Pouch product with enhanced flavor stability

Abstract

The present disclosure provides a product configured for use in the oral cavity, the product comprising a composition containing a porous alumina component and a releasable material retained in the pores of the porous alumina, the releasable material retained in the pores of the porous alumina being configured for controlled release therefrom.

Description

Technical Field

[0001] The present disclosure relates to flavored products intended for use by humans. These products are configured for oral use and deliver substances such as flavors and / or active ingredients during use. Such products may include tobacco or tobacco-derived products or may be tobacco-free alternatives.

Background Art

[0002] Tobacco can be enjoyed in so-called "smokeless" forms. Particularly popular smokeless tobacco products are used by inserting a form of processed tobacco or tobacco-containing compound into the user's mouth. Traditional forms of such smokeless tobacco products include moist snuff, snus, and chewing tobacco, which are typically formed almost entirely from particulate, granular, or shredded tobacco and are divided by the user or presented individually to the user, for example, in a disposable pouch or bag. Other traditional forms of smokeless products include compressed or aggregated forms such as plugs, tablets, or pellets. Alternative product forms such as tobacco-containing gum and mixtures of tobacco with other plant materials are also known.For example, U.S. Patent No. 1,376,586 by Schwartz; U.S. Patent No. 4,513,756 by Pittman et al.; U.S. Patent No. 4,528,993 by Sensabaugh, Jr. et al.; U.S. Patent No. 4,624,269 by Story et al.; U.S. Patent No. 4,991,599 by Tibbetts; U.S. Patent No. 4,987,907 by Townsend; U.S. Patent No. 5,092,352 by Sprinkle, III et al.; Whi U.S. Patent No. 5,387,416 by te et al.; U.S. Patent No. 6,668,839 by Williams; U.S. Patent No. 6,834,654 by Williams; U.S. Patent No. 6,953,040 by Atchley et al.; U.S. Patent No. 7,032,601 by Atchley et al.; and U.S. Patent No. 7,694,686 by Atchley et al.; U.S. Patent Publication No. 2004 / 0020503 by Williams; U.S. Patent Publication No. 6,834,654 by Quinter et al. U.S. Patent Publication No. 2005 / 0115580; Strickland et al. U.S. Patent Publication No. 2006 / 0191548; Holton, Jr. et al. U.S. Patent Publication No. 2007 / 0062549; Holton, Jr. et al. U.S. Patent Publication No. 2007 / 0186941; Strickland et al. U.S. Patent Publication No. 2007 / 0186942; Dube et al. U.S. Patent Publication No. 2008 / 0029110; Robinson et al. U.S. Patent Publication No. 2 See U.S. Patent Publication No. 008 / 0029116; U.S. Patent Publication No. 2008 / 0173317 by Robinson et al.; U.S. Patent Publication No. 2008 / 0209586 by Neilsen et al.; U.S. Patent Publication No. 2009 / 0065013 by Essen et al.; and U.S. Patent Publication No. 2010 / 0282267 by Atchley, as well as WO2004 / 095959 of the type of smokeless tobacco formulations, ingredients and processing methods described herein. These are each incorporated herein by reference.

[0003] Recently, various configurations of smokeless tobacco products have been proposed that combine tobacco materials with various binders and fillers, including product forms such as lozenges, tablets, gels, and extruded forms. For example, Engstrom et al., U.S. Patent Application Publication No. 2008 / 0196730; Crawford et al., U.S. Patent Application Publication No. 2008 / 0305216; Kumar et al., U.S. Patent Application Publication No. 2009 / 0293889; Gao et al., U.S. Patent Application Publication No. 2010 / 0291245; Mua et al., U.S. Patent Application Publication No. 2011 / 0139164; Cantrell et al., U.S. Patent Application Publication No. 2012 / 0037175; Hunt et al., U.S. Patent Application Publication No. 2012 / 0055494; Cantrell et al., U.S. Patent Application Publication No. 2012 / 0138073; Cantrell et al. See U.S. Patent Application Publication No. 2012 / 0138074; U.S. Patent Application Publication No. 2013 / 0074855 by Holton, Jr.; U.S. Patent Application Publication No. 2013 / 0074856 by Holton, Jr.; U.S. Patent Application Publication No. 2013 / 0152953 by Mua et al.; U.S. Patent Application Publication No. 2013 / 0274296 by Jackson et al.; U.S. Patent Application Publication No. 2015 / 0068545 by Moldoveanu et al.; U.S. Patent Application Publication No. 2015 / 0101627 by Marshall et al.; and U.S. Patent Application Publication No. 2015 / 0230515 by Lampe et al. for the types of products described herein. These are incorporated herein by reference, respectively.

[0004] All-white snus pouches are gaining popularity, offering a discrete and aesthetically pleasing alternative to traditional snus. Such modern "white" pouch products may or may not contain bleached tobacco. This type of product may suffer from certain drawbacks, such as poor product stability, which can lead to discoloration and / or undesirable sensory characteristics. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] U.S. Patent No. 1,376,586 [Patent Document 2] U.S. Patent No. 4513756 [Patent Document 3] U.S. Patent No. 4528993 [Patent Document 4] U.S. Patent No. 4624269 [Patent Document 5] U.S. Patent No. 4991599 [Patent Document 6] U.S. Patent No. 4987907 [Patent Document 7] U.S. Patent No. 5092352 [Patent Document 8] U.S. Patent No. 5387416 [Patent Document 9] U.S. Patent No. 6668839 [Patent Document 10] U.S. Patent No. 6,834,654 [Patent Document 11] U.S. Patent No. 6953040 [Patent Document 12] U.S. Patent No. 7032601 [Patent Document 13] U.S. Patent No. 7694686 [Patent Document 14] U.S. Patent Application Publication No. 2004 / 0020503 [Patent Document 15] U.S. Patent Application Publication No. 2005 / 0115580 [Patent Document 16] U.S. Patent Application Publication No. 2006 / 0191548 [Patent Document 17] U.S. Patent Application Publication No. 2007 / 0062549 [Patent Document 18] U.S. Patent Application Publication No. 2007 / 0186941 [Patent Document 19] U.S. Patent Application Publication No. 2007 / 0186942 [Patent Document 20] U.S. Patent Application Publication No. 2008 / 0029110 [Patent Document 21] U.S. Patent Application Publication No. 2008 / 0029116 [Patent Document 22] U.S. Patent Application Publication No. 2008 / 0173317 [Patent Document 23] U.S. Patent Application Publication No. 2008 / 0209586 [Patent Document 24] U.S. Patent Application Publication No. 2009 / 0065013 [Patent Document 25] U.S. Patent Application Publication No. 2010 / 0282267 [Patent Document 26] International Publication No. 2004 / 095959 [Patent Document 27] U.S. Patent Application Publication No. 2008 / 0196730 [Patent Document 28] U.S. Patent Application Publication No. 2008 / 0305216 [Patent Document 29] U.S. Patent Application Publication No. 2009 / 0293889 [Patent Document 30] U.S. Patent Application Publication No. 2010 / 0291245 [Patent Document 31] U.S. Patent Application Publication No. 2011 / 0139164 [Patent Document 32] U.S. Patent Application Publication No. 2012 / 0037175 [Patent Document 33] U.S. Patent Application Publication No. 2012 / 0055494 [Patent Document 34] U.S. Patent Application Publication No. 2012 / 0138073 [Patent Document 35] U.S. Patent Application Publication No. 2012 / 0138074 [Patent Document 36] U.S. Patent Application Publication No. 2013 / 0074855 [Patent Document 37] U.S. Patent Application Publication No. 2013 / 0074856 [Patent Document 38] U.S. Patent Application Publication No. 2013 / 0152953 [Patent Document 39] U.S. Patent Application Publication No. 2013 / 0274296 [Patent Document 40] U.S. Patent Application Publication No. 2015 / 0068545 [Patent Document 41] U.S. Patent Application Publication No. 2015 / 0101627 [Patent Document 42] U.S. Patent Application Publication No. 2015 / 0230515 [Overview of the Initiative]

[0006] (Summary) This disclosure generally provides products configured for oral use. These products may be configured to impart flavor when used orally and may additionally or alternatively deliver active ingredients such as nicotine to the consumer.

[0007] In one or more embodiments, the Disclosure may provide compositions and products configured for oral use. For example, such a product may include a particulate filler comprising a releaseable material and porous alumina, wherein at least a portion of the releaseable material is held by the porous alumina, and the product is configured such that at least a portion of the releaseable material held by the porous alumina is released therefrom when the product is present in the oral cavity.

[0008] In one or more embodiments, the Disclosure can provide a method for controlling the release rate of a releaseable material in a product configured for oral use. For example, such a method may include mixing a releaseable material with a particulate filler containing porous alumina such that at least a portion of the releaseable material is held by porous alumina, and that when the product is present in the oral cavity, at least a portion of the releaseable material held by the porous alumina is released from there at a controlled rate.

[0009] This disclosure includes, but is not limited to, the following embodiments.

[0010] Embodiment 1: A product configured for oral use, comprising a particulate filler containing a releaseable material and porous alumina, wherein at least a portion of the releaseable material is held by the porous alumina, and the product is configured such that at least a portion of the releaseable material held by the porous alumina is released when the product is in the oral cavity.

[0011] Embodiment 2: The product according to Embodiment 1, wherein the porous alumina can contain γ-alumina.

[0012] Embodiment 3: The product according to Embodiment 1 or 2, wherein the pores present in the porous alumina can have an average pore diameter of about 10 nm to about 500 nm.

[0013] Embodiment 4: The product according to any one of Embodiments 1 to 3, wherein the porous alumina can include pores having at least two different average particle sizes that do not overlap.

[0014] Embodiment 5: The product according to any one of Embodiments 1 to 4, wherein the porous alumina may contain pores having a first average pore diameter of about 10 nm to about 50 nm, and may also contain pores having a second average pore diameter of about 100 nm to about 500 nm.

[0015] Embodiment 6: The product according to any one of Embodiments 1 to 5, wherein pores having a first average particle size may be effective for releasing a releaseable material at a first release rate, and pores having a second average particle size may be effective for releasing a releaseable material at a second release rate different from the first release rate.

[0016] Embodiment 7: The product according to any one of Embodiments 1 to 6, wherein the releaseable material can contain one or more active ingredients.

[0017] Embodiment 8: The product according to any one of Embodiments 1 to 7, wherein one or more active ingredients may be selected from the group consisting of nicotine components, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutritional supplements, and combinations thereof.

[0018] Embodiment 9: The product according to any one of Embodiments 1 to 8, wherein the releaseable material can include one or more flavoring agents.

[0019] Embodiment 10: The product according to any one of Embodiments 1 to 9, wherein one or more flavoring agents include compounds having a carbon-carbon double bond, a carbon-oxygen double bond, or both.

[0020] Embodiment 11: The product according to any one of Embodiments 1 to 10, wherein one or more flavoring agents include one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal nerve sensory inducers, or combinations thereof.

[0021] Embodiment 12: The product according to any one of Embodiments 1 to 11, wherein one or more flavoring agents are selected from the group consisting of ethyl vanillin, cinnamaldehyde, sabinene, limonene, γ-terpinene, β-farnesene, citral, methyl salicylate, ethyl salicylate, menthol, peppermint, spearmint, other mint plant species, and combinations thereof.

[0022] Embodiment 13: The product according to any one of Embodiments 1 to 12, which may contain about 10% by weight or less of tobacco material based on the total weight of the mixture, excluding any nicotine components present.

[0023] Embodiment 14: The product according to any one of Embodiments 1 to 13, wherein the mixture can be enclosed within a pouch to form a pouch product and is optionally in a free-flowing particulate form.

[0024] Embodiment 15: The product according to any one of Embodiments 1 to 14, wherein the particulate filler may further contain a cellulose material.

[0025] Embodiment 16: The product according to any one of Embodiments 1 to 15, which may further comprise one or more salts, one or more sweeteners, one or more binders, one or more humectants, one or more gums, tobacco materials, or a combination thereof.

[0026] Embodiment 17: The product according to any one of Embodiments 1 to 16, wherein the porous alumina is in the form of particles having an average particle size of about 50 μm to about 500 μm.

[0027] Embodiment 18: A method for controlling the release rate of a releaseable material in a product configured for oral use, comprising mixing a releaseable material with a particulate filler containing porous alumina such that at least a portion of the releaseable material is held by porous alumina, and that when the product is present in the oral cavity, at least a portion of the releaseable material held by the porous alumina is released therefrom at a controlled rate.

[0028] Embodiment 19: The method according to Embodiment 18, wherein the porous alumina may contain pores having a first average pore diameter of about 10 nm to about 50 nm, and pores having a second average pore diameter of about 100 nm to about 500 nm.

[0029] Embodiment 20: The method according to Embodiment 18 or 19, wherein pores having a first average particle size may be effective for the release of a release material at a first release rate, and pores having a second average particle size are effective for the release of a releaseable material at a second release rate different from the first release rate.

[0030] Embodiment 21: Use of porous alumina in oral products.

[0031] Embodiment 22: Use of porous alumina to control the release rate of active ingredients in an oral product.

[0032] Embodiment 23: Use of porous alumina according to Embodiment 22, wherein the porous alumina is in the form of particles having an average particle size of about 50 μm to about 500 μm.

[0033] Embodiment 24: Use of porous alumina according to Embodiment 22 or 23, wherein the porous alumina may contain pores having a first average pore diameter of about 10 nm to about 50 nm and pores having a second average pore diameter of about 100 nm to about 500 nm.

[0034] Embodiment 25: Use of porous alumina according to any of Embodiments 22 to 24, wherein pores having a first average particle size may be effective for the release of the release material at a first release rate, and pores having a second average particle size are effective for the release of the releaseable material at a second release rate different from the first release rate.

[0035] Embodiment 26: Use of porous alumina according to any one of Embodiments 22 to 25, configured such that when the product is present in the oral cavity, at least a portion of the releaseable material held by the porous alumina is released therefrom at a controlled rate.

[0036] Embodiment 27: An oral product comprising porous alumina, configured to control the release of one or more active ingredients.

[0037] Embodiment 28: The oral product according to Embodiment 27, wherein the porous alumina can contain pores having at least two different average particle sizes that do not overlap.

[0038] Embodiment 29: The oral product according to Embodiment 28, wherein the porous alumina may contain pores having a first average pore diameter of about 10 nm to about 50 nm, and may also contain pores having a second average pore diameter of about 100 nm to about 500 nm.

[0039] Embodiment 30: The oral product according to Embodiment 28 or 29, wherein pores having a first average particle size may be effective for the release of a releaseable material at a first release rate, and pores having a second average particle size may be effective for the release of a releaseable material at a second release rate different from the first release rate.

[0040] Embodiment 31: An oral product according to any one of Embodiments 28 to 30, wherein the releaseable material can contain one or more active ingredients.

[0041] Embodiment 32: An oral product according to any one of Embodiments 28 to 31, wherein one or more active ingredients can be selected from the group consisting of nicotine components, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutritional supplements, and combinations thereof.

[0042] Embodiment 33: An oral product according to any one of Embodiments 28 to 32, wherein the releaseable material can contain one or more flavoring agents.

[0043] Embodiment 34: An oral product according to any one of Embodiments 28 to 33, wherein one or more flavoring agents may include compounds having a carbon-carbon double bond, a carbon-oxygen double bond, or both.

[0044] Embodiment 35: An oral product according to any of Embodiments 28 to 34, wherein one or more flavoring agents include one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal nerve sensory stimulants, or combinations thereof.

[0045] Embodiment 36: An oral product according to any of Embodiments 28 to 35, wherein one or more flavoring agents are selected from the group consisting of ethyl vanillin, cinnamaldehyde, sabinene, limonene, γ-terpinene, β-farnesene, citral, methyl salicylate, ethyl salicylate, menthol, peppermint, spearmint, other mint plant species, and combinations thereof.

[0046] These and other features, aspects and advantages of this disclosure will become apparent upon reading the following detailed description together with the accompanying drawings, which are briefly described below. The present invention includes any combination of two, three, four or more of the embodiments described above and any combination of two, three, four or more features or elements described herein, whether or not such features or elements are explicitly combined in the description of a particular embodiment herein. This disclosure is intended to be read as a whole, and unless otherwise clearly indicated by the context, to be understood that separable features or elements of the disclosed invention are intended to be combined in any of its various aspects and embodiments.

[0047] As the aspects of this disclosure have been described using the general terminology described herein, the attached drawings, which are not necessarily drawn to scale, should now be referenced. These drawings are for illustrative purposes only and should not be construed as limiting the disclosure. [Brief explanation of the drawing]

[0048] [Figure 1] This is a perspective view of a pouch product according to an exemplary embodiment of the present disclosure, comprising a pouch or fleece at least partially filled with a composition for oral use. [Modes for carrying out the invention]

[0049] This disclosure provides compositions and products formed from such compositions, particularly compositions and products configured for oral use. The compositions and products may incorporate one or more components that hold releaseable components and are then effective in releasing the releaseable components at a desired time, such as when in contact with the oral cavity. The components for holding the releaseable components may, in some embodiments, be adapted or configured to provide controlled release.

[0050] The present disclosure is hereby described more fully with reference to its exemplary embodiments. These exemplary embodiments are described in a manner that fully conveys the scope of the present disclosure to those skilled in the art, ensuring its completeness and comprehensiveness. Indeed, the present disclosure can be embodied in many different forms and should not be construed as being limited to the embodiments described herein, but rather these embodiments are provided so that the present disclosure may satisfy applicable legal requirements. As used herein and in the claims, the singular forms “a,” “an,” and “the” include plural nouns unless the context clearly indicates otherwise. References to “dry weight percentage” or “dry weight basis” refer to the weight based on the dry components (i.e., all components except water). References to “wet weight” refer to the weight of the mixture including water. Unless otherwise specified, references to “weight percentage” of a mixture reflect the total wet weight of the mixture (i.e., including water).

[0051] This disclosure provides compositions and products that may contain these compositions. More specifically, these compositions may be provided in various forms, and as further described herein, they may be provided in substantially solid forms such as aggregates of particles, fibers, etc. Thus, products may contain the compositions themselves or the compositions disposed within a unitized structure such as a pouch. In some embodiments, the compositions or products described herein may include particulate fillers and releaseable materials. Preferably, the particulate fillers may include at least porous alumina. Furthermore, in one or more embodiments, at least a portion of the releaseable material may be retained in pores present in the porous alumina. Furthermore, when the product is present in the oral cavity, at least a portion of the releaseable material retained in the pores present in the porous alumina may be released from there.

[0052] Filler components The mixtures described herein include at least one particulate filler component. Such particulate filler components may perform multiple functions, such as enhancing certain functional properties like texture and mouthfeel, or enhancing the cohesiveness or compressibility of the product. Generally, the filler component is a porous particulate material.

[0053] In various embodiments, at least one particulate filler may include at least one porous alumina. Alumina (Al2O3) can exist in various different forms and may include α-alumina, β-alumina, and γ-alumina. Both α-alumina and γ-alumina may be classified as nanoalumina, and both materials are inert, but γ-alumina can exhibit a much larger usable surface area. Any type of porous alumina may be used, but in some embodiments, γ-alumina may be used in particular as at least part of the filler components.

[0054] Porous alumina can be defined in relation to pores or porous networks present in the material. In some embodiments, porous alumina may contain pores having an overall average pore diameter in the range of about 10 nm to about 500 nm, about 20 nm to about 400 nm, or about 50 nm to about 300 nm. Porous alumina used as a filler in this specification may be adapted or configured to contain pores having at least two different non-overlapping average pore diameters. For example, porous alumina may exhibit pores of a first average pore diameter and pores of a second average pore diameter. In some embodiments, the first average pore diameter may be an average size less than 100 nm, less than 75 nm, or less than 50 nm, for example, in the range of about 10 nm to about 50 nm, about 10 nm to about 40 nm, or about 10 nm to about 30 nm. In some embodiments, the second average pore size may be an average size in the range of approximately 100 nm or more, approximately 150 nm or more, or approximately 200 nm or more, for example, approximately 100 nm to approximately 500 nm, approximately 150 nm to approximately 450 nm, or approximately 200 nm to approximately 400 nm. Each of the aforementioned average pore sizes may be referred to as a nanopore.

[0055] In one or more embodiments, porous alumina may be provided in the form of aggregates. The term “aggregate” may refer to a combination of particles bound together by various physical / chemical forces. Aggregates may be formed from multiple adjacent individual particles linked and connected at contact points. Aggregates of porous alumina may exhibit pore diameters much larger than those otherwise described above, and these may be referred to as macropores. Macropores may be defined as interparticle voids between the constituting alumina particles. Thus, porous alumina may exhibit nanopores of a single average pore diameter or multiple non-overlapping average pore diameters, and may also exhibit macropores. In some embodiments, macropores may exhibit an average size larger than the nanopore diameter. For example, macropore diameters may be greater than 500 nm, greater than 600 nm, greater than 700 nm, or greater than 800 nm, for example, in the range of about 550 nm to about 1000 nm, about 600 nm to about 1000 nm, or about 700 nm to about 1000 nm.

[0056] In some embodiments, alumina may be in the form of particles, having an average particle size of about 0.5 μm to about 500 μm or about 50 μm to about 500 μm. Individual alumina particles may have substantially small average particle sizes, for example, about 0.5 μm to about 250 μm, about 1 μm to about 150 μm or about 2 μm to about 100 μm, but aggregates may be significantly larger in size. Aggregates may have an average size of about 0.1 mm to about 10 mm, about 0.2 mm to about 8 mm, about 0.4 mm to about 5 mm or about 0.5 mm to about 2 mm. Aggregation of alumina particles can be achieved by known methods, such as pelletizing, extrusion, or bead forming in a rotating coating drum. In such methods, a granulation liquid, such as water, may be used to form aggregates. Preferably, most of the granulation liquid can be removed after the granulation drying step.

[0057] The porous alumina is preferably adapted or configured to retain at least a portion of the releaseable material as otherwise described herein. In particular, the releaseable material may be absorbed or adsorbed into the pores of the porous alumina. Retention of the releaseable material within the porous network of the porous alumina makes it possible to provide stable storage of the overall composition (i.e., no significant loss of releaseable material from the porous alumina - for example, no loss of less than 10% by weight, less than 5% by weight, less than 2% by weight, less than 1% by weight, less than 0.5% by weight, or less than 0.1% by weight of the releaseable material initially retained in the porous alumina).

[0058] In some embodiments, porous alumina may be adapted or configured to provide controlled release of at least one releaseable material. For this purpose, the at least one releaseable material can be retained by the alumina through one or more mechanisms, including but not limited to hydrogen bonding, van der Waals forces, absorption, adsorption, and similar forces or bonds. For example, the substantially small pore size of porous alumina may allow the releaseable material to be retained through the pores for a long period of time even after contact with the user's oral cavity, either to come into contact with the oral mucosa and / or in contact with saliva which can function to solubilize the releaseable material, or otherwise to facilitate the movement of the releaseable material from the pores. Controlled release can thus be defined in relation to the amount of time required for at least 90% by weight of the releaseable material to be released from the porous alumina after contact with the user's oral cavity.

[0059] Preferably, controlled release may indicate that at least 90% of the releaseable material is released over a time of 30 seconds or more, 1 minute or more, 2 minutes or more, 3 minutes or more, 4 minutes or more, 5 minutes or more, 6 minutes or more, 7 minutes or more, 8 minutes or more, 9 minutes or more, or 10 minutes or more (for example, up to a maximum time of about 30 minutes, about 45 minutes, or about 60 minutes). Since porous alumina having multiple average pore sizes may be provided, multiple different release rates may be provided. For example, pores having a first average particle size may be effective for releasing the releaseable material at a first release rate, and pores having a second average particle size may be effective for releasing the releaseable material at a second release rate different from the first release rate. Thus, it is possible to provide compositions having relatively rapid release rates and relatively slower release rates. For example, an average-sized pore exhibiting a relatively rapid release rate may be adapted or configured to release at least 90% by weight of the releaseable material held therein in a time of less than 5 minutes, less than 4 minutes, less than 3 minutes, less than 2 minutes, less than 1 minute, or less than 30 seconds (e.g., up to a minimum time of about 5 seconds or about 10 seconds).

[0060] For example, relatively rapid release rates may be in the range of about 30 seconds to about 5 minutes, about 45 seconds to about 4 minutes, or about 1 minute to about 2 minutes. Pores of average size exhibiting relatively slow release rates may be adapted or configured to release at least 90% by weight of the releaseable material held therein in the range of 5 minutes or more, 10 minutes or more, 15 minutes or more, or 20 minutes or more. For example, relatively slow release rates may be in the range of about 5 minutes to about 45 minutes, about 8 minutes to about 30 minutes, or about 10 minutes to about 20 minutes. In some embodiments, intermediate release rates may also be provided based on the average pore size. For example, intermediate release rates may overlap with relatively rapid release rates and / or relatively slow release rates. Thus, intermediate release rates may range from about 2 minutes to about 15 minutes, about 5 minutes to about 12 minutes, or about 5 minutes to about 10 minutes.

[0061] By providing various release rates based on the relative pore sizes of porous alumina, it is possible to provide sustained release profiles. In particular, releaseable material held in larger pores (e.g., larger average size nanopores and / or macropores) can be released at relatively rapid and / or intermediate release rates, while releaseable material held in smaller pores (e.g., larger average size nanopores and / or small average size nanopores) can be released at relatively slow and / or intermediate release rates. In this way, it is possible to provide release of releaseable material over a larger time frame.

[0062] In some embodiments, the compositions and products described herein may include multiple filler materials. For example, the compositions and products may include porous alumina as described above, in addition to at least one second filler. In some embodiments, further or secondary fillers may be cellulosic. For example, suitable particulate filler components are any non-tobacco plant material or derivative thereof, which include cellulosic materials derived from such sources. Examples of cellulosic non-tobacco plant materials include cereals and bran and starch derivatives (e.g., corn, oats, barley, rye, buckwheat, etc.), sugar beets (e.g., FIBREX® brand fillers available from International Fiber Corporation), bran fibers, bagasse, and mixtures thereof. Non-limiting examples of derivatives of non-tobacco plant materials include starch (e.g., from potatoes, wheat, rice, corn), natural cellulose, and modified cellulosic materials. Further 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.

[0063] As used herein, “starch” may refer to pure starch, modified starch, or starch derivatives from any source. Starch is typically found in granular form in almost all green plants, as well as in various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, sprouts, fruits, grains, and stems). Starch can differ not only in composition but also in granular shape and size. Often, starches from various sources have a variety of chemical and physical properties. Certain starches may be selected for inclusion in a mixture based on their ability to impart specific functional properties to a composition. Starches from various sources can be used. For example, the main sources of starch include grains (e.g., rice, wheat, and corn) and root vegetables (e.g., potatoes and cassava). Other examples of starch sources include acorns, arrowroot, arakacha, bananas, barley, beans (e.g., faba, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, taro, dogtooth violet, kudzu, maranga, millet, oats, oka, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnut, and yam. Certain starches are modified starches. Modified starches have undergone one or more structural modifications and are often designed to alter their high-temperature properties. Some starches have been developed through genetic modification and are considered "genetically modified" starches. Other starches are obtained and then modified by chemical, enzymatic, or physical means. For example, modified starch may be starch that has been subjected to chemical reactions such as acid-catalyzed esterification, etherification, oxidation, depolymerization by acid catalyst or oxidation in the presence of a base (reduction of viscosity), bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), crosslinking, acetylation, hydroxypropylation, and / or partial hydrolysis.Enzymatic treatment involves modifying maize starch by subjecting natural starch to enzyme isolates or concentrates, microbial enzymes, and / or natural enzymes from plant materials, such as amylase present in maize grains. Other starches are modified by heat treatment, such as gelatinization, dextrinization, and / or cold water swelling processes. Specific modified starches include phosphorylated starch, glycerol cross-linked starch, phosphate cross-linked starch esterified with sodium trimetaphosphate, phosphate monoesterified phosphate cross-linked starch, acetylated phosphate cross-linked starch, acetic acid esterified with acetic anhydride, acetic acid esterified with vinyl acetate, acetylated adipic acid cross-linked starch, acetylated glycerol cross-linked starch, hydroxypropyl starch, hydroxypropylated glycerol cross-linked starch, and sodium octenyl succinate starch.

[0064] In some embodiments, the particulate filler components are cellulose materials or cellulose derivatives. One particulate filler component particularly suitable for use in the products described herein is microcrystalline cellulose ("MCC"). MCC may be synthetic, semi-synthetic, or obtained entirely from natural cellulose. MCC can 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, as well as mixtures thereof. In one embodiment, the mixture contains MCC as a particulate filler component. The amount of MCC present in the mixtures described herein may vary depending on the desired properties. In some embodiments, cellulose derivatives or, in particular, combinations of such derivatives may be used with porous alumina, which may include cellulose derivatives such as cellulose ethers (including carboxyalkyl ethers), which means cellulose polymers in which one or more hydrogens of hydroxyl groups in the cellulose structure are replaced with alkyl, hydroxyalkyl, or aryl groups. Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethylcellulose, and carboxymethylcellulose ("CMC"). In one embodiment, the cellulose derivative is one or more of methylcellulose, HPC, HPMC, hydroxyethylcellulose, and CMC. In one embodiment, the cellulose derivative is HPC.

[0065] The amount of particulate filler components can vary, but is typically up to about 75 weight percent of the mixture based on the total weight of the mixture. A typical range of total particulate filler material in a mixture (e.g., porous alumina alone or in combination with further or secondary fillers) may be about 10 to about 75 weight percent of the total weight of the mixture, for example, 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 total amount of particulate filler material is at least about 10 weight percent based on the total weight of the mixture, for example, at least about 20 weight percent, or at least about 25 weight percent, or at least about 30 weight percent, or at least about 35 weight percent, or at least about 40 weight percent. When porous alumina and further or secondary fillers are used together, the porous alumina and further fillers may be supplied in specified ratios. For example, the ratio of porous alumina to further fillers (based on its weight) can be about 0.1 to about 10, about 0.2 to about 8, about 0.5 to about 5, or about 0.8 to about 2.

[0066] Releaseable materials As used herein, “releaseable material” may refer to any material that is held by a filler and, in particular, porous alumina, and is releaseable from there when in contact with the consumer’s mouth. The releaseable material may preferably be adapted or configured to be absorbed or adsorbed into the porous structure of the porous alumina, or otherwise entangled. In this way, the releaseable material may be configured to be held with a desired level of stability and / or to be released under controlled conditions from the porous structure of the porous alumina. A wide variety of releaseable materials may be available. In some embodiments, multiple releaseable materials may be used. In some embodiments, different releaseable materials may be adapted or configured to be preferentially held in pores of a particular dimensional range. For example, a first releaseable material may be adapted or configured to be preferentially held in pores of porous alumina having a relatively small average nanopore diameter. As a further example, a second releaseable material may be adapted or configured to be preferentially held in pores of porous alumina having a relatively large average nanopore diameter. As another example, a third releaseable material may be adapted or configured to be preferentially retained within the pores of porous alumina, which have a macropore diameter (i.e., in the interstitial pores of the aggregate).

[0067] active ingredient In some embodiments, the releaseable material may be an active ingredient. For example, the releaseable material may comprise a single active ingredient or multiple active ingredients. If desired, one or more active ingredients may be retained in porous alumina; otherwise, one or more active ingredients may be retained in the composition and / or product, for example, by being bound to further fillers, or by existing in a single form (e.g., pelletized active ingredient). As used herein, “active ingredient” means one or more substances belonging to one of the following classifications: APIs (pharmaceutical active ingredients), food additives, natural medicines, and naturally occurring substances that may affect humans. Exemplary active ingredients include any ingredient known to affect one or more biological functions in the body, such as ingredients that provide pharmacological activity or other direct effects in the diagnosis, cure, alleviation, treatment or prevention of disease, or that affect the structure or any function of the human body (e.g., ingredients that provide a stimulant effect on the central nervous system, resulting in an energy-granting effect, an antipyretic or analgesic effect, or otherwise a beneficial effect on the body). In some embodiments, the active ingredient may be of a type commonly referred to as a dietary supplement, nutritional supplement, “phytochemical,” or “functional food.” 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 beneficial biological effects (e.g., health promotion, disease prevention, or other pharmacological properties), but are not classified or regulated as drugs.

[0068] Non-limiting examples of active ingredients that may be used as releaseable materials in this specification and / or otherwise contained in the composition and / or product (e.g., when not held by porous alumina) include those belonging to the categories of botanical ingredients, stimulants, amino acids, nicotine components and / or pharmaceutical ingredients, nutritional supplements and medicinal ingredients (e.g., vitamins such as vitamins A, B3, B6, B12 and C, and / or cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD)). Each of these categories is further described below. The specific selection of active ingredients will vary depending on the desired flavor, texture and desired properties of a particular product.

[0069] 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 may include a combination of caffeine, theanine, and optionally ginseng. In another embodiment, the active ingredient includes a combination of theanine, gamma-aminobutyric acid (GABA), and lemon balm extract. In further embodiments, the active ingredient includes theanine, theanine and tryptophan, or theanine and one or more B vitamins (e.g., vitamin B6 or B12). In further embodiments, the active ingredient includes a combination of caffeine, taurine, and vitamin C.

[0070] The specific percentage of active ingredients present varies depending on the desired properties of the particular product. Typically, the active ingredients or combinations thereof are present at a total concentration of at least about 0.001% by weight of the composition, for example, in the range of about 0.001% to about 20% by weight. In some embodiments, the active ingredients or combinations thereof are present at a concentration of about 0.1% to about 10% by weight, based on the total weight of the composition, for example, about 0.5% to about 10%, about 1% to about 10%, or about 1% to about 5% by weight. In some embodiments, the active ingredient or combination of active ingredients is based on the total weight of the composition in amounts ranging from about 0.001% by weight, about 0.01% by weight, about 0.1% by weight, or about 1% to about 20% by weight, for example, about 0.001% by weight, about 0.002% by weight, about 0.003% by weight, about 0.004% by weight, about 0.005% by weight, about 0.006% by weight, about 0.007% by weight, about 0.008% by weight, about 0.009% by weight, about 0.01% by weight, about 0.02% by weight, about 0.03% by weight, about 0.04% by weight, about 0.05% by weight, about 0.06% by weight, about 0 It exists in concentrations of 0.07 wt%, about 0.08 wt%, about 0.09 wt%, about 0.1 wt%, about 0.2 wt%, about 0.3 wt%, about 0.4 wt%, about 0.5 wt%, about 0.6 wt%, about 0.7 wt%, about 0.8 wt%, or about 0.9 wt% to about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, or about 20 wt%. Further suitable ranges for specific active ingredients are provided below herein.

[0071] Botanical In some embodiments, the active ingredient includes a botanical component. As used herein, the terms “botanical component” or “botanical” refer to any plant material or fungal material, including plant material in its natural form, such as extracts or isolates from plant material or processed plant material, and plant material derived from natural plant material (e.g., plant material subjected to heat treatment, fermentation, bleaching or other processing processes that can alter the physical and / or chemical properties of the material). For the purposes of this disclosure, “botanical” refers to “herbal materials,” which are seed-producing plants that do not exhibit persistent woody tissue and are often valued for their medicinal or sensory properties (e.g., tea or chisan). References to botanical materials as “non-tobacco” are intended to exclude tobacco materials (i.e., Nicotiana species are not included). In some embodiments, the compositions disclosed herein may be characterized as not containing any nicotine component (e.g., none of the embodiments disclosed herein may contain any nicotine component at all or substantially). "Substantially free" means that tobacco material is not intentionally added. For example, certain embodiments may be characterized as having less than 0.001% by weight of tobacco, or less than 0.0001% by weight or even 0% by weight of tobacco.

[0072] If present, botanicals are typically present in concentrations of about 0.01% by weight to about 10% by weight, based on the total weight of the composition, for example, about 0.01% by weight, about 0.05% by weight, about 0.1% by weight, or about 0.5% by weight to about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, or about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, or about 15% by weight.

[0073] The botanical materials useful in this disclosure may include, but are not limited to, any of the compounds and sources described herein, including mixtures thereof. Certain botanical materials of this type may be referred to as dietary supplements, nutritional supplements, "phytochemicals," or "functional foods." Certain botanicals, as plant materials or extracts thereof, have been found to have uses in traditional herbal medicine, which are further described herein. Non-exclusive examples of botanicals or botanical-derived materials include ashwagandha, bacopa monniera, baobab, basil, Centella asiatica, chai-hu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus fruits, clove, cocoa, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba, ginseng (e.g., Panax ginseng), green tea, and Griffonia simplicifolia. simplicifolia), guarana, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thai ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha, Nardostachys chinensis, Viola odorata oil extract, peppermint, quercetin, resveratrol, Rhizoma gastrodiae, rhodoola, rooibos, rose essential oil, rosemary, Sceletium tortuosum, Schisandra, skullcap, spearmint extract, spikenard, terpenes, thisin, turmeric, Turnera aphrodisiac Contains aphrodisiaca, valerian, mulberry, and yerbamate.

[0074] In some embodiments, the active ingredient is lemon balm. Lemon balm (Melissa officinalis) is a mild lemon-scented herb belonging to the same family as mint (Lamiaceae). This herb is native to Europe, North Africa, and West Asia. Lemon balm tea, as well as its essential oil and extract, are used in traditional and alternative medicine. In some embodiments, the active ingredient is lemon balm extract. In some embodiments, the lemon balm extract is present in an amount of about 1 to about 4% by weight based on the total weight of the composition.

[0075] In some embodiments, the active ingredient is ginseng. Ginseng is the root of a plant of the genus Panax, which is characterized by the presence of its own steroid saponin phytochemicals (ginsenosides) and gintonin. Ginseng has uses in energy drinks or herbal teas, as well as in traditional medicine as a nutritional supplement. Cultivated varieties include Korean ginseng (P. ginseng), Southern Chinese ginseng (P. notoginseng), and American ginseng (P. quinquefolius). American ginseng and Korean ginseng differ in the types and amounts of various ginsenosides present. In some embodiments, ginseng is either American ginseng or Korean ginseng. In certain embodiments, the active ingredient is Korean ginseng. In some embodiments, ginseng is present in an amount of about 0.4 to about 0.6% by weight based on the total weight of the composition.

[0076] Stimulants In some embodiments, the active ingredient comprises one or more stimulants. As used herein, the term “stimulant” refers to a substance that increases the activity of the central nervous system and / or the body, for example, enhancing concentration, cognitive ability, vitality, mood, attention, etc. Non-limiting examples of stimulants include caffeine, theacrine, theobromine, and theophylline. Theacrine (1,3,7,9-tetramethyluric acid) is a purine alkaloid structurally related to caffeine and has stimulant, analgesic, and anti-inflammatory effects. Current stimulants may be natural, naturally derived, or completely synthetic. For example, certain botanical materials (guarana, tea, coffee, cocoa, etc.) may have stimulant effects due to the presence of caffeine or related alkaloids, and are therefore “natural” stimulants. “Naturally derived” means that the stimulant (e.g., caffeine, theacrine) is in a purified form outside of its natural (e.g., botanical) matrix. For example, caffeine can be obtained by extraction and purification from a botanical source (e.g., tea). "Complete synthesis" means that the stimulant was obtained by chemical synthesis. In some embodiments, the active ingredient contains caffeine. In some embodiments, caffeine exists in encapsulated form. An example of encapsulated caffeine is Vitashure®, available from Balchem ​​Corp., 52 Sunrise Park Road, New Hampton, NY, 10958.

[0077] If present, stimulants or combinations of stimulants (e.g., caffeine, theacrin, and combinations thereof) are typically present in concentrations of about 0.1% to about 15% by weight, based on the total weight of the composition, for example, 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%, or about 15% by weight. In some embodiments, the composition contains about 1.5% to about 6% by weight of caffeine based on the total weight of the composition.

[0078] amino acid In some embodiments, the active ingredient comprises an amino acid. As used herein, the term “amino acid” refers to an organic compound containing an amine (-NH2) and a carboxyl (-COOH) or sulfonic acid (SO3H) functional group, along with a side chain (R group) specific to each amino acid. Amino acids can be proteogenic or non-proteogenic. “Proteogenic” means that the amino acid is one of the 20 naturally occurring amino acids found in proteins. Examples of proteogenic 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. “Non-proteogenic” means that the amino acid is not naturally found in proteins or is not directly produced by cellular mechanisms (e.g., is a product of post-translational modification). Non-exclusive examples of non-proteinogenic amino acids include γ-aminobutyric acid (GABA), taurine (2-aminoethanesulfonic acid), theanine (L-γ-glutamylethylamide), hydroxyproline, and β-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.

[0079] If present, amino acids or combinations of amino acids (e.g., theanine, GABA, and combinations thereof) are typically present in concentrations of about 0.1% to about 15% by weight, based on the total weight of the composition, for example, 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%, or about 15% by weight.

[0080] vitamin In some embodiments, the active ingredient comprises a vitamin or a combination of vitamins. As used herein, the term “vitamin” refers to an organic molecule (or set of related molecules) that is an essential micronutrient necessary for the proper functioning of metabolism in mammals. There are 13 vitamins necessary for human metabolism, which are vitamin A (as all-trans-retinol, all-trans-retinyl ester, and all-trans-β-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 (cobalamin), vitamin C (ascorbic acid), vitamin D (calciferol), vitamin E (tocopherol and tocotrienol), and vitamin K (quinone). In some embodiments, the active ingredient comprises vitamin C. In some embodiments, the active ingredient is a combination of vitamin C, caffeine, and taurine.

[0081] If present, vitamins or combinations of vitamins (e.g., vitamin B6, vitamin B12, vitamin E, vitamin C, or combinations thereof) are typically present in concentrations of about 0.01% to about 6% by weight, based on the total weight of the composition, for example, 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% 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.

[0082] Antioxidant In some embodiments, the active ingredient comprises one or more antioxidants. As used herein, the term “antioxidant” refers to a substance that can prevent or inhibit oxidation by halting free radical reactions, thereby delaying or preventing certain types of cell 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.

[0083] Examples of botanical ingredients associated with antioxidant properties include acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot, black pepper, blueberry, borage seed oil, baguelleweed, cacao, calamus root, catnip, catuaba, cayenne pepper, chaga mushroom, chervil, cinnamon, dark chocolate, potato peel, grapeseed, ginseng, ginkgo biloba, St. John's wort, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile, clove, cocoa powder, cranberry, dandelion, grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew, and ginger. Goldenseal, hawthorn, hibiscus flower, jao gran, kava, lavender, licorice, marjoram, milk thistle, mint (mente), oolong tea, beetroot, orange, oregano, papaya, pennyroyal, peppermint, red clover, rooibos (red or green), rosehip, rosemary, sage, clary sage, savory, spearmint, spirulina, elm bark, sorghum bran high tannin, sorghum grain high tannin, sumac bran, comfrey leaf and root, goji berry, gutu kola, thyme, turmeric, uva ursi, valerian, wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa, bacopa monniera Examples include, but are not limited to, *Monniera*, *Withania somnifera*, *Lyon's mane*, and *Silybum marianum*. Such botanical materials may be provided in fresh or dried form, as essential oils, or as extracts. Botanical materials (and their extracts) often include various classes of compounds 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 endocarp, resveratrol, sulforaphane, β-carotene, lycopene, lutein, coenzyme Q, carnitine, quercetin, and kaempferol. See, for example, Santhosh et al., Phytomedicine, 12(2005) 216-220, incorporated herein by reference.

[0084] Other suitable antioxidants, though not limited to these, include citric acid, vitamin E or its derivatives, 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, catechol, resveratrol, oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tert-butylhydroquinone (TBHQ), and combinations thereof.

[0085] If present, the antioxidant is typically present in a concentration of about 0.001% by weight to about 10% by weight, based on the total weight of the composition, for example, about 0.001% by weight, about 0.005% by weight, about 0.01% by weight, about 0.05% by weight, about 0.1% by weight, or about 0.5% to about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, or about 10% by weight.

[0086] Nicotine components In certain embodiments, the active ingredient comprises a nicotine component. “Nicotine component” means any suitable form of nicotine (e.g., a free base or salt) to result in oral absorption of at least a portion of the nicotine present. Typically, the nicotine component is selected from the group consisting of nicotine free bases and nicotine salts. In some embodiments, the nicotine component is nicotine in its free base form, which can readily be adsorbed, for example, onto a microcrystalline cellulose material to form a microcrystalline cellulose-nicotine carrier complex. See, for example, Hansson's U.S. Patent Publication 2004 / 0191322, incorporated herein by reference, for the study of nicotine in its free base form.

[0087] In some embodiments, at least a portion of the nicotine components may be used in the form of salts. Nicotine salts can be provided using the types of components and techniques described in U.S. Patent No. 2,033,909 by Cox et al. and Perfetti, Beitrage Tabakforschung Int., 12:43-54 (1983), which are incorporated herein by reference. Furthermore, nicotine salts are available from suppliers such as Pfaltz and Bauer, Inc. and K&K Laboratories, Division of ICN Biochemicals, Inc. Typically, nicotine components are selected from the group consisting of nicotine free base, nicotine salts, e.g., hydrochloride, dihydrochloride, monotartrate, bisartrate, sulfate, salicylate, and nicotine zinc chloride. In some embodiments, the nicotine component or a portion thereof is a nicotine salt having at least a portion of one or more organic acids, as previously disclosed herein.

[0088] In some embodiments, at least a portion of the nicotine may be in the form of a nicotine resin composite, where the nicotine is bonded to an ion exchange resin such as nicotine polarilex, which is nicotine bonded to polymethacrylic acid, for example, Amberlite IRP64, Purolite C115HMR, or Doshion P551. See, for example, U.S. Patent No. 3,901,248, Lichtneckert et al., incorporated herein by reference. Another example is a nicotine-polyacrylate carbomer composite such as Carbopol 974P. In some embodiments, the nicotine may exist in the form of a nicotine-polyacrylate composite.

[0089] Typically, the nicotine component (calculated as free base) is present, if any, at a concentration of at least about 0.001% by weight of the composition, for example, in the range of about 0.001% to about 10%. In some embodiments, the nicotine component, calculated as free base, is at a concentration of about 0.1% to about 10% by weight based on the total weight of the composition, for example, 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%, or about 10% by weight. In some embodiments, the nicotine component is present in concentrations of about 0.1% to about 3% by weight, calculated as free base, based on the total weight of the composition, for example, about 0.1% to about 2.5% by weight, about 0.1% to about 2.0% by weight, about 0.1% to about 1.5% by weight, or about 0.1% to about 1% by weight.

[0090] In some embodiments, the products or compositions of the Disclosure may be characterized as being free of any nicotine component (for example, none of the embodiments disclosed herein may be completely or substantially free of any nicotine component). "Substantially free" means that nicotine is not intentionally added in amounts exceeding trace amounts that may naturally exist in the botanical materials, for example. For example, certain embodiments may be characterized as having less than 0.001% by weight of nicotine, less than 0.0001% by weight of nicotine, or even 0% by weight of nicotine, calculated as free base.

[0091] In some embodiments, the active ingredient includes nicotine components (for example, any product or composition of this disclosure may further include nicotine components in addition to any active ingredient or combination of active ingredients disclosed herein).

[0092] Cannabinoids In some embodiments, the active ingredient comprises one or more cannabinoids. As used herein, the term “cannabinoid” refers to a diverse class of chemical compounds that act on cannabinoid receptors (also known as the endocannabinoid system) within cells, altering neurotransmitter release in the brain. Ligands for these receptor proteins include endocannabinoids, which are naturally produced in the bodies of animals; plant cannabinoids, which are found in cannabis; and synthetic cannabinoids, which are artificially produced. Cannabinoids found in cannabis include, but are not limited to, cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabiclomevalin (CBCV), cannabigerovalin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerol acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivaric acid (THCV A). In certain embodiments, cannabinoids are selected from tetrahydrocannabinol (THC), the major psychoactive compound of cannabis, and cannabidiol (CBD), another major component of the plant that lacks psychoactivity. All of the aforementioned compounds can be used in the form of isolates from plant material or can be synthetically derived.

[0093] Alternatively, the active ingredient may be cannabimimetics, a class of compounds derived from plants other than cannabis that biologically affect the endogenous cannabinoid system, similar to cannabinoids. Examples include yangonin, α-amyrin or β-amyrin (also classified as terpenes), cyanidin, curcumin (turmeric), catechin, quercetin, salvinorin A, N-acylethanolamine, and N-alkylamide lipids.

[0094] If present, cannabinoids (e.g., CBD) or cannabimimetics are typically present in concentrations of at least about 0.1% by weight of the composition, based on the total weight of the composition, for example, in the range of about 0.1% to about 30% by weight, for example, 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.

[0095] Terpenes The active ingredients suitable for use in this disclosure can also be classified as terpenes, many of which are associated with biological effects such as sedative effects. Terpenes are (C5H8) n Terpenes have the general formula and are understood to include monoterpenes, sesquiterpenes, and diterpenes. Terpenes can have acyclic, monocyclic, or bicyclic structures. Some terpenes produce an entourage effect when used in combination with cannabinoids or cannabimimetics. Examples include β-caryophyllene, linalool, limonene, β-citronellol, linalyl acetate, pinene (α or β), geraniol, carvone, eucalyptol, menthone, isomentone, piperitone, myrcene, β-bulbonene, and germacrene, which can be used alone or in combination.

[0096] Medicinal active ingredients In some embodiments, the active ingredient comprises a pharmaceutically active ingredient (API). The API may be any known agent suitable for therapeutic, prophylactic, or diagnostic use. These include, for example, synthetic organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, phospholipids, inorganic compounds (e.g., magnesium, selenium, zinc, nitrates), neurotransmitters or their precursors (e.g., serotonin, 5-hydroxytryptophan, oxytriptan, 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, myo-inositol, docosahexaenoic acid (DHA, omega-3), arachidonic acid (AA, omega-6), S-adenosylmethionine (SAM), β-hydroxy-β-methyl butyrate (HMB), citicoline (cytidine-5'-choline diphosphate, 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.

[0097] The amount of API can vary. For example, if present, the API is typically in a concentration of about 0.001% by weight to about 10% by weight based on the total weight of the composition, such as about 0.01% by weight, about 0.02% by weight, about 0.03% by weight, about 0.04% by weight, about 0.05% by weight, about 0.06% by weight, about 0.07% by weight, about 0.08% by weight, about 0.09% by weight, about 0.1% by weight, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight, about 0.9% by weight, or about 1% by weight to about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, or about 10% by weight.

[0098] In some embodiments, the composition is substantially free of any APIs. "Substantially free of any APIs" means that the composition does not contain, and in particular excludes, any APIs as defined herein, such as any Food and Drug Administration (FDA) approved therapeutic agents intended to treat any medical condition.

[0099] Flavoring agent In some embodiments, the releaseable material may be a flavoring agent. As used herein, “flavoring agent” or “flavoring substance” is any flavor-rich or aromatic substance that can alter the sensory properties associated with an oral product. Examples of sensory properties that can be modified by a flavoring agent include taste, mouthfeel, moisture, coldness / heat and / or aroma. Flavoring agents may be natural or synthetic, and the flavor characteristics they impart may be described as fresh, sweet, herbal, confectionery, floral, fruity, or spicy, but are not limited to these. In some embodiments, the releaseable material may comprise a single flavoring agent or multiple flavoring agents. If desired, one or more flavoring agents may be retained in porous alumina, and one or more flavoring agents may otherwise be retained in the composition and / or product, for example, by binding to further fillers.

[0100] Non-limiting examples of flavoring agents that may be used as releaseable materials and / or otherwise contained in the Composition and / or Product (e.g., if not held by porous alumina) as described herein include vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, trigeminal sensates, terpenes, and any combination thereof. See also Leffingwell et al., Tobacco Flavoring for Smoking Products, RJ Reynolds Tobacco Company (1972), incorporated herein by reference. Flavoring agents may include components such as terpenes, terpenoids, aldehydes, ketones, and esters. In some embodiments, the flavoring agent is a trigeminal sensory evoker. As used herein, “trigeminal sensory evoker” refers to a flavoring agent that affects the trigeminal nerve and produces sensations including hot, cold, and tingling. Non-limiting examples of trigeminal sensory evoker flavoring agents include capsaicin, citric acid, menthol, Sichuan peony, erythritol, and cubebol. Flavorings may also include components considered as humectants, coolants, or smoothers, such as eucalyptus. These flavors may be provided neat (i.e., individually) or in complexes and may be used as concentrates or flavor packages (e.g., spearmint and menthol, orange and cinnamon; lime, pineapple, etc.). Representative types of components are also described in U.S. Patent No. 5,387,416 by White et al.; U.S. Patent Application Publication No. 2005 / 0244521 by Strickland et al.; and PCT Application Publication No. WO05 / 041699 by Quinter et al., which are incorporated herein by reference, respectively.In some cases, the flavoring agent may be provided in a spray-drying or liquid form.

[0101] Flavoring agents generally include at least one volatile flavor component. As used herein, “volatile” refers to a chemical substance that readily forms vapor at ambient temperature (i.e., a chemical substance that has a higher vapor pressure at a given temperature compared to a non-volatile substance). Typically, volatile flavor components have a molecular weight of less than about 400 Da and often include at least one carbon-carbon double bond, a carbon-oxygen double bond, or both. In one embodiment, at least one volatile flavor component includes one or more alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, or combinations 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 1-hydroxy-2-propanone and 2-hydroxy-3-methyl-2-cyclopentenone-1-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, γ-terpinene, β-farnesene, nerolidol, thujone, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. In one embodiment, at least one volatile flavor component comprises one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, γ-terpinene, β-farnesene, or citral. In a further embodiment, at least one volatile flavor component comprises one or more of methyl salicylate, ethyl salicylate, menthol, spearmint, peppermint, and other mint plant species or mint plant derivatives. In one embodiment, at least one volatile flavor component comprises ethyl vanillin.

[0102] The amount of flavoring agent used in the mixture may vary, but is typically up to about 10 weight percent, and certain embodiments feature a flavoring agent content of at least about 0.1 weight percent, for example, 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 mixture.

[0103] Tobacco materials In some embodiments, the composition and / or product may contain tobacco material. The tobacco material may vary in species, type, and form. Generally, the tobacco material is obtained from harvested plants of the Nicotiana species. Examples of Nicotiana species include N. tabacum, N. rustica, N. alata, N. arentsi, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N. gossei, and N. kawakam ii) N. knightiana, N. langsdorffi, N. otophora, N. setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis, N. undulata, Nx sandelae N. sanderae), N. africana, N. amplexicaulis, N. benavidesii, N. bonariensis, N. debneyi, N. longiflora, N. maritina, N. megalosiphon, N. occidentalis, N. paniculata, N. plum N. plumbaginifolia, N. raimondii, N. rosulata, N. simulans, N. stocktonii, N. suaveolens, N. umbrella, N. velutina, N. wigandioides, N. acaulis, N. acuminata, N.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 (subspecies hellsperis) Examples include subsp. Herperis, N. pauciflora, N. petunioides, N. quadrivalvis, N. repanda, N. rotundifolia, N. solanifolia, and N. spegazzinii. Various other representative plant types derived from the Nicotiana species are described in U.S. Patent No. 4,660,577 by Sensabaugh, Jr., et al.; U.S. Patent No. 5,387,416 by White, et al.; U.S. Patent No. 7,025,066 by Lawson, et al.; U.S. Patent No. 7,798,153 by Lawrence, Jr.; and U.S. Patent No. 8,186,360 by Marshall, et al., which are incorporated herein by reference. Descriptions of various types of tobacco, cultivation practices, and harvesting practices are found in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999), which is incorporated herein by reference.

[0104] Nicotiana species from which suitable tobacco material can be obtained can be induced using genetic modification or hybrid breeding techniques (for example, tobacco plants can generally be genetically modified or hybrid bred to increase or decrease the generation of components, traits, or attributes). See, for example, U.S. Patent No. 5,539,093 by Fitzmaurice et al.; U.S. Patent No. 5,668,295 by Wahab et al.; U.S. Patent No. 5,705,624 by Fitzmaurice et al.; U.S. Patent No. 5,844,119 by Weigl; U.S. Patent No. 6,730,832 by Dominguez et al.; U.S. Patent No. 7,173,170 by Liu et al.; U.S. Patent No. 7,208,659 by Colliver et al. and U.S. Patent No. 7,230,160 by Benning et al.; U.S. Patent Publication No. 2006 / 0236434 by Conkling et al.; and PCT WO2008 / 103935 by Nielsen et al. for types of genetic modification of plants. See also U.S. Patent No. 4,660,577 by Sensabaugh, Jr. et al.; U.S. Patent No. 5,387,416 by White et al.; and U.S. Patent No. 6,730,832 by Dominguez et al. These are incorporated herein by reference, respectively.

[0105] Nicotiana species can be selected in some embodiments based on the content of various compounds present therein. For example, plants can be selected based on the fact that they produce relatively large amounts of one or more compounds from which isolation is desired. In certain embodiments, Nicotiana species (e.g., Galpao commun tobacco) are cultivated in particular because of their richness in leaf surface compounds. Tobacco plants may be grown in greenhouses, growth chambers, or in open fields, or hydroponically.

[0106] Various parts or portions of the Nicotiana species plant may be included in the mixture as disclosed herein. For example, virtually the entire plant (e.g., the whole plant) can be harvested and used on its own. Alternatively, various parts or fragments of the plant can be harvested or separated for further use after harvesting. For example, flowers, leaves, stems, trunks, roots, seeds and various combinations thereof can be isolated for further use or processing. In some embodiments, the tobacco material includes tobacco leaves (leaf blades). The mixtures disclosed herein may include processed tobacco parts or fragments, cured and aged tobacco in essentially natural leaf blade and / or stem form, tobacco extracts, extracted tobacco pulp (e.g., using water as a solvent), or mixtures of the foregoing (e.g., a mixture of extracted tobacco pulp and granulated, cured and aged natural tobacco leaf blades).

[0107] In certain embodiments, the tobacco material comprises a solid tobacco material selected from the group consisting of leaf blades and stems. The tobacco used in this mixture most preferably comprises tobacco leaf blades, or a mixture of tobacco leaf blades and stems (at least a portion thereof being smoke-treated or treated by smoke perspiration). The tobacco portion in the mixture may have a processed form, such as processed tobacco stems (e.g., cut and rolled stems, cut, rolled and expanded stems, or cut and inflated stems) or volume-expanded tobacco (e.g., inflated tobacco such as dry ice-expanded tobacco (DIET)). See, for example, the tobacco expansion processes described in U.S. Patent No. 4,340,073 by de la Burde et al.; U.S. Patent No. 5,259,403 by Guy et al.; and U.S. Patent No. 5,908,032 by Poindexter et al.; and U.S. Patent No. 7,556,047 by Poindexter et al. All of these are incorporated by reference. Furthermore, the mixture may optionally incorporate fermented tobacco. See also the tobacco processing techniques of the type described in PCT WO2005 / 063060, Atchley et al., which are incorporated herein by reference.

[0108] Tobacco material is typically used in a form that can be described as particulate (i.e., in the form of shredded, crushed, granulated, or powdered). There can be various methods for providing tobacco material in a finely ground or powdered form. Preferably, parts or fragments of the plant are finely crushed, crushed, or pulverized into particulate form using apparatus and techniques for crushing, grinding, etc. Most preferably, the plant material is in a relatively dry state during crushing or grinding using apparatus such as a hammer mill, cutter head, or air-controlled mill. For example, parts or fragments of tobacco can be crushed or ground when their moisture content is less than about 15 weight percent or less than about 5 weight percent. Most preferably, tobacco material is used in the form of parts or fragments having an average particle size of 1.4 mm to 250 microns. In some cases, tobacco particles can be sized to pass through a screen mesh to obtain the required particle size range. If desired, an air classifier can be used to ensure that tobacco particles of a desired size or size range are collected. If desired, fragments of granulated tobacco of different sizes can be mixed together.

[0109] There can be various methods for providing tobacco in a finely ground or powdered form. Preferably, parts or fragments of tobacco are finely crushed, crushed, or pulverized into a powdered form using apparatus and techniques for crushing, grinding, etc. Most preferably, the tobacco is in a relatively dry state during crushing or grinding using apparatus such as a hammer mill, cutter head, or air-controlled mill. For example, parts or fragments of tobacco may be crushed or pulverized when their moisture content is less than about 15% by weight or less than about 5% by weight. For example, a tobacco plant or a part thereof can be separated into individual parts or fragments (for example, leaves can be removed from the stem, and / or stems and leaves can be removed from the trunk). The harvested plant or individual parts or fragments can be further subdivided into parts or fragments (for example, leaves can be shredded, cut, finely crushed, pulverized, ground, or crushed into fragments or parts that can be characterized as filler-type fragments, granules, fine particles or fine powder). Plants or parts thereof can be subjected to external forces or pressure (for example, by pressing or rolling). When such processing conditions are applied, plants or parts thereof may have a moisture content close to their natural moisture content (for example, their moisture content immediately after harvest), a moisture content achieved by adding water to the plants or parts thereof, or a moisture content resulting from drying the plants or parts thereof. For example, powdered, pulverized, crushed or ground fragments of plants or parts thereof may have a moisture content of less than about 25 weight percent, often less than about 20 weight percent, and frequently less than about 15 weight percent.

[0110] In the preparation of oral products, it is typical to subject harvested Nicotiana plants to a curing process. Tobacco material incorporated into mixtures for inclusion in products such as those disclosed herein is properly cured and / or aged. Descriptions of various types of curing processes for various types of tobacco are found in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999). Examples of techniques and conditions for curing full-cured tobacco are found in Nestor et al., Beitrage Tabakforsch. Int., 20, 467-475 (2003) and Peele's U.S. Patent No. 6,895,974, which are incorporated herein by reference. Typical techniques and conditions for air-curing tobacco are described in Groves et al., U.S. Patent No. 7,650,892; 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 tobacco may be subjected to alternative curing processes such as fire curing or sun curing.

[0111] In certain embodiments, possible tobacco materials include full-cured or Virginia (e.g., K326), Burley, sun-cured (e.g., Indian Carnool and Oriental tobaccos, which include Caterini, Prelip, Comotini, Xanthi and Yambol tobaccos), Maryland, Dark, Dark Fired, Dark Air-Cured (e.g., Madruk, Pasanda, Cubano, Jatin and Bezki tobaccos), Light Air-Cured (e.g., North Wisconsin and Galpao tobaccos), Indian Air-Cured, Red Russian and Rustika tobaccos, as well as various other rare or special tobaccos and various blends of any of the aforementioned tobaccos.

[0112] Tobacco materials may also be in so-called “blended” forms. For example, tobacco materials may include mixtures of parts or fragments of fluffed, Burley (e.g., Malawi Burley tobacco) and Oriental tobacco (e.g., as tobacco consisting of or derived from tobacco leaves, or a mixture of tobacco leaves and tobacco stems). For example, a typical blend may incorporate, on a dry weight basis, about 30 to about 70 parts Burley tobacco (e.g., leaves, or leaves and stems) and about 30 to about 70 parts fluffed tobacco (e.g., stems, leaves, or leaves and stems). Other exemplary tobacco blends may incorporate, on a dry weight basis, about 75 parts fluffed tobacco, about 15 parts Burley tobacco and about 10 parts Oriental tobacco; or about 65 parts fluffed tobacco, about 25 parts Burley tobacco and about 10 parts Oriental tobacco; or about 65 parts fluffed tobacco, about 10 parts Burley tobacco and about 25 parts Oriental tobacco. Other exemplary tobacco blends incorporate approximately 20 to 30 parts Oriental tobacco and 70 to 80 parts Flu-Cured tobacco on a dry weight basis.

[0113] The tobacco material used in this disclosure may be subjected to, for example, fermentation, bleaching, etc. If desired, the tobacco material may be subjected to, for example, irradiation, pasteurization, or other controlled heat treatment. Such processing processes are described in detail, for example, U.S. Patent No. 8,061,362, by Mua et al., which is incorporated herein by reference. In certain embodiments, the tobacco material may be treated with water and additives that can inhibit the reaction of asparagine to form acrylamide when the tobacco material is heated (e.g., additives selected from the group consisting of lysine, glycine, histidine, alanine, methionine, cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine, arginine, compositions incorporating divalent and trivalent cations, asparaginase, certain non-reducing sugars, certain reducing agents, phenolic compounds, certain compounds having at least one free thiol group or functional group, oxidizing agents, oxidation catalysts, natural plant extracts (e.g., rosemary extract), and combinations thereof). For example, refer to the types of processing described in U.S. Patent Publication No. 8,434,496, U.S. Patent Publication No. 8,944,072 and U.S. Patent Publication No. 8,991,403 by Chen et al., all of which are incorporated herein by reference. In certain embodiments, this type of processing is useful when the original tobacco material is subjected to heat in the aforementioned processes.

[0114] In some embodiments, the type of tobacco material is selected such that its color is initially visually brighter (e.g., whitened or bleached) than other tobacco materials. In certain embodiments, tobacco pulp can be whitened by any means known in the art. For example, bleached tobacco material can be produced by various whitening methods using various bleaching or oxidizing agents and oxidation catalysts. Exemplary oxidizing agents include peroxides (e.g., hydrogen peroxide), chlorites, chlorates, perchlorates, hypochlorites, ozone, ammonia, potassium permanganate, and combinations thereof. Exemplary oxidation catalysts include titanium dioxide, manganese dioxide, and combinations thereof.The process for treating tobacco with bleach is, for example, U.S. Patent No. 787,611 of Daniels, Jr.; U.S. Patent No. 1,086,306 of Oelenheinz; U.S. Patent No. 1,437,095 of Delling; U.S. Patent No. 1,757,477 of Rosenhoch; U.S. Patent No. 2,122,421 of Hawkinson; U.S. Patent No. 2,148,147 of Baier; U.S. Patent No. 2,170,107 of Baier; U.S. Patent No. 2,274,649 of Baier; U.S. Patent No. 2,770,239 of Prats, etc.; U.S. Patent No. 3 of Rosenhoch. U.S. Patent No. 612,065; Rosen's U.S. Patent No. 3,851,653; Rosen's U.S. Patent No. 3,889,689; Minami's U.S. Patent No. 3,943,940; Rosen's U.S. Patent No. 3,943,945; Rainer's U.S. Patent No. 4,143,666; Campbell's U.S. Patent No. 4,194,514; Rainer et al.'s U.S. Patents No. 4,366,823, 4,366,824 and 4,388,933; Schmekel et al.'s U.S. Patent No. 4,641,667; Berger's U.S. Patent No. 5,713,376; Byrd This is discussed in U.S. Patent No. 9,339,058 by Jr. et al.; U.S. Patent No. 9,420,825 by Beeson et al.; and U.S. Patent No. 9,950,858 by Byrd Jr. et al.; and U.S. Patent Publication No. 2012 / 0067361 by Bjorkholm et al.; U.S. Patent Publication No. 2016 / 0073686 by Crooks; U.S. Patent Publication No. 2017 / 0020183 by Bjorkholm; and U.S. Patent Publication No. 2017 / 0112183 by Bjorkholm; and PCT Publication WO1996 / 031255 by Giolvas and PCT Publication WO2018 / 083114 by Bjorkholm, all of which are incorporated herein by reference.

[0115] In some embodiments, the whitened tobacco material may 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 may have an ISO brightness in the range of about 50% to about 90%, about 55% to about 75%, or about 60% to about 70%. The ISO brightness may be measured according to ISO 3688:1999 or ISO 2470-1:2016.

[0116] In some embodiments, whitened tobacco material may be characterized as being lighter in color (e.g., "whitened") compared to untreated tobacco material. White is often defined by referring to the International Commission on Illumination (CIE) chromaticity diagram. In certain embodiments, whitened tobacco material may be characterized as being closer to pure white on the chromaticity diagram than untreated tobacco material.

[0117] In various embodiments, tobacco material may be processed to extract soluble components of the tobacco material therefrom. As used herein, “tobacco extract” refers to isolated components of tobacco material extracted from solid tobacco pulp by a solvent that is contacted with the tobacco material in the extraction process. Various extraction techniques for tobacco material can be used to provide tobacco extracts and tobacco solid materials. See, for example, the extraction process described in Beeson et al., U.S. Patent Application Publication No. 2011 / 0247640, which is incorporated herein by reference.Other exemplary techniques for extracting tobacco components include U.S. Patent No. 4,144,895 by Fiore; U.S. Patent No. 4,150,677 by Osborne, Jr., et al.; U.S. Patent No. 4,267,847 by Reid; U.S. Patent No. 4,289,147 by Wildman, et al.; U.S. Patent No. 4,351,346 by Brummer, et al.; U.S. Patent No. 4,359,059 by Brummer, et al.; U.S. Patent No. 4,506,682 by Muller; U.S. Patent No. 4,589,428 by Keritsis; U.S. Patent No. 4,605,016 by Soga, et al.; and Poul U.S. Patent No. 4,716,911 by ose et al.; U.S. Patent No. 4,727,889 by Niven, Jr. et al.; U.S. Patent No. 4,887,618 by Bernasek et al.; U.S. Patent No. 4,941,484 by Clapp et al.; U.S. Patent No. 4,967,771 by Fagg et al.; U.S. Patent No. 4,986,286 by Roberts et al.; U.S. Patent No. 5,005,593 by Fagg et al.; U.S. Patent No. 5,018,540 by Grubbs et al.; U.S. Patent No. 5,060,669 by White et al.; U.S. Patent No. 5,065,775 by Fagg et al.; U.S. Patent No. 5 by White et al. 5,099,862; 5,121,757; 5,131,414; 5,131,415; 5,148,819; 5,197,494; 5,230,354; 5,234,008; 5,243,999; 5,301,694; Gonzalez-Par These are described in U.S. Patent No. 5,318,050 by ra et al.; U.S. Patent No. 5,343,879 by Teague; U.S. Patent No. 5,360,022 by Newton; U.S. Patent No. 5,435,325 by Clapp et al.; U.S. Patent No. 5,445,169 by Brinkley et al.; U.S. Patent No. 6,131,584 by Lauterbach; U.S. Patent No. 6,298,859 by Kierulff et al.; U.S. Patent No. 6,772,767 by Mua et al.; and U.S. Patent No. 7,337,782 by Thompson, all of which are incorporated herein by reference.

[0118] The typical range of tobacco material content may vary depending on the properties and type of tobacco material and the intended effect on the final mixture, with exemplary ranges being 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 the total weight of the mixture (e.g., about 0.1 to about 15% by weight). In some embodiments, the products of the Disclosure may be characterized as being completely or substantially free of tobacco material (except for purified nicotine as an active ingredient). For example, certain embodiments may be characterized as having less than 1% by weight, less than 0.5% by weight, less than 0.1% by weight of tobacco material, or 0% by weight of tobacco material. In some embodiments, the compositions or products of the Disclosure may contain about 10% by weight or less of tobacco material, based on the total weight of the mixture, excluding any nicotine components present.

[0119] Further additives In some embodiments, one or more further additives may be included in the disclosed compositions and / or products. For example, these compositions may be processed, blended, formulated, combined and / or mixed with other materials or components. These additives may be artificial, or obtained or derived from herbal or biological sources. Certain types of further additives that may be included are described further below.

[0120] In some embodiments, compositions and products may contain water content. The water content of the composition in the product before consumer use may vary according to the desired properties. Typically, the composition present in the product before insertion into the user's mouth may contain less than 60% by weight, less than 50% by weight, less than 40% by weight, less than 30% by weight, less than 20% by weight, less than 10% by weight, or less than 5% by weight of water. For example, the total water content in the composition and / or product may be in the range of about 0.1% to about 60% by weight, about 1% to about 50% by weight, about 1.5% to about 40% by weight, or about 2% to about 25% by weight of water. In some embodiments, compositions and products may contain at least 1% by weight, at least 2% by weight, at least 5% by weight, at least 10% by weight, or at least 20% by weight of water.

[0121] In some embodiments, compositions and products may contain one or more organic acid contents. As used herein, the term “organic acid” refers to an organic (i.e., carbon-based) compound characterized by acidic properties. Typically, organic acids are relatively weak acids such as carboxylic acids (-CO2H) or sulfonic acids (-SO2OH) (i.e., they do not completely dissociate in the presence of water). As used herein, references to organic acids mean organic acids that are intentionally added. In this regard, organic acids may be intentionally added as specific components rather than simply existing as components of another component (e.g., small amounts of organic acids that may be essentially present in components such as tobacco materials). In some embodiments, one or more organic acids are added neat (i.e., in the form of their free acids, natural solids or liquids) or, for example, as a solution in water. In some embodiments, one or more organic acids are added in the form of salts, as described below herein.

[0122] In some embodiments, the organic acid is an alkylcarboxylic acid. Non-limiting examples of alkylcarboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, and linolenic acid. In some embodiments, the organic acid is an alkylsulfonic acid. Non-limiting examples of alkylsulfonic acids include propanesulfonic acid and octanesulfonic acid. In some embodiments, the alkylcarboxylic acid or sulfonic acid is substituted with one or more hydroxyl groups. Non-limiting examples include glycolic acid, 4-hydroxybutyric acid, and lactic acid. In some embodiments, the organic acid may contain 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 an organic acid containing multiple carboxylic acids (e.g., two to four carboxylic acid groups), one or more carboxylic acid groups may be esterified. Non-limiting examples include monoethyl succinate, monomethyl fumarate, monomethyl citrate, or dimethyl citrate.

[0123] In some embodiments, the organic acid may contain one or more carboxylic acid groups and one or more hydroxyl groups. Non-limiting examples of such acids include tartaric acid and citric acid. In some embodiments, the organic acid is an aryl carboxylic acid or aryl sulfonic acid. Non-limiting examples of aryl carboxylic acids and sulfonic acids include benzoic acid, toluic acid, salicylic acid, benzenesulfonic acid, and p-toluenesulfonic acid. In some embodiments, the organic acid is citric acid, malic acid, tartaric acid, octanoic acid, benzoic acid, 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, some or all of the organic acid may be added in the form of a salt having an alkaline component that may, but is not limited to, nicotine. For example, non-limiting examples of appropriate salts for nicotine include formate, acetate, propionate, isobutyrate, butyrate, α-methylbutyrate, isovalerate, β-methylvalerate, caproate, 2-fluteate, phenylacetate, heptanoate, octanoate, nonanoate, oxalate, malonate, glycolate, benzoate, tartrate, levulinate, ascorbate, fumarate, citrate, malate, lactate, aspartate, salicylate, tosylate, succinate, and pyruvate.

[0124] The amount of organic acid present in the composition may vary. Generally, the composition may contain 0 to about 10% by weight of one or more organic acids, based on the total weight of the mixture.

[0125] In some embodiments, the composition may further contain a salt (e.g., an alkali metal salt) in an amount sufficient to provide the composition and product with the desired sensory attributes. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, and flour salt. If present, a typical amount of salt is about 0.5 weight percent or more, about 1.0 weight percent or more, or about 1.5 weight percent or more, but typically accounts for about 10 weight percent or less, or about 7.5 weight percent or less, or about 5 weight percent or less (e.g., about 0.5 to about 5 weight percent) of the total weight of the composition or product.

[0126] The compositions and products may also contain one or more sweeteners. The sweeteners may 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, and honey. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, and neotame. In some embodiments, the sweeteners include one or more sugar alcohols. Sugar alcohols are polyols derived from monosaccharides or disaccharides in a partially or fully hydrogenated form. Sugar alcohols include, for example, those having about 4 to about 20 carbon atoms, such as erythritol, arabitol, ribitol, isomalt, maltitol, dalcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrolyzed starch). If present, a typical amount of sweetener may be about 0.1 to about 20 weight percent or more of the composition based on the total weight of the composition or product, for example, about 0.1 to about 1%, about 1 to about 5%, about 5 to about 10%, or about 10 to about 20% by weight of the composition or product.

[0127] In some embodiments, compositions and products may contain one or more binders. In certain embodiments, a binder (or combination of binders) may be used in an amount sufficient to provide the composition with desired physical attributes and physical integrity, and the binder may also often function as a thickener or gelling agent. Typical binders may be organic, inorganic, or a combination thereof. Representative binders include povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and combinations thereof. In some embodiments, the binder may include pectin or carrageenan or a combination thereof. The amount of binder used may vary, but is typically up to about 30% by weight, and certain embodiments feature a binder content of at least about 0.1% by weight, e.g., about 1 to about 30% by weight or about 5 to about 10% by weight, based on the total weight of the composition or product.

[0128] In certain embodiments, the binder includes gum, such as natural gum. As used herein, natural gum refers to naturally occurring polysaccharide materials that have binding properties and are also useful as thickeners or gelling agents. Typical plant-derived natural gums that are somewhat water-soluble include xanthan gum, guar gum, gum arabic, guatti gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof. Where present, the natural gum binder material is typically present in amounts up to about 5% by weight based on the total weight of the composition or product, for example, about 0.1% by weight, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight, about 0.9% by weight, or about 1% to about 2% by weight, about 3% by weight, about 4% by weight, or about 5% by weight.

[0129] In certain embodiments, one or more humectants may be used in the composition. Examples of humectants include, but are not limited to, glycerin and propylene glycol. If included, the humectant is typically provided in an amount sufficient to give the composition the desired moisture properties. Furthermore, in some cases, the humectant can impart desirable flow properties to the composition for deposition in a mold. If present, the humectant typically accounts for about 5% by weight or less of the weight of the composition or product (e.g., about 0.5% to about 5% by weight). If present, a typical 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 composition or product.

[0130] In certain embodiments, the compositions of the present disclosure may include pH adjusters or buffers. Examples of usable pH adjusters and buffers 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. If present, buffers are typically present in amounts of less than about 5% by weight based on the weight of the composition or product, for example, about 0.5% to about 5% by weight based on the total weight of the composition or product, for example, about 0.75% to about 4% by weight, about 0.75% to about 3% by weight, or about 1% to about 2% by weight. Non-limiting examples of suitable buffers include alkali metal acetates, glycines, phosphates, glycerophosphates, citrates, carbonates, bicarbonates, borates, or mixtures thereof.

[0131] In some embodiments, compositions and products may contain one or more colorants. The colorants may be used in an amount sufficient to provide the composition or product with the desired physical attributes. Examples of colorants include various dyes and pigments such as caramel color and titanium dioxide. The amount of colorant used in a composition or product may vary, but if present, is typically up to about 3% by weight, based on the total weight of the composition or product, for example, about 0.1% by weight, about 0.5% by weight, or about 1% to about 3% by weight.

[0132] Further examples of other types of additives that can be used in the present composition and product include thickeners or gelling agents (e.g., fish gelatin), emulsifiers, oral care additives (e.g., thyme oil, eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate), disintegrants, zinc or magnesium salts selected to be relatively water-soluble for more water-soluble compositions (e.g., magnesium gluconate or zinc gluconate) or zinc or magnesium salts selected to be relatively water-insoluble for compositions with reduced water solubility (e.g., magnesium oxide or zinc oxide) or combinations thereof. See, for example, U.S. Patent No. 9,237,769 by Mua et al., U.S. Patent No. 7,861,728 by Holton, Jr. et al., U.S. Patent Publication No. 2010 / 0291245 by Gao et al., and U.S. Patent Publication No. 2007 / 0062549 by Holton, Jr. et al. for typical components, combinations of components, relative amounts of components, and methods for using components, respectively. These are incorporated herein by reference. The typical range of such additional additives may vary depending on the properties and functions of the additive and the intended effect on the final mixture, with an exemplary range being up to about 10% by weight (e.g., about 0.1 to about 5% by weight) based on the total weight of the mixture.

[0133] The aforementioned additives may be used together (e.g., as an additive formulation) or separately (e.g., individual additive components may be added at different stages involved in the preparation of the final mixture). Furthermore, the aforementioned types of additives may be encapsulated, as provided in the final product or mixture. Exemplary encapsulated additives are described, for example, in Atchley's WO2010 / 132444, which has already been incorporated herein by reference.

[0134] particle In some embodiments, one or more of the filler components, tobacco materials, and the entire oral product described herein may be described as particulate materials. As used herein, the term “particulate” refers to a material in the form of a plurality of individual particles, some of which may be in the form of aggregates of the plurality of particles, and these particles have an average length-to-width ratio of less than 2:1, for example less than 1.5:1, for example about 1:1. In various embodiments, the particles of the particulate material may be described as substantially spherical or granular.

[0135] The particle size of particulate matter can be measured by sieve analysis. As will be readily apparent to those skilled in the art, sieve analysis (also known as gradation testing) is a method used to measure the particle size distribution of particulate matter. Typically, sieve analysis involves a nested column of sieves, preferably containing screens in the form of wire mesh. A pre-weighed sample may be introduced into the top or uppermost sieve of the column, which has the largest screen opening or mesh size (i.e., the largest pore size of the sieve). Each lower sieve in the column has a screen opening or mesh size that gradually decreases with increasing size compared to the upper sieves. Typically, the base of the sieve column has a receiver for collecting particles having a particle size smaller than the screen opening or mesh size of the bottom or lowermost sieve in the column (which has the smallest screen opening or mesh size).

[0136] In some embodiments, the sieve column may be placed above or inside a mechanical stirrer. The stirrer causes vibration of each sieve in the column. The mechanical stirrer can be operated for a predetermined period of time to ensure that all particles are collected on the correct sieve. In some embodiments, the sieve column is stirred for 0.5 to 10 minutes, e.g., 1 to 10 minutes, e.g., 1 to 5 minutes, e.g., about 3 minutes. Once the stirring of the sieves in the column is complete, the material collected on each sieve is weighed. The weight of each sample on each sieve can then be divided by the total weight to obtain the percentage of mass held on each sieve. As will be readily apparent to those skilled in the art, the screen opening size or mesh size for each sieve in the column used for sieve analysis may be selected based on the particle size of the sample to be analyzed or the known maximum / minimum particle size. In some embodiments, the sieve column may be used for sieve analysis, where the column comprises 2 to 20 sieves, e.g., 5 to 15 sieves. In some embodiments, a sieve column may be used for sieve analysis, where the column comprises 10 sieves. In some embodiments, the maximum screen opening or mesh size of the sieves used for sieve analysis may be 1000 μm, e.g., 500 μm, e.g., 400 μm, e.g., 300 μm.

[0137] In some embodiments, any particulate material referenced herein (e.g., filler components, tobacco materials, and entire oral products) may be characterized by having at least 50% by weight of particles with a particle size of about 1000 μm or less, e.g., about 500 μm or less, e.g., about 400 μm or less, e.g., about 350 μm or less, e.g., about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 60% by weight of particles of any particulate material referenced herein may have a particle size of about 1000 μm or less, e.g., about 500 μm or less, e.g., about 400 μm or less, e.g., about 350 μm or less, e.g., about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 70% by weight of particles of any particulate material referenced herein may have a particle size of about 1000 μm or less, e.g., about 500 μm or less, e.g., about 400 μm or less, e.g., about 350 μm or less, e.g., about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 80% by weight of the particles of any particulate material referenced herein have a particle size of about 1000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 90% by weight of the particles of any particulate material referenced herein have a particle size of about 1000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 95% by weight of the particles of any particulate material referenced herein have a particle size of about 1000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 99% by weight of the particles of any particulate material referenced herein have a particle size of about 1000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis.In some embodiments, about 100% by weight of the particles of any particulate material referenced herein have a particle size of about 1000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis.

[0138] In some embodiments, at least 50% by weight, e.g., at least 60% by weight, e.g., at least 70% by weight, e.g., at least 80% by weight, e.g., at least 90% by weight, e.g., at least 95% by weight, e.g., at least 99% by weight, of the particles of any particulate material referenced herein have a particle size of about 0.01 μm to about 1000 μm, e.g., about 0.05 μm to about 750 μm, e.g., about 0.1 μm to about 500 μm, e.g., about 0.25 μm to about 500 μm, as measured by sieve analysis. In some embodiments, at least 50% by weight, e.g., at least 60% by weight, e.g., at least 70% by weight, e.g., at least 80% by weight, e.g., at least 90% by weight, e.g., at least 95% by weight, e.g., at least 99% by weight, of the particles of any particulate material referenced herein have a particle size of about 10 μm to about 400 μm or less, e.g., about 50 μm to about 350 μm, e.g., about 100 μm to about 350 μm, e.g., about 200 μm to about 300 μm, as measured by sieve analysis.

[0139] preparation The method of combining the various components of this composition can vary. Therefore, the total mixture of the various components, for example, powdered mixture components, may be relatively homogeneous in nature. The above components, which may be in liquid or dry solid form, may be mixed in a pretreatment step before mixing with the remaining components of the mixture, or they may simply be mixed together with all the other liquid or dry components. The various components may be brought into contact, combined, or mixed together using any mixing technique or apparatus known in the art. Any mixing method that brings the mixed components into close contact may be used, such as a mixing apparatus featuring an impeller or other agitable structure. Examples of mixing apparatus include casing drums, conditioning cylinders or drums, liquid spray devices, conical type blenders, ribbon blenders, mixers available as FKM130, FKM600, FKM1200, FKM2000 and FKM3000 from Littleford Day, Inc., Plough Share type mixer cylinders, Hobart mixers, and the like. See also, for example, U.S. Patent No. 4,148,325 by Solomon et al.; U.S. Patent No. 6,510,855 by Korte et al.; and U.S. Patent No. 6,834,654 by Williams. These are each incorporated herein by reference. In some embodiments, the components forming the mixture are prepared so that the mixture can be used in a starch molding process for forming the mixture. Techniques and methods for compounding the mixture will be apparent to those skilled in the art. See, for example, U.S. Patent No. 4,148,325 by Solomon et al.; U.S. Patent No. 6,510,855 by Korte et al.; and U.S. Patent No. 6,834,654 by Williams, U.S. Patent No. 4,725,440 by Ridgway et al.; and U.S. Patent No. 6,077,524 by Bolder et al. These are each incorporated herein by reference.

[0140] Designed for oral use Provided herein are products configured for oral use. As used herein, the term “configured for oral use” means that the product is provided in such a form that, during use, one or more components of the mixture (e.g., flavoring agents and / or nicotine) are delivered to the user’s mouth by saliva in the user’s mouth. In certain embodiments, the product is adapted to deliver releaseable components to the user through the mucous membrane of the user’s mouth, and in some cases, the releaseable components are active ingredients (e.g., nicotine) that can be absorbed through the mucous membrane of the mouth when the product is used.

[0141] Products configured for oral use as described herein may take various forms, including gels, tablets, gums, lozenges, powders, and pouches. Gels may be soft or hard. Certain products configured for oral use are in the form of tablets. As used herein, the term "tablet" refers to a soluble oral product made by solidifying a liquid or gel mixture, and therefore the final product is a somewhat hardened solid gel. The stiffness of the gel can vary considerably. Certain products of this disclosure are in solid form. Certain products may exhibit, for example, one or more of the following characteristics: crispness, granularity, chewiness, syrupiness, pasteiness, fluffiness, smoothness, and / or creaminess. In certain embodiments, the desired texture properties may be selected from the group consisting of adhesiveness, cohesiveness, density, dryness, fragility, granularity, stickiness, hardness, weight, hygroscopicity, moisture release, mouth coating, roughness, slipperiness, smoothness, viscosity, wetness, and combinations thereof.

[0142] Products containing the mixtures of this disclosure may be soluble. As used herein, the terms “soluble,” “solubility,” and “soluble” refer to a mixture having water-soluble components that interact with oral moisture to enter a solution, thereby causing the product to be gradually consumed. In one embodiment, a soluble product may persist in the user’s mouth for a given period of time until it is completely dissolved. The rate of dissolution may vary widely from about 1 minute or less to about 60 minutes. For example, rapid-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 may occur by any means such as melting, mechanical destruction (e.g., chewing), enzymatic or other chemical decomposition, or by the breakdown of interactions between the components of the mixture. In some embodiments, the product may be soluble, as discussed, for example, in U.S. Patent Application Publication No. 2012 / 0037175, Cantrell et al. In another embodiment, the product does not dissolve while it remains in the user's mouth.

[0143] In one embodiment, a product comprising the composition of the present disclosure is in the form of a mixture placed in a moisture-permeable container (e.g., a permeable pouch). Such a mixture in the form of a permeable pouch is typically used by placing one pouch containing the mixture into the mouth of a human subject / user. Generally, the pouch is placed somewhere in the user's oral cavity, for example, under the lips, in the same manner as moist snuff products are generally used. The pouch is preferably not chewed or swallowed. Then, upon exposure to saliva, some components of the mixture within it (e.g., active ingredients such as flavoring agents and / or nicotine) pass through, for example, the permeable pouch, providing the user with flavor and satisfaction, and the user does not need to spit out any part of the mixture. After use / enjoyment for about 10 to 60 minutes, typically about 15 to 45 minutes, a considerable amount of the mixture has been ingested by the human subject, and the pouch may be removed from the human subject's mouth for disposal.

[0144] Accordingly, in certain embodiments, mixtures such as those disclosed herein and any other components described above are combined in a moisture-permeable packet or pouch that serves as a container for using the mixture to provide a pouch product configured for oral use. Certain embodiments of the disclosure are described with reference to the figures, and these described embodiments involve a snus-type product having an outer pouch and containing a mixture such as those described herein. As described in more detail below, such embodiments are provided merely as examples, and the pouch products of the disclosure may contain other forms of compositions. The mixture / construction of such packets or pouches, such as the container pouch 102 in the embodiments shown in the figures, can vary. Referring to the figures, a first embodiment of pouch product 100 is shown. Pouch product 100 comprises a moisture-permeable container in the form of a pouch 102, which contains a material 104 containing a composition such as those described herein. Pouch product 100 may be an example of a product such as those described herein, formed at least partially from the described compositions.

[0145] Suitable packets, pouches, or containers of the type used in the manufacture of smokeless tobacco products are available under the trademarks of 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 a pouch and packaged using a method that utilizes components of the type used in the manufacture of conventional snus-type products. The pouch provides a permeable container of a type that can be considered to have characteristics similar to the mesh-type material used in the construction of tea bags. The components of the mixture readily diffuse through the pouch to the user's mouth.

[0146] No. limiting examples of suitable types of pouches are described, for example, in U.S. Patent No. 5,167,244 of Kjerstad and U.S. Patent No. 8,931,493 of Sebastian et al.; and U.S. Patent Publication No. 2016 / 0000140 of Sebastian et al.; U.S. Patent Publication No. 2016 / 0073689 of Sebastian et al.; U.S. Patent Publication No. 2016 / 0157515 of Chapman et al.; and U.S. Patent Publication No. 2016 / 0192703 of Sebastian et al., which are incorporated herein by reference, respectively. Pouches may be provided as individual pouches, or multiple pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25, or 30 pouches) may be connected or joined together (e.g., end-to-end) so that a single pouch or individual part can be easily removed for use from the one-piece strand or matrix of pouches.

[0147] Exemplary pouches may be made from and manufactured from materials such as those that undergo controlled dispersion or dissolution during use by the user. Such pouch materials may take the form of mesh, screen, perforated paper, permeable cloth, etc. For example, a pouch material made from rice paper or perforated rice paper in a mesh form can dissolve in the user's mouth. As a result, the pouch and the mixture can each be completely dispersed in the user's mouth during normal use conditions, and thus both the pouch and the mixture can be ingested by the user. Other examples of pouch materials may be manufactured using water-dispersible film-forming materials (e.g., binders such as alginates, carboxymethylcellulose, xanthan gum, pullulan), as well as those materials in combination with materials such as crushed cellulose (e.g., fine-grained wood pulp). Preferred pouch materials are water-dispersible or water-soluble, but may be designed and manufactured such that, under normal use conditions, a considerable amount of mixture contents permeate the pouch material before the pouch loses its physical integrity. If desired, flavoring components, disintegration aids, and other desired components can be incorporated into or applied to the pouch material.

[0148] The amount of material contained in each product unit, for example, a pouch, can vary. In some embodiments, the weight of the mixture in each pouch is at least about 50 mg, for example, about 50 mg to about 2 grams, about 100 mg to about 1.5 grams, or about 200 to about 700 mg. In some relatively small embodiments, the weight of the mixture in each pouch may be about 100 to about 300 mg. In relatively large embodiments, the weight of the material in each pouch may be about 300 mg to about 700 mg, about 700 mg to about 1.5 grams, or about 1 gram to about 2 grams. If desired, other components may be included in each pouch. For example, at least one flavored strip, fragment, or sheet of a flavored, water-dispersible or water-soluble material (e.g., an edible film-type material that refreshes breath) may be placed in each pouch with or without at least one capsule. Such strips or sheets may be folded or rolled up so as to be easily incorporated into the pouch. See, for example, U.S. Patent No. 6,887,307 by Scott et al. and U.S. Patent No. 6,923,981 by Leung et al., which are incorporated herein by reference; and the types of materials and technologies described in The EFSA Journal (2004) 85, 1-32.

[0149] Pouch products as described herein may be packaged in any suitable inner packaging material and / or outer container. Also, for example, Henson et al., U.S. Patent No. 7,014,039; Kutsch et al., U.S. Patent No. 7,537,110; Kutsch et al., U.S. Patent No. 7,584,843; Gelardi et al., U.S. Patent No. 8,397,945; Thiellier et al., D592,956; Patel et al., D594,154; and Bailey et al., D625,178; Robinson et al., U.S. Patent Publication No. 2008 / 0173317; Clark et al., U.S. Patent Publication No. 2009 / 0014343; Bjorkholm, U.S. Patent Publication No. 2009 / 0014450; Bellamah et al., U.S. See also the various types of containers for smokeless products described in U.S. Patent Publication No. 2009 / 0250360; U.S. Patent Publication No. 2009 / 0266837 by Gelardi; U.S. Patent Publication No. 2009 / 0223989 by Gelardi; U.S. Patent Publication No. 2009 / 0230003 by Thiellier; U.S. Patent Publication No. 2010 / 0084424 by Gelardi; and U.S. Patent Publication No. 2010 / 0133140 by Bailey et al.; U.S. Patent Publication No. 2010 / 0264157 by Bailey et al.; and U.S. Patent Publication No. 2011 / 0168712 by Bailey et al. These are incorporated herein by reference.

[0150] Many improvements and other embodiments of the present invention will come to mind for those skilled in the art who benefit from the teachings presented in the above description in the art to which the invention relates. It should therefore be understood that the invention is not limited to the specific embodiments disclosed, and that improvements and other embodiments are intended to be included within the scope of the appended claims. Certain terms are used herein, but these are used for general descriptive purposes only and not for limiting purposes.

Claims

1. A product designed for oral use, Releaseable materials, and Particulate filler containing porous alumina, A mixture containing, The porous alumina contains nanoalumina, At least a portion of the releaseable material is held by porous alumina, and the product is configured such that at least a portion of the releaseable material held by the porous alumina is released when the product is in the oral cavity. The mixture is enclosed within the pouch to form the pouch product. product.

2. The product according to claim 1, wherein the porous alumina contains γ-alumina.

3. The product according to claim 1, wherein the pores present in the porous alumina have an average pore diameter of 10 nm to 500 nm.

4. The product according to claim 1, wherein the porous alumina comprises pores having at least two different average pore diameters that do not overlap.

5. The product according to claim 4, wherein the porous alumina includes pores having a first average pore diameter of 10 nm to 50 nm and pores having a second average pore diameter of 100 nm to 500 nm.

6. The product according to claim 5, wherein pores having a first average pore diameter are effective for releasing a releaseable material at a first release rate, and pores having a second average pore diameter are effective for releasing a releaseable material at a second release rate different from the first release rate.

7. The product according to any one of claims 1 to 6, wherein the releaseable material contains one or more active ingredients.

8. The product according to claim 7, wherein one or more active ingredients are selected from the group consisting of nicotine components, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutritional supplements, and combinations thereof.

9. The product according to any one of claims 1 to 6, wherein the releaseable material comprises one or more flavoring agents.

10. The product according to claim 9, wherein one or more flavoring agents include a compound having a carbon-carbon double bond, a carbon-oxygen double bond, or both.

11. The product according to claim 9, wherein one or more flavoring agents comprise one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal nerve sensory stimulants, or combinations thereof.

12. The product according to claim 9, wherein one or more flavoring agents are selected from the group consisting of ethyl vanillin, cinnamaldehyde, sabinene, limonene, γ-terpinene, β-farnesene, citral, methyl salicylate, ethyl salicylate, menthol, peppermint, spearmint, other mint plant species, and combinations thereof.

13. The product according to any one of claims 1 to 6, comprising 10% by weight or less of tobacco material based on the total weight of the mixture, excluding any nicotine components present.

14. The product according to any one of claims 1 to 6, wherein the particulate filler further comprises a cellulose material.

15. The product according to any one of claims 1 to 6, further comprising one or more salts, one or more sweeteners, one or more binders, one or more humectants, one or more gums, tobacco materials, or a combination thereof.

16. The product according to any one of claims 1 to 6, wherein the porous alumina is in the form of particles having an average particle size of 50 μm to 500 μm.

17. A method for controlling the release rate of a releaseable material in a product configured for oral use, comprising mixing a releaseable material with a particulate filler containing porous alumina to obtain a mixture such that at least a portion of the releaseable material is held by porous alumina, and that when the product is in the oral cavity, at least a portion of the releaseable material held by the porous alumina is released from there at a controlled rate, The porous alumina contains nanoalumina, The product in question is a pouch product containing a mixture enclosed within a pouch. method.

18. The method according to claim 17, wherein the porous alumina includes pores having a first average pore diameter of 10 nm to 50 nm and pores having a second average pore diameter of 100 nm to 500 nm.

19. The method according to claim 18, wherein pores having a first average pore diameter are effective for releasing a release material at a first release rate, and pores having a second average pore diameter are effective for releasing a releaseable material at a second release rate different from the first release rate.

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