Oral Products and Method of Manufacture

The present application is a continuation of U.S. patent application Ser. No. 17/848,536, filed Jun. 24, 2022, which claims the benefit of and priority to U.S. Provisional Patent Application No. 63/215,204, filed Jun. 25, 2021, the disclosures of which are both incorporated herein by reference in their entirety.

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

Tobacco may be enjoyed in a so-called “smokeless” form. Particularly popular smokeless tobacco products are employed by inserting some form of processed tobacco or tobacco-containing formulation into the mouth of the user. Conventional formats for such smokeless tobacco products include moist snuff, snus, and chewing tobacco, which are typically formed almost entirely of particulate, granular, or shredded tobacco, and which are either portioned by the user or presented to the user in individual portions, such as in single-use pouches or sachets. Other traditional forms of smokeless products include compressed or agglomerated forms, such as plugs, tablets, or pellets. Alternative product formats, such as tobacco-containing gums and mixtures of tobacco with other plant materials, are also known. See for example, the types of smokeless tobacco formulations, ingredients, and processing methodologies set forth in U.S. Pat. No. 1,376,586 to Schwartz; U.S. Pat. No. 4,513,756 to Pittman et al.; U.S. Pat. No. 4,528,993 to Sensabaugh, Jr. et al.; U.S. Pat. No. 4,624,269 to Story et al.; U.S. Pat. No. 4,991,599 to Tibbetts; U.S. Pat. No. 4,987,907 to Townsend; U.S. Pat. No. 5,092,352 to Sprinkle, III et al.; U.S. Pat. No. 5,387,416 to White et al.; U.S. Pat. No. 6,668,839 to Williams; U.S. Pat. No. 6,834,654 to Williams; U.S. Pat. No. 6,953,040 to Atchley et al.; U.S. Pat. No. 7,032,601 to Atchley et al.; and U.S. Pat. No. 7,694,686 to Atchley et al.; US Pat. Pub. Nos. 2004/0020503 to Williams; 2005/0115580 to Quinter et al.; 2006/0191548 to Strickland et al.; 2007/0062549 to Holton, Jr. et al.; 2007/0186941 to Holton, Jr. et al.; 2007/0186942 to Strickland et al.; 2008/0029110 to Dube et al.; 2008/0029116 to Robinson et al.; 2008/0173317 to Robinson et al.; 2008/0209586 to Neilsen et al.; 2009/0065013 to Essen et al.; and 2010/0282267 to Atchley, as well as WO2004/095959 to Arnarp et al., each of which is incorporated herein by reference.

Smokeless tobacco product configurations that combine tobacco material with various binders and fillers have been proposed more recently, with example product formats including lozenges, pastilles, gels, extruded forms, and the like. See, for example, the types of products described in US Patent App. Pub. Nos. 2008/0196730 to Engstrom et al.; 2008/0305216 to Crawford et al.; 2009/0293889 to Kumar et al.; 2010/0291245 to Gao et al; 2011/0139164 to Mua et al.; 2012/0037175 to Cantrell et al.; 2012/0055494 to Hunt et al.; 2012/0138073 to Cantrell et al.; 2012/0138074 to Cantrell et al.; 2013/0074855 to Holton, Jr.; 2013/0074856 to Holton, Jr.; 2013/0152953 to Mua et al.; 2013/0274296 to Jackson et al.; 2015/0068545 to Moldoveanu et al.; 2015/0101627 to Marshall et al.; and 2015/0230515 to Lampe et al., each of which is incorporated herein by reference.

All-white snus portions are growing in popularity, and offer a discrete and aesthetically pleasing alternative to traditional snus. Such modern “white” pouched products may include a bleached tobacco or may be tobacco-free. There is a continuing need in the art to lower the environmental impact of such pouched products while retaining acceptable sensory properties.

The present disclosure provides products configured for oral use, the products including one or more fillers in an amount of at least 20% by weight, based on the total weight of the composition, the one or more fillers typically comprising at least one non-tobacco cellulosic material having a bulk density of about 100 g/L or less. The composition further includes at least one additional component selected from the group consisting of active ingredients, flavorants, and combinations thereof. The disclosure includes, without limitations, the following embodiments.

Embodiment 1: A composition adapted for oral use, comprising: one or more fillers present in a total filler content of about 20% by weight or higher, based on the total weight of the composition, the one or more fillers comprising a first filler in the form of a dissolving grade pulp material or a non-woody microcrystalline cellulose, the first filler having an untapped bulk density of about 150 g/L or less; and at least one additional component selected from the group consisting of active ingredients, flavorants, and combinations thereof.

Embodiment 2: The composition of Embodiment 1, wherein the dissolving grade pulp material is derived from a plant source selected from the group consisting of wood sources, agricultural residue sources, annual plants and grasses, recycled plant material, and combinations thereof.

Embodiment 3: The composition of any one of Embodiments 1-2, wherein the dissolving grade pulp material is derived from a plant source selected from the group consisting of maize, oat, rice, barley, rye, buckwheat, sugar beet, bran, bamboo, hardwood, softwood, cotton, citrus, willow, cocoa, abaca, bagasse, esparto, eucalyptus, hemp, jute, kenaf, flax, sisal, and combinations thereof.

Embodiment 4: The composition of any one of Embodiments 1-3, wherein the dissolving grade pulp material is a hardwood or softwood dissolving grade pulp or a wheat straw dissolving grade pulp.

Embodiment 5: The composition of any one of Embodiments 1-4, wherein the dissolving grade pulp material has an untapped bulk density in the range of about 15 g/L to about 50 g/L.

Embodiment 6: The composition of any one of Embodiments 1-5, wherein the non-woody microcrystalline cellulose is derived from a plant source selected from the group consisting of agricultural residue sources, annual plants and grasses, recycled plant material, and combinations thereof.

Embodiment 7: The composition of any one of Embodiments 1-6, wherein the non-woody microcrystalline cellulose is derived from a plant source selected from the group consisting of maize, oat, rice, barley, rye, buckwheat, sugar beet, bran, bamboo, cotton, citrus, willow, cocoa, abaca, bagasse, esparto, eucalyptus, hemp, jute, kenaf, flax, sisal, and combinations thereof.

Embodiment 8: The composition of any one of Embodiments 1-7, wherein the non-woody microcrystalline cellulose has an untapped bulk density in the range of about 40 to about 120 g/L.

Embodiment 9: The composition of any one of Embodiments 1-8, wherein the first filler is present in an amount in the range of about 2 to about 10 weight percent, based on the total weight of the composition.

Embodiment 10: The composition of any one of Embodiments 1-9, wherein the first filler is present in an amount in the range of about 3 to about 6 weight percent, based on the total weight of the composition.

Embodiment 11: The composition of any one of Embodiments 1-10, wherein the total filler content is about 30 weight percent or higher, based on the total weight of the composition.

Embodiment 12: The composition of any one of Embodiments 1-11, wherein the total filler content is about 40 weight percent or higher, based on the total weight of the composition.

Embodiment 13: The composition of any one of Embodiments 1-12, wherein the total filler content is in the range of about 20 weight percent to about 60 weight percent, based on the total weight of the composition.

Embodiment 14: The composition of any one of Embodiments 1-13, further comprising a second filler in the form of a non-tobacco cellulosic material having a bulk density of about 250 g/L or higher.

Embodiment 15: The composition of Embodiment 14, wherein the non-tobacco cellulosic material has a bulk density in the range of about 250 g/L to about 1200 g/L.

Embodiment 16: The composition of any one of Embodiments 14-15, wherein the non-tobacco cellulosic material is microcrystalline cellulose, such as microcrystalline cellulose derived from a wood source.

Embodiment 17: The composition of Embodiment 16, wherein the microcrystalline cellulose has a particle size in the range of about 75 microns to about 150 microns.

Embodiment 18: The composition of any one of Embodiments 14-17, wherein the second filler is in particulate form and the first filler is in fibrous form.

Embodiment 19: The composition of any one of Embodiments 1-18, wherein the composition has a moisture content of about 30% by weight or higher, based on the total weight of the composition.

Embodiment 20: The composition of any one of Embodiments 1-19, wherein the moisture content of the composition is in the range of about 30 weight percent to about 60 weight percent, based on the total weight of the composition.

Embodiment 21: The composition of any one of Embodiments 1-20, wherein the moisture content of the composition is in the range of about 40 weight percent to about 55 weight percent, based on the total weight of the composition.

Embodiment 22: The composition of any one of Embodiments 1-21, wherein the at least one additional component comprises at least one active ingredient selected from the group consisting of botanical materials, stimulants, amino acids, vitamins, antioxidants, cannabinoids, cannabimimetics, terpenes, pharmaceutical agents, and combinations thereof.

Embodiment 23: The composition of any one of Embodiments 1-22, further comprising one or more of the following: a salt, a sweetener, a buffer, a humectant, a binder, and combinations thereof.

Embodiment 24: The composition of any one of Embodiments 1-23, wherein the composition comprises up to about 5 weight percent of tobacco, based on the total weight of the composition, the tobacco optionally being in a bleached form.

Embodiment 25: The composition of any one of Embodiments 1-24, wherein the composition is substantially free of tobacco.

Embodiment 26: The composition of any one of Embodiments 1-25, wherein the composition is substantially free of nicotine.

Embodiment 27: The composition of any one of Embodiments 1-25, wherein the composition comprises a nicotine component.

Embodiment 28: The composition of any one of Embodiments 1-27, wherein the composition is enclosed in a pouch to form a pouched product.

Embodiment 29: A method of forming a composition adapted for oral use, comprising: providing a dissolving grade pulp material having a moisture content of about 10% or less; grinding the dissolving grade pulp material to form a pulp material having an untapped bulk density of about 150 g/L or less; mixing the pulp material with at least one additional component selected from the group consisting of active ingredients, flavorants, and combinations thereof to form an oral composition adapted for oral use.

Embodiment 30: The method of Embodiment 29, wherein the dissolving grade pulp material is in a flake or sheet form prior to grinding.

Embodiment 31: The method of any one of Embodiments 29-30, further comprising mixing the pulp material with a non-tobacco cellulosic material having a bulk density of about 250 g/L or higher.

Embodiment 32: The method of Embodiment 31, wherein the non-tobacco cellulosic material is a wood-derived microcrystalline cellulose material.

Embodiment 33: The method of any one of Embodiments 29-32, wherein the dissolving grade pulp material is derived from a plant source selected from the group consisting of wood sources, agricultural residue sources, annual plants and grasses, recycled plant material, and combinations thereof.

Embodiment 34: The method of any one of Embodiments 29-33, wherein the dissolving grade pulp material is derived from a plant source selected from the group consisting of maize, oat, rice, barley, rye, buckwheat, sugar beet, bran, bamboo, hardwood, softwood, cotton, citrus, willow, cocoa, abaca, bagasse, esparto, eucalyptus, hemp, jute, kenaf, flax, sisal, and combinations thereof.

Embodiment 35: The method of any one of Embodiments 29-34, wherein the dissolving grade pulp material is a hardwood or softwood dissolving grade pulp or a wheat straw dissolving grade pulp.

Embodiment 36: The method of any one of Embodiments 29-35, wherein the pulp material has an untapped bulk density in the range of about 15 g/L to about 50 g/L.

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

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

The products as described herein comprise one or more fillers, and at least one additional component selected from the group consisting of active ingredients, flavorants, and combinations thereof. The relative amounts of the various components within the composition may vary, and typically are selected so as to provide the desired sensory and performance characteristics to the oral product. In certain embodiments, the oral products of the present disclosure are characterized by reduced density as compared to certain commercial products, which can provide both manufacturing and storage/transport cost savings, as well as improved environmental impact metrics generated from the lower weight, such as improved life cycle assessment (LCA)/reduced COfootprint. The example individual components of the composition are described herein below.

Compositions as described herein include at least one filler. Such fillers may fulfill multiple functions, such as enhancing certain organoleptic properties such as texture and mouthfeel, enhancing cohesiveness or compressibility of the product, and the like. Generally, the fillers are particulate materials and/or fibrous materials, and are cellulose-based. For example, suitable fillers are any plant material or derivative thereof, including cellulose materials derived from such sources. Although the plant material source can be a tobacco material, it is advantageous to use non-tobacco plant sources. Plant material sources for use as filler can vary, and will include wood sources, agricultural residue sources (e.g., straw materials), annual plants and grasses including bast fiber sources (e.g., hemp, jute, or kenaf), or recycled plant material. Examples of cellulosic non-tobacco plant material include cereal grains (e.g., maize, oat, rice, barley, rye, buckwheat, and the like), sugar beet (e.g., FIBREX® brand filler available from International Fiber Corporation), bran fiber, bamboo fiber, wood pulp fiber (hardwood and softwood), cotton fiber, citrus pulp fiber, grass fiber, willow fiber, poplar fiber, cocoa fiber, derivatives thereof, and mixtures thereof. Additional examples of plant sources include abaca, bagasse, esparto, eucalyptus, flax, and sisal. Note that many of the above plant sources for filler materials can be used in a variety of forms, including processed plant material in the form of particulates or fibers, or in relatively unprocessed forms (e.g., whole straw), such as straw materials from common grains such as rye, wheat, oat, or barley.

Non-limiting examples of derivatives of non-tobacco plant material include starches (e.g., from potato, rye, oat, barley, wheat, rice, corn), natural cellulose, and modified cellulosic materials. Additional examples of potential fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. As described in more detail below, combinations of fillers can also be used.

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

In various embodiments, the plant-based filler material can be used in the form of a dissolving pulp or microcrystalline cellulose. “Dissolving pulp” (also sometimes referred to as a “dissolving grade pulp”) as used herein may refer to a pulp material which has been treated such that the pulp has a high cellulose content (e.g., greater than 90% by weight). Typically, dissolving pulp can be produced by chemically treating a cellulosic plant material. Any of the plant sources noted herein can be used in a dissolving pulp form. The cellulosic plant material can be subjected to a sulfite process or a kraft process, as is known in the art, to remove water solubles, hemicelluloses, and lignin. Dissolving pulp typically have a high level of brightness, a relatively high chemical purity, and a low hemicellulose content.

To form a dissolving grade pulp, a plant material can be subjected to a plurality of operations, including chemical pulping a plant input to form a plant material pulp. Chemical pulping the plant material can comprise combining the plant material with a strong base (e.g., sodium hydroxide), and heating the plant material and the strong base. The resulting pulp material can also be subjected to bleaching to produce a dissolving grade pulp. By way of example, bleaching the plant material pulp can comprise chlorination of the pulp with a chlorine dioxide solution, and caustic extraction of the pulp with a second strong base (e.g., sodium hydroxide).