FIELD OF THE DISCLOSURE

The present disclosure relates to flavored products intended for human use. The products are configured for oral use and deliver substances such as flavors and/or active ingredients during use. Such products may include tobacco or a product derived from tobacco, or may be tobacco-free alternatives.

BACKGROUND

Tobacco may be enjoyed in a so-called "smokeless" form. Particularly popular smokeless tobacco products are employed by inserting some form of processed tobacco or tobacco-containing formulation into the mouth of the user. Conventional formats for such smokeless tobacco products include moist snuff, snus, and chewing tobacco, which are typically formed almost entirely of particulate, granular, or shredded tobacco, and which are either portioned by the user or presented to the user in individual portions, such as in single-use pouches or sachets. Other traditional forms of smokeless products include compressed or agglomerated forms, such as plugs, tablets, or pellets. Alternative product formats, such as tobacco- containing gums and mixtures of tobacco with other plant materials, are also known. See for example, the types of smokeless tobacco formulations, ingredients, and processing methodologies set forth in US Pat. Nos. 1,376,586 to Schwartz; 4,513,756 to Pittman et ak; 4,528,993 to Sensabaugh, Jr. et ak; 4,624,269 to Story et ak; 4,991,599 to Tibbetts; 4,987,907 to Townsend; 5,092,352 to Sprinkle, III et ak; 5,387,416 to White et ak; 6,668,839 to Williams; 6,834,654 to Williams; 6,953,040 to Atchley et ak; 7,032,601 to Atchley et ak; and 7,694,686 to Atchley et ak; US Pat. Pub. Nos. 2004/0020503 to Williams; 2005/0115580 to Quinter et ak; 2006/0191548 to Strickland et ak; 2007/0062549 to Holton, Jr. et ak; 2007/0186941 to Holton, Jr. et ak; 2007/0186942 to Strickland et ak; 2008/0029110 to Dube et ak; 2008/0029116 to Robinson et ak; 2008/0173317 to Robinson et ak; 2008/0209586 to Neilsen et ak; 2009/0065013 to Essen et ak; and 2010/0282267 to Atchley, as well as W02004/095959 to Amarp et ak, each of which is incorporated herein by reference.

Smokeless tobacco product configurations that combine tobacco material with various binders and fillers have been proposed more recently, with example product formats including lozenges, pastilles, gels, extruded forms, and the like. See, for example, the types of products described in US Patent App. Pub. Nos. 2008/0196730 to Engstrom et ak; 2008/0305216 to Crawford et ak; 2009/0293889 to Kumar et ak; 2010/0291245 to Gao et al; 2011/0139164 to Mua et ak; 2012/0037175 to Cantrell et ak; 2012/0055494 to Hunt et ak; 2012/0138073 to Cantrell et ak; 2012/0138074 to Cantrell et ak; 2013/0074855 to Holton, Jr.; 2013/0074856 to Holton, Jr.; 2013/0152953 to Mua et ak; 2013/0274296 to Jackson et ak; 2015/0068545 to Moldoveanu et ak; 2015/0101627 to Marshall et ak; and 2015/0230515 to Lampe et ak, each of which is incorporated herein by reference. All-white snus portions are growing in popularity, and offer a discrete and aesthetically pleasing alternative to traditional snus. Such modem "white" pouched products may include a bleached tobacco or may be tobacco-free.

BRIEF SUMMARY

The present disclosure generally provides fleece materials, oral products comprising those fleece materials, and methods of preparing products and fleece materials. Oral products as described herein may generally be referred to as being “configured for oral use.” The products may be configured to impart a taste when used orally and, additionally, or alternatively, may deliver active ingredients to a consumer, such as nicotine. Oral products of the present disclosure in particular may comprise various types of fleece materials and releasable components (e.g., flavoring agents and/or active ingredients).

In some embodiments, the present disclosure provides an oral product comprising a fleece material, wherein the fleece material comprises fibers and a releasable component. In some embodiments, the releasable component may comprise one or more active ingredients and/or one or more flavoring agents. In some embodiments, the one or more active ingredients may be selected from the group consisting of a nicotine component, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, and combinations thereof. In some embodiments, the one or more flavoring agents may comprise a compound having a carbon-carbon double bond, a carbon-oxygen double bond, or both. In some embodiments, the one or more flavoring agents may comprise one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal sensates, or combinations thereof. In some embodiments, the one or more flavoring agents may comprise one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-famesene, and citral.

In some embodiments, the releasable component may be embedded within the fleece material. In some embodiments, the releasable component may be absorbed in or adsorbed on at least one surface of the fleece material. In some embodiments, the releasable component may be encapsulated in a plurality of capsules. In some embodiments, the plurality of capsules may be rupturable by a user of the product to release the releasable component. In some embodiments, the plurality of capsules may be contained within the bulk of the fleece material. In some embodiments, the fibers comprise cellulose fibers, viscose fibers, regenerated cellulose fibers, wood fibers, cotton fibers, wool fibers, or other fleece forming polymers, such as polyglycolic acid fibers, polylactic acid fibers, polyhydroxyalkanoate fibers, polycaprolactone fibers, polybutylene succinate fibers, polybutylene succinate adipate fibers, and combinations thereof.

Methods of forming a releasable component-containing fleece material according to the present disclosure may comprise forming a fleece material comprising a plurality of fibers, and loading the fleece material with a releasable component to provide a releasable component-containing fleece material. In some embodiments, the fleece material may be extruded to provide an extruded fleece material prior to loading the fleece material with a releasable component. In some embodiments, methods of preparing oral products comprising such releasable component-containing fleece materials may comprise, for example, providing a continuous supply of a releasable component-containing fleece material, subdividing the releasable component-containing fleece material into discrete portions, and sealing two or more discrete portions together to provide a product configured for oral use.

In some embodiments, the present disclosure provides a pouched product configured for oral use, the pouched product comprising a fleece material in the form of a pouch and containing a substrate material, the fleece material comprising fibers and a releasable component. In some embodiments, the releasable component may comprise one or more active ingredients and/or one or more flavoring agents. In some embodiments, the one or more active ingredients may be selected from the group consisting of a nicotine component, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, and combinations thereof. In some embodiments, the one or more flavoring agents comprises a compound having a carbon-carbon double bond, a carbon-oxygen double bond, or both. In some embodiments, the one or more flavoring agents may comprise one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal sensates, or combinations thereof. In some embodiments, the one or more flavoring agents may comprise one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-famesene, and citral.

In some embodiments, the releasable component may be embedded within the fleece material. In some embodiments, the releasable component may be absorbed in or adsorbed on at least one surface of the fleece material. In some embodiments, the releasable component may be encapsulated in a plurality of capsules. In some embodiments, the plurality of capsules may be rupturable by a user of the product to release the releasable component. In some embodiments, the plurality of capsules may be contained within the bulk of the fleece material. In some embodiments, the pouched product may comprise a substrate material within a cavity defined by the fleece material. In some embodiments, the substrate material may comprise one or more of a tobacco material, a nicotine component, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, flavoring agents, and combinations thereof. In some embodiments, the fibers of the fleece materials described herein may comprise cellulose fibers, viscose fibers, regenerated cellulose fibers, wood fibers, cotton fibers, wool fibers, or other fleece forming polymers, such as polyglycolic acid fibers, polylactic acid fibers, polyhydroxyalkanoate fibers, polycaprolactone fibers, polybutylene succinate fibers, polybutylene succinate adipate fibers, and combinations thereof.

The disclosure includes, without limitations, the following embodiments. Embodiment 1: An oral product, comprising a fleece material, wherein the fleece material comprises fibers and a releasable component.

Embodiment 2: The oral product of Embodiment 1, wherein the releasable component comprises one or more active ingredients and/or one or more flavoring agents.

Embodiment 3 : The oral product of any of Embodiments 1 -2, wherein the one or more active ingredients are selected from the group consisting of a nicotine component, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, and combinations thereof.

Embodiment 4: The oral product of any of embodiments 1-3, wherein the one or more flavoring agents comprises a compound having a carbon-carbon double bond, a carbon-oxygen double bond, or both. Embodiment 5: The oral product of any of embodiments 1-4, wherein the one or more flavoring agents comprises one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal sensates, or combinations thereof.

Embodiment 6: The oral product of any of embodiments 1-5, wherein the one or more flavoring agents comprises one or more of ethyl vanillin, cinnam aldehyde, sabinene, limonene, gamma-terpinene, beta- famesene, and citral.

Embodiment 7: The oral product of any of embodiments 1-6, wherein the releasable component is embedded within the fleece material.

Embodiment 8: The oral product of any of embodiments 1-7, wherein the releasable component is absorbed in or adsorbed on at least one surface of the fleece material.

Embodiment 9: The oral product of any of embodiments 1-8, wherein the releasable component is encapsulated in a plurality of capsules.

Embodiment 10: The oral product of any of embodiments 1-9, wherein the plurality of capsules is rupturable by a user of the product to release the releasable component.

Embodiment 11: The oral product of any of embodiments 1-10, wherein the plurality of capsules is contained within the bulk of the fleece material.

Embodiment 12: The oral product of any of embodiments 1-11, wherein the fibers comprise cellulose fibers, viscose fibers, regenerated cellulose fibers, wood fibers, cotton fibers, wool fibers, or other fleece forming polymers, such as polyglycolic acid fibers, polylactic acid fibers, poly hydroxyalkano ate fibers, polycaprolactone fibers, polybutylene succinate fibers, polybutylene succinate adipate fibers, and combinations thereof.

Embodiment 13: A method of forming a releasable component-containing fleece material, the method comprising; forming a fleece material comprising a plurality of fibers; and loading the fleece material with a releasable component to provide a releasable component-containing fleece material. Embodiment 14: The method of embodiment 13, wherein the fleece material is extruded to provide an extruded fleece material prior to loading the fleece material with a releasable component.

Embodiment 15: A method of preparing an oral product, the method comprising: providing a continuous supply of a releasable component-containing fleece material prepared according to any of Embodiments 13-14; subdividing the releasable component-containing fleece material into discrete portions; and sealing two or more discrete portions together to provide a product configured for oral use.

Embodiment 16: An oral pouched product, comprising a fleece material in the form of a pouch and containing a substrate material, the fleece material comprising fibers and a releasable component. Embodiment 17: The oral pouched product of embodiment 16, wherein the releasable component comprises one or more active ingredients and/or one or more flavoring agents.

Embodiment 18: The oral pouched product of any of embodiments 16-17, wherein the one or more active ingredients are selected from the group consisting of a nicotine component, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, and combinations thereof. Embodiment 19: The oral pouched product of any of embodiments 16-18, wherein the one or more flavoring agents comprises a compound having a carbon-carbon double bond, a carbon-oxygen double bond, or both.

Embodiment 20: The oral pouched product of any of embodiments 16-19, wherein the one or more flavoring agents comprises one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal sensates, or combinations thereof.

Embodiment 21: The oral pouched product of any of embodiments 16-20, wherein the one or more flavoring agents comprises one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma- terpinene, beta-famesene, and citral.

Embodiment 22: The oral pouched product of any of embodiments 16-21, wherein the releasable component is embedded within the fleece material.

Embodiment 23: The oral pouched product of any of embodiments 16-22, wherein the releasable component is absorbed in or adsorbed on at least one surface of the fleece material.

Embodiment 24: The oral pouched product of any of embodiments 16-23, wherein the releasable component is encapsulated in a plurality of capsules.

Embodiment 25: The oral pouched product of any of embodiments 16-24, wherein the plurality of capsules is rupturable by a user of the product to release the releasable component.

Embodiment 26: The oral pouched product of any of embodiments 16-25, wherein the plurality of capsules is contained within the bulk of the fleece material.

Embodiment 27: The oral pouched product of any of embodiments 16-26, wherein the substrate material comprises one or more of a tobacco material, a nicotine component, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, flavoring agents, and combinations thereof.

Embodiment 28: The oral pouched product of any of embodiments 16-27, wherein the fibers comprise cellulose fibers, viscose fibers, regenerated cellulose fibers, wood fibers, cotton fibers, wool fibers, or other fleece forming polymers, such as polyglycolic acid fibers, polylactic acid fibers, polyhydroxyalkanoate fibers, polycaprolactone fibers, polybutylene succinate fibers, polybutylene succinate adipate fibers, and combinations thereof.

Embodiment 29: Use of a releasable component in a fleece material configured for use in an oral product, the fleece material having the releasable component embedded therein, absorbed therein, and/or adsorbed thereon.

Embodiment 30: Use of a releasable component within a plurality of rupturable capsules in a fleece material configured for use in an oral product, wherein the plurality of rupturable capsules is contained within the bulk of the fleece material.

Embodiment 31 : Use of a fleece material as an oral product, the oral product comprising one or more layers of the fleece material having a releasable component embedded therein.

These and other features, aspects, and advantages of the disclosure will be apparent from a reading of the following detailed description together with the accompanying drawings, which are briefly described below. The invention includes any combination of two, three, four, or more of the above-noted embodiments as well as combinations of any two, three, four, or more features or elements set forth in this disclosure, regardless of whether such features or elements are expressly combined in a specific embodiment description herein. This disclosure is intended to be read holistically such that any separable features or elements of the disclosed invention, in any of its various aspects and embodiments, should be viewed as intended to be combinable unless the context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus described aspects of the disclosure in the foregoing general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale. The drawings are exemplary only, and should not be construed as limiting the disclosure.

Fig. 1 is a front perspective view illustrating a pouched product configured for oral use according to an example embodiment of the present disclosure;

Fig. 2 is a front perspective view illustrating a pouchless product configured for oral use according to an example embodiment of the present disclosure; and Fig. 3 is a flow chart illustrating the general steps for manufacturing an oral product comprising a releasable component-containing fleece material according to an example embodiment of the present disclosure.

DETAILED DESCRIPTION

The present disclosure provides fleece materials and products formed therefrom, the fleece materials and products particularly being configured for oral use. Oral products as described herein may incorporate fleece materials that are effective for retaining a releasable component within the fleece and then releasing the releasable component at a desired time, such as when in contact with the oral cavity of a human user. The fleece materials effective for retaining the releasable component can be adapted to or configured to provide for controlled release in some embodiments.

The present disclosure will now be described more fully hereinafter with reference to example embodiments thereof. These example embodiments are described so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Indeed, the disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. As used in this specification and the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Reference to "dry weight percent" or "dry weight basis" refers to weight on the basis of dry ingredients (i.e., all ingredients except water). Reference to "wet weight" refers to the weight of the mixture including water. Unless otherwise indicated, reference to "weight percent" of a mixture reflects the total wet weight of the mixture (i.e., including water).

Aspects of the present disclosure provides for oral products comprising a fleece material, wherein the fleece material may be in the form of a fleece fabric material, such as in the form of a woven or nonwoven fabric comprising a plurality of fibers. In some embodiments, the fleece fabric material may be configured to have improved characteristics with respect to flavoring and or release of active ingredients to a user of the product. For example, some embodiments provide for a product configured for oral use, the product comprising a fleece material, wherein the fleece material comprises fibers and a releasable component.

The present disclosure provides fleece materials comprising fibers and a releasable component and products that can include those fleece materials, optionally in combination with a substrate material that may comprise one or more other additives or components therein. In some embodiments, a product as provided herein may solely include the fleece material itself (e.g., such as in a “pouchless” configuration as will be discussed further herein) or the product may comprise a unitizing structure wherein the fleece material is in the form of a pouch that contains a substrate material, such as in the form of a traditional pouched product or the like. In some embodiments, an oral product as described herein can comprise a fleece material containing a releasable component that is embedded within the fleece material, or absorbed in or adsorbed on at least one surface of the fleece material. Preferably, the releasable component may comprise one or more active ingredients and/or one or more flavoring agents. Further, in one or more embodiments, the releasable component may be encapsulated such that microcapsules containing the releasable component are retained within the bulk of the fleece material. In such embodiments, the microcapsules containing the releasable component may be in the form of breakable or rupturable capsules such that the releasable component is released upon breaking of the capsule (e.g., during use). Moreover, at least a portion of the releasable component retained within the fleece material may be configured for release immediately therefrom when the product is placed within a user’s oral cavity, or configured for controlled release, e.g., when the microcapsules are ruptured due to mechanical force applied by a user. Various types of pouched and pouchless products comprising one or more fleece materials as described herein and being configured for oral use are described in more detail herein below.

Pouched Products

Pouched products typically can include an outer water-permeable pouch and a composition situated within the outer water-permeable pouch. The composition positioned within the pouch can be any composition containing a water-soluble component capable of being released through the water- permeable pouch, such as tea or coffee materials (e.g., in the context of a beverage pouch adapted for brewing or steeping) or compositions adapted for oral use (e.g., tobacco-derived products such as snus or nicotine replacement therapy products). In certain embodiments, the composition within the cavity of the pouch can comprise at least one of a particulate tobacco material, nicotine, particulate non-tobacco material (e.g., MCC) that has been treated to contain nicotine and/or flavors, and fibrous plant material (e.g., beet root fiber) treated to contain a tobacco extract.

Various types of pouch materials and pouch manufacturing techniques are discussed in more detail below. Generally, the pouched products include a substrate material, which may be in the form of a powdered or granular composition adapted for oral use (e.g., a tobacco-containing composition, a nicotine-containing pharmaceutical composition, and/or a non-tobacco composition) that is disposed within a moisture-permeable container. That is, the composition adapted for oral use can be contained within a container, such as a pouch or bag, such as the type commonly used for the manufacture of snus types of products (e.g., a sealed, moisture permeable pouch that is sometimes referred to as a “portion”).

A representative moisture permeable pouch can preferably be composed of a “fleece” type of material.

For example, various fleece materials as described herein, e.g., such as those which advantageously retain releasable components therein, may be used as the moisture permeable pouch material described herein above.

The mixture/construction of such pouched products, such as providing a fleece material in the form of a pouch 102 in the embodiment illustrated in FIG. 1, may be varied as will be described further herein. Referring to FIG. 1, depicted is a pouched product 100 according to an example embodiment disclosed herein below. The pouched product 100 includes a fleece material in the form of a pouch 102, which contains a substrate material 104 comprising a composition of various different components as described herein below. As noted above, the fleece material in the form of a pouch 102 may further comprise a releasable component 106 as depicted in FIG. 1. The plurality of dots represents the releasable component 106 being retained throughout the fleece material in the form of a pouch 102. The orientation, size, and type of pouch material and the type and nature of the substrate material contained therein are not construed as limiting thereof.

“Pouchless ” Products

Advantageously, in some embodiments of the present disclosure, oral products comprising a fleece as provided herein are provided in a form other than the pouched configuration described above. Such products are referred to herein as having a “pouchless” configuration. A “pouchless” product as referred to herein is meant to define an oral product configured for oral use comprising one or more layers of a fleece material (e.g., a material as described herein), such that it is substantially devoid of an inner cavity and does not comprise an additional substrate material as is known to be incorporated into typical pouched products as described in the relevant art. For example, the oral products described herein may be formed solely of the multiple layers of fleece material that have been sealed together upon application of heat and/or pressure. Methods of preparing such oral products are described herein below in more detail.

The mixture/construction of such pouchless products may be varied. For example, FIG. 2 depicts a pouchless product configured for oral use according to an example embodiment of the present disclosure which will be described further herein below. Referring to FIG. 2, the product 200 includes a fleece material 202 comprising fibers (not shown) and a releasable component 204, as depicted by the plurality of dots throughout the fleece material 202. The plurality of dots represents the releasable component 204 being retained throughout the fleece material 202. For example, in some embodiments according to the present disclosure, the releasable component may be embedded within the fleece material, absorbed in or adsorbed on a surface of the fleece material, or contained within the bulk of the fleece material, either directly or in the form of a plurality of microcapsules. Various configurations and types of fleece materials and releasable components as disclosed herein below may be suitable for providing the desired release of flavoring agents and/or active ingredients that are retained within those fleece materials. The orientation, size, and configuration of the oral product that is illustrated in FIG. 2 is not to be construed as limiting thereof.

Fleece Material

As referenced above, the pouched and pouchless products provided herein comprise at least one fleece material. These fleece materials may be in the form of a fleece fabric material, such as in the form of a woven or nonwoven fabric comprising a plurality of fibers. In some embodiments, the fleece fabric material may be configured to have improved characteristics with respect to flavoring and or release of active ingredients and/or flavoring agents to a user of products comprising such fleece materials therein. As referenced above, the pouched products provided herein comprise at least one fleece material.

“Fleece materials” as referred to herein may be in the form of a fleece fabric material, such as in the form of a woven or nonwoven fabric comprising a plurality of fibers.

As used herein, the term “fiber” is defined as a basic element of textiles. Fibers are often in the form of a rope- or string-like element. As used herein, the term “fiber” is intended to include fibers, filaments, continuous filaments, staple fibers, and the like.

The term “nonwoven” is used herein in reference to fibrous materials, webs, mats, batts, or sheets in which fibers are aligned in an undefined or random orientation. The nonwoven fibers are initially presented as unbound fibers or filaments. An important step in the manufacturing of nonwovens involves binding the various fibers or filaments together. The manner in which the fibers or filaments are bound can vary, and include thermal, mechanical and chemical techniques that are selected in part based on the desired characteristics of the final product, as discussed in more detail herein below.

In some embodiments, fleece materials of the present disclosure may be configured to have improved characteristics with respect to organoleptic properties and/or dissolution profile. A “fleece material” according to the present disclosure may be formed from various types of fibers (e.g., conventional cellulosic fibers (e.g., such as viscose fibers, regenerated cellulose fibers, cellulose fibers, and wood pulps), cotton fibers, wool fibers, other natural fibers, polymer/synthetic-type fibers, and combinations thereof) capable of being formed into a traditional fleece fabrics or other traditional pouch materials. For example, fleece materials may be provided in the form of a woven or nonwoven fabric. Suitable types of fleece materials, for example, are described in U.S. Patent No. 8,931,493 to Sebastian et ah; US Patent App. Pub. No. 2016/0000140 to Sebastian et ak; and US Patent App. Pub. No. 2016/0073689 to Sebastian et ak; which are all incorporated herein by reference. Nonwoven fabric forming methods for natural and synthetic fibers may include drylaid, airlaid and wetlaid methods. In some embodiments, the nonwoven fabric can be formed using a spunlaid or spunmelt process, which includes both spunbond and meltblown processes, wherein such processes are understood to typically entail melting, extruding, collecting and bonding thermoplastic polymer materials to form a fibrous nonwoven web. The technique of meltblowing is known in the art and is discussed in various patents, for example, U.S. Pat. Nos. 3,849,241 to Butin, 3,987,185 to Buntin et al., 3,972,759 to Buntin, and 4,622,259 to McAmish et al., each of which is herein incorporated by reference in its entirety. General spunbonding processes are described, for example, in U.S. Patent Nos. 4,340,563 to Appel et al., 3,692,618 to Dorschner et al, 3,802,817 to Matsuki et al, 3,338,992 and 3,341,394 to Kinney, 3,502,763 to Hartmann, and 303,542,615 to Dobo et al, which are all incorporated herein by reference.

In some embodiments, the fibers within the fleece material may include, but are not limited to, a polymer selected from the group consisting of polyglycolic acid, polylactic acid, polyhydroxyalkanoates, polycaprolactone, polybutylene succinate, polybutylene succinate adipate, and copolymers thereof. In some embodiments, the fibers within the fleece material may be selected from the groups consisting of cellulose fibers, viscose fibers, regenerated cellulose fibers, other wood fibers, and the like.

The fleece materials can have varying thicknesses, porosities and other parameters. For example, the fleece material can be formed such that the fiber orientation and porosity of the fleece material is altered to achieve the desired release characteristics of the releasable component contained therein. In some embodiments, a coating or other additive may be added to the fibers prior to forming the fleece material. For example, in some embodiments a coating of an acrylic polymer may be used that acts as the fiber binder in the nonwoven fabric and provides for heat-bonding/sealing of the fleece material. Releasable Comvonent

A “releasable component” as used herein refers to any material that is retained by the fleece material and that is releasable therefrom in response to a certain stimulus, e.g., when in contact with the oral cavity of a user or upon a certain minimum mechanical force applied to the product by the user, e.g., chewing or working the product in the oral cavity. The releasable component preferably can be adapted to or configured to absorb, adsorb, or otherwise become directly entrained/embedded within the porous structure of the fleece material. In this manner, the releasable component may be retained with a desired level of stability and/or may be configured for controlled release from the naturally porous structure of the fleece material. Further, the releasable component may be adapted for enhancing one or more sensory characteristics of the product, such as taste, mouthfeel, moistness, coolness/heat, and/or fragrance. A wide variety of releasable components may be utilized. In some embodiments, a plurality of releasable components may be used. In some embodiments, different releasable components may be adapted to or configured to preferentially become retained within pores of the fleece materials. The pores within the fleece material may be altered during the production thereof so as to deliver an oral product with the desired release profile of the releasable components therefrom. In some embodiments, products are provided with multiple layers of fleeced materials, and such individual layers may comprise the same or other releasable components associated therewith. In some embodiments, the releasable component may be encapsulated prior to being impregnated within the fleece material or otherwise provided in a surface coating applied to the fleece materials. For example, in some embodiments, the releasable component may be provided in the form of a plurality of microcapsules that are contained within the bulk of the fleece material. As used herein “contained within the bulk of the fleece material” means that the plurality of capsules is positioned substantially within one or more layers of the fleece material, either individually or combined. For example, the plurality of capsules may be contained within the bulk of the fleece material if at least about 70% of the surface area of the capsules is retained within the peripheral edges of the fleece material, at least about 80% of the surface area of the capsules is retained within the peripheral edges of the fleece material, at least about 90% of the surface area of the capsules is retained within the peripheral edges of the fleece material, or at least about 95% of the surface area of the capsules is retained within the peripheral edges of the fleece material. In some embodiments, exposed surface area can be measured to define the amount of material “embedded/absorbed/contained within,” e.g., to distinguish such material from material in the form of a surface flavoring or the like.

An encapsulated releasable component is generally contained within an outer shell or coating.

The outer shell or coating of the plurality of such capsules serves as a barrier between the releasable component and the oral cavity of a user. Generally, this outer shell or coating is designed to be temporary, e.g., meaning the barrier is designed to stop serving as a barrier, and thereby release the releasable component, under certain conditions of product use. In many embodiments, the releasable component is released when the outer shell undergoes some type of physical destruction, breakage, or other loss of physical integrity (e.g., through disintegration, softening, crushing, application of pressure, or the like), and thereby alters the sensory or functional properties of the product during use. Thus, for example, a plurality of capsules may be incorporated within the fleece material, and during use, contact of the capsules with moisture present in the user’s mouth may cause the capsules to soften, lose their physical integrity, and release the additive within the user’s mouth.

In some embodiments, the capsules may be purposefully crushed upon application of pressure; i.e., when chewed or worked by a user of the product, such that the releasable component retained with the capsules is released within the fleece material. Such a release of the releasable component may alter or enhance the flavor or other sensory characteristics of the product, extend the period of time that a user may enjoy the product, or provide other functional advantages. Examples of breakable capsules that can be provided in smokeless tobacco products, and which may in some embodiments be incorporated within or adapted for use within the disclosed products are described in detail in U.S. Patent No. 7,861,728 to Holton Jr. et ak, which is incorporated by reference herein in its entirety. It should be noted that various releasable components may be incorporated as microencapsulates, adsorbent materials, and/or in the form of flavored polymers incorporated into one or more surface coatings or other materials applied to the fleece and/or to a formed pouch. For example, at least one flavoring agent/active ingredient may be incorporated as microencapsulates, adsorbent materials, and/or in the form of flavored polymers incorporated during a polymer fiber spinning process used to make the fleece. As provided in further detail below, in certain embodiments, the releasable component comprises one or more active ingredients and/or one or more flavoring agents.

Active ingredient

In some embodiments, the releasable component may comprise an active ingredient. For example, the releasable component may include a single active ingredient or a plurality of active ingredients. If desired, one or more active ingredients may be embedded within the fleece material, absorbed in or adsorbed on at least one surface of the fleece material, or contained within the bulk of the fleece material. As used herein, an "active ingredient" refers to one or more substances belonging to any of the following categories: API (active pharmaceutical ingredient), food additives, natural medicaments, and naturally occurring substances that can have an effect on humans. Example active ingredients include any ingredient known to impact one or more biological functions within the body, such as ingredients that furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or which affect the structure or any function of the body of humans (e.g., provide a stimulating action on the central nervous system, have an energizing effect, an antipyretic or analgesic action, or an otherwise useful effect on the body). In some embodiments, the active ingredient may be of the type generally referred to as dietary supplements, nutraceuticals, "phytochemicals" or "functional foods." These types of additives are sometimes defined in the art as encompassing substances typically available from naturally-occurring sources (e.g., botanical materials) that provide one or more advantageous biological effects (e.g., health promotion, disease prevention, or other medicinal properties), but are not classified or regulated as drugs.

Non-limiting examples of active ingredients include those falling in the categories of botanical ingredients, stimulants, amino acids, nicotine components, and/or pharmaceutical, nutraceutical, and medicinal ingredients (e.g., vitamins, such as A, B3, B6, B12, and C, and/or cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD)). Each of these categories is further described herein below. The particular choice of active ingredients will vary depending upon the desired flavor, texture, and desired characteristics of the particular product.

In certain embodiments, the active ingredient is selected from the group consisting of caffeine, taurine, GABA, theanine, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof. For example, the active ingredient can include a combination of caffeine, theanine, and optionally ginseng. In another embodiment, the active ingredient includes a combination of theanine, gamma-amino butyric acid (GABA), and lemon balm extract. In a further embodiment, the active ingredient includes theanine, theanine and tryptophan, or theanine and one or more B vitamins (e.g., vitamin B6 or B12). In a still further embodiment, the active ingredient includes a combination of caffeine, taurine, and vitamin C.

The particular percentages of active ingredients present will vary depending upon the desired characteristics of the particular product. Typically, an active ingredient or combination thereof is present in a total concentration of at least about 0.001% by weight of the overall product, not including the fleece material, such as in a range from about 0.001% to about 20%. As used herein, any “weight percentage of a releasable component” refers to a percentage by weight of that releasable component relative to the total weight of the oral product, not including the weight of the fleece material. For example, in embodiments of pouchless products, the total weight of a pouchless product is equal to the combined weight of all releasable components (e.g., active ingredients and flavoring agents) and all other additives (e.g., such as water, salts, sweeteners, fillers, binders, active ingredients, flavoring agents, organic acids, buffering agents, colorants, humectants, and the like), not including the weight fleece material. Likewise, in embodiments of pouched products, the total weight of a pouched product is equal to the combined weight of all releasable components and the substrate material (e.g., including all additives provided within the substrate material), not including the weight of the fleece material.

In some embodiments, the active ingredient or combination of active ingredients is present in a concentration from about 0.1% w/w to about 10% by weight, such as, e.g., from about 0.5% w/w to about 10%, from about 1% to about 10%, from about 1% to about 5% by weight, based on the total weight of the oral product (not including the fleece material). In some embodiments, the active ingredient or combination of active ingredients is present in a concentration of from about 0.001%, about 0.01%, about 0.1% , or about 1%, up to about 20% by weight, such as, e.g., from about 0.001%, about 0.002%, about 0.003%, about 0.004%, about 0.005%, about 0.006%, about 0.007%, about 0.008%, about 0.009%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, or about 20% by weight, based on the total weight of the oral product (not including the fleece material). Further suitable ranges for specific active ingredients are provided herein below.

Botanical

In some embodiments, the active ingredient comprises a botanical ingredient. As used herein, the term "botanical ingredient" or "botanical" refers to any plant material or fungal-derived material, including plant material in its natural form and plant material derived from natural plant materials, such as extracts or isolates from plant materials or treated plant materials (e.g., plant materials subjected to heat treatment, fermentation, bleaching, or other treatment processes capable of altering the physical and/or chemical nature of the material). For the purposes of the present disclosure, a "botanical" includes, but is not limited to, "herbal materials," which refer to seed-producing plants that do not develop persistent woody tissue and are often valued for their medicinal or sensory characteristics (e.g., teas or tisanes). Reference to botanical material as "non-tobacco" is intended to exclude tobacco materials (i.e., does not include any Nicotiana species). In some embodiments, the compositions as disclosed herein can be characterized as free of any tobacco material (e.g., any embodiment as disclosed herein may be completely or substantially free of any tobacco material). By "substantially free" is meant that no tobacco material has been intentionally added. For example, certain embodiments can be characterized as having less than 0.001% by weight of tobacco, or less than 0.0001%, or even 0% by weight of tobacco.

When present, a botanical is typically at a concentration of from about 0.01% w/w to about 10% by weight, such as, e.g., from about 0.01% w/w, about 0.05%, about 0.1%, or about 0.5%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the oral product (not including the fleece material).

The botanical materials useful in the present disclosure may comprise, without limitation, any of the compounds and sources set forth herein, including mixtures thereof. Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemicals" or "functional foods." Certain botanicals, as the plant material or an extract thereof, have found use in traditional herbal medicine, and are described further herein. Non-limiting examples of botanicals or botanical-derived materials include ashwagandha, Bacopa monniera, baobab, basil, Centella asiatica, Chai-hu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus, cloves, cocoa, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba, ginseng (e.g., Panax ginseng ), green tea, Griffonia simplicifolia, guarana, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thai ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha, Nardostachys chinensis, oil-based extract of Viola odorata, peppermint, quercetin, resveratrol, Rhizoma gastrodiae, Rhodiola, rooibos, rose essential oil, rosemary, Sceletium tortuosum, Schisandra, Skullcap, spearmint extract, Spikenard, terpenes, tisanes, turmeric, Turnera aphrodisiaca, valerian, white mulberry, and Yerba mate.

In some embodiments, the active ingredient comprises lemon balm. Lemon balm ( Melissa officinalis ) is a mildly lemon-scented herb from the same family as mint (Lamiaceae). The herb is native to Europe, North Africa, and West Asia. The tea of lemon balm, as well as the essential oil and the extract, are used in traditional and alternative medicine. In some embodiments, the active ingredient comprises lemon balm extract. In some embodiments, the lemon balm extract is present in an amount of from about 1 to about 4% by weight, based on the total weight of the oral product (not including the fleece material).

In some embodiments, the active ingredient comprises ginseng. Ginseng is the root of plants of the genus Panax, which are characterized by the presence of unique steroid saponin phytochemicals (ginsenosides) and gintonin. Ginseng finds use as a dietary supplement in energy drinks or herbal teas, and in traditional medicine. Cultivated species include Korean ginseng (P. ginseng ), South China ginseng (P. notoginseng), and American ginseng (P. quinquefolius). American ginseng and Korean ginseng vary in the type and quantity of various ginsenosides present. In some embodiments, the ginseng is American ginseng or Korean ginseng. In specific embodiments, the active ingredient comprises Korean ginseng. In some embodiments, ginseng is present in an amount of from about 0.4 to about 0.6% by weight, based on the total weight of the oral product (not including the fleece material).

Stimulants

In some embodiments, the active ingredient comprises one or more stimulants. As used herein, the term "stimulant" refers to a material that increases activity of the central nervous system and/or the body, for example, enhancing focus, cognition, vigor, mood, alertness, and the like. Non-limiting examples of stimulants include caffeine, theacrine, theobromine, and theophylline. Theacrine (1,3,7,9-tetramethyluric acid) is a purine alkaloid which is structurally related to caffeine, and possesses stimulant, analgesic, and anti-inflammatory effects. Present stimulants may be natural, naturally derived, or wholly synthetic. For example, certain botanical materials (guarana, tea, coffee, cocoa, and the like) may possess a stimulant effect by virtue of the presence of e.g., caffeine or related alkaloids, and accordingly are "natural" stimulants. By "naturally derived" is meant the stimulant (e.g., caffeine, theacrine) is in a purified form, outside its natural (e.g., botanical) matrix. For example, caffeine can be obtained by extraction and purification from botanical sources (e.g., tea). By "wholly synthetic", it is meant that the stimulant has been obtained by chemical synthesis. In some embodiments, the active ingredient comprises caffeine. In some embodiments, the caffeine is present in an encapsulated form. On example of an encapsulated caffeine is Vitashure ^® , available from Balchem Corp., 52 Sunrise Park Road, New Hampton, NY, 10958.

When present, a stimulant or combination of stimulants (e.g., caffeine, theacrine, and combinations thereof) is typically at a concentration of from about 0.1% w/w to about 15% by weight, such as, e.g., from about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the oral product (not including the fleece material). In some embodiments, the composition comprises caffeine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the oral product (not including the fleece material); Amino acids

In some embodiments, the active ingredient comprises an amino acid. As used herein, the term "amino acid" refers to an organic compound that contains amine (-NH2) and carboxyl (-COOH) or sulfonic acid (SO ₃ H) functional groups, along with a side chain (R group), which is specific to each amino acid. Amino acids may be proteinogenic or non-proteinogenic. By "proteinogenic" is meant that the amino acid is one of the twenty naturally occurring amino acids found in proteins. The proteinogenic amino acids include alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, and valine. By "non-proteinogenic" is meant that either the amino acid is not found naturally in protein, or is not directly produced by cellular machinery (e.g., is the product of post-tranlational modification). Non limiting examples of non-proteinogenic amino acids include gamma-aminobutyric acid (GABA), taurine (2-aminoethanesulfonic acid), theanine (L-y-glutamylethylamide), hydroxyproline, and beta-alanine. In some embodiments, the active ingredient comprises theanine. In some embodiments, the active ingredient comprises GABA. In some embodiments, the active ingredient comprises a combination of theanine and GABA. In some embodiments, the active ingredient is a combination of theanine, GABA, and lemon balm. In some embodiments, the active ingredient is a combination of caffeine, theanine, and ginseng. In some embodiments, the active ingredient comprises taurine. In some embodiments, the active ingredient is a combination of caffeine and taurine.

When present, an amino acid or combination of amino acids (e.g., theanine, GABA, and combinations thereof) is typically at a concentration of from about 0.1% w/w to about 15% by weight, such as, e.g., from about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the oral product (not including the fleece material).

Vitamins

In some embodiments, the active ingredient comprises a vitamin or combination of vitamins. As used herein, the term "vitamin" refers to an organic molecule (or related set of molecules) that is an essential micronutrient needed for the proper functioning of metabolism in a mammal. There are thirteen vitamins required by human metabolism, which are: vitamin A (as all-trans-retinol, all-trans-retinyl-esters, as well as all -trans-beta-carotene and other provitamin A carotenoids), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B7 (biotin), vitamin B9 (folic acid or folate), vitamin B12 (cobalamins), vitamin C (ascorbic acid), vitamin D (calciferols), vitamin E (tocopherols and tocotrienols), and vitamin K (quinones). In some embodiments, the active ingredient comprises vitamin C. In some embodiments, the active ingredient is a combination of vitamin C, caffeine, and taurine.

When present, a vitamin or combination of vitamins (e.g., vitamin B6, vitamin B12, vitamin E, vitamin C, or a combination thereof) is typically at a concentration of from about 0.01% w/w to about 6% by weight, such as, e.g., from about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% w/w, to about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5% , or about 6% by weight, based on the total weight of the oral product (not including the fleece material).

Antioxidants

In some embodiments, the active ingredient comprises one or more antioxidants. As used herein, the term "antioxidant" refers to a substance which prevents or suppresses oxidation by terminating free radical reactions, and may delay or prevent some types of cellular damage. Antioxidants may be naturally occurring or synthetic. Naturally occurring antioxidants include those found in foods and botanical materials. Non-limiting examples of antioxidants include certain botanical materials, vitamins, polyphenols, and phenol derivatives.

Examples of botanical materials which are associated with antioxidant characteristics include without limitation acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot, black pepper, blueberries, borage seed oil, bugleweed, cacao, calamus root, catnip, catuaba, cayenne pepper, chaga mushroom, chervil, cinnamon, dark chocolate, potato peel, grape seed, ginseng, gingko biloba, Saint John's Wort, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile, cloves, cocoa powder, cranberry, dandelion, grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew, ginger, goldenseal, hawthorn, hibiscus flower, jiaogulan, kava, lavender, licorice, marjoram, milk thistle, mints (menthe), oolong tea, beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover, rooibos (red or green), rosehip, rosemary, sage, clary sage, savory, spearmint, spirulina, slippery elm bark, sorghum bran hi-tannin, sorghum grain hi-tannin, sumac bran, comfrey leaf and root, goji berries, gutu kola, thyme, turmeric, uva ursi, valerian, wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa, bacopa monniera, withania somnifera, Lion’s mane, and silybum marianum. Such botanical materials may be provided in fresh or dry form, essential oils, or may be in the form of an extracts. The botanical materials (as well as their extracts) often include compounds from various classes known to provide antioxidant effects, such as minerals, vitamins, isoflavones, phytoesterols, allyl sulfides, dithiolthiones, isothiocyanates, indoles, lignans, flavonoids, polyphenols, and carotenoids. Examples of compounds found in botanical extracts or oils include ascorbic acid, peanut endocarb, resveratrol, sulforaphane, beta-carotene, lycopene, lutein, co-enzyme Q, carnitine, quercetin, kaempferol, and the like. See, e.g., Santhosh et ak, Phytomedicine, 12(2005) 216-220, which is incorporated herein by reference. Non-limiting examples of other suitable antioxidants include citric acid, Vitamin E or a derivative thereof, a tocopherol, epicatechol, epigallocatechol, epigallocatechol gallate, erythorbic acid, sodium erythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B, theaflavin digallate, phenolic acids, glycosides, quercitrin, isoquercitrin, hyperoside, polyphenols, catechols, resveratrols, oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tertiary butylhydroquinone (TBHQ), and combinations thereof.

When present, an antioxidant is typically at a concentration of from about 0.001% w/w to about 10% by weight, such as, e.g., from about 0.001%, about 0.005%, about 0.01% w/w, about 0.05%, about 0.1%, or about 0.5%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%, based on the total weight of the oral product (not including the fleece material).

Nicotine component

In certain embodiments, the active ingredient comprises a nicotine component. By "nicotine component" is meant any suitable form of nicotine (e.g., free base or salt) for providing oral absorption of at least a portion of the nicotine present. Typically, the nicotine component is selected from the group consisting of nicotine free base and a nicotine salt. In some embodiments, the nicotine component is nicotine in its free base form, which easily can be adsorbed in for example, a microcrystalline cellulose material to form a microcrystalline cellulose-nicotine carrier complex. See, for example, the discussion of nicotine in free base form in US Pat. Pub. No. 2004/0191322 to Hansson, which is incorporated herein by reference.

In some embodiments, at least a portion of the nicotine component can be employed in the form of a salt. Salts of nicotine can be provided using the types of ingredients and techniques set forth in US Pat. No. 2,033,909 to Cox et al. and Perfetti, Beitrage Tabakforschung Int., 12: 43-54 (1983), which are incorporated herein by reference. Additionally, salts of nicotine are available from sources such as Pfaltz and Bauer, Inc. and K&K Laboratories, Division of ICN Biochemicals, Inc. Typically, the nicotine component is selected from the group consisting of nicotine free base, a nicotine salt such as hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, and nicotine zinc chloride.

In some embodiments, at least a portion of the nicotine can be in the form of a resin complex of nicotine, where nicotine is bound in an ion-exchange resin, such as nicotine polacrilex, which is nicotine bound to, for example, a polymethacrilic acid, such as Amberlite IRP64, Purolite Cl 15HMR, or Doshion P551. See, for example, US Pat. No. 3,901,248 to Lichtneckert et al., which is incorporated herein by reference. Another example is a nicotine-polyacrylic carbomer complex, such as with Carbopol 974P. In some embodiments, nicotine may be present in the form of a nicotine polyacrylic complex.

Typically, the nicotine component (calculated as the free base) when present, is in a concentration of at least about 0.001% by weight of the oral product (not including the fleece material), such as in a range from about 0.001% to about 10%. In some embodiments, the nicotine component is present in a concentration from about 0.1% w/w to about 10% by weight, such as, e.g., from about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight, calculated as the free base and based on the total weight of the oral product (not including the fleece material). In some embodiments, the nicotine component is present in a concentration from about 0.1% w/w to about 3% by weight, such as, e.g., from about 0.1% w/w to about 2.5%, from about 0.1% to about 2.0%, from about 0.1% to about 1.5%, or from about 0.1% to about 1% by weight, calculated as the free base and based on the total weight of the oral product (not including the fleece material).

In some embodiments, the products or compositions of the disclosure can be characterized as free of any nicotine component (e.g., any embodiment as disclosed herein may be completely or substantially free of any nicotine component). By "substantially free" is meant that no nicotine has been intentionally added, beyond trace amounts that may be naturally present in e.g., a botanical material. For example, certain embodiments can be characterized as having less than 0.001% by weight of nicotine, or less than 0.0001%, or even 0% by weight of nicotine, calculated as the free base.

In some embodiments, the active ingredient comprises a nicotine component (e.g., any product or composition of the disclosure, in addition to comprising any active ingredient or combination of active ingredients as disclosed herein, may further comprise a nicotine component).

Cannabinoids

In some embodiments, the active ingredient comprises one or more cannabinoids. As used herein, the term "cannabinoid" refers to a class of diverse chemical compounds that acts on cannabinoid receptors, also known as the endocannabinoid system, in cells that alter neurotransmitter release in the brain. Ligands for these receptor proteins include the endocannabinoids produced naturally in the body by animals; phytocannabinoids, found in cannabis; and synthetic cannabinoids, manufactured artificially. Cannabinoids found in cannabis include, without limitation: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A). In certain embodiments, the cannabinoid is selected from tetrahydrocannabinol (THC), the primary psychoactive compound in cannabis, and cannabidiol (CBD) another major constituent of the plant, but which is devoid of psychoactivity. All of the above compounds can be used in the form of an isolate from plant material or synthetically derived. Alternatively, the active ingredient can be a cannabimimetic, which is a class of compounds derived from plants other than cannabis that have biological effects on the endocannabinoid system similar to cannabinoids. Examples include yangonin, alpha-amyrin or beta-amyrin (also classified as terpenes), cyanidin, curcumin (tumeric), catechin, quercetin, salvinorin A, N-acylethanolamines, and N-alkylamide lipids.

When present, a cannabinoid (e.g., CBD) or cannabimimetic is typically in a concentration of at least about 0.1% by weight of the oral product (not including the fleece material), such as in a range from about 0.1% to about 30%, such as, e.g., from about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 15%, about 20%, or about 30% by weight, based on the total weight of the oral product (not including the fleece material).

Terpenes

Active ingredients suitable for use in the present disclosure can also be classified as terpenes, many of which are associated with biological effects, such as calming effects. Terpenes are understood to have the general formula of (C5Hg) and include monoterpenes, sesquiterpenes, and diterpenes. Terpenes can be acyclic, monocyclic or bicyclic in structure. Some terpenes provide an entourage effect when used in combination with cannabinoids or cannabimimetics. Examples include beta-caryophyllene, linalool, limonene, beta-citronellol, linalyl acetate, pinene (alpha or beta), geraniol, carvone, eucalyptol, menthone, iso-menthone, piperitone, myrcene, beta-bourbonene, and germacrene, which may be used singly or in combination.

Pharmaceutical ingredients

In some embodiments, the active ingredient comprises an active pharmaceutical ingredient (API). The API can be any known agent adapted for therapeutic, prophylactic, or diagnostic use. These can include, for example, synthetic organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, phospholipids, inorganic compounds (e.g., magnesium, selenium, zinc, nitrate), neurotransmitters or precursors thereof (e.g., serotonin, 5-hydroxytryptophan, oxitriptan, acetylcholine, dopamine, melatonin), and nucleic acid sequences, having therapeutic, prophylactic, or diagnostic activity. Non-limiting examples of APIs include analgesics and antipyretics (e.g., acetylsalicylic acid, acetaminophen, 3-(4-isobutylphenyl)propanoic acid), phosphatidylserine, myoinositol, docosahexaenoic acid (DHA, Omega-3), arachidonic acid (AA, Omega-6), S-adenosylmethionine (SAM), beta-hydroxy- beta-methylbutyrate (HMB), citicoline (cytidine-5 '-diphosphate-choline), and cotinine. In some embodiments, the active ingredient comprises citicoline. In some embodiments, the active ingredient is a combination of citicoline, caffeine, theanine, and ginseng. In some embodiments, the active ingredient comprises sunflower lecithin. In some embodiments, the active ingredient is a combination of sunflower lecithin, caffeine, theanine, and ginseng.

The amount of API may vary. For example, when present, an API is typically at a concentration of from about 0.001% w/w to about 10% by weight, such as, e.g., from about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1%, to about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight, based on the total weight of the oral product (not including the fleece material).

In some embodiments, the composition is substantially free of any API. By "substantially free of any API" means that the composition does not contain, and specifically excludes, the presence of any API as defined herein, such as any Food and Drug Administration (FDA) approved therapeutic agent intended to treat any medical condition.

Flavoring _. Agents

In some embodiments, the releasable component may comprise a flavoring agent. For example, the releasable component may include a single flavoring agent or a plurality of flavoring agents. If desired, one or more flavoring agents may be embedded within the fleece material, absorbed in or adsorbed on at least one surface of the fleece material, or contained within the bulk of the fleece material.

As used herein, a "flavoring agent" or "flavorant" is any flavorful or aromatic substance capable of altering the sensory characteristics associated with the oral product. Examples of sensory characteristics that can be modified by the flavoring agent include taste, mouthfeel, moistness, coolness/heat, and/or fragrance/aroma. Flavoring agents may be natural or synthetic, and the character of the flavors imparted thereby may be described, without limitation, as fresh, sweet, herbal, confectionary, floral, fruity, or spicy. Non-limiting examples of flavoring agents that may be used as a releasable component herein (e.g., when retained within the fleece material) can include vanilla, coffee, chocolate/cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamon, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, terpenes, trigeminal senstates, and any combinations thereof. See also, Leffingwell et al., Tobacco Flavoring for Smoking Products, R. J. Reynolds Tobacco Company (1972), which is incorporated herein by reference. Flavorings also may include components that are considered moistening, cooling or smoothening agents, such as eucalyptus. These flavors may be provided neat (i.e., alone) or in a composite, and may be employed as concentrates or flavor packages (e.g., spearmint and menthol, orange and cinnamon; lime, pineapple, and the like). Representative types of components also are set forth in US Pat. No. 5,387,416 to White et al.; US Pat. App. Pub. No. 2005/0244521 to Strickland et al.; and PCT Application Pub. No. WO 05/041699 to Quinter et al., each of which is incorporated herein by reference. In some instances, the flavoring agent may be provided in a spray -dried form or a liquid form.

The flavoring agent may be a volatile flavor component. As used herein, "volatile" refers to a chemical substance that forms a vapor readily at ambient temperatures (i.e., a chemical substance that has a high vapor pressure at a given temperature relative to a nonvolatile substance). Typically, a volatile flavor component has a molecular weight below about 400 Da, and often include at least one carbon- carbon double bond, carbon-oxygen double bond, or both. In one embodiment, the at least one volatile flavor component comprises one or more alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, or a combination thereof. Non-limiting examples of aldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal, furfural, isovaleraldehyde, cuminaldehyde, benzaldehyde, and citronellal. Non-limiting examples of ketones include l-hydroxy-2-propanone and 2-hydroxy-3-methyl-2- cyclopentenone-l-one. Non -limiting examples of esters include allyl hexanoate, ethyl heptanoate, ethyl hexanoate, isoamyl acetate, and 3-methylbutyl acetate. Non-limiting examples of terpenes include sabinene, limonene, gamma-terpinene, beta-famesene, nerolidol, thujone, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. In one embodiment, the at least one volatile flavor component comprises one or more of ethyl vanillin, cinnam aldehyde, sabinene, limonene, gamma-terpinene, beta- famesene, or citral. In one embodiment, the at least one volatile flavor component comprises ethyl vanillin.

The amount of flavoring agent utilized in the releasable component can vary, but is typically up to about 10% by weight, and certain embodiments are characterized by a flavoring agent content of at least about 0.1% by weight, such as about 0.5 to about 10%, about 1 to about 5%, or about 2 to about 4% weight, based on the total weight of the oral product (not including the fleece material).

Methods of Manufacturing Pouchless Products

Some aspects of the present disclosure provide for methods of forming releasable component- containing fleece materials and methods of forming oral products comprising such releasable component- containing fleece-materials (e.g., such as the oral products described herein above), e.g., as illustrated in FIG. 3. As depicted in FIG. 3, methods of forming releasable component-containing fleece materials according to the present disclosure may comprise forming a fleece material comprising a plurality of fibers, as depicted at operation 210; and loading the fleece material with a releasable component to provide a releasable component-containing fleece material, as depicted at operation 230. It should be noted that the foregoing steps are meant to be interchangeable and thus the fleece material may be loaded with the releasable component prior to, during, or after forming the fleece material. For example, the releasable component may be impregnated into and already formed fleece fabric or microcapsules of the releasable component may be combined with a fiber slurry prior to forming the fleece fabric. As noted above, various types of fibers (e.g., such as cellulosic fibers or other polymer/synthetic fibers fibers) may be used in forming the fleece materials according to the present disclosure. Further, the fleece materials may be formed using any method of forming a woven or nonwoven fabric as detailed herein above. As noted above, various types and combinations of fibers and releasable components may be incorporated into fleece materials prepared according to the methods described herein and thus, such methods as described herein below with respect to one embodiment, should not be construed as limiting in any way.

In some embodiments, the fleece material may optionally be extruded, as depicted at operation 220, prior to loading the fleece material with a releasable component at operation 230. Fleece materials may be extruded by any means commonly known in the art. In some embodiments, the fleece materials may be extruded prior to, during, or after incorporation of the releasable component. As noted above, fleece materials of the present disclosure can be formed using a spunlaid or spunmelt process, for example, which includes both spunbond and meltblown processes, wherein such processes are understood to typically entail melting, extruding, collecting and bonding fibrous materials to form a fibrous nonwoven web. Typically, the extruding parameters may vary, for example, the extruding parameters may be altered based on the types of materials or components used within the fleece materials

As is seen in FIG. 3, a method of preparing an oral product incorporating steps 210 and 230 is also provided in an embodiment of the present disclosure. For example, an oral product may be prepared by providing a continuous supply of a releasable component-containing fleece material 240 wherein that fleece material has been prepared according to the methods disclosed at operations 210 and 230. Next, the releasable component-containing fleece material may be subdivided into discrete portions, as depicted at operation 250; and two or more discrete portions may be sealed together at operation 260 (e.g., by application of heat and/or pressure) to provide a product configured for oral use. The “discrete portions” as described herein are basically cut segments of a continuous fleece material as described herein that have been cut to the desired dimensions; e.g., the length and width of the desired oral product. Further, these discrete portions can be layered on top of each other prior to the sealing step so as to form an oral product that essentially contains multiple layers of the releasable component-containing fleece material. It is noted that such discrete portions may comprise portions from the same fleece material or different fleece materials (e.g., allowing for the layering of fleece layers comprising the same releasable component and/or for the layering of fleece layers with different releasable component, so as to include, e.g., one or more layers comprising a flavorant and one or more layers comprising an active ingredient).

In some embodiments, the two or more discrete portions may be sealed together by applying pressure and or heat to the layered portions. In some embodiments, the seal may be applied across the entirety of the layered portions or, alternatively, the layered portions may be sealed only in specified portions thereof. For example, the layered portions of fleece material may be sealed only along the periphery of the discrete portions such that the inner cross section of the product is bulkier when compared with the sealed peripheral edges. Such a configuration may provide for a mouth-feel and other organoleptic properties that mimic a traditional pouched product when inserted into the mouth of a user of the product.

The number of discrete portions of fleece materials that can be layered on top of each other prior to sealing those portions together to form an oral product may vary. For example, in some embodiments, the number of individual layers of fleece material in the product may be in the range of about 1 to about 20, or about 4 to about 16, or about 8 to about 12. In some embodiments, the number of individual layers of fleece material in the product may be at least about 3, at least about 6, at least about 9, at least about 12, at least about 15, or at least about 18.

Products confieured for oral use

As referenced herein above, various types of oral products are described herein, which can incorporate a releasable component-containing fleece, e.g., pouched products and pouchless products.

Pouchless products may consist essentially of one or more layers of the releasable component- containing fleece. The layers are advantageously sealed together as referenced above to provide a pouchless fleece product, comprising one or both of an active ingredient and a flavoring agent. As noted above, various types of fleece materials and releasable components are provided herein, and such materials and various combinations thereof are suitable for use in the pouchless products described herein.

Pouched products typically can include an outer water-permeable pouch formed of one or more layers of the releasable component-containing fleece and a composition situated within the outer water- permeable pouch. The composition is typically in the form of a substrate material as referenced above that is inserted into a cavity defined within the outer-water permeable pouch in order to provide a pouched product, comprising one or both of an active ingredient and a flavoring agent.

One aspect of the present disclosure provides for pouched products configured for oral use, wherein such pouched products may comprise a fleece material in the form of a pouch and containing a substrate material, the fleece material comprising fibers and a releasable component. As noted above, various types of fleece materials and releasable components are provided herein, and such materials are suitable for use in the pouched products as disclosed herein below. Advantageously, use of such fleece materials in combination with a substrate material can, in some embodiments, provide for extended release of one or more active ingredients and/or flavoring agents. For example, the releasable component (e.g., active ingredient and/or flavoring agent) may be delivered to a user of the product in a relatively short period of time (e.g., substantially immediately) upon insertion of the product in the oral cavity of the user, whereas components of the substrate material within the pouch (which can also comprise active ingredients and/or flavoring agents, or which can comprise only other types of components, e.g., such as those outlined herein below) may be released more slowly as they are allowed to permeate through the fleece material over time during use.

Combinations of releasable components and substrate materials within the pouched products may vary. Advantageously, such combinations may be varied based on the desired release profile and characteristics of the final product. For example, in some embodiments, a pouched product may comprise an active ingredient as a releasable component in the fleece and a flavoring agent provided as a component of the substrate material (e.g., such that the product provides immediate release of the active ingredient and delayed release of the flavor material). In some embodiments, a pouched product may comprise a flavoring agent as a releasable component in the fleece and an active ingredient provided as a component of the substrate material (e.g., such that the product provides immediate release of the flavor material and delayed release of the active ingredient). In some embodiments, a pouched product may comprise both a flavoring agent and an active ingredient in the substrate material and an additional flavoring agent as a releasable component in the fleece (e.g., such that the product provides immediate release of the flavoring agent in the fleece and delayed release of the active ingredient and the additional flavoring agent, which may optionally be the same as or different than the flavor provided in the fleece). It should be noted that the above examples are not to be construed as limiting and that any combination of ingredients may be provided as components in the releasable component and the substrate material so as to provide the desired release profile in the final pouched product. For example, the active ingredients and flavoring agents, in particular, can advantageously be provided as both releasable component and/or substrate material, and any possible combinations thereof, so as to alter the release profile of these components to a user of the pouched product to provide controlled release of one or more flavors and one or more active ingredients.

In some embodiments, pouched products of the present disclosure may include at least one active ingredient in the fleece material (e.g., in the form of a releasable component), the substrate material, or both the fleece material and the substrate material. For example, if desired, one or more active ingredients may be embedded within the fleece material as described herein above, and/or one or more active ingredients may be otherwise retained in the substrate material, such as being bound to a further filler or being present in a unitary form (e.g., pelletized active ingredients). In some embodiments, a first active ingredient is provided in the fleece material and a second active ingredient is provided within the substrate material. In such embodiments, the first and second active ingredients may be the same or different.

Any active ingredient as described herein above (e.g., in reference to the releasable component) is meant to be suitable for use within the substrate material. For example, in some embodiments, the substrate material may comprise a nicotine component. Typically, the nicotine component (calculated as the free base) when present, is in a concentration of at least about 0.001% by weight of the substrate material, such as in a range from about 0.001% to about 10%. In some embodiments, the nicotine component is present in a concentration from about 0.1% w/w to about 10% by weight, such as, e.g., from about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight, calculated as the free base and based on the total weight of the substrate material. In some embodiments, the nicotine component is present in a concentration from about 0.1% w/w to about 3% by weight, such as, e.g., from about 0.1% w/w to about 2.5%, from about 0.1% to about 2.0%, from about 0.1% to about 1.5%, or from about 0.1% to about 1% by weight, calculated as the free base and based on the total weight of the substrate material. These ranges can also apply to other active ingredients noted herein that may be incorporated into the substrate material.

In some embodiments, pouched products of the present disclosure may include at least one flavoring agent in the fleece material (e.g., in the form of a releasable component), the substrate material, or both the fleece material and the substrate material. For example, if desired, one or more flavoring agents may be embedded within the fleece material as described herein above, and/or one or more flavoring agents may be otherwise retained in the substrate material, such as being bound to a further filler or being present in a unitary form (e.g., pelletized active ingredients). In some embodiments, a first flavoring agent is provided in the fleece material and a second flavoring agent is provided within the substrate material. In such embodiments, the first and second flavoring agents may be the same or different.

Any flavoring agent as described herein above (e.g., in reference to the releasable component) is meant to be suitable for use within the substrate material. The amount of flavoring agent utilized in the substrate material can vary, but is typically up to about 10 weight percent, and certain embodiments are characterized by a flavoring agent content of at least about 0.1 weight percent, such as about 0.5 to about 10 weight percent, about 1 to about 6 weight percent, or about 2 to about 5 weight percent, based on the total weight of the substrate material.

Where the product of the present disclosure is a pouched product, the pouched product can include various other components, e.g., associated with the substrate. Such components are not intended to be limiting; rather, various example components that may be incorporated within pouched products are provided herein below. It is noted that these components are described with specific reference to inclusion within pouched products; however, in some embodiments, it may be possible to incorporate such additional components within a fleece material or to otherwise associate such additional components with a fleece material (in addition to the referenced releasable components(s) to provide the pouchless product referenced herein).

Filler Comvonent

The substrate material as described herein may include at least one particulate filler component. Such particulate filler components may fulfill multiple functions, such as enhancing certain organoleptic properties such as texture and mouthfeel, enhancing cohesiveness or compressibility of the product, and the like. Generally, the filler components are porous particulate materials and are cellulose-based. For example, suitable particulate filler components are any non-tobacco plant material or derivative thereof, including cellulose materials derived from such sources. Examples of cellulosic non-tobacco plant material include cereal grains (e.g., maize, oat, barley, rye, buckwheat, and the like), sugar beet (e.g., FIBREX ^® brand filler available from International Fiber Corporation), bran fiber, and mixtures thereof. Non-limiting examples of derivatives of non-tobacco plant material include starches (e.g., from potato, wheat, rice, com), natural cellulose, and modified cellulosic materials. Additional examples of potential particulate filler components include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Combinations of fillers can also be used.

"Starch" as used herein may refer to pure starch from any source, modified starch, or starch derivatives. Starch is present, typically in granular form, in almost all green plants and in various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, shoots, fruits, grains, and stems). Starch can vary in composition, as well as in granular shape and size. Often, starch from different sources has different chemical and physical characteristics. A specific starch can be selected for inclusion in the mixture based on the ability of the starch material to impart a specific organoleptic property to composition. Starches derived from various sources can be used. For example, major sources of starch include cereal grains (e.g., rice, wheat, and maize) and root vegetables (e.g., potatoes and cassava). Other examples of sources of starch include acorns, arrowroot, arracacha, bananas, barley, beans (e.g., favas, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, colacasia, katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnuts, and yams. Certain starches are modified starches. A modified starch has undergone one or more structural modifications, often designed to alter its high heat properties. Some starches have been developed by genetic modifications, and are considered to be "genetically modified" starches. Other starches are obtained and subsequently modified by chemical, enzymatic, or physical means. For example, modified starches can be starches that have been subjected to chemical reactions, such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), cross-linking, acetylation, hydroxypropylation, and/or partial hydrolysis. Enzymatic treatment includes subjecting native starches to enzyme isolates or concentrates, microbial enzymes, and/or enzymes native to plant materials, e.g., amylase present in com kernels to modify com starch. Other starches are modified by heat treatments, such as pregelatinization, dextrinization, and/or cold water swelling processes. Certain modified starches include monostarch phosphate, distarch glycerol, distarch phosphate esterified with sodium trimetaphosphate, phosphate distarch phosphate, acetylated distarch phosphate, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated distarch adipate, acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol, starch sodium octenyl succinate.

In some embodiments, the particulate filler component is a cellulose material or cellulose derivative. One particularly suitable particulate filler component for use in the products described herein is microcrystalline cellulose ("MCC"). The MCC may be synthetic or semi-synthetic, or it may be obtained entirely from natural celluloses. The MCC may be selected from the group consisting of AVICEL ^® grades PH-100, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-302, VIVACEL ^® grades 101, 102, 12, 20 and EMOCEL ^® grades 50M and 90M, and the like, and mixtures thereof. In one embodiment, the mixture comprises MCC as the particulate filler component. The quantity of MCC present in the mixture as described herein may vary according to the desired properties.

The amount of particulate filler component can vary, but is typically up to about 75 percent of the substrate material by weight, based on the total weight of the substrate material. A typical range of particulate filler material (e.g., MCC) within the substrate material can be from about 10 to about 75 percent by total weight of the mixture, for example, from about 10, about 15, about 20, about 25, or about 30, to about 35, about 40, about 45, or about 50 weight percent (e.g., about 20 to about 50 weight percent or about 25 to about 45 weight percent). In certain embodiments, the amount of particulate filler material is at least about 10 percent by weight, such as at least about 20 percent, or at least about 25 percent, or at least about 30 percent, or at least about 35 percent, or at least about 40 percent, based on the total weight of the substrate material.

In one embodiment, the particulate filler component further comprises a cellulose derivative or a combination of such derivatives. In some embodiments, the mixture comprises from about 1 to about 10% of the cellulose derivative by weight, based on the total weight of the mixture, with certain embodiments comprising about 1 to about 5% by weight of cellulose derivative. In certain embodiments, the cellulose derivative is a cellulose ether (including carboxyalkyl ethers), meaning a cellulose polymer with the hydrogen of one or more hydroxyl groups in the cellulose structure replaced with an alkyl, hydroxyalkyl, or aryl group. Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethyl cellulose, and carboxymethylcellulose ("CMC"). In one embodiment, the cellulose derivative is one or more of methylcellulose, HPC, HPMC, hydroxyethyl cellulose, and CMC. In one embodiment, the cellulose derivative is HPC. In some embodiments, the mixture comprises from about 1 to about 3% HPC by weight, based on the total weight of the substrate material. Tobacco material

In some embodiments, the substrate material of the pouched product may include a tobacco material. The tobacco material can vary in species, type, and form. Generally, the tobacco material is obtained from for a harvested plant of the Nicotiana species. Example Nicotiana species include N. tabacum, N. rustica, N. alata, N. arentsii, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N. gossei,

N. kawakamii, N. knightiana, N. langsdorffi, N. otophora, N. setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis, N. undulata, N. x sanderae, N. africana, N. amplexicaulis, N. benavidesii, N. bonariensis, N. debneyi, N. longiflora, N. maritina, N. megalosiphon, N. occidentalis, N. paniculata, N. plumbaginifolia, N. raimondii, N. rosulata, N. simulans, N. stocktonii, N. suaveolens, N. umbratica, N. velutina, N. wigandioides, N. acaulis, N. acuminata, N. attenuata, N. benthamiana, N. cavicola, N. clevelandii, N. cordifolia, N. corymbosa, N. fragrans, N. goodspeedii, N. linearis, N. miersii, N. nudicaulis, N. obtusifolia, N. occidentalis subsp. Hersperis, N. pauciflora, N. petunioides, N. quadrivalvis, N. repanda, N. rotundifolia, N. solanifolia, and N. spegazzinii. Various representative other types of plants from the Nicotiana species are set forth in Goodspeed, The Genus Nicotiana, (Chonica Botanica) (1954); US Pat. Nos. 4,660,577 to Sensabaugh, Jr. et ah; 5,387,416 to White et ak, 7,025,066 to Lawson et ak; 7,798,153 to Lawrence, Jr. and 8,186,360 to Marshall et ak; each of which is incorporated herein by reference. Descriptions of various types of tobaccos, growing practices and harvesting practices are set forth in Tobacco Production, Chemistry and Technology, Davis et ak (Eds.) (1999), which is incorporated herein by reference.

Nicotiana species from which suitable tobacco materials can be obtained can be derived using genetic-modification or crossbreeding techniques (e.g., tobacco plants can be genetically engineered or crossbred to increase or decrease production of components, characteristics or attributes). See, for example, the types of genetic modifications of plants set forth in US Pat. Nos. 5,539,093 to Fitzmaurice et ak; 5,668,295 to Wahab et ak; 5,705,624 to Fitzmaurice et ak; 5,844,119 to Weigl; 6,730,832 to Dominguez et ak; 7,173,170 to Liu et ak; 7,208,659 to Colliver et ak and 7,230,160 to Benning et ak; US Patent Appk Pub. No. 2006/0236434 to Conkling et ak; and PCT W02008/103935 to Nielsen et ak See, also, the types of tobaccos that are set forth in US Pat. Nos. 4,660,577 to Sensabaugh, Jr. et ak; 5,387,416 to White et ak; and 6,730,832 to Dominguez et ak, each of which is incorporated herein by reference.

The Nicotiana species can, in some embodiments, be selected for the content of various compounds that are present therein. For example, plants can be selected on the basis that those plants produce relatively high quantities of one or more of the compounds desired to be isolated therefrom. In certain embodiments, plants of the Nicotiana species (e.g., Galpao commun tobacco) are specifically grown for their abundance of leaf surface compounds. Tobacco plants can be grown in greenhouses, growth chambers, or outdoors in fields, or grown hydroponically. Various parts or portions of the plant of the Nicotiana species can be included within a mixture as disclosed herein. For example, virtually all of the plant (e.g., the whole plant) can be harvested, and employed as such. Alternatively, various parts or pieces of the plant can be harvested or separated for further use after harvest. For example, the flower, leaves, stem, stalk, roots, seeds, and various combinations thereof, can be isolated for further use or treatment. In some embodiments, the tobacco material comprises tobacco leaf (lamina). The substrate material disclosed herein can include processed tobacco parts or pieces, cured and aged tobacco in essentially natural lamina and/or stem form, a tobacco extract, extracted tobacco pulp (e.g., using water as a solvent), or a mixture of the foregoing (e.g., a mixture that combines extracted tobacco pulp with granulated cured and aged natural tobacco lamina).

In certain embodiments, the tobacco material comprises solid tobacco material selected from the group consisting of lamina and stems. The tobacco that is used for the substrate material most preferably includes tobacco lamina, or a tobacco lamina and stem mixture (of which at least a portion is smoke- treated). Portions of the tobaccos within the substrate material may have processed forms, such as processed tobacco stems (e.g., cut-rolled stems, cut-rolled-expanded stems or cut-puffed stems), or volume expanded tobacco (e.g., puffed tobacco, such as dry ice expanded tobacco (DIET)). See, for example, the tobacco expansion processes set forth in US Pat. Nos. 4,340,073 to de la Burde et ak; 5,259,403 to Guy et ak; and 5,908,032 to Poindexter, et ak; and 7,556,047 to Poindexter, et ak, all of which are incorporated by reference. In addition, the substrate material optionally may incorporate tobacco that has been fermented. See, also, the types of tobacco processing techniques set forth in PCT W02005/063060 to Atchley et ak, which is incorporated herein by reference.

The tobacco material is typically used in a form that can be described as particulate (i.e., shredded, ground, granulated, or powder form). The manner by which the tobacco material is provided in a finely divided or powder type of form may vary. Preferably, plant parts or pieces are comminuted, ground or pulverized into a particulate form using equipment and techniques for grinding, milling, or the like. Most preferably, the plant material is relatively dry in form during grinding or milling, using equipment such as hammer mills, cutter heads, air control mills, or the like. For example, tobacco parts or pieces may be ground or milled when the moisture content thereof is less than about 15 weight percent or less than about 5 weight percent. Most preferably, the tobacco material is employed in the form of parts or pieces that have an average particle size between 1.4 millimeters and 250 microns. In some instances, the tobacco particles may be sized to pass through a screen mesh to obtain the particle size range required. If desired, air classification equipment may be used to ensure that small sized tobacco particles of the desired sizes, or range of sizes, may be collected. If desired, differently sized pieces of granulated tobacco may be mixed together. The manner by which the tobacco is provided in a finely divided or powder type of form may vary. Preferably, tobacco parts or pieces are comminuted, ground or pulverized into a powder type of form using equipment and techniques for grinding, milling, or the like. Most preferably, the tobacco is relatively dry in form during grinding or milling, using equipment such as hammer mills, cutter heads, air control mills, or the like. For example, tobacco parts or pieces may be ground or milled when the moisture content thereof is less than about 15 weight percent to less than about 5 weight percent. For example, the tobacco plant or portion thereof can be separated into individual parts or pieces (e.g., the leaves can be removed from the stems, and/or the stems and leaves can be removed from the stalk). The harvested plant or individual parts or pieces can be further subdivided into parts or pieces (e.g., the leaves can be shredded, cut, comminuted, pulverized, milled or ground into pieces or parts that can be characterized as filler-type pieces, granules, particulates or fine powders). The plant, or parts thereof, can be subjected to external forces or pressure (e.g., by being pressed or subjected to roll treatment). When carrying out such processing conditions, the plant or portion thereof can have a moisture content that approximates its natural moisture content (e.g., its moisture content immediately upon harvest), a moisture content achieved by adding moisture to the plant or portion thereof, or a moisture content that results from the drying of the plant or portion thereof. For example, powdered, pulverized, ground or milled pieces of plants or portions thereof can have moisture contents of less than about 25 weight percent, often less than about 20 weight percent, and frequently less than about 15 weight percent.

For the preparation of oral products, it is typical for a harvested plant of the Nicotiana species to be subjected to a curing process. The tobacco materials incorporated within the substrate material for inclusion within products as disclosed herein are those that have been appropriately cured and/or aged. Descriptions of various types of curing processes for various types of tobaccos are set forth in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999). Examples of techniques and conditions for curing flue-cured tobacco are set forth in Nestor et al., Beitrage Tabakforsch. Int., 20, 467- 475 (2003) and US Pat. No. 6,895,974 to Peele, which are incorporated herein by reference. Representative techniques and conditions for air curing tobacco are set forth in US Pat. No. 7,650,892 to Groves et al.; Roton et al., Beitrage Tabakforsch. Int., 21, 305-320 (2005) and Staaf et al., Beitrage Tabakforsch. Int., 21, 321-330 (2005), which are incorporated herein by reference. Certain types of tobaccos can be subjected to alternative types of curing processes, such as fire curing or sun curing.

In certain embodiments, tobacco materials that can be employed include flue-cured or Virginia (e.g., K326), hurley, sun-cured (e.g., Indian Kumool and Oriental tobaccos, including Katerini, Prelip, Komotini, Xanthi and Yambol tobaccos), Maryland, dark, dark -fired, dark air cured (e.g., Madole, Passanda, Cubano, Jatin and Bezuki tobaccos), light air cured (e.g., North Wisconsin and Galpao tobaccos), Indian air cured, Red Russian and Rustica tobaccos, as well as various other rare or specialty tobaccos and various blends of any of the foregoing tobaccos.

The tobacco material may also have a so-called "blended" form. For example, the tobacco material may include a mixture of parts or pieces of flue-cured, burley (e.g., Malawi burley tobacco) and Oriental tobaccos (e.g., as tobacco composed of, or derived from, tobacco lamina, or a mixture of tobacco lamina and tobacco stem). For example, a representative blend may incorporate about 30 to about 70 parts burley tobacco (e.g., lamina, or lamina and stem), and about 30 to about 70 parts flue cured tobacco (e.g., stem, lamina, or lamina and stem) on a dry weight basis. Other example tobacco blends incorporate about

75 parts flue-cured tobacco, about 15 parts burley tobacco, and about 10 parts Oriental tobacco; or about

65 parts flue-cured tobacco, about 25 parts burley tobacco, and about 10 parts Oriental tobacco; or about

65 parts flue-cured tobacco, about 10 parts burley tobacco, and about 25 parts Oriental tobacco; on a dry weight basis. Other example tobacco blends incorporate about 20 to about 30 parts Oriental tobacco and about 70 to about 80 parts flue-cured tobacco on a dry weight basis.

Tobacco materials used in the present disclosure can be subjected to, for example, fermentation, bleaching, and the like. If desired, the tobacco materials can be, for example, irradiated, pasteurized, or otherwise subjected to controlled heat treatment. Such treatment processes are detailed, for example, in US Pat. No. 8,061,362 to Mua et al., which is incorporated herein by reference. In certain embodiments, tobacco materials can be treated with water and an additive capable of inhibiting reaction of asparagine to form acrylamide upon heating of the tobacco material (e.g., an additive selected from the group consisting of lysine, glycine, histidine, alanine, methionine, cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine, arginine, compositions incorporating di- and trivalent cations, asparaginase, certain non-reducing saccharides, certain reducing agents, phenolic compounds, certain compounds having at least one free thiol group or functionality, oxidizing agents, oxidation catalysts, natural plant extracts (e.g., rosemary extract), and combinations thereof. See, for example, the types of treatment processes described in US Pat. Pub. Nos. 8,434,496, 8,944,072, and 8,991,403 to Chen et al., which are all incorporated herein by reference. In certain embodiments, this type of treatment is useful where the original tobacco material is subjected to heat in the processes previously described.

In some embodiments, the type of tobacco material is selected such that it is initially visually lighter in color than other tobacco materials to some degree (e.g., whitened or bleached). Tobacco pulp can be whitened in certain embodiments according to any means known in the art. For example, bleached tobacco material produced by various whitening methods using various bleaching or oxidizing agents and oxidation catalysts can be used. Example oxidizing agents include peroxides (e.g., hydrogen peroxide), chlorite salts, chlorate salts, perchlorate salts, hypochlorite salts, ozone, ammonia, potassium permanganate, and combinations thereof. Example oxidation catalysts are titanium dioxide, manganese dioxide, and combinations thereof. Processes for treating tobacco with bleaching agents are discussed, for example, in US Patent Nos. 787,611 to Daniels, Jr.; 1,086,306 to Oelenheinz; 1,437,095 to Delling; 1,757,477 to Rosenhoch; 2,122,421 to Hawkinson; 2,148,147 to Baier; 2,170,107 to Baier; 2,274,649 to Baier; 2,770,239 to Prats et ah; 3,612,065 to Rosen; 3,851,653 to Rosen; 3,889,689 to Rosen; 3,943,940 to Minami; 3,943,945 to Rosen; 4,143,666 to Rainer; 4,194,514 to Campbell; 4,366,823, 4,366,824, and 4,388,933 to Rainer et al.; 4,641,667 to Schmekel et ah; 5,713,376 to Berger; 9,339,058 to Byrd Jr. et ak; 9,420,825 to Beeson et al.; and 9,950,858 to Byrd Jr. et ak; as well as in US Pat. App. Pub. Nos. 2012/0067361 to Bjorkholm et ak; 2016/0073686 to Crooks; 2017/0020183 to Bjorkholm; and 2017/0112183 to Bjorkholm, and in PCT Pubh Apph Nos. WO1996/031255 to Giolvas and WO2018/083114 to Bjorkholm, all of which are incorporated herein by reference.

In some embodiments, the whitened tobacco material can have an ISO brightness of at least about 50%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, or at least about 80%. In some embodiments, the whitened tobacco material can have an ISO brightness in the range of about 50% to about 90%, about 55% to about 75%, or about 60% to about 70%. ISO brightness can be measured according to ISO 3688:1999 or ISO 2470-1:2016.

In some embodiments, the whitened tobacco material can be characterized as lightened in color (e.g., "whitened") in comparison to an untreated tobacco material. White colors are often defined with reference to the International Commission on Illumination's (CIE's) chromaticity diagram. The whitened tobacco material can, in certain embodiments, be characterized as closer on the chromaticity diagram to pure white than an untreated tobacco material.

In various embodiments, the tobacco material can be treated to extract a soluble component of the tobacco material therefrom. "Tobacco extract" as used herein refers to the isolated components of a tobacco material that are extracted from solid tobacco pulp by a solvent that is brought into contact with the tobacco material in an extraction process. Various extraction techniques of tobacco materials can be used to provide a tobacco extract and tobacco solid material. See, for example, the extraction processes described in US Pat. Apph Pub. No. 2011/0247640 to Beeson et ak, which is incorporated herein by reference. Other example techniques for extracting components of tobacco are described in US Pat. Nos. 4,144,895 to Fiore; 4,150,677 to Osborne, Jr. et ak; 4,267,847 to Reid; 4,289,147 to Wildman et ak; 4,351,346 to Brummer et ak; 4,359,059 to Brummer et ak; 4,506,682 to Muller; 4,589,428 to Keritsis; 4,605,016 to Soga et ak; 4,716,911 to Poulose et ak; 4,727,889 to Niven, Jr. et ak; 4,887,618 to Bemasek et ak; 4,941,484 to Clapp et ak; 4,967,771 to Fagg et ak; 4,986,286 to Roberts et ak; 5,005,593 to Fagg et ak; 5,018,540 to Grubbs et ak; 5,060,669 to White et ak; 5,065,775 to Fagg; 5,074,319 to White et ak; 5,099,862 to White et ak; 5,121,757 to White et ak; 5,131,414 to Fagg; 5,131,415 to Munoz et ak; 5,148,819 to Fagg; 5,197,494 to Kramer; 5,230,354 to Smith et ak; 5,234,008 to Fagg; 5,243,999 to Smith; 5,301,694 to Raymond et al.; 5,318,050 to Gonzalez-Parra et al.; 5,343,879 to Teague; 5,360,022 to Newton; 5,435,325 to Clapp et al.; 5,445,169 to Brinkley et al.; 6,131,584 to Lauterbach; 6,298,859 to Kierulff et al.; 6,772,767 to Mua et al.; and 7,337,782 to Thompson, all of which are incorporated by reference herein.

Typical inclusion ranges for tobacco materials can vary depending on the nature and type of the tobacco material, and the intended effect on the final mixture, with an example range of up to about 30% by weight (or up to about 20% by weight or up to about 10% by weight or up to about 5% by weight), based on total weight of the mixture (e.g., about 0.1 to about 15% by weight).

It should be noted that inclusion of a tobacco material into the compositions and products described herein is meant to be optional and is not required. In some embodiments, oral products as described herein can generally be characterized as being tobacco free-altematives. For example, in some embodiments, oral products of the present disclosure may be said to be completely free or substantially free of tobacco material (other than purified nicotine as an active ingredient). Oral products that are referred to as “completely free of’ or “substantially free of’ a tobacco material herein are meant to refer to oral products that can be characterized as having less than about 1.0% by weight, less than about 0.5% by weight, less than about 0.1% by weight of tobacco material, or 0% by weight of tobacco material. Further Additives

In some embodiments, one or more further additives can be included in the substrate material. For example, the compositions can be processed, blended, formulated, combined and/or mixed with other materials or ingredients. The additives can be artificial, or can be obtained or derived from herbal or biological sources. Specific types of further additives that may be included are further described below.

In some embodiments, the substrate material may include a content of water. The water content of the composition within the product, prior to use by a consumer of the product, may vary according to the desired properties. Typically, the composition, as present within the product prior to insertion into the mouth of the user, can comprise less than 60%, less than 50%, less than 40%, less than 30%, less than 20%, less than 10%, or less than 5% by weight of water. For example, total water content in the composition and/or product may be in the range of about 0.1% to about 60%, about 1% to about 50%, about 1.5% to about 40%, or about 2% to about 25% by weight of water. In some embodiments, the compositions and products may include at least 1%, at least 2%, at least 5%, at least 10%, or at least 20% by weight water.

In some embodiments, the substrate material may include a content of one or more organic acids. As used herein, the term "organic acid" refers to an organic (i.e., carbon-based) compound that is characterized by acidic properties. Typically, organic acids are relatively weak acids (i.e., they do not dissociate completely in the presence of water), such as carboxylic acids (-CO2H) or sulfonic acids (- SO2OH). As used herein, reference to organic acid means an organic acid that is intentionally added. In this regard, an organic acid may be intentionally added as a specific ingredient as opposed to merely being inherently present as a component of another ingredient (e.g., the small amount of organic acid which may inherently be present in an ingredient such as a tobacco material). In some embodiments, the one or more organic acids are added neat (i.e., in their free acid, native solid or liquid form) or as a solution in, e.g., water. In some embodiments, the one or more organic acids are added in the form of a salt, as described herein below.

In some embodiments, the organic acid is an alkyl carboxylic acid. Non-limiting examples of alkyl carboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, and the like. In some embodiments, the organic acid is an alkyl sulfonic acid. Non-limiting examples of alkyl sulfonic acids include propanesulfonic acid and octanesulfonic acid. In some embodiments, the alkyl carboxylic or sulfonic acid is substituted with one or more hydroxyl groups. Non-limiting examples include glycolic acid, 4 -hydroxy butyric acid, and lactic acid. In some embodiments, an organic acid may include more than one carboxylic acid group or more than one sulfonic acid group (e.g., two, three, or more carboxylic acid groups). Non-limiting examples include oxalic acid, fumaric acid, maleic acid, and glutaric acid. In organic acids containing multiple carboxylic acids (e.g., from two to four carboxylic acid groups), one or more of the carboxylic acid groups may be esterified. Non-limiting examples include succinic acid monoethyl ester, monomethyl fumarate, monomethyl or dimethyl citrate, and the like.

In some embodiments, the organic acid may include more than one carboxylic acid group and one or more hydroxyl groups. Non-limiting examples of such acids include tartaric acid, citric acid, and the like. In some embodiments, the organic acid is an aryl carboxylic acid or an aryl sulfonic acid. Non-limiting examples of aryl carboxylic and sulfonic acids include benzoic acid, toluic acids, salicylic acid, benzenesulfonic acid, and / olucncsullbnic acid. In some embodiments, the organic acid is citric acid, malic acid, tartaric acid, octanoic acid, benzoic acid, a toluic acid, salicylic acid, or a combination thereof. In some embodiments, the organic acid is benzoic acid. In some embodiments, the organic acid is citric acid. In alternative embodiments, a portion, or even all, of the organic acid may be added in the form of a salt with an alkaline component, which may include, but is not limited to, nicotine. Non-limiting examples of suitable salts, e.g., for nicotine, include formate, acetate, propionate, isobutyrate, butyrate, alpha-methylbutyate, isovalerate, beta-methylvalerate, caproate, 2-furoate, phenylacetate, heptanoate, octanoate, nonanoate, oxalate, malonate, glycolate, benzoate, tartrate, levulinate, ascorbate, fumarate, citrate, malate, lactate, aspartate, salicylate, tosylate, succinate, pyruvate, and the like. The amount of organic acid present in the compositions may vary. Generally, the compositions can comprise from 0 to about 10% by weight of organic acid, present as one or more organic acids, based on the total weight of the substrate material.

In some embodiments, the substrate material may further comprise a salt (e.g., alkali metal salts), typically employed in an amount sufficient to provide desired sensory attributes to the compositions and products. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, flour salt, and the like. When present, a representative amount of salt is about 0.5 percent by weight or more, about 1.0 percent by weight or more, or at about 1.5 percent by weight or more, but will typically make up about 10 percent or less of the total weight of the substrate material, or about 7.5 percent or less or about 5 percent or less (e.g., about 0.5 to about 5 percent by weight).

The substrate material also may include one or more sweeteners. The sweeteners can be any sweetener or combination of sweeteners, in natural or artificial form, or as a combination of natural and artificial sweeteners. Examples of natural sweeteners include fructose, sucrose, glucose, maltose, mannose, galactose, lactose, isomaltulose stevia, honey, and the like. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame and the like. In some embodiments, the sweetener comprises one or more sugar alcohols. Sugar alcohols are polyols derived from monosaccharides or disaccharides that have a partially or fully hydrogenated form. Sugar alcohols have, for example, about 4 to about 20 carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates). When present, a representative amount of sweetener may make up from about 0.1 to about 20 percent or more of the of the composition by weight, for example, from about 0.1 to about 1%, from about 1 to about 5%, from about 5 to about 10%, or from about 10 to about 20% of the substrate material on a weight basis, based on the total weight of the substrate material.

In some embodiments, the substrate material may include one or more binding agents. A binder (or combination of binders) may be employed in certain embodiments, in amounts sufficient to provide the desired physical attributes and physical integrity to the composition, and binders also often function as thickening or gelling agents. Typical binders can be organic or inorganic, or a combination thereof. Representative binders include povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof. In some embodiments, the binder comprises pectin or carrageenan or combinations thereof. The amount of binder utilized can vary, but is typically up to about 30 weight percent, and certain embodiments are characterized by a binder content of at least about 0.1% by weight, such as about 1 to about 30% by weight, or about 5 to about 10% by weight, based on the total weight of the substrate material. In certain embodiments, the binder includes a gum, for example, a natural gum. As used herein, a natural gum refers to polysaccharide materials of natural origin that have binding properties, and which are also useful as a thickening or gelling agents. Representative natural gums derived from plants, which are typically water soluble to some degree, include xanthan gum, guar gum, gum arabic, ghatti gum, gum tragacanth, karaya gum, locust bean gum, gellan gum, and combinations thereof. When present, natural gum binder materials are typically present in an amount of up to about 5% by weight, for example, from about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, or about 1%, to about 2, about 3, about 4, or about 5% by weight, based on the total weight of the substrate material.

In certain embodiments, one or more humectants may be employed in the compositions. Examples of humectants include, but are not limited to, glycerin, propylene glycol, and the like. Where included, the humectant is typically provided in an amount sufficient to provide desired moisture attributes to the compositions. Further, in some instances, the humectant may impart desirable flow characteristics to the composition for depositing in a mold. When present, a humectant will typically make up about 5% or less of the weight of the substrate material (e.g., from about 0.5 to about 5% by weight). When present, a representative amount of humectant is about 0.1% to about 1% by weight, or about 1% to about 5% by weight, based on the total weight of the substrate material.

In certain embodiments, the substrate materials of the present disclosure can comprise pH adjusters or buffering agents. Examples of pH adjusters and buffering agents that can be used include, but are not limited to, metal hydroxides (e.g., alkali metal hydroxides such as sodium hydroxide and potassium hydroxide), and other alkali metal buffers such as metal carbonates (e.g., potassium carbonate or sodium carbonate), or metal bicarbonates such as sodium bicarbonate, and the like. Where present, the buffering agent is typically present in an amount less than about 5 percent based on the weight of the substrate material, for example, from about 0.5% to about 5%, such as, e.g., from about 0.75% to about 4%, from about 0.75% to about 3%, or from about 1% to about 2% by weight, based on the total weight of the substrate material. Non-limiting examples of suitable buffers include alkali metals acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, hydrogen carbonates, borates, or mixtures thereof.

In some embodiments, the substrate material may include one or more colorants. A colorant may be employed in amounts sufficient to provide the desired physical attributes to the composition or product. Examples of colorants include various dyes and pigments, such as caramel coloring and titanium dioxide. The amount of colorant utilized in the compositions or products can vary, but when present is typically up to about 3 weight percent, such as from about 0.1%, about 0.5%, or about 1%, to about 3% by weight, based on the total weight of the substrate material. Examples of even further types of additives that may be used in the present substrate materials include thickening or gelling agents (e.g., fish gelatin), emulsifiers, oral care additives (e.g., thyme oil, eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate and the like), disintegration aids, zinc or magnesium salts selected to be relatively water soluble for compositions with greater water solubility (e.g., magnesium or zinc gluconate) or selected to be relatively water insoluble for compositions with reduced water solubility (e.g., magnesium or zinc oxide), or combinations thereof. See, for example, those representative components, combination of components, relative amounts of those components, and manners and methods for employing those components, set forth in US Pat. No. 9,237,769 to Mua et ak, US Pat. No. 7,861,728 to Holton, Jr. et ak, US Pat. App. Pub. No. 2010/0291245 to Gao et ak, and US Pat. App. Pub. No. 2007/0062549 to Holton, Jr. et ak, each of which is incorporated herein by reference. Typical inclusion ranges for such additional additives can vary depending on the nature and function of the additive and the intended effect on the final mixture, with an example range of up to about 10% by weight, based on total weight of the substrate material (e.g., about 0.1 to about 5% by weight).

The aforementioned additives can be employed together (e.g., as additive formulations) or separately (e.g., individual additive components can be added at different stages involved in the preparation of the final substrate material). Furthermore, the aforementioned types of additives may be encapsulated as provided in the final product or substrate material. Exemplary encapsulated additives are described, for example, in WO2010/132444 to Atchley, which has been previously incorporated by reference herein.

Particles

In some embodiments, any one or more of a filler component, a tobacco material, and the overall substrate material described herein can be described as a particulate material. As used herein, the term "particulate" refers to a material in the form of a plurality of individual particles, some of which can be in the form of an agglomerate of multiple particles, wherein the particles have an average length to width ratio less than 2:1, such as less than 1.5:1, such as about 1:1. In various embodiments, the particles of a particulate material can be described as substantially spherical or granular.

The particle size of a particulate material may be measured by sieve analysis. As the skilled person will readily appreciate, sieve analysis (otherwise known as a gradation test) is a method used to measure the particle size distribution of a particulate material. Typically, sieve analysis involves a nested column of sieves which comprise screens, preferably in the form of wire mesh cloths. A pre-weighed sample may be introduced into the top or uppermost sieve in the column, which has the largest screen openings or mesh size (i.e. the largest pore diameter of the sieve). Each lower sieve in the column has progressively smaller screen openings or mesh sizes than the sieve above. Typically, at the base of the column of sieves is a receiver portion to collect any particles having a particle size smaller than the screen opening size or mesh size of the bottom or lowermost sieve in the column (which has the smallest screen opening or mesh size).

In some embodiments, the column of sieves may be placed on or in a mechanical agitator. The agitator causes the vibration of each of the sieves in the column. The mechanical agitator may be activated for a pre-determined period of time in order to ensure that all particles are collected in the correct sieve. In some embodiments, the column of sieves is agitated for a period of time from 0.5 minutes to 10 minutes, such as from 1 minute to 10 minutes, such as from 1 minute to 5 minutes, such as for approximately 3 minutes. Once the agitation of the sieves in the column is complete, the material collected on each sieve is weighed. The weight of each sample on each sieve may then be divided by the total weight in order to obtain a percentage of the mass retained on each sieve. As the skilled person will readily appreciate, the screen opening sizes or mesh sizes for each sieve in the column used for sieve analysis may be selected based on the granularity or known maximum/minimum particle sizes of the sample to be analysed. In some embodiments, a column of sieves may be used for sieve analysis, wherein the column comprises from 2 to 20 sieves, such as from 5 to 15 sieves. In some embodiments, a column of sieves may be used for sieve analysis, wherein the column comprises 10 sieves. In some embodiments, the largest screen opening or mesh sizes of the sieves used for sieve analysis may be 1000 pm, such as 500 pm, such as 400 pm, such as 300 pm.

In some embodiments, any particulate material referenced herein (e.g., filler component, tobacco material, and the overall substrate material) can be characterized as having at least 50% by weight of particles with a particle size as measured by sieve analysis of no greater than about 1000 pm, such as no greater than about 500 pm, such as no greater than about 400 pm, such as no greater than about 350 pm, such as no greater than about 300 pm. In some embodiments, at least 60% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about 1000 pm, such as no greater than about 500 pm, such as no greater than about 400 pm, such as no greater than about 350 pm, such as no greater than about 300 pm. In some embodiments, at least 70% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about 1000 pm, such as no greater than about 500 pm, such as no greater than about 400 pm, such as no greater than about 350 pm, such as no greater than about 300 pm. In some embodiments, at least 80% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about 1000 pm, such as no greater than about 500 pm, such as no greater than about 400 pm, such as no greater than about 350 pm, such as no greater than about 300 pm. In some embodiments, at least 90% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about 1000 pm, such as no greater than about 500 pm, such as no greater than about 400 pm, such as no greater than about 350 mih. such as no greater than about 300 mhi. In some embodiments, at least 95% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about 1000 pm, such as no greater than about 500 pm, such as no greater than about 400 pm, such as no greater than about 350 pm, such as no greater than about 300 pm. In some embodiments, at least 99% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about 1000 pm, such as no greater than about 500 pm, such as no greater than about 400 pm, such as no greater than about 350 pm, such as no greater than about 300 pm. In some embodiments, approximately 100% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about 1000 pm, such as no greater than about 500 pm, such as no greater than about 400 pm, such as no greater than about 350 pm, such as no greater than about 300 pm.

In some embodiments, at least 50% by weight, such as at least 60% by weight, such as at least 70% by weight, such as at least 80% by weight, such as at least 90% by weight, such as at least 95% by weight, such as at least 99% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of from about 0.01 pm to about 1000 pm, such as from about 0.05 pm to about 750 pm, such as from about 0.1 pm to about 500 pm, such as from about 0.25 pm to about 500 pm. In some embodiments, at least 50% by weight, such as at least 60% by weight, such as at least 70% by weight, such as at least 80% by weight, such as at least 90% by weight, such as at least 95% by weight, such as at least 99% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of from about 10 pm to about 400 pm, such as from about 50 pm to about 350 pm, such as from about 100 pm to about 350 pm, such as from about 200 pm to about 300 pm.

Prevaration of the substrate material

The manner by which the various components of the substrate material are combined may vary. As such, the overall mixture of various components with e.g., powdered mixture components may be relatively uniform in nature. The components noted above, which may be in liquid or dry solid form, can be admixed in a pretreatment step prior to mixture with any remaining components of the substrate material, or simply mixed together with all other liquid or dry ingredients. The various components of the substrate material may be contacted, combined, or mixed together using any mixing technique or equipment known in the art. Any mixing method that brings the substrate ingredients into intimate contact can be used, such as a mixing apparatus featuring an impeller or other structure capable of agitation. Examples of mixing equipment include casing drums, conditioning cylinders or drums, liquid spray apparatus, conical-type blenders, ribbon blenders, mixers available as FKM130, FKM600, FKM1200, FKM2000 and FKM3000 from Littleford Day, Inc., Plough Share types of mixer cylinders, Hobart mixers, and the like. See also, for example, the types of methodologies set forth in US Pat. Nos. 4,148,325 to Solomon et al.; 6,510,855 to Korte et al.; and 6,834,654 to Williams, each of which is incorporated herein by reference. In some embodiments, the components forming the substrate material are prepared such that the mixture thereof may be used in a starch molding process for forming the mixture. Manners and methods for formulating mixtures will be apparent to those skilled in the art. See, for example, the types of methodologies set forth in US Pat. No. 4,148,325 to Solomon et al.; US Pat. No. 6,510,855 to Korte et al.; and US Pat. No. 6,834,654 to Williams, US Pat. Nos. 4,725,440 to Ridgway et al., and 6,077,524 to Bolder et al., each of which is incorporated herein by reference.

Method of Manufacturing Pouched Products

An example pouch may be manufactured from materials, and in such a manner, such that during use by the user, the pouch undergoes a controlled dispersion or dissolution of the releasable component embedded in the pouch and subsequently one or more components of the substrate material. Such pouch materials may have the form of a mesh, screen, perforated paper, permeable fabric, or the like. Preferably, water-permeable pouch materials are provided by forming a pouch from the fleece materials described herein above. Such fleece materials advantageously retain releasable components therein while having sufficient permeability to allow for passage of components in the substrate material through the pouched fleece material and to the user of the product. As a result, the releasable component and substrate material each may undergo complete dispersion within the mouth of the user during normal conditions of use, and hence the releasable component and substrate material both may be ingested by the user. In some embodiments, the fleece material itself may be dissolvable or disintegrable, such that the pouch and the substrate material may be ingested by the user. Preferred pouch materials, though water dispersible or dissolvable, may be designed and manufactured such that under conditions of normal use, a significant amount of the substrate material contents permeate through the pouch material prior to the time that the pouch undergoes loss of its physical integrity.

Example packets, pouches or containers of the type used for the manufacture of smokeless tobacco products are available under the tradenames CatchDry, Ettan, General, Granit, Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf and TreAnkrare. The mixture may be contained in pouches and packaged, in a manner and using the types of components used for the manufacture of conventional snus types of products. The pouch provides a liquid-permeable container of a type that may be considered to be similar in character to the mesh-like type of material that is used for the construction of a tea bag. Components of the mixture readily diffuse through the pouch and into the mouth of the user.

Non-limiting examples of suitable types of pouches and methods of forming said pouches are set forth in, for example, US Pat. Nos. 5,167,244 to Kjerstad and 8,931,493 to Sebastian et al.; as well as US Patent App. Pub. Nos. 2016/0000140 to Sebastian et al.; 2016/0073689 to Sebastian et al.; 2016/0157515 to Chapman et al.; and 2016/0192703 to Sebastian et al., each of which are incorporated herein by reference. Pouches can be provided as individual pouches, or a plurality of pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30 pouches) can be connected or linked together (e.g., in an end-to-end manner) such that a single pouch or individual portion can be readily removed for use from a one-piece strand or matrix of pouches.

The amount of material contained within each product unit, for example, a pouch, may vary. In some embodiments, the weight of the substrate material within each pouch is at least about 50 mg, for example, from about 50 mg to about 2 grams, from about 100 mg to about 1.5 grams, or from about 200 to about 700 mg. In some smaller embodiments, the weight of the substrate material within each pouch may be from about 100 to about 300 mg. For a larger embodiment, the weight of the substrate material within each pouch may be from about 300 mg to about 700 mg. If desired, other components can be contained within each pouch. For example, at least one flavored strip, piece or sheet of flavored water dispersible or water soluble material (e.g., a breath-freshening edible film type of material) may be disposed within each pouch along with or without at least one capsule. Such strips or sheets may be folded or crumpled in order to be readily incorporated within the pouch. See, for example, the types of materials and technologies set forth in US Pat. Nos. 6,887,307 to Scott et al. and 6,923,981 to Leung et al.; and The EFSA Journal (2004) 85, 1-32; which are incorporated herein by reference.

Configured for oral use

Provided herein are products configured for oral use. Irrespective of whether the product is provided in the form of a pouchless product configured for oral use, as depicted in FIG. 2, or in the form of a pouched product configured for oral use, as depicted in FIG. 1; the term "configured for oral use" as used herein means that the product is provided in a form such that during use, saliva in the mouth of the user causes one or more of the releasable component (e.g., a flavoring agent and/or an active ingredient) and the substrate material wherein included (e.g., prepared according to methods and compositions provided herein above) to pass into the mouth of the user. In certain embodiments, the product is adapted to deliver releasable components to a user through mucous membranes in the user's mouth and, in some instances, said releasable component is an active ingredient (including, but not limited to, for example, nicotine) that can be absorbed through the mucous membranes in the mouth when the product is used.

Products configured for oral use as described herein may take various forms, including, but not limited to, pouchless products (which can be in the form, e.g., of an orally administered fleece material or an oral film), and pouched products. Certain such products can exhibit, for example, one or more of the following characteristics: crispy, granular, chewy, syrupy, pasty, fluffy, smooth, and/or creamy. In certain embodiments, the desired textural property can be selected from the group consisting of adhesiveness, cohesiveness, density, dryness, fracturability, graininess, gumminess, hardness, heaviness, moisture absorption, moisture release, mouthcoating, roughness, slipperiness, smoothness, viscosity, wetness, and combinations thereof.

The products comprising the fleece materials of the present disclosure may be at least partially dissolvable. As used herein, the terms "dissolve," "dissolving," and "dissolvable" refer to fleece materials and substrate materials having aqueous-soluble components that interact with moisture in the oral cavity and enter into solution, thereby causing gradual consumption of the product. According to one aspect, the dissolvable product is capable of lasting in the user’s mouth for a given period of time until it completely dissolves. Dissolution rates can vary over a wide range, from about 1 minute or less to about 60 minutes. For example, fast release mixtures typically dissolve and/or release the active substance in about 2 minutes or less, often about 1 minute or less (e.g., about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less). Dissolution can occur by any means, such as melting, mechanical disruption (e.g., chewing), enzymatic or other chemical degradation, or by disruption of the interaction between the components of the mixture. In other embodiments, the products do not dissolve during the product’s residence in the user’s mouth.

In some embodiments, the oral products comprising a fleece material comprising a releasable component, and optionally containing a substrate material, may be provided in the form of a pouched product (e.g., a water-permeable pouch formed of the fleece material) or in a “pouchless” configuration as noted above. Such oral products are typically used by placing one “unit” (i.e., one pouch or one “pouchless” product) containing the releasable component, and optionally a substrate material, in the mouth of a human subject/user. Generally, the unit is placed somewhere in the oral cavity of the user, for example under the lips, in the same way as moist snuff products are generally used. The unit preferably is not chewed or swallowed. Exposure to saliva then causes some of the releasable components therein (e.g., flavoring agents and/or active ingredients, such as nicotine) to be released into the mouth of the user and further can cause some of the substrate material therein to pass through, e.g., the fleece material and provide the user with flavor and satisfaction, and the user is not required to spit out any portion of the mixture. After about 10 minutes to about 60 minutes, typically about 15 minutes to about 45 minutes, of use/enjoyment, substantial amounts of the releasable component and or the substrate material have been ingested by the human subject, and the unit may be removed from the mouth of the human subject for disposal. The foregoing embodiments are provided by way of example only, and the oral products of the present disclosure can include various releasable components and various substrate materials in other forms.

A pouchless product and/or a pouched product as described herein can be packaged within any suitable inner packaging material and/or outer container. See also, for example, the various types of containers for smokeless types of products that are set forth in US Pat. Nos. 7,014,039 to Henson et al.; 7,537,110 to Kutsch et al.; 7,584,843 to Kutsch et al.; 8,397,945 to Gelardi et al., D592,956 to Thiellier; D594,154 to Patel et al.; and D625,178 to Bailey et al.; US Pat. Pub. Nos. 2008/0173317 to Robinson et al.; 2009/0014343 to Clark et al.; 2009/0014450 to Bjorkholm; 2009/0250360 to Bellamah et al.; 2009/0266837 to Gelardi et al.; 2009/0223989 to Gelardi; 2009/0230003 to Thiellier; 2010/0084424 to

Gelardi; and 2010/0133140 to Bailey et al; 2010/0264157 to Bailey et al.; and 2011/0168712 to Bailey et al. which are incorporated herein by reference.

Many modifications and other embodiments of the invention will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing description. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.