binder is unavailable for hydrogen bonding (e.g., when the binder is not solvated) will not facilitate the formation of a physical hydrogel including both the binder and the flavorant. In another example, providing flavorant outside of proximity of a binder for hydrogen bonding (e.g., as an encapsulated flavorant, in a different layer, absorbed and / or adsorbed in a solid carrier, etc.) will not facilitate the formation of a physical hydrogel including both the binder and the flavorant. In another example, providing flavorant and binder in a solvent with other elements may not facilitate the formation of a physical hydrogel because the other elements may interfere with formation of the physical hydrogel.

[0112] FIG. 4 is a flowchart illustrating a method of making an oral product including a physical hydrogel according to at least one example embodiment.

[0113] At least one example embodiment relates to a method of making an oral product including a physical hydrogel, as shown in FIG. 4. The method may generally include tuning desired oral product characteristics at S400; preparing a wet granulation at S404; preparing a physical hydrogel at S408; and incorporating the physical hydrogel into an oral product at S412. Each of these steps is described in greater detail below.

[0114] At S400, the method includes tuning desired characteristics of an oral product to be produced. Desired oral product characteristics may include dissolution rate, active ingredient release rate, flavorant retention prior to use, and / or moisture resistance. Tuning the desired oral product characteristics may include selecting one or more flavorants having desired flavorant characteristics. In at least one example embodiment, the desired flavorant characteristics include polar flavorant molecules. The desired flavorant characteristics may further include a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof, as described above in the discussions accompanying FIGS. 2-3. Tuning the dissolution characteristics may further include selecting one or more binders having desired binder characteristics. Desired binder characteristics may include a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof. Tuning the dissolution characteristics may further include providing a desired amount of binder and / or flavorant.

[0115] At S404, the method includes preparing a wet granulation including binder, solvent, and flavorant. In at least one example embodiment, the wet granulation includes the solvent in an amount to facilitate breaking existing binder hydrogen bonds, thorough admixing of the binder and flavorant, and retention of the binder and flavorant in close enough proximity to form hydrogen bonds. In at least one example embodiment, the wet granulation includes the solvent in an amount greater than or equal to about 12 weight percent (e.g., greater than or equal to about 15 weight percent, greater than or equal to about 20 weight percent, greater than or equal to about 25 weight percent, greater than or equal to about 30 weight percent, greater than or equal to about 35 weight percent, greater than or equal to about 40 weight percent, greater than or equal to about 45 weight percent, or greater than or equal to about 50 weight percent). The wet granulation may include the solvent in an amount less than or equal to about 55 weight percent (e.g., less than or equal to about 50 weight percent, less than or equal to about 45 weight percent, less than or equal to about 40 weight percent, less than or equal to about 35 weight percent, less than or equal to about 30 weight percent, less than or equal to about 25 weight percent, less than or equal to about 20 weight percent, or less than or equal to about 15 weight percent). The solvent may be configured to break existing and / or initial hydrogen bonds in the binder. The solvent may be an organic solvent. In at least one example embodiment, the solvent includes water, ethanol, or a combination of water and ethanol.

[0116] In at least one example embodiment, the wet granulation includes the flavorant in an amount greater than or equal to about 1 weight percent (e.g., greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 4.5 weight percent, greater than or equal to about 5 weight percent, or greater than or equal to about 5.5 weight percent). In at least one example embodiment, the wet granulation includes the flavorant in an amount less than or equal to about 6 weight percent (e.g., less than or equal to about 5.5 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, or less than or equal to about 1.5 weight percent).

[0117] In at least one example embodiment, the wet granulation includes the binder in an amount greater than or equal to about 1 weight percent (e.g., greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 4.5 weight percent, greater than or equal to about 5 weight percent, or greater than or equal to about 5.5 weight percent). In at least one example embodiment, the wet granulation includes the binder in an amount less than or equal to about 6 weight percent (e.g., less than or equal to about 5.5 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, or less than or equal to about 1.5 weight percent).

[0118] In at least one example embodiment, the wet granulation further includes other elements, such as insoluble element(s), soluble element(s), active ingredient(s), and / or other elements discussed herein. In at least one example embodiment, the wet granulation may include insoluble element(s) in an amount less than or equal to about 60 weight percent (e.g., less than or equal to about 55 weight percent, less than or equal to about 50 weight percent, less than or equal to about 45 weight percent, less than or equal to about 40 weight percent, less than or equal to about 35 weight percent, less than or equal to about 30 weight percent, less than or equal to about 25 weight percent, less than or equal to about 20 weight percent, less than or equal to about 5 weight percent, less than or equal to about 0 weight percent, or less than or equal to about 5 weight percent). In at least one example embodiment, the wet granulation may include soluble element(s) in an amount less than or equal to about 70 weight percent (e.g., less than or equal to about 65 weight percent, less than or equal to about 60 weight percent, less than or equal to about 55 weight percent, less than or equal to about 50 weight percent, less than or equal to about 45 weight percent, less than or equal to about 40 weight percent, less than or equal to about 35 weight percent, less than or equal to about 30 weight percent, less than or equal to about 25 weight percent, less than or equal to about 20 weight percent, less than or equal to about 5 weight percent, less than or equal to about 0 weight percent, or less than or equal to about 5 weight percent).

[0119] In at least one example embodiment, preparing the wet granulation further includes admixing additional elements of the oral product, such as those described below. In at least one example embodiment, preparing the wet granulation includes first admixing the binder and the solvent, and second adding the flavorant. In the first step, the solvent breaks existing hydrogen bonds in the binder. In the second step, the flavorant is admixed with the solvent and binder so as to place the flavorant in close enough proximity with the binder to form hydrogen bonds as the solvent is reduced and / or removed.

[0120] In at least one example embodiment, the wet granulation consists essentially of the binder, the solvent, and the flavorant. As used herein, “consisting essentially of” means that the wet granulation is free of other elements that would interfere with formation of a hydrogen bonding network. The wet granulation may consist of the binder, the solvent, and the flavorant. In at least one other example embodiment, the wet granulation further includes other elements (e.g., insoluble filler and / or soluble elements). The other elements, if present, may be present in an amount such that they do not substantially interfere with formation of the hydrogen bonding network.

[0121] S404 may include mixing and / or stirring the solvent, binder, and flavorant to form wet granules. The mixing and / or stirring may be performed at speed low enough to reduce or prevent breaking apart granules. In at least one example embodiment, the rotational speed may be less than or equal to about 10 rotations per minute (RPM) (e.g., less than or equal to about 9 RPM, less than or equal to about 8 RPM, less than or equal to about 7 RPM, less than or equal to about 6 RPM, or less than or equal to about 5 RPM). In at least one example embodiment, the mixing may be performed in a kitchen mixer and / or blender. In at least one example embodiment, the mixing may include gravity tumbling ingredients to build wet granules through adhesion.

[0122] In at least one example embodiment, S404 is performed at a temperature of greater than or equal to about 20° C. (e.g., greater than or equal to about 21° C., greater than or equal to about 22° C., greater than or equal to about 23° C., greater than or equal to about 24° C., greater than or equal to about 25° C., greater than or equal to about 26° C., greater than or equal to about 27° C., greater than or equal to about 28° C., or greater than or equal to about 29° C.). S404 may be performed at a temperature of less than or equal to about 30° C. (e.g., less than or equal to about 29° C., less than or equal to about 28° C., less than or equal to about 27° C., less than or equal to about 26° C., less than or equal to about 25° C., less than or equal to about 24° C., less than or equal to about 23° C., less than or equal to about 22° C., or less than or equal to about 21° C.).

[0123] In at least one example embodiment S404 may be performed for a duration of greater than or equal to about 5 minutes (e.g., greater than or equal to about 10 minutes, greater than or equal to about 15 minutes, greater than or equal to about 20 minutes, greater than or equal to about 25 minutes, greater than or equal to about 20 minutes, greater than or equal to about 35 minutes, greater than or equal to about 40 minutes, greater than or equal to about 45 minutes, greater than or equal to about 50 minutes, or greater than or equal to about 55 minutes). S404 may be performed for a duration of less than or equal to about 60 minutes (e.g., less than or equal to about 55 minutes, less than or equal to about 50 minutes, less than or equal to about 45 minutes, less than or equal to about 40 minutes, less than or equal to about 35 minutes, less than or equal to about 30 minutes, less than or equal to about 25 minutes, less than or equal to about 20 minutes, less than or equal to about 15 minutes, or less than or equal to about 10 minutes).

[0124] At S408, the method includes preparing a physical hydrogel. Preparing the physical hydrogel may include drying the wet granulation to remove at least a portion of (e.g., substantially all) of the solvent while retaining the binder and the flavorant in close proximity with one another. During drying, hydrogen bonds may be formed between at least a portion of the binder and at least a portion of the flavorant. Binder-to-binder and flavorant-to-flavorant hydrogen bonds may also be formed. In at least one example embodiment, the physical hydrogel is in the form of a dry granulation. If additional elements were added to the wet granulation in S404, then the dry granules may further include the additional elements. In at least one example embodiment, the dry granules may consist essentially of the binder and the flavorant. In at least one example embodiment, the method does not include adding any additional elements after preparing the wet granulation at S404 and before preparing the physical hydrogel at S408.

[0125] In at least one example embodiment, S408 includes drying via vacuum, fluidized bed, laminar airflow, or any combination thereof. In at least one example embodiment, S408 is performed at a temperature of greater than or equal to about 20° C. (e.g., greater than or equal to about 22.5° C., greater than or equal to about 25° C., greater than or equal to about 27.5° C., greater than or equal to about 30° C., greater than or equal to about 32.5° C., greater than or equal to about 35° C., greater than or equal to about 37.5° C., greater than or equal to about 40° C., greater than or equal to about 42.5° C., greater than or equal to about 45° C., or greater than or equal to about 47.5° C.). The temperature may be less than or equal to about 50° C. (e.g., less than or equal to about 47.5° C., less than or equal to about 45° C., less than or equal to about 42.5° C., less than or equal to about 40° C., less than or equal to about 37.5° C., less than or equal to about 35° C., less than or equal to about 32.5° C., less than or equal to about 30° C., less than or equal to about 27.5° C., less than or equal to about 25° C., or less than or equal to about 22.5° C.).

[0126] In at least one example embodiment, S408 may be performed for a duration of greater than or equal to about 1 hour (e.g., greater than or equal to about 2 hours, greater than or equal to about 4 hours, greater than or equal to about 6 hours, greater than or equal to about 8 hours, greater than or equal to about 10 hours, greater than or equal to about 12 hours, greater than or equal to about 14 hours, greater than or equal to about 16 hours, greater than or equal to about 18 hours, greater than or equal to about 20 hours, or greater than or equal to about 22 hours). S408 may be performed for a duration of less than or equal to about 24 hours (e.g., less than or equal to about 22 hours, less than or equal to about 20 hours, less than or equal to about 18 hours, less than or equal to about 16 hours, less than or equal to about 14 hours, less than or equal to about 12 hours, less than or equal to about 10 hours, less than or equal to about 8 hours, less than or equal to about 6 hours, less than or equal to about 4 hours, or less than or equal to about 2 hours).

[0127] At S412, the method includes incorporating the physical hydrogel into an oral product, optionally with additional elements, such as an active ingredient and / or other elements described herein. Depending on the oral product to be formed, S412 may be performed concurrently with S404 and / or S408. In at least one example embodiment, dry granules formed in S408 are admixed and / or combined with additional elements of the oral product. In at least one example embodiment, S412 includes pouching the dry granules, optionally together with additional elements. The oral product may be in the form of a form of loose material (e.g., the dry granules), shaped material (e.g., plugs or twists), pouched material (shown in FIGS. 5-7), gums (shown in FIG. 8), lozenges (shown in FIG. 9), tablets (shown in FIG. 10), films (shown in FIG. 11), gels, sprays, any other oral product, or any combination thereof.

[0128] At least one example embodiment relates to an oral product including a physical hydrogel. The physical hydrogel includes a binder and a flavorant, with at least a portion of the binder hydrogen bonded to at least a portion of the flavorant. The oral product may have desired characteristics, such as rapid and / or prolonged dissolution, active ingredient release rate, flavorant retention, and / or moisture resistance. In at least one example embodiment, the oral product has a reduced amount of binder compared to an oral product without the physical hydrogel, as described above. In at least one example embodiment, the oral product is free of an antioxidant.

[0129] In at least one example embodiment, the oral product is a dry oral product. Limiting moisture in the oral product facilitates retention of hydrogen bonds in the physical hydrogel such that the oral product retains the desired characteristics. In at least one other example embodiment, the oral product has a medium or high (e.g., 10-50 weight percent, 10-20 weight percent, greater than 20 weight percent, greater than 30 weight percent, 20-35 weight percent, or 40-65 weight percent) water content, but the water is substantially separated from the physical hydrogel so as to retain integrity of the hydrogen bonds in the physical hydrogel until use.

[0130] The dry oral product may have a water content of greater than or equal to about 0.5 weight percent (e.g., greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 4.5 weight percent, greater than or equal to about 5 weight percent, greater than or equal to about 5.5 weight percent, greater than or equal to about 6 weight percent, greater than or equal to about 7 weight percent, greater than or equal to about 8 weight percent, or greater than or equal to about 9 weight percent). The dry oral product may have a water content of less than or equal to about 10 weight percent (e.g., less than or equal to about 9 weight percent, less than or equal to about 8 weight percent, less than or equal to about 7 weight percent, less than or equal to about 6 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, less than or equal to about 1.5 weight percent, or less than or equal to about 1 weight percent).

[0131] The dry oral product may have an oven volatiles content of greater than or equal to about 0.5 weight percent (e.g., greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 4.5 weight percent, greater than or equal to about 5 weight percent, greater than or equal to about 5.5 weight percent, greater than or equal to about 6 weight percent, greater than or equal to about 7 weight percent, greater than or equal to about 8 weight percent, or greater than or equal to about 9 weight percent). The dry oral product may have an oven volatiles content of less than or equal to about 10 weight percent (e.g., less than or equal to about 9 weight percent, less than or equal to about 8 weight percent, less than or equal to about 7 weight percent, less than or equal to about 6 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, less than or equal to about 1.5 weight percent, or less than or equal to about 1 weight percent).

[0132] In at least one example embodiment, the oral product includes a first region having first desired characteristics and a second region having second desired characteristics different from the first desired characteristics. The first region may include a first physical hydrogel and the second region may include a second physical hydrogel. At least one of the first and second physical hydrogels includes flavorant hydrogen bonded to binder. In at least one example embodiment, the first physical hydrogen is the physical hydrogel 200 of FIG. 2 and the second physical hydrogel is the physical hydrogel 300 of FIG. 3.

[0133] In at least one example embodiment, the oral product is an oral tobacco product, an oral non-tobacco product, an oral cannabis product, or any combination thereof. The oral product may include chewing tobacco, snus, moist snuff tobacco, dry snuff tobacco, other smokeless tobacco and non-tobacco products for oral consumption, or any combination thereof.

[0134] Where the oral product is an oral tobacco product including smokeless tobacco product, the smokeless tobacco product may include tobacco that is whole, shredded, cut, granulated, reconstituted, cured, aged, fermented, pasteurized, or otherwise processed. Tobacco may be present as whole or portions of leaves, flowers, roots, stems, extracts (e.g., nicotine), or any combination thereof.

[0135] In at least one example embodiment, the oral product includes a tobacco extract, such as a tobacco-derived nicotine extract, and / or synthetic nicotine. The oral product may include nicotine alone or in combination with a carrier (e.g., white snus), such as a cellulosic material. The carrier may be a non-tobacco material (e.g., microcrystalline cellulose) or a tobacco material (e.g., tobacco fibers having reduced or eliminated nicotine content, which may be referred to as “exhausted tobacco plant tissue or fibers”). In some example embodiments, the exhausted tobacco plant tissue or fibers can be treated to remove at least 25%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, or 95% of the nicotine. For example, the tobacco plant tissue can be washed with water or another solvent to remove the nicotine.

[0136] In at least one example embodiment, the oral product includes tobacco plant tissue. The tobacco plant tissue may be in the form of a tobacco dust. The tobacco plant tissue may be whitened and / or bleached. The oral product may include the tobacco plant tissue in an amount greater than or equal to about 0.5 weight percent (e.g., greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 5 weight percent, greater than or equal to about 7 weight percent, or greater than or equal to about 10 weight percent). The oral product may include the tobacco plant tissue in an amount less than or equal to about 15 weight percent. (e.g., less than or equal to about 10 weight percent, less than or equal to about 7 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2_weight percent, less than or equal to about 1.5 weight percent, or less than or equal to about 1 weight percent).

[0137] In other example embodiments, the oral product may include cannabis, such as cannabis plant tissue and / or cannabis extracts. In at least one example embodiment, the cannabis material includes leaf and / or flower material from one or more species of cannabis plants and / or extracts from the one or more species of cannabis plants. The one or more species of cannabis plants may include Cannabis sativa, Cannabis indica, and / or Cannabis ruderalis. In at least one example embodiment, the cannabis may be in the form of fibers. In at least one example embodiment, the cannabis may include a cannabinoid, a terpene, and / or a flavonoid. In at least one example embodiment, the cannabis material may be a cannabis-derived cannabis material, such as a cannabis-derived cannabinoid, a cannabis-derived terpene, and / or a cannabis-derived flavonoid.

[0138] The oral product may be sized and / or shaped and / or configured to be wholly received in an oral cavity of an adult tobacco consumer. The oral product may have an oval shape, a rounded shield shape, a flat shield shape an elliptical shape, an elongated elliptical shape, a semi-circular shape, a square shape, a rounded-edge square shape, a rectangular shape, an elongated rectangular shape, a rounded-edge rectangular shape, a football shape, a boomerang shape, a teardrop shape, a comma shape, a bowtie shape, a peanut shape, or any combination thereof. The oral product may have an oral-shaped cross section, a rectangular cross section, an elongated rectangular cross section, a lens or football shaped cross section, a boomerang-shaped cross section, a shield-shaped cross section, or any combination thereof. In at least one example embodiment, the size and / or shape and / or configuration of the oral product may be selected to promote desired positioning of the oral product within the oral cavity and / or packaging.

[0139] In at least one example embodiment, the oral product may have dimensions ranging from about 1 millimeter to about 25 millimeters (e.g., about 1 millimeter to about 10 millimeters, about 1 millimeter to about 5 millimeters, about 5 millimeters to about 25 millimeters, about 5 millimeters to about 10 millimeters, about 10 millimeters to about 15 millimeters, about 15 millimeters to about 20 millimeters, or about 20 millimeters to about 25 millimeters). In at least one example embodiment, the oral product has a first dimension (e.g., smallest dimension or thickness) ranging from about 1 millimeter to about 10 millimeters (e.g., about 2.5 millimeters). In at least one example embodiment, the oral product has a largest dimension (e.g., diameter, height, or width) ranging from about 5 millimeters to about 25 millimeters (e.g., about 12 millimeters).

[0140] In at least one example embodiment, the oral product may have a weight ranging from about 1 milligram to about 10 grams (e.g., about 1 gram to about 9 grams, about 1 gram to about 8 grams, about 1 gram to about 7 grams, about 1 gram to about 6 grams, about 1 gram to about 5 grams, about 1 gram to about 4 grams, about 1 gram to about 3 grams, about 1 gram to about 2 grams, about 2 grams to about 9 grams, about 2 grams to about 8 grams, about 2 grams to about 7 grams, about 2 grams to about 6 grams, about 2 grams to about 5 grams, about 2 grams to about 4 grams, about 2 grams to about 3 grams, about 3 grams to about 9 grams, about 3 grams to about 8 grams, about 3 grams to about 7 grams, about 3 grams to about 6 grams, about 3 grams to about 5 grams, about 3 grams to about 4 grams, about 4 grams to about 9 grams, about 4 grams to about 8 grams, about 4 grams to about 7 grams, about 4 grams to about 6 grams, about 4 grams to about 5 grams, about 5 grams to about 9 grams, about 5 grams to about 8 grams, about 5 grams to about 7 grams, about 5 grams to about 6 grams, about 6 grams to about 9 grams, about 6 grams to about 8 grams, about 6 grams to about 7 grams, about 7 grams to about 9 grams, about 7 grams to about 8 grams, about 8 grams to about 9 grams).

[0141] In at least one example embodiment, the oral product may include one or more elements or additives such as a mouth-stable polymer, a mouth-soluble polymer, a sweetener, an energizing agent, a soothing agent, a focusing agent, a plasticizer, mouth-soluble or partially-soluble fibers (e.g., sugar beet fibers), an alkaloid, a mineral, a vitamin, a dietary supplement, a nutraceutical, a coloring agent, an amino acid, a chemesthetic agent, an antioxidant, a food-grade emulsifier (e.g., glycerol monostearate, propylene glycol monostearate, and / or an acetylated monoglyceride), a pH modifier, a botanical (e.g., green tea), a tooth-whitening agent (e.g., sodium hexametaphosphate (SHMP)), a therapeutic agent, a processing aid, a stearate (e.g., magnesium and / or potassium), a wax (e.g., glycerol monostearate, propylene glycol monostearate, and / or an acetylated monoglyceride), a stabilizer (e.g., ascorbic acid and monosterol citrate, butylated hydroxytoluene (BHT), or butylated hydroxyanisole (BHA)), a lubricant (e.g., sodium lauryl sulfate (SLS)), a disintegrating agent, a preservative (e.g., sodium benzoate), a filler, a flavorant, an effervescent (e.g., carbon dioxide embedded in a flavorant or a filling material), a flavor masking agent, a bitterness receptor site blocker, a receptor site enhancer, other additives, or any combination thereof. The oral product may include multiple additional elements. Additionally, a single element may belong to more than one of the categories above.

[0142] As used herein, “mouth-soluble” means that the polymer experiences significant degradation when exposed to saliva within an oral cavity of an adult consumer over a period of about four hours. In at least one example embodiment, the mouth-soluble polymer disintegrates when exposed to saliva having a normal human body temperature (i.e., 98.6° F.) for a period of less than or equal to about an hour (e.g., less than or equal to about 30 minutes, less than or equal to about 15 minutes, less than or equal to about 10 minutes, or less than or equal to about 5 minutes).

[0143] In at least one example embodiment, the oral product is free of a mouth-soluble polymer. In at least one example embodiment, the oral product includes a mouth-soluble polymer. The mouth-soluble polymer may include, for example, a cellulosic polymer, a natural polymer, a seaweed-derived polymer, a microbial-derived polymer, an extract, an exudate, a synthetic polymer, or any combination thereof. Other useful mouth soluble polymers are known in the art, for example, see Krochta et al., Food Technology (1997) at 51:61-74; Glicksman Food Hydrocolloids CRC 1982; Krochta Edible Coatings and Films to Improve Food Quality Technomic 1994; Industrial Gums Academic 1993; and / or Nussinovitch Water-Soluble Polymer Applications in Foods Blackwell Science 2003, the entire contents of which are hereby incorporated by reference.

[0144] In at least one example embodiment, the cellulosic polymer may include, for example, carboxymethyl cellulose (CMC), hydroxypropyl (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methylcellulose (HPMC), methyl cellulose (MC), or any combination thereof. In at least one example embodiment, the natural polymer may include, for example, a starch, a modified starch, konjac, collagen, inulin, soy protein, whey protein, casein, wheat gluten, or any combination thereof. In at least one example embodiment, the seaweed-derived polymer may include, for example, a carrageenan, an alginate, or a combination of a carrageenan and an alginate. In at least one example embodiment, the carrageenan may include, for example, kappa carrageenan, iota carrageenan, lambda carrageenan, or any combination thereof. In at least one example embodiment, the alginate may include, for example, propylene glycol alginate. In at least one example embodiment, the microbial-derived polymer may include, for example, xanthan, dextran, pullulan, curdlan, gellan, or any combination thereof. In at least one example embodiment, the extract may include, for example, locust bean gum, guar gum, tara gum, gum tragacanth, pectin (e.g., low methoxy and amidated), agar, zein, karaya, gelatin, psyllium seed, chitin, chitosan, or any combination thereof. In at least one example embodiment, the exudate may include, for example, gum acacia (arabic), shellac, or any combination thereof. In at least one example embodiment, the synthetic polymer may include, for example, polyvinyl pyrrolidone, polyethylene oxide, polyvinyl alcohol, or any combination thereof.

[0145] As used herein, “mouth-stable” means that the polymer does not appreciably dissolve or disintegrate when exposed to saliva at the normal human body temperature (i.e., 98.6° F.) over a period of about one hour. In at least one example embodiment, the mouth-stable polymer is a biodegradable polymer that is configured to break down over a period of days, weeks, months, or years but does not appreciably break down when held in an oral cavity and exposed to saliva for a period of about one hour. In at least one example embodiment, the mouth-stable polymer is stable within an oral cavity and exposed to saliva at the normal human body temperature for a period of greater than or equal to about 2 hours (e.g., greater than or equal to about 6 hours, greater than or equal to about 12 hours, greater than or equal to about 1 day, or greater than or equal to about 2 days). Accordingly, an oral product including a mouth-stable polymer according to at least one example embodiment is configured to remain intact when placed in an adult consumer's mouth. After a period of time, the mouth-stable polymer and any other mouth-stable elements may be removed from the adult consumer's mouth and discarded.

[0146] The mouth-stable polymer may be biocompatible and biostable. The mouth-stable polymer may generally be recognized as safe and in compliance with applicable food-contact regulations by an appropriate regulatory agency (e.g., the U.S. Food and Drug Administration (FDA)). In at least one example embodiment, the mouth-stable polymer has a flexural modulus of greater than or equal to about 5 MPa (e.g., greater than or equal to about 10 MPa) when tested according to ASTM Testing Method D790 or ISO 178 at 23° C.

[0147] In at least one example embodiment, the oral product is free of a mouth-stable polymer. In at least one example embodiment, the oral product includes a mouth-stable polymer. In at least one example embodiment, the mouth-stable polymer may include, for example, a polyurethane, a silicone, a polyester, a polyacrylate, a polyethylene, a polypropylene, a polyetheramide, a polystyrene, a polyvinyl alcohol, a polyvinyl acetate, a polyvinyl chloride, a polybutyl acetate, a butyl rubber, poly(styrene-ethylene-butylene-styrene) (SEBS), poly(styrene-butadiene-styrene) (SBS), poly(styrene-isoprene-styrene) (SIS), any copolymer thereof, or any combination thereof. In at least one example embodiment, the mouth-stable polymer includes a food-grade or medical-grade polymer, such as medical-grade polyurethane.

[0148] In at least one example embodiment, the mouth-stable polymer includes, for example, a thermoplastic polymer. The thermoplastic polymer may include a thermoplastic elastomer. In at least one example embodiment, the mouth-stable polymer includes a thermoplastic elastomer meeting the requirements of the FDA modified ISO 10993, Part 1 “Biological Evaluation of Medical Devices” tests with human tissue contact time of 30 days or less. In at least one example embodiment, the mouth-stable polymer has a shore Hardness of 50 D or softer, a melt flow index of about 3 g / 10 min at 200° C. / 10 kg, a tensile strength of greater than or equal to about 10 MPa (using ISO 37), and / or an ultimate elongation of less than about 100% (using ISO 37).

[0149] In at least one example embodiment, the oral product is free of a sweetener. In at least one example embodiment, the oral product includes a sweetener. In at least one example embodiment, the oral product includes an encapsulated sweetener. The sweetener may include a synthetic sweetener, a natural sweetener, or a combination of a synthetic sweetener and a natural sweetener.

[0150] The natural sweetener may include, for example, a sugar such as monosaccharide, a disaccharide, a polysaccharide, or any combination thereof. The natural sweetener may include, for example, sucrose, honey, a mixture of low-molecular-weight sugars excluding sucrose, glucose (i.e., grape sugar, corn sugar, dextrose), molasses, corn sweetener, glucose syrup (i.e., corn syrup), fructose (i.e., fruit sugar), lactose (i.e., milk sugar), maltose (i.e., malt sugar, maltobiose), sorghum syrup, fruit juice concentrate, or any combination thereof.

[0151] In at least one example embodiment, the sweetener includes a sugar alcohol. The sugar alcohol may include, for example, 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. In at least one example embodiment, the sweetener includes a non-nutritive sweetener. The non-nutritive sweetener may include, for example, stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof.

[0152] As used herein, the term “nutraceuticals” refers to any ingredient in foods that has a beneficial effect on human health. Nutraceuticals include particular compounds and / or compositions isolated from natural food sources and genetically modified food sources. Suitable nutraceuticals include, without limitation, various phytonutrients derived from natural plants and genetically engineered plants. In at least one example embodiment, the oral product is free of a nutraceutical. In at least one example embodiment, the oral product includes the nutraceutical. The nutraceuticals can be included in an amount ranging from about 0.1 weight percent to about 5 weight percent of the composition.

[0153] In at least one example embodiment, the oral product is free of an energizing agent. In at least one example embodiment, the oral product may include the energizing agent. In at least one example embodiment, the energizing agent includes caffeine, taurine, glucaronalactone, guarana, vitamin B6, vitamin B12, or any combination thereof.

[0154] Caffeine, also known as 1,3,7-trimethylxanthine, is a white, odorless, bitter tasting substance. Caffeine occurs naturally in tea, coffee, and chocolate, and is commonly added to soft drinks, energy drinks and some foods. However, because of the bitter taste of caffeine, the flavor of drinks or foods having a relatively high caffeine content can be unappealing. Caffeine may include synthetic caffeine and / or natural caffeine, such as coffee bean-extracted caffeine. In at least one example embodiment, the oral product includes caffeine in an amount greater than or equal to about 10 mg (e.g., greater than or equal to about 25 mg, or greater than greater than or equal to about 150 mg) The caffeine may be included in an amount less than or equal to about 200 mg (e.g., less than or equal to about 150 mg, less than or equal to about 100 mg, less than or equal to about 75 mg, less than or equal to about 50 mg, or less than or equal to about 25 mg).

[0155] The oral product may have a relatively high caffeine content so as to provide a consumer with a burst of energy. Moreover, the oral product macontain about 50 mg to about 200 mg of caffeine or about 75 mg to about 175 mg of caffeine (e.g., 100 mg to about 150 mg of caffeine) so as to provide a burst of energy to the consumer. The composition provides a single serving of a food, drink, oral tobacco product or oral non-tobacco product. A single serving of food can have a weight of about 5 g to about 450 g. A single serving of drink is about 200 mL to about 600 mL. A single serving of an oral pouch product includes one oral pouch product formed as described herein.

[0156] Optionally, the oral product can also include additional energizing ingredients in addition to the caffeine complex. Suitable additional energizing ingredients include, without limitation, taurine, citicoline, and guarana. The additional energizing ingredients can be included in an amount of about 0.1 weight percent to about 5 weight percent of the oral product.

[0157] In at least one example embodiment, the oral product is free of a soothing agent. In at least one example embodiment, the oral product includes a soothing agent. In at least one example embodiment, the soothing agent includes theanine, melatonin, or both theanine and melatonin. Additionally or alternatively, the soothing agent may include, for example only, chamomile, lavender, jasmine, soursop, cannabidiol, or any combination thereof. The soothing agent can be added as a flavorant and or aroma embedded in the product and / or the package. In at least one example embodiment, the oral product includes the soothing agent in an amount greater than or equal to about 0.1 weight percent (e.g., greater than or equal to about 0.5 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 4.5 weight percent). In at least one example embodiment, the oral product includes the soothing agent in an amount less than or equal to about 5 weight percent (e.g., less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, less than or equal to about 1.5 weight percent, less than or equal to about 1 weight percent, or less than or equal to about 0.5 weight percent).

[0158] In at least one example embodiment, the oral product is free of a plasticizer. In at least one example embodiment, the oral product includes a plasticizer. The plasticizer may include, for example, a monoglyceride, a diglyceride, a triglyceride (e.g., long, medium, and / or short chain), triacetin, propylene glycol, glycerin, vegetable oil, a phthalate, an ester of a polycarboxylic acid with a linear or branched aliphatic alcohol of moderate chain length, or any combination thereof. In at least one example embodiment, the plasticizer may be present in addition to triglycerides and / or other oils in a liquid carrier.

[0159] In at least one example embodiment, the oral product is free of mouth-soluble fibers. In at least one example embodiment, the oral product includes a mouth-soluble fibers. In at least one example embodiment, the mouth-soluble fibers include maltodextrin, psyllium, starch, or any combination thereof. In at least one example embodiment, the mouth-soluble fibers include soluble dietary fibers. In at least one example embodiment, the oral product includes partially soluble fibers, such as sugar beet fibers.

[0160] In at least one example embodiment, the oral product is free of minerals. In at least one example embodiment, the oral product includes a mineral. The mineral may be in addition to any that may be present due to the inclusion, for example, of fruits and / or vegetables. The mineral may include, for example, calcium, magnesium, phosphorus, iron, zinc, iodine, selenium, potassium, copper, manganese, molybdenum, chromium, and any combination thereof. The amount of minerals incorporated into the oral product for adult human consumption can be varied according to the type of mineral and the intended adult consumer. The amount of minerals may be formulated to include an amount less than or equal to the recommendations of the United States Department of Agriculture Recommended Daily Allowances.

[0161] In at least one example embodiment, the oral product is free of a focusing agent. In at least one example embodiment, the oral product includes a focusing agent. The focusing agent may include ginkgo biloba.

[0162] In at least one example embodiment, the oral product is free of a sensate and / or chemesthesis agent. In at least one example embodiment, the oral product includes a sensate and / or chemesthesis agent. The sensate and / or chemesthesis agent may include mint, menthol, cinnamon, pepper, jambu, or any combination thereof. The sensate and / or chemesthesis agent may include any soothing, cooling, and / or warming agent. For example, in some example embodiments, the sensate and / or chemesthesis agent may include capsaicin, pipeline, alpha-hydroxy-sanshool, and (8)-gingerole, which may be selected so as to provide a warm, tingling or burning sensation. In other example embodiments, the sensate and / or chemesthesis 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 so as to provide a cooling sensation. The sensate and / or chemesthesis agent may be included in an amount ranging from about 0.01 weight percent to about 5 weight percent of the oral product.

[0163] In at least one example embodiment, the oral product is free of vitamins. In at least one other example embodiment, the oral product includes a vitamin. The vitamin may include, for example, vitamin C, vitamin B, magnesium, calcium, or any combination thereof. In at least one example embodiment, the oral product may include one or more vitamins in addition to any that may be present due to the inclusion, for example, of fruits and / or vegetables. The one or more additional vitamins may include, for example, vitamin A (retinol), vitamin D (cholecalciferol), vitamin E group, vitamin K group (phylloquinones and menaquinones), thiamine (vitamin B1), riboflavin (vitamin B2), niacin, niacinamide, pyridoxine (vitamin B6 group), folic acid, choline, inositol, vitamin B12 (cobalamins), PABA (para aminobezoic acid), biotin, vitamin C (ascorbic acid), and any combination thereof. The amount of vitamins may be chosen so as to provide an amount less than or equal to the recommendations of the United States Department of Agriculture Recommended Daily Allowances.

[0164] In at least one example embodiment, the oral product is free of an antioxidant. In at least one example embodiment, the oral product includes an antioxidant. In at least one example embodiment, the antioxidant may include ascorbyl palmitate, butylated hydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA), Vitamin E, and any combination or derivative thereof. The presence of the antioxidant may help to limit the formation of nicotine-N-oxides.

[0165] In at least one example embodiment, the oral product is free of a mineral. In at least one example embodiment, the oral product includes a mineral. Suitable minerals include, without limitation, calcium, magnesium, phosphorus, iron, zinc, iodine, selenium, potassium, copper, manganese, molybdenum, chromium, or any combination thereof. The amount of minerals incorporated into the oral product can be varied according to the type of mineral and the intended adult consumer. For example, the amount of minerals may be formulated to include an amount less than or equal to the recommendations of the United States Department of Agriculture Recommended Daily Allowances.

[0166] In at least one example embodiment, the oral product is free of amino acids. In at least one example embodiment, the oral product includes an amino acid. Suitable amino acids include, without limitation, the eight essential amino acids that cannot be biosynthetically produced in humans, including valine, leucine, isoleucine, lysine, threonine, tryptophan, methionine, and phenylalanine. Examples of suitable amino acids include the non-essential amino acids including alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, proline, serine, and tyrosine. The amino acids can be included in an amount ranging from about 0.1 weight percent to about 5 weight percent of the composition.

[0167] In at least one example embodiment, the oral product includes the amino acid in an amount greater than or equal to about 0.1 weight percent (e.g., greater than or equal to about 0.5 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 4.5 weight percent). In at least one example embodiment, the oral product includes the amino acid in an amount less than or equal to about 5 weight percent (e.g., less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, less than or equal to about 1.5 weight percent, less than or equal to about 1 weight percent, or less than or equal to about 0.5 weight percent).

[0168] In at least one example embodiment, the oral product is free of a coloring agent. In at least one example embodiment, the oral product includes a coloring agent. The coloring agent may include a natural colorant, an artificial colorant, or any combination thereof.

[0169] In at least one example embodiment, the oral product is free of a pH modifier. In at least one example embodiment, the oral product includes a pH modifier. The pH modifier may include, for example, ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, calcium carbonate, potassium carbonate, potassium bicarbonate, potassium hydroxide, sodium carbonate, sodium bicarbonate, sodium hydroxide, or any combination thereof.

[0170] In at least one example embodiment, the oral product includes the pH modifier in an amount less than or equal to about 2 weight percent (e.g., less than or equal to about 1 weight percent, less than or equal to about 0.5 weight percent, less than or equal to about 0.1 weight percent, or less than or equal to about 0.05 weight percent). In at least one example embodiment, the oral product includes the pH modifier in an amount ranging from about 0.01 weight percent to 2 weight percent.

[0171] In at least one example embodiment, the oral product is free of a wax. In at least one example embodiment, the oral product includes a wax. The wax may include, for example, paraffin, microcrystalline wax, or both paraffin and microcrystalline wax.

[0172] In at least one example embodiment, the oral product is free of a filler. In at least one example embodiment, the oral product includes a filler. The filler may be configured to alter a texture or pliability of the oral product. The filler may include mouth-soluble elements, mouth-insoluble elements, or both mouth-soluble and mouth-insoluble elements. Mouth-soluble elements may be configured to dissolve or disintegrate when in an adult consumer's mouth so as to render the oral product more pliable. The filler may include, for example, dicalcium phosphate, calcium sulfate, a clay, silica, glass particles, glyceryl palmitostearate, sodium stearyl fumarate, talc, or any combination thereof. In at least one example embodiment, certain other compounds or elements or components, including, for example, mouth-soluble fibers, sweeteners, minerals, as described, may be classified as fillers. For example, in at least one example embodiment, cellulosic materials may be present in the oral product as fillers in addition to as or an alternative to being carriers for active ingredients, additives, and / or liquid ingredients.

[0173] In at least one example embodiment, the oral product includes the filler in an amount less than or equal to 20 weight percent (e.g., less than or equal to 15 weight percent, less than or equal to 10 weight percent, less than or equal to 9 weight percent, less than or equal to 8 weight percent, less than or equal to 7 weight percent, less than or equal to 6 weight percent, less than or equal to 5 weight percent, less than or equal to 4 weight percent, less than or equal to 3 weight percent, less than or equal to 2 weight percent, or less than or equal to 1 weight percent). In at least one example embodiment, the oral product includes the filler in an amount greater than or equal to about 0 weight percent (e.g., greater than or equal to about 1 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 5 weight percent). In at least one example embodiment, the oral product includes the filler in an amount ranging from about 0 weight percent to about 8 weight percent.

[0174] In at least one example embodiment, the oral product is free of a flavorant. In at least one example embodiment, the oral product includes a flavorant. In at least one example embodiment, the oral product includes an encapsulated flavorant. The flavorant may be natural or artificial. The flavorant may include, for example, a fruit flavorant (e.g., bergamot, berry, cherry, lemon, and / or orange), a liquor or liqueur flavorant (e.g., bourbon, cognac, scotch, whiskey, and / or DRAMBUIE brand liqueur), a mint flavorant (e.g., Japanese mint, menthol, peppermint, spearmint, wintergreen, and / or mint oils from a species of the genus Mentha), a floral flavorant (e.g., geranium, lavender, and / or rose), a spice, an herb, or another botanical or botanical-derived flavorant (e.g., anise, apium graveolens, caraway, cardamom, cascarilla, cassia, cinnamon, chamomile, clove, cocoa, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pimento, sage, sandalwood vanilla, and / or ylang-ylang), honey essence, or any combination thereof.

[0175] In at least one example embodiment, the oral product is free of a carrier. In at least one example embodiment, the oral product includes a carrier. The carrier may include a liquid carrier. The liquid carrier may include, for example, water, propylene, glycol, glycerin, ethanol, or any combination thereof.

[0176] In at least one example embodiment, the oral product is free of an oil. In at least one example embodiment, the oral product includes an oil. The oil may include, for example, a monoglyceride, a diglyceride, a triglyceride, triacetin, a flavor oil, or any combination thereof. The flavor oil may be or may include a flavorant.

[0177] An amount of oil may be selected to achieve a desired texture and / or softness. For example, the softness of the oral product may be increased as an amount of the oil in the oral product increases. In at least one example embodiment, the oral product includes oil in an amount greater than or equal to about 5 weight percent (e.g., greater than or equal to about 8 weight percent, greater than or equal to about 9 weight percent, greater than or equal to about 10 weight percent, greater than or equal to about 11 weight percent, greater than or equal to about 12 weight percent, greater than or equal to about 13 weight percent, or greater than or equal to about 15 weight percent). In at least one example embodiment, the oral product includes oil in an amount less than or equal to about 20 weight percent (e.g., less than or equal to about 15 weight percent, less than or equal to about 14 weight percent, less than or equal to about 13 weight percent, less than or equal to about 12 weight percent, less than or equal to about 11 weight percent, less than or equal to about 10 weight percent, or less than or equal to about 8 weight percent). In at least one example embodiment, the oral product includes the oil in an amount ranging from about 8 weight percent to about 16 weight percent (e.g., about 10 weight percent to about 14 weight percent, about 11 weight percent to about 13 weight percent, or about 12 weight percent).

[0178] FIG. 5 is a perspective view of an oral pouch product according to at least one example embodiment.

[0179] In at least one example embodiment, the oral product may be an oral pouch product 500. The oral pouch product 500 may include a pouch or outer web 502 formed from a permeable fabric. In at least one example embodiment, the outer web 502 is formed from a material that is generally recognized as safe (“GRAS”) for use and / or contact with food. The material may be stain resistant, water permeable, and / or porous. For example, in at least one example embodiment, the outer web 502 comprises a paper. For example, the outer web 502 can be formed of a cellulose fiber material, such as tea bag material or other materials typically used to form snus pouches. In at least one example embodiment, the outer web 502 has a desired (or alternatively, predetermined) level for basis weight and / or wet strength so as to reduce occurrence of breakage of the outer web 502 during manufacturing operations, storage, and placement in an adult consumer's mouth. For example, the outer web 502 may comprise a tea bag material having a basis weight of about 16.5 g / m2 with a wet tensile CD strength of 68 N / m. In another example embodiment, the outer web 502 may be formed of a paper having a wet MD tensile strength of about 45 N / mm to about 52 N / mm.

[0180] In at least one example embodiment, the outer web 502 is formed of a hydrophobic paper or material. The hydrophobic paper may be formed of a cellulosic material. The hydrophobic paper may be non-woven material and may include any hydrophobic materials. The hydrophobic materials may be synthetic materials and / or semi-synthetic materials. The hydrophobic materials may include viscose, rayon, lyocell, polyester, polyurethane, polyethylene, polypropylene, and / or modal fibers. The outer web 502 may be treated to make the outer web 502 hydrophobic. In other example embodiments, the hydrophobic material may be a woven material.

[0181] FIG. 6 is a sectional view of the oral pouch product of FIG. 5 taken at line VI-VI of FIG. 5 according to at least one example embodiment.

[0182] In at least one example embodiment, as shown in FIG. 6, the outer web 502 defines an interior region 600. The outer web 502 contains an inner filling material 602 within the interior region 600. In at least one example embodiment, the inner filling material 602 includes a physical hydrogel having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant (see, e.g., physical hydrogel 200 of FIG. 2, physical hydrogel 300 of FIG. 3). The inner filling material 602 may further include an active ingredient and / or any of the elements described above. In at least one example embodiment, the inner filling material 602 includes dry granules prepared according to the method of FIG. 4, optionally together with other elements.

[0183] The oral pouch product 500 may be a pouched product as described in any of U.S. patent application Ser. No. 17 / 223,823, filed on Apr. 2, 2021 and published as 2022 / 0312826; U.S. Pat. No. 9,066,540, issued Jun. 30, 2015; U.S. Pat. No. 8,978,661, issued Mar. 17, 2015; U.S. Pat. No. 10,039,309, issued Aug. 7, 2018; U.S. Pat. No. 9,414,624, issued Aug. 16, 2016; U.S. Pat. No. 9,693,582, issued Jul. 4, 2017; or U.S. Pat. No. 9,462,827, issued Oct. 11, 2016, the entire contents of each of which are incorporated herein by this reference hereto, and further including a physical hydrogel having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant (see, e.g., physical hydrogel 200 of FIG. 2, physical hydrogel 300 of FIG. 3).

[0184] FIG. 7 is a perspective view of another oral pouch product according to at least one example embodiment.

[0185] In at least one example embodiment, as shown in FIG. 7, an oral pouch product 700 is the same as the pouch product 500 of FIGS. 5-6, except that an outer web 702 is a non-woven material formed of a polymer, including synthetic or natural polymer. For example, the outer web 702 may be formed of a mesh material formed of spun or melt-blown fibers, such as polyurethane fibers as described in U.S. Pat. Nos. 10,448,669, 10,463,070, and / or 9,414,624, the entire contents of each of which is incorporated herein by reference thereto. The mesh material may be at least partially elastomeric. Further, because of the material used to form the oral pouch product 700, the oral pouch product 700 may exclude seams so as to provide a softer pouch. In at least one example embodiment, the mesh material encloses a filling material including a physical hydrogel having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant.

[0186] FIG. 8 is a perspective view of a chewing gum according to at least one example embodiment.

[0187] In at least one example embodiment, the oral product includes a chewing gum 800, as shown in FIG. 8. The chewing gum 800 includes a gum base and a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3) having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant. In at least one example embodiment, the chewing gum 800 includes a gum base and dry granules formed according to the method of FIG. 4, optionally with other elements. The chewing gum 800 may be a coated chewing gum or an uncoated chewing gum.

[0188] In at least one example embodiment, the gum base includes an elastomer, a resin, a wax, a fat, an emulsifier, a filler, an antioxidant, or any combination thereof. The elastomer may include couma macrocarpa, loquat, tunu, jelutong, chicle, styrene-butadiene rubber, butyl rubber, polyisobutylene, or any combination thereof, by way of example. The resin may include glycerol esters of gum, terpene resins, polyvinyl acetate, or any combination thereof, by way of example. The wax may include paraffin, microcrystalline wax, or both paraffin and microcrystalline wax, by way of example. The fat may include a hydrogenated vegetable oil, by way of example. The emulsifier may include lecithin, glycerol monostearate, or a combination of lecithin and glycerol monostearate, by way of example. The filler may include calcium carbonate, talc, or both calcium carbonate and talc, by way of example. The antioxidant may include butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), tocopherol, ascorbyl palmitate, ascorbic acid, sodium ascorbate, monosterol citrate, tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ), Vitamin E, or any combination thereof, by way of example. In at least one example embodiment, the gum base includes a natural latex, a vegetable gum (e.g., chicle), a spruce gum, a mastic gum, or any combination thereof.

[0189] In at least one example embodiment, the chewing gum 800 may be a chewing gum as described in U.S. patent application Ser. No. 17 / 223,800, filed on Apr. 6, 2021 and published as US 2022 / 0313679; or U.S. patent application Ser. No. 18 / 778,364, filed on Jul. 19, 2024, the entire contents of each which is incorporated herein by this reference thereto, and further including a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3).

[0190] FIG. 9 is a perspective view of a lozenge according to at least one example embodiment.

[0191] In at least one example embodiment, the oral product is a lozenge 900, as shown in FIG. 9. The lozenge 900 may include a solid solution and a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3) having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant. In at least one example embodiment, the lozenge 900 includes the solid solution and dry granules formed according to the method of FIG. 4, optionally with other elements. The solid solution may include soluble fibers and a sugar alcohol, such as those described above. In at least one example embodiment, the solid solution includes isomalt. In at least one example embodiment, the lozenge 900 may be a lozenge as described in U.S. Pat. No. 9,351,936, issued May 31, 2016, the entire contents of which is incorporated herein by this reference thereto, and further including a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3).

[0192] FIG. 10 is a perspective view of an oral tablet according to at least one example embodiment.

[0193] In at least one example embodiment, the oral product is a tablet 1000, as shown in FIG. 10. The tablet 1000 includes a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3) having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant. In at least one example embodiment, the tablet 1000 includes dry granules formed according to the method of FIG. 4, optionally with other elements.

[0194] In at least one example embodiment, the tablet 1000 a dissolvable tablet. The dissolvable tablet may include a mouth-soluble polymer, such as those described above, and the physical hydrogel. In at least one example embodiment, the dissolvable tablet may be a tablet (or tab) as described in U.S. application Ser. No. 14 / 505,814, filed Oct. 3, 2014; U.S. Pat. No. 9,930,909, issued Apr. 3, 2018; or U.S. Pat. No. 8,469,036, issued Jun. 25, 2013, the entire contents of each of which are incorporated herein by this reference thereto, and further including the physical hydrogel.

[0195] In at least one example embodiment, the tablet 1000 is a non-dissolvable chew. The non-dissolvable chew may include a mouth-stable polymer, such as those described above, and the physical hydrogel. The non-dissolvable chew may be a chew as described in U.S. Pat. No. 9,854,831, issued Jan. 2, 2018; U.S. Pat. No. 10,098,376, issued Oct. 16, 2018; U.S. Pat. No. 9,420,827, issued Aug. 23, 2016; or U.S. Pat. No. 9,185,931, issued Nov. 17, 2015, the entire contents of each of which are incorporated herein by this reference hereto, and further including the physical hydrogel.

[0196] FIG. 11 is a perspective view of a dissolvable film according to at least one example embodiment.

[0197] In at least one example embodiment, as shown in FIG. 11, the oral product may be a dissolvable film 1100. The dissolvable film 1000 may be a film as described in U.S. Pat. No. 8,469,036, issued Jun. 25, 2013, the entire contents of which is incorporated herein by this reference hereto, and further including a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3) having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant. In at least one example embodiment, the dissolvable film 1100 includes dry granules formed according to the method of FIG. 4, optionally with other elements.EXAMPLE

[0198] FIG. 12 illustrates a chemical structure of a physical hydrogel according to at least one example embodiment.

[0199] In at least one example embodiment, as shown in FIG. 12, a physical hydrogel includes first and second polymer binders hydrogen bonded to a flavor ingredient.Illustrative Embodiments

[0200] Illustrative Embodiment 1. A method of manufacturing an oral product comprising: preparing a wet granulation including, a binder, a flavorant, and a solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation; forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including, removing at least a portion of the solvent; and incorporating the physical hydrogel into an oral product including an active ingredient.

[0201] Illustrative Embodiment 2. The method of Illustrative Embodiment 1, further comprising: tuning a dissolution profile of the oral product by providing the flavorant having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

[0202] Illustrative Embodiment 3. The method of Illustrative Embodiment 2, wherein the tuning further comprises: providing the binder having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

[0203] Illustrative Embodiment 4. The method of Illustrative Embodiment 2, wherein the desired dipole moment magnitude of the flavorant ranges from 2 to 4.

[0204] Illustrative Embodiment 5. The method of Illustrative Embodiment 1, wherein the flavorant further comprises: a first hydrogen bonding site including a donor site, and a second hydrogen bonding site including an acceptor site.

[0205] Illustrative Embodiment 6. The method of Illustrative Embodiment 5, wherein the flavorant further includes a third hydrogen bonding site, and each of the first hydrogen bonding site, the second hydrogen bonding site, and the third hydrogen bonding site has a dipole moment magnitude of greater than or equal to 0.3.

[0206] Illustrative Embodiment 7. The method of Illustrative Embodiment 1, wherein the flavorant includes one or more hydrogen bonding sites, and either all of the one or more hydrogen bonding sites are donor sites, or all of the one or more hydrogen bonding sites are acceptor sites.

[0207] Illustrative Embodiment 8. The method of Illustrative Embodiment 1, wherein the binder includes acrylic acid, methacrylic acid, poly(vinylpyrollidone), hydroxypropylmethyl cellulose, ethyl cellulose, poly(vinyl alcohol), poly(lactic acid), poly(ethylene glycol, or any combination thereof.

[0208] Illustrative Embodiment 9. The method of Illustrative Embodiment 1, wherein the preparing further comprises: admixing a first binder and a second binder.

[0209] Illustrative Embodiment 10. The method of Illustrative Embodiment 1, wherein the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof.

[0210] Illustrative Embodiment 11. The method of Illustrative Embodiment 1, wherein the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof.

[0211] Illustrative Embodiment 12. The method of Illustrative Embodiment 1, wherein the preparing includes, admixing the binder and the solvent, and after the admixing, adding the flavorant to the binder and the solvent.

[0212] Illustrative Embodiment 13. The method of Illustrative Embodiment 1, wherein the solvent includes water, ethanol, or both water and ethanol.

[0213] Illustrative Embodiment 14. The method of Illustrative Embodiment 1, wherein the preparing includes preparing a wet granulation consisting essentially of the binder, the flavorant, and the solvent.

[0214] Illustrative Embodiment 15. The method of Illustrative Embodiment 1, wherein the preparing is performed at a temperature ranging from 20° C. to 30° C.

[0215] Illustrative Embodiment 16. The method of Illustrative Embodiment 1, wherein the preparing is performed for a duration of less than or equal to 60 minutes.

[0216] Illustrative Embodiment 17. The method of Illustrative Embodiment 1, wherein the preparing includes stirring, gravity tumbling, or a combination of stirring and gravity tumbling.

[0217] Illustrative Embodiment 18. The method of Illustrative Embodiment 1, wherein the forming is performed at a temperature ranging from 30° C. to 50° C.

[0218] Illustrative Embodiment 19. The method of Illustrative Embodiment 1, wherein the forming is performed for a duration ranging from 1 hour to 24 hours.

[0219] Illustrative Embodiment 20. The method of Illustrative Embodiment 1, wherein the forming includes vacuum drying, fluidized bed drying, laminar airflow drying, or any combination thereof.

[0220] Illustrative Embodiment 21. The method of Illustrative Embodiment 1, wherein the active ingredient includes nicotine.

[0221] Illustrative Embodiment 22. A method of manufacturing a prolonged release oral product comprising: preparing a wet granulation including, a binder, a flavorant including, a hydrogen bonding donor site having a dipole moment magnitude of greater than or equal to about 2 D, and a hydrogen bonding acceptor site having a dipole moment magnitude of greater than or equal to about 2 D, and a solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation; forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including, removing at least a portion of the solvent; and incorporating the physical hydrogel into an oral product including an active ingredient.

[0222] Illustrative Embodiment 23. A method of manufacturing a delayed release oral product comprising: preparing a wet granulation including, a binder, a flavorant including, one or more hydrogen bonding sites, all of the one or more hydrogen bonding sites being hydrogen bond donor sites or all of the one or more hydrogen bonding sites being hydrogen bond acceptor sites, and a solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation; forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including, removing at least a portion of the solvent; and incorporating the physical hydrogel into an oral product including an active ingredient.

[0223] Illustrative Embodiment 24. An oral product comprising: a physical hydrogel including, a binder in an amount less than 5 weight percent of the oral product, and a flavorant, at least a portion of the flavorant is hydrogen bonded to at least a portion of the binder; and an active ingredient configured to be released from the oral product when the physical hydrogel is exposed to saliva, the oral product being free of an antioxidant.

[0224] Illustrative Embodiment 25. The oral product of Illustrative Embodiment 24, wherein the binder is present in an amount ranging from 2 weight percent to 4 weight percent of the oral product.

[0225] Illustrative Embodiment 26. The oral product of Illustrative Embodiment 24, wherein

[0226] the binder includes, a first hydrogen bonding site, the first hydrogen bonding site being a proton donor, and a second hydrogen bonding site, the second hydrogen bonding site being a proton acceptor, and the flavorant includes, a third hydrogen bonding site.

[0227] Illustrative Embodiment 27. The oral product of Illustrative Embodiment 26, wherein each of the first hydrogen bonding site, the second hydrogen bonding site, and the third hydrogen bonding site has a dipole moment magnitude of greater than or equal to 0.3 D.

[0228] Illustrative Embodiment 28. The oral product of Illustrative Embodiment 26, wherein the flavorant includes one or more hydrogen bonding sites including the third hydrogen bonding site, and either all of the one or more hydrogen bonding sites are donor sites, or all of the one or more hydrogen bonding sites are acceptor sites.

[0229] Illustrative Embodiment 29. The oral product of Illustrative Embodiment 24, wherein the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof.

[0230] Illustrative Embodiment 30. The oral product of Illustrative Embodiment 24, wherein the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof.

[0231] Illustrative Embodiment 31. The oral product of Illustrative Embodiment 24, wherein the oral product has a water content of less than or equal to about 10 weight percent.

[0232] Illustrative Embodiment 32. The oral product of Illustrative Embodiment 31, wherein the water content ranges from 1 weight percent to 10 weight percent.

[0233] Illustrative Embodiment 33. The oral product of Illustrative Embodiment 24, wherein the oral product has a water content ranging from 10 weight percent to 20 weight percent.

[0234] Illustrative Embodiment 34. The oral product of Illustrative Embodiment 24, wherein the oral product has a water content of greater than 20 weight percent.

[0235] Illustrative Embodiment 35. The oral product of Illustrative Embodiment 24, wherein the oral product has a water content of greater than 30 weight percent.

[0236] Illustrative Embodiment 36. The oral product of Illustrative Embodiment 24, further comprising: a first region including, a first physical hydrogel, the first physical hydrogel including the physical hydrogel; and a second region including, a second physical hydrogel having a different composition than the first physical hydrogel.

[0237] Illustrative Embodiment 37. The oral product of Illustrative Embodiment 24, wherein the active ingredient includes nicotine.

[0238] Illustrative Embodiment 38. An oral pouch product comprising: a pouch defining an interior region; and a filling material in the interior region, the filling material including, a physical hydrogel including, a binder in an amount less than 5 weight percent of the oral pouch product, and a flavorant, at least a portion of the flavorant is hydrogen bonded to at least a portion of the binder, and an active ingredient configured to be released from the oral pouch product when the physical hydrogel is exposed to saliva, the oral pouch product being free of an antioxidant.

[0239] Illustrative Embodiment 39. The oral pouch product of Illustrative Embodiment 38, wherein the pouch is formed from an elastomeric material.

[0240] Illustrative Embodiment 40. The oral pouch product of Illustrative Embodiment 39, wherein the elastomeric material includes, a plurality of non-woven fibers.

[0241] Illustrative Embodiment 41. The oral pouch product of Illustrative Embodiment 38, wherein the pouch includes polyurethane fibers.

[0242] Illustrative Embodiment 42. The oral pouch product of Illustrative Embodiment 38, wherein the pouch includes paper.

[0243] Illustrative Embodiment 43. The oral pouch product of Illustrative Embodiment 38, wherein the active ingredient includes nicotine.

[0244] Illustrative Embodiment 44. The oral pouch product of Illustrative Embodiment 38, wherein the filling material further includes tobacco.

[0245] Illustrative Embodiment 45. The oral pouch product of Illustrative Embodiment 44, wherein the filling material includes the tobacco in an amount less than 5 weight percent.

[0246] Illustrative Embodiment 46. A physical hydrogel comprising: a plurality of binder molecules, each of the plurality of binder molecules having a plurality of hydrogen bonding sites including a binder hydrogen bond donor site and a binder hydrogen bond acceptor site; and a plurality of polar flavorant molecules, at least a portion of the plurality of polar flavorant molecules hydrogen bonded to at least a portion of the binder molecules.

[0247] Illustrative Embodiment 47. The physical hydrogel of Illustrative Embodiment 46, wherein each of the plurality of polar flavorant molecules includes a flavorant hydrogen bond donor site and a flavorant hydrogen bond acceptor site, and the flavorant hydrogen bond donor site has a dipole moment magnitude of greater than or equal to about 2 D, and the flavorant hydrogen bond acceptor site has a dipole moment magnitude of greater than or equal to about 2 D.

[0248] Illustrative Embodiment 48. The physical hydrogel of Illustrative Embodiment 46, wherein each of the plurality of polar flavorant molecules includes one or more hydrogen bonding sites, and all of the one or more hydrogen bonding sites are flavorant hydrogen bond donor sites or all of the one or more hydrogen bonding sites are flavorant hydrogen bond acceptor sites.

[0249] Illustrative Embodiment 49. The physical hydrogel of Illustrative Embodiment 46, wherein the plurality of binder molecules includes plurality of first binder molecules and a plurality of second binder molecules different from the plurality of first binder molecules.

[0250] Illustrative Embodiment 50. The physical hydrogel of Illustrative Embodiment 46, wherein the plurality of polar flavorant molecules includes plurality of first polar flavorant molecules and a plurality of second polar flavorant molecules different from the plurality of first polar flavorant molecules.

[0251] While some example embodiments have been disclosed herein, it should be understood that other variations may be possible. Such variations are not to be regarded as a departure from the spirit and scope of the present disclosure, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

[0252] Although described with reference to specific examples and drawings, modifications, additions and substitutions of example embodiments may be variously made according to the description by those of ordinary skill in the art. For example, the described techniques may be performed in an order different with that of the methods described, and / or elements such as the described system, architecture, devices, circuit, and the like, may be connected or combined to be different from the above-described methods, or results may be appropriately achieved by other elements or equivalents.

Examples

example

[0198]FIG. 12 illustrates a chemical structure of a physical hydrogel according to at least one example embodiment.

[0199]In at least one example embodiment, as shown in FIG. 12, a physical hydrogel includes first and second polymer binders hydrogen bonded to a flavor ingredient.

Illustrative Embodiments

[0200]Illustrative Embodiment 1. A method of manufacturing an oral product comprising: preparing a wet granulation including, a binder, a flavorant, and a solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation; forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including, removing at least a portion of the solvent; and incorporating the physical hydrogel into an oral product including an active ingredient.

[0201]Illustrative Embodiment 2. The method of Illustrative Embodiment 1, further comprising: tuning a dissolution profile of the oral product by providing the fl...

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims the benefit of U.S. Provisional Application No. 63 / 729,539, filed on Dec. 9, 2024, the entire disclosure of which is incorporated herein by reference thereto in its entirety.BACKGROUNDField

[0002] The present disclosure relates to oral products having tailored performance.Description of Related Art

[0003] Oral products are available in a variety of formats, such as chewing gums, sprays, lozenges, dissolvable tablets, non-dissolvable chews, films, gels, capsules, and pouches (e.g., containing fibers and / or granules). Oral products may include oral tobacco products, oral non-tobacco products, and oral cannabis products.SUMMARY

[0004] At least one example embodiment relates to a method of manufacturing an oral product.

[0005] In at least one example embodiment, the method includes preparing a wet granulation. The wet granulation includes a binder, a flavorant, and a solvent. The solvent is present in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation. The method further includes forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder. The forming includes removing at least a portion of the solvent. The method further includes incorporating the physical hydrogel into an oral product including an active ingredient.

[0006] In at least one example embodiment, the method further includes tuning a dissolution profile of the oral product. The tuning includes providing the flavorant having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

[0007] In at least one example embodiment, the tuning further includes providing the binder having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

[0008] In at least one example embodiment, the desired dipole moment magnitude of the flavorant ranges from 2 to 4.

[0009] In at least one example embodiment, the flavorant further includes a first hydrogen bonding site including a donor site and a second hydrogen bonding site including an acceptor site.

[0010] In at least one example embodiment, the flavorant further includes a third hydrogen bonding site. Each of the first hydrogen bonding site, the second hydrogen bonding site, and the third hydrogen bonding site has a dipole moment magnitude of greater than or equal to 0.3.

[0011] In at least one example embodiment, the flavorant includes one or more hydrogen bonding sites. Either: (i) all of the one or more hydrogen bonding sites are donor sites, or (ii) all of the one or more hydrogen bonding sites are acceptor sites.

[0012] In at least one example embodiment, the binder includes acrylic acid, methacrylic acid, poly(vinylpyrollidone), hydroxypropylmethyl cellulose, ethyl cellulose, poly(vinyl alcohol), poly(lactic acid), poly(ethylene glycol, or any combination thereof.

[0013] In at least one example embodiment, the preparing further includes admixing a first binder and a second binder.

[0014] In at least one example embodiment, the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof.

[0015] In at least one example embodiment, the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof.

[0016] In at least one example embodiment, the preparing includes, admixing the binder and the solvent, and after the admixing, adding the flavorant to the binder and the solvent.

[0017] In at least one example embodiment, the solvent includes water, ethanol, or both water and ethanol.

[0018] In at least one example embodiment, the preparing includes preparing a wet granulation consisting essentially of the binder, the flavorant, and the solvent.

[0019] In at least one example embodiment, the preparing is performed at a temperature ranging from 20° C. to 30° C.

[0020] In at least one example embodiment, the preparing is performed for a duration of less than or equal to 60 minutes.

[0021] In at least one example embodiment, the preparing includes stirring, gravity tumbling, or a combination of stirring and gravity tumbling.

[0022] In at least one example embodiment, the forming is performed at a temperature ranging from 30° C. to 50° C.

[0023] In at least one example embodiment, the forming is performed for a duration ranging from 1 hour to 24 hours.

[0024] In at least one example embodiment, the forming includes vacuum drying, fluidized bed drying, laminar airflow drying, or any combination thereof.

[0025] In at least one example embodiment, the active ingredient includes nicotine.

[0026] At least one example embodiment relates to a method of manufacturing a prolonged release oral product.

[0027] In at least one example embodiment, the method includes preparing a wet granulation. The wet granulation includes a binder, a flavorant, and a solvent. The flavorant includes a hydrogen bonding donor site having a dipole moment magnitude of greater than or equal to about 2 D and a hydrogen bonding acceptor site having a dipole moment magnitude of greater than or equal to about 2 D. The solvent is present in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation. The method further includes forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder. The forming includes removing at least a portion of the solvent. The method further includes incorporating the physical hydrogel into an oral product including an active ingredient.

[0028] At least one example embodiment relates to a method of manufacturing a delayed release oral product.

[0029] In at least one example embodiment, the method includes preparing a wet granulation. The wet granulation includes a binder, a flavorant, and a solvent. The flavorant includes or more hydrogen bonding sites. All of the one or more hydrogen bonding sites are hydrogen bond donor sites or all of the one or more hydrogen bonding sites are hydrogen bond acceptor sites. The solvent is present in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation. The method further includes forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder. The forming includes removing at least a portion of the solvent. The method further includes incorporating the physical hydrogel into an oral product including an active ingredient.

[0030] At least one example embodiment relates to an oral product.

[0031] In at least one example embodiment, the oral product includes a physical hydrogel and an active ingredient. The physical hydrogel includes a binder and a flavorant. The binder is present in an amount less than 5 weight percent of the oral product. At least a portion of the flavorant is hydrogen bonded to at least a portion of the binder. The active ingredient is configured to be released from the oral product when the physical hydrogel is exposed to saliva. The oral product is free of an antioxidant.

[0032] In at least one example embodiment, the binder is present in an amount ranging from 2 weight percent to 4 weight percent of the oral product.

[0033] In at least one example embodiment, the binder includes a first hydrogen bonding site and a second hydrogen bonding site. The first hydrogen bonding site is a proton donor. The second hydrogen bonding site is a proton acceptor. The flavorant includes a third hydrogen bonding site.

[0034] In at least one example embodiment, each of the first hydrogen bonding site, the second hydrogen bonding site, and the third hydrogen bonding site has a dipole moment magnitude of greater than or equal to 0.3 D.

[0035] In at least one example embodiment, the flavorant includes one or more hydrogen bonding sites including the third hydrogen bonding site. Either (i) all of the one or more hydrogen bonding sites are donor sites, or (ii) all of the one or more hydrogen bonding sites are acceptor sites.

[0036] In at least one example embodiment, the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof.

[0037] In at least one example embodiment, the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof.

[0038] In at least one example embodiment, the oral product has a water content of less than or equal to about 10 weight percent.

[0039] In at least one example embodiment, the water content ranges from 1 weight percent to 10 weight percent.

[0040] In at least one example embodiment, the oral product has a water content ranging from 10 weight percent to 20 weight percent.

[0041] In at least one example embodiment, the oral product has a water content of greater than 20 weight percent.

[0042] In at least one example embodiment, the oral product has a water content of greater than 30 weight percent.

[0043] In at least one example embodiment, the oral product includes a first region and a second region. The first region includes a first physical hydrogel. The first physical hydrogel includes the physical hydrogel. The second region includes a second physical hydrogel having a different composition than the first physical hydrogel.

[0044] In at least one example embodiment, the active ingredient includes nicotine.

[0045] At least one example embodiment relates to an oral pouch product.

[0046] In at least one example embodiment, the oral pouch product includes a pouch and a filling material. The pouch defines an interior region. The filling material is in the interior region. The filling material includes a physical hydrogel and an active ingredient. The physical hydrogel includes a binder and a flavorant. The binder is present in an amount less than 5 weight percent of the oral pouch product. At least a portion of the flavorant is hydrogen bonded to at least a portion of the binder. The active ingredient is configured to be released from the oral pouch product when the physical hydrogel is exposed to saliva. The oral pouch product is free of an antioxidant.

[0047] In at least one example embodiment, the pouch is formed from an elastomeric material.

[0048] In at least one example embodiment, the elastomeric material includes a plurality of non-woven fibers.

[0049] In at least one example embodiment, the pouch includes polyurethane fibers.

[0050] In at least one example embodiment, the pouch includes paper.

[0051] In at least one example embodiment, the active ingredient includes nicotine.

[0052] In at least one example embodiment, the filling material further includes tobacco.

[0053] In at least one example embodiment, the filling material includes the tobacco in an amount less than 5 weight percent.

[0054] At least one example embodiment relates to a physical hydrogel.

[0055] In at least one example embodiment, the physical hydrogel includes a plurality of binder molecules and a plurality of flavorant molecules. Each of the plurality of binder molecules has a plurality of hydrogen bonding sites including a binder hydrogen bond donor site and a binder hydrogen bond acceptor site. At least a portion of the plurality of polar flavorant molecules hydrogen bonded to at least a portion of the binder molecules.

[0056] In at least one example embodiment, each of the plurality of polar flavorant molecules includes a flavorant hydrogen bond donor site and a flavorant hydrogen bond acceptor site. The flavorant hydrogen bond donor site has a dipole moment magnitude of greater than or equal to about 2 D. The flavorant hydrogen bond acceptor site has a dipole moment magnitude of greater than or equal to about 2 D.

[0057] In at least one example embodiment, each of the plurality of polar flavorant molecules includes one or more hydrogen bonding sites. All of the one or more hydrogen bonding sites are flavorant hydrogen bond donor sites or all of the one or more hydrogen bonding sites are flavorant hydrogen bond acceptor sites.

[0058] In at least one example embodiment, the plurality of binder molecules includes plurality of first binder molecules and a plurality of second binder molecules different from the plurality of first binder molecules.

[0059] In at least one example embodiment, the plurality of polar flavorant molecules includes plurality of first polar flavorant molecules and a plurality of second polar flavorant molecules different from the plurality of first polar flavorant molecules.BRIEF DESCRIPTION OF THE DRAWINGS

[0060] The various features and advantages of the non-limiting embodiments herein may become more apparent upon review of the detailed description in conjunction with the accompanying drawings. The accompanying drawings are merely provided for illustrative purposes and should not be interpreted to limit the scope of the claims. The accompanying drawings are not to be considered as drawn to scale unless explicitly noted. For purposes of clarity, various dimensions of the drawings may have been exaggerated.

[0061] FIG. 1 is a schematic illustration of a physical hydrogel according to at least one example embodiment.

[0062] FIG. 2 is a schematic illustration of another physical hydrogel according to at least one example embodiment.

[0063] FIG. 3 is a schematic illustration of another physical hydrogel according to at least one example embodiment.

[0064] FIG. 4 is a flowchart illustrating a method of making an oral product including a physical hydrogel according to at least one example embodiment.

[0065] FIG. 5 is a perspective view of an oral pouch product according to at least one example embodiment.

[0066] FIG. 6 is a sectional view of the oral pouch product of FIG. 5 taken at line VI-VI of FIG. 5 according to at least one example embodiment.

[0067] FIG. 7 is a perspective view of another oral pouch product according to at least one example embodiment.

[0068] FIG. 8 is a perspective view of a chewing gum according to at least one example embodiment.

[0069] FIG. 9 is a perspective view of a lozenge according to at least one example embodiment.

[0070] FIG. 10 is a perspective view of an oral tablet according to at least one example embodiment.

[0071] FIG. 11 is a perspective view of a dissolvable film according to at least one example embodiment.

[0072] FIG. 12 illustrates a chemical structure of a physical hydrogel according to at least one example embodiment.DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0073] Some detailed example embodiments are disclosed herein. However, specific structural and functional details disclosed herein are merely representative for purposes of describing example embodiments. Example embodiments may, however, be embodied in many alternate forms and should not be construed as limited to only the example embodiments set forth herein.

[0074] Accordingly, while example embodiments are capable of various modifications and alternative forms, example embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit example embodiments to the particular forms disclosed, but to the contrary, example embodiments are to cover all modifications, equivalents, and alternatives thereof. Like numbers refer to like elements throughout the description of the figures.

[0075] It should be understood that when an element or layer is referred to as being “on,”“connected to,”“coupled to,”“attached to,”“adjacent to,” or “covering” another element or layer, it may be directly on, connected to, coupled to, attached to, adjacent to or covering the other element or layer or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,”“directly connected to,” or “directly coupled to” another element or layer, there are no intervening elements or layers present. Like numbers refer to like elements throughout the specification. As used herein, the term “and / or” includes any and all combinations or sub-combinations of one or more of the associated listed items.

[0076] It should be understood that, although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer, or section from another region, layer, or section. Thus, a first element, component, region, layer, or section discussed below could be termed a second element, component, region, layer, or section without departing from the teachings of example embodiments.

[0077] Spatially relative terms (e.g., “beneath,”“below,”“lower,”“above,”“upper,” and the like) may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It should be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the term “below” may encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0078] The terminology used herein is for the purpose of describing various example embodiments only and is not intended to be limiting of example embodiments. As used herein, the singular forms “a,”“an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “includes,”“including,”“comprises,” and / or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0079] While the term “same” or “identical” is used in description of example embodiments, it should be understood that some imprecisions may exist. Thus, when one element is referred to as being the same as another element, it should be understood that an element or a value is the same as another element within a desired manufacturing or operational tolerance range (e.g., ±10%).

[0080] When the terms “about” or “substantially” are used in this specification in connection with a numerical value, it is intended that the associated numerical value includes a manufacturing or operational tolerance (e.g., ±10%) around the stated numerical value. Moreover, when the words “generally” and “substantially” are used in connection with geometric shapes, it is intended that precision of the geometric shape is not required but that latitude for the shape is within the scope of the disclosure. Further, regardless of whether numerical values or shapes are modified as “about” or “substantially,” it will be understood that these values and shapes should be construed as including a manufacturing or operational tolerance (e.g., ±10%) around the stated numerical values or shapes.

[0081] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiments belong. It will be further understood that terms, including those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0082] FIG. 1 is a schematic illustration of a physical hydrogel according to at least one example embodiment.

[0083] At least one example embodiment relates to a physical hydrogel 100, as shown in FIG. 1. The physical hydrogel 100 includes a plurality of binder molecules 102. Each of the binder molecules 102 includes a plurality of hydrogen bonding sites. The hydrogen bonding sites include donors 106 and acceptors 108. A hydrogen bonding site that is a donor 106 has a partial positive charge, as indicated by δ+. A hydrogen bonding site that is an acceptor 108 has a partial negative charge, as indicated by δ−. A molecule having only a single hydrogen bonding site may form a hydrogen bond with a network to effectively terminate the chain, since it has no additional hydrogen bonding sites to continue the network. A molecule having two hydrogen bonding sites may be capable of forming a linear chain hydrogen bonding network. A molecule having three or more hydrogen bonding sites may be capable of forming a strong, branched hydrogen bonding network.

[0084] The binder molecules 102 are linked by a plurality of hydrogen bonds 110 so as to form a hydrogen bonding network. Each hydrogen bond 110 is formed between a donor 106 and an acceptor 108, such as a donor 106 on one of the binder molecules 102 and an acceptor 108 the other of the binder molecules 102.

[0085] The hydrogen bonding network exists until the hydrogen bonds 110 are broken. Thus, the hydrogen bonding network may be considered to be reversible and / or made of up quasi-linkages. In at least one example embodiment, the hydrogen bonds 110 are configured to be broken in the presence of saliva, water, or another solvent.

[0086] In at least one example embodiment, as will be described in greater detail below, the physical hydrogel 100 may be part of an oral product. The oral product may include other elements, such as an active ingredient (e.g., nicotine). The physical hydrogel 100 may bind all or portions of the oral product together and facilitate retention of elements, such as the active ingredient, until the hydrogen bonds 110 are broken, such as in the presence of saliva.

[0087] In at least one example embodiment, one or flavorants are part of a physical hydrogel (see, e.g., FIGS. 2-3). That is, flavorants may participate in a hydrogen bonding network. Flavorants may be used to tune characteristics of an oral product containing the physical hydrogel. In at least one example embodiment, flavorant is used to strengthen a hydrogen bonding network (see, e.g., FIG. 2). In at least one other example embodiments, flavorant is used to interfere with a hydrogen bonding network so as to weaken the hydrogen bonding network (see, e.g., FIG. 3). Strength of hydrogen bonding network can affect dissolution rate and release of flavorant and / or other elements of the oral product.

[0088] Both flavorant molecule characteristics and method of making an oral product including a binder and flavorant affect a participation of the flavorant in a hydrogen bonding network. Flavorant characteristics may include whether the flavorant is polar or nonpolar. In at least one example embodiment, the flavorant is a nonpolar flavorant that cannot form hydrogen bonds, does not participate in the hydrogen bonding network, and is not part of a physical hydrogel formed by the binder. In at least one other example embodiment, the flavorant is a polar flavorant that may be capable of forming hydrogen bonds, participating in the hydrogen bonding network, and being part of the physical hydrogel, depending on a method of manufacturing.

[0089] A polar flavorant may participate in the hydrogen bonding network with the binder to either strengthen the network or, alternatively, interfere with the network. Whether the flavorant strengthens or interferes with the network depends on quantity of hydrogen bonding sides, polarity of hydrogen bonding sides (i.e., whether the hydrogen bonding sites are donor sites or acceptor sites), and overall dipole moment of the individual hydrogen bonding sites, as will be described in greater detail below.

[0090] Flavorants may be natural or artificial. In at least one example embodiment, the flavorant may include a fruit flavorant (e.g., bergamot, berry, cherry, lemon, and / or orange), a liquor or liqueur flavorant (e.g., bourbon, cognac, scotch, whiskey, and / or DRAMBUIE brand liqueur), a mint flavorant (e.g., Japanese mint, menthol, peppermint, spearmint, wintergreen, and / or mint oils from a species of the genus Mentha), a floral flavorant (e.g., geranium, lavender, and / or rose), a spice, an herb, or another botanical or botanical-derived flavorant (e.g., anise, apium 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.

[0091] In at least one example embodiments, a binder for use in a physical hydrogel may have a desired quantity of hydrogen bonding sites, polarity of hydrogen bonding sites, and / or dipole moments of hydrogen bonding sites. In at least one example embodiment, the binder includes acrylic acid, methacrylic acid, poly(vinylpyrollidone), hydroxypropylmethyl cellulose, ethyl cellulose, poly(vinyl alcohol), poly(lactic acid), poly(ethylene glycol, or any combination thereof.

[0092] FIG. 2 is a schematic illustration of another physical hydrogel according to at least one example embodiment.

[0093] In at least one example embodiment, a physical hydrogel 200 includes binder molecules 202 and flavorant molecules 204. At least a portion of the flavorant molecules 202 are linked to at least a portion of the binder molecules 202 via hydrogen bonds 206. A hydrogen bonding network of the physical hydrogel 200 including the binder molecules 202 and the flavorant molecules 204 may generally be stronger than a hydrogen bonding network formed from only the binder molecules 202 or primarily the binder molecules 202. The flavorant molecules 204 participate in the hydrogen bonding network by forming additional hydrogen bonds 206 with the binder molecules 202 such that a quantity of hydrogen bonds, size of the hydrogen bonding network, and / or total strength of the hydrogen bonds is increased compared to the hydrogen bonding network having only binder molecules 202.

[0094] In at least one example embodiment, when used in an oral product, the physical hydrogel 200 may facilitate retention of the flavorant molecules 204 in the oral product until contact with a solvent, such as saliva. For example, the large network of hydrogen bonds may reduce or prevent direct paths to an external surface, thereby acting as a net to trap flavorant molecules 202 therein. The trapped flavorant molecules 202 would need to take a tortuous path to reach a surface and volatilize. Thus, loss of the flavorant molecules 204 prior to contact with saliva may be reduced or prevented. Additionally, larger hydrogen bonding networks are less soluble in water than smaller networks. As a result, during use, the physical hydrogel 200 having the strong hydrogen bonding network may be configured to have a prolonged release of elements, such as an active ingredient, during a period of use by an adult consumer (i.e., contact with saliva). In at least one example embodiment, a physical hydrogel includes greater than or equal to 1 binder (e.g., greater than or equal to 2 binders, or greater than or equal to 3 binders).

[0095] The flavorant molecule 204 may have greater than or equal to 2 hydrogen bonding sites (e.g., greater than or equal to 3 hydrogen bonding sites, greater than or equal to 4 hydrogen bonding sites, greater than or equal to 5 hydrogen bonding sites, or greater than or equal to about 6 hydrogen bonding sites). Accordingly, the flavorant molecule 204 can form a hydrogen bond with the binder molecule 202 and still have remaining hydrogen bonding sites available to form additional hydrogen bonds with binder molecules 202 and / or flavorant molecules 204 so as to strengthen the hydrogen bonding network. In at least one example embodiment, the flavorant molecule 204 may be a difunctional molecule. In at least one example embodiment, the binder molecules 202 and flavorant molecules 204 form a branched network.

[0096] At least a portion of the hydrogen bonding sites on the flavorant molecule 204 are hydrogen bond donors 208 and at least a portion of the bonding sites are hydrogen bond acceptors 210. The flavorant molecule 204 includes greater than or equal to 1 hydrogen bond donor 208 (e.g., greater than or equal to 2, or greater than or equal to 3). The flavorant molecule 204 includes greater than or equal to 1 hydrogen bond acceptor 210 (e.g., greater than or equal to 2, or greater than or equal to 3).

[0097] In at least one example embodiment, all or a portion of the hydrogen bonding sites have dipole moments within a desired range. In at least one example embodiment, greater than or equal to 1 of the hydrogen bonding sites has a dipole moment within the desired range (e.g., greater than or equal to 2, greater than or equal to 3, greater than or equal to 4, greater than or equal to 5, or greater than or equal to 6). In at least one example embodiment, all of the hydrogen bonding sites of the flavorant molecule 204 have dipole moments within the desired range. In at least one example embodiment, the desired range is greater than or equal to about 0.3 Debye (D) (e.g., greater than or equal to about 0.5 D, greater than or equal to about 1 D, greater than or equal to about 1.25 D, greater than or equal to about 1.5 D, greater than or equal to about 1.75 D, greater than or equal to about 2 D, greater than or equal to about 2.25 D, greater than or equal to about 2.5 D, greater than or equal to about 2.75 D, greater than or equal to about 3 D, greater than or equal to about 3.25 D, greater than or equal to about 3.5 D, greater than or equal to about 3.75 D, greater than or equal to about 4 D, or greater than or equal to about 4.25 D). The desired range may be less than or equal to about 4.5 D (e.g., less than or equal to about 4.25 D, less than or equal to about 4 D, less than or equal to about 3.75 D, less than or equal to about 3.5 D, less than or equal to about 3.25 D, less than or equal to about 3 D, less than or equal to about 2.75 D, less than or equal to about 2.5 D, less than or equal to about 2.25 D, less than or equal to about 2 D, less than or equal to about 1.75 D, less than or equal to about 1.5 D, or less than or equal to about 1.25 D). In at least one example embodiment, the dipole moment may have a strong dipole moment ranging from about 1 D to about 4.5 D.

[0098] In at least one example embodiment, the flavorant may be generally recognized as safe (GRAS) by the Flavor and Extract Manufacturers Association of the United States (FEMA). For example, the flavorant may be a FEMA GRAS flavorant that has at one hydrogen bond donor site and at least one hydrogen bond acceptor site, each having the dipole moments within the desired range. In at least one example embodiment, the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof. In at least one example embodiment, the physical hydrogel 200 includes a single flavorant. In other example embodiments, the physical hydrogel 200 includes multiple flavorants (e.g., 2 flavorants or 3 flavorants).

[0099] In at least one example embodiment, an oral product including the physical hydrogel 200 may have less binder than an oral product including the physical hydrogel 100 without a flavorant. That is, the increased strength of the hydrogen bonding network when the flavorant molecule 204 forms hydrogen bonds with the binder molecule 202 may facilitate the use of less binder while achieving desired characteristics of the oral product. In at least one example embodiment, an oral product including the physical hydrogel 200 includes binder in amount greater than or equal to about 0.25 weight percent (e.g., greater than or equal to about 0.5 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 5 weight percent). The oral product may include the binder in an amount less than or equal to about 10 weight percent (e.g., less than or equal to about 9 weight percent, less than or equal to about 8 weight percent, less than or equal to about 7 weight percent, less than or equal to about 6 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3 weight percent, or less than or equal to about 2 weight percent).

[0100] In at least one example embodiment, use of the physical hydrogel 200 in an oral product including the active ingredient (e.g., nicotine) may facilitate the use of less antioxidant or no antioxidant compared to an oral product including the physical hydrogel 100. The oral product including the physical hydrogel 200 may include an active ingredient (e.g., nicotine) and be substantially free of an antioxidant. In at least one example embodiment, the oral product including the physical hydrogel 200 further includes nicotine and is free of ascorbyl palmitate, butylated hydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA), and Vitamin E.

[0101] FIG. 3 is a schematic illustration of another physical hydrogel according to at least one example embodiment.

[0102] In at least one example embodiment, a physical hydrogel 300 includes binder molecules 302 and flavorant molecules 304. At least a portion of the flavorant molecules 304 are linked to at least a portion of the binder molecules 302 via hydrogen bonds 306. The flavorant molecules 304 may inhibit the hydrogen bonding network such that the hydrogen bonding network including the binder molecules 302 and the flavorant molecules 304 is generally weaker than a hydrogen bonding network formed from only the binder molecules 302 or primarily the binder molecules 302. The flavorant molecules 304 participate in the hydrogen bonding network by blocking hydrogen bonding sites so as to reduce hydrogen bonding between binder molecules 302 and / or additional flavorant molecules304.

[0103] In at least one example embodiment, the physical hydrogel 300 includes a smaller and / or weaker hydrogen bonding network than the physical hydrogel 100 of FIG. 1 or the physical hydrogel 200 of FIG. 2. Smaller hydrogen bonding networks may be more soluble in water than larger networks. As a result, during use, the physical hydrogel 300 having the smaller and / or weaker hydrogen bonding network may be configured to have a rapid release of elements, such as an active ingredient, during a period of use by an adult consumer (i.e., contact with saliva). In at least one example embodiment, a physical hydrogel 300 includes greater than or equal to 1 binder (e.g., greater than or equal to 2 binders, or greater than or equal to 3 binders).

[0104] The flavorant molecule 304 may have greater than or equal to 1 hydrogen bonding sites (e.g., greater than or equal to 2 hydrogen bonding sites, greater than or equal to 3 hydrogen bonding sites, or greater than or equal to 4 hydrogen bonding sites). In at least one example embodiment, the flavorant molecule 304 has only a small quantity of hydrogen bonding sites (e.g., a single hydrogen bonding site) so as to create a cap or stop in the hydrogen bonding network and reduce or prevent the formation of additional hydrogen bonds with the flavorant molecule 304. The flavorant molecule 304 may have a single hydrogen bonding site. In at least one example embodiment, an oral product including the physical hydrogel 300 may further include a nonpolar flavorant having zero hydrogen bonding sites, which does not directly interact with the hydrogen bonding network, but may passively inhibit chain formation. In at least one example embodiment, the flavorant molecule 304 has greater than 1 hydrogen bonding site, but weak dipole moments, as will be described in greater detail below.

[0105] In at least one example embodiment, all of the hydrogen bonding sites on the flavorant molecule 304 have the same polarity so as to reduce or prevent hydrogen bonding. For example, all or a majority of hydrogen bonding sites on the flavorant molecule 304 may hydrogen bond donors 308. In another example, all or a majority of hydrogen bonding sites on the flavorant molecule 304 may be hydrogen bond acceptors 310.

[0106] In at least one example embodiment, all or a portion of the hydrogen bonding sites have dipole moments within a desired range. In at least one example embodiment, greater than or equal to 1 of the hydrogen bonding sites has a dipole moment within the desired range (e.g., greater than or equal to 2, greater than or equal to 3, greater than or equal to 4, greater than or equal to 5, or greater than or equal to 6). In at least one example embodiment, all of the hydrogen bonding sites of the flavorant molecule 304 have dipole moments within the desired range. In at least one example embodiment, the desired range is greater than or equal to about 0.1 D (e.g., greater than or equal to about 0.2 D, greater than or equal to about 0.3 D, greater than or equal to about 0.4 D, greater than or equal to about 0.5 D, greater than or equal to about 1 D, greater than or equal to about 1.25 D, greater than or equal to about 1.5 D, greater than or equal to about 1.75 D, greater than or equal to about 2 D, greater than or equal to about 2.25 D, greater than or equal to about 2.5 D, greater than or equal to about 2.75 D, greater than or equal to about 3 D, greater than or equal to about 3.25 D, greater than or equal to about 3.5 D, or greater than or equal to about 3.75 D). The desired range may be less than or equal to about 4.5 D (e.g., less than or equal to about 4.25 D, less than or equal to about 4 D, less than or equal to about 3.75 D, less than or equal to about 3.5 D, less than or equal to about 3.25 D, less than or equal to about 3 D, less than or equal to about 2.75 D, less than or equal to about 2.5 D, less than or equal to about 2.25 D, less than or equal to about 2 D, less than or equal to about 1.75 D, less than or equal to about 1.5 D, less than or equal to about 1.25 D, less than or equal to about 1 D, less than or equal to about 0.75 D, less than or equal to about 0.5 D, less than or equal to about 0.4 D, less than or equal to about 0.3 D, or less than or equal to about 0.2 D).

[0107] In at least one example embodiment, the flavorant molecule 304 has a single hydrogen bonding site having a strong dipole moment ranging from about 1 D to about 4.5 D. Thus, the flavorant molecule 304 may form relatively strong hydrogen bonds with the binder 302 and cap or terminate the network. In at least one other example embodiment, the flavorant molecule 304 has greater than or equal to 2 hydrogen bonding sites and a weak dipole moment of less than or equal to about 1 D. Thus, the flavorant molecule 304 may form a relatively weak network with the binder molecule 302.

[0108] In at least one example embodiment, the flavorant may be generally recognized as safe (GRAS) by the FEMA. For example, the flavorant may be a FEMA GRAS flavorant having the above characteristics. In at least one example embodiment, the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof. In at least one example embodiment, the flavorant is a natural flavorant. Natural flavorants may inhibit network formation because they contain many different compounds (e.g., hundreds of different compounds), such that there may be too much interference from poor dipole and / or single reactive site molecules to achieve strong hydrogen bonding network formation.

[0109] In at least one example embodiment, an oral product including the physical hydrogel 300 includes greater than or equal to about 3 weight percent of binder (e.g., greater than or equal to about 5 weight percent, greater than or equal to about 6 weight percent, greater than or equal to about 7 weight percent, greater than or equal to about 7.5 weight percent, greater than or equal to about 8 weight percent, greater than or equal to about 8.5 weight percent, greater than or equal to about 9 weight percent, greater than or equal to about 9.5 weight percent, greater than or equal to about 10 weight percent, greater than or equal to about 10.5 weight percent, greater than or equal to about 11 weight percent, greater than or equal to about 11.5 weight percent, greater than or equal to about 12 weight percent, greater than or equal to about 13 weight percent, greater than or equal to about 14 weight percent, or greater than or equal to about 15 weight percent). The oral product including the physical hydrogel 300 may include less than or equal to about 20 weight percent of binder (e.g., less than or equal to about 15 weight percent, less than or equal to about 14 weight percent, less than or equal to about 13 weight percent, less than or equal to about 12 weight percent, less than or equal to about 11.5 weight percent, less than or equal to about 11 weight percent, less than or equal to about 10.5 weight percent, less than or equal to about 10 weight percent, less than or equal to about 9.5 weight percent, less than or equal to about 9 weight percent, less than or equal to about 8.5 weight percent, less than or equal to about 8 weight percent, less than or equal to about 7.5 weight percent, less than or equal to about 7 weight percent, less than or equal to about 6 weight percent, or less than or equal to about 5 weight percent).

[0110] At least one example embodiment relates to a method of making an oral product including a physical hydrogel. The physical hydrogel includes a binder and a flavorant, with at least a portion of the flavorant hydrogen bonded to at least a portion of the binder. The method may include tuning the oral product to have desired properties, such as desired dissolution characteristics, active ingredient release, flavorant retention, and / or moisture resistance.

[0111] The mere presence of binder and flavorant in an oral product does not necessarily lead to formation of a hydrogen bonding network or physical hydrogel including both the binder and the flavorant. Whether a physical hydrogel is formed between the binder and flavorant may depend at least upon flavorant characteristics, as described above, and method of making the oral product. For example, a physical hydrogel may be formed by providing and retaining a suitable flavorant (e.g., a polar flavorant) and a suitable binder in close proximity to one another, with limited or nointerference from other elements, while the binder is available for hydrogen bonding, so as to create hydrogen bonds between the binder and the flavorant instead of only the binder. In one example, adding a nonpolar flavorant to an oral product at any time during manufacturing, and at any proximity to a solvated binder, will not form a physical hydrogel including the binder and the flavorant because the nonpolar flavorant is not capable of forming hydrogen bonds. In another example, adding flavorant to the oral product when the binder is unavailable for hydrogen bonding (e.g., when the binder is not solvated) will not facilitate the formation of a physical hydrogel including both the binder and the flavorant. In another example, providing flavorant outside of proximity of a binder for hydrogen bonding (e.g., as an encapsulated flavorant, in a different layer, absorbed and / or adsorbed in a solid carrier, etc.) will not facilitate the formation of a physical hydrogel including both the binder and the flavorant. In another example, providing flavorant and binder in a solvent with other elements may not facilitate the formation of a physical hydrogel because the other elements may interfere with formation of the physical hydrogel.

[0112] FIG. 4 is a flowchart illustrating a method of making an oral product including a physical hydrogel according to at least one example embodiment.

[0113] At least one example embodiment relates to a method of making an oral product including a physical hydrogel, as shown in FIG. 4. The method may generally include tuning desired oral product characteristics at S400; preparing a wet granulation at S404; preparing a physical hydrogel at S408; and incorporating the physical hydrogel into an oral product at S412. Each of these steps is described in greater detail below.

[0114] At S400, the method includes tuning desired characteristics of an oral product to be produced. Desired oral product characteristics may include dissolution rate, active ingredient release rate, flavorant retention prior to use, and / or moisture resistance. Tuning the desired oral product characteristics may include selecting one or more flavorants having desired flavorant characteristics. In at least one example embodiment, the desired flavorant characteristics include polar flavorant molecules. The desired flavorant characteristics may further include a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof, as described above in the discussions accompanying FIGS. 2-3. Tuning the dissolution characteristics may further include selecting one or more binders having desired binder characteristics. Desired binder characteristics may include a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof. Tuning the dissolution characteristics may further include providing a desired amount of binder and / or flavorant.

[0115] At S404, the method includes preparing a wet granulation including binder, solvent, and flavorant. In at least one example embodiment, the wet granulation includes the solvent in an amount to facilitate breaking existing binder hydrogen bonds, thorough admixing of the binder and flavorant, and retention of the binder and flavorant in close enough proximity to form hydrogen bonds. In at least one example embodiment, the wet granulation includes the solvent in an amount greater than or equal to about 12 weight percent (e.g., greater than or equal to about 15 weight percent, greater than or equal to about 20 weight percent, greater than or equal to about 25 weight percent, greater than or equal to about 30 weight percent, greater than or equal to about 35 weight percent, greater than or equal to about 40 weight percent, greater than or equal to about 45 weight percent, or greater than or equal to about 50 weight percent). The wet granulation may include the solvent in an amount less than or equal to about 55 weight percent (e.g., less than or equal to about 50 weight percent, less than or equal to about 45 weight percent, less than or equal to about 40 weight percent, less than or equal to about 35 weight percent, less than or equal to about 30 weight percent, less than or equal to about 25 weight percent, less than or equal to about 20 weight percent, or less than or equal to about 15 weight percent). The solvent may be configured to break existing and / or initial hydrogen bonds in the binder. The solvent may be an organic solvent. In at least one example embodiment, the solvent includes water, ethanol, or a combination of water and ethanol.

[0116] In at least one example embodiment, the wet granulation includes the flavorant in an amount greater than or equal to about 1 weight percent (e.g., greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 4.5 weight percent, greater than or equal to about 5 weight percent, or greater than or equal to about 5.5 weight percent). In at least one example embodiment, the wet granulation includes the flavorant in an amount less than or equal to about 6 weight percent (e.g., less than or equal to about 5.5 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, or less than or equal to about 1.5 weight percent).

[0117] In at least one example embodiment, the wet granulation includes the binder in an amount greater than or equal to about 1 weight percent (e.g., greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 4.5 weight percent, greater than or equal to about 5 weight percent, or greater than or equal to about 5.5 weight percent). In at least one example embodiment, the wet granulation includes the binder in an amount less than or equal to about 6 weight percent (e.g., less than or equal to about 5.5 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, or less than or equal to about 1.5 weight percent).

[0118] In at least one example embodiment, the wet granulation further includes other elements, such as insoluble element(s), soluble element(s), active ingredient(s), and / or other elements discussed herein. In at least one example embodiment, the wet granulation may include insoluble element(s) in an amount less than or equal to about 60 weight percent (e.g., less than or equal to about 55 weight percent, less than or equal to about 50 weight percent, less than or equal to about 45 weight percent, less than or equal to about 40 weight percent, less than or equal to about 35 weight percent, less than or equal to about 30 weight percent, less than or equal to about 25 weight percent, less than or equal to about 20 weight percent, less than or equal to about 5 weight percent, less than or equal to about 0 weight percent, or less than or equal to about 5 weight percent). In at least one example embodiment, the wet granulation may include soluble element(s) in an amount less than or equal to about 70 weight percent (e.g., less than or equal to about 65 weight percent, less than or equal to about 60 weight percent, less than or equal to about 55 weight percent, less than or equal to about 50 weight percent, less than or equal to about 45 weight percent, less than or equal to about 40 weight percent, less than or equal to about 35 weight percent, less than or equal to about 30 weight percent, less than or equal to about 25 weight percent, less than or equal to about 20 weight percent, less than or equal to about 5 weight percent, less than or equal to about 0 weight percent, or less than or equal to about 5 weight percent).

[0119] In at least one example embodiment, preparing the wet granulation further includes admixing additional elements of the oral product, such as those described below. In at least one example embodiment, preparing the wet granulation includes first admixing the binder and the solvent, and second adding the flavorant. In the first step, the solvent breaks existing hydrogen bonds in the binder. In the second step, the flavorant is admixed with the solvent and binder so as to place the flavorant in close enough proximity with the binder to form hydrogen bonds as the solvent is reduced and / or removed.

[0120] In at least one example embodiment, the wet granulation consists essentially of the binder, the solvent, and the flavorant. As used herein, “consisting essentially of” means that the wet granulation is free of other elements that would interfere with formation of a hydrogen bonding network. The wet granulation may consist of the binder, the solvent, and the flavorant. In at least one other example embodiment, the wet granulation further includes other elements (e.g., insoluble filler and / or soluble elements). The other elements, if present, may be present in an amount such that they do not substantially interfere with formation of the hydrogen bonding network.

[0121] S404 may include mixing and / or stirring the solvent, binder, and flavorant to form wet granules. The mixing and / or stirring may be performed at speed low enough to reduce or prevent breaking apart granules. In at least one example embodiment, the rotational speed may be less than or equal to about 10 rotations per minute (RPM) (e.g., less than or equal to about 9 RPM, less than or equal to about 8 RPM, less than or equal to about 7 RPM, less than or equal to about 6 RPM, or less than or equal to about 5 RPM). In at least one example embodiment, the mixing may be performed in a kitchen mixer and / or blender. In at least one example embodiment, the mixing may include gravity tumbling ingredients to build wet granules through adhesion.

[0122] In at least one example embodiment, S404 is performed at a temperature of greater than or equal to about 20° C. (e.g., greater than or equal to about 21° C., greater than or equal to about 22° C., greater than or equal to about 23° C., greater than or equal to about 24° C., greater than or equal to about 25° C., greater than or equal to about 26° C., greater than or equal to about 27° C., greater than or equal to about 28° C., or greater than or equal to about 29° C.). S404 may be performed at a temperature of less than or equal to about 30° C. (e.g., less than or equal to about 29° C., less than or equal to about 28° C., less than or equal to about 27° C., less than or equal to about 26° C., less than or equal to about 25° C., less than or equal to about 24° C., less than or equal to about 23° C., less than or equal to about 22° C., or less than or equal to about 21° C.).

[0123] In at least one example embodiment S404 may be performed for a duration of greater than or equal to about 5 minutes (e.g., greater than or equal to about 10 minutes, greater than or equal to about 15 minutes, greater than or equal to about 20 minutes, greater than or equal to about 25 minutes, greater than or equal to about 20 minutes, greater than or equal to about 35 minutes, greater than or equal to about 40 minutes, greater than or equal to about 45 minutes, greater than or equal to about 50 minutes, or greater than or equal to about 55 minutes). S404 may be performed for a duration of less than or equal to about 60 minutes (e.g., less than or equal to about 55 minutes, less than or equal to about 50 minutes, less than or equal to about 45 minutes, less than or equal to about 40 minutes, less than or equal to about 35 minutes, less than or equal to about 30 minutes, less than or equal to about 25 minutes, less than or equal to about 20 minutes, less than or equal to about 15 minutes, or less than or equal to about 10 minutes).

[0124] At S408, the method includes preparing a physical hydrogel. Preparing the physical hydrogel may include drying the wet granulation to remove at least a portion of (e.g., substantially all) of the solvent while retaining the binder and the flavorant in close proximity with one another. During drying, hydrogen bonds may be formed between at least a portion of the binder and at least a portion of the flavorant. Binder-to-binder and flavorant-to-flavorant hydrogen bonds may also be formed. In at least one example embodiment, the physical hydrogel is in the form of a dry granulation. If additional elements were added to the wet granulation in S404, then the dry granules may further include the additional elements. In at least one example embodiment, the dry granules may consist essentially of the binder and the flavorant. In at least one example embodiment, the method does not include adding any additional elements after preparing the wet granulation at S404 and before preparing the physical hydrogel at S408.

[0125] In at least one example embodiment, S408 includes drying via vacuum, fluidized bed, laminar airflow, or any combination thereof. In at least one example embodiment, S408 is performed at a temperature of greater than or equal to about 20° C. (e.g., greater than or equal to about 22.5° C., greater than or equal to about 25° C., greater than or equal to about 27.5° C., greater than or equal to about 30° C., greater than or equal to about 32.5° C., greater than or equal to about 35° C., greater than or equal to about 37.5° C., greater than or equal to about 40° C., greater than or equal to about 42.5° C., greater than or equal to about 45° C., or greater than or equal to about 47.5° C.). The temperature may be less than or equal to about 50° C. (e.g., less than or equal to about 47.5° C., less than or equal to about 45° C., less than or equal to about 42.5° C., less than or equal to about 40° C., less than or equal to about 37.5° C., less than or equal to about 35° C., less than or equal to about 32.5° C., less than or equal to about 30° C., less than or equal to about 27.5° C., less than or equal to about 25° C., or less than or equal to about 22.5° C.).

[0126] In at least one example embodiment, S408 may be performed for a duration of greater than or equal to about 1 hour (e.g., greater than or equal to about 2 hours, greater than or equal to about 4 hours, greater than or equal to about 6 hours, greater than or equal to about 8 hours, greater than or equal to about 10 hours, greater than or equal to about 12 hours, greater than or equal to about 14 hours, greater than or equal to about 16 hours, greater than or equal to about 18 hours, greater than or equal to about 20 hours, or greater than or equal to about 22 hours). S408 may be performed for a duration of less than or equal to about 24 hours (e.g., less than or equal to about 22 hours, less than or equal to about 20 hours, less than or equal to about 18 hours, less than or equal to about 16 hours, less than or equal to about 14 hours, less than or equal to about 12 hours, less than or equal to about 10 hours, less than or equal to about 8 hours, less than or equal to about 6 hours, less than or equal to about 4 hours, or less than or equal to about 2 hours).

[0127] At S412, the method includes incorporating the physical hydrogel into an oral product, optionally with additional elements, such as an active ingredient and / or other elements described herein. Depending on the oral product to be formed, S412 may be performed concurrently with S404 and / or S408. In at least one example embodiment, dry granules formed in S408 are admixed and / or combined with additional elements of the oral product. In at least one example embodiment, S412 includes pouching the dry granules, optionally together with additional elements. The oral product may be in the form of a form of loose material (e.g., the dry granules), shaped material (e.g., plugs or twists), pouched material (shown in FIGS. 5-7), gums (shown in FIG. 8), lozenges (shown in FIG. 9), tablets (shown in FIG. 10), films (shown in FIG. 11), gels, sprays, any other oral product, or any combination thereof.

[0128] At least one example embodiment relates to an oral product including a physical hydrogel. The physical hydrogel includes a binder and a flavorant, with at least a portion of the binder hydrogen bonded to at least a portion of the flavorant. The oral product may have desired characteristics, such as rapid and / or prolonged dissolution, active ingredient release rate, flavorant retention, and / or moisture resistance. In at least one example embodiment, the oral product has a reduced amount of binder compared to an oral product without the physical hydrogel, as described above. In at least one example embodiment, the oral product is free of an antioxidant.

[0129] In at least one example embodiment, the oral product is a dry oral product. Limiting moisture in the oral product facilitates retention of hydrogen bonds in the physical hydrogel such that the oral product retains the desired characteristics. In at least one other example embodiment, the oral product has a medium or high (e.g., 10-50 weight percent, 10-20 weight percent, greater than 20 weight percent, greater than 30 weight percent, 20-35 weight percent, or 40-65 weight percent) water content, but the water is substantially separated from the physical hydrogel so as to retain integrity of the hydrogen bonds in the physical hydrogel until use.

[0130] The dry oral product may have a water content of greater than or equal to about 0.5 weight percent (e.g., greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 4.5 weight percent, greater than or equal to about 5 weight percent, greater than or equal to about 5.5 weight percent, greater than or equal to about 6 weight percent, greater than or equal to about 7 weight percent, greater than or equal to about 8 weight percent, or greater than or equal to about 9 weight percent). The dry oral product may have a water content of less than or equal to about 10 weight percent (e.g., less than or equal to about 9 weight percent, less than or equal to about 8 weight percent, less than or equal to about 7 weight percent, less than or equal to about 6 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, less than or equal to about 1.5 weight percent, or less than or equal to about 1 weight percent).

[0131] The dry oral product may have an oven volatiles content of greater than or equal to about 0.5 weight percent (e.g., greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 4.5 weight percent, greater than or equal to about 5 weight percent, greater than or equal to about 5.5 weight percent, greater than or equal to about 6 weight percent, greater than or equal to about 7 weight percent, greater than or equal to about 8 weight percent, or greater than or equal to about 9 weight percent). The dry oral product may have an oven volatiles content of less than or equal to about 10 weight percent (e.g., less than or equal to about 9 weight percent, less than or equal to about 8 weight percent, less than or equal to about 7 weight percent, less than or equal to about 6 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, less than or equal to about 1.5 weight percent, or less than or equal to about 1 weight percent).

[0132] In at least one example embodiment, the oral product includes a first region having first desired characteristics and a second region having second desired characteristics different from the first desired characteristics. The first region may include a first physical hydrogel and the second region may include a second physical hydrogel. At least one of the first and second physical hydrogels includes flavorant hydrogen bonded to binder. In at least one example embodiment, the first physical hydrogen is the physical hydrogel 200 of FIG. 2 and the second physical hydrogel is the physical hydrogel 300 of FIG. 3.

[0133] In at least one example embodiment, the oral product is an oral tobacco product, an oral non-tobacco product, an oral cannabis product, or any combination thereof. The oral product may include chewing tobacco, snus, moist snuff tobacco, dry snuff tobacco, other smokeless tobacco and non-tobacco products for oral consumption, or any combination thereof.

[0134] Where the oral product is an oral tobacco product including smokeless tobacco product, the smokeless tobacco product may include tobacco that is whole, shredded, cut, granulated, reconstituted, cured, aged, fermented, pasteurized, or otherwise processed. Tobacco may be present as whole or portions of leaves, flowers, roots, stems, extracts (e.g., nicotine), or any combination thereof.

[0135] In at least one example embodiment, the oral product includes a tobacco extract, such as a tobacco-derived nicotine extract, and / or synthetic nicotine. The oral product may include nicotine alone or in combination with a carrier (e.g., white snus), such as a cellulosic material. The carrier may be a non-tobacco material (e.g., microcrystalline cellulose) or a tobacco material (e.g., tobacco fibers having reduced or eliminated nicotine content, which may be referred to as “exhausted tobacco plant tissue or fibers”). In some example embodiments, the exhausted tobacco plant tissue or fibers can be treated to remove at least 25%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, or 95% of the nicotine. For example, the tobacco plant tissue can be washed with water or another solvent to remove the nicotine.

[0136] In at least one example embodiment, the oral product includes tobacco plant tissue. The tobacco plant tissue may be in the form of a tobacco dust. The tobacco plant tissue may be whitened and / or bleached. The oral product may include the tobacco plant tissue in an amount greater than or equal to about 0.5 weight percent (e.g., greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 4 weight percent, greater than or equal to about 5 weight percent, greater than or equal to about 7 weight percent, or greater than or equal to about 10 weight percent). The oral product may include the tobacco plant tissue in an amount less than or equal to about 15 weight percent. (e.g., less than or equal to about 10 weight percent, less than or equal to about 7 weight percent, less than or equal to about 5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2_weight percent, less than or equal to about 1.5 weight percent, or less than or equal to about 1 weight percent).

[0137] In other example embodiments, the oral product may include cannabis, such as cannabis plant tissue and / or cannabis extracts. In at least one example embodiment, the cannabis material includes leaf and / or flower material from one or more species of cannabis plants and / or extracts from the one or more species of cannabis plants. The one or more species of cannabis plants may include Cannabis sativa, Cannabis indica, and / or Cannabis ruderalis. In at least one example embodiment, the cannabis may be in the form of fibers. In at least one example embodiment, the cannabis may include a cannabinoid, a terpene, and / or a flavonoid. In at least one example embodiment, the cannabis material may be a cannabis-derived cannabis material, such as a cannabis-derived cannabinoid, a cannabis-derived terpene, and / or a cannabis-derived flavonoid.

[0138] The oral product may be sized and / or shaped and / or configured to be wholly received in an oral cavity of an adult tobacco consumer. The oral product may have an oval shape, a rounded shield shape, a flat shield shape an elliptical shape, an elongated elliptical shape, a semi-circular shape, a square shape, a rounded-edge square shape, a rectangular shape, an elongated rectangular shape, a rounded-edge rectangular shape, a football shape, a boomerang shape, a teardrop shape, a comma shape, a bowtie shape, a peanut shape, or any combination thereof. The oral product may have an oral-shaped cross section, a rectangular cross section, an elongated rectangular cross section, a lens or football shaped cross section, a boomerang-shaped cross section, a shield-shaped cross section, or any combination thereof. In at least one example embodiment, the size and / or shape and / or configuration of the oral product may be selected to promote desired positioning of the oral product within the oral cavity and / or packaging.

[0139] In at least one example embodiment, the oral product may have dimensions ranging from about 1 millimeter to about 25 millimeters (e.g., about 1 millimeter to about 10 millimeters, about 1 millimeter to about 5 millimeters, about 5 millimeters to about 25 millimeters, about 5 millimeters to about 10 millimeters, about 10 millimeters to about 15 millimeters, about 15 millimeters to about 20 millimeters, or about 20 millimeters to about 25 millimeters). In at least one example embodiment, the oral product has a first dimension (e.g., smallest dimension or thickness) ranging from about 1 millimeter to about 10 millimeters (e.g., about 2.5 millimeters). In at least one example embodiment, the oral product has a largest dimension (e.g., diameter, height, or width) ranging from about 5 millimeters to about 25 millimeters (e.g., about 12 millimeters).

[0140] In at least one example embodiment, the oral product may have a weight ranging from about 1 milligram to about 10 grams (e.g., about 1 gram to about 9 grams, about 1 gram to about 8 grams, about 1 gram to about 7 grams, about 1 gram to about 6 grams, about 1 gram to about 5 grams, about 1 gram to about 4 grams, about 1 gram to about 3 grams, about 1 gram to about 2 grams, about 2 grams to about 9 grams, about 2 grams to about 8 grams, about 2 grams to about 7 grams, about 2 grams to about 6 grams, about 2 grams to about 5 grams, about 2 grams to about 4 grams, about 2 grams to about 3 grams, about 3 grams to about 9 grams, about 3 grams to about 8 grams, about 3 grams to about 7 grams, about 3 grams to about 6 grams, about 3 grams to about 5 grams, about 3 grams to about 4 grams, about 4 grams to about 9 grams, about 4 grams to about 8 grams, about 4 grams to about 7 grams, about 4 grams to about 6 grams, about 4 grams to about 5 grams, about 5 grams to about 9 grams, about 5 grams to about 8 grams, about 5 grams to about 7 grams, about 5 grams to about 6 grams, about 6 grams to about 9 grams, about 6 grams to about 8 grams, about 6 grams to about 7 grams, about 7 grams to about 9 grams, about 7 grams to about 8 grams, about 8 grams to about 9 grams).

[0141] In at least one example embodiment, the oral product may include one or more elements or additives such as a mouth-stable polymer, a mouth-soluble polymer, a sweetener, an energizing agent, a soothing agent, a focusing agent, a plasticizer, mouth-soluble or partially-soluble fibers (e.g., sugar beet fibers), an alkaloid, a mineral, a vitamin, a dietary supplement, a nutraceutical, a coloring agent, an amino acid, a chemesthetic agent, an antioxidant, a food-grade emulsifier (e.g., glycerol monostearate, propylene glycol monostearate, and / or an acetylated monoglyceride), a pH modifier, a botanical (e.g., green tea), a tooth-whitening agent (e.g., sodium hexametaphosphate (SHMP)), a therapeutic agent, a processing aid, a stearate (e.g., magnesium and / or potassium), a wax (e.g., glycerol monostearate, propylene glycol monostearate, and / or an acetylated monoglyceride), a stabilizer (e.g., ascorbic acid and monosterol citrate, butylated hydroxytoluene (BHT), or butylated hydroxyanisole (BHA)), a lubricant (e.g., sodium lauryl sulfate (SLS)), a disintegrating agent, a preservative (e.g., sodium benzoate), a filler, a flavorant, an effervescent (e.g., carbon dioxide embedded in a flavorant or a filling material), a flavor masking agent, a bitterness receptor site blocker, a receptor site enhancer, other additives, or any combination thereof. The oral product may include multiple additional elements. Additionally, a single element may belong to more than one of the categories above.

[0142] As used herein, “mouth-soluble” means that the polymer experiences significant degradation when exposed to saliva within an oral cavity of an adult consumer over a period of about four hours. In at least one example embodiment, the mouth-soluble polymer disintegrates when exposed to saliva having a normal human body temperature (i.e., 98.6° F.) for a period of less than or equal to about an hour (e.g., less than or equal to about 30 minutes, less than or equal to about 15 minutes, less than or equal to about 10 minutes, or less than or equal to about 5 minutes).

[0143] In at least one example embodiment, the oral product is free of a mouth-soluble polymer. In at least one example embodiment, the oral product includes a mouth-soluble polymer. The mouth-soluble polymer may include, for example, a cellulosic polymer, a natural polymer, a seaweed-derived polymer, a microbial-derived polymer, an extract, an exudate, a synthetic polymer, or any combination thereof. Other useful mouth soluble polymers are known in the art, for example, see Krochta et al., Food Technology (1997) at 51:61-74; Glicksman Food Hydrocolloids CRC 1982; Krochta Edible Coatings and Films to Improve Food Quality Technomic 1994; Industrial Gums Academic 1993; and / or Nussinovitch Water-Soluble Polymer Applications in Foods Blackwell Science 2003, the entire contents of which are hereby incorporated by reference.

[0144] In at least one example embodiment, the cellulosic polymer may include, for example, carboxymethyl cellulose (CMC), hydroxypropyl (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methylcellulose (HPMC), methyl cellulose (MC), or any combination thereof. In at least one example embodiment, the natural polymer may include, for example, a starch, a modified starch, konjac, collagen, inulin, soy protein, whey protein, casein, wheat gluten, or any combination thereof. In at least one example embodiment, the seaweed-derived polymer may include, for example, a carrageenan, an alginate, or a combination of a carrageenan and an alginate. In at least one example embodiment, the carrageenan may include, for example, kappa carrageenan, iota carrageenan, lambda carrageenan, or any combination thereof. In at least one example embodiment, the alginate may include, for example, propylene glycol alginate. In at least one example embodiment, the microbial-derived polymer may include, for example, xanthan, dextran, pullulan, curdlan, gellan, or any combination thereof. In at least one example embodiment, the extract may include, for example, locust bean gum, guar gum, tara gum, gum tragacanth, pectin (e.g., low methoxy and amidated), agar, zein, karaya, gelatin, psyllium seed, chitin, chitosan, or any combination thereof. In at least one example embodiment, the exudate may include, for example, gum acacia (arabic), shellac, or any combination thereof. In at least one example embodiment, the synthetic polymer may include, for example, polyvinyl pyrrolidone, polyethylene oxide, polyvinyl alcohol, or any combination thereof.

[0145] As used herein, “mouth-stable” means that the polymer does not appreciably dissolve or disintegrate when exposed to saliva at the normal human body temperature (i.e., 98.6° F.) over a period of about one hour. In at least one example embodiment, the mouth-stable polymer is a biodegradable polymer that is configured to break down over a period of days, weeks, months, or years but does not appreciably break down when held in an oral cavity and exposed to saliva for a period of about one hour. In at least one example embodiment, the mouth-stable polymer is stable within an oral cavity and exposed to saliva at the normal human body temperature for a period of greater than or equal to about 2 hours (e.g., greater than or equal to about 6 hours, greater than or equal to about 12 hours, greater than or equal to about 1 day, or greater than or equal to about 2 days). Accordingly, an oral product including a mouth-stable polymer according to at least one example embodiment is configured to remain intact when placed in an adult consumer's mouth. After a period of time, the mouth-stable polymer and any other mouth-stable elements may be removed from the adult consumer's mouth and discarded.

[0146] The mouth-stable polymer may be biocompatible and biostable. The mouth-stable polymer may generally be recognized as safe and in compliance with applicable food-contact regulations by an appropriate regulatory agency (e.g., the U.S. Food and Drug Administration (FDA)). In at least one example embodiment, the mouth-stable polymer has a flexural modulus of greater than or equal to about 5 MPa (e.g., greater than or equal to about 10 MPa) when tested according to ASTM Testing Method D790 or ISO 178 at 23° C.

[0147] In at least one example embodiment, the oral product is free of a mouth-stable polymer. In at least one example embodiment, the oral product includes a mouth-stable polymer. In at least one example embodiment, the mouth-stable polymer may include, for example, a polyurethane, a silicone, a polyester, a polyacrylate, a polyethylene, a polypropylene, a polyetheramide, a polystyrene, a polyvinyl alcohol, a polyvinyl acetate, a polyvinyl chloride, a polybutyl acetate, a butyl rubber, poly(styrene-ethylene-butylene-styrene) (SEBS), poly(styrene-butadiene-styrene) (SBS), poly(styrene-isoprene-styrene) (SIS), any copolymer thereof, or any combination thereof. In at least one example embodiment, the mouth-stable polymer includes a food-grade or medical-grade polymer, such as medical-grade polyurethane.

[0148] In at least one example embodiment, the mouth-stable polymer includes, for example, a thermoplastic polymer. The thermoplastic polymer may include a thermoplastic elastomer. In at least one example embodiment, the mouth-stable polymer includes a thermoplastic elastomer meeting the requirements of the FDA modified ISO 10993, Part 1 “Biological Evaluation of Medical Devices” tests with human tissue contact time of 30 days or less. In at least one example embodiment, the mouth-stable polymer has a shore Hardness of 50 D or softer, a melt flow index of about 3 g / 10 min at 200° C. / 10 kg, a tensile strength of greater than or equal to about 10 MPa (using ISO 37), and / or an ultimate elongation of less than about 100% (using ISO 37).

[0149] In at least one example embodiment, the oral product is free of a sweetener. In at least one example embodiment, the oral product includes a sweetener. In at least one example embodiment, the oral product includes an encapsulated sweetener. The sweetener may include a synthetic sweetener, a natural sweetener, or a combination of a synthetic sweetener and a natural sweetener.

[0150] The natural sweetener may include, for example, a sugar such as monosaccharide, a disaccharide, a polysaccharide, or any combination thereof. The natural sweetener may include, for example, sucrose, honey, a mixture of low-molecular-weight sugars excluding sucrose, glucose (i.e., grape sugar, corn sugar, dextrose), molasses, corn sweetener, glucose syrup (i.e., corn syrup), fructose (i.e., fruit sugar), lactose (i.e., milk sugar), maltose (i.e., malt sugar, maltobiose), sorghum syrup, fruit juice concentrate, or any combination thereof.

[0151] In at least one example embodiment, the sweetener includes a sugar alcohol. The sugar alcohol may include, for example, 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. In at least one example embodiment, the sweetener includes a non-nutritive sweetener. The non-nutritive sweetener may include, for example, stevia, saccharin, aspartame, sucralose, acesulfame potassium, or any combination thereof.

[0152] As used herein, the term “nutraceuticals” refers to any ingredient in foods that has a beneficial effect on human health. Nutraceuticals include particular compounds and / or compositions isolated from natural food sources and genetically modified food sources. Suitable nutraceuticals include, without limitation, various phytonutrients derived from natural plants and genetically engineered plants. In at least one example embodiment, the oral product is free of a nutraceutical. In at least one example embodiment, the oral product includes the nutraceutical. The nutraceuticals can be included in an amount ranging from about 0.1 weight percent to about 5 weight percent of the composition.

[0153] In at least one example embodiment, the oral product is free of an energizing agent. In at least one example embodiment, the oral product may include the energizing agent. In at least one example embodiment, the energizing agent includes caffeine, taurine, glucaronalactone, guarana, vitamin B6, vitamin B12, or any combination thereof.

[0154] Caffeine, also known as 1,3,7-trimethylxanthine, is a white, odorless, bitter tasting substance. Caffeine occurs naturally in tea, coffee, and chocolate, and is commonly added to soft drinks, energy drinks and some foods. However, because of the bitter taste of caffeine, the flavor of drinks or foods having a relatively high caffeine content can be unappealing. Caffeine may include synthetic caffeine and / or natural caffeine, such as coffee bean-extracted caffeine. In at least one example embodiment, the oral product includes caffeine in an amount greater than or equal to about 10 mg (e.g., greater than or equal to about 25 mg, or greater than greater than or equal to about 150 mg) The caffeine may be included in an amount less than or equal to about 200 mg (e.g., less than or equal to about 150 mg, less than or equal to about 100 mg, less than or equal to about 75 mg, less than or equal to about 50 mg, or less than or equal to about 25 mg).

[0155] The oral product may have a relatively high caffeine content so as to provide a consumer with a burst of energy. Moreover, the oral product macontain about 50 mg to about 200 mg of caffeine or about 75 mg to about 175 mg of caffeine (e.g., 100 mg to about 150 mg of caffeine) so as to provide a burst of energy to the consumer. The composition provides a single serving of a food, drink, oral tobacco product or oral non-tobacco product. A single serving of food can have a weight of about 5 g to about 450 g. A single serving of drink is about 200 mL to about 600 mL. A single serving of an oral pouch product includes one oral pouch product formed as described herein.

[0156] Optionally, the oral product can also include additional energizing ingredients in addition to the caffeine complex. Suitable additional energizing ingredients include, without limitation, taurine, citicoline, and guarana. The additional energizing ingredients can be included in an amount of about 0.1 weight percent to about 5 weight percent of the oral product.

[0157] In at least one example embodiment, the oral product is free of a soothing agent. In at least one example embodiment, the oral product includes a soothing agent. In at least one example embodiment, the soothing agent includes theanine, melatonin, or both theanine and melatonin. Additionally or alternatively, the soothing agent may include, for example only, chamomile, lavender, jasmine, soursop, cannabidiol, or any combination thereof. The soothing agent can be added as a flavorant and or aroma embedded in the product and / or the package. In at least one example embodiment, the oral product includes the soothing agent in an amount greater than or equal to about 0.1 weight percent (e.g., greater than or equal to about 0.5 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 4.5 weight percent). In at least one example embodiment, the oral product includes the soothing agent in an amount less than or equal to about 5 weight percent (e.g., less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, less than or equal to about 1.5 weight percent, less than or equal to about 1 weight percent, or less than or equal to about 0.5 weight percent).

[0158] In at least one example embodiment, the oral product is free of a plasticizer. In at least one example embodiment, the oral product includes a plasticizer. The plasticizer may include, for example, a monoglyceride, a diglyceride, a triglyceride (e.g., long, medium, and / or short chain), triacetin, propylene glycol, glycerin, vegetable oil, a phthalate, an ester of a polycarboxylic acid with a linear or branched aliphatic alcohol of moderate chain length, or any combination thereof. In at least one example embodiment, the plasticizer may be present in addition to triglycerides and / or other oils in a liquid carrier.

[0159] In at least one example embodiment, the oral product is free of mouth-soluble fibers. In at least one example embodiment, the oral product includes a mouth-soluble fibers. In at least one example embodiment, the mouth-soluble fibers include maltodextrin, psyllium, starch, or any combination thereof. In at least one example embodiment, the mouth-soluble fibers include soluble dietary fibers. In at least one example embodiment, the oral product includes partially soluble fibers, such as sugar beet fibers.

[0160] In at least one example embodiment, the oral product is free of minerals. In at least one example embodiment, the oral product includes a mineral. The mineral may be in addition to any that may be present due to the inclusion, for example, of fruits and / or vegetables. The mineral may include, for example, calcium, magnesium, phosphorus, iron, zinc, iodine, selenium, potassium, copper, manganese, molybdenum, chromium, and any combination thereof. The amount of minerals incorporated into the oral product for adult human consumption can be varied according to the type of mineral and the intended adult consumer. The amount of minerals may be formulated to include an amount less than or equal to the recommendations of the United States Department of Agriculture Recommended Daily Allowances.

[0161] In at least one example embodiment, the oral product is free of a focusing agent. In at least one example embodiment, the oral product includes a focusing agent. The focusing agent may include ginkgo biloba.

[0162] In at least one example embodiment, the oral product is free of a sensate and / or chemesthesis agent. In at least one example embodiment, the oral product includes a sensate and / or chemesthesis agent. The sensate and / or chemesthesis agent may include mint, menthol, cinnamon, pepper, jambu, or any combination thereof. The sensate and / or chemesthesis agent may include any soothing, cooling, and / or warming agent. For example, in some example embodiments, the sensate and / or chemesthesis agent may include capsaicin, pipeline, alpha-hydroxy-sanshool, and (8)-gingerole, which may be selected so as to provide a warm, tingling or burning sensation. In other example embodiments, the sensate and / or chemesthesis 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 so as to provide a cooling sensation. The sensate and / or chemesthesis agent may be included in an amount ranging from about 0.01 weight percent to about 5 weight percent of the oral product.

[0163] In at least one example embodiment, the oral product is free of vitamins. In at least one other example embodiment, the oral product includes a vitamin. The vitamin may include, for example, vitamin C, vitamin B, magnesium, calcium, or any combination thereof. In at least one example embodiment, the oral product may include one or more vitamins in addition to any that may be present due to the inclusion, for example, of fruits and / or vegetables. The one or more additional vitamins may include, for example, vitamin A (retinol), vitamin D (cholecalciferol), vitamin E group, vitamin K group (phylloquinones and menaquinones), thiamine (vitamin B1), riboflavin (vitamin B2), niacin, niacinamide, pyridoxine (vitamin B6 group), folic acid, choline, inositol, vitamin B12 (cobalamins), PABA (para aminobezoic acid), biotin, vitamin C (ascorbic acid), and any combination thereof. The amount of vitamins may be chosen so as to provide an amount less than or equal to the recommendations of the United States Department of Agriculture Recommended Daily Allowances.

[0164] In at least one example embodiment, the oral product is free of an antioxidant. In at least one example embodiment, the oral product includes an antioxidant. In at least one example embodiment, the antioxidant may include ascorbyl palmitate, butylated hydroxytoluene (BHT), ascorbic acid, sodium ascorbate, monosterol citrate, tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA), Vitamin E, and any combination or derivative thereof. The presence of the antioxidant may help to limit the formation of nicotine-N-oxides.

[0165] In at least one example embodiment, the oral product is free of a mineral. In at least one example embodiment, the oral product includes a mineral. Suitable minerals include, without limitation, calcium, magnesium, phosphorus, iron, zinc, iodine, selenium, potassium, copper, manganese, molybdenum, chromium, or any combination thereof. The amount of minerals incorporated into the oral product can be varied according to the type of mineral and the intended adult consumer. For example, the amount of minerals may be formulated to include an amount less than or equal to the recommendations of the United States Department of Agriculture Recommended Daily Allowances.

[0166] In at least one example embodiment, the oral product is free of amino acids. In at least one example embodiment, the oral product includes an amino acid. Suitable amino acids include, without limitation, the eight essential amino acids that cannot be biosynthetically produced in humans, including valine, leucine, isoleucine, lysine, threonine, tryptophan, methionine, and phenylalanine. Examples of suitable amino acids include the non-essential amino acids including alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, proline, serine, and tyrosine. The amino acids can be included in an amount ranging from about 0.1 weight percent to about 5 weight percent of the composition.

[0167] In at least one example embodiment, the oral product includes the amino acid in an amount greater than or equal to about 0.1 weight percent (e.g., greater than or equal to about 0.5 weight percent, greater than or equal to about 1 weight percent, greater than or equal to about 1.5 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 2.5 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 3.5 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 4.5 weight percent). In at least one example embodiment, the oral product includes the amino acid in an amount less than or equal to about 5 weight percent (e.g., less than or equal to about 4.5 weight percent, less than or equal to about 4 weight percent, less than or equal to about 3.5 weight percent, less than or equal to about 3 weight percent, less than or equal to about 2.5 weight percent, less than or equal to about 2 weight percent, less than or equal to about 1.5 weight percent, less than or equal to about 1 weight percent, or less than or equal to about 0.5 weight percent).

[0168] In at least one example embodiment, the oral product is free of a coloring agent. In at least one example embodiment, the oral product includes a coloring agent. The coloring agent may include a natural colorant, an artificial colorant, or any combination thereof.

[0169] In at least one example embodiment, the oral product is free of a pH modifier. In at least one example embodiment, the oral product includes a pH modifier. The pH modifier may include, for example, ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, calcium carbonate, potassium carbonate, potassium bicarbonate, potassium hydroxide, sodium carbonate, sodium bicarbonate, sodium hydroxide, or any combination thereof.

[0170] In at least one example embodiment, the oral product includes the pH modifier in an amount less than or equal to about 2 weight percent (e.g., less than or equal to about 1 weight percent, less than or equal to about 0.5 weight percent, less than or equal to about 0.1 weight percent, or less than or equal to about 0.05 weight percent). In at least one example embodiment, the oral product includes the pH modifier in an amount ranging from about 0.01 weight percent to 2 weight percent.

[0171] In at least one example embodiment, the oral product is free of a wax. In at least one example embodiment, the oral product includes a wax. The wax may include, for example, paraffin, microcrystalline wax, or both paraffin and microcrystalline wax.

[0172] In at least one example embodiment, the oral product is free of a filler. In at least one example embodiment, the oral product includes a filler. The filler may be configured to alter a texture or pliability of the oral product. The filler may include mouth-soluble elements, mouth-insoluble elements, or both mouth-soluble and mouth-insoluble elements. Mouth-soluble elements may be configured to dissolve or disintegrate when in an adult consumer's mouth so as to render the oral product more pliable. The filler may include, for example, dicalcium phosphate, calcium sulfate, a clay, silica, glass particles, glyceryl palmitostearate, sodium stearyl fumarate, talc, or any combination thereof. In at least one example embodiment, certain other compounds or elements or components, including, for example, mouth-soluble fibers, sweeteners, minerals, as described, may be classified as fillers. For example, in at least one example embodiment, cellulosic materials may be present in the oral product as fillers in addition to as or an alternative to being carriers for active ingredients, additives, and / or liquid ingredients.

[0173] In at least one example embodiment, the oral product includes the filler in an amount less than or equal to 20 weight percent (e.g., less than or equal to 15 weight percent, less than or equal to 10 weight percent, less than or equal to 9 weight percent, less than or equal to 8 weight percent, less than or equal to 7 weight percent, less than or equal to 6 weight percent, less than or equal to 5 weight percent, less than or equal to 4 weight percent, less than or equal to 3 weight percent, less than or equal to 2 weight percent, or less than or equal to 1 weight percent). In at least one example embodiment, the oral product includes the filler in an amount greater than or equal to about 0 weight percent (e.g., greater than or equal to about 1 weight percent, greater than or equal to about 2 weight percent, greater than or equal to about 3 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 5 weight percent). In at least one example embodiment, the oral product includes the filler in an amount ranging from about 0 weight percent to about 8 weight percent.

[0174] In at least one example embodiment, the oral product is free of a flavorant. In at least one example embodiment, the oral product includes a flavorant. In at least one example embodiment, the oral product includes an encapsulated flavorant. The flavorant may be natural or artificial. The flavorant may include, for example, a fruit flavorant (e.g., bergamot, berry, cherry, lemon, and / or orange), a liquor or liqueur flavorant (e.g., bourbon, cognac, scotch, whiskey, and / or DRAMBUIE brand liqueur), a mint flavorant (e.g., Japanese mint, menthol, peppermint, spearmint, wintergreen, and / or mint oils from a species of the genus Mentha), a floral flavorant (e.g., geranium, lavender, and / or rose), a spice, an herb, or another botanical or botanical-derived flavorant (e.g., anise, apium graveolens, caraway, cardamom, cascarilla, cassia, cinnamon, chamomile, clove, cocoa, coffee, coriander, fennel, ginger, jasmine, licorice, nutmeg, pimento, sage, sandalwood vanilla, and / or ylang-ylang), honey essence, or any combination thereof.

[0175] In at least one example embodiment, the oral product is free of a carrier. In at least one example embodiment, the oral product includes a carrier. The carrier may include a liquid carrier. The liquid carrier may include, for example, water, propylene, glycol, glycerin, ethanol, or any combination thereof.

[0176] In at least one example embodiment, the oral product is free of an oil. In at least one example embodiment, the oral product includes an oil. The oil may include, for example, a monoglyceride, a diglyceride, a triglyceride, triacetin, a flavor oil, or any combination thereof. The flavor oil may be or may include a flavorant.

[0177] An amount of oil may be selected to achieve a desired texture and / or softness. For example, the softness of the oral product may be increased as an amount of the oil in the oral product increases. In at least one example embodiment, the oral product includes oil in an amount greater than or equal to about 5 weight percent (e.g., greater than or equal to about 8 weight percent, greater than or equal to about 9 weight percent, greater than or equal to about 10 weight percent, greater than or equal to about 11 weight percent, greater than or equal to about 12 weight percent, greater than or equal to about 13 weight percent, or greater than or equal to about 15 weight percent). In at least one example embodiment, the oral product includes oil in an amount less than or equal to about 20 weight percent (e.g., less than or equal to about 15 weight percent, less than or equal to about 14 weight percent, less than or equal to about 13 weight percent, less than or equal to about 12 weight percent, less than or equal to about 11 weight percent, less than or equal to about 10 weight percent, or less than or equal to about 8 weight percent). In at least one example embodiment, the oral product includes the oil in an amount ranging from about 8 weight percent to about 16 weight percent (e.g., about 10 weight percent to about 14 weight percent, about 11 weight percent to about 13 weight percent, or about 12 weight percent).

[0178] FIG. 5 is a perspective view of an oral pouch product according to at least one example embodiment.

[0179] In at least one example embodiment, the oral product may be an oral pouch product 500. The oral pouch product 500 may include a pouch or outer web 502 formed from a permeable fabric. In at least one example embodiment, the outer web 502 is formed from a material that is generally recognized as safe (“GRAS”) for use and / or contact with food. The material may be stain resistant, water permeable, and / or porous. For example, in at least one example embodiment, the outer web 502 comprises a paper. For example, the outer web 502 can be formed of a cellulose fiber material, such as tea bag material or other materials typically used to form snus pouches. In at least one example embodiment, the outer web 502 has a desired (or alternatively, predetermined) level for basis weight and / or wet strength so as to reduce occurrence of breakage of the outer web 502 during manufacturing operations, storage, and placement in an adult consumer's mouth. For example, the outer web 502 may comprise a tea bag material having a basis weight of about 16.5 g / m2 with a wet tensile CD strength of 68 N / m. In another example embodiment, the outer web 502 may be formed of a paper having a wet MD tensile strength of about 45 N / mm to about 52 N / mm.

[0180] In at least one example embodiment, the outer web 502 is formed of a hydrophobic paper or material. The hydrophobic paper may be formed of a cellulosic material. The hydrophobic paper may be non-woven material and may include any hydrophobic materials. The hydrophobic materials may be synthetic materials and / or semi-synthetic materials. The hydrophobic materials may include viscose, rayon, lyocell, polyester, polyurethane, polyethylene, polypropylene, and / or modal fibers. The outer web 502 may be treated to make the outer web 502 hydrophobic. In other example embodiments, the hydrophobic material may be a woven material.

[0181] FIG. 6 is a sectional view of the oral pouch product of FIG. 5 taken at line VI-VI of FIG. 5 according to at least one example embodiment.

[0182] In at least one example embodiment, as shown in FIG. 6, the outer web 502 defines an interior region 600. The outer web 502 contains an inner filling material 602 within the interior region 600. In at least one example embodiment, the inner filling material 602 includes a physical hydrogel having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant (see, e.g., physical hydrogel 200 of FIG. 2, physical hydrogel 300 of FIG. 3). The inner filling material 602 may further include an active ingredient and / or any of the elements described above. In at least one example embodiment, the inner filling material 602 includes dry granules prepared according to the method of FIG. 4, optionally together with other elements.

[0183] The oral pouch product 500 may be a pouched product as described in any of U.S. patent application Ser. No. 17 / 223,823, filed on Apr. 2, 2021 and published as 2022 / 0312826; U.S. Pat. No. 9,066,540, issued Jun. 30, 2015; U.S. Pat. No. 8,978,661, issued Mar. 17, 2015; U.S. Pat. No. 10,039,309, issued Aug. 7, 2018; U.S. Pat. No. 9,414,624, issued Aug. 16, 2016; U.S. Pat. No. 9,693,582, issued Jul. 4, 2017; or U.S. Pat. No. 9,462,827, issued Oct. 11, 2016, the entire contents of each of which are incorporated herein by this reference hereto, and further including a physical hydrogel having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant (see, e.g., physical hydrogel 200 of FIG. 2, physical hydrogel 300 of FIG. 3).

[0184] FIG. 7 is a perspective view of another oral pouch product according to at least one example embodiment.

[0185] In at least one example embodiment, as shown in FIG. 7, an oral pouch product 700 is the same as the pouch product 500 of FIGS. 5-6, except that an outer web 702 is a non-woven material formed of a polymer, including synthetic or natural polymer. For example, the outer web 702 may be formed of a mesh material formed of spun or melt-blown fibers, such as polyurethane fibers as described in U.S. Pat. Nos. 10,448,669, 10,463,070, and / or 9,414,624, the entire contents of each of which is incorporated herein by reference thereto. The mesh material may be at least partially elastomeric. Further, because of the material used to form the oral pouch product 700, the oral pouch product 700 may exclude seams so as to provide a softer pouch. In at least one example embodiment, the mesh material encloses a filling material including a physical hydrogel having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant.

[0186] FIG. 8 is a perspective view of a chewing gum according to at least one example embodiment.

[0187] In at least one example embodiment, the oral product includes a chewing gum 800, as shown in FIG. 8. The chewing gum 800 includes a gum base and a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3) having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant. In at least one example embodiment, the chewing gum 800 includes a gum base and dry granules formed according to the method of FIG. 4, optionally with other elements. The chewing gum 800 may be a coated chewing gum or an uncoated chewing gum.

[0188] In at least one example embodiment, the gum base includes an elastomer, a resin, a wax, a fat, an emulsifier, a filler, an antioxidant, or any combination thereof. The elastomer may include couma macrocarpa, loquat, tunu, jelutong, chicle, styrene-butadiene rubber, butyl rubber, polyisobutylene, or any combination thereof, by way of example. The resin may include glycerol esters of gum, terpene resins, polyvinyl acetate, or any combination thereof, by way of example. The wax may include paraffin, microcrystalline wax, or both paraffin and microcrystalline wax, by way of example. The fat may include a hydrogenated vegetable oil, by way of example. The emulsifier may include lecithin, glycerol monostearate, or a combination of lecithin and glycerol monostearate, by way of example. The filler may include calcium carbonate, talc, or both calcium carbonate and talc, by way of example. The antioxidant may include butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), tocopherol, ascorbyl palmitate, ascorbic acid, sodium ascorbate, monosterol citrate, tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ), Vitamin E, or any combination thereof, by way of example. In at least one example embodiment, the gum base includes a natural latex, a vegetable gum (e.g., chicle), a spruce gum, a mastic gum, or any combination thereof.

[0189] In at least one example embodiment, the chewing gum 800 may be a chewing gum as described in U.S. patent application Ser. No. 17 / 223,800, filed on Apr. 6, 2021 and published as US 2022 / 0313679; or U.S. patent application Ser. No. 18 / 778,364, filed on Jul. 19, 2024, the entire contents of each which is incorporated herein by this reference thereto, and further including a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3).

[0190] FIG. 9 is a perspective view of a lozenge according to at least one example embodiment.

[0191] In at least one example embodiment, the oral product is a lozenge 900, as shown in FIG. 9. The lozenge 900 may include a solid solution and a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3) having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant. In at least one example embodiment, the lozenge 900 includes the solid solution and dry granules formed according to the method of FIG. 4, optionally with other elements. The solid solution may include soluble fibers and a sugar alcohol, such as those described above. In at least one example embodiment, the solid solution includes isomalt. In at least one example embodiment, the lozenge 900 may be a lozenge as described in U.S. Pat. No. 9,351,936, issued May 31, 2016, the entire contents of which is incorporated herein by this reference thereto, and further including a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3).

[0192] FIG. 10 is a perspective view of an oral tablet according to at least one example embodiment.

[0193] In at least one example embodiment, the oral product is a tablet 1000, as shown in FIG. 10. The tablet 1000 includes a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3) having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant. In at least one example embodiment, the tablet 1000 includes dry granules formed according to the method of FIG. 4, optionally with other elements.

[0194] In at least one example embodiment, the tablet 1000 a dissolvable tablet. The dissolvable tablet may include a mouth-soluble polymer, such as those described above, and the physical hydrogel. In at least one example embodiment, the dissolvable tablet may be a tablet (or tab) as described in U.S. application Ser. No. 14 / 505,814, filed Oct. 3, 2014; U.S. Pat. No. 9,930,909, issued Apr. 3, 2018; or U.S. Pat. No. 8,469,036, issued Jun. 25, 2013, the entire contents of each of which are incorporated herein by this reference thereto, and further including the physical hydrogel.

[0195] In at least one example embodiment, the tablet 1000 is a non-dissolvable chew. The non-dissolvable chew may include a mouth-stable polymer, such as those described above, and the physical hydrogel. The non-dissolvable chew may be a chew as described in U.S. Pat. No. 9,854,831, issued Jan. 2, 2018; U.S. Pat. No. 10,098,376, issued Oct. 16, 2018; U.S. Pat. No. 9,420,827, issued Aug. 23, 2016; or U.S. Pat. No. 9,185,931, issued Nov. 17, 2015, the entire contents of each of which are incorporated herein by this reference hereto, and further including the physical hydrogel.

[0196] FIG. 11 is a perspective view of a dissolvable film according to at least one example embodiment.

[0197] In at least one example embodiment, as shown in FIG. 11, the oral product may be a dissolvable film 1100. The dissolvable film 1000 may be a film as described in U.S. Pat. No. 8,469,036, issued Jun. 25, 2013, the entire contents of which is incorporated herein by this reference hereto, and further including a physical hydrogel (e.g., the physical hydrogel 200 of FIG. 2 or the physical hydrogel 300 of FIG. 3) having at least a portion of a binder hydrogen bonded to at least a portion of a flavorant. In at least one example embodiment, the dissolvable film 1100 includes dry granules formed according to the method of FIG. 4, optionally with other elements.EXAMPLE

[0198] FIG. 12 illustrates a chemical structure of a physical hydrogel according to at least one example embodiment.

[0199] In at least one example embodiment, as shown in FIG. 12, a physical hydrogel includes first and second polymer binders hydrogen bonded to a flavor ingredient.Illustrative Embodiments

[0200] Illustrative Embodiment 1. A method of manufacturing an oral product comprising: preparing a wet granulation including, a binder, a flavorant, and a solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation; forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including, removing at least a portion of the solvent; and incorporating the physical hydrogel into an oral product including an active ingredient.

[0201] Illustrative Embodiment 2. The method of Illustrative Embodiment 1, further comprising: tuning a dissolution profile of the oral product by providing the flavorant having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

[0202] Illustrative Embodiment 3. The method of Illustrative Embodiment 2, wherein the tuning further comprises: providing the binder having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

[0203] Illustrative Embodiment 4. The method of Illustrative Embodiment 2, wherein the desired dipole moment magnitude of the flavorant ranges from 2 to 4.

[0204] Illustrative Embodiment 5. The method of Illustrative Embodiment 1, wherein the flavorant further comprises: a first hydrogen bonding site including a donor site, and a second hydrogen bonding site including an acceptor site.

[0205] Illustrative Embodiment 6. The method of Illustrative Embodiment 5, wherein the flavorant further includes a third hydrogen bonding site, and each of the first hydrogen bonding site, the second hydrogen bonding site, and the third hydrogen bonding site has a dipole moment magnitude of greater than or equal to 0.3.

[0206] Illustrative Embodiment 7. The method of Illustrative Embodiment 1, wherein the flavorant includes one or more hydrogen bonding sites, and either all of the one or more hydrogen bonding sites are donor sites, or all of the one or more hydrogen bonding sites are acceptor sites.

[0207] Illustrative Embodiment 8. The method of Illustrative Embodiment 1, wherein the binder includes acrylic acid, methacrylic acid, poly(vinylpyrollidone), hydroxypropylmethyl cellulose, ethyl cellulose, poly(vinyl alcohol), poly(lactic acid), poly(ethylene glycol, or any combination thereof.

[0208] Illustrative Embodiment 9. The method of Illustrative Embodiment 1, wherein the preparing further comprises: admixing a first binder and a second binder.

[0209] Illustrative Embodiment 10. The method of Illustrative Embodiment 1, wherein the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof.

[0210] Illustrative Embodiment 11. The method of Illustrative Embodiment 1, wherein the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof.

[0211] Illustrative Embodiment 12. The method of Illustrative Embodiment 1, wherein the preparing includes, admixing the binder and the solvent, and after the admixing, adding the flavorant to the binder and the solvent.

[0212] Illustrative Embodiment 13. The method of Illustrative Embodiment 1, wherein the solvent includes water, ethanol, or both water and ethanol.

[0213] Illustrative Embodiment 14. The method of Illustrative Embodiment 1, wherein the preparing includes preparing a wet granulation consisting essentially of the binder, the flavorant, and the solvent.

[0214] Illustrative Embodiment 15. The method of Illustrative Embodiment 1, wherein the preparing is performed at a temperature ranging from 20° C. to 30° C.

[0215] Illustrative Embodiment 16. The method of Illustrative Embodiment 1, wherein the preparing is performed for a duration of less than or equal to 60 minutes.

[0216] Illustrative Embodiment 17. The method of Illustrative Embodiment 1, wherein the preparing includes stirring, gravity tumbling, or a combination of stirring and gravity tumbling.

[0217] Illustrative Embodiment 18. The method of Illustrative Embodiment 1, wherein the forming is performed at a temperature ranging from 30° C. to 50° C.

[0218] Illustrative Embodiment 19. The method of Illustrative Embodiment 1, wherein the forming is performed for a duration ranging from 1 hour to 24 hours.

[0219] Illustrative Embodiment 20. The method of Illustrative Embodiment 1, wherein the forming includes vacuum drying, fluidized bed drying, laminar airflow drying, or any combination thereof.

[0220] Illustrative Embodiment 21. The method of Illustrative Embodiment 1, wherein the active ingredient includes nicotine.

[0221] Illustrative Embodiment 22. A method of manufacturing a prolonged release oral product comprising: preparing a wet granulation including, a binder, a flavorant including, a hydrogen bonding donor site having a dipole moment magnitude of greater than or equal to about 2 D, and a hydrogen bonding acceptor site having a dipole moment magnitude of greater than or equal to about 2 D, and a solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation; forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including, removing at least a portion of the solvent; and incorporating the physical hydrogel into an oral product including an active ingredient.

[0222] Illustrative Embodiment 23. A method of manufacturing a delayed release oral product comprising: preparing a wet granulation including, a binder, a flavorant including, one or more hydrogen bonding sites, all of the one or more hydrogen bonding sites being hydrogen bond donor sites or all of the one or more hydrogen bonding sites being hydrogen bond acceptor sites, and a solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation; forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including, removing at least a portion of the solvent; and incorporating the physical hydrogel into an oral product including an active ingredient.

[0223] Illustrative Embodiment 24. An oral product comprising: a physical hydrogel including, a binder in an amount less than 5 weight percent of the oral product, and a flavorant, at least a portion of the flavorant is hydrogen bonded to at least a portion of the binder; and an active ingredient configured to be released from the oral product when the physical hydrogel is exposed to saliva, the oral product being free of an antioxidant.

[0224] Illustrative Embodiment 25. The oral product of Illustrative Embodiment 24, wherein the binder is present in an amount ranging from 2 weight percent to 4 weight percent of the oral product.

[0225] Illustrative Embodiment 26. The oral product of Illustrative Embodiment 24, wherein

[0226] the binder includes, a first hydrogen bonding site, the first hydrogen bonding site being a proton donor, and a second hydrogen bonding site, the second hydrogen bonding site being a proton acceptor, and the flavorant includes, a third hydrogen bonding site.

[0227] Illustrative Embodiment 27. The oral product of Illustrative Embodiment 26, wherein each of the first hydrogen bonding site, the second hydrogen bonding site, and the third hydrogen bonding site has a dipole moment magnitude of greater than or equal to 0.3 D.

[0228] Illustrative Embodiment 28. The oral product of Illustrative Embodiment 26, wherein the flavorant includes one or more hydrogen bonding sites including the third hydrogen bonding site, and either all of the one or more hydrogen bonding sites are donor sites, or all of the one or more hydrogen bonding sites are acceptor sites.

[0229] Illustrative Embodiment 29. The oral product of Illustrative Embodiment 24, wherein the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof.

[0230] Illustrative Embodiment 30. The oral product of Illustrative Embodiment 24, wherein the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof.

[0231] Illustrative Embodiment 31. The oral product of Illustrative Embodiment 24, wherein the oral product has a water content of less than or equal to about 10 weight percent.

[0232] Illustrative Embodiment 32. The oral product of Illustrative Embodiment 31, wherein the water content ranges from 1 weight percent to 10 weight percent.

[0233] Illustrative Embodiment 33. The oral product of Illustrative Embodiment 24, wherein the oral product has a water content ranging from 10 weight percent to 20 weight percent.

[0234] Illustrative Embodiment 34. The oral product of Illustrative Embodiment 24, wherein the oral product has a water content of greater than 20 weight percent.

[0235] Illustrative Embodiment 35. The oral product of Illustrative Embodiment 24, wherein the oral product has a water content of greater than 30 weight percent.

[0236] Illustrative Embodiment 36. The oral product of Illustrative Embodiment 24, further comprising: a first region including, a first physical hydrogel, the first physical hydrogel including the physical hydrogel; and a second region including, a second physical hydrogel having a different composition than the first physical hydrogel.

[0237] Illustrative Embodiment 37. The oral product of Illustrative Embodiment 24, wherein the active ingredient includes nicotine.

[0238] Illustrative Embodiment 38. An oral pouch product comprising: a pouch defining an interior region; and a filling material in the interior region, the filling material including, a physical hydrogel including, a binder in an amount less than 5 weight percent of the oral pouch product, and a flavorant, at least a portion of the flavorant is hydrogen bonded to at least a portion of the binder, and an active ingredient configured to be released from the oral pouch product when the physical hydrogel is exposed to saliva, the oral pouch product being free of an antioxidant.

[0239] Illustrative Embodiment 39. The oral pouch product of Illustrative Embodiment 38, wherein the pouch is formed from an elastomeric material.

[0240] Illustrative Embodiment 40. The oral pouch product of Illustrative Embodiment 39, wherein the elastomeric material includes, a plurality of non-woven fibers.

[0241] Illustrative Embodiment 41. The oral pouch product of Illustrative Embodiment 38, wherein the pouch includes polyurethane fibers.

[0242] Illustrative Embodiment 42. The oral pouch product of Illustrative Embodiment 38, wherein the pouch includes paper.

[0243] Illustrative Embodiment 43. The oral pouch product of Illustrative Embodiment 38, wherein the active ingredient includes nicotine.

[0244] Illustrative Embodiment 44. The oral pouch product of Illustrative Embodiment 38, wherein the filling material further includes tobacco.

[0245] Illustrative Embodiment 45. The oral pouch product of Illustrative Embodiment 44, wherein the filling material includes the tobacco in an amount less than 5 weight percent.

[0246] Illustrative Embodiment 46. A physical hydrogel comprising: a plurality of binder molecules, each of the plurality of binder molecules having a plurality of hydrogen bonding sites including a binder hydrogen bond donor site and a binder hydrogen bond acceptor site; and a plurality of polar flavorant molecules, at least a portion of the plurality of polar flavorant molecules hydrogen bonded to at least a portion of the binder molecules.

[0247] Illustrative Embodiment 47. The physical hydrogel of Illustrative Embodiment 46, wherein each of the plurality of polar flavorant molecules includes a flavorant hydrogen bond donor site and a flavorant hydrogen bond acceptor site, and the flavorant hydrogen bond donor site has a dipole moment magnitude of greater than or equal to about 2 D, and the flavorant hydrogen bond acceptor site has a dipole moment magnitude of greater than or equal to about 2 D.

[0248] Illustrative Embodiment 48. The physical hydrogel of Illustrative Embodiment 46, wherein each of the plurality of polar flavorant molecules includes one or more hydrogen bonding sites, and all of the one or more hydrogen bonding sites are flavorant hydrogen bond donor sites or all of the one or more hydrogen bonding sites are flavorant hydrogen bond acceptor sites.

[0249] Illustrative Embodiment 49. The physical hydrogel of Illustrative Embodiment 46, wherein the plurality of binder molecules includes plurality of first binder molecules and a plurality of second binder molecules different from the plurality of first binder molecules.

[0250] Illustrative Embodiment 50. The physical hydrogel of Illustrative Embodiment 46, wherein the plurality of polar flavorant molecules includes plurality of first polar flavorant molecules and a plurality of second polar flavorant molecules different from the plurality of first polar flavorant molecules.

[0251] While some example embodiments have been disclosed herein, it should be understood that other variations may be possible. Such variations are not to be regarded as a departure from the spirit and scope of the present disclosure, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

[0252] Although described with reference to specific examples and drawings, modifications, additions and substitutions of example embodiments may be variously made according to the description by those of ordinary skill in the art. For example, the described techniques may be performed in an order different with that of the methods described, and / or elements such as the described system, architecture, devices, circuit, and the like, may be connected or combined to be different from the above-described methods, or results may be appropriately achieved by other elements or equivalents.

Examples

example

[0198]FIG. 12 illustrates a chemical structure of a physical hydrogel according to at least one example embodiment.

[0199]In at least one example embodiment, as shown in FIG. 12, a physical hydrogel includes first and second polymer binders hydrogen bonded to a flavor ingredient.

Illustrative Embodiments

[0200]Illustrative Embodiment 1. A method of manufacturing an oral product comprising: preparing a wet granulation including, a binder, a flavorant, and a solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation; forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including, removing at least a portion of the solvent; and incorporating the physical hydrogel into an oral product including an active ingredient.

[0201]Illustrative Embodiment 2. The method of Illustrative Embodiment 1, further comprising: tuning a dissolution profile of the oral product by providing the fl...

Claims

1. A method of manufacturing an oral product comprising:preparing a wet granulation including,a binder,a flavorant, anda solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation;forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including,removing at least a portion of the solvent; andincorporating the physical hydrogel into an oral product including an active ingredient.

2. The method of claim 1, further comprising:tuning a dissolution profile of the oral product by providing the flavorant having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

3. The method of claim 2, wherein the tuning further comprises:providing the binder having a desired quantity of hydrogen bonding sites, a desired polarity of one or more hydrogen bonding sites, a desired dipole moment magnitude of one or more hydrogen bonding sites, or any combination thereof.

4. The method of claim 2, wherein the desired dipole moment magnitude of the flavorant ranges from 2 to 4.

5. The method of claim 1, wherein the flavorant further comprises:a first hydrogen bonding site including a donor site, anda second hydrogen bonding site including an acceptor site.

6. The method of claim 5, whereinthe flavorant further includes a third hydrogen bonding site, andeach of the first hydrogen bonding site, the second hydrogen bonding site, and the third hydrogen bonding site has a dipole moment magnitude of greater than or equal to 0.3.

7. The method of claim 1, whereinthe flavorant includes one or more hydrogen bonding sites, andeitherall of the one or more hydrogen bonding sites are donor sites, orall of the one or more hydrogen bonding sites are acceptor sites.

8. The method of claim 1, wherein the binder includes acrylic acid, methacrylic acid, poly(vinylpyrollidone), hydroxypropylmethyl cellulose, ethyl cellulose, poly(vinyl alcohol), poly(lactic acid), poly(ethylene glycol, or any combination thereof.

9. The method of claim 1, wherein the preparing further comprises:admixing a first binder and a second binder.

10. The method of claim 1, wherein the flavorant includes alpha ionone, cinnamyl cinnamate, 2,5-dimethylpyrazine, isovaleric acid, or any combination thereof.

11. The method of claim 1, wherein the flavorant includes vanillin, raspberry ketone, cinnamyl alcohol, methyl anthranilate, methyl salicylate, ethyl salicylate, ethyl vanillin, or any combination thereof.

12. The method of claim 1, wherein the preparing includes,admixing the binder and the solvent, andafter the admixing, adding the flavorant to the binder and the solvent.

13. The method of claim 1, wherein the preparing includes preparing a wet granulation consisting essentially of the binder, the flavorant, and the solvent.

14. The method of claim 1, whereinthe preparing is performed at a temperature ranging from 20° C. to 30° C., andthe preparing is performed for a duration of less than or equal to 60 minutes.

15. The method of claim 1, wherein the preparing includes stirring, gravity tumbling, or a combination of stirring and gravity tumbling.

16. The method of claim 1, whereinthe forming is performed at a temperature ranging from 30° C. to 50° C., andthe forming is performed for a duration ranging from 1 hour to 24 hours.

17. The method of claim 1, wherein the forming includes vacuum drying, fluidized bed drying, laminar airflow drying, or any combination thereof.

18. The method of claim 1, wherein the active ingredient includes nicotine.

19. A method of manufacturing a prolonged release oral product comprising:preparing a wet granulation including,a binder,a flavorant including,a hydrogen bonding donor site having a dipole moment magnitude of greater than or equal to about 2 D, anda hydrogen bonding acceptor site having a dipole moment magnitude of greater than or equal to about 2 D, anda solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation;forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including,removing at least a portion of the solvent; andincorporating the physical hydrogel into an oral product including an active ingredient.

20. A method of manufacturing a delayed release oral product comprising:preparing a wet granulation including,a binder,a flavorant including,one or more hydrogen bonding sites, all of the one or more hydrogen bonding sites being hydrogen bond donor sites or all of the one or more hydrogen bonding sites being hydrogen bond acceptor sites, anda solvent in an amount ranging from 12 weight percent to 55 weight percent of the wet granulation;forming a physical hydrogel by hydrogen bonding at least a portion of the flavorant to at least a portion of the binder, the forming including,removing at least a portion of the solvent; andincorporating the physical hydrogel into an oral product including an active ingredient.

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