CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Application Serial No. 61/886,355, filed on October 3, 2013, U.S. Application Serial No. 61/886,325, filed on October 3, 2013, U.S.

Application Serial No. 61/886,367, filed on October 3, 2013, U.S. Application Serial No.

61/886,358, filed on October 3, 2013, the contents of which are hereby incorporated by reference in their entirety.

TECHNICAL FIELD

This document relates to dissolvable-chewable tablets and methods for making dissolvable-chewable tablets. For example, a dissolvable-chewable tablet can include one or more ingredients, such as nicotine, within a solid solution of soluble fiber and one or more sugar alcohols.

BACKGROUND

Oral products providing flavor and/or one or more active ingredients are well known. One such oral product is chewing gum. Other oral products include hard pieces (e.g., mints). Softer gelatin-based oral products are also known. Pharmaceutical and therapeutic products (e.g., cough-suppressant lozenges) can also be provided in a solid form for oral consumption. The flavor release and/or active agent release characteristics for an oral product are important for providing an improved consumer product.

Tobacco can be enjoyed by adult tobacco consumers in a variety of forms. Smoking tobacco is combusted and the aerosol either tasted or inhaled (e.g., in a cigarette, cigar, or pipe). Smokeless tobacco products are not combusted and include: chewing tobacco, moist smokeless tobacco, snus, and dry snuff. Chewing tobacco is coarsely divided tobacco leaf that is typically packaged in a large pouch-like package and used in a plug or twist. Moist smokeless tobacco is a moist, more finely divided tobacco that is provided in loose form or in pouch form and is typically packaged in round cans and used as a pinch or in a pouch placed between an adult tobacco consumer's cheek and gum. Snus is a heat treated smokeless tobacco. Dry snuff is finely ground tobacco that is placed in the mouth or used nasally.

Nicotine is a component of various tobacco products. Over the years, however, various methods and systems have been developed for providing nicotine to adult consumers without the presence of tobacco plant tissue. Some ways nicotine, in the absence of tobacco, is provided include transdermal patches, lozenges, and nicotine chewing gums.

Nicotine, or 3-(l-methyl-2-pyrrolidinyl) pyridine, is a tertiary amine with the following structure:

Under ambient conditions, nicotine is an oily, volatile, hygroscopic liquid that is sensitive to light and air. Chemical and physical properties of nicotine present a number of processing and stability issues. For example, because nicotine is volatile, it may evaporate during its incorporation into a gum or lozenge. In an effort to reduce potential processing and stability issues associated with the nicotine compound, a number of nicotine complexes have been developed. For example, one method includes the preparation of a complex of nicotine and an ion exchange resin. A well-known complex that is currently used in the commercially-available nicotine chewing gums is nicotine polacrilex, which is a complex of nicotine and the cation exchange resin AMBERLITE 164.

SUMMARY

A dissolvable-chewable tablet provided herein provides a satisfying tactile and/or flavor experience. A dissolvable-chewable tablet provided herein is at least partially receivable in an oral cavity of an adult tobacco consumer. In some cases, a dissolvable-chewable tablet provided herein is wholly receivable in an oral cavity. A dissolvable-chewable tablet provided herein can include a solid solution of soluble fiber, one or more additives, and one or more sugar alcohols, with tobacco plant tissue, exhausted-tobacco fibers, or nicotine additives dispersed therein. In some cases, a dissolvable-chewable tablet provided herein can include unbound nicotine. In some cases, a dissolvable-chewable tablet provided herein includes at least 20 weight percent of soluble fiber. In some cases, soluble fiber in dissolvable-chewable tablet provided herein can include digestion-resistant maltodextrin. In some cases, a dissolvable-chewable tablet provided herein includes at least 20 weight percent of one or more sugar alcohols. A dissolvable - chewable tablet provided herein can be adapted to release exhausted-tobacco plant tissue, one or more additives nicotine a derivative thereof therefrom when received within the oral cavity of an adult tobacco consumer and/or chewed by tobacco consumer.

Dissolvable-chewable tablets provided herein, in some cases, include one or more additives selected from the categories of flavorants, sweeteners, vitamins, minerals, therapeutic agents, nutraceuticals, energizing agents, soothing agents, coloring agents, amino acids, chemesthic agents, antioxidants, food grade emulsifiers, pH modifiers, botanicals, teeth whitening agents, and/or alkaloids (e.g., caffeine). Combinations of additives (e.g., sweeteners, flavorants, and caffeine) can be combined to provide a favorable tactile and flavor experience.

A dissolvable-chewable tablet provided herein can, in some cases, include between 1 and 40 weight percent exhausted-tobacco fibers. In some cases, the tobacco used in the dissolvable- chewable exhausted-tobacco tobacco tablet includes between 5 and 35 weight percent exhausted- tobacco fibers. In some cases, the tobacco used in the dissolvable-chewable exhausted-tobacco tobacco tablet includes between 10 and 30 weight percent exhausted-tobacco fibers. In some cases, the tobacco used in the dissolvable-chewable exhausted-tobacco tobacco tablet includes between 15 and 25 weight percent exhausted-tobacco fibers. In some cases, the tobacco used in the dissolvable-chewable exhausted-tobacco tobacco tablet includes between 1 and 10 weight percent exhausted-tobacco fibers. In some cases, exhausted-tobacco fibers used in a dissolvable- chewable tablet provided herein can be processed to have an average fiber length of less than 200 micrometers, less than 150 micrometers, less than 125 micrometers, less than 100 micrometers, less than 75 micrometers, less than 50 micrometers, less than 25 micrometers, less than 20 micrometers, or less than 10 micrometers. In some cases, exhausted-tobacco fibers used in a dissolvable-chewable tablet provided herein can be processed to have an average fiber length of at least 1 micrometer, at least 5 micrometers, at least 10 micrometers, at least 25 micrometers, at least 50 micrometers, at least 75 micrometers, at least 100 micrometers, at least 125 micrometers, or at least 150 micrometers. In some cases, exhausted-tobacco fibers used in a dissolvable- chewable tablet provided herein can be processed to have an average fiber length of between 25 and 125 micrometers. A solid solution of soluble fiber and one or more sugar alcohols provided herein can have a glass transition temperature selected to provide a stable product at ambient temperatures, but that is chewable at body temperature. For example, by using the relatively high soluble fiber content, the glass transition temperature of a dissolvable-chewable tablet provided herein can be selected such that it is relatively close to ambient temperature, which can permit an adult tobacco consumer to experience an enjoyable tactile experience (e.g., mouth feel). A dissolvable-chewable tablet provided herein can include a single and continuous phase of the solid solution having one or more additives dissolved therein or a matrix of the solid solution having dispersed additives therein (e.g., oil, cellulosic fiber, nicotine, particles of tobacco.) At ambient temperatures, the solid solution can be amorphous and glassy.

A method of making dissolvable-chewable tablets provided herein includes forming a molten mixture of at least 20 weight percent soluble fiber, at least 20 weight percent of one or more sugar alcohols, exhausted-tobacco fibers, one or more additives (e.g., nicotine or a derivative thereof), and less than 15 weight percent water, while maintaining a mixture temperature of less than 150 °C, and portioning the molten mixture into a plurality of

dissolvable-chewable tablets. In some cases, the ingredients can be mixed to form the molten mixture in an extruder and individual dissolvable-chewable tablets formed from the molten mixture as it leaves the extruder. Plasticizers, such as oil, can be added to the molten mixture (e.g., in an extruder). In some cases, oil is added to increase the chewiness of a dissolvable- chewable tablet provided herein. In some cases, oil can be added to a molten mixture to cool the molten mixture to a temperature such that the molten mixture becomes a solid solution having some shape stability.

Unlike a traditional cooking process where sugars or sugar alcohols are heated to a temperature such that caramelization and other cross-linking occurs (e.g., greater than 160 °C)„ methods provided herein include a controlled mixing and heating of soluble fiber and sugar alcohols to form a molten mixture and dispersing nicotine (and optionally one or more additives) in the solid solution without creating significant crosslinking of the sugar alcohols. Because exhausted-tobacco fibers and certain additives (e.g., therapeutic agents and/or nicotine) can experience accelerated degradation can when exposed to elevated temperatures over 150 °C, a temperature of a molten mixture provided herein can be maintained at a temperature of 150 °C or below over a residence time of five to ten minutes or less during the mixing (for example, if an extrusion process is utilized). In some cases, a molten mixture provided herein is heated to a maximum temperature of between 80 °C and 150 °C. In some cases, a molten mixture provided herein is heated to a temperature of between 100 °C and 1 10 °C. When cooled to ambient temperatures, a molten mixture provided herein solidifies into an amorphous, non-porous, glassy, body consisting of a single and continuous phase of the solid solution and dispersed additives (e.g., oil, exhausted-tobacco fibers, and cellulosic fiber). Because the soluble fibers and sugar alcohols do not become cross-linked, they can remain soluble and thus dissolve when placed in an adult tobacco consumer's mouth.

In some cases, a dissolvable-chewable tablet provided herein can include a digestion- resistant soluble fiber. In some cases, a dissolvable-chewable tablet provided herein can include a digestion-resistant maltodextrin derived from maze. For example, Fibersol®-2 is a digestion- resistant corn-derived maltodextrin soluble fiber, which can be used as the soluble fiber in a dissolvable-chewable tablet provided herein. Other starch sources such as potato, rice, wheat, barley, peas, beans, lentils, oats, or tapioca can be processed to form digestion-resistant soluble fiber. A digestion resistant soluble fiber can include starch linkages that remain undigested by enzymes of the human digestive tract. Soluble fiber used in a dissolvable-chewable tablet provided herein can be a soluble fiber generally recognized as safe ("GRAS") by the Food and Drug Administration or another appropriate private, state, or national regulatory agency.

In some cases, a dissolvable-chewable tablet provided herein can include one or more sugar alcohols selected from the following group: mannitol, sorbitol, xylitol, erythritol, isomalt, lactitol, maltitol, maltitol syrup, and hydrogenated starch hydro lysates [HSH]. In some cases, a dissolvable-chewable tablet provided herein can include two or more sugar alcohols. In some cases, a dissolvable-chewable tablet provided herein can include mannitol and sorbitol. Sugar alcohols used in a dissolvable-chewable tablet provided herein can be generally recognized as safe ("GRAS") by the Food and Drug Administration or another appropriate private, state, or national regulatory agency.

A dissolvable-chewable tablet provided herein can, in some cases, include up to 15 weight percent water. In some cases, a dissolvable-chewable tablet provided herein can include between 0.5 weight percent and 7 weight percent water. In some cases, a dissolvable-chewable tablet provided herein can include between 1 weight percent and 5 weight percent water. In some cases, a dissolvable-chewable tablet provided herein can include between 2 weight percent and 4 weight percent water.

In some cases, nicotine or a derivative thereof can be included in a dissolvable-chewable tablet provided herein. Nicotine or derivatives thereof added to a dissolvable-chewable tablet provided herein can be in any suitable form. In some cases, a dissolvable-chewable tablet provided herein includes between 0.1 mg and 20 mg nicotine. In some cases, a dissolvable- chewable tablet provided herein includes between 0.5 mg and 10 mg nicotine. In some cases, a dissolvable-chewable tablet provided herein includes between 1.0 mg and 6 mg nicotine. In some cases, a dissolvable-chewable tablet provided herein includes between 1.0 mg and 3.0 mg in nicotine. In some cases, nicotine in a dissolvable-chewable tablet provided herein includes tobacco-derived nicotine. In some cases, nicotine tablet provided herein includes synthetic nicotine.

In some cases, a chewable dissolvable nicotine tablet provided herein, in some cases, can be substantially free of tobacco plant tissue.

In some cases, a liquid nicotine can be absorbed into exhausted-tobacco fibers and/or additional cellulose fibers. Combining liquid nicotine with cellulosic fiber (such as exhausted- tobacco fibers) can provide stabilized nicotine such that can be added to a dissolvable-chewable tablet provided herein in a method provided herein. In some cases, liquid nicotine is added to exhausted-tobacco fibers and/or cellulosic fiber prior to mixing the exhausted-tobacco fibers and/or cellulosic fiber fibers and nicotine into a mixture of soluble fiber and one or more additives (e.g., sugar alcohols) and be dispersed in a matrix of a solid solution provided herein.

Cellulosic fibers can be derived from plant tissue. In some cases, the cellulosic fibers include cellulose. Cellulosic fibers can further include lignin and/or lipids. Cellulosic fibers can be non-tobacco cellulosic fibers. In some cases, a chewable dissolvable-chewable nicotine tablet provided herein can include between 0.01 weight percent and 40 weight percent cellulosic fibers. In some cases, a chewable dissolvable nicotine tablet provided herein can include between 5 weight percent and 40 weight percent cellulosic fibers. In some cases, a chewable dissolvable nicotine tablet provided herein can include between 10 weight percent and 40 weight percent cellulosic fibers. In some cases, a chewable dissolvable nicotine tablet provided herein can include between 15 weight percent and 40 weight percent cellulosic fibers. In some cases, a chewable dissolvable nicotine tablet provided herein can include between 20 weight percent and 40 weight percent cellulosic fibers. In some cases, a chewable dissolvable nicotine tablet provided herein can include between 25 weight percent and 40 weight percent cellulosic fibers. In some cases, a chewable dissolvable nicotine tablet provided herein can include between 30 weight percent and 40 weight percent cellulosic fibers. A dissolvable-chewable tablet provided herein can include a sweetener dispersed therein. Suitable sweeteners include saccharine, sucralose, aspartame, acesulfame potassium, and combinations thereof. In some cases, a dissolvable-chewable tablet provided herein can be substantially free of sugars. For example, a dissolvable-chewable tablet can be substantially free of sugars, but include one or more sugar alcohols and non-nutritive sweeteners. In some cases, a dissolvable-chewable tablet provided herein can include non-caramelized sugars in a percentage of no more than 25 weight percent.

A tablet provided herein can include one or more flavorants as an additive. The flavorants can be natural or artificial. Flavorants can be selected from the following: licorice, wintergreen, cherry and berry type flavorants, Drambuie, bourbon, scotch, whiskey, spearmint, peppermint, lavender, cinnamon, cardamon, apium graveolents, clove, cascarilla, nutmeg, sandalwood, bergamot, geranium, honey essence, rose oil, vanilla, lemon oil, orange oil, Japanese mint, cassia, caraway, cognac, jasmin, chamomile, menthol, ylang ylang, sage, fennel, pimenta, ginger, anise, chai, coriander, coffee, mint oils from a species of the genus Mentha, cocoa, and combinations thereof. Synthetic flavorants can also be used. The particular combination of flavorants can be selected from flavorants that are GRAS in a particular country, such as the United States. Flavorants can also be included in the dissolvable-chewable tablet as encapsulated flavorants.

A dissolvable-chewable tablet provided herein can include a plasticizer dispersed in the solid solution. For example, the plasticizer can be propylene glycol, triacetin, glycerin, vegetable oil, partially hydrogenated oil, triglycerides, or a combination thereof. Plasticizers can be added as processing aids and/or to make a tablet chewier. In some cases, oil can be added to a molten mixture including sugar alcohol(s), soluble fibers, and to cool the molten mixture. In some cases, a dissolvable-chewable tablet provided herein can include oil dispersed within a matrix of a solid solution provided herein.

A body of a dissolvable-chewable tablet provided herein can have a variety of different shapes, some of which include disk, shield, heart, rectangle, and square. In some cases, a body of a dissolvable-chewable tablet provided herein can have rounded corners. In some cases, the body of the dissolvable-chewable tablet can be spherical. According to certain embodiments, the body can have a length or width of between 1 mm and 25 mm and a thickness of between 1 mm and 25 mm. In some cases, the body can have a length or width of between 5 mm and 15 mm and a thickness of between 2 mm and 5 mm. In some cases, a dissolvable-chewable tablet provided herein can include a colorant. For example, a body of a dissolvable-chewable tablet provided herein can include titanium dioxide, which can provide the body with a white color. In some cases, a coating on the body can include a colorant.

A method of forming dissolvable-chewable tablets can include forming a molten mixture of at least 20 weight percent soluble fiber, at least 20 weight percent of one or more sugar alcohols, exhausted-tobacco fibers, and one or more additives (e.g., nicotine), and less than 15 weight percent water, while maintaining a mixture temperature of less than 150 °C. In some cases, the molten mixture includes at less than 13 weight percent, less than 10 weight percent, less than 8 weight percent, less than 7 weight percent, less than 6 weight percent, or less than 5 weight percent water. In some cases, the molten mixture includes at least 0.5 weight percent, at least 1 weight percent, at least 2 weight percent, or at least 3 weight percent water. In addition to exhausted-tobacco, nicotine, water, sugar alcohol(s) and soluble fiber (e.g., maltodextrin), a molten mixture provided herein can include one or more additives selected from colorants, sweeteners, flavorants, plasticizers, antioxidants, processing aids, and combinations thereof. In some cases, the molten mixture is substantially free of sugars.

In some cases, the molten mixture provided herein is formed in an extruder. The extruder can be a multi-staged extruder having different sections that are heated to different temperatures and/or have different ingredients introduced. In some cases, an extruder provided herein can include multiple stages and can be used in a method provided herein in a process where the maximum temperature in any stage is no more than 150 °C (e.g., no more than 120 °C, no more than 110 °C, or no more than 105 °C). Portioning the molten mixture provided herein can be accomplished using any suitable method. A method provided herein can further include cooling dissolvable-chewable tablets and packaging dissolvable-chewable tablets.

The details of one or more embodiments of the subject matter described in this specification are set forth in the accompanying drawings and the description below. Other features, aspects, and advantages of the subject matter will become apparent from the

description, the drawings, and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of a chewable dissolvable nicotine tablet provided herein. Figures lA-10 illustrates various additional exemplary shapes of chewable dissolvable nicotine tablets provided herein.

Figure 2 depicts differential scanning calorimetry data for a chewable dissolvable nicotine tablet provided herein.

Figure 3 depicts differential scanning calorimetry data for sorbitol provided herein.

Figure 4 depicts differential scanning calorimetry data for maltodextrin provided herein.

Figure 5 depicts differential scanning calorimetry data for mannitol provided herein.

Figures 6A-6D depict x-ray microtomography cross sections of a chewable dissolvable nicotine tablet provided herein.

Figure 7 depicts an image of a chewable dissolvable nicotine tablet provided herein generated by a scanning electron microscope.

Figure 8 is a process diagram for making chewable dissolvable nicotine tablets according to a method provided herein.

DETAILED DESCRIPTION

The dissolvable-chewable tablets described herein include a solid solution of soluble fiber and one or more sugar alcohols. Nicotine or a derivative thereof (and optionally additional additives) can be dispersed in the solid solution such that the ingredients, e.g., one or more additives, are released from the dissolvable-chewable tablet when the dissolvable-chewable tablet is chewed and/or dissolved within an oral cavity. The dissolvable-chewable tablets described herein can provide a favorable additive release profile and tactile experience. In some cases, a dissolvable-chewable tablet provided herein includes unbound nicotine in the solid solution and/or absorbed into cellulosic fibers dispersed in a matrix of the solid solution.

Unlike traditional cooking processes, which typically solidify the ingredients by heating the ingredients to a temperature such that sugars and/or sugar alcohols caramelize, dissolvable- chewable tablets provided herein can be made by forming a solid solution of soluble fiber and one or more sugar alcohols in a controlled heating and mixing process maintained at a temperature of 150 °C or below. The solid solutions described herein exhibit a glass transition temperature (Tg) in the range of -75°C to 40 °C. Because the degradation of certain additive, exhausted-tobacco, or liquid nicotine can be accelerated when exposed to elevated temperatures over extended periods of time, the temperature of a molten mixture provided herein can be maintained at a temperature of 200 °C below or 150 °C below with a residence time of five to ten minutes or less during the mixing (for example, if an extrusion process is utilized) to produce a chewable dissolvable nicotine tablet that includes liquid nicotine dispersed in the tablet. In some cases, an extruder can be used for this controlled heating and mixing process. A desired texture of the dissolvable-chewable tablet can be determined by the selection and weight percentages of the soluble fiber and sugar alcohol(s) and the mixing process conditions. In some cases, a dissolvable-chewable tablet provided herein can include maltodextrin as the soluble fiber. In some cases, a dissolvable-chewable tablet provided herein can include at least 20 weight percent maltodextrin. In some cases, the soluble fiber can be digestion resistant soluble fiber (e.g., digestion resistant maltodextrin such as Fibersol®-2). By changing the ratio of soluble fiber to sugar alcohols, the Tg of the mixture can be altered and therefore the desired final texture of the product. In some cases, plasticizers can be incorporated into a dissolvable-chewable tablet provided herein to make it more chewable.

A dissolvable-chewable tablet provided herein can take up to 4 hours, up to 3 hours, up to 2 hours, or up to 1 hour to dissolve when placed in an adult consumer's mouth. Chewing can increase the rate of dissolution. In some cases, a dissolvable-chewable tablet provided herein can take less than 1 minute or as long as 30 minutes to dissolve when placed in an adult tobacco consumer's mouth. In some cases, a dissolvable-chewable tablet provided herein can take between 2 minutes and 15 minutes to dissolve when chewed in an adult consumer's mouth.

In some cases, a chewable dissolvable nicotine tablet can be substantially free of tobacco plant tissue. As used herein, the term "tobacco plant tissue" refers to processed or non-processed cellulosic parts (e.g., leaves, stems) of a member of the genus Nicotiana, but does not include extracts of tobacco (e.g., tobacco-derived nicotine). As used herein, "substantially free of tobacco plant tissue" means that the product includes less than 0.5 weight percent of tobacco plant tissue. For example, a chewable dissolvable nicotine tablet provided herein can include one or more organoleptic components extracted from raw or processed tobacco, yet be substantially free of tobacco plant tissue. In some cases, a chewable dissolvable nicotine tablet provided herein can include one or more organoleptic components extracted from raw or processed tobacco, yet include no tobacco plant tissue. As used herein, the term "tobacco plant tissue" refers to processed or non-processed cellulosic parts (e.g., leaves, stems) of a member of the genus Nicotiana, but does not include extracts of tobacco (e.g., tobacco-derived nicotine).

In addition to nicotine and/or derivatives thereof, one or more additional additives can be included in a chewable dissolvable nicotine tablet provided herein and adapted to be released from the chewable dissolvable nicotine tablet when the chewable dissolvable nicotine tablet is placed in an oral cavity and chewed by an adult consumer. In some cases, a chewable dissolvable nicotine tablet provided herein can include a combination of nicotine, sweeteners, and flavorants to mimic the flavor profile and tactile experience of certain tobacco products. In some cases, these additional additives include one or more additives selected from the categories of flavorants, sweeteners, vitamins, minerals, therapeutic agents, nutraceuticals, energizing agents, soothing agents, coloring agents, amino acids, chemesthic agents, antioxidants, food grade emulsifiers, pH modifiers, botanicals, teeth whitening agents, and/or alkaloids (e.g., caffeine). Combinations of additives (e.g., sweeteners, flavorants, and caffeine) can be combined to provide a favorable tactile and flavor experience.

In addition to exhausted-tobacco, tobacco plant tissue, nicotine and/or derivatives thereof, one or more additional additives can be included in a tablet provided herein and adapted to be released from the tablet when the tablet is placed in an oral cavity and chewed by an adult tobacco consumer. In some cases, a tablet provided herein can include a combination of nicotine and/or derivatives thereof, sweeteners, one or more additives, and flavorants to mimic the flavor profile and tactile experience of certain tobacco products.

In addition to additives, sweeteners, and flavorants, a dissolvable-chewable tablet provided herein can also include cellulosic fibers, fillers, plasticizers, and/or processing aids. Cellulosic fibers can at least partially absorb nicotine and/or other additives (e.g., sweeteners and/or flavorants). Fillers can also be included in the solid solution to alter the texture or pliability of the dissolvable-chewable tablet. The solid solution can also include plasticizers, which can increase the softness and/or chewability of the dissolvable-chewable tablet.

Processing aids can also be present in the dissolvable-chewable tablet and be used to facilitate shaping processes.

In some cases, a chewable dissolvable nicotine tablet can be substantially free of tobacco plant tissue. As used herein, "substantially free of tobacco plant tissue" means that the product includes less than 0.5 weight percent of tobacco plant tissue. For example, a chewable dissolvable nicotine tablet provided herein can include one or more organoleptic components extracted from raw or processed tobacco, yet be substantially free of tobacco plant tissue. In some cases, a chewable dissolvable nicotine tablet provided herein can include one or more organoleptic components extracted from raw or processed tobacco, yet include no tobacco plant tissue.

Chewable dissolvable-chewable tablet Shapes and Packaging

Figure 1 depicts an example of a chewable dissolvable nicotine tablet 110. Chewable dissolvable nicotine tablet 110 can have a length of about 16 mm, width of about 14 mm and a thickness of about 9 mm.

Referring now to Figures 1A-1N, the chewable dissolvable nicotine tablet 110 can be molded into any desired shape. For example, referring to Figures 1A-1L, the chewable dissolvable nicotine tablet 110A-L can be formed in a shape that promotes improved positioning in the oral cavity, improved packaging characteristics, or both. In some circumstances, the chewable dissolvable nicotine tablet 110A-L can be configured to be: (A) an elliptical-shaped chewable dissolvable nicotine tablet 110A ; (B) an elongated elliptical-shaped chewable dissolvable nicotine tablet HOB; (C) semi-circular chewable dissolvable nicotine tablet 1 IOC; (D) square or rectangular-shaped chewable dissolvable nicotine tablet HOD; (E) football-shaped chewable dissolvable nicotine tablet 110E; (F) elongated rectangular-shaped chewable dissolvable nicotine tablet 110F; (G) boomerang-shaped chewable dissolvable nicotine tablet HOG; (H) rounded-edge rectangular-shaped chewable dissolvable nicotine tablet 110H; (I) teardrop- or comma-shaped chewable dissolvable nicotine tablet 1101; (J) bowtie-shaped chewable dissolvable nicotine tablet 110 J; (K) peanut-shaped chewable dissolvable nicotine tablet 110K; and (L) shield-shaped chewable dissolvable nicotine tablet. Alternatively, the chewable dissolvable nicotine tablet can have different thicknesses or dimensionality, such that a beveled article (e.g., a wedge) is produced (see, for example, product 110M depicted in Figure 1M) or a hemi-spherical shape is produced. In some cases, the chewable dissolvable nicotine tablet has a shield shape. In addition or in the alternative to flavorants being included within the soluble fiber matrix, flavorants can be included on an exterior of a dissolvable-chewable tablet provided herein. For example, referring to Figure IN some embodiments of a dissolvable-chewable tablet 1 ION can be equipped with flavor strips 116.

Referring to Figure 10, particular embodiments of a dissolvable-chewable dissolvable- chewable exhausted-tobacco nicotine tablet 110 can be embossed or stamped with a design (e.g., a logo, an image, or the like). For example, the chewable dissolvable-chewable tablet 110O, such as shown in FIG. 10, can be embossed or stamped with any type of design 117 including, but not limited to, a trademark, a product name, or any type of image. The design 117 can be formed directly into the dissolvable-chewable tablet, arranged along the exterior of the product 110O. The design 117 can also be embossed or stamped into those embodiments with a dissolvable film 116 applied thereto.

In some cases, the dissolvable-chewable tablet 110 can be wrapped or coated in an edible or dissolvable film, which may be opaque, substantially transparent, or translucent. The dissolvable film can readily dissipate when the dissolvable-chewable tablet 110 is placed in an oral cavity. In some cases, the dissolvable-chewable tablet 110 can be coated with a mouth- soluble material. Exemplary coating materials include Carnuba wax, Beeswax, gelatin, acetylated monoglyceride, starch (e.g., native potato starch, high amylose starch, and

hydroxypropylated potato starch), Zein, Shellac, ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and combinations thereof. Additives, such as miglycol, titanium dioxide, kaoline, bentonite, can be incorporated into the coating material to improve oxygen or moisture barrier and mechanical properties for the coating or film. For example, a coating can include a combination of gelatin, and methylcellulose, or gelatin and hydroxymethylcellulose. In some cases, the coating can contain sugar alcohols such as sorbitol, mannitol, xylitol, erythritol), disaccharide-derived (e.g., isomalt, lactitol, maltitol), or polysaccharide-derived mixtures (e.g., maltitol syrup, hydrogenated starch hydro lysates [HSH]) or combinations thereof. In some cases, a coating material can contain sugar alcohols and hydroxymethylcellulose, gelatin, wax, with additives. In some cases, a coating material can include a plasticizer. In some cases, a coating can include a colorant, a flavorant, and/or a one or more of the additives discussed above. For example, a coating can include nicotine to provide a user with an initial burst (e.g., the nicotine is readily available.) In some cases, the solid solution can form a body that can have surfaces roughened to improve the adherence of a coating. In some cases, a coating can provide a glossy or semi-glossy appearance, a smooth surface, and/or an appealing visual aesthetic (e.g., a nice color). In some cases, the coating (e.g., a Beeswax, Carnuba wax, Zein, acetylated monoglyceride, and/or hydroxypropylated potato starch coating) can provide a soft mouth feel. In some cases, the coating (e.g., a methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, ethyl cellulose, and/or gelatin coating) can provide a hard outer coating.

One or more dissolvable-chewable tablets 110 can be packaged in a variety of

conventional and non-conventional manners. For example, a plurality of dissolvable-chewable tablets 110 can be packaged in a container having a lid. In some cases, a plurality of dissolvable- chewable tablets 110 can be stacked and packaged in a paper, plastic, and/or aluminum foil tube. In some cases, such as when dissolvable-chewable tablets provided herein include a therapeutic agent, the packaging can have a child-resistant lid.

Dissolvable-Chewable Tablet Properties

The tablets provided herein can provide a favorable tactile experience (e.g., mouth feel). While the chewable can retain its shape during processing, shipping, handling, the chewable a solid solution that dissolves or disintegrates when the chewable tablet 110 is placed in an oral cavity, exposed to saliva, and/or chewed. Prior to dissolution or disintegration in an oral cavity, dissolvable-chewable tablet provided herein can undergo a phase transition from a glassy state to a rubbery state then finally into to a viscous state. To further promote a favorable tactile experience (e.g., mouth feel), in some cases, chewable dissolvable-chewable tablet 110 can be formulated to exhibit a smooth texture. Working of the dissolvable-chewable tablet 110 within the oral cavity can accelerate the release of the nicotine within the solid solution.

During use, the environment surrounding the chewable dissolvable nicotine tablet 110 transitions from room temperature (e.g., ~25°C) to body temperature (e.g., ~37°C). One way of characterizing the properties of the chewable dissolvable nicotine tablet 110 is by determining the phase transition points of a chewable dissolvable nicotine tablet using differential scanning calorimetry (DSC). The chewable dissolvable nicotine tablet 110 is composed of various ingredients; therefore, the thermal transitions of the chewable dissolvable nicotine tablet can differ not only due to the individual properties of each ingredient, but also due to the ratios of those ingredients. For example, Figure 2 illustrates the thermal transitions of a chewable dissolvable nicotine tablet with approximately 30-40 weight percent of maltodextrin, a mixture of mannitol and sorbitol of approximately 30-40 weight percent, and water content from 0.5 weight percent to 7 weight percent. In some cases, a glass transition temperature (T _g ) 202 of the dissolvable-chewable tablet 110 can be from -65°C to 60°C (e.g., -65°C to 40°C, -50 °C to 40 °C, -40 °C to 30 °C, -30 °C to 20 °C, -20 °C to 10 °C, and -10 °C to 0 °C). The approximate T _g of this formulation can be from -20 to 10 °C. Thus, at room temperature the dissolvable- chewable tablet 110 is at the end of the transition from a glassy state to a rubbery/viscous state. Once the dissolvable-chewable tablet 110 is placed in an oral cavity at body temperature, the dissolvable-chewable tablet 110 can complete the phase transition to a rubbery/viscous state. In particular embodiments, the dissolvable-chewable tablet 110 is coated to facilitate bulk packaging.

Still referring to Figure 2, in some cases, a peak 204 at approximately 28°C (82.4°F) represents a melting transition point (T _m ) of the oil dispersed in the chewable dissolvable nicotine tablet 110. As the chewable dissolvable nicotine tablet 110 is exposed to body temperature that exceeds the T _m of the oil, the oil undergoes a phase transition to a liquid state. This transition can provide a favorable tactile experience (e.g., mouth feel) to the user as it causes the chewable dissolvable nicotine tablet to soften. For example, referring to Figures 6A- 6D, the multiple phases in the chewable dissolvable nicotine tablet are visible through x-ray microtomography. A soluble fiber, sugar alcohol, and nicotine mixture appears as a dense matrix 602 domain, while the oil and the nicotine are partitioned in the oil domains 604. This partition stabilizes the nicotine in the chewable dissolvable nicotine tablets. For example, as shown in Table 1, all nicotine degradants at week 16 were undetectable under controlled conditions of 25 °C, 65% relative humidity, and atmospheric pressure.

Table 1- % of Target Nicotine Concentration of Chewable Chewable dissolvable nicotine tablets at Week 16 Still referring to Figure 2, no peaks are present at 100 °C, which is the melting point of sorbitol, as depicted in Figure 3, the DSC for pure sorbitol does show a melting point at 100 °C. Figure 5 shows the DSC for pure mannitol with a melting temperature at 166°C is shown.

Figure 5 shows the DSC for pure mannitol with a melting temperature at 166°C. The mannitol peak can be absent (e.g., melting point) at 166° C can be absent in the DSC of Figure 2. Figure 4 shows the DSC for pure maltodextrin as a reference sample. The mixture of mannitol, sorbitol and maltodextrin can be amorphous for the example shown in Figure 2. Therefore, the product does not have "crumbly" texture in the chewable product.

The multiple phases in the dissolvable tobacco tablet are visible through x-ray

microtomography. A soluble fiber, sugar alcohol, and tobacco mixture appears as a dense matrix domain, while the oil is partitioned in the oil domains.

The dissolvable-chewable tablet 110 can have a variety of colors. In some cases, the tablet 110 has an off- white color. For example, referring to Figure 7, titanium dioxide (Ti02) can be added to the exhausted-tobacco, soluble fiber, sugar alcohol blend, and cellulose fiber mixture. The dark voids 702 dispersed throughout the dense matrix can indicate pockets of oil, flavor, and/or nicotine. In some cases, natural and artificial coloring can be added to a molten mixture that forms the solid solution during a molding process to form dissolvable-chewable tablets 110 having a predetermined color. Encapsulated flavors can be added during the extrusion process to create speckles, patterns, or dots within a dissolvable-chewable tablet.

Soluble Fiber

Soluble fiber dissolves in ambient water. Insoluble fiber does not dissolve in ambient water. Soluble fibers can attract water and form a gel. Not only are many soluble fibers safe for consumption, but some soluble fibers are used as a dietary supplement. As a dietary supplement, soluble fiber can slow down digestion and delay the emptying of a stomach. Instead of using soluble fiber as a mere additive, however, dissolvable-chewable tablets provided herein include a solid solution of soluble fiber and sugar alcohols that can be combined with additives to provide a satisfying tactile and/or flavor experience.

Any suitable soluble fiber or combination of soluble fibers can be used to form a soluble- fiber solution provided herein. Suitable soluble fibers include maltodextrin, psyllium, pectin, guar gum, gum arabic, inulin, arabinoxylans, cellulose, and many other plant components such as resistant starch, resistant dextrins, lignin, pectins, beta-glucans, and oligosaccharides or a combination thereof. In some cases, tablet provided herein can include a digestion-resistant soluble fiber. A digestion resistant soluble fiber can include starch linkages that remain undigested by enzymes of the human digestive tract. In some cases, tablet provided herein can include a digestion-resistant maltodextrin. In some cases, a digestion-resistant maltodextrin can be derived from maze. Suitable maltodextrins can include those that are soluble in water up to 70% at 20° C, have a viscosity of about 15 cps for a 30% solution at 30° C, a DE in the range of about 6-16, and contain random a- 1,2, a- 1,3, a- 1,4, β -1,2, β -1,3 and β -1,4 glucose linkages in addition to the normal a- 1,4 glucose linkages found in partially hydrolyzed starch. See, e.g., US Patent Nos. 5,410,035; 5,380,717, which are hereby incorporated by reference. For example, Fibersol ^® -2 is a maltodextrin of DE 6-10 processed from corn starch using hydrochloric acid and enzymes, which can be used as the soluble fiber in tablet provided herein. Fibersol®-2 is partially indigestible because human digestive enzymes are incapable of digesting β 1,2, β 1,3 and β 1,6 glucose bonds. See, e.g., US Patent No. 6,203,842, which is hereby incorporated by reference. Other starch sources such as potato, rice, wheat, barley, peas, beans, lentils, oats, or tapioca can be processed to form digestion-resistant soluble fiber. A digestion resistant soluble fiber includes starch linkages that cannot be hydrolyzed by enzymes of the human digestive tract. In some cases, suitable soluble fibers include Pinefibre, Pinefibre C, Dexflow and Pineflow as discussed in U.S. Patent No. 5,236,719, which is hereby incorporated by reference. Soluble fiber used in a tablet provided herein can be GRAS by the Food and Drug Administration or another appropriate private, state, or national regulatory agency.

A dissolvable-chewable tablet provided herein can include at least 20 weight percent of soluble fiber, at least 25 weight percent of soluble fiber, at least 30 weight percent of soluble fiber, at least 35 weight percent of soluble fiber, at least 40 weight percent of soluble fiber, at least 45 weight percent of soluble fiber, at least 50 weight percent of soluble fiber, at least 55 weight percent of soluble fiber, at least 60 weight percent of soluble fiber, at least 65 weight percent of soluble fiber, or at least 70 weight percent of soluble fiber. In some cases, a dissolvable-chewable tablet provided herein can include at least 20 weight percent maltodextrin, at least 25 weight percent maltodextrin, at least 30 weight percent maltodextrin, at least 35 weight percent maltodextrin, at least 40 weight percent maltodextrin, at least 45 weight percent maltodextrin, at least 50 weight percent maltodextrin, at least 55 weight percent maltodextrin, at least 60 weight percent maltodextrin, at least 65 weight percent maltodextrin, or at least 70 weight percent maltodextrin. In some cases, a dissolvable-chewable tablet provided herein can include less than 70 weight percent maltodextrin, less than 60 weight percent maltodextrin, less than 50 weight percent maltodextrin, or less than 40 weight percent maltodextrin. In some cases, a dissolvable-chewable tablet provided herein can include at least 20 weight percent digestion- resistant maltodextrin, at least 25 weight percent digestion-resistant maltodextrin, at least 30 weight percent digestion-resistant maltodextrin, at least 35 weight percent digestion-resistant maltodextrin, at least 40 weight percent digestion-resistant maltodextrin, at least 45 weight percent digestion-resistant maltodextrin, at least 50 weight percent digestion-resistant

maltodextrin, at least 55 weight percent digestion-resistant maltodextrin, at least 60 weight percent digestion-resistant maltodextrin, at least 65 weight percent digestion-resistant

maltodextrin, or at least 70 weight percent digestion-resistant maltodextrin.

Tobacco

Tobacco plant tissue (e.g., tobacco particles) can be mixed with the solid solution during an extrusion process. Tobacco plant tissue can provide passages in the dissolvable-chewable tobacco tablet, which can permit certain tobacco constituents and/or additives within the dissolvable-chewable tobacco tablet to be released into an oral cavity when the dissolvable- chewable tobacco tablet is received in an oral cavity and/or chewed.

Suitable tobaccos include fermented and unfermented tobaccos. In addition to

fermentation, the tobacco can be processed using other techniques. For example, tobacco can be processed by heat treatment (e.g., cooking, toasting), flavoring, enzyme treatment, expansion and/or curing. Both fermented and non-fermented tobaccos can be processed using these techniques. In other embodiments, the tobacco can be unprocessed tobacco. Specific examples of suitable processed tobaccos include dark air-cured, dark fire cured, burley, flue cured, and cigar filler or wrapper, as well as the products from the whole leaf stemming operation. In some embodiments, the tobacco fibers includes up to 70% dark tobacco on a fresh weight basis. For example, tobacco can be conditioned by heating, sweating, and/or pasteurizing steps as described in U.S. Publication Nos. 2004/0118422 or 2005/0178398, each of which is hereby incorporated by reference. Fermenting typically is characterized by high initial moisture content, heat generation, and a 10 to 20% loss of dry weight. See, e.g., U.S. Patent Nos. 4,528,993; 4,660,577; 4,848,373; and 5,372,149; each of which is hereby incorporated by reference. In addition to modifying the aroma of the leaf, fermentation can change either or both the color and texture of a leaf. Also during the fermentation process, evolution gases can be produced, oxygen can be taken up, the pH can change, and the amount of water retained can change. See, for example, U.S. Publication No. 2005/0178398 and Tso (1999, Chapter 1 in Tobacco, Production,

Chemistry and Technology, Davis & Nielsen, eds., Blackwell Publishing, Oxford), each of which is hereby incorporated by reference. Cured, or cured and fermented tobacco can be further processed (e.g., cut, expanded, blended, milled or comminuted) prior to incorporation into the oral tobacco product. The tobacco, in some embodiments, is long cut fermented cured moist tobacco having an oven volatiles content of between 48 and 50 weight percent prior to mixing with the mouth-stable polymer and optionally flavorants and other additives.

The tobacco can, in some embodiments, be prepared from plants having less than 20 μg of DVT per cm ² of green leaf tissue. For example, the tobacco fibers can be selected from the tobaccos described in U.S. Patent Publication No. 2008/0209586, which is hereby incorporated by reference. Tobacco compositions containing tobacco from such low-DVT varieties exhibits improved flavor characteristics in sensory panel evaluations when compared to tobacco or tobacco compositions that do not have reduced levels of DVTs.

Green leaf tobacco can be cured using conventional means, e.g., flue-cured, barn-cured, fire-cured, air-cured or sun-cured. See, for example, Tso (1999, Chapter 1 in Tobacco,

Production, Chemistry and Technology, Davis & Nielsen, eds., Blackwell Publishing, Oxford) for a description of different types of curing methods. Cured tobacco is usually aged in a wooden drum (i.e., a hogshead) or cardboard cartons in compressed conditions for several years (e.g., two to five years), at a moisture content ranging from 10% to about 25%. See, U.S. Patent Nos. 4,516,590 and 5,372,149, each of which is hereby incorporated by reference. Cured and aged tobacco then can be further processed. Further processing includes conditioning the tobacco under vacuum with or without the introduction of steam at various temperatures, pasteurization, and fermentation. Fermentation typically is characterized by high initial moisture content, heat generation, and a 10 to 20%> loss of dry weight. See, e.g., U.S. Patent Nos.

4,528,993, 4,660,577, 4,848,373, 5,372,149; U.S. Publication No. 2005/0178398; and Tso (1999, Chapter 1 in Tobacco, Production, Chemistry and Technology, Davis & Nielsen, eds., Blackwell Publishing, Oxford), each of which is hereby incorporated by reference. Cured, aged, and fermented tobacco can be further processed (e.g., cut, shredded, expanded, or blended). See, for example, U.S. Patent Nos. 4,528,993; 4,660,577; and 4,987,907; each of which is hereby incorporated by reference.

Tobacco plant tissue can be processed to a desired size (e.g., a desired particle size). In some cases, the tobacco fiber can be processed to have an average fiber size of less than 200 micrometers, less than 150 micrometers, less than 125 micrometers, less than 100 micrometers, less than 75 micrometers, less than 50 micrometers, less than 25 micrometers, less than 20 micrometers, or less than 10 micrometers. In some cases, tobacco plant tissue used in a dissolvable-chewable tobacco tablet provided herein can be processed to have an average particle size of at least 1 micrometer, at least 5 micrometers, at least 10 micrometers, at least 25 micrometers, at least 50 micrometers, at least 75 micrometers, at least 100 micrometers, at least 125 micrometers, or at least 150 micrometers. In some cases, tobacco plant tissue used in a dissolvable-chewable tobacco tablet provided herein can be processed to have an average particle size of between 25 and 125 micrometers. In some embodiments, the tobacco fibers includes long cut tobacco, which can be cut or shredded into widths of about 10 cuts/inch up to about 110 cuts/inch and lengths of about 0.1 inches up to about 1 inch. Double cut tobacco fibers can have a range of particle sizes such that about 70% of the double cut tobacco fibers fall between the mesh sizes of 20 mesh and 80 mesh.

Tobacco plant tissue used in a dissolvable-chewable tobacco tablet provided herein can have a total oven volatiles content of about 10% by weight or greater; about 20% by weight or greater; about 40%> by weight or greater; about 15% by weight to about 25% by weight; about 20%) by weight to about 30%> by weight; about 30%> by weight to about 50%> by weight; about 45%) by weight to about 65 % by weight; or about 50%> by weight to about 60%> by weight. Those of skill in the art will appreciate that "moist" tobacco typically refers to tobacco that has an oven volatiles content of between about 40%> by weight and about 60%> by weight (e.g., about 45% by weight to about 55% by weight, or about 50% by weight). As used herein, "oven volatiles" are determined by calculating the percentage of weight loss for a sample after drying the sample in a pre-warmed forced draft oven at 110 °C for 3.25 hours. The dissolvable-chewable tobacco tablet can have a different overall oven volatiles content than the oven volatiles content of the tobacco fibers used to make the oral tobacco product. The processing steps described herein can reduce or increase the oven volatiles content. Sugar Alcohol(s)

Sugar alcohols, also known as polyols or polyhydric alcohols, are hydrogenated carbohydrates that can be used as sugar replacers. Sugar alcohols are non-cariogenic, low- glycemic, low-energy, low-insulinemic, low digestible, osmotic, carbohydrates that dissolve in water. Sugar alcohols can be used in comestible products to take advantage of these various properties. For example, sugar alcohols can be used to replace sugar because sugar alcohols contain fewer calories per gram than sugar and sugar alcohols do not cause tooth decay. A chewable digestible tablet described herein can include at least one sugar alcohol combined with soluble fiber to provide a solid solution that can hold nicotine (and other optional additive) to provide a satisfying tactile and/or flavor experience.

Any suitable sugar alcohol can be used in a solid solution provided herein. Suitable sugar alcohols used in a dissolvable-chewable tablet provided herein can be monosaccharide-derived (e.g., sorbitol, mannitol, xylitol, erythritol), disaccharide-derived (e.g., isomalt, lactitol, maltitol), or polysaccharide-derived mixtures (e.g., maltitol syrup, hydrogenated starch hydrolysates

[HSH]). Sugar alcohols used in a dissolvable-chewable tablet provided herein can be a sugar alcohol generally recognized as safe ("GRAS") or approved food additives by the Food and Drug Administration or another appropriate private, state, or national regulatory agency.

A dissolvable-chewable tablet provided herein can include at least 20 weight percent of one or more sugar alcohols, at least 25 weight percent of one or more sugar alcohols, at least 30 weight percent of one or more sugar alcohols, at least 35 weight percent of one or more sugar alcohols, at least 40 weight percent of one or more sugar alcohols, at least 45 weight percent of one or more sugar alcohols, at least 50 weight percent of sugar alcohol, or at least 55 weight percent of one or more sugar alcohols. In some cases, a dissolvable-chewable tablet provided herein can include less than 75 weight percent of one or more sugar alcohols, less than 60 weight percent of one or more sugar alcohols, or less than 50 weight percent of one or more sugar alcohols. In some cases, a dissolvable-chewable tablet provided herein can include at least 2 weight percent sorbitol, at least 5 weight percent sorbitol, at least 10 weight percent sorbitol, at least 15 weight percent sorbitol, at least 20 weight percent sorbitol, at least 25 weight percent sorbitol, at least 30 weight percent sorbitol, or at least 35 weight percent sorbitol. In some cases, a dissolvable-chewable tablet provided herein can include at least 2 weight percent mannitol, at least 5 weight percent mannitol, at least 10 weight percent mannitol, at least 15 weight percent mannitol, at least 20 weight percent mannitol, at least 25 weight percent mannitol, at least 30 weight percent mannitol, or at least 35 weight percent mannitol.

Nicotine

Nicotine used in dissolvable-chewable tablet provided herein can be tobacco-derived nicotine, synthetic nicotine, or a combination thereof. In some cases, the nicotine can be liquid nicotine. Liquid nicotine can be purchased from commercial sources, whether tobacco-derived or synthetic. In some cases, a dissolvable-chewable tablet provided herein includes between 0.1 and 20.0 mg of nicotine, between 0.5 mg and 10.0 mg of nicotine, between 1.0 mg and 6.0 mg of nicotine, between 1.0 mg and 3.0 mg of nicotine. In some cases, cellulosic fiber-nicotine mixtures can be premixed with exhausted-tobacco fibers in the methods described in U.S.

Application No. 61/856,409, which is incorporated herein by reference, and incorporated into a chewable dissolvable

Tobacco-derived nicotine can include one or more other tobacco organoleptic

components other than nicotine. The tobacco-derived nicotine can be extracted from raw (e.g., green leaf) tobacco and/or processed tobacco. Processed tobaccos can include fermented and unfermented tobaccos, dark air-cured, dark fire cured, burley, flue cured, and cigar filler or wrapper, as well as the products from the whole leaf stemming operation. The tobacco can also be conditioned by heating, sweating, and/or pasteurizing steps as described in U.S. Publication Nos. 2004/0118422 or 2005/0178398, each of which is incorporated herein by reference.

Fermenting typically is characterized by high initial moisture content, heat generation, and a 10 to 20% loss of dry weight. See, e.g., U.S. Patent Nos. 4,528,993; 4,660,577; 4,848,373; and 5,372,149, each of which is hereby incorporated by reference. By processing the tobacco prior to extracting nicotine and other organoleptic components, the tobacco-derived nicotine may include ingredients that provide a favorable experience. The tobacco-derived nicotine can be obtained by mixing cured tobacco or cured and fermented tobacco with water or another solvent (e.g., ethanol) followed by removing the insoluble tobacco material. The tobacco extract may be further concentrated or purified. In some cases, select tobacco constituents can be removed. Nicotine can also be extracted from tobacco in the methods described in the following patents: U.S. Patent Nos. 2,162,738; 3,139,436; 3,396,735; 4,153,063; 4,448,208; and 5,487,792, each of which is hereby incorporated by reference.

Liquid nicotine can be pure, substantially pure, or diluted prior to combination with a molten mixture of soluble fiber and one or more sugar alcohols. A diluting step is optional. In some cases, liquid nicotine is mixed with cellulosic fibers prior to adding the nicotine to a molten mixture of soluble fiber and one or more sugar alcohols.

The nicotine can also be purchased from commercial sources, whether tobacco-derived or synthetic. In some cases, the tablet can include a derivative of nicotine (e.g., a salt of nicotine).

The nicotine degradants are non-detectable at 16 weeks under controlled conditions of 25 °C, 65% relative humidity, and atmospheric pressure (see Table 1.)

Exhausted-Tobacco Fibers

Dissolvable-chewable tablets provided herein can include exhausted-tobacco fibers within a matrix of the solid solution. As disclosed below, the exhausted-tobacco fibers can be mixed with the soluble fiber and/or one or more sugar alcohols prior to an extrusion. Exhausted- tobacco fibers can provide passages in a matrix of the solid solution, which can permit certain additives within a tablet to be more readily accessible. The water-soluble additives can be wicked by the exhausted-tobacco fibers.

Exhausted-tobacco fibers can be derived from tobacco plant tissue. Exemplary species of tobacco include N. rustica, N. tabacum, N. tomentosiformis, and N. sylvestris. The exhausted- tobacco fibers can be obtained from any part of a tobacco plant, including the steps, leaves, or roots of a tobacco plant. The tobacco plant tissue is treated to remove at least 10 weight percent of the tobacco's soluble components, which can include alkaloids (e.g., nicotine), nitrosamines. In some embodiments, the exhausted-tobacco plant tissue can be treated to remove at least 25%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, or 95%, or 99% of the tobacco's soluble components. In some embodiments, the exhausted-tobacco fibers include less than 75%, less than 50%, less than 25%, less than 10%, less than 5%, or less than 1% of the nicotine normally found in tobacco plant tissue. In some embodiments, the exhausted-tobacco fibers include less than 75%), less than 50%, less than 25%, less than 10%, less than 5%, or less than 1% of the nitrosamines normally found in tobacco plant tissue. The treatment can also remove other soluble components of the tobacco plant tissue. In some embodiments, the exhausted-tobacco can be obtained by washing tobacco plant tissue (e.g., tobacco stems) with slightly basic buffer solution. In other embodiments, the exhausted-tobacco can be obtained by treating the tobacco with supercritical fluids. For example, the exhausted-tobacco can be obtained by the processes described in U.S. Patent No. 7,798,151, which is hereby incorporated by reference.

Before or after treatment to remove at least some of the tobacco's soluble components, the tobacco plant tissue can be treated by one or more conventional tobacco treating techniques, which may affect the flavor, aroma, color, and/or texture of the tobacco plant tissue. Some conventional tobacco treating techniques include fermentation, heat treating, enzyme treating, expanding, and curing. The exhausted-tobacco fibers can have the aroma of tobacco without contributing significantly to the components released by the exhausted-tobacco dissolvable- chewable tablet. Desired quantities of particular components can be added the exhausted- tobacco dissolvable-chewable tablet.

The exhausted-tobacco fibers can, in some embodiments, be prepared from plants having less than 20 μg of DVT per cm ² of green leaf tissue. For example, the tobacco fibers can be selected from the tobaccos described in U.S. Patent Publication No. 2008/0209586, which is hereby incorporated by reference.

The exhausted-tobacco fibers can be processed to a desired length. In certain

embodiments, the cellulosic fiber can be processed to have an average fiber length of less than 200 micrometers. In particular, embodiments, the fibers are between 25 and 125 micrometers. In other embodiments, the fibers are processed to have a an average length of 75 micrometers or less. In still other embodiments, the exhausted-tobacco fibers can be cut or shredded into widths of about 10 cuts/inch up to about 110 cuts/inch and lengths of about 0.1 inches up to about 1 inch. Exhausted-tobacco fibers can also be cut twice to have a range of fiber lengths such that about 70% of the exhausted-tobacco fibers fall between the mesh sizes of 20 mesh and 80 mesh.

The exhausted-tobacco fibers can have a total oven volatiles content of about 10% by weight or greater; about 20%> by weight or greater; about 40%> by weight or greater; about 15% by weight to about 25% by weight; about 20%> by weight to about 30%> by weight; about 30%> by weight to about 50%> by weight; about 45% by weight to about 65 % by weight; or about 50% by weight to about 60% by weight. As used herein, "oven volatiles" are determined by calculating the percentage of weight loss for a sample after drying the sample in a pre -warmed forced draft oven at 110 °C for 3.25 hours. The dissolvable-chewable tablet can have a different overall oven volatiles content than the oven volatiles content of the tobacco fibers used to make the oral tobacco product. The processing steps described herein can reduce or increase the oven volatiles content.

Exhausted-tobacco fibers can also be combined with non-tobacco cellulosic fibers.

Suitable sources for non-tobacco cellulosic fibers include wood pulp, cotton, sugar beets, bran, citrus pulp fiber, switch grass and other grasses, Salix (willow), tea, and Populus (poplar). In some cases, the non-tobacco cellulosic fibers can be plant tissue comprising various natural flavors, sweeteners, or active ingredients.

Additives

A variety of additives can be included in a dissolvable-chewable tablet provided herein. The additives can include alkaloids (e.g., caffeine), minerals, vitamins, dietary supplements, nutraceuticals, energizing agents, soothing agents, coloring agents, amino acids, chemesthic agent, antioxidants, food grade emulsifiers, pH modifiers, botanicals (e.g., green tea), teeth whitening (e.g., SHMP), therapeutic agents, sweeteners, flavorants, and combinations thereof. A soothing agent provides a soothing sensation to the throat and oral cavity. Suitable soothing agents include, without limitation, chamomile, lavender, jasmine, and the like. Suitable chemesthic ingredients provide, without limitation, hot, spicy, or cooling flavors such as mint, menthol, cinnamon, pepper, and the like. In some cases, the additives include nicotine, sweeteners, and flavorants. With certain combinations of exhausted-tobacco, nicotine, sweeteners, and flavorants, a dissolvable-chewable tablet provided herein may provide a flavor profile and tactile experience similar to certain tobacco products.

Energizing ingredients or vitamins include, without limitation, caffeine, taurine, guarana, vitamin B6, vitamin B 12, and the like. According to certain embodiments, a

The tablets provided herein can also include vitamins, dietary minerals, other dietary supplements, and/or therapeutic agents. For example, suitable vitamins include Vitamins A, Bl, B2, B6, C, D2, D3, E, F, and K. For example, an oral product 110 can include C-vitamins with or without the presence of caffeine. Suitable dietary minerals include calcium (as carbonate, citrate, etc.) or magnesium (as oxide, etc.), chromium (usually as picolinate), and iron (as bis- glycinate). One or more dietary minerals could be included in an oral product with or without the use of other additives. Other dietary supplements and/or therapeutic agents can also be included as additives.

In some cases, a dissolvable-chewable tablet provided herein includes a therapeutic agent that is preferable absorbed transbuccally. For example, so therapeutic agents do not pass into the blood stream if they are swallowed. Exemplary therapeutic agents that can be included in an oral product 110 provided herein can include Gerd, Buprenorphin, Nitroglycerin, Diclofenac, Fentanyl, Carbamazepine, Galantamine, Acyclovir, Polyamidoamine Nanoparticles,

Chlorpheniramine, Testosterone, Estradiol, Progesterone, Calcitonin, Fluorouracil, Naltrexone, Odansetron, Decitabine, Selegiline, Lamotrigine, and Prochlorperazine. For example, an oral product 110 can include Buprenorphine and be used for pain treatment.

In some cases, an oral product 110 can include Nitroglycerin and be used for Angina Pectoris treatment. Because of the release, properties, in some cases the tablet provided herein tablet provided herein can also include fillers such as starch, di-calcium phosphate, lactose, sorbitol, mannitol, and microcrystalline cellulose, calcium carbonate, dicalcium phosphate, calcium sulfate, clays, silica, sodium lauryl sulfate (SLS), glyceryl palmitostearate, sodium benzoate, sodium stearyl fumarate, talc, and stearates (e.g., Mg or K), and waxes (e.g., glycerol monostearate, propylene glycol monostearate, and acetylated monoglycerides), stabilizers (e.g., ascorbic acid and monosterol citrate, BHT, or BHA), disintegrating agents (e.g., starch, sodium starch glycolate, cross caramellose, cross linked PVP), pH stabilizers, or preservatives.

In some cases, the amount of filler in a dissolvable-chewable tablet provided herein is limited to less than 10 weight percent in sum. In some cases, the amount of filler in a

dissolvable-chewable tablet provided herein is limited to be less than 5 weight percent in sum. In some cases, the fillers are mouth stable. In some cases, the fillers can dissolve or disintegrate during use and thus result in an oral product that becomes more pliable during use. .

In some cases, humectants can be added help maintain the moisture levels in a

dissolvable-chewable tablet provided herein. Examples of humectants include glycerin and propylene glycol. In some cases, anti-microbial agents can be added to prevent spoilage and to lengthen shelf-life.

The tablets provided herein may optionally include other additives. For example, these additives can further include non-nicotine alkaloids, dietary minerals, vitamins, dietary supplements, therapeutic agents, and fillers. For example, a dissolvable-chewable tablet 110 can include C-vitamins with or without the presence of nicotine. One or more dietary minerals could be included in a dissolvable- chewable tablet with or without the use of other additives. In some cases, an amount of filler in the dissolvable-chewable tablet 110 is limited to less than 10 weight percent in sum. In some cases, an amount of filler in the dissolvable-chewable tablet 110 is limited to be less than 5 weight percent in sum. In some cases, fillers can dissolve or disintegrate during use and thus result in a dissolvable-chewable tablet that becomes more pliable during use.

Antioxidants

A chewable dissolvable-chewable exhausted-tobacco nicotine tablet 110 provided herein can include one or more antioxidants. Antioxidants can result in a significant reduction in the conversion of nicotine into nicotine-N-oxide when compared to nicotine products without antioxidants. In some cases, a chewable dissolvable-chewable exhausted-tobacco nicotine tablet provided herein can include 0.01 and 5.00 weight percent antioxidant, between 0.05 and 1.0 weight percent antioxidant, between 0.10 and 0.75 weigh percent antioxidant, or between 0.15 and 0.5 weight percent antioxidant. Suitable examples of antioxidants include ascorbyl palmitate (a vitamin C ester), BHT, ascorbic acid (Vitamin C), and sodium ascorbate (Vitamin C salt). In some cases, monosterol citrate, tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA), Vitamin E, or a derivative thereof can be used as the antioxidant. For example, ascorbyl palmitate can be the antioxidant in the formulations listed in Table I. Antioxidants can be incorporated into the solid solution during a mixing process (e.g., added to an extruder mixing the ingredients).

In some cases, the tablet 110 can have a conversion of less than 0.50 % of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 2 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.20% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 2 weeks at 25 °C and 65%> relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.70% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 4 weeks at 25 °C and 65%> relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.30% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 4 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.80 % of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 6 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.40% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 6 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.30% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 6 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.85 % of nicotine into nicotine-N-oxide after aging the dissolvable- chewable tablet 110 for 8 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.50% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 8 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.85 % of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 10 weeks at 25 °C and 65%> relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.55% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 10 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.95 % of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 12 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.60% of nicotine into nicotine-N-oxide after aging the dissolvable- chewable tablet 110 for 12 weeks at 25 °C and 65% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.0% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 2 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.5% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 2 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.4% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 4 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.8% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 4 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.6% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 6 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.2% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 6 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 0.9% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 6 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.7% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 8 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.4% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 8 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.1% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 8 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.8% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 10 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.3% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 10 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.2% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 10 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.8% of nicotine into nicotine-N-oxide after aging the dissolvable- chewable tablet 110 for 12 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.7% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 12 weeks at 40 °C and 75% relative humidity. In some cases, the dissolvable-chewable tablet 110 can have a conversion of less than 1.5% of nicotine into nicotine-N-oxide after aging the dissolvable-chewable tablet 110 for 12 weeks at 40 °C and 75% relative humidity. The presence of antioxidants may also reduce the formation of other tobacco derived impurities, such as Cotinine and myosime. Sweeteners

A variety of synthetic and/or natural sweeteners can be used as additives in the dissolvable-chewable tablet 110. Suitable natural sweeteners include sugars, for example, monosaccharides, disaccharides, and/or polysaccharide sugars, and/or mixtures of two or more sugars. According to some embodiments, the dissolvable-chewable tablet 110 includes one or more of the following: sucrose or table sugar; honey or a mixture of low molecular weight sugars not including sucrose; glucose or grape sugar or corn sugar or dextrose; molasses; corn sweetener; corn syrup or glucose syrup; fructose or fruit sugar; lactose or milk sugar; maltose or malt sugar or maltobiose; sorghum syrup; mannitol or manna sugar; sorbitol or d-sorbite or d- sobitol; fruit juice concentrate; and/or mixtures or blends of one or more of these ingredients. A dissolvable-chewable tablet provided herein can also include non-nutritive sweeteners. Suitable non-nutritive sweeteners include: stevia, saccharin; aspartame; sucralose; or acesulfame potassium.

Flavorants

The dissolvable-chewable tablet 110 can optionally include one or more flavorants as an additive. The flavorants can be natural or artificial. For example, suitable flavorants include wintergreen, cherry and berry type flavorants, various liqueurs and liquors (such as Dramboui, bourbon, scotch, and whiskey) spearmint, peppermint, lavender, cinnamon, cardamon, apium graveolents, clove, cascarilla, nutmeg, sandalwood, bergamot, geranium, honey essence, rose oil, vanilla, lemon oil, orange oil, Japanese mint, cassia, caraway, cognac, jasmin, chamomile, menthol, ylang ylang, sage, fennel, pimenta, ginger, anise, chai, coriander, coffee, liquorish, and mint oils from a species of the genus Mentha, and encapsulated flavors. Mint oils useful in particular, embodiments of tablet 110 include spearmint and peppermint. Synthetic flavorants can also be used. In some cases, a combination of flavorants can be combined to imitate a tobacco flavor. The particular combination of flavorants can be selected from flavorants that are GRAS in a particular country, such as the United States. Flavorants can also be included in the dissolvable-chewable tablet as encapsulated flavorants.

In some cases, the flavorants in the dissolvable-chewable tablet 110 are limited to less than 20 weight percent in sum. In some cases, the flavorants in the dissolvable-chewable tablet 110 are limited to be less than 10 weight percent in sum. For example, certain flavorants can be included in the dissolvable-chewable tablet 110 in amounts of about 1 weight percent to 5 weight percent.

Cellulosic Fibers

The chewable dissolvable-chewable tablets provided herein can include cellulosic fibers within a matrix of a solid solution provided herein. Cellulosic fibers can be mixed with soluble fibers and sugar alcohol(s) during an extrusion process. In some cases, as discussed above, cellulosic fibers can be mixed with liquid nicotine before that liquid nicotine is mixed with soluble fiber and sugar alcohol(s).

Cellulosic fiber used in a chewable dissolvable nicotine tablet provided herein can further include lignin and/or lipids. Suitable sources for cellulosic fibers include wood pulp, cotton, sugar beets, bran, citrus pulp fiber, switch grass and other grasses, Salix (willow), tea, and Populus (poplar), bamboo. In some cases, cellulosic fiber used in chewable dissolvable nicotine tablets provided herein can be chopped or shredded plant tissue comprising various natural flavors, sweeteners, or active ingredients. Cellulosic fiber used in chewable dissolvable nicotine tablets provided herein can include a plurality of fibers having a variety of dimensions. In some cases, cellulosic fiber used chewable dissolvable nicotine tablets provided herein can include one or more cellulosic fibers that are generally recognized as safe ("GRAS") for human

consumption.

Cellulosic fibers suitable for inclusion in a chewable dissolvable nicotine tablet provided herein can have a variety of dimensions. The dimensions of included cellulosic fibers (in addition to the amount) can affect the release characteristics of the additives. For example, cellulosic fibers can be hydrophilic, thus water soluble additives (e.g., nicotine) can be added into solid solution. In some cases, cellulosic fiber used in a chewable dissolvable nicotine tablet provided herein can be processed to have an average fiber length of less than 200 micrometers. In particular, embodiments, the fibers are between 25 and 125 micrometers. In some cases, the fibers are processed to have a length of 75 micrometers or less. Exemplary average lengths are in the range of 1 to 1000 micrometers, e.g., about 800, 500, 250, 100, 80, 75, 50, 25, 20, 15, 10, 8, 6, 5, 3, 2, or 1 micrometers or less. Dimensions of the cellulosic fibers (in addition to the amount) can affect the release characteristics of liquid nicotine from a chewable dissolvable nicotine tablet provided herein. Cellulosic fiber used in dissolvable-chewable tablets provided herein can have pores. In some cases, cellulosic fibers provided herein have pores sizes that range from between 3 nanometers to 300 nanometers. In some cases, cellulosic fibers provided herein have pores sizes that range from between 10 nanometers to 200 nanometers. In some cases, cellulosic fibers provided herein have pores sizes that range from between 20 nanometers to 100 nanometers. In some cases, one or more additives (e.g., nicotine) can become absorbed into the pores in the cellulosic fibers and held there by van der Waals forces. The number, sizes, and size

distribution, chemical, and physical surface properties of the pores can affect the release rate of one or more additives (e.g, nicotine) incorporated into cellulosic fiber and into an oral product. The release rate can also be manipulated due to compression of cellulosic fiber (e.g., by chewing a chewable-dissolvable nicotine tablet provided herein). The hydrophobicity of the cellulose fibers can be selected to provide a desired sensorial experience when included in an oral product. For example, cellulosic fiber can be hydrophilic, thus water soluble additives (e.g., caffeine or nicotine) can preferentially be absorbed in cellulosic fiber.

Plasticizers

The tablets provided herein can also include one or more plasticizers. Plasticizers can soften the final dissolvable-chewable tablet and thus increase its flexibility. Suitable plasticizers include propylene glycol, triacetin, glycerin, vegetable oil, partially hydrogenated oil, triglycerides, triacetin, medium chain triglycerides, and combinations thereof. In some cases, the plasticizer can include phthalates. Esters of polycarboxylic acids with linear or branched aliphatic alcohols of moderate chain length can also be used as plasticizers. Moreover, plasticizers can facilitate the extrusion processes described below. In some cases, the

dissolvable-chewable tablet 110 can include up to 20 weight percent plasticizer. In some cases, a dissolvable-chewable tablet provided herein includes between 0.05 and 10 weight percent plasticizer, between 1 and 8 weight percent plasticizer, or between 2 and 4 weight percent plasticizer. For example, a dissolvable-chewable tablet provided herein can include about 3 to 6.5 weight percent of propylene glycol. Molding Processes

The tablets provided herein can be produced by forming a molten mixture of soluble fiber, sugar alcohols (e.g., sorbitol and mannitol), exhausted-tobacco, and optionally one or more additives (e.g., nicotine or derivatives thereof) and shaping that molten mixture into individual dissolvable-chewable tablets. The molten mixture is formed under controlled heating conditions such that a solution of soluble fiber, sugar alcohol(s), water, and exhausted-tobacco is formed without degrading the exhausted-tobacco or creating cross-linking between the sugar alcohol(s) and/or the soluble fiber. In some cases, a temperature of the molten mixture is maintained at a temperature below 150 °C. In some cases, a rod or sheet of the molten mixture is extruded and cut into individual dissolvable-chewable tablets. In some cases, a molten mixture of soluble fiber, sugar alcohol(s), and nicotine can be injection molded, compression molded, or injection- compression molded.

Cooking processes forming dissolvable edible products sometimes utilize the cross- linking of sugars or sugar alcohols that occurs after heating to caramelization temperatures. Such heating results in a desirable caramelization of the product. The relatively high

temperatures required for caramelization, however, can accelerate the degradation of exhausted- tobacco and/or nicotine because of the high temperatures and other factors (e.g., residence time during extrusion). Because additive, exhausted-tobacco, and/or nicotine degradation can be accelerated when exposed to elevated temperatures over extended periods of time, the temperature of a molten mixture provided herein can be maintained at a temperature of 200 °C or below over a processing time (e.g., a residence time of five to ten minutes or less if an extrusion process is utilized). In some cases, the temperature of a molten mixture provided herein can be maintained at a temperature of 150 °C or below over a processing time (e.g., a residence time of five to ten minutes or less if an extrusion process is utilized). In some cases, a molten mixture provided herein is heated to a temperature of between 80 °C and 200 °C. In some cases, a molten mixture provided herein is heated to a temperature of between 100 °C and 110 °C. In some cases, a molten mixture provided herein is heated to a temperature of between 80 °C and 150 °C. When cooled below its glass transition temperature, a molten mixture provided herein solidifies into an amorphous, non-porous, soluble fiber matrix containing additives and/or exhausted-nicotine. A solid solution of soluble fibers and/or tobacco and sugar alcohol(s), however, can provide a dissolvable-chewable tablet provided herein with a suitable dissolution time when place in an adult consumer's mouth. A dissolvable-chewable tablet provided herein can also be chewable.

A molten mixture can be mixed and heated in any suitable but controlled method. In some cases, such as shown in Figure 8, ingredients for a molten mixture can be combined in an extruder and mixed in a continuous extrusion process. Unlike a traditional cooking method dissolvable-chewable tablet provided herein can have attributes precisely controlled by extruder operation parameters, such as feed rate, barrel temperature profile, screw design, rpms, etc.

Water added to molten mixture can be maintained at a percentage of less than 15 weight percent. A water content of a dissolvable-chewable tablet provided herein can be controlled in the extrusion process to ensure that the molten mixture becomes a solid solution. In some cases, a molten mixture can have a water content of less than 15 weight percent. In some cases, water content in a dissolvable-chewable tablet provided herein ranges from 0.5 weight percent to 7 weight percent. In some cases, water content in a dissolvable-chewable tablet provided herein ranges from 1 weight percent to 5 weight percent.

Referring to the extrusion process 800 illustrated in Figure 8, soluble fibers (e.g., maltodextrin or digestion resistant maltodextrin), sugar alcohol or blend of multiple sugar alcohols (e.g., sorbitol and mannitol), cellulose insoluble fibers, and color (e.g., T1O2) can be introduced 802 into the extrusion process 800 and can undergo a powder mixing 804 before progressing to the extruder 816. A mixing extruder 816 can include multiple stages controlled to be maintained at a predetermined temperature. As shown, extruder 816 can include stages having temperatures ranging between 80 °C and 150 °C. For example, an extruder can have seven stages with each stage controlled to a specific temperature (e.g., some stages range between 80 °C and 200 °C, 80 °C and 100 °C, 100 °C and 110 °C, 60 °C and 160 °C, 60 °C and 150 °C, 60 °C and 200 °C, 100 °C and 130 °C, 100 °C and 140 °C, 100 °C and 150 °C, from 80 °C and 120 °C). This extruder can rotate at approximately 40-80 revolutions per minute. A mixture of sweetener and water can also be introduced 806 into the process 800 and can also undergo a solution mixing step 808 for a period of time before progressing to the extruder 816. Any combination of nicotine, flavor, propylene glycol, and antioxidants can also be introduced 810 into the process 800 and can undergo a solution mixing step 812 for a period of time before progressing to the extruder 816. In some cases, this process allows nicotine and optionally other ingredients such as exhausted tobacco, tobacco particles and one or more additives to be incorporated into the process with minimum exposure to temperature and air. A plasticizer (e.g., partially hydrogenated vegetable oil) can also undergo a solution mixing step 814 for a period of time before progressing into the extruder 816. The extruder 816 can maintain a warm internal temperature (e.g., between approximately 60 °C to 160 °C). The low temperature of the extruder 816 has the advantage of reducing undesirable degradation of additives (e.g., nicotine) and cross- linking of the sugar alcohol(s). The molten mixture can exit the extruder 816 and be allowed to cool (e.g., to ambient temperature) to form a viscous material including a solid solution of soluble fiber, sugar alcohol(s), nicotine, and other additives, which is then cut in a portioning process 820 to form individual chewable dissolvable nicotine tablets. Portioning process 820 can include a process of rounding the edges of the chewable dissolvable nicotine tablets. For example, a pelletizer can be used to round the edges. After portioning, the chewable dissolvable- chewable tablets can undergo a coating process 822 and a packaging process 824, each of which is discussed above.

In addition to extrusion, there are other methods for mixing and carefully controlling the temperature of a molten mixture used to form chewable dissolvable nicotine tablets provided herein.

Other Embodiments

It is to be understood that, while the invention has been described herein in conjunction with a number of different aspects, the foregoing description of the various aspects is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims.

Disclosed are methods and compositions that can be used for, can be used in conjunction with, can be used in preparation for, or are products of the disclosed methods and compositions. These and other materials are disclosed herein, and it is understood that combinations, subsets, interactions, groups, etc. of these methods and compositions are disclosed. That is, while specific reference to each various individual and collective combinations and permutations of these compositions and methods may not be explicitly disclosed, each is specifically

contemplated and described herein. For example, if a particular composition of matter or a particular method is disclosed and discussed and a number of compositions or methods are discussed, each and every combination and permutation of the compositions and the methods are specifically contemplated unless specifically indicated to the contrary. Likewise, any subset or combination of these is also specifically contemplated and disclosed.