Tobacco-containing gel composition

Abstract

To provide an enjoyable form of a tobacco product, such as a smokeless tobacco product, and to provide processes for preparing tobacco-containing compositions suitable for use in smokeless tobacco products.SOLUTION: There is provided a smokeless tobacco gel product comprising: a tobacco material in an amount of at least about 0.01 wt.%; one or more sugar alcohols of at least about 50 wt.%; a humectant in an amount of at least about 0.1 wt.%; and water in an amount of at least about 10 wt.% based on the total weight of the smokeless tobacco gel product. The tobacco material (e.g., particulate tobacco or a tobacco extract such as tobacco-derived nicotine) is present in an amount of about 0.1 to about 10 wt.%. The humectant amount can be varied to vary the properties of the gel product. More paste-like consistency is achieved with a humectant amount of at least about 7 wt.%, and more syrup-like consistency is achieved with a humectant amount of less than about 6 wt.%.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to products made from or derived from tobacco, or those incorporating tobacco or tobacco constituents by other means and intended for human consumption.

Background Art

[0002] Cigarettes, cigars, and pipes are popular smoking articles that use tobacco in various forms. For example, a conventional cigarette has a substantially cylindrical rod-shaped structure and includes a charge, roll, or column of smoking material such as shredded tobacco (e.g., in shredded filler form) surrounded by cigarette paper, thereby forming a so-called "smoking rod," "tobacco rod," or "cigarette rod." Tobacco can also be enjoyed in a so-called smokeless form. Particularly popular smokeless tobacco products are used by inserting some form of processed tobacco or tobacco-containing formulation into the user's oral cavity. See, for example, the representative types of smokeless tobacco products described in the background art referred to in U.S. Patent Publication Nos. 2011 / 0303511 to Brinkley et al. and 2013 / 0206150 to Duggins et al., which are incorporated herein by reference, as well as various smokeless tobacco formulations, ingredients, and processing methods.

[0003] It would be desirable to provide enjoyable forms of tobacco products such as smokeless tobacco products, and methods for preparing tobacco-containing compositions suitable for use in smokeless tobacco products.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

[0005] The present disclosure relates to a soluble smokeless tobacco product configured for insertion into a user's oral cavity and a method for preparing a smokeless tobacco composition suitable for use in a smokeless tobacco product. The smokeless tobacco composition of the present disclosure provides a soluble smokeless tobacco gel product having a gel-like texture. The composition of the smokeless tobacco gel product disclosed herein can vary and can provide products having a wide range of textures and other physical properties such as paste-like or syrup-like characteristics.

[0006] In one aspect, the present invention provides a smokeless tobacco gel product comprising tobacco material in an amount of at least about 0.01 weight percent based on the total weight of the smokeless tobacco gel product, at least about 50 weight percent of one or more sugar alcohols, a humectant in an amount of at least about 0.1 weight percent, and water in an amount of at least about 10 weight percent. In certain embodiments, the tobacco material (e.g., particulate tobacco or a tobacco extract such as nicotine derived from tobacco) is present in an amount of about 0.1 to about 10 weight percent.

[0007] The smokeless tobacco gel product of the claims will often contain at least about 60 weight percent of one or more sugar alcohols, such as at least about 65 weight percent of one or more sugar alcohols. Exemplary sugar alcohols include erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, dulcitol, iditol, isomalt, maltitol, lactitol, polyglycitols, and combinations thereof. In certain embodiments, the product contains isomalt as the major sugar alcohol constituent in combination with one or more of maltitol, sorbitol, erythritol, or xylitol. In some embodiments, isomalt constitutes at least about 50%, such as at least about 60% of the total dry weight of the sugar alcohols.

[0008] The humectant may be present in an amount of at least about 1.0 weight percent in some embodiments. An exemplary humectant is glycerin. In one embodiment, the humectant is present in an amount of at least about 7 weight percent, such as in the case of a particular smokeless tobacco gel having a paste-like consistency. In another embodiment, the humectant is present in an amount of less than about 6 weight percent, such as in the case of a particular smokeless tobacco gel having a syrup-like consistency.

[0009] The water content of the gel product can vary, but is typically more than about 14 weight percent water. In one embodiment, the water is present in an amount of from about 15 to about 40 weight percent water.

[0010] Other ingredients such as sweeteners, salts, buffers, pH adjusters, colorants, flavorants, and combinations thereof can also be added to the smokeless tobacco gel product. In certain embodiments, the gel product is translucent. The various embodiments of the gel product can be characterized as having a syrup-like, jelly-like, gelatin-like, paste-like, or taffy-like texture. In some embodiments, the gel product exhibits a user intraoral retention time of from about 1 to about 10 minutes before complete dissolution of the product.

[0011] In a particular embodiment, the smokeless tobacco gel product comprises from about 0.05 to about 0.5 weight percent nicotine, from about 55 to about 80 weight percent of one or more sugar alcohols, from about 1 weight percent to about 20 weight percent humectant, and from about 15 to about 40 weight percent water. Optionally, the product can further comprise one or more of the following: from about 0.001 to about 0.1 weight percent of one or more sweeteners, up to about 2 percent of one or more flavorants, and up to about 2 weight percent salt.

[0012] The smokeless tobacco gel product may optionally further include an edible coating. For example, the edible coating may include a soft shell coating, a gel coating, or a hard shell coating. The composition of the edible coating can vary. In certain embodiments, the edible coating may include a second tobacco material. For example, in some embodiments, the edible coating includes at least about 50 dry weight percent of one or more sugar alcohols or at least about 80 dry weight percent of one or more sugar alcohols. In some embodiments, one or more sugar alcohols of the edible coating may include sugar alcohols selected from the group consisting of isomalt, maltitol, sorbitol, and combinations thereof. The edible coatings described herein may include, but are not limited to, various other components selected from the group consisting of film-forming polymers, sweeteners, salts, humectants, buffers, pH adjusters, colorants, flavorants, and combinations thereof.

[0013] In another aspect, a method of preparing a smokeless tobacco gel product is provided that includes mixing one or more sugar alcohols with a humectant and a tobacco material to form a gel mixture, and depositing the gel mixture within an airtight container or encapsulating the gel mixture with a coating composition to prevent curing of the gel mixture in the presence of air. During the mixing step (at any point during mixing, not necessarily for the entire duration of mixing), heat may be applied at a temperature lower than the hard crack stage of the one or more sugar alcohols. For a more paste-like texture, the method may further include aerating the gel mixture.

[0014] The encapsulating method may include dipping the gel mixture into a coating composition, spraying the coating composition onto the gel mixture, or preparing the coating composition in the form of a sheet and enclosing the gel mixture between two sheets of the coating composition.

[0015] Depositing the gel mixture in an airtight container may include depositing the gel mixture in a container equipped with a dispensing mechanism adapted to propel the gel mixture towards an opening when operated by a consumer. Alternatively, the depositing step may include depositing the gel mixture in an air-impermeable pouch or straw, the pouch or straw including at least one heat-sealed or resealable end.

[0016] The present invention includes, but is not limited to, the following embodiments. Embodiment 1: A smokeless tobacco gel product comprising at least about 0.01 weight percent of tobacco material based on the total weight of the smokeless tobacco gel product, at least about 50 weight percent of one or more sugar alcohols, at least about 0.1 weight percent of a humectant, and at least about 10 weight percent of water. Embodiment 2: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the tobacco material is present in an amount of about 0.1 to about 10 weight percent. Embodiment 3: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the tobacco material includes particulate tobacco. Embodiment 4: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the tobacco material includes a tobacco extract. Embodiment 5: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the tobacco material includes tobacco-derived nicotine. Embodiment 6: The smokeless tobacco gel product according to any of the foregoing or following embodiments, including at least about 60 weight percent of one or more sugar alcohols. Embodiment 7: The smokeless tobacco gel product according to any of the foregoing or following embodiments, including at least about 65 weight percent of one or more sugar alcohols. Embodiment 8: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the one or more sugar alcohols are selected from the group consisting of erythritol, trehalose, arabinitol, xylitol, ribitol, mannitol, sorbitol, dulcitol, iditol, isomalt, maltitol, lactitol, polyglycitols, and combinations thereof. Embodiment 9: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the one or more sugar alcohols are selected from the group consisting of isomalt, maltitol, xylitol, sorbitol, erythritol, and combinations thereof. Embodiment 10: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the one or more sugar alcohols include isomalt as a main sugar alcohol constituent. Embodiment 11: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the one or more sugar alcohols further include one or more of maltitol, sorbitol, erythritol, and xylitol. Embodiment 12: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the isomalt constitutes at least about 50% of the total dry weight of the sugar alcohol. Embodiment 13: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the isomalt constitutes at least about 60% of the total dry weight of the sugar alcohol. Embodiment 14: The smokeless tobacco gel product according to any of the foregoing or following embodiments, containing at least about 1.0 weight percent of a humectant. Embodiment 15: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the humectant is present in an amount of at least about 7 weight percent and the smokeless tobacco gel has a paste-like consistency. Embodiment 16: The smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the humectant is present in an amount of less than about 6 weight percent and the smokeless tobacco gel has a syrup-like consistency. Embodiment 17: A smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the wetting agent contains glycerin. Embodiment 18: A smokeless tobacco gel product according to any of the foregoing or following embodiments, which contains more than about 14% by weight of water. Embodiment 19: A smokeless tobacco gel product according to any of the foregoing or following embodiments, which contains about 15% to about 40% by weight of water. Embodiment 20: A smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the product further contains one or more components selected from the group consisting of sweeteners, salts, buffers, pH adjusters, colorants, flavorants, and combinations thereof. Embodiment 21: A smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the product is translucent. Embodiment 22: A smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the product exhibits a texture in the form of syrup, jelly, gelatin, paste, or taffy. Embodiment 23: A smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the product exhibits a residence time in the user's oral cavity of about 1 to about 10 minutes before complete dissolution of the product. Embodiment 24: A smokeless tobacco gel product according to any of the foregoing or following embodiments, which further contains an edible coating. Embodiment 25: A smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the edible coating comprises a soft shell coating, a gel coating, or a hard shell coating. Embodiment 26: A smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the edible coating contains a second tobacco material. Embodiment 27: A smokeless tobacco gel product according to any of the foregoing or following embodiments, which contains about 0.05% to about 0.5% by weight of nicotine, about 55% to about 80% by weight of one or more sugar alcohols, about 1% to about 20% by weight of a wetting agent, and about 15% to about 40% by weight of water. Embodiment 28: A smokeless tobacco gel product according to any of the foregoing or following embodiments, further comprising one or more of the following: (a) one or more sweeteners in an amount of from about 0.001 to about 0.1 weight percent, (b) one or more flavoring agents in an amount of up to about 2 percent, and (c) salt in an amount of up to about 2 weight percent. Embodiment 29: A smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the wetting agent is present in an amount of at least about 7 weight percent and the smokeless tobacco gel has a paste-like consistency. Embodiment 30: A smokeless tobacco gel product according to any of the foregoing or following embodiments, wherein the wetting agent is present in an amount of less than about 6 weight percent and the smokeless tobacco gel has a syrup-like consistency. Embodiment 31: A method for preparing a smokeless tobacco gel product, comprising mixing one or more sugar alcohols with a wetting agent and a tobacco material to form a gel mixture, and depositing the gel mixture in an airtight container or encapsulating the gel mixture with a coating composition to prevent curing of the gel mixture in the presence of air. Embodiment 32: The method according to any of the foregoing or following embodiments, further comprising applying heat at a temperature lower than the hard crack stage of the one or more sugar alcohols during the mixing step. Embodiment 33: The encapsulating step includes (a) immersing the gel mixture in a coating composition, (b) spraying the coating composition onto the gel mixture, or (c) preparing the coating composition in the form of a sheet and enclosing the gel mixture between two sheets of the coating composition, according to any of the foregoing or following embodiments. Embodiment 34: The step of depositing the gel mixture in an airtight container includes depositing the gel mixture in a container equipped with a dispensing mechanism adapted to propel the gel mixture towards an opening when operated by a consumer, according to any of the foregoing or following embodiments. Embodiment 35: The step of depositing the gel mixture within an airtight container includes depositing the gel mixture within an air-impermeable pouch or straw, the pouch or straw including at least one heat-sealed or resealable end, the method according to any of the foregoing or following embodiments. Embodiment 36: The mixing step further includes incorporating into the gel mixture one or more components selected from the group consisting of sweeteners, salts, buffering agents, pH adjusters, colorants, flavorants, and combinations thereof, the method according to any of the foregoing or following embodiments. Embodiment 37: The method according to any of the foregoing or following embodiments further includes the step of aerating the gel mixture to impart a pasty texture to the gel mixture.

[0017] These and other features, aspects, and advantages of the present disclosure will become apparent from reading the following detailed description of the invention in conjunction with the accompanying drawings, which are briefly described below. The present invention includes any two, three, four, or more arbitrary combinations of the above embodiments, and any two, three, four, or more combinations of features or elements described in the present disclosure, regardless of whether such features or elements are explicitly combined in the description of specific embodiments herein. This disclosure is intended to be read comprehensively such that any separable features or elements of the disclosed invention are combinable in any of its various aspects and embodiments, as long as it is not clearly indicated otherwise in context.

Brief Description of the Drawings

[0018] To assist in understanding the embodiments of the present invention, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale. The drawings are merely exemplary and should not be construed as limiting the present invention.

Figure 1

Figure 2

[0019] The present invention will now be described more fully hereinafter. The invention, however, 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 be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. References to "percent dry weight" or "dry weight basis" refer to weights based on dry components (i.e., all components excluding water).

[0020] The present invention provides novel nicotine-containing and / or tobacco-containing products suitable for use as oral formulations. Certain gels of the present disclosure typically include at least one tobacco material (e.g., particulate tobacco material or an extract derived from tobacco), one or more sugar alcohols, and a humectant.

[0021] The products described herein are generally soluble oral gel products. In some embodiments, the oral gel products can be described as "hard gels" or "soft gels". As used herein, the term "gel" is intended to mean a solid, semi-solid, or viscous liquid material having a degree of flexibility and / or fluidity. The rigidity, texture, consistency, viscosity, and rheological properties of the gels according to the present invention can vary. For example, certain embodiments of the gels of the present invention can be characterized as thixotropic. Additional embodiments can be characterized as thick and syrupy. Certain embodiments can be characterized as having physical properties similar to gelatin, jelly, paste, glue, taffy, or honey. Thus, the gels can have various levels of shape retention, elasticity, rubberiness, adhesiveness, fluidity, etc. As used herein, the terms "dissolve", "dissolving", and "dissolvable" refer to a composition having water-soluble components that interact with the moisture in the oral cavity to enter into solution, thereby causing progressive consumption of the product. The products of the present disclosure typically do not exhibit a highly deformable biting and squeezing texture such as can be found in conventional chewing gums.

[0022] In certain embodiments of the present invention, gels having syrupy properties are provided, such as gels exhibiting fluidity and adhesiveness similar to honey. In other embodiments, the present invention provides gels having properties associated with paste, such as gels exhibiting viscosity and texture similar to toothpaste.

[0023] The above properties of the gels of the present invention can be altered by adjusting the composition. For example, adjusting the water content of the gel formulation can result in the adjustment of certain gel properties. Additionally, adjusting the amount of a humectant such as glycerin can change the properties of the resulting gel. In addition, the presence or absence of certain binders can affect many of the above properties of the gel.

[0024] The products of the present disclosure typically incorporate plants of some form of tobacco species, most preferably, their compositions or the compositions incorporate some form of tobacco. The selection of plants from tobacco species can be diverse, and in particular, the type(s) of tobacco can be diverse. Examples of tobacco that can be used include flue-cured or Virginia (e.g., K326), burley, sun-cured (e.g., including tobacco from Indian Carnool and Oriental such as Caterini, Prillep, Komotini, Xanthi, and Yambol tobacco), Maryland, dark, dark fired, dark air-cured (e.g., tobacco from Pasanda, Cubano, Jatin, and Bezuki), light air-cured (e.g., tobacco from North Wisconsin and Galpao), Indian air-cured, Red Russian, and Rustica tobacco, as well as various other rare or select tobaccos. Descriptions of various types of tobacco, cultivation practices, and harvesting practices are set forth in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999), which is incorporated herein by reference. Tobacco species can be derived using genetic modification or breeding techniques (e.g., tobacco plants can be genetically recombined or bred to increase or decrease the production of, or otherwise change other specific components, characteristics, attributes). Additional information regarding tobacco species suitable for use in the present invention can be found in U.S. Patent Application Publication No. 2012 / 0192880 to Dube et al., which is incorporated herein by reference. Tobacco plants can be cultivated in a greenhouse, growth chamber, or outdoor field, or can be hydroponically cultivated.

[0025] The parts of the tobacco plant used in accordance with the present invention can be various. For example, virtually the entire plant (e.g., the whole plant) can be harvested and used as such. Alternatively, various parts or fragments of the plant can be harvested or separated for further use after harvesting. For example, leaves, stems, axes, roots, laminas, flowers, seeds, and various parts, as well as combinations thereof, can be isolated for further use or processing. The plant material of the present invention can thus include the whole plant or any part of the tobacco plant. See, for example, the parts of the tobacco plant described in U.S. Patent Application Publication No. 2011 / 0174323 to Coleman, III et al. and U.S. Patent Application Publication No. 2012 / 0192880 to Dube et al., which are incorporated herein by reference.

[0026] The tobacco plant can be used in either an immature or mature form, and can be used in either a green or dry form, as described in Dube et al.'s U.S. Patent Application Publication No. 2012 / 0192880, which is incorporated herein by reference.

[0027] The tobacco material can be subjected to various processing processes such as refrigeration, freezing, drying (e.g., lyophilization or spray drying), radiation, yellowing, heating, cooking (e.g., roasting, frying, or boiling), fermentation, bleaching, etc., or can be subjected to storage or treatment for later use. Exemplary processing techniques are described, for example, in U.S. Patent Application Publication No. 2009 / 0025739 to Brinkley et al. and U.S. Patent Application Publication No. 2011 / 0174323 to Coleman, III et al., which are incorporated herein by reference.

[0028] As discussed in Marshall et al.'s U.S. Patent Application Publication No. 2013 / 0269719 and Moldoveanu's U.S. Patent Application Publication No. 2014 / 0020694, which are incorporated herein by reference, tobacco materials can be treated with enzymes and / or live bacteria before or after harvest. Tobacco materials can be subjected to radiation, pasteurization, or heat treatment. Representative processes are described in U.S. Patent Publication Nos. 2009 / 0025738 to Mua et al., 2009 / 0025739 to Brinkley et al., and 2011 / 0247640 to Beeson et al., which are incorporated herein by reference. In one embodiment, the tobacco material is heat treated at about 88° C. for about 60 minutes in the presence of water, NaOH, and an additive (e.g., lysine). Such heat treatment can assist in preventing acrylamide formation resulting from the reaction of asparagine with reducing sugars in the tobacco material and can provide a degree of pasteurization. See, for example, U.S. Patent Publication No. 2010 / 0300463 to Chen et al., which is incorporated herein by reference. Tobacco materials can be contacted with imprinted or non-imprinted polymers as described in, for example, U.S. Patent Publication Nos. 2007 / 0186940 to Bhattacharyya et al., 2011 / 0041859 to Rees et al., 2011 / 0159160 to Jonsson et al., and 2012 / 0291793 to Byrd et al., all of which are incorporated herein by reference.

[0029] The harvested part(s) of a tobacco plant can be physically processed. The part(s) of the plant can be separated into individual parts or pieces (e.g., the roots can be removed from the shaft, the stems can be removed from the shaft, the leaves can be removed from the stems and / or the shaft, and the petals can be removed from the remaining parts of the flower). The harvested part(s) of the plant can be further subdivided into parts or pieces (e.g., shredded, cut, crushed, micronized, pulverized, or milled into filler-type pieces, granules, particles, or pieces or parts characterized as fine powder). The harvested part(s) of the plant can be subjected to external forces or pressures (e.g., by being pressed or subjected to a rolling process). When performing such processing conditions, the harvested part(s) of the plant can have a water content close to its natural water content (e.g., its water content immediately after harvesting), a water content achieved by adding water to the harvested part(s) of the plant, or a water content resulting from the drying of the harvested part(s) of the plant.

[0030] In certain embodiments, the tobacco material is used in a form that can be described as particles (i.e., in shredded, ground, granulated, or powdered form). The manner in which the tobacco material is provided in a finely divided or powdered form can vary. Preferably, the plant parts or fragments are crushed, ground, or micronized into particle form using equipment and techniques for grinding, pulverizing, etc. Most preferably, the plant material is in a relatively dry state while being ground or pulverized using equipment such as a hammer mill, cutter head, air control mill, etc. For example, a tobacco part or fragment can be ground or pulverized if its water content is less than about 15 weight percent or less than about 5 weight percent. Most preferably, the tobacco material is used in the form of parts or fragments having an average particle size of less than about 50 micrometers. In one embodiment, the average particle size of the tobacco microparticles can be about 25 micrometers or less. In some cases, the tobacco microparticles are sized to pass through a sieve. If desired, air classification equipment may be used so that small tobacco microparticles of the desired size or various sizes can always be collected. If desired, granulated tobacco fragments of different sizes may be mixed. The use of micronized tobacco microparticles (or other botanical constituents of a small size) can be advantageous if the user desires to reduce or minimize post-use product waste.

[0031] In certain embodiments, at least a portion of the tobacco material used in the tobacco composition or product may be in the form of an extract. The tobacco extract can be obtained by extracting tobacco using a solvent having a water-soluble nature, such as distilled water or tap water. Thus, a water-soluble tobacco extract can be provided by extracting tobacco with water such that the water-insoluble pulp material is separated from the aqueous solvent and the water-soluble and dispersible tobacco constituents are dissolved and dispersed therein.Exemplary techniques for extracting tobacco components are described in U.S. Patent No. 4,144,895 to Fiore, U.S. Patent No. 4,150,677 to Osborne, Jr. et al., U.S. Patent No. 4,267,847 to Reid, U.S. Patent No. 4,289,147 to Wildman et al., U.S. Patent No. 4,351,346 to Brummer et al., U.S. Patent No. 4,359,059 to Brummer et al., U.S. Patent No. 4,506,682 to Muller, U.S. Patent No. 4,589,428 to Keritsis, U.S. Patent No. 4,605,016 to Soga et al., U.S. Patent No. 4,716,911 to Poulose et al., U.S. Patent No. 4,727,889 to Niven, Jr. et al., U.S. Patent No. 4,887,618 to Bernasek et al., U.S. Patent No. 4,941,484 to Clapp et al., U.S. Patent No. 4,967,771 to Fagg et al., U.S. Patent No. 4,986,286 to Roberts et al., U.S. Patent No. 5,005,593 to Fagg et al., U.S. Patent No. 5,018,540 to Grubbs et al., U.S. Patent No. 5,060,669 to White et al., U.S. Patent No. 5,065,775 to Fagg, U.S. Patent No. 5,074,319 to White et al., U.S. Patent No. 5,099,862 to White et al., U.S. Patent No. 5,121,757 to White et al., U.S. Patent No. 5,131,414 to Fagg, U.S. Patent No. 5,131,415 to Munoz et al., U.S. Patent No. 5,148,819 to Fagg, U.S. Patent No. 5,197,494 to Kramer, U.S. Patent No. 5,230,354 to Smith et al., U.S. Patent No. 5,234,008 to Fagg, U.S. Patent No. 5,243,999 to Smith, U.S. Patent No. 5,301,694 to Raymond et al., U.S. Patent No. 5,318,050 to Gonzalez-Parra et al., U.S. Patent No. 5,343,879 to Teague, U.S. Patent No. 5,360,022 to Newton, U.S. Patent No. 5,435,325 to Clapp et al., U.S. Patent No. 5,445,169 to Brinkley et al., U.S. Patent No. 6,131,584 to Lauterbach, U.S. Patent No. 6,284,875 to Turpen et al., U.S. Patent No. 6,298,859 to Kierulff et al., U.S. Patent No. 6,772,767 to Mua, U.S. Patent No. 6,817,970 to Berit, U.S. Patent No. 6,906,172 to Bratcher, U.S. Patent No. 7,034,128 to Turpen et al., U.S. Patent No. 7,048,211 to Bratcher, and U.S. Patent No. 7,337,782 to Thompson (all of which are incorporated herein by reference).Reference is also made to the ultrafiltered translucent tobacco extracts described in U.S. Patent Application Publication Nos. 2013 / 0074855 and 2013 / 0074856 to Holton, Jr., both of which are incorporated herein by reference.

[0032] Tobacco-derived extracts will typically contain a mixture of desired components isolated from plants of the genus Nicotiana by a variety of means. However, if desired, tobacco-derived extracts can be highly purified with respect to a single component of the extract or a small number of extract components. Typical separation processes by which the components of a tobacco extract can be further purified or isolated include one or more process steps such as solvent extraction (e.g., using a polar solvent, an organic solvent, or a supercritical fluid), chromatography (e.g., preparative liquid chromatography), clarification, distillation, filtration (e.g., ultrafiltration), recrystallization, and / or partitioning between solvents. In some embodiments, the plant or a portion thereof is pretreated, for example, to release certain compounds to make the desired compounds available for more efficient separation. In some embodiments, multiple methods are used to isolate and / or purify the desired compounds. See, for example, the descriptions of isolated tobacco components and isolation techniques in U.S. Patent Application Publication Nos. 2011 / 0174323, 2011 / 0259353, 2012 / 0192880, 2012 / 0192882, and 2012 / 0211016 to Coleman, III et al., Coleman, III et al., Dube et al., Dube et al., and Byrd, Jr. et al., respectively, each of which is incorporated herein by reference.

[0033] The tobacco extracts used in the smokeless tobacco gel products of the present disclosure may, in some embodiments, be characterized as translucent or transparent. In certain embodiments, such extracts may be characterized by the molecular weights of their components. For example, a translucent tobacco extract may consist of compounds having a molecular weight of less than about 50,000 Da, or compounds having a molecular weight of less than about 5,000 Da. The translucency of the tobacco extract may be characterized by a percent light transmittance of at least about 30% at visible light wavelengths greater than about 600 nm, or at least about 40% at visible light wavelengths greater than about 600 nm, or at least about 50% at visible light wavelengths greater than about 600 nm (or even higher levels such as greater than about 60%, or greater than about 70%, or greater than about 80% at visible light wavelengths greater than about 600 nm, etc.), as compared to 100% transmittance of water, in terms of percent light transmittance.

[0034] The reference to "tobacco extract" described above includes extracts that are highly purified with respect to one or a few components. For example, highly purified tobacco-derived nicotine (e.g., pharmaceutical grade nicotine having a purity greater than 98% or greater than 99%) or its derivatives can be used in the present invention. Representative nicotine-containing extracts can be provided using the techniques described in U.S. Patent No. 5,159,942 to Brinkley et al., which is incorporated herein by reference. Extracts containing a relatively high nicotine content can be buffered, for example, using a buffering agent such as citric acid that lowers the pH of the extract.

[0035] The form of the tobacco extract (or an isolate thereof) obtained according to the present invention can be various. Typically, the isolate is in solid, liquid, or semi-solid form. The formulation can be used in a specific, absolute, or undiluted form. Examples of solid form tobacco isolates include spray-dried and freeze-dried forms (e.g., freeze-dried full-cured extract or spray-dried fire-cured extract). Examples of liquid form tobacco isolates include formulations contained within an aqueous or organic solvent carrier.

[0036] In certain embodiments, the gels of the present invention can contain any form of nicotine from any source, whether tobacco-derived or synthetically-derived. Generally, the nicotine compounds used in the present invention are selected from the group consisting of nicotine base, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulfate, nicotine zinc chloride, such as nicotine zinc chloride monohydrate, and nicotine salicylate. In some embodiments, the nicotine is in a free base form that can optionally be incorporated onto a carrier (e.g., microcrystalline cellulose) for inclusion within a smokeless tobacco product. See, for example, the nicotine / carrier compositions described in Hansson U.S. Patent Publication No. 2004 / 0191322, which is incorporated herein by reference.

[0037] The relative amounts of tobacco materials within the smokeless tobacco composition can vary and depend to some extent on the type of tobacco material used (e.g., ground tobacco or tobacco extract). Preferably, the total amount of the tobacco material (from any source including tobacco extracts or isolates and particulate tobacco materials) formulation within the smokeless tobacco gel is from about 0.01 to about 40 weight percent, more typically from about 0.2 to about 20 weight percent (e.g., from about 0.3 to about 10 weight percent), based on the total weight of the composition. For embodiments containing only a tobacco extract as the tobacco constituent (including pharmaceutical grade nicotine), the gel will typically contain no more than about 10 weight percent, such as no more than about 8 weight percent, no more than about 5 weight percent, or no more than about 3 weight percent (e.g., from about 0.01 to about 10 weight percent) of the tobacco constituent. For embodiments containing a particulate tobacco constituent (e.g., tobacco fine powder) either as the sole tobacco constituent or in combination with a tobacco extract, the gel will typically contain no more than about 20 weight percent, such as no more than about 15 weight percent, no more than about 10 weight percent, or no more than about 8 weight percent (e.g., from about 1 to about 12 weight percent) of the tobacco constituent. The amount of the tobacco material (or combination of tobacco material and other botanical constituents) will typically not exceed 50 weight percent.

[0038] In addition to (or, in certain embodiments, instead of) the tobacco materials, the products of the present invention may further include additional non-tobacco botanical materials. As used herein, the term "botanical material" refers to any plant material, including plant materials in their natural form and plant materials derived from natural plant materials, such as extracts or isolates from plant materials or processed plant materials (e.g., plant materials that have been subjected to heat treatment, fermentation, or other processing processes that can modify the chemical properties of the material). In the present disclosure, "botanical material" includes, but is not limited to, "herb material", which refers to seed-producing plants that do not grow persistent woody tissue and are often valued for their medicinal or sensory properties (e.g., tea or herbal infusions). Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemicals" or "functional foods".Exemplary botanical materials include acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, beavermint, wild bergamot, black pepper, blueberry, borage oil, bugbane, cocoa, calamus root, dog fennel, katsuobushi, cayenne pepper, chaga, chervil, cinnamon, dark chocolate, potato peel, grape seed, Chinese carrot, ginkgo, sweet cicely, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile, clove, cocoa powder, cranberry, dandelion, grapefruit, honeybush, echinacea, garlic, motherwort, white lettuce, ginger, goldenseal, hawthorn, hibiscus flower, licorice, kava, lavender, licorice root, marjoram, great burdock, mint (menthe), oolong tea, beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover, rooibos (red or green), rose hip, rosemary, sage, clary sage, celery, spearmint, spirulina, bark of the red alder, high tannin sorghum bran variety, high tannin sorghum grain variety, urushi bran, leaves and roots of comfrey, goji berry, gotu kola, thyme, turmeric, Japanese aralia, wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa, bacopa monnieri, ashwagandha, and maria thistle, but are not limited thereto, and many of these are associated with antioxidant properties. When present in the composition, such botanical materials can be used in the same form as described above for tobacco (e.g., ground particles or extracts), and the amount utilized is typically such that the total botanical materials of tobacco and non-tobacco fit within the above-listed total amount with respect to the tobacco material in the composition of the present invention. In other words, the total content of tobacco and non-tobacco botanical materials will typically be about 0.1 to about 40 weight percent, more typically about 0.2 to about 20 weight percent (e.g., about 0.3 to about 12 weight percent) based on the total weight of the composition.Most preferably, the non-tobacco botanical material is used in the form of an aqueous extract (e.g., a freeze-dried or spray-dried extract) or a powder (e.g., having an average particle size of less than about 50 micrometers).

[0039] In certain embodiments, the non-tobacco plant will provide other functional benefits such as advantageous sensory properties (e.g., taste, aroma, or color), or functions as a binder or filler. In certain embodiments, the non-tobacco plant may be associated with health-related effects such as desirable bioactivity or antioxidant properties. In particularly preferred embodiments, the non-tobacco botanical components will complement the sensory properties associated with the tobacco-derived materials in the formulation and, in some cases, even impart tobacco-like sensory properties. In some embodiments, the presence of the non-tobacco plant is associated with oral and throat sensory properties that are not discordant with the overall desirable sensory properties of the product and, in some cases, may contribute to the reduction of oral and / or throat irritation otherwise associated with the formulation. Green tea (Camellia sinesis), guayusa, rooibos (especially green rooibos) and honeybush (especially red honeybush) are particularly advantageous non-tobacco botanical components that can lead to the desirable properties described above.

[0040] Honeybush (Cyclopia) is a flowering plant of the legume family named after the honey-like fragrance of its flowers. Honeybush plants are endemic to South Africa, and exemplary species include Cyclopia genistoides, Cyclopia longifolia, Cyclopia maculata, Cyclopia subternata, and Cyclopia intermedia. The leaves of honeybush plants are sometimes used in herbal infusions. The new shoots (leaves and twigs) of honeybush plants are typically harvested and chopped or shredded. This plant material can then be used as is in a lighter-colored and less sweet "green" form, or subjected to a fermentation process to produce a "red" honeybush with enhanced sweetness and a rich caramel color. Honeybush in either form can be purchased from tea specialty distributors. Honeybush plants are rich in antioxidants such as mangiferin, and their potential cancer-preventive efficacy is being studied. See Kokotkiewicz, A & Luczkiewics, M. 2009. Honeybush (Cyclopia sp.) - A rich source of compounds with high antimutagenic properties. Fitoterapia 80 (2009) 3 - 11. In certain embodiments, honeybush is present in an amount of up to about 15 weight percent, such as about 1 to about 5 weight percent in the form of an aqueous extract or about 5 to about 10 weight percent in the form of a powder.

[0041] Similar to honeybush, rooibos (Aspalathus linearis) is also a flowering plant of the legume family native to South Africa, and its leaves are also used in herbal teas. The rooibos plant is harvested and processed in a manner similar to the above honeybush and is available in green or red (fermented) forms. Both forms of rooibos can be purchased from tea specialty distributors. The rooibos plant is rich in antioxidants and its potential health-maintaining efficacy is being studied. See The Science Behind Roobios - South Africa’s Unique and Healthy Herbal Tea, South African Rooibos Council, July 2013. In certain embodiments, rooibos is present in an amount of up to about 15 weight percent, such as from about 1 to about 5 weight percent in the form of an aqueous extract or from about 5 to about 10 weight percent in the form of a powder.

[0042] The smokeless tobacco composition of the present disclosure typically includes at least one sugar alcohol, and the compositions of the present invention often contain multiple sugar alcohols. A sugar alcohol is a polyol derived from a monosaccharide or disaccharide having a partially or fully hydrogenated form. Exemplary sugar alcohols have from about 4 to about 20 carbon atoms and include erythritol, arabinitol, ribitol, isomalt, polyglycitols, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (such as hydrogenated starch hydrolysates). Sugar alcohols are typically added to the compositions of the present disclosure in the form of an aqueous solution or suspension, such as a solution or suspension having a solids content of from about 50 to about 90 weight percent. Sugar alcohols can serve multiple functions, such as providing sweetness, enhancing certain sensory stimulating properties such as texture and mouthfeel, and increasing the cohesiveness or compressibility of the product.

[0043] The exact combination of sugar alcohols typically utilized in the present invention and used in a given formulation can be selected based on several factors, including the laxative threshold, relative sweetness, calorie content, glycemic index, degree of hygroscopicity, etc. In the present invention, the major sugar alcohol constituent is typically isomalt, which is used in an amount of at least about 50% of the total dry weight of the sugar alcohol, such as at least about 60%, or at least about 70%, or at least about 80%, etc., based on the dry weight. Exemplary weight percentages of isomalt as a percentage of the total dry weight of the sugar alcohol are from about 65% to about 85% (e.g., from about 70% to about 85%).

[0044] The combination of sugar alcohols also includes at least one additional sugar alcohol, and in certain embodiments, at least two additional sugar alcohols will be included. In certain embodiments, the additional sugar alcohols will include two additional sugar alcohols in a dry weight ratio of at least about 1.5:1, at least about 2:1, or at least about 2.5:1. Exemplary sugar alcohols useful as the greater component in this ratio include erythritol, maltitol, or sorbitol. Examples of the lesser component in this ratio include maltitol, sorbitol, erythritol, or xylitol.

[0045] The total sugar alcohol content of the gels of the present invention will typically range from about 60% to about 85% by weight, or from about 65% to about 80% by weight, etc., based on the total weight of the gel, typically from about 50% to about 90% by weight. The sugar alcohol content of the gel will typically be at least about 50% by weight, or at least about 55% by weight, or at least about 60% by weight. The sugar alcohol content of the gel will typically not exceed about 90% by weight, such as not exceeding about 85% by weight, or not exceeding about 80% by weight, etc.

[0046] A humectant (e.g., glycerin or propylene glycol) can be used in an amount sufficient to provide the desired moisture attributes to the smokeless tobacco composition. Further, in some cases, the humectant can impart desirable flow characteristics to the smokeless tobacco composition. When present, representative amounts of the humectant are at least about 0.1 weight percent, or at least about 0.5 weight percent, or at least about 1.0 weight percent, but will typically constitute less than about 20 percent by weight of the total weight of the composition (e.g., about 2 to about 15 weight percent, about 1 to about 20 weight percent, etc.).

[0047] The amount of humectant can have a significant impact on the overall fluidity and other properties of the gel. Gels having a paste-like consistency will typically have more than about 7 weight percent, more than about 8 weight percent, or more than about 9 weight percent, etc. (e.g., about 8 to about 15 weight percent) of the humectant. Gels having a consistency similar to syrup (e.g., honey) will typically contain less than about 6 weight percent, less than about 5 weight percent, or less than about 4 weight percent, etc. (e.g., about 2 to about 6 weight percent) of the humectant.

[0048] The gels of the present invention will typically contain a significant amount of water. The total water content of the gels of the present invention will typically be more than about 10 weight percent, based on the total weight of the gel formulation, such as more than about 12 weight percent or more than about 14 weight percent, etc. The water content of the gels of the present invention will typically not exceed about 40 weight percent or less than about 35 weight percent, etc., not exceeding about 45 weight percent. Gels having a more paste-like consistency will typically have a higher water content (e.g., about 25 to about 40 weight percent), while gels having a more syrup-like gel structure will typically have a lower water content (e.g., about 15 to about 25 weight percent).

[0049] The tobacco materials (and / or botanical materials) used in the manufacture of smokeless tobacco gel products can be processed, blended, formulated, combined, and mixed with other materials or components in addition to the above components. For example, see the representative components, combinations of components, the relative amounts of those components and ingredients to the tobacco, and the ways and methods for using those components as described in U.S. Patent Publication Nos. 2007 / 0062549 to Holton et al. and 2007 / 0186941 to Holton et al., each of which is incorporated herein by reference.

[0050] Accordingly, provided herein are gel-less tobacco products that may further comprise one or more additional components. The additional components may be artificial or may be obtained or derived from herbs or biological sources.Additional exemplary types of components include salts (e.g., sodium chloride, potassium chloride, sodium citrate, potassium citrate, sodium acetate, potassium acetate, flour salt, etc.), natural sweeteners (e.g., fructose, sucrose, glucose, maltose, vanillin, ethyl vanillin glucoside, mannose, galactose, lactose, stevia, etc.), artificial sweeteners (e.g., sucralose, sucrose, isomaltulose, saccharin, aspartame, acesulfame K, neotame, etc.), organic and inorganic fillers (e.g., grains, processed grains, puffed grains, maltodextrin, dextrose, calcium carbonate, calcium phosphate, corn starch, lactose, microcrystalline cellulose, etc.), binders (e.g., povidone, sodium carboxymethyl cellulose (CMC), and other modified cellulose type binders, sodium alginate, xanthan gum, starch based binders, gum arabic, agar, gellan gum, polydextrose, etc.), gelling agents (e.g., fish gelatin, sorghum malt, or carrageenan), pH adjusters or buffers (e.g., metal hydroxides, preferably alkali metal hydroxides such as sodium hydroxide and potassium hydroxide, and other alkali metal buffers such as metal carbonates, preferably potassium carbonate or sodium carbonate, or metal bicarbonates such as sodium bicarbonate, etc.), emulsifiers, colorants (e.g., dyes and pigments including caramel dyes, titanium dioxide, etc.), wetting agents (e.g., glycerin, etc.), foaming materials such as certain acid / base combinations, lipids / oils (e.g., coconut oil, lecithin such as sunflower lecithin, palm kernel oil, and palm oil), oral care components (e.g., thyme oil, eucalyptus oil, food grade aloe vera gel, and zinc), preservatives (e.g., potassium sorbate, etc.), syrups (e.g., honey, high fructose corn syrup, corn syrup, etc.), disintegrants or compression aids (e.g., microcrystalline cellulose, croscarmellose sodium, crospovidone, sodium starch glycolate, pregelatinized corn starch, etc.), flavoring agents and flavoring blends, antioxidants, and mixtures thereof. Exemplary encapsulating components are described, for example, in Atchley International Publication No. 2010 / 132444, which is incorporated herein by reference.Other exemplary types of components can include, for example, those described in U.S. Patent Publication Nos. 2010 / 0291245 to Gao, 2012 / 0055494 to Hunt, and 2012 / 0199145 to Byrd, which are incorporated herein by reference.

[0051] Such components may be provided in powder or granulated form for mixing with the tobacco material formulation, or in liquid form. Most preferably, when the additional component is provided in powder or granulated form, it is used in the form of portions or fragments having an average particle size of less than about 50 micrometers. According to some embodiments, the average particle size of the component can be about 25 micrometers or less. The water content of the component provided in powder or granulated form can vary. The specific percentages and component selections will vary depending on the desired flavor, texture, and other properties.

[0052] As used herein, "flavorant" or "odorant" is any flavorful or fragrant substance that can modify the sensory properties associated with a smokeless tobacco composition. Exemplary sensory properties that can be modified by a flavorant include taste, mouthfeel, moisture, coldness / heat, and / or aroma / smell. Flavorants can be natural or synthetic, and the character of these flavors can be described as, but is not limited to, fresh, sweet, herbaceous, confectionary, floral, fruity, or spicy. Specific types of flavors include, but are not limited to, vanilla, coffee, chocolate, cream, mint (e.g., mint oil), spearmint, menthol, peppermint, wintergreen, lavender, cardamom, nutmeg, cinnamon, clove, cassia, patchouli, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, raspberry, and strawberry. The flavorants utilized in the present disclosure can also include components that are considered humectants, coolants, or lubricants, such as eucalyptus. These flavors can be provided undiluted (i.e., alone) or in combination (e.g., spearmint and menthol or orange and cinnamon). In some cases, the flavorants can be provided in a spray-dried form or in a liquid form. Flavorants are typically present in an amount of from about 0.05 to about 5 weight percent, often from about 0.1 to about 2 weight percent.

[0053] Sweeteners can be used in natural or artificial forms, or as a combination of artificial and natural sweeteners. In certain embodiments, the composition can advantageously include sucralose as a sweetener. When present, the amount of representative sweeteners, whether artificial sweeteners and / or natural sugars, can constitute at least about 0.001 percent, at least about 0.01 percent, or at least about 0.1 percent of the total weight of the composition. The typical gel-free tobacco compositions described herein contain less than about 10 weight percent, less than about 8 weight percent, less than about 5 weight percent, or less than about 2 weight percent of sweeteners. Exemplary ranges of sweeteners in the gel-free tobacco compositions of the present disclosure are from about 0.001 weight percent to about 1 weight percent, for example, from about 0.002 weight percent to about 0.5 weight percent.

[0054] Salts (e.g., sodium chloride, fine salt) can be used in an amount sufficient to provide the desired sensory attributes to the smokeless tobacco composition. When present, the amount of representative salts is at least about 0.1 weight percent or at least about 0.2 weight percent, but will typically constitute less than about 5 percent of the total weight of the composition (e.g., from about 0.1 to about 2 weight percent).

[0055] Preferred buffering agents buffer in the pH range of about 6 to about 10, and exemplary buffering agents include metal hydroxides (e.g., NaOH), metal carbonates, metal bicarbonates, or mixtures thereof. The buffering agent is typically present in an amount of less than about 1 percent based on the weight of the formulation.

[0056] A binder (or combination of binders) or gelling agent can be used in an amount sufficient to provide the desired physical attributes (e.g., gel-like properties) and physical integrity to the smokeless tobacco composition. In certain embodiments, the binder or gelling agent can be beneficial in delaying the recrystallization of the sugar alcohol component of the gel. Exemplary binders or gelling agents include natural gums such as carrageenan and gum arabic. Representative amounts of binders or gelling agents can constitute at least about 5 percent or at least about 10 percent of the total weight of the composition. In certain embodiments, the binder component(s) of the composition will be present in an amount of at least about 20 weight percent, at least about 25 weight percent, at least about 30 weight percent, at least about 35 weight percent, or at least about 40 weight percent. Often, the amount of binder within the desired composition will not exceed about 50 percent of the total weight of the composition. Thus, the total amount of binder in certain embodiments can range from about 5 weight percent to about 50 weight percent (e.g., from about 10 weight percent to about 30 weight percent such as from about 15 weight percent to about 25 weight percent).

[0057] In certain embodiments, the binder material includes natural gum. As used herein, natural gum refers to a naturally derived polysaccharide material useful as a thickening or gelling agent. When present, the natural gum binder material is typically present in an amount of at least about 15 weight percent, or at least about 20 weight percent, or at least about 25 weight percent. Representative natural gums derived from plants are typically somewhat water-soluble and include agar, xanthan gum, guar gum, gum arabic, ghatti gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof.

[0058] Examples of lipid components within such gel compositions include, but are not limited to, fats, oils, or wax substances (or combinations thereof). Exemplary fats that may be used include palm oil, palm kernel oil, soybean oil, cottonseed oil, and combinations thereof. According to some embodiments, the lipid substance may be hydrogenated, partially hydrogenated, or non-hydrogenated. In some cases, the lipid substance may include a blend of lipid components. For example, the lipid substance may include a blend of palm oil and palm kernel oil. Further information regarding lipid components is provided, for example, in U.S. Patent Publication No. 2012 / 0037175 to Cantrell et al., which is incorporated herein by reference. The relative amounts of lipid substances within the smokeless tobacco composition can vary. When present, the lipid component may be present in an amount of at least about 5 weight percent or at least about 10 weight percent, based on the total weight of the gel formulation, in some embodiments. Exemplary weight ranges for lipids include from about 1 to about 40 weight percent, more typically from about 1 to about 30 weight percent.

[0059] The acidity or alkalinity of a smokeless tobacco product is often characterized in terms of pH and can vary and will depend in part on whether the product is formulated with a pH adjuster (e.g., citric acid) or buffer. Typically, the pH of the formulation will be in the range of about 4 to about 9. When a base or alkaline buffer is present, the pH will typically be towards the upper end of this range, such as about 6.5 to about 8. When the product is formulated without a pH adjuster or buffer, in certain embodiments, the pH will be in the range of about 4.5 to about 6.5. Representative techniques for determining the pH of a smokeless tobacco formulation involve dispersing 5 g of the formulation in 100 ml of high performance liquid chromatography water and measuring the pH of the resulting suspension / solution (e.g., with a pH meter).

[0060] Certain representative smokeless tobacco compositions can incorporate, based on the total weight of the smokeless tobacco gel composition, from about 0.05 to about 0.5 weight percent nicotine (e.g., tobacco-derived nicotine), from about 55 to about 80 weight percent of one or more sugar alcohols, from about 1 weight percent to about 20 weight percent humectant (e.g., glycerin), from about 15 to about 40 weight percent water, optionally from about 0.001 to about 0.1 weight percent of one or more sweeteners, one or more optional flavorants present in a total amount of up to about 2 percent, and optionally salt in an amount of up to about 2 weight percent. For embodiments of the above composition having a more pasty consistency, the humectant content is greater than about 7 weight percent, greater than about 8 weight percent, or greater than about 9 weight percent (e.g., about 7 to about 15 weight percent). For embodiments of the above composition having a more syrupy consistency, the humectant content is less than about 6 weight percent, less than about 5 weight percent, or less than about 4 weight percent (e.g., about 2 to about 6 weight percent). In certain embodiments of the above composition, the major sugar alcohol constituent is isomalt in an amount of at least about 60%, or at least about 70%, or at least about 80%, etc., typically at least about 50% of the total dry weight of the sugar alcohols. In certain embodiments, the one or more sugar alcohols will mainly comprise isomalt in combination with one or more of maltitol, sorbitol, and erythritol.

[0061] Typical smokeless tobacco gel products according to the present invention can have various types of formats and configurations, and as a result, the character, nature, behavior, consistency, shape, form, size, and weight of the composition can vary. Representative shapes of the composition can generally be spherical, cylindrical (e.g., ranging from the general shape of a flat disk to the general shape of a relatively elongated rod), helical, obloid, square, rectangular, etc., or the composition can have the form of beads, capsules, films, flakes, etc. The shape of the composition can be similar to a wide range of products such as pills, tablets, lozenges, capsules, and caplets. According to one aspect, the smokeless tobacco gel product can preferably persist in the user's oral cavity for about 1 to about 10 minutes until it completely dissolves. In the case of a smokeless tobacco gel product with an outer coating, this time refers to the time when both the coating and the gel composition contained therein dissolve. Typically, the amount of time required for the coating to dissolve is less than the amount required for the gel composition to dissolve. For example, in a particular coated product, the coating can dissolve in the user's oral cavity in about 0.5 to about 5 minutes (e.g., about 1 minute, about 0.5 to about 2 minutes), and the gel composition can dissolve in the user's oral cavity in about 3 to about 10 minutes (e.g., about 7 minutes, about 5 to about 8 minutes). Preferably, the product does not leave any residue in the user's oral cavity to any significant extent and does not impart a smooth, waxy, or sticky sensation to the user's oral cavity. Advantageously, the product can present a mouthfeel of some kind of gel, syrup, jelly-like, gelatinous, taffy-like, or paste-like.

[0062] The appearance of the smokeless gel products provided herein can be various. In certain embodiments, the gel product can exhibit a degree of translucency (e.g., at least about 30% light transmittance percent at visible light wavelengths greater than about 600 nm, or at least about 40% light transmittance percent at visible light wavelengths greater than about 600 nm, or at least about 50% light transmittance percent at visible light wavelengths greater than about 600 nm (or even higher levels such as greater than about 60%, or greater than about 70%, or greater than about 80% at visible light wavelengths greater than about 600 nm)). It is understood, of course, that the translucent appearance of the gel can be altered by the direct addition of various components to the gel and / or by the application of a coating thereto. For example, although the gel itself can exhibit a degree of translucency, in some embodiments, a coating can be provided that gives the overall product a lower degree of translucency (or even opacity).

[0063] The means by which smokeless tobacco gel products can be produced can be various, and generally, the components of the product can be combined by such formulations and / or by any means for providing such a product. Exemplary means for providing certain types of formulations are provided herein, but it is noted that other methods can be used without departing from the present invention. For example, the various components of the smokeless tobacco gel composition can be contacted, combined, or mixed in a conical blender such as a Hobart mixer, a drum mixer, a ribbon blender, etc. Therefore, the entire mixture of the various components and the tobacco material can be relatively homogeneous in nature in some embodiments. See also, for example, the types described in U.S. Patent Nos. 4,148,325 to Solomon et al., 6,510,855 to Korte et al., and 6,834,654 to Williams, each of which is incorporated herein by reference.

[0064] Typical conditions for the manufacture of food-grade products as described herein include heat and temperature control (i.e., the degree of heat to which various components are exposed during manufacture and the temperature of the manufacturing environment), water content (e.g., the degree of moisture present within individual components and within the final composition), humidity within the manufacturing environment, atmosphere control (e.g., nitrogen atmosphere), air flow impinging on various components during the manufacturing process, as well as other similar types of factors. Note that the various process steps involved in product manufacture may involve the selection of specific solvents and processing aids, the use of heat and radiation, conditions related to refrigeration and low temperatures, component mixing ratios, etc. The manufacturing conditions can also be controlled by the selection of the form of the various components (e.g., solid, liquid, or gas), the particle size or crystallinity of components in solid form, the concentration of components in liquid form, etc. The components can be processed into the desired composition by techniques such as extrusion, compression, spraying, etc.

[0065] In certain embodiments, it is preferred to maintain the composition after manufacture in an airtight and / or air-purged environment so that the product is not significantly exposed to air. When the gels of the present invention are exposed to air for extended periods, typically the gels will harden into a form that does not have the desirable properties (such as fluidity and physical properties similar to syrups, pastes, etc.) described herein. Thus, the method of storing the gels of the present invention preferably includes measures taken to minimize the interaction between air and the product, such as sealing the product within an airtight packaging. However, introducing a certain amount of air under control during manufacture can be advantageous for enhancing certain desired properties of the final product. For example, by stirring or agitating the composition during cooling, a certain amount of air can be introduced over a short period. Such an aeration step during cooling can result in a product having a more pasty texture.

[0066] In certain embodiments, the sugar alcohol or combination of sugar alcohols is first heated to a high temperature, typically a temperature sufficient to reach a molten form. In certain embodiments, the sugar alcohol is initially in particulate or syrup form. This heating step will typically not involve heating to the "hard crack" stage of the particular sugar alcohol(s). Instead, heating will typically be done at a heating stage referred to as "soft ball" or "hard ball" in the confectionery art. An exemplary temperature range for the heating step is from about 115°C to about 130°C. Other components are added at various temperatures and the final composition is typically deposited (e.g., in a mold or other container) or processed while still warm (e.g., via extrusion). The final composition is advantageously placed in an airtight and / or air-purged environment to prevent or reduce product hardening due to exposure to air. Some of the additional product components can be added at the maximum temperature of the heated sugar material. Others are temperature sensitive and can be added at a more cooled temperature. For example, the product mixture can be cooled to below 100°C and nicotine, certain pH adjusting or buffering components, colorants, flavorants, etc. can be added. Once all components are incorporated into the product composition, the product can be cooled to room temperature and stored in an airtight container. To obtain a more pasty consistency, the product mixture can be aerated through stirring / agitation during cooling until the desired pasty texture and properties are obtained. In certain embodiments, the product mixture can be aerated through stirring / agitation for about 20 minutes to about 40 minutes. Thereafter, the product can be stored in an airtight container. As used herein, "airtight" or "air-purged" in relation to the environment surrounding the product refers to an environment where the interaction between the product and air is minimized and the product does not harden into a solid form.

[0067] During final cooling of the product, the product of the present invention can be shaped, if desired. For example, such a product can be extruded into a desired shape. Exemplary extrusion methods are described, for example, in U.S. Patent Nos. 3,806,617 to Smylie et al. and 4,880,018 to Graves, Jr. et al., which are incorporated herein by reference. In some embodiments, various types of molding techniques (including, but not limited to, starch molding or injection molding) can be used. In some embodiments, the composition is deposited into a mold, such as a starch mold as used in a starch molding process to form a troche. Troche production processes that can be used for the production of smokeless tobacco gel products according to the present disclosure are described in U.S. Patent Nos. 4,725,440 to Ridgway et al. and 6,077,524 to Bolder et al., which are incorporated herein by reference. When the product is molded, other types of molds, such as starch-free molds, plastic tray molds, metal tray molds, neoprene tray molds, etc., can be used in the process. Such molded compositions are generally removed from the mold prior to distribution.

[0068] In some embodiments, the composition can be coated to facilitate the handling of the smokeless tobacco gel product, reduce unnecessary packaging, and / or reduce the exposure of the product to air. The terms "coated" and "coating" as used herein mean that the gel smokeless tobacco composition is partially or substantially encompassed by or encapsulated within the coating. Typically, such coatings are edible. For example, a gel product as described herein can be housed within an edible pouch as described in U.S. Patent Application Publication No. 2006 / 0280777 to Schydlowsy, which is incorporated herein by reference. In certain embodiments, the outer coating can be in the form of a coating or casing of the type used for single-piece or two-piece capsules known in the art.

[0069] The outer coating can also help improve the packaging process by improving the storage stability of the smokeless tobacco gel product of the present disclosure and reducing brittleness and powdering. The method of application can vary, and the coating can be applied, for example, by preparing the composition in sheet form and encapsulating a gel smokeless tobacco formulation such as those described herein between the two sheets, or by dipping or spraying the coating composition onto the outer surface of the gel smokeless tobacco formulation. Examples of devices for providing an external coating layer to the products of the present disclosure include pan coaters and spray coaters, and in particular, coating devices available from Thomas Engineering as CompuLab 24, CompuLab 36, Accela-Cota 48, and Accela-Cota 60.

[0070] Edible coatings generally contain ingredients that are safe for oral consumption, such as those described above herein (e.g., sugar alcohols, binders, flavorants, sweeteners, salts, colorants, etc.). Edible coatings can have various textures and can be, for example, gel coatings, soft shell coatings, or hard shell coatings. The coating can be applied in a wide range of thicknesses.

[0071] In some embodiments, a gel or soft shell coating is applied to the gel smokeless tobacco composition of the present disclosure to provide a smokeless tobacco gel product. Again, the specific texture and properties of the coating can vary (e.g., from taffy-like to jelly-like, gelatinous, pasty). In some embodiments, the gel or soft shell coating can be characterized as having some chewiness, resilience, and / or elasticity.

[0072] For example, in certain embodiments, an exemplary gel or soft-shell coating is applied that includes one or more sugar alcohols (as described in detail above) and optionally further includes flavorants, colorants, salts, sweeteners, buffers, acidic components, and / or other components of the types described herein. The coating composition can include a tobacco material (e.g., a tobacco extract). For example, in certain embodiments, such a coating can include at least about 90 wt% of one or more sugar alcohols, at least about 95% of one or more sugar alcohols, at least about 97% of one or more sugar alcohols, or at least about 98 dry wt% of one or more sugar alcohols. It should be understood that the specific method by which a given composition is prepared can contribute to the final form and / or texture of that composition. For example, the principles of confectionery making can be applied to compositions containing significant amounts of sugar alcohols, and it is understood that the higher the heating temperature, the harder and more brittle the composition can be, while the lower the heating temperature, the softer the composition can be. In certain embodiments, the coating composition can be maintained in a softer form (i.e., as a gel or soft-shell coating) by combining the components of the coating composition, and the sugar alcohol component(s) are heated at a temperature below the hard crack stage of the sugar alcohol component(s), e.g., between the soft crack stage and the hard crack stage, between the hard ball stage and the hard crack stage, between the hard ball stage and the soft crack stage, between the firm ball stage and the hard crack stage, between the firm ball stage and the soft crack stage, between the firm ball stage and the hard ball stage, between the soft ball stage and the hard crack stage, between the soft ball stage and the soft crack stage, between the soft ball stage and the hard ball stage, or between the soft ball stage and the firm ball stage.

[0073] In other embodiments, a hard shell coating is applied to the gel-less tobacco composition of the present disclosure to provide a smokeless tobacco gel product. The method for preparing such a coating can be various. In some embodiments, a composition such as the above composition can be used, and it is understood that the sugar alcohol(s) is heated at a higher temperature (e.g., above the hard crack stage) to provide the composition in a hard shell form.

[0074] In some embodiments, a glazing or non-stick coating such as CAPOL 410 (available from Centerchem, Inc.) can be applied to the smokeless tobacco gel composition to provide free-flow characteristics. In some embodiments, an exemplary outer coating includes one or more sugar alcohols (as described in detail above) and a film-forming polymer such as a cellulose-type polymer (e.g., carboxymethyl cellulose or CMC). For example, such a coating can include, for example, about 70 to about 90 dry weight percent of one or more sugar alcohols and about 10 to about 30 dry weight percent of a film-forming polymer. Such a coating can optionally further include flavorants, colorants, salts, sweeteners, buffers, and / or other components of the types described herein. The coating composition can include tobacco materials (e.g., tobacco extracts). Other exemplary film-forming polymers include cellulose-type polymers such as methylcellulose, hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), hydroxyethyl cellulose, and carboxymethyl cellulose. Other exemplary coating compositions and coating methods are described in U.S. Patent Application Publication Nos. 2012 / 0055494 to Hunt et al. and 2013 / 0206150 to Duggins et al., which are incorporated herein by reference.

[0075] The above description has focused on compositions that are homogeneous through each product unit, but the product can also be formed by different formulations having different properties within the same product unit. For example, two different compositions can be deposited within a single mold to produce a layered product. Further, two different compositions can be co-extruded to form a product having different properties across its cross-section. Using such processes, a product can be provided having two different compositions characterized by different dissolution rates such that a first portion of the product dissolves at a first rate (e.g., a faster rate) and a second portion dissolves at a second, more gradual rate.

[0076] The products of the present disclosure may be packaged or stored within any suitable packaging. When the gel products of the present invention are packaged within individual product units, the gel products may be packaged within convenient portable containers. See, for example, various types of containers for smokeless types of products described in U.S. Patent Nos. 7,014,039 to Henson, 7,537,110 to Kutsch, 7,584,843 to Kutsch, D592,956 to Thiellier, and D594,154 to Patel, and U.S. Patent Publications 2008 / 0173317 to Robinson, 2009 / 0014343 to Clark, 2009 / 0014450 to Bjorkholm, 2009 / 0250360 to Bellamah, 2009 / 0266837 to Gelardi, 2009 / 0223989 to Gelardi, 2009 / 0230003 to Thiellier, 2010 / 0084424 to Gelardi, and 2010 / 0133140 to Bailey, 2010 / 0264157 to Bailey, 2011 / 0168712 to Bailey, and 2011 / 0204074 to Gelardi, which are incorporated herein by reference.

[0077] Typically, the gel products of the present invention are provided as a gel contained within moisture and an air barrier (e.g., a container / packaging or coating). In some embodiments, the composition can be deposited into a container for storage, distribution, and / or end use. The types of containers used can vary and can be, for example, cups, buckets, pouches, or tubes of various sizes and shapes. In some specific embodiments, the gel smokeless tobacco composition may be provided within a straw-type structure (e.g., including, but not limited to, a pouch-shaped or tube-shaped structure in which the gel smokeless tobacco composition is housed within the open interior of a tube structure). The ends of the non-edible straw-type structure may be sealed or non-sealed. Typically, the straw-type structure will be non-edible (e.g., constructed from a non-edible plastic material such as various thermoplastic plastics like polyethylene terephthalate, polyethylene, or polypropylene). Exemplary means for filling such containers are known and are described, for example, in Peters U.S. Patent No. 4,939,884 and Hamilton U.S. Patent No. 7,047,709, which are incorporated herein by reference. An exemplary gel product sealed within a straw-shaped outer case is shown in FIG. 1. As shown, the product unit 10 may include a fluid gel composition 30 (e.g., a syrup or honey-like composition) positioned within a plastic straw or pouch 20. Specific examples of such product containers will include sealed ends 12 and 14. Such ends may be heat-sealed such that access to the product requires opening one of the sealed ends (by cutting, etc.). In other embodiments, the sealed end may be in the form of a resealable seal such as a container with a chuck.

[0078] Alternatively, the gel product of the present invention may be positioned within a container that includes a movable element positioned to urge the contents of the container toward an open end through which the product can be dispensed by operation of a wheel or ring element by a consumer. Such a container would be particularly useful for gels having a relatively high degree of rigidity and cohesiveness. Such a container may have a shape and / or functionality similar to the containers described in U.S. Patent Nos. 4,605,330 to Crowley, 4,932,803 to Goldberger, 5,007,755 to Thompson, 7,105,173 to Rolling, 7,147,393 to Yoon, 8,136,686 to Schlatter, 8,292,532 to Nasu et al., and 8,511,922 to Prischak, which are incorporated herein by reference. Certain containers may have the characteristics of the types of containers commercially utilized for products characterized, for example, as lip cream, lipstick, or paste products. For example, representative containers that are used or can be suitably modified are of the type used for lip cream products sold by Pfizer Consumer Healthcare, The Clorox Company, and Neutrogena Corporation. Representative types of such containers are also available from sources such as Rustic Escentuals, LLC, etc.

[0079] An exemplary dispensing container is shown in FIG. 2, in which the dispensing container 40 includes a container body 45 and a cap 50. The cap 50 is attached to the container body and is shown in a state of covering the upper lip portion (shown by a dotted line in the figure) surrounding the dispensing opening of the container body. The container body 45 is shown as transparent for the purpose of illustrating the present invention. Inside the container body 45, there is a gel composition 55 (for example, a paste-like composition) of the type described in the present invention. The dispensing container 40 further includes a rotatable wheel 70 attached to a threaded support column 65, and the support column rotates together with the wheel. The non-rotatable movable floor portion 60 is in a screwed state with the support column 65, and the rotation of the wheel 70 (and the support column) will move the floor portion inside the container. In this way, when the wheel 70 is operated by the consumer, the floor portion 60 can push the columnar portion of the gel composition 55 toward the dispensing opening of the container body 45. Once the desired portion of the gel composition 55 is exposed from the dispensing opening, the consumer can fold or bite off the exposed portion for oral use.

[0080] Experiment Aspects of the present invention are more fully described by the following examples, which are shown for the purpose of illustrating specific aspects of the invention and should not be construed as limiting it.

[0081] Example 1: Paste-like Gel Containing Nicotine Combine isomalt, maltitol, and erythritol (all in syrup form), and sucralose, and heat to 260°F (about 127°C). Hold the mixture at 260°F (about 127°C) and combine salt, glycerin, and water and add them to the mixture. The addition of these components causes the mixture to cool, so reheat the resulting mixture to 220 - 225°F (about 104 - 107°C), cool it below 200°F (about 93°C), and add citric acid, color, flavor, and nicotine. The amounts of each component are shown in Table 1 below.

[0082]

Table 1

[0083] The resulting paste mixture is stirred well and the mixture is aerated until the color of the paste mixture becomes homogeneous, then cooled to 80°F (about 27°C) and deposited in an airtight container. Keep the container open until a paste-like consistency is obtained and stir periodically to provide a homogeneous texture. Once the desired consistency is obtained, seal the container airtight to prevent hardening. Since there is moisture present in other ingredients, especially the sugar alcohol syrups, the final water content is higher than that shown in Table 1. The total water content is maintained at less than about 40% by weight.

[0084] Example 2: Syrup Gel Containing Nicotine Combine isomalt, maltitol, and erythritol (all in syrup form), as well as sucralose and salt, heat to 260°F (about 127°C), and stir to ensure complete dissolution of the total solids. Cool the mixture to 250°F (about 121°C), combine glycerin and water and add to the mixture, and stir the mixture well. Reheat the resulting mixture to 220 - 225°F (about 104 - 107°C), cool to 180°F - 200°F (about 82 - 93°C), and add citric acid, color, flavor, and nicotine. The amounts of each ingredient are shown in Table 2 below.

[0085]

Table 2

[0086] The resulting gel mixture is stirred well until the color of the gel mixture becomes homogeneous, then deposited in a container while still warm. Seal the container airtight to prevent hardening. Since there is moisture present in other ingredients, especially the sugar alcohol syrups, the final water content is higher than that shown in Table 2. The total water content is maintained at less than about 40% by weight. The resulting product has the consistency of a honey-like syrup.

[0087] Example 3: Paste Gel Containing Particulate Tobacco Replace the nicotine solution with 10 grams of finely ground tobacco material and prepare the paste-like gel according to Example 1, except for removing erythritol.

[0088] Example 4: Paste-like Gel Containing Tobacco Extract Replace the nicotine solution with 5 grams of freeze-dried tobacco extract and prepare the paste-like gel according to Example 1, except for removing erythritol.

[0089] Example 5: Syrup-like Gel Containing Tobacco Extract Replace the nicotine solution with 5 grams of freeze-dried tobacco extract and prepare the syrup-like gel according to Example 2, except for removing erythritol.

[0090] Example 6: Syrup-like Gel Containing Granular Tobacco Replace the nicotine solution with 10 grams of finely ground tobacco material and prepare the syrup-like gel according to Example 2, except for removing erythritol.

[0091] Example 7: Coating for Gel Place warm water (100 g) on a hot plate, add NaOH, mix and dissolve. Add the tobacco extract, mix and dissolve. Add CMC15, mix and dissolve, and heat the mixture to about 135°F (about 57°C). Separately combine sorbitol, isomalt, maltitol syrup, and sucralose, melt them into a liquid form at a temperature of 290 - 300°F (about 143 - 149°C), cool to about 275°F (135°C), and add to the mixture. To limit air entrainment, stir the resulting combination at low speed using a portable mixer. Add flavor to this combination. The amounts of each component are shown in Table 3 below.

[0092]

Table 3

[0093] The resulting coating can be applied to the gel of the present invention in various ways. If the desired product is a sheet, a casting knife can be used to cast the coating material into a sheet on a stainless steel plate to form an outer layer surrounding the gel layer. If the desired product is a spray coating, the mixture is maintained at a high temperature (>150°F (about 66°C)) and used in a sprayer while restricting the intake of air into the mixture.

[0094] Example 8: Taffy-like Coating Combine isomalt, maltitol, vanillin, sucralose, and salt, heat to 240°F (about 116°C), and stir to ensure complete dissolution of all solids. Cool the mixture to 200°F (about 93°C) and add citric acid, color, flavor, and nicotine. The amounts of each component are shown in Table 4 below.

[0095]

Table 4

[0096] Stir the resulting mixture well and then deposit it on sulfuric acid paper. Once the deposited material has cooled to a still warm state, roll or press it into a sheet.

[0097] To apply this coating, deposit the gel of the present invention on one sheet of coating formulation, place a second sheet of coating formulation on top, and tension the sides. Then, place this multi-layer product in a drop roller to form individual product units.

[0098] Example 9: Poorly Soluble Coating Combine isomalt, maltitol, vanillin, sucralose, and salt, heat to 240°F (about 116°C), and stir to ensure complete dissolution of all solids. Cool the mixture to 200°F (about 93°C) and add citric acid, color, flavor, and nicotine. The amounts of each component are shown in Table 5 below.

[0099]

Table 5

[0100] The resulting mixture is stirred well and then deposited onto sulfuric acid paper. Once the deposited material has cooled to still being warm, it is rolled or pressed into a sheet.

[0101] To apply this coating, the gel of the present invention is deposited onto one coating formulation sheet, the second coating formulation sheet is placed on top, and the sides are tensioned. Thereafter, this multi-layer product can be placed in a drop roller to form individual product units.

[0102] Example 10: Hard Shell Coating Combine isomalt, maltitol, vanillin, sucralose, and salt, heat to 240°F (about 116°C), and stir to ensure complete dissolution of the total solids. Cool the mixture to 200°F (about 93°C) and add. The amounts of each component are shown in Table 6 below.

[0103]

Table 6

[0104] The resulting mixture is stirred well and then deposited onto sulfuric acid paper. Once the deposited material has cooled to still being warm, it is rolled or pressed into a sheet.

[0105] To apply this coating, the gel of the present invention is deposited onto one coating formulation sheet, the second coating formulation sheet is placed on top, and the sides are tensioned. Thereafter, this multi-layer product can be placed in a drop roller to form individual product units.

[0106] Those skilled in the art to which the present invention pertains will, with the assistance of the teachings presented in the foregoing description, be able to conceive of numerous modifications and other embodiments of the present invention. It will also become apparent to those skilled in the art that they can make variations and modifications of the present invention without departing from the scope and spirit of the present invention. Accordingly, the present invention is not limited to the specific embodiments disclosed herein, and modifications and other embodiments are intended to be included within the scope of the appended claims. Specific terms are used herein, but they are used in a merely general and descriptive sense and not for purposes of limitation.

Claims

**Claim 1** A soluble gel product comprising a) at least about 60 weight percent of one or more sugar alcohols; b) about 1 to about 20 weight percent of a wetting agent; c) at least about 10 weight percent of water; d) (i) nicotine in an amount of at least about 0.01 weight percent and non - tobacco plant material in an amount of about 0.2 to about 20 weight percent as an active ingredient, based on the total weight of the soluble gel product, or (ii) non - tobacco plant material in an amount of about 0.2 to about 20 weight percent as an active ingredient, based on the total weight of the soluble gel product; wherein the wetting agent is present in an amount of at least about 7 weight percent and the soluble gel product has a paste - like consistency, or the wetting agent is present in an amount of less than about 6 weight percent and the soluble gel product has a syrup - like consistency, a soluble gel product. **Claim 2** The soluble gel product according to claim 1, comprising at least about 65 weight percent of one or more sugar alcohols. **Claim 3** The soluble gel product according to claim 1 or 2, wherein the one or more sugar alcohols are selected from the group consisting of erythritol, trehalose, arabinitol, xylitol, ribitol, mannitol, sorbitol, dulcitol, iditol, isomalt, maltitol, lactitol, polyglycitols, and combinations thereof. **Claim 4** The soluble gel product according to claim 3, wherein the one or more sugar alcohols are selected from the group consisting of isomalt, maltitol, xylitol, sorbitol, erythritol, and combinations thereof. **Claim 5** The soluble gel product according to claim 1, wherein the one or more sugar alcohols include isomalt as the most abundant sugar alcohol component in the soluble gel product. **Claim 6** The soluble gel product according to claim 5, wherein isomalt constitutes at least about 50% of the total dry weight of the sugar alcohols. **Claim 7** The soluble gel product according to claim 6, wherein isomalt constitutes at least about 60% of the total dry weight of the sugar alcohols. **Claim 8** The soluble gel product according to any one of claims 5 - 7, wherein the one or more sugar alcohols further comprise one or more of maltitol, sorbitol, erythritol, and xylitol. **Claim 9** The solubility gel product according to any one of claims 1 to 8, wherein the non-tobacco plant material is selected from the group consisting of acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, beaver balm, wild bergamot, black pepper, blueberry, borage oil, chikusetsu, cocoa, calamus root, houttuynia cordata, katsuobushi, cayenne pepper, chaga, chervil, cinnamon, dark chocolate, potato peel, grape seed, carrot, ginkgo, common yarrow, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile, clove, cocoa powder, cranberry, dandelion, grapefruit, honeybush, echinacea, garlic, matsuyoi, natsushirogiku, ginger, goldenseal, hawthorn, hibiscus flower, licorice, kava, lavender, licorice, marjoram, thistle, mint, oolong tea, beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover, rooibos (red or green), rose hip, rosemary, sage, clary sage, celery, spearmint, spirulina, acanthophyllum bark, sorghum bran high tannin variety, sorghum grain high tannin variety, urushi bran, comfrey leaves and roots, goji berry, gotu kola, thyme, turmeric, euonymus, kansosou, wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa, bacopa monnieri, ashwagandha, and maria thistle and combinations thereof.

10. The solubility gel product according to claim 9, wherein the non-tobacco plant material is selected from green tea, mayusa, rooibos, honeybush, and combinations thereof.

11. The solubility gel product according to claim 9 or 10, which does not contain tobacco material.

12. The solubility gel product according to claim 1, wherein the non-tobacco plant material is in particulate form.

13. The solubility gel product according to claim 1, wherein the non-tobacco plant material is in the form of an extract or isolate from a plant material.

14. The solubility gel product according to claim 1, wherein the nicotine is tobacco-derived nicotine.

15. The solubility gel product according to claim 1, wherein the nicotine is synthetic-derived nicotine.

16. The soluble gel product according to claim 1, wherein nicotine is present in an amount of about 0.05 to about 0.5% by weight.

17. The soluble gel product according to claim 1, comprising both nicotine and non-tobacco plant material.

18. The soluble gel product according to claim 1, comprising more than about 14% by weight of water.

19. The soluble gel product according to claim 18, comprising about 15 to about 40% by weight of water.

20. A method for preparing the soluble gel product according to claim 1, comprising: (a) mixing a wetting agent with (i) non-tobacco plant material in an amount of about 0.2 to about 20 weight percent and nicotine in an amount of at least about 0.01 weight percent, or (ii) non-tobacco plant material in an amount of about 0.2 to about 20 weight percent and one or more sugar alcohols, based on the total weight of the soluble gel product, to form a gel mixture, wherein the gel mixture comprises at least about 60% by weight of the one or more sugar alcohols; (b) depositing the gel mixture in an airtight container or encapsulating the gel mixture with a coating composition to prevent curing of the gel mixture in the presence of air; and comprising a method.

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