Oral products having filler material for controlled release of active compounds

Abstract

An oral product includes a filler and an active ingredient. The filler includes a modified agglomerate and a surface modifier. The modified agglomerate includes a porous carrier. The surface modifier coats at least a portion of a surface of the agglomerate, is in pores of the agglomerate, or both coats at least a portion of the surface of the agglomerate and is in pores of the agglomerate. The surface modifier includes a sugar alcohol or a hydrophobic material. The active ingredient is admixed with the filler.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 693,334, filed on Sep. 11, 2024, the disclosure of which is incorporated herein by reference thereto in its entirety.BACKGROUNDField

[0002] The present disclosure relates to oral products having filler material for controlled release of active compounds.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 an oral product.

[0005] In at least one example embodiment, the oral product includes a filler and an active ingredient. The filler includes a modified agglomerate. The modified agglomerate includes an agglomerate and a surface modifier. The agglomerate includes a porous carrier. The surface modifier coats at least a portion of a surface of the agglomerate, is in pores of the agglomerate, or both coats at least a portion of the surface of the agglomerate and is in pores of the agglomerate. The surface modifier includes a sugar alcohol or a hydrophobic material. The active ingredient is admixed with the filler.

[0006] In at least one example embodiment, the porous carrier material includes cellulose.

[0007] In at least one example embodiment, the porous carrier material includes microcrystalline cellulose.

[0008] In at least one example embodiment, the modified agglomerate further includes a flavoring agent absorbed in the porous carrier material.

[0009] In at least one example embodiment, the filler has a water content ranging from 1 weight percent to 50 weight percent.

[0010] In at least one example embodiment, the water content ranges from 1 weight percent to 10 weight percent.

[0011] In at least one example embodiment, the water content ranges from 1 weight percent to 5 weight percent.

[0012] In at least one example embodiment, the water content ranges from 10 weight percent to 20 weight percent.

[0013] In at least one example embodiment, the water content is greater than 20 weight percent.

[0014] In at least one example embodiment, the water content is greater than 30 weight percent.

[0015] In at least one example embodiment, the surface modifier includes the hydrophobic material.

[0016] In at least one example embodiment, the hydrophobic material has an artificial saliva contact angle ranging from 60° to 80°.

[0017] In at least one example embodiment, the hydrophobic material includes corn zein.

[0018] In at least one example embodiment, the hydrophobic material further includes pectin and sodium stearate.

[0019] In at least one example embodiment, the surface modifier further includes a pH modifier.

[0020] In at least one example embodiment, the pH modifier includes a base.

[0021] In at least one example embodiment, the surface modifier includes the sugar alcohol.

[0022] In at least one example embodiment, the sugar alcohol has a water solubility ranging from 0.1 g / g to less than or equal to about 2.5 g / g.

[0023] In at least one example embodiment, the sugar alcohol includes sorbitol, xylitol, maltitol, lactitol, erythritol, isomaltose, mannitol, or any combination thereof.

[0024] In at least one example embodiment, the sugar alcohol includes maltitol.

[0025] In at least one example embodiment, the modified agglomerate has an average particle size ranging from 200 μm to 450 μm.

[0026] In at least one example embodiment, the modified agglomerate has a porosity ranging from 40% to 70%.

[0027] In at least one example embodiment, the porosity of the modified agglomerate ranges from 55% to 60%.

[0028] In at least one example embodiment, the porous carrier material has a porosity ranging from 60% to 80%.

[0029] In at least one example embodiment, the porosity of the porous carrier material ranges from 70% to 75%.

[0030] In at least one example embodiment, the modified agglomerate has an average pore size ranging from 3 micrometers (μm) to 8 μm.

[0031] In at least one example embodiment, the porous carrier material has an average pore size ranging from 6.5 micrometers (μm) to 9 μm.

[0032] In at least one example embodiment, the active ingredient includes nicotine.

[0033] In at least one example embodiment, the nicotine includes liquid nicotine.

[0034] In at least one example embodiment, the oral product further comprises an active ingredient solution. The active ingredient solution is admixed with the filler. The active ingredient solution includes triglycerides and the liquid nicotine dissolved in the triglycerides.

[0035] In at least one example embodiment, the filler further includes tobacco in an amount less than or equal to 5 weight percent.

[0036] In at least one example embodiment, the oral product further comprises a pouch. The filler and the active ingredient are in the pouch.

[0037] In at least one example embodiment, the pouch includes an elastomeric material.

[0038] In at least one example embodiment, the pouch includes polyurethane fibers.

[0039] In at least one example embodiment, the pouch is nonwoven.

[0040] In at least one example embodiment, the pouch includes a paper material.

[0041] At least one example embodiment relates to method of manufacturing a filler for an oral product.

[0042] In at least one example embodiment, the method includes forming an agglomerate by agglomerating a porous carrier material. The method further includes forming a modified agglomerate by contacting a surface modifier with the agglomerate such that the surface modifier coats at least a portion of a surface of the agglomerate, impregnates pores of the agglomerate, or both coats at least a portion of the surface of the agglomerate and impregnates pores of the agglomerate. The method further includes preparing the filler by drying the modified agglomerate.

[0043] In at least one example embodiment, the forming an agglomerate includes fluidizing a plurality of particles of the porous carrier material in a fluidized bed. The forming further includes concurrently with the fluidizing, spraying water on the plurality of particles of the porous carrier material to form the agglomerate.

[0044] In at least one example embodiment, the forming a modified agglomerate includes fluidizing the agglomerate in a fluidized bed. The forming further includes concurrently with the fluidizing, spraying a surface modifier solution or a surface modifier suspension on the agglomerate to form the modified agglomerate.

[0045] In at least one example embodiment, the method further comprises preparing the surface modifier solution by dissolving a sugar alcohol in water. The forming the agglomerate includes spraying the solution modifier solution on the agglomerate.

[0046] In at least one example embodiment, the method further comprises preparing the surface modifier suspension by dispersing a hydrophobic material in in water. The forming the agglomerate includes spraying the surface modifier suspension on the agglomerate.

[0047] In at least one example embodiment, the preparing the surface modifier suspension further includes dispersing pectin and sodium stearate in the water.

[0048] In at least one example embodiment, the method further comprises prior to the forming the agglomerate, absorbing a flavoring agent in the porous carrier material.

[0049] In at least one example embodiment, the preparing includes drying the modified agglomerate to a water content ranging from 1 weight percent to 5 weight percent.

[0050] In at least one example embodiment, the preparing includes drying the modified agglomerate at a temperature ranging from 22° C. to 50° C.

[0051] In at least one example embodiment, prior to the forming the agglomerate, the porous carrier material has a first porosity. The modified agglomerate has a second porosity. The second porosity is less than the first porosity.

[0052] In at least one example embodiment, a ratio of the second porosity to the first porosity ranges from 0.7 to 0.85.

[0053] In at least one example embodiment, prior to the forming the agglomerate, the porous carrier material has a first average pore size. The modified agglomerate has a second average pore size. The second average pore size is less than the first average pore size.

[0054] In at least one example embodiment, a ratio of the second average pore size to the first average pore size ranges from 0.4 to 0.55.

[0055] At least one example embodiment relates to a method of manufacturing an oral product.

[0056] In at least one example embodiment, the method includes preparing a filler material. The preparing includes forming an agglomerate by agglomerating a porous carrier material. The preparing further includes forming a modified agglomerate by contacting a surface modifier with the agglomerate such that the surface modifier coats at least a portion of a surface of the agglomerate, impregnates pores of the agglomerate, or both coats at least a portion of the surface of the agglomerate and impregnates pores of the agglomerate. The preparing further includes drying the modified agglomerate. The method further includes forming the oral product by admixing an active ingredient with the filler material.

[0057] In at least one example embodiment, the forming the oral product further includes, after the admixing, pouching the active ingredient and the filler material.

[0058] In at least one example embodiment, the releasable ingredient includes an active ingredient.

[0059] In at least one example embodiment, the active ingredient includes liquid nicotine.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 sectional view of an oral product including a surface-modified agglomerate according to at least one example embodiment.

[0062] FIG. 2 is a schematic view of the surface-modified agglomerate of FIG. 1 according to at least one example embodiment.

[0063] FIG. 3 is a perspective view of the oral product of FIG. 1 according to at least one example embodiment.

[0064] FIG. 4 is a perspective view of another oral product according to at least one example embodiment.

[0065] FIG. 5 a flowchart illustrating a method of manufacturing an oral product according to at least one example embodiment.

[0066] FIG. 6 is a graph illustrating water activity for surface-modified agglomerates according to at least one example embodiment.

[0067] FIG. 7 is a graph illustrating nicotine release for pouches including surface-modified agglomerate according to at least one example embodiment.DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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%).

[0075] 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.

[0076] 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.

[0077] 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 be in a form of loose material (e.g., loose cellulosic material), shaped material (e.g., plugs or twists), pouched material, tablets, lozenges, chews, gums, films, any other oral product, or any combination thereof.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] The oral product (e.g., the oral tobacco product, the oral non-tobacco product, or the oral cannabis product) may have various ranges of moisture. In at least one example embodiment, the oral product is a dry oral product having a moisture content ranging from 5% by weight to 10% by weight. In at least one example embodiment, the oral product has a medium moisture content, such as a moisture content ranging from 20% by weight to 35% by weight. In at least one example embodiment, the oral product is a wet oral product having a moisture content ranging from 40% by weight to 55% by weight.

[0083] 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.

[0084] 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).

[0085] 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).

[0086] FIG. 1 is a schematic sectional view of an oral product according to at least one example embodiment.

[0087] In at least one example embodiment, as shown in FIG. 1, an oral product is provided. The oral product may be an oral pouch product 100. The oral pouch product 100 includes a pouch or porous wrap 102 at least partially defining an inner cavity 103. A composition or filling material 104 is at least partially contained within the inner cavity 103 of the pouch 102. The composition 104 includes a surface-modified agglomerate 106, as will be described in greater detail in the discussion accompanying FIG. 2, and a releasable ingredient 108. The surface-modified agglomerate 106 may be admixed and / or otherwise combined with the releasable ingredient 108. As used herein, “admix,” means that two or more elements are combined together heterogeneous, inhomogeneous, or homogeneous manner. In at least one example embodiment, the surface-modified agglomerate 106 facilitates controlled release of the releasable ingredient 108 from the pouch 102, such as when the composition 104 is contacted with saliva of an adult consumer.

[0088] The releasable ingredient 108 may include an active ingredient (e.g., nicotine, caffeine, etc.) and / or an additive (e.g., flavoring agent, etc.). In at least one example embodiment, the releasable ingredient includes an active ingredient. In at least one example embodiment, the active ingredient includes a tobacco extract, such as tobacco-derived nicotine extract, and / or synthetic nicotine. The nicotine may be in the form of liquid nicotine. In at least one other example embodiment, the active ingredient includes a cannabis extract. The cannabis extract may include a cannabis-derived cannabinoid, a cannabis-derived terpene, and / or a cannabis-derived flavonoid.

[0089] In at least one example embodiment, additionally or alternatively, the releasable ingredient includes a non-nicotine, non-cannabis additive. The additive may include a sweetener, an energizing agent, a soothing agent, a focusing agent, an alkaloid, a mineral, a vitamin, a dietary supplement, a nutraceutical, an amino acid, a chemesthetic agent, a botanical, a tooth-whitening agent, a therapeutic agent, a flavoring agent, a flavor masking agent, a bitterness receptor site blocker, a receptor site enhancers, any of the additives described below, other additives, or any combination thereof. The releasable ingredient may include multiple additives. Additionally, a single ingredient may belong to more than one of the categories above.

[0090] In at least one example embodiment, the releasable ingredient 108 is admixed with, dispersed in, at least partially dissolved in, or fully dissolved in a carrier liquid. In at least one example embodiment, the releasable ingredient 108 is in the form of a solution in which the releasable ingredient 108 is at least partially dissolved in the carrier liquid. In at least one example embodiment, the composition 104 is free of a carrier liquid. In at least one example embodiment, the carrier liquid includes an oil and / or a plasticizer. The oil and / or plasticizer 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 flavoring agent. In at least one other example embodiment, the carrier liquid includes water, propylene, glycol, glycerin, ethanol, or any combination thereof.

[0091] In at least one example embodiment, the releasable ingredient 108 and the carrier liquid may be provided at a desired weight ratio. The desired weight ratio of the releasable ingredient 108 to the carrier liquid may be greater than or equal to about 5:95 (e.g., greater than or equal to about 7.5:92.5, greater than or equal to about 10:90, greater than or equal to about 12.5:87.5, greater than or equal to about 15:85, greater than or equal to about 17.5:82.5, greater than or equal to about 20:80, greater than or equal to about 22.5:77.5, greater than or equal to about 25:75, greater than or equal to about 27.5:72.5, greater than or equal to about 30:70, greater than or equal to about 32.5:67.5, greater than or equal to about 35:65, greater than or equal to about 40:60, or greater than or equal to about 45:55). The desired weight ratio may be less than or equal to about 50:50 (e.g., less than or equal to about 45:55, less than or equal to about 40:60, less than or equal to about 35:65, less than or equal to about 32.5:67.5, less than or equal to about 30:70, less than or equal to about 27.5:72.5, less than or equal to about 25:75, less than or equal to about 22.5:77.5, less than or equal to about 20:80, less than or equal to about 17.5:82.5, less than or equal to about 15:85, less than or equal to about 12.5:87.5, less than or equal to about 10:90, or less than or equal to about 7.5:92.5).

[0092] In at least one example embodiment, the oral pouch product 100 may be configured to release substantially all or a portion of the releasable ingredient 108 when exposed to saliva of an adult consumer. In at least one example embodiment, compared to an oral product without the surface-modified agglomerate 106, the oral pouch product 100 is configured to release more of the releasable ingredient 108 (e.g., substantially all of the releasable ingredient 108) and / or release the releasable ingredient 108 at a higher rate as compared to an oral product without the surface-modified agglomerate 106.

[0093] FIG. 2 is a schematic view of a particle of a surface-modified agglomerate according to at least one example embodiment.

[0094] In at least one example embodiment, as shown in FIG. 2, the surface-modified agglomerate 106 includes an agglomerate 202 and a surface modifier204. In at least one example embodiment, the surface modifier 204 coats at least a portion of a surface 206 of the agglomerate 202 and / or impregnates the agglomerate 202 (i.e., is in pores 208 of the agglomerate 202).

[0095] In at least one example embodiment, the surface-modified agglomerate 106 has an average particle size (e.g., diameter) of greater than or equal to about 200 microns (e.g., greater than or equal to about 225 microns, greater than or equal to about 250 microns, greater than or equal to about 275 microns, greater than or equal to about 300 microns, greater than or equal to about 325 microns, greater than or equal to about 350 microns, greater than or equal to about 375 microns, greater than or equal to about 400 microns, or greater than or equal to about 425 microns). The surface-modified agglomerate 106 may have an average particle size of less than or equal to about 450 microns (e.g., less than or equal to about 425 microns, less than or equal to about 400 microns, less than or equal to about 375 microns, less than or equal to about 350 microns, less than or equal to about 325 microns, less than or equal to about 300 microns, less than or equal to about 275 microns, less than or equal to about 250 microns, or less than or equal to about 225 microns).

[0096] In at least one example embodiment, the surface-modified agglomerate 106 has a porosity of greater than or equal to about 45% (e.g., greater than or equal to about 50%, greater than or equal to about 55%, greater than or equal to about 60%, or greater than or equal to about 65%). The porosity may be less than or equal to about 70% (e.g., less than or equal to about 65%, less than or equal to about 60%, less than or equal to about 55%, or less than or equal to about 50%). In at least one example embodiment, the surface-modified agglomerate 106 has an average pore size ranging from about 3 micrometers (μm) (e.g., greater than or equal to about 3.5 μm, greater than or equal to about 4 μm, greater than or equal to about 4.5 μm, greater than or equal to about 5 μm, greater than or equal to about 5.5 μm, greater than or equal to about 6 μm, greater than or equal to about 6.5 μm, greater than or equal to about 7 μm, or greater than or equal to about 7.5 μm). The average pore size may be less than or equal to about 8 μm (e.g., less than or equal to about 7.5 μm, less than or equal to about 7 μm, less than or equal to about 6.5 μm, less than or equal to about 6 μm, less than or equal to about 5.5 μm, less than or equal to about 5 μm, less than or equal to about 4.5 μm, less than or equal to about 4 μm, or less than or equal to about 3.5 μm).

[0097] The agglomerate 202 is made up of a plurality of particles of a carrier material 212. In at least one example embodiment, the carrier material 212 is porous. In at least one example embodiment, the carrier material 212 is porous. The carrier material, prior to agglomeration and surface modification, may have a porosity of greater than or equal to about 60% (e.g., greater than or equal to about 62.5%, greater than or equal to about 65%, greater than or equal to about 67.5%, greater than or equal to about 70%, greater than or equal to about 72.5%, greater than or equal to about 75%, or greater than or equal to about 77.5%). The porosity may be less than or equal to 80% (e.g., less than or equal to about 77.5%, less than or equal to about 75%, less than or equal to about 72.5%, less than or equal to about 70%, less than or equal to about 67.5%, less than or equal to about 65%, or less than or equal to about 62.5%). In at least one example embodiment, the carrier material, prior to agglomeration and surface modification, has a pore size of greater than or equal to about 6.5 μm (e.g., greater than or equal to about 7 μm, greater than or equal to about 7.5 μm, greater than or equal to about 8 μm, or greater than or equal to about 8.5 μm). The average particle size may be less than or equal to about 9 μm (e.g., less than or equal to about 8.5 μm, less than or equal to about 8 μm, less than or equal to about 7.5 μm, or less than or equal to about 7 μm).

[0098] The porosity of the carrier material 212 prior to agglomeration and surface modification is referred to as a first porosity, and the porosity of the surface-modified agglomerate 106 may be referred to as a second porosity. In at least one example embodiment, the second porosity is lower than the first porosity. In at least one example embodiment, a ratio of the second porosity to the first porosity is greater than or equal to about 0.55 (e.g., greater than or equal to about 0.6, greater than or equal to about 0.65, greater than or equal to about 0.7, greater than or equal to about 0.75, greater than or equal to about 0.8, greater than or equal to about 0.85, greater than or equal to about 0.9, or greater than or equal to about 0.95). The ratio of the second porosity to the first porosity may be less than about 1 (e.g., less than or equal to about 0.95, less than or equal to about 0.9, less than or equal to about 0.85, less than or equal to about 0.8, less than or equal to about 0.75, less than or equal to about 0.7, less than or equal to about 0.65, or less than or equal to about 0.6).

[0099] The average pore size of the carrier material 212 prior to agglomeration and surface modification is referred to as a first average pore size, and the average pore size of the surface-modified agglomerate 106 may be referred to as a second average pore size. In at least one example embodiment, the second average pore size is lower than the first average pore size. In at least one example embodiment, a ratio of the second average pore size to the first average pore size is greater than or equal to about 0.33 (e.g., greater than or equal to about 0.35, greater than or equal to about 0.4, greater than or equal to about 0.45, greater than or equal to about 0.5, greater than or equal to about 0.55, greater than or equal to about 0.6, greater than or equal to about 0.65, greater than or equal to about 0.7, greater than or equal to about 0.75, greater than or equal to about 0.8, greater than or equal to about 0.85, greater than or equal to about 0.9, or greater than or equal to about 0.95). The ratio of the second porosity to the first porosity may be less than about 1 (e.g., less than or equal to about 0.95, less than or equal to about 0.9, less than or equal to about 0.85, less than or equal to about 0.8, less than or equal to about 0.75, less than or equal to about 0.7, less than or equal to about 0.65, less than or equal to about 0.6, less than or equal to about 0.55, less than or equal to about 0.5, less than or equal to about 0.45, less than or equal to about 0.4, or less than or equal to about 0.35).

[0100] The carrier material 212 may be in the form of a particle and / or fiber. In at least one example embodiment, the carrier material 212 may be an inert material. In at least one example embodiment, the carrier material 212 includes a non-tobacco material, such as cellulose (e.g., microcrystalline cellulose (MCC) and / or amorphous cellulose). In at least one example embodiment, the carrier material includes a botanical, such as sugar beet, wood pulp, cotton, bran, citrus pulp, grass, willow, poplar, or any combination thereof. In at least one example embodiment, additionally or alternatively, the carrier material includes chemically-treated cellulosic material, such as carboxymethyl cellulose (CMC), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), MCC, or any combination thereof. In at least one other example embodiment, additionally or alternatively, the carrier material 212 may include 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 about 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.

[0101] The agglomerate 202 may be formed from the carrier material 212 and a binder. In at least one example embodiment, the binder is used in the formation of the agglomerate, but substantially removed (e.g., evaporated) from the agglomerate prior preparation of the surface-modified agglomerate 106 and / or composition 104. In at least one other example embodiment, at least a portion of the binder remains in the agglomerate 202.

[0102] In at least one example embodiment, the surface modifier 204 includes a sugar alcohol, a hydrophobic material, or both a sugar alcohol and the hydrophobic material. In at least one example embodiment, the sugar alcohol includes sorbitol, xylitol, maltitol, lactitol, isomaltose, erythritol, mannitol, ethylene glycol, glycerol, threitol, arabitol, ribitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt, maltotriitol, maltotetraitol, polyglycitol, or any combination thereof. In at least one example embodiment, the hydrophobic material includes a prolamine protein. The prolamine protein may be high in glutamine and / or proline amino acid. In at least one example embodiment, the prolamine protein includes, or is derived from, zein, such as corn zein.

[0103] In at least one example embodiment, the surface modifier 204 including the hydrophobic material further includes a dispersion aid to facilitate colloidally dispersing the hydrophobic material in a solvent, such as water. The dispersion aid may include sodium stearate and / or pectin (e.g., low methoxy pectin). In at least one example embodiment, the surface modifier includes a zein protein, sodium stearate, and pectin. In at least one example embodiment, the surface modifier 204 including the hydrophobic material further includes a pH adjuster. The pH adjuster may be configured to bring a pH of a solution including the surface modifier 204 and a solvent, such as water, to a range from about 10.5 to about 11.5. The pH modifier may be a pH modifying base. In at least one example embodiment, the pH adjusting base is sodium hydroxide.

[0104] In at least one example embodiment, the surface modifier 204 may be configured to impart desired physical, chemical, and / or sensorial properties to the oral pouch product 100 (shown in FIG. 1). In at least one example embodiment, water solubility of the surface modifier 204 affects a release profile of the releasable ingredient (e.g., active ingredient). In at least one example embodiment, the surface modifier 204 has a water solubility of greater than or equal to about 0.1 g / g (e.g., greater than or equal to about 0.2 g / g, greater than or equal to about 0.3 g / g, greater than or equal to about 0.5 g / g, greater than or equal to about 0.75 g / g, greater than or equal to about 1 g / g, greater than or equal to about 1.25 g / g, greater than or equal to about 1.5 g / g, greater than or equal to about 1.75 g / g, greater than or equal to about 2 g / g, or greater than or equal to about 2.25 g / g). The surface modifier 204 may have a water solubility of less than or equal to about 2.5 g / g (e.g., less than or equal to about 2.25 g / g, less than or equal to about 2 g / g, less than or equal to about 1.75 g / g, less than or equal to about 1.5 g / g, less than or equal to about 1.25 g / g, less than or equal to about 1 g / g, less than or equal to about 0.75 g / g, less than or equal to about 0.5 g / g, less than or equal to about 0.3 g / g, or less than or equal to about 0.2 g / g). In at least one example embodiment the surface modifier 204 affects hydrophobicity and / or hydrophilicity of the agglomerate 202, which may alter water absorption capacity of the surface-modified agglomerate 106 and / or release profile of the releasable ingredient 108.

[0105] As used herein, “artificial saliva contact angle” means an angle that would be defined between a planar surface having the surface modifier 204 thereon (e.g., a glass slide having a film of the surface modifier 204 applied to a surface) and a droplet of artificial saliva on the surface. In at least one example embodiment, the surface modifier 204 is a hydrophobic material that defines an artificial saliva contact angle of greater than or equal to about 45° (e.g., greater than or equal to about 50°, greater than or equal to about 55°, greater than or equal to about 60°, greater than or equal to about 62.5°, greater than or equal to about 65°, greater than or equal to about 67.5°, greater than or equal to about 70°, greater than or equal to about 72.5°, greater than or equal to about 75°, greater than or equal to about 77.5°, greater than or equal to about 80°, or greater than or equal to about) 85°. The surface modifier 204 that is the hydrophobic material may define an artificial saliva contact angle of less than about 90° (e.g., less than or equal to about 85°, less than or equal to about 80°, less than or equal to about 77.5°, less than or equal to about 75°, less than or equal to about 72.5°, less than or equal to about 70°, less than or equal to about 67.5°, less than or equal to about 65°, less than or equal to about 62.5°, less than or equal to about 60°, less than or equal to about 55°, or less than or equal to about) 50°.

[0106] In at least one example embodiment, a weight ratio of the surface modifier 204 to the carrier material 212 in the surface-modified agglomerate 106 is greater than or equal to about 0.1:99.1 (e.g., greater than or equal to about 0.5:99.5, greater than or equal to about 0.75:99.25, greater than or equal to about 1:99, greater than or equal to about 1.25:98.75, greater than or equal to about 1.5:98.5, greater than or equal to about 1.75:98.25, greater than or equal to about 2:98, greater than or equal to about 2.25:97.75, greater than or equal to about 2.5:97.5, greater than or equal to about 5:95, greater than or equal to about 7.5:92.5, greater than or equal to about 10:90, greater than or equal to about 12.5:87.5, greater than or equal to about 15:85, greater than or equal to about 17.5:82.5, greater than or equal to about 20:80, greater than or equal to about 22.5:77.5, greater than or equal to about 25:75, or greater than or equal to about 30:70). The weight ratio of the surface modifier 204 to the carrier material 212 in the surface-modified agglomerate 106 may be less than or equal to about 35:65 (e.g., less than or equal to about 30:70, less than or equal to about 25:75, less than or equal to about 22.5:77.5, less than or equal to about 20:80, less than or equal to about 17.5:82.5, less than or equal to about 15:85, less than or equal to about 12.5:87.5, less than or equal to about 10:90, less than or equal to about 7.5:92.5, less than or equal to about 5:95, less than or equal to about 2.5:97.5, less than or equal to about 2.25:97.75, less than or equal to about 2:98, less than or equal to about 1.75:98.25, less than or equal to about 1.5:98.5, less than or equal to about 1.25:98.75, less than or equal to about 1:99, or less than or equal to about 0.75:99.25, or less than or equal to about 0.5:99.5).

[0107] In at least one example embodiment, the surface-modified agglomerate 106 includes a surface modifier 204 including a sugar alcohol. The weight ratio of the sugar alcohol to the carrier material may be greater than or equal to about 5:95 (e.g., greater than or equal to about 6:94, greater than or equal to about 7:93, greater than or equal to about 8:92, greater than or equal to about 9:91, greater than or equal to about 10:90, greater than or equal to about 11:89, greater than or equal to about 12:88, greater than or equal to about 13:87, greater than or equal to about 14:86, greater than or equal to about 15:85, greater than or equal to about 16:84, greater than or equal to about 17:83, greater than or equal to about 18:92, or greater than or equal to about 19:81). The surface-modified agglomerate 106 may include the sugar alcohol in an amount less than or equal to about 20:80 (e.g., less than or equal to about 19:81, less than or equal to about 18:82, less than or equal to about 17:83, less than or equal to about 16:84, less than or equal to about 15:85, less than or equal to about 14:86, less than or equal to about 13:87, less than or equal to about 12:88, less than or equal to about 11:89, less than or equal to about 10:90, less than or equal to about 9:91, less than or equal to about 8:92, less than or equal to about 7:93, or less than or equal to about 6:94).

[0108] In at least one example embodiment, the surface-modified agglomerate 106 includes a surface modifier 204 including a hydrophobic material. The weight ratio of the hydrophobic material to the carrier material may be greater than or equal to about 0.5:99.5 (e.g., greater than or equal to about 0.6:99.4, greater than or equal to about 0.7:99.3, greater than or equal to about 0.8:99.2, greater than or equal to about 0.9:99.1, greater than or equal to about 1:99, greater than or equal to about 1.05:98.05, greater than or equal to about 1.1:98.9, greater than or equal to about 1.15:98.85, greater than or equal to about 1.2:98.8, greater than or equal to about 1.25:98.75, greater than or equal to about 1.3:98.7, greater than or equal to about 1.35:98.65, greater than or equal to about 1.4:98.6, greater than or equal to about 1.45:98.55, greater than or equal to about 1.5:98.5, greater than or equal to about 1.55:98.45, greater than or equal to about 1.6:98.4, greater than or equal to about 1.65:98.35, greater than or equal to about 1.7:98.3, greater than or equal to about 1.75:98.25, greater than or equal to about 1.8:98.2, greater than or equal to about 1.85:98.15, greater than or equal to about 1.9:98.1, greater than or equal to about 1.95:98.05, greater than or equal to about 2:98, greater than or equal to about 2.1:97.9, greater than or equal to about 2.2:97.8, greater than or equal to about 2.3:97.7, or greater than or equal to about 2.4:97.6). The surface-modified agglomerate 106 may include the hydrophobic material in an amount less than or equal to about 2.5:97.5 (e.g., less than or equal to about 2.4:97.6, less than or equal to about 2.3:97.7, less than or equal to about 2.2:97.8, less than or equal to about 2.1:97.1, less than or equal to about 2:98, less than or equal to about 1.95:98.95, less than or equal to about 1.9:98.9, less than or equal to about 1.85:98.15, less than or equal to about 1.8:98.2, less than or equal to about 1.75:98.25, less than or equal to about 1.7:98.3, less than or equal to about 1.65:98.35, less than or equal to about 1.6:98.4, less than or equal to about 1.55:98.45, less than or equal to about 1.5:98.5, less than or equal to about 1.45:98.55, less than or equal to about 1.4:98.6, less than or equal to about 1.35:98.65, less than or equal to about 1.3:98.7, less than or equal to about 1.25:98.75, less than or equal to about 1.2:98.8, less than or equal to about 1.15:98.85, less than or equal to about 1.1:98.9, less than or equal to about 1.05:98.95, less than or equal to about 1:99, less than or equal to about 0.9:99.1, less than or equal to about 0.8:98.2, less than or equal to about 0.7:98.3, or less than or equal to about 0.6:98.4).

[0109] In at least one example embodiment, the oral pouchy product 100 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, 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 pouch product 100 may include multiple additional elements. Additionally, a single element may belong to more than one of the categories above.

[0110] 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).

[0111] In at least one example embodiment, the oral pouch product 100 is free of a mouth-soluble polymer. In at least one example embodiment, the oral pouch product 100 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.

[0112] 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.

[0113] 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.

[0114] 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.

[0115] In at least one example embodiment, the oral pouch product 100 is free of a mouth-stable polymer. In at least one example embodiment, the oral pouch product 100 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.

[0116] 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).

[0117] Additives, including those described below, may be present in the surface-modified agglomerate 106, in the composition 104, and / or on the pouch 102. Additives that are in the surface-modified agglomerate 106 may be impregnated in the carrier material 212, coated on the carrier material 212, absorbed in the carrier material 212, adsorbed on the carrier material 212, in pores 208 of the agglomerate 202, on the surface 206 of the agglomerate, and / or on a surface 214 of the surface-modified agglomerate 106. Additives that are in the composition 104 may be admixed with the surface-modified agglomerate 106 (e.g., as the releasable ingredient 108 and / or in addition to the releasable ingredient 108). Additives may be impregnated in and / or coated on material forming the pouch 102, as will be described in greater detail below in the discussion accompanying FIG. 3.

[0118] In at least one example embodiment, the oral pouch product 100 is free of a sweetener. In at least one example embodiment, the oral pouch product 100 includes a sweetener. The sweetener may be present in the surface-modified agglomerate 106, in the composition 104, and / or on the pouch 102. Sweeteners included in different portions of the oral pouch product 100 may be the same or different. In at least one example embodiment, the oral pouch product 100 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.

[0119] 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.

[0120] 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.

[0121] In at least one example embodiment, the sweetener includes a low-glycemic-index sweetener. The low-glycemic-index sweetener may have a glycemic index of less than or equal to about 35 (e.g., less than or equal to about 30, less than or equal to about 25, less than or equal to about 20, less than or equal to about 15, less than or equal to about 10, or less than or equal to about 5). The low-glycemic-index sugar may include acesulfame K, agave, alitame, aspartame, brazzein, brown rice syrup, curculin, cyciamate, erythritol, fructose, galactose, glycerol, glycyrrhizin, HFCF-90, HSH, inulin, isomalt, lactitol, locust honey, luo ham guo, maltitol, mannitol, miraculin, monellin, monk fruit, neotame, oligofructose, pentadin, psicose, raw non-refined honey, saccharin, sorbitol, Stevia, sucralose, tagatose, thaumatin, trehalose, xylitol, yacon syrup, 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.

[0122] 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 pouch product 100 is free of a nutraceutical. In at least one example embodiment, the oral pouch product 100 includes the nutraceutical. The nutraceuticals can be included in an amount ranging from about 0.1 weight percent of the composition to about 5 weight percent of the composition.

[0123] In at least one example embodiment, the oral pouch product 100 is free of an energizing agent. In at least one example embodiment, the oral pouch product 100 may include the energizing agent. In at least one example embodiment, the energizing agent includes caffeine, citicoline, taurine, glucaronalactone, guarana, vitamin B6, vitamin B12, or any combination thereof.

[0124] 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 pouch product 100 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).

[0125] The compositions for human consumption may have a relatively high caffeine content so as to provide a consumer with a burst of energy. Moreover, the compositions for human consumption contain 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 product formed as described herein.

[0126] Optionally, the composition for human consumption 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 ranging from about 0.1 weight percent of the composition for human consumption to about 5 weight percent of the composition for human consumption.

[0127] In at least one example embodiment, the oral pouch product 100 is free of a soothing agent. In at least one example embodiment, the oral pouch product 100 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 pouch product 100 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 pouch product 100 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).

[0128] In at least one example embodiment, the oral pouch product 100 is free of a plasticizer. In at least one example embodiment, the oral pouch product 100 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 the liquid mixture.

[0129] In at least one example embodiment, the oral pouch product 100 is free of mouth-soluble fibers. In at least one example embodiment, the oral pouch product 100 includes 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 pouch product 100 includes partially-soluble fibers, such as sugar beet fibers.

[0130] In at least one example embodiment, the oral pouch product 100 is free of minerals. In at least one example embodiment, the oral pouch product 100 includes a mineral in addition to any that may be present due to the inclusion, for example, of fruits and / or vegetables. The mineral may be present in the surface-modified agglomerate 106, in the composition 104 (e.g., as the releasable ingredient), and / or on the pouch 102. Minerals included in different portions of the oral pouch product 100 may be the same or different. 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 pouch product 100 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.

[0131] In at least one example embodiment, the oral pouch product 100 is free of a focusing agent. In at least one example embodiment, the oral pouch product 100 includes a focusing agent. The focusing agent may be present in the surface-modified agglomerate 106, in the composition 104, and / or on the pouch 102. Focusing agents included in different portions of the oral pouch product 100 may be the same or different. In at least one example embodiment, the focusing agent includes Ginkgo biloba.

[0132] In at least one example embodiment, the oral pouch product 100 is free of a sensate and / or chemesthesis agent. In at least one example embodiment, the oral pouch product 100 includes a sensate and / or chemesthesis agent. The sensate and / or chemesthesis agent may be present in the surface-modified agglomerate 106, in the composition 104, and / or on the pouch 102. The sensate and / or chemesthesis agents included in different portions of the oral pouch product 100 may be the same or different. 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 of the oral pouch product 100 to about 5 weight percent of the oral pouch product 100.

[0133] In at least one example embodiment, the oral pouch product 100 is free of vitamins. In at least one example embodiment, the oral pouch product 100 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 pouch product 100 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.

[0134] In at least one example embodiment, the oral pouch product 100 is free of an antioxidant. In at least one example embodiment, the oral pouch product 100 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.

[0135] In at least one example embodiment, the oral pouch product 100 is free of an amino acid. In at least one example embodiment, the oral pouch product 100 includes an amino acid. The amino acid may be present in the surface-modified agglomerate 106, in the composition 104, and / or on the pouch 102. Amino acids included in different portions of the oral pouch product 100 may be the same or different. 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 of the composition to about 5 weight percent of the composition.

[0136] In at least one example embodiment, the oral pouch product 100 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 pouch product 100 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).

[0137] In at least one example embodiment, the oral pouch product 100 is free of a coloring agent. In at least one example embodiment, the oral pouch product 100 includes a coloring agent. The coloring agent may include a natural colorant, an artificial colorant, or any combination thereof.

[0138] In at least one example embodiment, the oral pouch product 100 is free of a pH modifier. In at least one example embodiment, the oral pouch product 100 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.

[0139] In at least one example embodiment, the oral pouch product 100 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 pouch product 100 includes the pH modifier in an amount ranging from about 0.01 weight percent to 2 weight percent.

[0140] In at least one example embodiment, the oral pouch product 100 is free of a wax. In at least one example embodiment, the oral pouch product 100 includes a wax. The wax may include, for example, paraffin, microcrystalline wax, or both paraffin and microcrystalline wax.

[0141] In at least one example embodiment, the oral pouch product 100 is free of a filler. In at least one example embodiment, the oral pouch product 100 includes a filler. The filler may be configured to alter a texture or pliability of the oral pouch product 100. 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 pouch product 100 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 pouch product 100 as fillers in addition to or as an alternative to being carriers for active ingredients, additives, and / or liquid ingredients.

[0142] In at least one example embodiment, the oral pouch product 100 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 pouch product 100 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 pouch product 100 includes the filler in an amount ranging from about 0 weight percent to about 8 weight percent.

[0143] In at least one example embodiment, the oral pouch product 100 is free of a flavoring agent. In at least one example embodiment, the oral pouch product 100 includes a flavoring agent. The flavoring agent may be present in the surface-modified agglomerate 106, in the composition 104, and / or on the pouch 102. In at least one example embodiment, the carrier material 212 may be impregnated and / or coated with a flavoring agent prior to agglomeration. Flavoring agents included in different portions of the oral pouch product 100 may be the same or different. In at least one example embodiment, the oral pouch product 100 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.

[0144] In at least one example embodiment, the oral pouch product 100 is free of a carrier. In at least one example embodiment, the oral pouch product 100 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.

[0145] In at least one example embodiment, the oral pouch product 100 is free of an oil. In at least one example embodiment, the oral pouch product 100 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.

[0146] An amount of oil may be selected to achieve a desired texture and / or softness. For example, the softness of the oral pouch product 100 may be increased as an amount of the oil in the oral pouch product 100 increases. In at least one example embodiment, the oral pouch product 100 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 pouch product 100 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 pouch product 100 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).

[0147] In at least one example embodiment, the oral pouch product 100 includes moisture (e.g., water). The oral pouch product 100 may include water 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, greater than or equal to about 4.5 weight percent, or greater than or equal to about 5 weight percent). The oral pouch product 100 may include water in an amount less than or equal to about 10 weight percent (e.g., 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, less than or equal to about 1 weight percent, or less than or equal to about 0.5 weight percent). In at least one other example embodiment, the oral pouch product 100 may include greater than 10 weight percent water.

[0148] As used herein, “water activity” is a ratio of the vapor pressure in a product (P) to the vapor pressure of pure water (P0). Water activity may be used to predict whether the water is on surface of product to be available to micro-organisms on the surface and externally. In at least one example embodiment, the surface-modified agglomerate 106 has a desired (or alternatively, predetermined) water activity. The desired water activity may be greater than or equal to about 0.44 (e.g., greater than or equal to about 0.445, greater than or equal to about 0.45, greater than or equal to about 0.455, greater than or equal to about 0.46, greater than or equal to about 0.465, greater than or equal to about 0.47, greater than or equal to about 0.475, greater than or equal to about 0.48. The desired water activity may be less than or equal to about 0.5 (e.g., less than or equal to about 0.49, less than or equal to about 0.485, less than or equal to about 0.48, less than or equal to about 0.475, less than or equal to about 0.47, less than or equal to about 0.465, less than or equal to about 0.46, less than or equal to about 0.455, less than or equal to about 0.45, or less than or equal to about 0.445).

[0149] In at least one example embodiment, the surface-modified agglomerate 106 may have a desired (or alternatively, predetermined) tapped density. Tapped density may be determined by filling 100 mL cylinder with powder (about 45 grams), tapping the cylinder on a surface for about 10 minutes and / or 2600 taps, and then determining the density. The desired tapped density may be greater than or equal to about 0.5 g / cm3 (e.g., greater than or equal to about 0.550 g / cm3, greater than or equal to about 0.560 g / cm3, greater than or equal to about 0.561 g / cm3, greater than or equal to about 0.562 g / cm3, greater than or equal to about 0.563 g / cm3, greater than or equal to about 0.564 g / cm3, greater than or equal to about 0.565 g / cm3). The desired tapped density may be less than or equal to about 0.572 g / cm3 (e.g., less than or equal to about 0.571 g / cm3, less than or equal to about 0.570 g / cm3, less than or equal to about 0.569 g / cm3, less than or equal to about 0.568 g / cm3, less than or equal to about 0.567 g / cm3, less than or equal to about 0.566 g / cm3, less than or equal to about 0.565 g / cm3, less than or equal to about 0.564 g / cm3, or less than or equal to about 0.563 g / cm3).

[0150] In at least one example embodiment, the surfactant-modified agglomerate 106 is configured to release the releasable ingredient 108 (e.g., the active ingredient) at a desired rate. In at least one example embodiment, the surfactant-modified agglomerate 106 is configured to release greater than about 10% by weight of the releasable ingredient 108 after 5 minutes in contact with saliva of an adult consumer (e.g., greater than or equal to about 12.5%, greater than or equal to about 15%, greater than or equal to about 17.5%, or greater than or equal to about 20%). The surfactant-modified agglomerate 106 may be configured to release less than or equal to about 50% by weight of the releasable ingredient 108 after 5 minutes in contact with saliva of the adult consumer (e.g., less than or equal to about 45%, less than or equal to about 40%, less than or equal to about 35%, less than or equal to about 30%, less than or equal to about 25%, or less than or equal to about 20%).

[0151] In at least one example embodiment, the surfactant-modified agglomerate 106 is configured to release greater than about 30% by weight of the releasable ingredient 108 after 10 minutes in contact with saliva of an adult consumer (e.g., greater than or equal to about 35%, greater than or equal to about 40%, greater than or equal to about 45%, or greater than or equal to about 50%). The surfactant-modified agglomerate 106 may be configured to release less than or equal to about 60% by weight of the releasable ingredient 108 after 10 minutes in contact with saliva of the adult consumer (e.g., less than or equal to about 55%, less than or equal to about 50%, less than or equal to about 45% less than or equal to about 40%, or less than or equal to about 35%).

[0152] In at least one example embodiment, the surfactant-modified agglomerate 106 is configured to release greater than about 40% by weight of the releasable ingredient 108 after 15 minutes in contact with saliva of an adult consumer (e.g., greater than or equal to about 45%, greater than or equal to about 50%, greater than or equal to about 55%, greater than or equal to about 60%, greater than or equal to about 65%, or greater than or equal to about 70%). The surfactant-modified agglomerate 106 may be configured to release less than or equal to about 80% by weight of the releasable ingredient 108 after 15 minutes in contact with saliva of the adult consumer (e.g., less than or equal to about 75%, less than or equal to about 70%, less than or equal to about 65% less than or equal to about 60%, less than or equal to about 55%, less than or equal to about 50%, or less than or equal to about 45%).

[0153] In at least one example embodiment, the surfactant-modified agglomerate 106 is configured to release greater than about 65% by weight of the releasable ingredient 108 after 30 minutes in contact with saliva of an adult consumer (e.g., greater than or equal to about 70%, greater than or equal to about 75%, greater than or equal to about 80%, greater than or equal to about 85%, or greater than or equal to about 90%). The surfactant-modified agglomerate 106 may be configured to release less than or equal to about 95% by weight of the releasable ingredient 108 after 30 minutes in contact with saliva of the adult consumer (e.g., less than or equal to about 90%, less than or equal to about 85% less than or equal to about 80%, less than or equal to about 75%, or less than or equal to about 70%).

[0154] In at least one example embodiment, the surfactant-modified agglomerate 106 is configured to release greater than about 75% by weight of the releasable ingredient 108 after 60 minutes in contact with saliva of an adult consumer (e.g., greater than or equal to about 80%, greater than or equal to about 85%, or greater than or equal to about 90%). The surfactant-modified agglomerate 106 may be configured to release less than or equal to about 100% by weight of the releasable ingredient 108 after 60 minutes in contact with saliva of the adult consumer (e.g., less than or equal to about 95%, less than or equal to about 90%, or less than or equal to about 85%).

[0155] In at least one example embodiment, as discussed above, the surface-modified agglomerate 106 is included in the oral pouch product 100. However, the surface-modified agglomerate 106 may alternatively be included in other oral products, together with a releasable ingredient as described above. The oral products may be in a form of loose material (e.g., loose cellulosic material), shaped material (e.g., plugs or twists), tablets, lozenges, chews, gums, films, any other oral product, or any combination thereof, for example.

[0156] FIG. 3 is a perspective view of the oral product of FIG. 1 according to at least one example embodiment.

[0157] In at least one example embodiment, as shown in FIG. 3, the oral pouch product 100 is configured to fit in an adult consumer's mouth. For example, an adult consumer can suck, chew, or otherwise orally manipulate the oral pouch product 100 so as to release flavor and / or functional ingredients contained therein. The oral pouch product 100 may be an oral pouch product having, for example only, a generally rectangular shape. In still other embodiments, the oral pouch product 100 may have a pouch shape that is similar to a ravioli or pillow shape, an oblong shape, or any other suitable shape.

[0158] Various shapes may be utilized so long as the shapes fit comfortably and discreetly in an adult consumer's mouth. In at least one example embodiment, the oral pouch product 100 is substantially free of oral cavity irritant, which, as used herein, means that the shape, configuration, and position of the oral pouch product 100 do not irritate oral tissues (e.g., gums) via sharp edges and the like. Furthermore, “substantial” and “substantially free” as used in connection with oral cavity irritant means that the shape, configuration, and position of the oral pouch product 100 does not irritate oral tissues (e.g., gums) in a time frame or period having the same order of magnitude as a typical length of time during which the oral pouch product 100 may be enjoyed by an adult consumer. Generally, sharp corners are avoided as sharp corners may lead to oral discomfort.

[0159] The oral pouch product 100 may be sized and configured to fit comfortably in an adult consumer's mouth, such as between the cheek and gum. In at least one example embodiment, the oral pouch product 100 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 pouch product 100 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 pouch product 100 has a largest dimension (e.g., diameter, height, or width) ranging from about 5 millimeters to about 25 millimeters (e.g., about 12 millimeters).

[0160] In at least one example embodiment, the oral pouch product 100 may have a weight ranging from about 1 gram 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, or about 8 grams to about 9 grams).

[0161] The oral pouch product 100 may be placed in an adult consumer's mouth for about 1 minute to about 3 hours (e.g., about 1 minute to about 2 hours, about 5 minutes to about 90 minutes, about 10 minutes to about 60 minutes, about 20 minutes to about 40 minutes). The size of the oral pouch product 100 may be selected based on desired length of placement in an adult consumer's mouth. For example, a larger pouch including a larger amount of filling material may provide for longer placement. In at least one example embodiment, the oral pouch product 100 is discarded after a single placement in an adult consumer's mouth.

[0162] In at least one example embodiment, as shown in FIG. 3, the oral pouch product 100 includes the pouch or porous wrap 102. The pouch 102 can be sealed around one or more edges (e.g., at least one seam) so as to define the inner cavity 103 that is configured to carry the composition 104 (shown in FIG. 1). For example, the pouch 102 can include at least one longitudinal seal 302 and one or more fin seals 304. The longitudinal seal 302 extends between the fin seals 304. In at least one example embodiment, the oral pouch product 100 is formed on a high speed, vertical fill and seal machine.

[0163] In at least one example embodiment, the pouch 102 includes an outer web or pouch material 306. The outer web 306 may have a thickness of about 0.05 mm to about 0.25 mm (e.g., about 0.075 mm to about 0.100 mm or about 0.1 mm to about 0.20 mm). The outer web 306 can be formed of a permeable material or a semi-permeable material, such that, for example, saliva, water, or both saliva and water can pass through the outer web 306 and into the inner cavity 103 defined by the pouch 102. Flavors and juices formed by mixing of the saliva and / or water with the composition 104 (shown in FIG. 1) contained within the oral pouch product 100 can be drawn out of the oral pouch product 100 through the outer web 306.

[0164] In at least one example embodiment, the outer web 306 is formed from a material that is generally recognized as safe (“GRAS”) for use and / or contact with food. The material forming the outer web 306 may be stain resistant, water permeable, and / or porous. For example, in at least one example embodiment, the outer web 306 comprises a paper. For example, the outer web 306 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 306 has a desired (or alternatively, predetermined) level for basis weight and / or wet strength so as to reduce occurrence of breakage of the pouch 102 during manufacturing operations, storage, and placement in an adult consumer's mouth. For example, the outer web 306 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 306 may be formed of a paper having a wet MD tensile strength of about 45 N / mm to about 52 N / mm.

[0165] In at least one example embodiment, the outer web 306 is formed of a hydrophobic paper. The hydrophobic paper may be formed of a cellulosic material. The hydrophobic paper may be non-woven material, and may include viscose and / or other hydrophobic materials. The hydrophobic materials may be synthetic materials.

[0166] The material used to form the outer web 306 may have a neutral or pleasant taste and / or aroma. Further, the outer web 306 may be substantially white in color. However, in other example embodiments, the outer web 306 may be colored so as to indicate a flavor of the composition 104 (shown in FIG. 1) contained therein.

[0167] In at least one example embodiment, the outer web 306 may be impregnated or coated with a pouch additive. The pouch additive can include one or more of the additives discussed above. In at least one example embodiment, the pouch additive includes a flavoring agent, a cannabis material, a tobacco material, a binder, a sensate and / or chemesthesis agent, a functional ingredient (e.g., an antioxidant, a soothing agent, an energizing agent, and / or an effervescent), a salivation inducing ingredient, or any combination thereof. The pouch additive may enhance a flavor of the composition 104 (shown in FIG. 1) contained within the oral pouch product 100. A substantially continuous coating including the pouch additive may be coated on outer (exterior facing) surfaces of the outer web 306. In at least one example embodiment, the coating may be formed on only a portion of the outer web 306, such as only along the seams or only on one side of the pouch 102. The coating can provide an initial flavor burst upon placement of the oral pouch product 100 in an oral cavity, while the composition 104 provides a later flavor release so as to prolong flavor release during placement in an adult consumer's mouth.

[0168] FIG. 4 is a perspective view of another oral product according to at least one example embodiment.

[0169] In at least one other example embodiment, an oral product 400 is the same as the pouch product 100 of FIGS. 1 and 3, except that an outer web 402 is a non-woven material formed of a polymer, including synthetic or natural polymer. For example, the outer web 402 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 pouch product 400, the pouch product 400 may exclude seams so as to provide a softer pouch. In at least one example embodiment, the mesh material encloses a composition or filling material that is the same as the composition 104 of FIG. 1.

[0170] FIG. 5 is a flowchart illustrating a method of manufacturing an oral product according to at least one example embodiment.

[0171] In at least one example embodiment, as shown in FIG. 5, a method of forming an oral product may include optionally combining an additive with a carrier material at S500; forming an agglomerate from the carrier material at S504; preparing a surface modifier solution or suspension at S508; forming a modified agglomerate precursor from the agglomerate and the surface modifier solution or suspension at S512; preparing a surface-modified agglomerate from the modified agglomerate at S516; preparing a filling material by admixing the surface-modified agglomerate with a releasable ingredient at S520; and forming an oral product including the filling material at S524.

[0172] At S500, the method optionally includes combining an additive with a carrier material, such as the carrier material 212 (shown in FIG. 2). The additive may be referred to as a “carrier additive.” Combining may including admixing the carrier additive with the carrier material, at least partially coating the carrier additive on a surface of the carrier material, absorbing the carrier additive into the carrier material, and / or adsorbing the carrier additive onto the carrier material. The carrier additive may include any of the additives discussed above. In at least one example embodiment, the carrier additive includes a sweetener, an energizing agent, a soothing agent, a focusing agent, an alkaloid, a mineral, a vitamin, a dietary supplement, a nutraceutical, an amino acid, a chemesthetic agent, a botanical, a tooth-whitening agent, a therapeutic agent, a flavoring agent, a flavor masking agent, a bitterness receptor site blocker, a receptor site enhancers, or any combination thereof. In at least one example embodiment, the carrier additive includes a flavoring agent.

[0173] At S504, the method includes forming an agglomerate from the carrier material. In at least one example embodiment, the agglomerate is formed from the carrier material and a binder. The binder may include water, a water-holding polymer, or any combination thereof. In at least one example embodiment, the water-holding polymer includes guar gum, xanthan gum, gum arabic, pregelatinized starch, hydroxy propyl methyl cellulose (HPMC), carboxymethyl cellulose (CMC), methyl cellulose (MC), pullulan, polyvinyl pyrrolidone (PVP / Povidone), Carrageenan, sodium alginate, or any combination thereof. The water-holding polymer may be food, nutraceutical, GRAS, and / or USP grade. In at least one example embodiment, forming the agglomerate may include loading the carrier material into a fluidized bed. Forming the agglomerate may further include fluidizing the carrier material in a chamber of the fluidized bed, such as by directing a fluid, such as air, at the carrier material. The fluid may be directed from a bottom of the chamber toward a top of the chamber to counteract gravity. Forming the agglomerate may further include, concurrently with the fluidizing, directing a binder toward the fluidized carrier material. The binder may be atomized in an atomizing nozzle and discharged or sprayed toward the carrier material. For example, the atomizing nozzle may be at a top of the chamber. In at least one example embodiment, S504 is performed at a temperature of greater than or equal to about 45° C. (e.g., greater than or equal to about 48° C., greater than or equal to about 50° C., greater than or equal to about 52° C., greater than or equal to about 54° C., greater than or equal to about 56° C., greater than or equal to about 58° C., or greater than or equal to about 60° C.). S504 may be performed at a temperature of less than or equal to about 65° C. (e.g., less than or equal to about 62° C., less than or equal to about 60° C., less than or equal to about 58° C., less than or equal to about 56° C., less than or equal to about 54° C., less than or equal to about 52° C., or less than or equal to about 50° C.). In at least one example embodiment, S504 is performed for a duration of greater than or equal to about 10 minutes (e.g., greater than or equal to about 12 minutes, greater than or equal to about 14 minutes, greater than or equal to about 16 minutes, greater than or equal to about 18 minutes, greater than or equal to about 20 minutes, greater than or equal to about 22 minutes, greater than or equal to about 24 minutes, greater than or equal to about 26 minutes, or greater than or equal to about 28 minutes). S504 may be performed for a duration of less than or equal to about 30 minutes (e.g., less than or equal to about 28 minutes, less than or equal to about 26 minutes, less than or equal to about 24 minutes, less than or equal to 22 minutes, less than or equal to about 20 minutes, less than or equal to about 18 minutes, less than or equal to about 6 minutes, less than or equal to about 14 minutes, or less than or equal to about 12 minutes). In at least one example embodiment, S504 is performed at a nozzle air pressure of greater than or equal to about 10 psi (e.g., greater than or equal to about 10.5 psi, greater than or equal to about 11 psi, greater than or equal to about 11 psi, greater than or equal to about 11 psi, greater than or equal to about 11 psi, greater than or equal to about 11 psi, greater than or equal to about 11 psi, greater than or equal to about 11 psi, greater than or equal to about 11 psi). The nozzle air pressure may be less than or equal to about 15 psi (e.g., less than or equal to about 14.5 psi, less than or equal to about 14 psi, less than or equal to about 13.5 psi, less than or equal to about 13 psi, less than or equal to about 12.5 psi, less than or equal to about 12 psi, less than or equal to about 11.5 psi, less than or equal to about 11 psi, or less than or equal to about 10.5 psi). In at least one example embodiment, S504 is performed at an air flow rate of greater than or equal to about 35 liters per minute (LPM) (e.g., greater than or equal to about 37.5 LPM, greater than or equal to about 40 LPM, greater than or equal to about 41 LPM, greater than or equal to about 42 LPM, greater than or equal to about 43 LPM, greater than or equal to about 44 LPM, greater than or equal to about 45 LPM, greater than or equal to about 46 LPM, greater than or equal to about 47 LPM, greater than or equal to about 48 LPM, greater than or equal to about 49 LPM, greater than or equal to about 50 LPM, or greater than or equal to about 52.5 LPM). The air flow rate may be less than or equal to about 55 LPM (e.g., less than or equal to about 52.5 LPM, less than or equal to about 50 LPM, less than or equal to about 49 LPM, less than or equal to about 48 LPM, less than or equal to about 47 LPM, less than or equal to about 46 LPM, less than or equal to about 45 LPM, less than or equal to about 44 LPM, less than or equal to about 43 LPM, less than or equal to about 42 LPM, less than or equal to about 41 LPM, less than or equal to about 40 LPM, or less than or equal to about 37.5 LPM). S504 may be performed in a plurality of cycles, where each cycle includes a first period of spraying a binder, followed by a second period of not spraying the binder. The first period may be longer than the second period, the same as the second period, or shorter than the second period. The first period may have a duration of greater than or equal to about 0.01 minutes (e.g., greater than or equal to about 0.05 minutes, greater than or equal to about 0.1 minutes, greater than or equal to about 0.2 minutes, greater than or equal to about 0.3 minutes, greater than or equal to about 0.4 minutes, greater than or equal to about 0.5 minutes, greater than or equal to about 0.6 minutes, greater than or equal to about 0.7 minutes, greater than or equal to about 0.8 minutes, greater than or equal to about 0.9 minutes, or greater than or equal to about 1 minutes). The first period may be less than or equal to about 2 minutes (e.g., less than or equal to about 1 minute, less than or equal to about 0.9 minutes, less than or equal to about 0.8 minutes, less than or equal to about 0.7 minutes, less than or equal to about 0.6 minutes, less than or equal to about 0.5 minutes, less than or equal to about 0.4 minutes, less than or equal to about 0.3 minutes, less than or equal to about 0.2 minutes, less than or equal to about 0.1 minutes, less than or equal to about 0.05 minutes). The second period may have a duration of greater than or equal to about 0.01 minutes (e.g., greater than or equal to about 0.05 minutes, greater than or equal to about 0.1 minutes, greater than or equal to about 0.2 minutes, greater than or equal to about 0.3 minutes, greater than or equal to about 0.4 minutes, greater than or equal to about 0.5 minutes, greater than or equal to about 0.6 minutes, greater than or equal to about 0.7 minutes, greater than or equal to about 0.8 minutes, greater than or equal to about 0.9 minutes, or greater than or equal to about 1 minutes). The second period may be less than or equal to about 2 minutes (e.g., less than or equal to about 1 minute, less than or equal to about 0.9 minutes, less than or equal to about 0.8 minutes, less than or equal to about 0.7 minutes, less than or equal to about 0.6 minutes, less than or equal to about 0.5 minutes, less than or equal to about 0.4 minutes, less than or equal to about 0.3 minutes, less than or equal to about 0.2 minutes, less than or equal to about 0.1 minutes, less than or equal to about 0.05 minutes). The total cycle (including first and second periods) may therefore be greater than or equal to about 0.02 minutes (e.g., greater than or equal to about 0.05 minutes, greater than or equal to about 0.1 minutes, greater than or equal to about 0.2 minutes, greater than or equal to about 0.6 minutes, greater than or equal to about 0.8 minutes, greater than or equal to about 1 minutes, greater than or equal to about 1.5 minutes, greater than or equal to about 2 minutes, greater than or equal to about 2.5 minutes, greater than or equal to about 3 minutes, or greater than or equal to about 3.5 minutes). The total cycle may be less than or equal to about 4 minutes (e.g., less than or equal to about 3.5 minutes, less than or equal to about 3 minutes, less than or equal to about 2.5 minutes, less than or equal to about 2 minutes, less than or equal to about 1.5 minutes, less than or equal to about 1 minute, less than or equal to about 0.9 minutes, less than or equal to about 0.8 minutes, less than or equal to about 0.7 minutes, less than or equal to about 0.6 minutes, less than or equal to about 0.5 minutes, less than or equal to about 0.4 minutes, less than or equal to about 0.3 minutes, less than or equal to about 0.2 minutes, less than or equal to about 0.1 minutes, or less than or equal to about 0.05 minutes). In at least one example embodiment, a quantity of cycles is greater than or equal to about 30 cycles (e.g., greater than or equal to about 35 cycles, greater than or equal to about 40 cycles, greater than or equal to about 41 cycles, greater than or equal to about 42 cycles, greater than or equal to about 43 cycles, greater than or equal to about 44 cycles, greater than or equal to about 45 cycles, greater than or equal to about 46 cycles, greater than or equal to about 47 cycles, greater than or equal to about 48 cycles, greater than or equal to about 49 cycles, greater than or equal to about 50 cycles, greater than or equal to about 55 cycles). The quantity of cycles may be less than or equal to about 60 cycles (e.g., less than or equal to about 55 cycles, less than or equal to about 50 cycles, less than or equal to about 49 cycles, less than or equal to about 48 cycles, less than or equal to about 47 cycles, less than or equal to about 46 cycles, less than or equal to about 45 cycles, less than or equal to about 44 cycles, less than or equal to about 43 cycles, less than or equal to about 42 cycles, less than or equal to about 41 cycles, less than or equal to about 40 cycles, or less than or equal to about 35 cycles). In at least one example embodiment, S504, each cycle may use a spray rate of greater than or equal to about 0.15 grams of binder per cycle (gpc) (e.g., greater than or equal to about 0.2 gpc, greater than or equal to about 0.25 gpc, greater than or equal to about 0.3 gpc, greater than or equal to about 0.35 gpc, greater than or equal to about 0.4 gpc, or greater than or equal to about 0.45 gpc). The spray rate may be less than or equal to about 0.5 gpc (e.g., less than or equal to about 0.45 gpc, less than or equal to about 0.4 gpc, less than or equal to about 0.35 gpc, less than or equal to about 0.3 gpc, less than or equal to about 0.25 gpc, or less than or equal to about 0.2 gpc). At S508, the method includes preparing a surface modifier solution or suspension. In at least one example embodiment, the surface modifier solution includes the surface modifier as a solute, at least partially dissolved in a solvent. For example, the surface modifier may include a sugar alcohol and the solvent may include water. Preparing the surface modifier solution may include heating and / or stirring the solute and solvent until achieving a desired (or alternatively, predetermined) level of dissolution. In at least one other example embodiment, the surface modifier suspension includes the surface modifier as a solid and a solvent as a liquid. For example, the surface modifier may include a hydrophobic material, optionally with pectin and / or sodium stearate, and the solvent may include water. Preparing the surface modifier suspension may include dispersing the surface modifier in the solvent. The dispersion may be substantially homogeneous. S508 may be performed after S504 or before S504 (including, optionally, before S500).

[0174] At S512, the method includes forming a modified agglomerate precursor (also referred to as wet modified agglomerate) from the agglomerate and the surface modifier solution or suspension. Forming the modified agglomerate precursor may include at least partially coating and / or impregnating the agglomerate with the surface modifier solution or suspension. Additionally or alternatively, the surface modifier solution or suspension may be absorbed in and / or absorbed on the agglomerate. In at least one example forming the modified agglomerate precursor includes fluidizing the agglomerate in the fluidized bed chamber. Forming the modified agglomerate may further include, concurrently with fluidizing the agglomerate, spraying the agglomerate with the surface modifier solution or suspension. Spraying at S512 may be performed for a duration of greater than or equal to about 15 minutes (e.g., greater than or equal to about 17 minutes, greater than or equal to about 19 minutes, greater than or equal to about 20 minutes, greater than or equal to about 21 minutes, greater than or equal to about 22 minutes, greater than or equal to about 23 minutes, greater than or equal to about 24 minutes, greater than or equal to about 25 minutes, greater than or equal to about 6 minutes, or greater than or equal to about 28 minutes). Spraying at S512 may be performed for a duration of less than or equal to about 30 minutes (e.g., less than or equal to about 28 minutes, less than or equal to about 26 minutes, less than or equal to about 25 minutes, less than or equal to 24 minutes, less than or equal to about 23 minutes, less than or equal to about 22 minutes, less than or equal to 21 minutes, less than or equal to about 20 minutes, less than or equal to about 19 minutes, or less than or equal to about 17 minutes). In at least one example embodiment, S512 is performed at a temperature of greater than or equal to about 15° C. (e.g., greater than or equal to about 17° C., greater than or equal to about 19° C., 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 28° C., or greater than or equal to about 30° C.). The temperature may be less than or equal to about 32° C. (e.g., less than or equal to about 30° C., less than or equal to about 28° 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., less than or equal to about 21° C., less than or equal to about 19° C., or less than or equal to about 21° C., or less than or equal to about 17° C.).

[0175] In at least one example embodiment, S512 is performed directly after S504. S504 and S512 may be performed with a single fluidizing step such that, the carrier material is fluidized, the binder is applied to form the agglomerate, and the agglomerate is retained fluidized for application of the surface modifier. In at least one other example embodiment, S504 and S512 are performed at spaced apart times and / or in different equipment.

[0176] At S516, the method includes preparing the surface-modified agglomerate. Preparing the surface-modified agglomerate may include drying the modified agglomerate precursor to form a surface-modified agglomerate. In at least one example embodiment, drying the modified agglomerate precursor may include fluidizing the modified agglomerate precursor in the fluidized bed chamber at a desired (or alternatively, predetermined) temperature. The desired temperature may be a desired temperature of the fluid used to fluidized the modified agglomerate, such as air. In at least one example embodiment, the desired temperature is greater than or equal to about 20° C. (e.g., greater than or equal to about 22° C., greater than or equal to about 25° C., greater than or equal to about 30° C., greater than or equal to about 35° C., greater than or equal to about 40° C., or greater than or equal to about 45° C.). The desired temperature may be less than or equal to about 50° C. (e.g., less than or equal to about 45° C., less than or equal to about 40° C., less than or equal to about 35° C., less than or equal to about 30° C., or less than or equal to about 25° C.).

[0177] The drying may include drying the modified agglomerate to a desired (or alternatively, predetermined) moisture content. The desired moisture content may be greater than or equal to about 0 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 3.5 weight percent, greater than or equal to about 4 weight percent, or greater than or equal to about 4.5 weight percent). The desired moisture content may be less than or equal to about 10 weight percent (e.g., 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).

[0178] In at least one example embodiment, S516 is performed directly after S512. S512 and S516 may be performed with a single fluidizing step such that, the carrier the agglomerate is retained fluidized for application of the surface modifier, and the modified agglomerate precursor is retained fluidized for drying. In at least one example embodiment, S504 and S512, and S516 are performed with a single fluidizing step such that, the carrier material is fluidized, the binder is applied to form the agglomerate, the agglomerate is retained fluidized for application of the surface modifier, and the modified agglomerate precursor is retained fluidized for drying. In at least one other example embodiment, S512 and S516 are performed at spaced apart times and / or in different equipment.

[0179] At S520, the method may include forming a filling material (e.g., the composition 104 of FIG. 1) by admixing the surface-modified agglomerate with a releasable ingredient. As discussed above, the releasable ingredient may be an active ingredient and / or an additive. In at least one example embodiment, a weight ratio of the surface-modified ingredient to the releasable ingredient may be greater than or equal to about 25:75 (e.g., greater than or equal to about 30:70, greater than or equal to about 35:65, greater than or equal to about 40:60, greater than or equal to about 45:65, greater than or equal to about 46:54, greater than or equal to about 47:53, greater than or equal to about 48:52, greater than or equal to about 49:51, greater than or equal to about 50:50, greater than or equal to about 55:45, greater than or equal to about 60:40, greater than or equal to about 65:35, greater than or equal to about 70:30, or greater than or equal to about 75:25). The weight ratio of the surface-modified ingredient to the releasable ingredient may be less than or equal to about 75:25 (e.g., less than or equal to about 70:30, less than or equal to about 65:35, less than or equal to about 60:40, less than or equal to about 55:45, less than or equal to about 50:50, less than or equal to about 49:51, less than or equal to about 48:52, less than or equal to about 47:53, less than or equal to about 46:54, less than or equal to about 45:65, less than or equal to about 40:60, less than or equal to about 35:65, less than or equal to about 30:70, or less than or equal to about 25:75).

[0180] In at least one example embodiment, S520 further includes admixing additional additives with the surface-modified agglomerate and releasable ingredient. The additional additives may be added at the same time that the surface-modified agglomerate and releasable ingredient are combined, or in one or more additional steps.

[0181] At S524, the method may include forming an oral product including the filling material. In at least one example embodiment, forming the oral pouch product 100 includes pouching the filling material a pouched oral product (e.g., the oral pouch product). In at least one other example embodiment, S524 includes forming a different oral product, such as a loose material, shaped material (e.g., plugs or twists), tablets, lozenges, chews, gums, films, any other oral product, or any combination thereof. In at least one example embodiment, S520 and S524 are performed concurrently.

[0182] In at least one example embodiment, a method of controlling release of a releasable ingredient is provided. The method may include blocking at least a portion of pores in a carrier (e.g., blocking greater than or equal to about 5% of pore volume, greater than or equal to about 10% of pore volume, greater than or equal to about 20% of pore volume, greater than or equal to about 30% of pore volume, greater than or equal to about 40% of pore volume, greater than or equal to about 50% of pore volume, greater than or equal to about 60% of pore volume, greater than or equal to about 70% of pore volume, greater than or equal to about 80% of pore volume, or greater than or equal to about 90% of pore volume). Blocking at least a portion of the pores of the carrier may include forming a surface-modified agglomerate from the carrier, as described above. In at least one example embodiment, decreasing the pore volume is believed to cause an increase in rate of release of the releasable ingredient. For example, as pores are blocked, less saliva is absorbed into pores, and more saliva is available for delivery of the releasable ingredient to the adult consumer. In at least one example embodiment, blockage of at least a portion of the pore volume of the carrier material facilitates a more complete release of the releasable ingredient.Example 1

[0183] A first slide is prepared by spraying a dispersion including zein onto a glass slide. The first slide is dried overnight to form a substantially uniform film coating on a surface of the glass slide. A drop of saliva is dripped onto the surface of the first slide. A first artificial saliva contact angle is measured to be 70.18°.

[0184] A second slide is prepared by spraying a solution including maltitol and polyvinylpyrrolidone (PVP) onto a glass slide. The second slide is dried overnight to form a substantially uniform film coating on a surface of the glass slide. A drop of saliva is dripped onto the surface of the second slide. A second artificial saliva contact angle is measured to be 3.93°.Example 2

[0185] A first or control filler is prepared by admixing 1 g agglomerated MCC with 1.5 g artificial saliva and drying in a fume hood overnight. A sugar alcohol-modified agglomerate includes MCC and 11 weight percent zein. A second filler is prepared by admixing 1 g of the sugar alcohol-modified MCC with 1.5 g artificial saliva and drying in a fume hood overnight. A hydrophobic material-modified agglomerate includes MCC and 1.32 weight percent zein. A third filler is prepared by admixing 1 g of the hydrophobic material-modified agglomerate with 1.5 g artificial saliva and drying overnight in a fume hood.

[0186] FIG. 6 is a graph illustrating water activity for surface-modified agglomerates according to at least one example embodiment.

[0187] As shown in FIG. 6, the first filler including the agglomerated MCC has a water activity of 0.435 aw. The second filler including the sugar alcohol-modified agglomerate has a water activity of 0.443 aw. The third filler including the hydrophobic material-modified agglomerate has a water activity of 0.485 aw. Thus, the second filler including the sugar alcohol-modified agglomerate has a higher water activity than the first filler including the agglomerated MCC. The third filler including the hydrophobic material-modified agglomerate has a higher water activity than both the second filler including the sugar alcohol-modified agglomerate and the first filler including the agglomerated MCC.Example 3

[0188] A first or control pouch is prepared by pouching a first filler including an admixture of a nicotine solution and MCC. The nicotine solution includes nicotine and MCT. A second pouch is prepared by pouching a second filler including a 1.32 weight percent zein-modified agglomerated MCC and the nicotine solution including the nicotine and the MCT. A third pouch is prepared by pouching a third filler including a 1.92 weight percent zein-modified agglomerated MCC and the nicotine solution including the nicotine and the MCT. The respective zein-modified agglomerated MCC of the second and third pouches is prepared by homogenizing the zein into stable water suspensions using zein, sodium stearate, and pectin. A fourth pouch is prepared by pouching a fourth filler including 11 weight percent maltitol-modified agglomerated MCC and the nicotine solution including the nicotine and the MCT. A fifth pouch is prepared by pouching a fifth filler including 15.7 weight percent maltitol-modified agglomerated MCC and the nicotine solution including the nicotine and the MCT.

[0189] A dissolution test is performed on each of the five pouches. In each of the dissolution tests, the respective pouch is placed into a container. Artificial saliva is flowed through the container at a rate of 4 mL / min at ambient / room temperature. Nicotine release is measured. The test is performed 2-3 times for each of the five types of pouches and average nicotine release is calculated.

[0190] FIG. 7 is a graph illustrating nicotine release for pouches including surface-modified agglomerate according to at least one example embodiment.

[0191] In at least one example embodiment, as shown in FIG. 7, nicotine release for each of the five pouches is determined at seven different times-4 minutes, 8 minutes, 12 minutes, 16 minutes, 20 minutes, 30 minutes, and 30 minutes. The x-axis represents time, in minutes, after the start of artificial saliva flow. The y-axis represents weight percentage of total nicotine in the respective pouch that is released from the pouch. Dissolution of the first or control pouch is represented by x-shaped markers. Dissolution of the second pouch is represented by white triangle-shaped markers. Dissolution of the third pouch is represented by solid black triangle-shaped markers. Dissolution of the fourth pouch is represented by white square-shaped markers. Dissolution of the fifth pouch is represented by solid black square-shaped markers. As shown in the graph, each of the pouches containing a surface-modified agglomerate 702, 704, 406, 708 releases more nicotine than the control pouch 700 over the 60 minutes of artificial saliva flow.

[0192] 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.

[0193] 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.ILLUSTRATIVE EMBODIMENTS

[0194] Illustrative Embodiment 1. An oral product comprising: a filler including, a modified agglomerate including, an agglomerate including, a porous carrier material, and a surface modifier coating at least a portion of a surface of the agglomerate, in pores of the agglomerate, or both coating at least a portion of the surface of the agglomerate and in pores of the agglomerate, the surface modifier including, a sugar alcohol, or a hydrophobic material; and a releasable ingredient admixed with the filler.

[0195] Illustrative Embodiment 2. The oral product of Illustrative Embodiment 1, wherein the porous carrier material includes cellulose.

[0196] Illustrative Embodiment 3. The oral product of Illustrative Embodiment 1, wherein the porous carrier material includes microcrystalline cellulose.

[0197] Illustrative Embodiment 4. The oral product of Illustrative Embodiment 1, wherein the modified agglomerate further includes a flavoring agent absorbed in the porous carrier material.

[0198] Illustrative Embodiment 5. The oral product of Illustrative Embodiment 1, wherein the filler has a water content ranging from 1 weight percent to 50 weight percent.

[0199] Illustrative Embodiment 6. The oral product of Illustrative Embodiment 5, wherein the water content ranges from 1 weight percent to 10 weight percent.

[0200] Illustrative Embodiment 7. The oral product of Illustrative Embodiment 5, wherein the water content ranges from 10 weight percent to 20 weight percent.

[0201] Illustrative Embodiment 8. The oral product of Illustrative Embodiment 5, wherein the water content is greater than 20 weight percent.

[0202] Illustrative Embodiment 9. The oral product of Illustrative Embodiment 5, wherein the water content is greater than 30 weight percent.

[0203] Illustrative Embodiment 10. The oral product of Illustrative Embodiment 1, wherein the surface modifier includes the hydrophobic material.

[0204] Illustrative Embodiment 11. The oral product of Illustrative Embodiment 10, wherein a surface of the hydrophobic material has an artificial saliva contact angle ranging from 60° to 80°.

[0205] Illustrative Embodiment 12. The oral product of Illustrative Embodiment 10, wherein the hydrophobic material includes corn zein.

[0206] Illustrative Embodiment 13. The oral product of Illustrative Embodiment 12, wherein the hydrophobic material further includes pectin and sodium stearate.

[0207] Illustrative Embodiment 14. The oral product of Illustrative Embodiment 12, wherein the hydrophobic material further includes a pH modifier.

[0208] Illustrative Embodiment 15. The oral product of Illustrative Embodiment 14, wherein the pH modifier includes a base.

[0209] Illustrative Embodiment 16. The oral product of Illustrative Embodiment 1, wherein the surface modifier includes the sugar alcohol.

[0210] Illustrative Embodiment 17. The oral product of Illustrative Embodiment 16, wherein the sugar alcohol has a water solubility ranging from 0.1 g / g to less than or equal to about 2.5 g / g.

[0211] Illustrative Embodiment 18. The oral product of Illustrative Embodiment 16, wherein the sugar alcohol includes sorbitol, xylitol, maltitol, lactitol, erythritol, isomaltose, mannitol, or any combination thereof.

[0212] Illustrative Embodiment 19. The oral product of Illustrative Embodiment 18, wherein the sugar alcohol includes maltitol.

[0213] Illustrative Embodiment 20. The oral product of Illustrative Embodiment 1, wherein the modified agglomerate has an average particle size ranging from 200 μm to 450 μm.

[0214] Illustrative Embodiment 21. The oral product of Illustrative Embodiment 1, wherein in the modified agglomerate has a porosity ranging from 40% to 70%.

[0215] Illustrative Embodiment 22. The oral product of Illustrative Embodiment 21, wherein the porosity of the modified agglomerate ranges from 55% to 60%.

[0216] Illustrative Embodiment 23. The oral product of Illustrative Embodiment 1, wherein the porous carrier material has a porosity ranging from 60% to 80%.

[0217] Illustrative Embodiment 24. The oral product of Illustrative Embodiment 23, wherein the porosity of the porous carrier material ranges from 70% to 75%.

[0218] Illustrative Embodiment 25. The oral product of Illustrative Embodiment 1, wherein the modified agglomerate has an average pore size ranging from 3 micrometers (μm) to 8 μm.

[0219] Illustrative Embodiment 26. The oral product of Illustrative Embodiment 1, wherein the porous carrier material has an average pore size ranging from 6.5 micrometers (μm) to 9 μm.

[0220] Illustrative Embodiment 27. The oral product of Illustrative Embodiment 1, wherein the releasable ingredient includes an active ingredient.

[0221] Illustrative Embodiment 28. The oral product of Illustrative Embodiment 1, wherein the active ingredient includes nicotine.

[0222] Illustrative Embodiment 29. The oral product of Illustrative Embodiment 28, wherein the nicotine includes liquid nicotine.

[0223] Illustrative Embodiment 30. The oral product of Illustrative Embodiment 22, further comprising: an active ingredient solution admixed with the filler, the active ingredient solution including, triglycerides, and the liquid nicotine dissolved in the triglycerides. Illustrative Embodiment 30. The oral product of Illustrative Embodiment 28, wherein the filler further includes tobacco in an amount less than or equal to 5 weight percent.

[0224] Illustrative Embodiment 31. The oral product of Illustrative Embodiment 1, further comprising: a pouch, wherein the filler and the releasable ingredient are in the pouch.

[0225] Illustrative Embodiment 32. The oral product of Illustrative Embodiment 31, wherein the pouch includes an elastomeric material.

[0226] Illustrative Embodiment 33. The oral product of Illustrative Embodiment 31, wherein the pouch includes polyurethane fibers.

[0227] Illustrative Embodiment 34. The oral product of Illustrative Embodiment 31, wherein the pouch is nonwoven.

[0228] Illustrative Embodiment 35. The oral product of Illustrative Embodiment 31, wherein the pouch includes a paper material.

[0229] Illustrative Embodiment 36. A method of manufacturing a filler for an oral product, the method comprising: forming an agglomerate by agglomerating a porous carrier material; forming a modified agglomerate by contacting a surface modifier with the agglomerate such that the surface modifier coats at least a portion of a surface of the agglomerate, impregnates pores of the agglomerate, or both coats at least a portion of the surface of the agglomerate and impregnates pores of the agglomerate; and preparing the filler by drying the modified agglomerate.

[0230] Illustrative Embodiment 37. The method of Illustrative Embodiment 36, wherein the forming an agglomerate includes, fluidizing a plurality of particles of the porous carrier material in a fluidized bed, and concurrently with the fluidizing, spraying water on the plurality of particles of the porous carrier material to form the agglomerate.

[0231] Illustrative Embodiment 38. The method of Illustrative Embodiment 36, wherein the forming a modified agglomerate includes, fluidizing the agglomerate in a fluidized bed, and concurrently with the fluidizing, spraying a surface modifier solution or a surface modifier suspension on the agglomerate to form the modified agglomerate.

[0232] Illustrative Embodiment 39. The method of Illustrative Embodiment 38, further comprising: preparing the surface modifier solution by dissolving a sugar alcohol in water, wherein the forming the agglomerate includes spraying the solution modifier solution on the agglomerate.

[0233] Illustrative Embodiment 40. The method of Illustrative Embodiment 38, further comprising: preparing the surface modifier suspension by dispersing a hydrophobic material in water, wherein the forming the agglomerate includes spraying the surface modifier suspension on the agglomerate.

[0234] Illustrative Embodiment 41. The method of Illustrative Embodiment 40, wherein the preparing the surface modifier suspension further includes dispersing pectin and sodium stearate in the water.

[0235] Illustrative Embodiment 42. The method of Illustrative Embodiment 36, further comprising: prior to the forming the agglomerate, absorbing a flavoring agent in the porous carrier material.

[0236] Illustrative Embodiment 43. The method of Illustrative Embodiment 36, wherein the preparing includes drying the modified agglomerate to a moisture content ranging from 1 weight percent to 5 weight percent.

[0237] Illustrative Embodiment 44. The method of Illustrative Embodiment 36, wherein the preparing includes drying the modified agglomerate at a temperature ranging from 22° C. to 50° C.

[0238] Illustrative Embodiment 45. The method of Illustrative Embodiment 36, wherein prior to the forming the agglomerate, the porous carrier material has a first porosity, the modified agglomerate has a second porosity, and the second porosity is less than the first porosity.

[0239] Illustrative Embodiment 46. The method of Illustrative Embodiment 45, wherein a ratio of the second porosity to the first porosity ranges from 0.7 to 0.85.

[0240] Illustrative Embodiment 47. The method of Illustrative Embodiment 36, wherein prior to the forming the agglomerate, the porous carrier material has a first average pore size, the modified agglomerate has a second average pore size, and the second average pore size is less than the first average pore size.

[0241] Illustrative Embodiment 48. The method of Illustrative Embodiment 47, wherein a ratio of the second average pore size to the first average pore size ranges from 0.4 to 0.55.

[0242] Illustrative Embodiment 49. A method of manufacturing an oral product, the method comprising: preparing a filler material including, forming an agglomerate by agglomerating a porous carrier material, forming a modified agglomerate by contacting a surface modifier with the agglomerate such that the surface modifier coats at least a portion of a surface of the agglomerate, impregnates pores of the agglomerate, or both coats at least a portion of the surface of the agglomerate and impregnates pores of the agglomerate, and preparing the filler material by drying the modified agglomerate; and forming the oral product by admixing a releasable ingredient with the filler material.

[0243] Illustrative Embodiment 50. The method of Illustrative Embodiment 49, wherein the forming the oral product further includes, after the admixing, pouching the releasable ingredient and the filler material.

[0244] Illustrative Embodiment 51. The method of Illustrative Embodiment 49, wherein the releasable ingredient includes an active ingredient.

[0245] Illustrative Embodiment 52. The method of Illustrative Embodiment 51, wherein the active ingredient includes liquid nicotine.

Claims

1. An oral product comprising:a filler including,a modified agglomerate including,an agglomerate including,a porous carrier material, anda surface modifier coating at least a portion of a surface of the agglomerate, in pores of the agglomerate, or both coating at least a portion of the surface of the agglomerate and in pores of the agglomerate, the surface modifier including, a sugar alcohol, ora hydrophobic material; anda releasable ingredient admixed with the filler.

2. The oral product of claim 1, wherein the porous carrier material includes cellulose.

3. The oral product of claim 1, wherein the porous carrier material includes microcrystalline cellulose.

4. The oral product of claim 1, wherein the modified agglomerate further includes a flavoring agent absorbed in the porous carrier material.

5. The oral product of claim 1, the filler has a water content ranging from 1 weight percent to 5 weight percent.

6. The oral product of claim 1, wherein the surface modifier includes the hydrophobic material.

7. The oral product of claim 6, wherein a surface of the hydrophobic material has an artificial saliva contact angle ranging from 60° to 80°.

8. The oral product of claim 6, wherein the hydrophobic material includes corn zein.

9. The oral product of claim 6, wherein the surface modifier further includes a base.

10. The oral product of claim 1, wherein the surface modifier includes the sugar alcohol.

11. The oral product of claim 10, wherein the sugar alcohol has a water solubility ranging from 0.1 g / g to less than or equal to about 2.5 g / g.

12. The oral product of claim 10, wherein the sugar alcohol includes sorbitol, xylitol, maltitol, lactitol, erythritol, isomaltose, mannitol, or any combination thereof.

13. The oral product of claim 12, wherein the sugar alcohol includes maltitol.

14. The oral product of claim 1, wherein the modified agglomerate has an average particle size ranging from 200 μm to 450 μm.

15. The oral product of claim 1, wherein in the modified agglomerate has a porosity ranging from 40% to 70%.

16. The oral product of claim 1, wherein the modified agglomerate has an average pore size ranging from 3 micrometers (μm) to 8 μm.

17. The oral product of claim 1, wherein the releasable ingredient includes nicotine.

18. The oral product of claim 1, further comprising:a pouch,wherein the filler and the releasable ingredient are in the pouch.

19. A method of manufacturing a filler for an oral product, the method comprising:forming an agglomerate by agglomerating a porous carrier material;forming a modified agglomerate by contacting a surface modifier with the agglomerate such that the surface modifier coats at least a portion of a surface of the agglomerate, impregnates pores of the agglomerate, or both coats at least a portion of the surface of the agglomerate and impregnates pores of the agglomerate; andpreparing the filler by drying the modified agglomerate.

20. A method of manufacturing an oral product, the method comprising:preparing a filler material including,forming an agglomerate by agglomerating a porous carrier material,forming a modified agglomerate by contacting a surface modifier with the agglomerate such that the surface modifier coats at least a portion of a surface of the agglomerate, impregnates pores of the agglomerate, or both coats at least a portion of the surface of the agglomerate and impregnates pores of the agglomerate, andpreparing the filler material by drying the modified agglomerate; andforming the oral product by admixing a releasable ingredient with the filler material.

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