Oral products

Abstract

The present disclosure relates to oral products, processes for making oral products, and uses of the oral products, which are in solid chewable form and contain a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) taurine, at least one binder, and at least one bulking agent selected from the group consisting of a sugar alcohol, a sugar, or a combination of at least one sugar alcohol and at least one sugar.

Description

[Technical Field]

[0001] The present disclosure relates to oral products, processes for making oral products, and uses of oral products. [Background technology]

[0002] The present disclosure relates to products and compositions intended for human use. The products are configured for oral use and deliver substances such as flavors and / or active ingredients during use.

[0003] Products that are easy to administer orally and can provide beneficial effects on specific mood states in humans or animals have become popular in recent years. For example, confectionery-type products (e.g., gummies or lozenges) containing vitamins or other mood-enhancing actives provide a convenient and comfortable mode of administration for such active ingredients. Other convenient modes of administration are foods and beverages, such as energy drinks. Such products may contain active ingredients that are delivered to the user to elicit a biological response in the user that can enhance the user's physical or mental performance.

[0004] Beverages containing theanine and caffeine are described in U.S. Patent Nos. 5,780,086 and 6,268,009. More recently, European Patent No. 1819241 describes a beverage containing theanine and caffeine in a ratio of 5:1 to 1:1.5. Other beverages, such as chamomile tea and other herbal teas, are consumed by some users to aid in sleep and relaxation.

[0005] It is desirable to provide an oral product configured for oral use that can deliver the active ingredient to the consumer in an enjoyable and effective form, such as in the form of a solid chew. Summary of the Invention

[0006] The present disclosure generally provides products configured for oral use that include a combination of active ingredients, at least one binder and at least one sugar, or at least one sugar alcohol, or a combination of at least one sugar and at least one sugar alcohol. The oral product is solid and can be in a form suitable for oral use, such as a chewable form, such as a dissolvable chew or lozenge.

[0007] According to some embodiments described herein, there is provided a solid oral product comprising a combination of active ingredients, at least one binder, and at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar, wherein the combination of active ingredients comprises: (i) caffeine, (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) taurine.

[0008] According to some embodiments described herein, (a) contacting at least one binder with at least one sugar, or at least one sugar alcohol, or a combination of at least one sugar and at least one sugar alcohol, and optionally adding water; (b) heating a mixture of binder, sugar alcohol and / or sugar, and optionally water; (c) adding a combination of active ingredients including: (i) caffeine; (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine; (d) solidifying the resulting mixture to obtain an oral chew product.

[0009] According to some embodiments described herein, there is provided a use of a combination of active ingredients for increasing alertness and / or energy levels in a human or animal, the combination of active ingredients comprising: (i) caffeine; (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine.

[0010] According to some embodiments described herein, there is provided a use of a combination of active ingredients for increasing mental and / or physical energy in a human or animal, the combination of active ingredients including: (i) caffeine; (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine.

[0011] According to some embodiments described herein, there is provided a use of a combination of active ingredients for increasing cognitive performance in a human or animal, the combination of active ingredients comprising: (i) caffeine; (ii) a combination of B vitamins comprising at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine.

[0012] According to some embodiments described herein, there is provided a chewable solid oral product comprising a combination of active ingredients, at least one binder, and at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar, wherein the combination of active ingredients comprises (i) caffeine, (ii) ginseng, and (iii) taurine.

[0013] According to some embodiments described herein, there is provided a chewable solid oral product comprising a combination of active ingredients, at least one binder, and at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar, wherein the combination of active ingredients includes: (i) caffeine; (ii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) ginseng.

[0014] According to some embodiments described herein, there is provided a chewable solid oral product comprising a combination of active ingredients, at least one binder, and at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar, wherein the combination of active ingredients includes: (i) caffeine, (ii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) taurine, and (iv) vitamin C.

[0015] In a preferred embodiment, each of the oral products of the above embodiments may be provided in the form of a dissolvable chew.

[0016] These and other features, aspects, and advantages of the present disclosure will become apparent upon reading the following detailed description. The present invention includes any combination of two, three, four, or more of the above-described embodiments, as well as combinations of any two, three, four, or more features or elements described in this disclosure, regardless of whether such features or elements are explicitly combined in the description of a particular embodiment herein. The present disclosure, in any of its various aspects and embodiments, is intended to be read as a whole such that any separable features or elements of the disclosed invention(s) should be considered as intended to be combinable unless the context clearly dictates otherwise.

[0017] For ease of reference, these and further aspects of the present invention are discussed herein under appropriate section headings, however, the teachings under each section are not necessarily limited to each particular section.

[0018] Having thus described aspects of the present disclosure in general terms above, reference is now made to the accompanying drawings, which are not necessarily drawn to scale, which are illustrative only and are not to be construed as limiting the disclosure.

[0019] In all figures, the dashed line indicates placebo (three chews), CP indicates a commercial energy product, X2 indicates two chews of Example 5 and one placebo chew, and X3 indicates three chews of Example 5.

[0020] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0021] [Figure 1] 1 is a graph showing the results of a test on cognitive accuracy (RVIP) after ingestion of the oral product of Example 5 (2 chews and 3 chews) compared to a placebo and a commercial energy product. In this figure, A indicates placebo (3 chews), B indicates commercial energy product (2 chews) and placebo (1 chew), C indicates Example 5 (2 chews) and placebo (1 chew), and D indicates Example 5 (3 chews), with letters (e.g., "AB") indicating significant changes from the corresponding product. [Figure 2]1 is a graph showing the results of mental arithmetic (serial subtraction by sevens) following ingestion of the oral product of Example 5 (two chews and three chews) compared to a placebo and a commercial energy product. In this figure, A represents placebo (three chews), B represents the commercial energy product (two chews) and placebo (one chew), C represents Example 5 (two chews) and placebo (one chew), and D represents Example 5 (three chews), with letters (as in FIG. 1 ) indicating significant changes from the corresponding product. [Figure 3] 1 is a graph showing global cognitive scores as measured by RVIP, NWM, serial subtraction by 3, and serial subtraction by 7 composite scores following ingestion of the oral product of Example 5 (two chews and three chews) compared to placebo and a commercial energy product. In this figure, A represents placebo (three chews), B represents the commercial energy product (two chews) and placebo (one chew), C represents Example 5 (two chews) and placebo (one chew), and D represents Example 5 (three chews), with letters indicating significant changes from the corresponding product. [Figure 4] 1 is a graph showing alertness measured by VAS after ingestion of the oral product of Example 5 (two chews and three chews) compared to a placebo and a commercial energy product. In this figure, A represents placebo (three chews), B represents commercial energy product (two chews) and placebo (one chew), C represents Example 5 (two chews) and placebo (one chew), and D represents Example 5 (three chews), where letters indicate significant changes from the corresponding product and ** represents the first epoch jump at 20 minutes. [Figure 5] 1 is a graph showing physical energy as measured by VAS after ingestion of the oral product of Example 5 (2 chews and 3 chews) compared to placebo and a commercial energy product. In this figure, A represents placebo (3 chews), B represents commercial product (2 chews) and placebo (1 chew), C represents Example 5 (2 chews) and placebo (1 chew), and D represents Example 5 (3 chews), with letters indicating significant changes from the corresponding product. [Figure 6] 1 is a graph showing fatigue measured by VAS after ingestion of the oral product of Example 5 (2 chews and 3 chews) compared to placebo and a commercial energy product. In this figure, A represents placebo (3 chews), B represents the commercial product (2 chews) and placebo (1 chew), C represents Example 5 (2 chews) and placebo (1 chew), and D represents Example 5 (3 chews), with letters indicating significant changes from the corresponding product. [Figure 7] 1 is a graph showing irritation measured by VAS after ingestion of the oral product of Example 5 (2 chews and 3 chews) compared to placebo and a commercial energy product. In this figure, A represents placebo (3 chews), B represents the commercial product (2 chews) and placebo (1 chew), C represents Example 5 (2 chews) and placebo (1 chew), and D represents Example 5 (3 chews), with letters indicating significant changes from the corresponding product. [Figure 8] 1 is a graph showing physical tremor measured by VAS after ingestion of the oral product of Example 5 (2 chews and 3 chews) compared to placebo and a commercial energy product. In this figure, A represents placebo (3 chews), B represents commercial product (2 chews) and placebo (1 chew), C represents Example 5 (2 chews) and placebo (1 chew), and D represents Example 5 (3 chews), with letters indicating significant changes from the corresponding product. [Figure 9] 1 is a graph showing overall mood maintenance as measured by POMS after ingestion of the oral product of Example 5 (2 chews and 3 chews) compared to placebo and a commercial energy product. In this figure, A represents placebo (3 chews), B represents the commercial product (2 chews) and placebo (1 chew), C represents Example 5 (2 chews) and placebo (1 chew), and D represents Example 5 (3 chews), with letters indicating significant changes from the corresponding product. DETAILED DESCRIPTION OF THE INVENTION

[0022] It is to be understood that the invention is not limited to the particular configurations, process steps, and materials disclosed herein, as such configurations, process steps, and materials may vary somewhat. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the invention will be limited only by the appended claims and their equivalents.

[0023] As used herein and in the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. References to "dry weight %" or "dry weight basis" refer to weight based on dry ingredients (i.e., all ingredients excluding water). References to "wet weight" refer to the weight of the product or composition including water. Unless otherwise specified, references to "wt %" (or "wt %") of a product or composition reflect the total wet weight (i.e., including water) of the product or composition.

[0024] As used herein, unless otherwise specified, the term "about" modifying the amount of an ingredient in an oral product of the invention or used in a method of the invention refers to variations in the numerical amount that may occur, for example, through typical measuring and liquid handling procedures used to make concentrates or use solutions in the real world, through inadvertent errors in these procedures, and through differences in the manufacture, source, or purity of ingredients used to make the oral product or perform the method. The term "about" also encompasses amounts that differ due to different equilibrium conditions for a product or composition resulting from a particular initial mixture. The claims include equivalents to amounts whether or not modified by the term "about."

[0025] Oral products As described herein, there is provided a solid oral product comprising an active ingredient, at least one binder, and at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar, wherein the combination of active ingredients includes: (i) caffeine, (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) taurine.

[0026] Oral products are configured for oral use and therefore for insertion into the mouth (i.e., oral cavity) of a user. As used herein, unless otherwise specified, the term "oral" in relation to a product refers to a product that is suitable for being ingested or placed somewhere in the oral cavity of a user in normal use. For example, the product may be placed in the mouth or chewed in the oral cavity, for example, in the form of a chew or chewing gum. In a preferred embodiment, the product is in the form of a chew rather than a chewing gum.

[0027] The ranges provided herein provide preferred amounts of each component. Each of these ranges can be used alone or in combination with one or more other component ranges to provide preferred embodiments of the present invention.

[0028] Active ingredient combination The products disclosed herein include an active ingredient.

[0029] As used herein, an active substance may be a physiologically active material, which is a material intended to achieve or enhance a physiological response. The active substance may be selected from, for example, a nutraceutical, a nootropic, or a psychotropic drug. The active substance may be naturally derived or synthetically obtained.

[0030] The active ingredient combination includes suitable active ingredients that elicit a biological response in humans or animals. As used herein, an active ingredient can be a physiologically active material, which is a material intended to achieve or enhance a physiological response.

[0031] According to one embodiment of the present invention, the combination of active ingredients includes at least (i) caffeine, (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) taurine.

[0032] Each active ingredient may be present in an amount suitable to provide the desired biological response in human animals. The inventors have found that the specific combination of active ingredients contained in the oral product provides a rapid onset of mental and / or physical energy. The combination of active ingredients has been found to provide users with a short-, medium-, or long-term boost in mental and / or physical energy. In particular, the specific combination of active ingredients in the oral product has been found to increase mental energy (i.e., improve cognitive performance, increase energy (alertness, irritability), or reduce mental fatigue, increasing the consumer's motivation to perform mental tasks) and physical energy (i.e., improve endurance athletic performance and stamina). The inventors have found that the specific combination of active ingredients of the present invention can improve energy levels over a short or sustained period. Increased energy levels can also increase feelings of confidence, motivation, joy, and excitement, as well as overall enjoyment and enthusiasm in the user. The inventors have also found that cognitive performance improves for at least 90 minutes after ingestion. The inventors have further discovered that dosage can be adjusted to optimize support for increased mental energy and / or increased physical energy.

[0033] It has also been found that the combination of active ingredients described herein can provide a safe product with desirable pharmacokinetics (Tmax, Cmax, half-life), bioavailability and metabolism.

[0034] Caffeine is a stimulant of the central nervous system. Caffeine (1,3,7-trimethylxanthine) is a bitter alkaloid found naturally in various plant species, such as tea leaves, cola nuts, cocoa, guarana, and coffee beans. Upon ingestion, caffeine is metabolized by the liver via the cytochrome p450 enzyme system, enters all body tissues, and can cross the blood-brain barrier. Caffeine can be used to enhance alertness, attention, cognitive performance, and physical performance.

[0035] Caffeine may be included as a natural stimulant, meaning that it is naturally derived. "Naturally derived" means that the caffeine is in a purified form outside of its natural (e.g., plant) matrix. For example, caffeine can be obtained by extraction and purification from a plant source (e.g., tea). Alternatively or additionally, caffeine may be provided in a synthetic form, i.e., obtained by chemical synthesis. Caffeine may be provided in the form of an extract or powder (e.g., powdered extract). For example, caffeine may be included in the form of green tea extract powder or black tea extract powder. Caffeine may also be provided in the form of guarana seed extract powder. In some embodiments, caffeine is present in an encapsulated form. An example of encapsulated caffeine is Vitashure®, available from Balchem ​​Corp., 52 Sunrise Park Road, New Hampton, NY 10958, USA.

[0036] Caffeine can be present in any suitable amount, such as at least about 0.001%, at least about 0.01%, or at least about 0.1% by weight of the oral product, hi some embodiments, caffeine can be present in an amount of no more than about 20%, no more than about 10%, no more than about 5%, or no more than about 1% by weight of the oral product.

[0037] Caffeine may be present in an amount of about 0.01% to about 20% by weight of the oral product. In some embodiments, caffeine is present in an amount of about 0.01% to about 10% by weight of the oral product. Caffeine is preferably present in an amount of about 0.1% to about 5% by weight of the oral product.

[0038] In some embodiments, caffeine is present in an amount of about 0.01% to about 4% by weight of the oral product, e.g., about 0.05% to about 3% by weight of the oral product, e.g., about 0.1% to about 2.5% by weight of the oral product, e.g., about 0.15% to about 2% by weight of the oral product, e.g., about 0.2% to about 1.5% by weight of the oral product, e.g., about 0.25% to about 1% by weight of the oral product. In some preferred embodiments, caffeine may be present in an amount of about 0.5% to about 1% by weight of the oral product.

[0039] The combination of active ingredients further includes a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12.

[0040] The term "B vitamins" includes a group of eight water-soluble vitamins that affect cellular functions, such as cellular metabolism and red blood cell synthesis. B vitamins act as coenzymes in a significant proportion of enzymatic processes for cellular physiological functions. B vitamins can generally be divided into two categories: those that act as coenzymes in catabolic enzyme reactions (resulting in the production of energy) and those that act as coenzymes in anabolic enzyme reactions (resulting in enhanced brain function).

[0041] B vitamins are thought to play a role in aspects of brain function and energy production.

[0042] The eight water-soluble B vitamins are vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid or its salts, e.g., calcium pantothenate), vitamin B6 (pyridoxine hydrochloride), vitamin B7 (biotin), vitamin B9 (folate or folic acid), and vitamin B12 (cyanocobalamin). Vitamins B2, B3, B6, B9, and B12 have been found to aid in anabolic metabolism and enhance brain function. Vitamins B1, B2, B3, B5, and B7 have been found to aid in catabolic metabolism and enhance energy levels.

[0043] In a preferred embodiment, the oral product comprises all five B vitamins, which help anabolic metabolism.In other words, according to the first aspect, the combination of active ingredients comprises the combination of vitamins B2, B3, B6, B9 and B12.It has been found that by including at least these B vitamins, perceived physical and mental fatigue can be reduced, and psychological and cognitive function can be enhanced.Each of these B vitamins can contribute to reducing fatigue and tiredness, and the inclusion of all five B vitamins can produce a synergistic effect in this regard.

[0044] In some embodiments, the B vitamin combination consists essentially of all anabolic vitamins, i.e., vitamins B2, B3, B6, B9, and B12. In some embodiments, the B vitamin combination consists essentially of all anabolic vitamins, i.e., vitamins B2, B3, B6, B9, and B12.

[0045] In some embodiments, the B vitamin combination further comprises at least one catabolic B vitamin selected from the group consisting of vitamin B1, vitamin B5, vitamin B7, and combinations thereof.

[0046] The ratio of the total amount of vitamins B6, B9, and B12 to the total amount of vitamins B2 and B3 can be about 2:1 to about 1:2, or about 1:1 to about 1:2. Alternatively, the ratio of the total amount of vitamins B6, B9, and B12 to the total amount of vitamins B2 and B3 can be about 2:1 to about 1:20, or about 1:1 to about 1:15.

[0047] The amount of B vitamins included in the composition can be any amount suitable to provide the desired effect while also providing a product that is safe to take and has reduced side effects.

[0048] The total amount of B vitamins included in the combination can be any suitable amount to provide the desired brain function-enhancing effect. In some embodiments, the total amount of B vitamins (e.g., the total amount of a combination of vitamins B2, B3, B6, B9, and B12) can be at least about 0.01% by weight of the oral product, preferably at least about 0.1% by weight. For example, the total amount of B vitamins can be about 0.01% to about 5% by weight of the oral product, preferably about 0.1% to about 1% by weight. For example, this amount can be about 0.1% to about 0.5% by weight of the oral product, or about 0.1% to about 0.25% by weight of the oral product.

[0049] When present, the total amount of catabolic B vitamins (i.e., the total amount of vitamins B1, B5, and B7 combined) can be at least about 0.0001%, preferably at least about 0.001%, and more preferably at least about 0.01% by weight of the oral product. For example, the total amount of catabolic B vitamins can be from about 0.001% to about 1%, or from about 0.01% to about 0.5% by weight of the oral product.

[0050] In some embodiments, vitamin B2 may be present in an amount of about 1% to about 20% by weight of the total amount of B vitamins in the oral product. For example, vitamin B2 may be present in an amount of about 5% to about 15% by weight of the total amount of B vitamins in the oral product.

[0051] In some embodiments, vitamin B3 may be present in an amount of about 20% to about 80% by weight of the total amount of B vitamins in the oral product. For example, vitamin B3 may be present in an amount of about 40% to about 70% by weight, and preferably about 40% to about 50% by weight, of the total amount of B vitamins in the oral product. Alternatively, vitamin B3 may be present in an amount of about 30% to about 80% by weight, and preferably about 50% to about 80% by weight, of the total amount of B vitamins in the oral product.

[0052] In some embodiments, vitamin B6 may be present in an amount of about 1% to about 15% by weight of the total amount of B vitamins in the oral product. For example, vitamin B6 may be present in an amount of about 5% to about 10% by weight of the total amount of B vitamins in the oral product.

[0053] In some embodiments, vitamin B9 may be present in an amount of about 1% to about 15% by weight of the total amount of B vitamins in the oral product. For example, vitamin B9 may be present in an amount of about 1% to about 10% by weight of the total amount of B vitamins in the oral product.

[0054] In some embodiments, vitamin B12 may be present in an amount of about 1% to about 40% by weight, e.g., about 10% to about 30% by weight, e.g., about 20% to about 30% by weight, of the total amount of B vitamins in the oral product. In some embodiments, vitamin B12 may be present in an amount of about 0.01% to about 30% by weight, e.g., about 0.01% to about 25% by weight, e.g., about 0.01% to about 15% by weight, of the total amount of B vitamins in the oral product.

[0055] Taurine, or 2-aminoethanesulfonic acid, is an organic compound widely distributed in animal tissues. Taurine is known to play a role in energy metabolism. The combination of taurine and caffeine may result in taurine neutralizing some of the negative side effects that excess caffeine can cause (e.g., tremors or increased heart rate). The inclusion of taurine can improve muscle strength and endurance, as well as performance during physical activity. The addition of taurine can also enhance energy metabolism.

[0056] Taurine can be present in any suitable amount, such as at least about 0.001%, at least about 0.01%, or at least about 0.1% by weight of the oral product, hi some embodiments, taurine can be present in an amount of no more than about 20%, no more than about 10%, or no more than about 5% by weight of the oral product.

[0057] Taurine may be present in an amount of about 0.001% to about 20% by weight of the oral product. In some embodiments, taurine is present in an amount of about 0.01% to about 10% by weight of the oral product. Taurine may preferably be present in an amount of about 0.05% to about 5% by weight of the oral product, or about 0.05% to about 1% by weight of the oral product.

[0058] In some preferred embodiments, taurine is present in an amount of about 0.01% to about 0.1% by weight of the oral product. In other preferred embodiments, taurine is present in an amount of about 0.05% to about 3% by weight of the oral product, e.g., about 0.1% to about 2.5% by weight of the oral product, e.g., about 0.2% to about 1% by weight of the oral product, e.g., about 0.25% to about 0.5% by weight of the oral product.

[0059] In some embodiments, taurine is present in an amount of about 0.1% to about 0.5% by weight of the oral product.

[0060] In addition to caffeine, a combination of B vitamins, and taurine, the active ingredient combination may include one or more additional active ingredients. The additional active ingredients may be any suitable active ingredient that increases physical and / or mental energy levels and / or increases alertness, and may be selected from, for example, nutraceuticals, nootropics, and psychoactive substances. The additional active ingredients may be naturally occurring or synthetically obtained.

[0061] Non-limiting examples of additional active ingredients include those in the categories of botanical ingredients (such as, for example, ginseng, bacopa monnieri, or rhodiola), stimulants, amino acids or analogs (e.g., L-tyrosine, L-theanine), functional foods and / or medicinal ingredients (e.g., additional vitamins, such as vitamins A, C, D, E, or K, and / or cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD)).

[0062] Additional active ingredients may include, for example, L-tyrosine, L-theanine, theine, vitamins such as vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, ginseng, echinacea, cannabinoids, choline, alpha GPC, theobromine, guayusa, maca, matcha, methylliberin, nitrates, or beet root juice, yerba mate, glucose, theacrine, or components, derivatives, or combinations thereof.

[0063] In some embodiments, the one or more additional active ingredients are selected from botanicals (e.g., echinacea, ginseng, peppermint, rosemary, ginger, maca, or herbal teas), stimulants (e.g., guarana), amino acids (e.g., L-theanine, phenylalanine, tyrosine, or tryptophan), cannabinoids, and / or functional food or medicinal ingredients (e.g., vitamins such as vitamin D, vitamin C, and / or vitamin A).

[0064] In some preferred embodiments, the combination of active ingredients further includes vitamin C (ascorbic acid). Vitamin C acts as an antioxidant, helping to protect cells from damage caused by free radicals. It is also used by the body to create collagen, a protein that can aid in wound healing. Additionally, vitamin C improves iron absorption from plant-based foods and helps the immune system function properly to protect the body from disease.

[0065] The inclusion of vitamin C can reduce fatigue and tiredness and improve energy metabolism.

[0066] When present, vitamin C can be present in any suitable amount, such as at least about 0.001%, at least about 0.01%, or at least about 0.1% by weight of the oral product, hi some embodiments, vitamin C can be present in an amount of no more than about 20%, no more than about 10%, or no more than about 5% by weight of the oral product.

[0067] When present, vitamin C may be present in an amount of about 0.01% to about 20%, or about 0.05% to about 10% by weight of the oral product. Vitamin C may preferably be present in an amount of about 0.1% to about 5% by weight of the oral product. In some embodiments, vitamin C is present in an amount of about 0.2% to about 2.5%, and preferably about 0.5% to about 1% by weight of the oral product.

[0068] In some embodiments, the combination of active ingredients further comprises ginseng. Ginseng is the root of plants of the genus Panax and is characterized by the presence of unique steroidal saponin phytochemicals (ginsenosides) and gintonin. The presumed major active components of ginseng include over 100 specific triterpene saponins or "ginsenosides." Ginseng and ginseng extracts also contain a range of other potentially bioactive components, including alkaloids, phytosterols, sesquiterpenes, and polyphenols. Ginseng has found use in energy drinks or herbal teas, and as a dietary supplement in traditional medicine.

[0069] The ginseng may include any suitable form of ginseng, such as Panax ginseng (Korean ginseng), Sanshi ginseng (Chinese ginseng), and American ginseng (American ginseng). The ginseng may also include Ashwagandha (Withania somnifera), commonly known as Indian ginseng. The ginseng may be present in the form of ginseng extract, coarsely chopped ginseng, shredded ginseng, or powdered ginseng. Preferably, the ginseng is included in the form of ginseng extract or powdered ginseng extract. The ginseng may be white ginseng, raw ginseng, or red ginseng. In some embodiments, the ginseng is red ginseng, such as red ginseng extract or powdered red ginseng extract. It has been found that the addition of ginseng can enhance brain function and / or increase cognitive benefits. The inclusion of ginseng has been found to be beneficial in improving the cognitive benefits of the composition and reducing mental and physical fatigue in users.

[0070] When present, ginseng may be included in any suitable amount, such as at least about 0.0001%, at least about 0.001%, or at least about 0.01% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.0001% to about 5% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.001% to about 1% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.001% to about 0.1% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.01% to about 0.05% by weight of the oral product. Ginseng may be present in an amount of about 2% or less by weight of the oral product, for example, about 1% or less by weight.

[0071] In some preferred embodiments, the active ingredient combination further comprises ginseng in an amount of about 0.001% to about 1% by weight of the oral product, preferably about 0.01% to about 0.1% by weight of the oral product.

[0072] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, taurine, and ginseng.

[0073] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, taurine, and vitamin C.

[0074] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, taurine, vitamin C, and ginseng.

[0075] In some embodiments, the active ingredient combination includes (i) caffeine in an amount of about 0.01% to about 10% by weight of the oral product, (ii) a B vitamin combination where the total amount of B vitamins is about 0.001% to about 5% by weight of the oral product, and (iii) taurine in an amount of about 0.001% to about 10% by weight of the oral product. In some embodiments, the active ingredient combination includes (i) caffeine in an amount of about 0.1% to about 5% by weight of the oral product, (ii) a B vitamin combination where the total amount of B vitamins is about 0.001% to about 1% by weight of the oral product, and (iii) taurine in an amount of about 0.01% to about 5% by weight of the oral product. In some embodiments, the active ingredient combination includes (i) caffeine in an amount of about 0.1% to about 1% by weight of the oral product, (ii) a B vitamin combination in which the total amount of B vitamins is about 0.01% to about 1% by weight of the oral product, and (iii) taurine in an amount of about 0.1% to about 1% by weight of the oral product.

[0076] In some embodiments, the active ingredient combination includes (i) caffeine in an amount of about 0.1% to about 1% by weight of the oral product, (ii) a B vitamin combination in which the total amount of B vitamins is about 0.01% to about 1% by weight of the oral product, and (iii) taurine in an amount of about 0.01% to about 0.5% by weight of the oral product.

[0077] In any of these embodiments, the active ingredient combination may further include vitamin C in an amount of about 0.1% to about 5% by weight of the oral product. In any of these embodiments, the active ingredient combination may further include ginseng in an amount of about 0.001% to about 1% by weight of the oral product, or about 0.01% to about 0.1% by weight of the oral product. In any of these embodiments, the active ingredient combination may further include vitamin C in an amount of about 0.1% to about 5% by weight of the oral product, and ginseng in an amount of about 0.01% to about 1% by weight of the oral product.

[0078] In some embodiments, the active ingredient combination includes (i) caffeine in about 0.01% to about 10% by weight of the oral product, (ii) a B vitamin combination where the total amount of B vitamins is about 0.001% to about 5% by weight of the oral product, (iii) taurine in about 0.001% to about 10% by weight of the oral product, and (iv) vitamin C in about 0.05% to about 10% by weight of the oral product. In some embodiments, the active ingredient combination includes (i) caffeine in about 0.1% to about 5% by weight of the oral product, (ii) a B vitamin combination where the total amount of B vitamins is about 0.001% to about 1% by weight of the oral product, (iii) taurine in about 0.01% to about 5% by weight of the oral product, and (iv) vitamin C in about 0.1% to about 5% by weight of the oral product. In some embodiments, the active ingredient combination includes: (i) caffeine in an amount of about 0.1% to about 1% by weight of the oral product; (ii) a B vitamin combination in which the total amount of B vitamins is about 0.01% to about 1% by weight of the oral product; (iii) taurine in an amount of about 0.01% to about 1% by weight of the oral product; and (iv) vitamin C in an amount of about 0.1% to about 1% by weight of the oral product.

[0079] In some embodiments, the active ingredient combination includes: (i) caffeine in an amount of from about 0.01% to about 5% by weight of the oral product; (ii) a B vitamin combination, wherein the total amount of B vitamins is from about 0.001% to about 1% by weight of the oral product; and (iii) taurine in an amount of from about 0.01% to about 5% by weight of the oral product; and (iv) vitamin C in an amount of from about 0.1% to about 5% by weight of the oral product.

[0080] In some embodiments, the active ingredient combination includes: (i) caffeine in an amount of about 0.1% to about 5% by weight of the oral product; (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.001% to about 1% by weight of the oral product; and (iii) taurine in an amount of about 0.01% to about 5% by weight of the oral product; and (v) ginseng in an amount of about 0.01% to about 1% by weight of the oral product.

[0081] In some embodiments, the active ingredient combination includes: (i) caffeine in about 0.1% to about 5% by weight of the oral product; (ii) a B vitamin combination where the total amount of B vitamins is about 0.001% to about 1% by weight of the oral product; (iii) taurine in about 0.01% to about 5% by weight of the oral product; (iv) vitamin C in about 0.1% to about 5% by weight of the oral product; and (v) ginseng in about 0.01% to about 1% by weight of the oral product.

[0082] The inventors have found that the amounts of active ingredients described above provide the beneficial effects of increasing energy levels and enhancing brain function while providing a safe product with reduced side effects. The amounts can be adjusted to ensure the product is highly effective while ensuring consumer safety and avoiding any overdose of the active substance.

[0083] Other suitable additional active ingredients are described below.

[0084] L-theanine is a compound of L-γ-glutamylethylamide and N 5 L-theanine is an amino acid analog also known as -ethyl-L-glutamine. When present, L-theanine may be included in an amount of about 0.01% to about 10% by weight of the oral product. L-theanine is preferably present in an amount of about 0.1% to about 5% by weight of the oral product.

[0085] In some embodiments, the active ingredient combination further comprises a botanical active ingredient. As used herein, the term "botanical ingredient" or "botanical" refers to any plant or fungal-derived material, including plant material in its natural form and plant material derived from natural plant material, such as extracts or isolates from plant material or processed plant material (e.g., plant material that has been subjected to heat treatment, fermentation, bleaching, or other treatment processes that can alter the physical and / or chemical properties of the material). For purposes of this disclosure, "botanical" includes, but is not limited to, "herbal materials," which refer to seed-producing plants that do not develop persistent woody tissue and are often valued for their medicinal or sensory characteristics (e.g., tea or herbal tea). Botanical materials useful in the present disclosure may include, but are not limited to, any of the compounds and sources (including mixtures thereof) described herein. Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemicals," or "functional foods." Certain botanical substances, either as plant materials or extracts thereof, find use in traditional herbal medicine and are further described herein.Non-limiting examples of plant materials or plant-derived materials include ashwagandha, bacopa monnieri, baobab, basil, Centella asiatica, Bupleurum Root, chamomile, cherry blossom, chlorophyll, cinnamon, citrus fruits, clove, cocoa, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, ginkgo, ginseng (e.g., ginseng), Griffonia simplicifolia, guarana, cannabis, hemp, hops, jasmine, black ginger (ginseng), kava , lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha, nardostatis chinensis, viola odorata oil extract, peppermint, quercetin, resveratrol, tian hemp, passion flower, guayusa, maca, matcha, beet root juice, rhodiola rosea, rooibos, rose essential oil, rosemary, sceletium tortuosum, schisandra berry, skullcap, spearmint extract, spikenard, terpenes, herbal tea, turmeric, turnera aphrodisiac, valerian, silver mulberry, echinacea, and yerba mate.

[0086] In some embodiments, the active ingredient combination further comprises Echinacea, a genus of herbaceous flowering plants in the Daisy family, commonly called coneflower. When present, Echinacea may be present in an amount of from about 0.001% to about 3% by weight of the oral product, and preferably from about 0.01% to about 1% by weight of the oral product.

[0087] The active ingredient combination may further comprise a vitamin selected from vitamin A, vitamin D, vitamin E, and vitamin K, or a mixture thereof. In some preferred embodiments, the active ingredient combination may optionally further comprise vitamin D in an amount of about 0.001% to about 1% by weight of the oral product.

[0088] The active ingredient combination may further comprise an amino acid, such as an amino acid selected from the group consisting of alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, gamma-aminobutyric acid (GABA), L-theanine, hydroxyproline, and beta-alanine. In some embodiments, the active ingredient combination comprises L-tyrosine.

[0089] In some embodiments, the combination of active ingredients includes one or more of choline, alpha GPC, theobromine, guayusa, maca, matcha, methylliberin, nitrates or beet root juice, yerba mate, glucose, or theacrine.

[0090] In some embodiments, the combination of active ingredients includes a cannabinoid. The cannabinoid may be a derivative or extract of cannabis. Cannabinoids are a class of natural or synthetic chemical compounds that act on intracellular cannabinoid receptors (i.e., CB1 and CB2) to inhibit the release of neurotransmitters in the brain. Cannabinoids are cyclic molecules that exhibit certain properties, such as the ability to easily cross the blood-brain barrier. Cannabinoids may be naturally occurring from plants such as cannabis (phytocannabinoids), from animals (endocannabinoids), or artificially produced (synthetic cannabinoids). Cannabis species exhibit at least 85 different plant cannabinoids, which may be classified into subclasses including cannabigerol, cannabichromene, cannabidiol, tetrahydrocannabinol, cannabinol, cannabinodiol, and other cannabinoids. In some embodiments, the cannabinoid is selected from the group consisting of cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN) and cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabiditriol (CBO), tetrahydrocannabimolic acid (THCA), tetrahydrocannabivaric acid (THCV A), and mixtures thereof. In some embodiments, the cannabinoid is tetrahydrocannabinol (THC) or comprises at least tetrahydrocannabinol (THC). In some embodiments, the cannabinoid is or at least includes cannabidiol (CBD).

[0091] In some embodiments, the active ingredient combination comprises a cannabinoid (such as cannabidiol) in an amount ranging from at least about 0.001% by weight of the oral product, such as from about 0.001% to about 10% by weight, such as from about 0.01% to about 5% by weight, such as from about 0.1% to about 2.5% by weight, for example, from 0.5% to about 1% by weight.

[0092] In some embodiments, the active ingredient combination includes magnesium glycinate, which, when present, may be included in an amount of about 0.1% to about 10% by weight of the oral product, such as about 0.5% to about 5% by weight, or about 0.5% to about 1% by weight.

[0093] For the avoidance of doubt, combinations of the above endpoints are expressly contemplated by this disclosure, as are any of the ranges disclosed herein.

[0094] Ratio of active ingredients The ratio of active ingredients in an oral product may be selected to increase the perceived effect of the oral product on the consumer.

[0095] In some embodiments, the caffeine and taurine are present in a weight ratio of about 10:1 to about 1:10, preferably about 5:1 to about 1:5, and more preferably about 5:1 to about 1:1. In preferred embodiments, the caffeine and taurine can be present in a weight ratio of about 3:1. Alternatively, the caffeine and taurine can be present in a weight ratio of about 2:1 to about 4:1.

[0096] In some embodiments, the total amount of caffeine and B vitamins is present in a weight ratio of about 1:1 to about 15:1, such as about 1:1 to about 10:1. In preferred embodiments, the total amount of caffeine and B vitamins is present in a weight ratio of about 2:1 to about 10:1, or 3:1 to about 5:1. In particularly preferred embodiments, the total amount of caffeine and B vitamins is present in a weight ratio of about 2:1 to about 10:1.

[0097] In some embodiments, the total amount of taurine and B vitamins is present in a weight ratio of about 10:1 to about 1:2, for example, about 7.5:1 to about 1:2. In some preferred embodiments, the total amount of taurine and B vitamins is present in a weight ratio of about 7.5:1 to about 2:1. In other preferred embodiments, the total amount of taurine and B vitamins is present in a weight ratio of about 1:1 to about 1:2. In preferred embodiments, the total amount of taurine and B vitamins is present in a weight ratio of about 5:1 to about 1:2, or 3:1 to about 1:2.

[0098] When present, the ratio of ginseng in the product may also provide benefits for improving cognition and mental alertness. When present, ginseng may be present in an amount such that the weight ratio of caffeine to ginseng is about 50:1 to about 1:1, for example, about 45:1 to about 15:1. Preferably, ginseng may be present in an amount such that the weight ratio of caffeine to ginseng is about 40:1 to about 30:1. Alternatively, when present, ginseng may be present in an amount such that the weight ratio of caffeine to ginseng is about 60:1 to about 1:1, for example, about 60:1 to about 15:1. Preferably, ginseng may be present in an amount such that the weight ratio of caffeine to ginseng is about 60:1 to about 20:1.

[0099] When present, ginseng may be present in an amount such that the weight ratio of taurine to ginseng is about 5:1 to about 50:1. In some embodiments, the weight ratio of taurine to ginseng is about 5:1 to about 40:1, e.g., about 10:1 to about 30:1. In some embodiments, the weight ratio of taurine to ginseng is about 10:1 to about 20:1.

[0100] In some embodiments (e.g., when the oral product is in the form of a lozenge or chew), the taurine and ginseng are present in a weight ratio of about 5:1 to about 50:1, e.g., about 10:1 to about 20:1. In some embodiments (e.g., when the oral product is in the form of a lozenge or chew), the taurine and ginseng are present in a weight ratio of about 10:1 to about 30:1. In some embodiments (e.g., when the oral product is in the form of a lozenge or chew), the caffeine and ginseng are present in a weight ratio of about 10:1 to about 100:1, e.g., about 20:1 to about 50:1. In some embodiments (e.g., when the oral product is in the form of a lozenge or chew), the caffeine and ginseng are present in a weight ratio of about 30:1 to about 60:1.

[0101] When present, vitamin C may be included such that the weight ratio of vitamin C to caffeine is about 5:1 to about 1:5. In some preferred embodiments, the weight ratio of vitamin C to caffeine is about 3:1 to about 1:3, more preferably about 2:1 to about 1:1 or about 3:1 to about 1:2. When present, vitamin C may be included such that the weight ratio of vitamin C to taurine is about 15:1 to about 1:5. In some preferred embodiments, the weight ratio of vitamin C to taurine is about 10:1 to about 1:1, more preferably about 10:1 to about 2:1. When present, vitamin C may be included such that the weight ratio of vitamin C to total B vitamins is about 1:1 to about 15:1.

[0102] In some embodiments, the oral product comprises: It comprises a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, and (iii) taurine, wherein the weight ratio of caffeine to taurine is about 5:1 to about 1:1; The weight ratio of caffeine to the total amount of B vitamins is about 1:1 to about 10:1, The weight ratio of taurine to the total amount of B vitamins is about 10:1 to about 1:2.

[0103] In some embodiments, the oral product comprises: It comprises a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, and (iii) taurine, wherein the weight ratio of caffeine to taurine is about 3:1 and the B vitamin combination is as described in any of the above embodiments.

[0104] In some embodiments, the oral product comprises: It comprises a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, and (iii) taurine, wherein the weight ratio of caffeine to taurine is about 2:1 to about 4:1, and the combination of B vitamins is as described in any of the above embodiments.

[0105] In some embodiments, the oral product comprises: A combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, (iii) taurine, and (iv) ginseng, wherein the weight ratio of caffeine to ginseng is from about 40:1 to about 130:1, and optionally the weight ratio of caffeine to taurine is from about 4:1 to about 1:1.

[0106] In some embodiments, the oral product comprises: A combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, (iii) taurine, and (iv) ginseng, wherein the weight ratio of caffeine to taurine is about 4:1 to about 1:1; the weight ratio of caffeine to the total amount of B vitamins is about 1:1 to about 10:1; and The weight ratio of caffeine to ginseng is about 240:1 to about 30:1.

[0107] additives Depending on the type of oral product being processed, the product may contain one or more additional ingredients in addition to the combination of active ingredients. For example, the oral product may further contain an additive selected from the group consisting of flavoring agents, sweeteners, buffering agents, acidifying agents, thickeners, fillers, binders, humectants, preservatives, salts, coloring agents, oral care additives, disintegration aids, antioxidants, water, or mixtures thereof. In some embodiments, the oral product further contains one or more additives selected from the group consisting of flavoring agents, sweeteners, acidifying agents, thickeners, fillers, binders, humectants, preservatives, and mixtures thereof.

[0108] Fillers or extenders Depending on the product form, oral products may contain fillers or bulking agents, which can serve multiple functions, such as improving certain organoleptic properties, such as texture and mouthfeel, or improving the cohesiveness or compressibility of the product.

[0109] In some embodiments, the filler is a porous granular material and is cellulosic. For example, the filler or bulking agent may be a non-tobacco plant material or its derivative, including cellulosic materials derived from such sources. Examples of cellulosic non-tobacco plant materials include grains (e.g., corn, oats, barley, rye, buckwheat, etc.), sugar beet (e.g., FIBREX® brand filler available from International Fiber Corporation), bran fiber, and mixtures thereof. In some embodiments, the filler is a cellulosic material selected from the group consisting of corn fiber, oat fiber, barley fiber, rye fiber, buckwheat fiber, sugar beet fiber, bran fiber, bamboo fiber, wood pulp fiber, cotton fiber, citrus pulp fiber, vegetable fiber, willow fiber, poplar fiber, cocoa fiber, derivatives thereof, and combinations thereof. In some embodiments, the filler is a cellulosic material selected from the group consisting of sugar beet fiber, wood pulp fiber, bamboo fiber, derivatives thereof, and combinations thereof.

[0110] In some embodiments, the filler is derived from wood pulp fibers. One particularly suitable filler for use in the products described herein is microcrystalline cellulose ("MCC"). The MCC may be synthetic or semi-synthetic, or may be derived entirely from natural cellulose. The MCC may be selected from the group consisting of AVICEL® grades PH-100, PH-101, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-301, PH-302, VIVACEL® grades 101, 102, 12, 20, and EMOCEL® grades 50M and 90M, and the like, and mixtures thereof.

[0111] In some embodiments, the filler is a non-tobacco plant material or a derivative thereof. Non-limiting examples of derivatives of non-tobacco plant materials include starches (e.g., potato, wheat, rice, corn), natural cellulose, and modified cellulose materials. Further examples of potential fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Combinations of these fillers can also be used.

[0112] As used herein, "starch" may refer to pure starch, modified starch, or starch derivatives from any source. Starch, typically in granular form, is present in almost all green plants and various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, sprouts, fruits, grains, and stems). Starch can vary in composition and granule shape and size. Starches from different sources often have different chemical and physical characteristics. A particular starch can be selected for inclusion in a product based on the ability of the starch material to impart particular organoleptic properties to the product. Starch from a variety of sources can be used. For example, major sources of starch include grains (e.g., rice, wheat, and corn) and root vegetables (e.g., potato and cassava). Other examples of starch sources include acorns, arrowroot, arracacha, bananas, barley, legumes (e.g., faba beans, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnut, taro, dogtooth violet, arrowroot, malanga, millet, oats, wood sorrel, yam, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnut, and yam. Certain starches are modified starches. Modified starches have undergone one or more structural modifications, often designed to alter their high thermal properties. Some starches have been developed through genetic engineering and are considered "modified" starches. Other starches are obtained and subsequently processed. For example, modified starches can be starches that have been subjected to chemical reactions such as esterification, etherification, oxidation, depolymerization (thinning) by oxidation in the presence of an acid catalyst or a base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), crosslinking, enzyme treatment, acetylation, hydroxypropylation, and / or partial hydrolysis. Other starches are processed by heat treatments such as pregelatinization, dextrinization, and / or cold water swelling processes.Specific modified starches include phosphated starch, glycerol cross-linked starch, phosphate cross-linked starch esterified with sodium trimetaphosphate, phosphorylated phosphate cross-linked starch, acetylated phosphate cross-linked starch, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated adipate cross-linked starch, acetylated glycerol cross-linked starch, hydroxypropyl starch, hydroxypropylglycerol cross-linked starch, and starch sodium octenyl succinate.

[0113] Other suitable fillers or bulking agents include sugar alcohols. Sugar alcohols are polyols derived from partially or fully hydrogenated mono- or disaccharides. Sugar alcohols, for example, have from about 4 to about 20 carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof. In some embodiments, the filler, if present, may be selected from the group consisting of isomalt, maltitol, and mixtures thereof.

[0114] water The moisture content (eg, water content) of an oral product can be varied according to the desired properties prior to consumer use of the product.

[0115] Typically, for solid oral products, prior to insertion into the user's mouth, the water content is less than about 60% by weight of the oral product, generally from about 1% to about 60% by weight, e.g., from about 5% to about 55% by weight, from about 10% to about 50% by weight, from about 20% to about 45% by weight, or from about 25% to about 40% by weight, including water contents of at least about 5%, at least about 10%, at least about 15%, and at least about 20% by weight of the oral product.

[0116] Flavoring agents As used herein, the term "flavoring agent" (or "flavor" and "flavoring agent") refers to a material that may be used, where local regulations permit, to create a desired taste, aroma, or other somatic sensation in a product intended for adult consumers. Examples of sensory characteristics that may be modified by a flavoring agent include taste, texture, moistness, coolness / heat, and / or aroma / scent. Flavoring agents may be natural or synthetic, and the flavor characteristics imparted thereby may be described as, but are not limited to, fresh, sweet, herbal, confectionery, floral, fruity, or spicy.

[0117] Flavoring agents may be naturally occurring flavoring materials, botanicals, extracts of botanicals, synthetically derived materials, or combinations thereof (e.g., tobacco, cannabis, licorice, hydrangea, eugenol, magnolia leaf, chamomile, fenugreek, clove, maple, matcha, menthol, Japanese mint, aniseed, cinnamon, turmeric, Indian spices, Asian spices, herbs, wintergreen, cherry, berry, red berry, cranberry, peach, apple, orange, mango, clementine, lemon, lime, tropical fruit, citrus ... Calfruit, papaya, rhubarb, grapes, durian, dragon fruit, cucumber, blueberry, mulberry, citrus fruits, Drambuie, bourbon, scotch, whiskey, gin, tequila, rum, spearmint, peppermint, lavender, aloe vera, cardamom, coconut, celery, cascarilla, nutmeg, sandalwood, bergamot, geranium, khat, eggplant, betel nut, shisha, pine, honey essence, rose oil, vanilla, lemon oil, orange oil, orange blossom, cherry blossom, cassia, caraway, cognac, jasmine, ylang-ylang Orchids, sage, fennel, wasabi, bell peppers, ginger, coriander, coffee, hemp, peppermint oil from any species of the genus Mentha, eucalyptus, star anise, cocoa, lemongrass, rooibos, flax, ginkgo, hazel, hibiscus, bay leaf, yerba mate, orange peel, rose, tea such as green tea or black tea, thyme, juniper, elderflower, basil, bay leaf, cumin, oregano, paprika, rosemary, saffron, lemon peel, mint, shiso, curcuma, cilantro, myrtle, black currant, valerian, pimento, mace, damien, marjoram, The additives may be selected from the group consisting of: olive, lemon balm, lemon basil, chives, Calvi, verbena, tarragon, limonene, thymol, camphene), flavor enhancers, bitter taste receptor site blockers, sensory receptor site activators or stimulants, sugars and / or sugar substitutes (e.g., honey, sucralose, acesulfame potassium, aspartame, saccharin, cyclamate, lactose, sucrose, glucose, fructose, sorbitol, or mannitol), and other additives such as charcoal, chlorophyll, minerals, botanicals, or breath fresheners.The flavoring agent may be an imitation, synthetic, or natural ingredient, or a blend thereof. The flavoring agent may be in any suitable form, for example, a liquid such as an oil, a solid such as a powder, or a gas.

[0118] In some embodiments, the flavoring agent comprises a natural flavoring agent such as berry (e.g., raspberry, blueberry, or strawberry), honey, citrus (e.g., lemon, bergamot, orange, or lime), or other botanical flavoring.

[0119] In some embodiments, the flavoring agent comprises menthol, spearmint, and / or peppermint. In some embodiments, the flavoring agent comprises cucumber, blueberry, citrus, and / or red berry flavor components. In some embodiments, the flavoring agent comprises eugenol. In some embodiments, the flavoring agent comprises flavor components extracted from tobacco. In some embodiments, the flavoring agent comprises flavor components extracted from cannabis.

[0120] In some embodiments, the flavoring agent may include a sensation eliciting agent intended to achieve somatic sensations typically chemically induced and perceived by stimulation of the fifth cranial nerve (trigeminal nerve) in addition to, or instead of, scent or taste nerves, and may include agents that produce heating, cooling, tingling, or numbing effects. A suitable heating agent may be, but is not limited to, vanillyl ethyl ether, and a suitable cooling agent may be, but is not limited to, eucalyptol, WS-3.

[0121] When present, the flavoring agent may be included in the oral product in an amount of up to about 10% by weight of the oral product, such as up to about 5% by weight, for example, up to about 1% by weight of the oral product. In some embodiments, the flavoring agent is present in an amount of from about 0.01% to about 5% by weight of the oral product, preferably from about 0.1% to about 2.5% by weight, and more preferably from about 0.25% to about 1% by weight of the oral product.

[0122] Binder In some embodiments, the oral product may further comprise at least one binder. In certain embodiments, a binder (or combination of binders) may be used in the product in an amount sufficient to provide the product with desired physical attributes and physical integrity.

[0123] The binder may be organic or inorganic, or a combination thereof. Representative binders include cellulose derivatives, povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof. The amount of binder utilized in the product may vary but may be up to about 30% by weight, with certain embodiments being characterized by a binder content of at least about 0.1% by weight, e.g., from about 1% to about 30% by weight, or from about 1% to about 10% by weight, based on the total weight of the oral product.

[0124] In some embodiments, the binder comprises pectin. Pectin is a natural polymer related to carbohydrates and is an acidic heteropolysaccharide (a polysaccharide containing multiple monosaccharide units). In contrast to carbohydrates, the C-6 position of pectin contains a carboxylic acid (or the corresponding methyl ester or carboxamide) group instead of a hydroxymethyl group. The primary subunit is known as galacturonic acid, which can copolymerize with L-rhamnose. Other sugars are characterized by side-chain substituents. Pectin acts as a thickener and gelling agent. Pectin isolated from sources such as apple pomace, citrus peel, sugar beet waste from sugar manufacturing, sunflower heads discarded from seed harvesting, mango waste, and other commercially available pectins can be used. In combination with certain sugars, under acidic conditions (e.g., a pH of about 2.5 to about 5), or in the presence of gelling agents (calcium or other divalent alkaline earth elements), pectin can provide a gel or gum consistency to the products disclosed herein. In some embodiments, the binder comprises low methoxy pectin. Suitable low methoxy pectins include, for example, "GENU® Pectin Type LM-104 AS" available from CP Kelco (Atlanta, Georgia, USA). In some embodiments, the binder comprises low methoxy pectin in combination with a gelling agent. In some embodiments, the gelling agent comprises calcium ions, such as, but not limited to, calcium diphosphate. In some embodiments, the binder comprises high methoxy pectin in combination with an organic acid, as described hereinbelow. In some embodiments, the binder comprises high methoxy pectin in combination with citric acid.

[0125] When present, the pectin binder is typically present in an amount of up to about 3% by weight, e.g., from about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1% by weight, to about 1.1%, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about 1.9%, about 2%, about 2.1%, about 2.2%, about 2.3%, about 2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%, or about 3% by weight, based on the total weight of the oral product.

[0126] In some embodiments, the binder comprises a cellulose derivative. In certain embodiments, a cellulose derivative is a cellulose ether (including a carboxyalkyl ether), which refers to a cellulose polymer in which the hydrogen of one or more hydroxyl groups in the cellulose structure has been replaced with an alkyl, hydroxyalkyl, or aryl group. Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropyl cellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethyl cellulose, and carboxymethylcellulose ("CMC"). In some embodiments, the cellulose derivative is or comprises HPC. In some embodiments, the cellulose derivative is a combination of HPC and HPMC. In some embodiments, the oral product comprises from about 1% to about 10% by weight of the cellulose derivative (e.g., HPC), and in certain embodiments, from about 1% to about 5% by weight of the cellulose derivative (e.g., HPC) based on the weight of the product.

[0127] In certain embodiments, the binder comprises a gum, such as a natural gum. As used herein, natural gum refers to a naturally occurring polysaccharide material that has binding properties and is also useful as a thickening or gelling agent. Representative natural gums derived from plants, which are typically somewhat water-soluble, include xanthan gum, guar gum, gum arabic, gum ghatti, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof. When present, the natural gum binder material may be present in an amount of up to about 5% by weight, e.g., about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1% by weight, based on the total weight of the product, up to about 2%, about 3%, about 4%, or about 5% by weight.

[0128] Wetting agent In some embodiments, the oral product includes at least one humectant. Examples of suitable humectants that may be included in the product include, but are not limited to, glycerin, 1,2-propanediol (propylene glycol), 1,3-propanediol, dipropylene glycol, sorbitol, xylitol, mannitol, and the like. In some embodiments, the humectant is or includes glycerin. In some embodiments, the oral product includes glycerin. In some embodiments, the humectant is or includes propylene glycol. In some embodiments, the oral product includes polypropylene glycol. The amount of humectant utilized in the oral product can vary but may be up to about 5% by weight, with certain embodiments being characterized by a humectant content of at least about 1% by weight of the oral product, e.g., from about 2% to about 5% by weight. In some embodiments, the humectant (such as glycerin and / or propylene glycol) may be present in an amount of from about 0.01% to about 25% by weight of the oral product, such as from about 0.1% to about 20% by weight of the oral product, such as from about 0.5% to about 15% by weight of the oral product, such as from about 1% to about 10% by weight of the oral product, for example, from about 5% to about 10% by weight of the oral product.

[0129] sweetener One or more sweeteners may be added to improve the sensory properties of oral products. The sweetener can be any sweetener or combination of sweeteners, whether natural or artificial, or a combination of natural and artificial sweeteners. Examples of natural sweeteners include fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, etc. Examples of artificial sweeteners include sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, etc.

[0130] In some embodiments, the sweetener comprises one or more sugar alcohols. The sugar alcohols may include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof. In some embodiments, the sweetener is selected from the group consisting of fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and mixtures thereof.

[0131] In some embodiments, the sweetener is selected from the group consisting of sucralose, acesulfame K, aspartame, maltodextrin, mannitol, sucrose, and mixtures thereof. Preferably, the sweetener can be sucralose and / or acesulfame K. When present in an oral product, the sweetener (such as sucralose and / or acesulfame K) can be present in an amount of about 0.001% to about 5% by weight of the oral product, for example, about 0.01% to about 3% by weight, preferably about 0.01% to about 1% by weight.

[0132] buffer Non-limiting examples of suitable buffering agents that may be included in the oral product include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, bicarbonates, borates, or mixtures thereof. In some embodiments in which a buffering agent is present, the buffering agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, sodium phosphate, ammonium phosphate, dicalcium phosphate, tricalcium phosphate, and mixtures thereof. In some embodiments, the buffering agent is sodium bicarbonate and / or sodium carbonate. When present, the buffering agent (e.g., sodium bicarbonate and / or sodium carbonate) may be present in an amount less than about 5% by weight of the oral product, such as from about 0.5% to about 5% by weight, e.g., from about 0.75% to about 4% by weight, from about 0.75% to about 3% by weight, or from about 1% to about 2% by weight, based on the total weight of the oral product.

[0133] organic acid In some embodiments, the product includes an organic acid. As used herein, the term "organic acid" refers to an organic (i.e., carbon-based) compound characterized by acidic properties. Typically, organic acids are relatively weak acids (i.e., they do not completely dissociate in the presence of water), such as carboxylic acids (-COH) or sulfonic acids (-SOOH). As used herein, reference to an organic acid refers to an organic acid that is intentionally added. In this regard, the organic acid may be intentionally added as a specific mixture component, rather than simply being inherently present as a component of another mixture component (e.g., a small amount of organic acid that may be inherently present in a mixture component, such as tobacco material). In some embodiments, one or more organic acids are added as such (i.e., in their free acid, natural solid or liquid form) or as a solution, for example, in water. In some embodiments, one or more organic acids are added in the form of a salt.

[0134] In some embodiments, the organic acid is a carboxylic acid or a sulfonic acid. The carboxylic acid or sulfonic acid functional group can be, for example, an alkyl group having 1 to 20 carbon atoms (C1 to C6). 20In some embodiments, the organic acid is an alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl carboxylic or sulfonic acid.

[0135] In some embodiments, the organic acid is an alkyl carboxylic acid. Non-limiting examples of alkyl carboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, etc. In some embodiments, the organic acid is an alkyl sulfonic acid. Non-limiting examples of alkyl sulfonic acids include propane sulfonic acid and octane sulfonic acid.

[0136] In some embodiments, the alkyl carboxylic or sulfonic acid is substituted with one or more hydroxyl groups. Non-limiting examples include glycolic acid, 4-hydroxybutyric acid, and lactic acid.

[0137] In some embodiments, the organic acid may contain two or more carboxylic acid groups or two or more sulfonic acid groups (e.g., two, three, or more carboxylic acid groups). Non-limiting examples include oxalic acid, fumaric acid, maleic acid, and glutaric acid. In organic acids containing multiple carboxylic acids (e.g., two to four carboxylic acid groups), one or more carboxylic acid groups may be esterified. Non-limiting examples include succinic acid monoethyl ester, monomethyl fumarate, monomethyl citrate, or dimethyl citrate.

[0138] In some embodiments, the organic acid may contain two or more carboxylic acid groups and one or more hydroxyl groups. Non-limiting examples of such acids include tartaric acid, citric acid, etc. In some preferred embodiments, the organic acid is citric acid, sodium citrate, calcium citrate, or a combination thereof.

[0139] In some embodiments, the organic acid is an aryl carboxylic acid or aryl sulfonic acid. Non-limiting examples of aryl carboxylic and sulfonic acids include benzoic acid, toluene acid, salicylic acid, benzene sulfonic acid, and p-toluene sulfonic acid.

[0140] Further non-limiting examples of suitable organic acids include 2,2-dichloroacetic acid, 2-hydroxyethanesulfonic acid, 2-oxoglutaric acid, 4-acetamidobenzoic acid, 4-aminosalicylic acid, acetic acid, adipic acid, ascorbic acid (L), aspartic acid (L), camphoric acid (+), camphor-10-sulfonic acid (+), capric acid, caproic acid, caprylic acid, cinnamic acid, cyclamic acid, decanoic acid, dodecyl sulfuric acid, ethane-1,2-disulfonic acid, ethanol, ethanolamine, ethanolamine, ethanolamine esters ... Examples of suitable acids include benzoic acid, benzoic acid, benzoyl sulfonic acid, benzoic acid, benzoyl estersulf ...

[0141] Preferably, the organic acid is selected from the group consisting of citric acid, malic acid, lactic acid, benzoic acid, tartaric acid, and mixtures thereof, hi some preferred embodiments, the organic acid is or comprises citric acid or a salt thereof.

[0142] In some embodiments, the product comprises an alkali metal salt of an organic acid. For example, at least a portion of the organic acid may be present in the product in the form of an alkali metal salt. Suitable alkali metal salts include lithium, sodium, and potassium. In some embodiments, the alkali metal is sodium or potassium. In some embodiments, the alkali metal is sodium. In some embodiments, the product comprises an organic acid and a sodium salt of an organic acid. In some embodiments, the organic acid is or comprises sodium citrate (such as trisodium citrate).

[0143] In some preferred embodiments, the organic acid is or includes citric acid anhydride.

[0144] The amount of organic acid present in the product can vary. Oral products can contain from about 0.01% to about 10% by weight of an organic acid (e.g., citric acid or a salt thereof) present as one or more organic acids, based on the total weight of the oral product. In some embodiments, the oral product contains at least about 0.01%, at least about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or at least about 10% by weight of an organic acid, based on the total weight of the oral product. In some preferred embodiments, the oral product contains from about 0.01% to about 5% by weight of an organic acid (e.g., citric acid or a salt thereof), based on the weight of the oral product. For example, the oral product contains the organic acid in an amount of about 0.1% to about 2.5% by weight of the oral product. If a salt of the organic acid is added (e.g., citric acid anhydrous), the weight percentage is calculated based on the weight of the free acid, without any counterion that may be present.

[0145] In certain embodiments, the inclusion of an organic acid is sufficient to provide a product pH of about 4.0 to about 9.0, e.g., about 4.5 to about 7.0, or about 5.5 to about 7.0, about 4.0 to about 5.5, or about 7.0 to about 9.0. In some embodiments, the inclusion of an organic acid is sufficient to provide a product pH of about 4.5 to about 6.5, e.g., about 4.5, about 5.0, or about 5.5, to about 6.0 or about 6.5. In some embodiments, the organic acid is provided in an amount sufficient to provide a product pH of about 5.5 to about 6.5, e.g., about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, or about 6.0, to about 6.1, about 6.2, about 6.3, about 6.4, or about 6.5.

[0146] In other embodiments, a mineral acid (eg, hydrochloric acid, sulfuric acid, phosphoric acid, etc.) is added to adjust the product pH to a desired value.

[0147] The organic acid (e.g., citric acid) can be added neat (i.e., as a solid) or in solution, e.g., in water. In some embodiments, the organic acid is added as a 50% solution in water.

[0148] salt The oral product may further comprise a salt, which may be included in an amount sufficient to provide the product with desired sensory attributes. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, flour salt, sodium acetate, sodium citrate, and the like. The salt may be included in any suitable amount, such as at least about 0.5% by weight of the oral product, e.g., at least about 1% by weight, e.g., at least about 1.5% by weight. In some embodiments, the oral product may comprise salt in an amount of about 0.5% to about 10% by weight, e.g., about 1% to about 7.5% by weight, e.g., about 1.5% to about 5% by weight, based on the total weight of the oral product.

[0149] thickener In some embodiments, the oral product may contain a thickener. Suitable thickeners may include hydrocolloids such as xanthan gum, guar gum, konjac gum, tragacanth gum, and gum arabic. For example, xanthan gum is understood to be a thickener that thickens the composition when added during cold processing (i.e., when no heat is applied).

[0150] When present, thickening agents (eg, xanthan gum) may be included in amounts of from about 0.001% to about 5%, preferably from about 0.01% to about 1%, by weight of the oral product.

[0151] coloring agent Colorants can be used in an amount sufficient to provide the desired physical attributes. Examples of colorants include various dyes and pigments, such as caramel color and titanium dioxide. Natural colorants, such as curcumin, beet juice extract, and spirulina, as well as various synthetic pigments, can also be used. The amount of colorant utilized in oral products can vary, but when present, is typically up to about 3% by weight, for example, about 0.1%, about 0.5%, or about 1% to about 3% by weight, based on the total weight of the oral product.

[0152] Other additives Other ingredients, such as preservatives (e.g., potassium sorbate), disintegration aids (e.g., croscarmellose sodium, crospovidone, sodium starch glycolate, pregelatinized corn starch, etc.), and / or antioxidants, can also be used. Typically, such ingredients, if used, are used in an amount of up to about 10% by weight of the oral product, e.g., at least about 0.1% by weight, e.g., about 0.5% to about 10% by weight. Disintegration aids can be used in an amount sufficient to provide control of the desired physical attributes of the oral product, for example, by providing for loss of physical integrity and dispersibility of the various component materials upon contact of the formulation with water (e.g., by undergoing swelling upon contact with water).

[0153] Further examples of additives include zinc or magnesium salts, or combinations thereof, selected to be relatively water-soluble for compositions with higher water solubility (e.g., magnesium gluconate or zinc gluconate), or relatively water-insoluble for compositions with reduced water solubility (e.g., magnesium oxide or zinc oxide). See, for example, U.S. Patent No. 9,237,769 to Mua et al., U.S. Patent No. 7,861,728 to Holton, Jr. et al., U.S. Patent Application Publication No. 2010 / 0291245 to Gao et al., and U.S. Patent Application Publication No. 2007 / 0062549 to Holton, Jr. et al. (each of which is incorporated herein by reference) for their representative components, combinations of components, relative amounts of components, and modes and methods for using these components. Typical content ranges of such additional additives can vary depending on the nature and function of the additive and its intended effect on the final product, and can range, for example, up to about 10% by weight (e.g., about 0.1% to about 5% by weight) based on the total weight of the oral product.

[0154] In some embodiments, the oral product comprises a magnesium salt. A non-limiting example of a suitable magnesium salt is magnesium gluconate. In some embodiments, the oral product comprises magnesium in an amount of about 0.1% to about 2% by weight, or about 0.2% to about 1% by weight, based on elemental magnesium.

[0155] In some preferred embodiments, the oral product comprises zinc or zinc gluconate in an amount of about 0.1% to about 2% by weight, or about 0.1% to about 1% by weight, based on the oral product.

[0156] The aforementioned additives can be used together (e.g., as an additive blend) or separately (e.g., individual additive components can be added at different stages involved in the preparation of the final product). Additionally, additives of the aforementioned types can be encapsulated to provide them in the final product or composition. Exemplary encapsulated additives are described, for example, in Atchley, International Publication No. 2010 / 132444, which has been previously incorporated by reference herein.

[0157] Oral products The products or compositions described herein are configured for oral use. As used herein, the term "configured for oral use" means that the product is provided in a form such that, during use, saliva in the user's mouth passes one or more components (e.g., active ingredients) of the product into the user's mouth. In certain embodiments, the product is adapted to deliver the active ingredient(s) and optionally flavoring agent(s) to the user through the mucous membranes in the user's mouth, the user's digestive system, or both. In some examples, the active ingredient(s) and optionally flavoring agent(s) can be absorbed through the mucous membranes in the mouth or can be absorbed through the digestive tract when the product is used.

[0158] In some embodiments, the oral product comprises the combination of active ingredients in an amount of at least about 0.01% by weight of the oral product, such as at least about 0.1% by weight, or preferably at least about 1% by weight. The oral product may comprise, for example, at least about 0.25%, at least about 0.3%, at least about 0.5%, at least about 0.75%, at least about 1%, at least about 1.5%, at least about 2%, at least about 3%, at least about 4%, or at least about 5% by weight of the oral product. The combination of active ingredients may be present in an amount of about 50% by weight or less of the oral product, such as about 40% by weight or less, such as about 30% by weight or less, such as about 20% by weight or less, for example about 10% by weight or less.

[0159] The active ingredient combination may be present in an amount of about 0.01% to about 20% by weight. For example, the active ingredient combination may be present in an amount of about 0.05% to about 15% by weight of the oral product, such as about 0.1% to about 10% by weight, or about 0.5% to about 5% by weight. Preferably, the active ingredient combination is present in an amount of about 0.1% to about 10% by weight of the oral product. Preferably, the active ingredient combination is present in an amount of about 0.5% to about 5% by weight, more preferably about 1% to about 5% by weight of the oral product.

[0160] In some embodiments, the combination of active ingredients may be present in an amount of about 1.5% to about 20% by weight of the oral product, such as about 2.5% to about 15% by weight, for example about 5% to about 10% by weight.

[0161] The oral product can be in any form suitable for application to the oral cavity of a human or animal, hi some embodiments, the oral product is a solid oral dosage form.

[0162] The oral products described herein can take a variety of forms, including lozenges or chews.

[0163] solid oral dosage forms As described herein, the oral product is in a solid form. As used herein, the term "solid" means that the product is capable of substantially maintaining its physical form when not supported by external means, such as packaging. Thus, the product is considered to be in a solid, solid-like, solid form, or solid-like form at room temperature. For the avoidance of doubt, a solid product remains substantially solid up to 30°C. In some embodiments, the oral product is in a solid form, such as in the form of a chew or lozenge. In some embodiments, the oral product is a chew or lozenge. In some embodiments, the oral product can be a chewing gum product. In some embodiments, the oral product is a chew.

[0164] The oral products disclosed herein can be formed into a variety of shapes, including pills, tablets, spheres, strips, films, sheets, coins, cubes, beads, ovals, obloids, cylinders, beans, sticks, or rods. The cross-sectional shape of the product can vary, with representative cross-sectional shapes including round, square, oval, rectangular, etc. Such shapes can be formed in a variety of ways using equipment such as moving belts, nips, extruders, granulating devices, compression devices, etc.

[0165] In some embodiments, the solid oral product is in a form selected from the group consisting of a chew or a lozenge.

[0166] In other embodiments, the oral product is in a solid form, such as a loose wet snuff, a loose dry snuff, a chewing tobacco-type form, a pelleted piece, an extruded or molded strip, a piece, a rod or stick, a finely ground powder, a finely ground or pulverized agglomerate of powdered pieces and ingredients, a flake-like piece, a molded piece, a gum, a film, a film or strip that is easily dissolved or dispersed in water, a capsule-like material, a tablet, a lozenge, etc. In some embodiments, the oral product is a tablet or a lozenge. In some embodiments, the oral product may be a chewing gum product. In some embodiments, the oral product is in the form of a wet snuff or snus, which may or may not contain tobacco.

[0167] Kiss In some embodiments, the product may be chewable, meaning that the product has a gentle elasticity or "bounce" when chewed and a desirable degree of malleability. Chewable products may dissolve completely, or may be in the form of a non-dissolving gum in which only certain ingredients (e.g., active ingredients, flavors, sweeteners) dissolve, leaving a non-dissolving matrix. In a preferred embodiment, the product is in a chewable form that dissolves completely.

[0168] As described herein, a "chew" is a confectionery-type product that can be chewed by the user before dissolving in the mouth (i.e., a dissolvable chew) or can be a chewing gum. Preferably, the "chew" dissolves completely in the user's mouth. The product can be dissolvable. As used herein, the terms "dissolve," "dissolution," and "dissolvable" refer to a product having water-soluble components that interact with the moisture in the oral cavity to go into solution, thereby causing gradual uptake of the product. According to one embodiment, a dissolvable product can persist in the user's mouth for a predetermined period of time until it completely dissolves. Dissolution rates can vary over a wide range, from about 1 minute or less to about 60 minutes. For example, fast-release products typically dissolve and / or release desired ingredients (e.g., active ingredients, flavors, etc.) in about 2 minutes or less, often about 1 minute or less (e.g., about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less). Dissolution can occur by any means, such as melting, mechanical disruption (eg, chewing), enzymatic or other chemical degradation, or disruption of interactions between components of the product.

[0169] In other embodiments, the product does not dissolve while the product is in the user's mouth.

[0170] Chews generally include a binder such as a natural gum, pectin, agar, carrageenan, starch, or a combination thereof. In some embodiments, the binder includes or is pectin.

[0171] In some embodiments, the chewable product (i.e., "chew") comprises a combination of active ingredients, at least one bulking agent selected from the group consisting of a sugar alcohol, or at least one sugar, or a combination of at least one sugar alcohol and at least one sugar, and at least one binder. In some embodiments, the chewable product (i.e., "chew") comprises a combination of active ingredients, at least one bulking agent selected from the group consisting of a sugar alcohol, or at least one sugar, or a combination of at least one sugar alcohol and at least one sugar, and at least one binder in an amount of about 0.1% to about 10% by weight of the oral product. The chewable product or chew may also optionally comprise a sweetener and / or a flavoring agent.

[0172] Representative chew compositions and products may incorporate about 0.1% to about 20% by weight of the active ingredient combination, about 0.1% to about 10% by weight of a binder (e.g., pectin, agar, carrageenan, starch, or a combination thereof), and at least about 30% by weight of at least one bulking agent selected from the group consisting of a sugar alcohol, at least one sugar, or a combination of at least one sugar alcohol and at least one sugar, based on the total weight of the oral product. Optionally, the oral product may further comprise about 0.01% to about 2% by weight of a sweetener, and / or about 0.1% to about 10% by weight of at least one flavoring agent, based on the total weight of the oral product. The specific proportions and selection of ingredients will vary depending on the desired flavor, texture, and other characteristics. For example, the active ingredient combination may be present in the chew in an amount of about 0.1% to about 10% by weight of the oral product.

[0173] In some embodiments, the oral chew product comprises pectin and an organic acid, along with one or more sugar alcohols, in an amount of at least 30% by weight of the oral product.

[0174] In some embodiments, the oral chew product comprises at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar. In some embodiments, the at least one bulking agent is selected from a sugar alcohol or a sugar. In some embodiments, the at least one bulking agent is selected from a sugar alcohol. In some embodiments, the at least one bulking agent is selected from a sugar. In some embodiments, the at least one bulking agent is selected from a combination of at least one sugar alcohol and at least one sugar.

[0175] The total amount of bulking agent (preferably sugar alcohol) may be at least about 30% by weight of the oral product, such as at least about 40% by weight, for example at least about 45% by weight. In some preferred embodiments, the total amount of bulking agent (preferably sugar alcohol) may be at least about 50% by weight of the oral product.

[0176] In some embodiments, the total amount of bulking agent (preferably sugar alcohol) is present in an amount of about 30% to about 99% by weight of the oral product, e.g., about 40% to about 99% by weight, e.g., about 45% to about 99% by weight, e.g., about 50% to about 99% by weight, e.g., about 60% to about 95% by weight, and preferably about 70% to about 90% by weight. Preferably, the bulking agent (preferably sugar alcohol) is present in an amount of about 80% to about 95% by weight of the oral product.

[0177] In some preferred embodiments, the total amount of bulking agent (preferably sugar alcohol) is present in an amount of about 40% to about 60% by weight of the oral product.

[0178] Alternatively, in some preferred embodiments, the total amount of bulking agent sugar alcohol is from about 50% to about 90% by weight of the oral product. In such embodiments, the bulking agent may consist of a sugar alcohol.

[0179] The sugar alcohol may be selected from the group consisting of isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or mixtures thereof. In some embodiments, the sugar alcohol is selected from the group consisting of maltitol, sorbitol, erythritol, mannitol, lactitol, xylitol, isomalt, and mixtures thereof. In some embodiments, the sugar alcohol is selected from the group consisting of maltitol, isomalt, and mixtures thereof. In some embodiments, the sugar alcohol is or comprises isomalt. In some embodiments, the sugar alcohol is or comprises maltitol. In some embodiments, the sugar alcohol comprises a combination of isomalt and maltitol.

[0180] In some embodiments, the sugar substitute may be a substitute for a sugar alcohol or may be used in combination with one or more sugar alcohols. Suitable sugar substitutes include allulose, soluble tapioca fiber, inulin, and combinations thereof.

[0181] In some embodiments, sugars may be included as a substitute for sugar alcohols or may be used in combination with one or more sugar alcohols. When present, sugars may be included in the form of glucose, fructose, galactose, sucrose, or mixtures thereof. In some embodiments, the oral chew product includes a sugar (e.g., sucrose) in combination with at least one sugar alcohol (e.g., maltitol and / or isomalt). The sugar may be present in any suitable amount, such as from 10% to about 50% by weight of the oral product, for example, from about 20% to about 40% by weight.

[0182] In some embodiments, the bulking agent comprises at least one sugar alcohol selected from maltitol and / or isomalt and sucrose. In some embodiments, at least one bulking agent comprises maltitol and sucrose. In some embodiments, at least one bulking agent comprises isomalt and sucrose.

[0183] In some embodiments, the bulking agent comprises a combination of maltitol and sugar, wherein the maltitol may be present in an amount of about 20% to about 50% by weight of the oral product, and the sugar may be present in an amount of about 10% to about 50% by weight.

[0184] In some embodiments, the bulking agent comprises a combination of isomalt and sugar, where the isomalt may be present in an amount of about 20% to about 50% by weight of the oral product, and the sugar may be present in an amount of about 10% to about 50% by weight.

[0185] In some embodiments, the binder is selected from the group consisting of pectin, agar, carrageenan, starch, and mixtures thereof. In some preferred embodiments, the binder is or includes pectin. In some embodiments, the binder (e.g., pectin) is present in an amount of about 0.1% to about 10% by weight of the oral product. Preferably, the binder (e.g., pectin) is present in an amount of about 1% to about 5% by weight of the oral product.

[0186] The oral product may also include an organic acid to cross-link the pectin, a gelling agent, or both.

[0187] In some embodiments, the oral chew product includes an acidifying agent. The acidifying agent may be an organic acid or an inorganic acid. The organic acid may be any suitable organic acid. Suitable organic acids are as described hereinabove in the section entitled "Additives." For example, the organic acid may be selected from the group consisting of citric acid, malic acid, lactic acid, benzoic acid, tartaric acid, and mixtures or salts thereof. In a preferred embodiment, the organic acid is citric acid and / or a salt thereof. The organic acid may include, for example, a combination of citric acid and a salt of citric acid (e.g., a sodium salt).

[0188] Oral products of the present disclosure in the form of chews may contain varying amounts of water. For example, the moisture content of the chew product may be provided within a specific range to define the final form of the product. The moisture content of the chew products described herein may vary within such ranges according to the desired properties and characteristics, in addition to defining the final form of the product, prior to consumer use of the product. For example, chew-shaped products may have a moisture content ranging from about 0.1% to about 20% by weight of the oral product, e.g., from about 1% to about 10% by weight.

[0189] Oral chew products include: (a) a combination of active ingredients described herein in an amount of about 0.1% to about 10% by weight of the oral product; (b) at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar, wherein the total amount of sugar alcohol and / or sugar is from about 40% to about 99% by weight of the oral product; (c) at least one binder in an amount of about 0.1% to about 10% by weight of the oral product; Optionally, (d) flavoring agents, organic acids and / or sweetening agents may be included.

[0190] Oral chew products include: (a) a combination of active ingredients described herein in an amount of about 0.1% to about 10% by weight of the oral product; (b) at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar, wherein the total amount of sugar alcohol and / or sugar is from about 40% to about 99% by weight of the oral product; (c) at least one binder in an amount of about 0.1% to about 10% by weight of the oral product; (d) an organic acid in an amount of about 0.1% to about 5% by weight of the oral product, and Optionally, (e) flavoring agents and / or sweetening agents may be included.

[0191] Oral chew products include: (a) a combination of active ingredients described herein in an amount of about 0.1% to about 10% by weight of the oral product; (b) at least one sugar alcohol, wherein the total amount of sugar alcohols is about 50% to about 90% by weight of the oral product, and the at least one sugar alcohol is selected from the group consisting of isomalt, maltitol, and mixtures thereof; (c) at least one binder in an amount of about 0.1% to about 10% by weight of the oral product, wherein the at least one binder is or comprises pectin; Optionally, (d) flavoring agents, organic acids and / or sweetening agents may be included.

[0192] Oral chew products include: (a) a combination of active ingredients described herein in an amount of about 0.1% to about 10% by weight of the oral product; (b) at least one sugar alcohol, optionally in combination with a sugar, wherein the total amount of sugar alcohol is about 40% to about 60% by weight of the oral product, and the at least one sugar alcohol is or comprises maltitol; (c) at least one binder in an amount of about 0.1% to about 10% by weight of the oral product, wherein the at least one binder is or comprises pectin; Optionally, (d) flavoring agents, organic acids and / or sweetening agents may be included.

[0193] In some embodiments, the combination of active ingredients in the oral chew product includes (i) caffeine, (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) taurine, and (v) ginseng. The combination of active ingredients in the oral chew product can include (i) caffeine, (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) taurine, (iv) vitamin C, and (v) ginseng.

[0194] The oral chew product may have a weight of about 0.1 g to about 10 g, for example, about 0.5 g to about 5 g. Preferably, the oral chew product has a weight of about 1 g to about 5 g. An exemplary chew product may have a weight of about 4 g.

[0195] An oral chew product (e.g., having a total weight of about 1 g to about 5 g) may contain caffeine in an amount of about 1 mg to about 250 mg, preferably about 10 mg to about 200 mg or about 10 mg to about 100 mg, more preferably about 20 mg to about 50 mg.

[0196] An oral chew product (e.g., having a total weight of about 1 g to about 5 g) may contain taurine in an amount of about 1 mg to about 200 mg, preferably about 5 mg to about 100 mg or about 5 mg to about 50 mg, and more preferably about 10 mg to about 25 mg.

[0197] An oral chew product (e.g., having a total weight of about 1 g to about 5 g) may contain a total amount of B vitamins in an amount of about 0.1 mg to about 100 mg, preferably about 1 mg to about 50 mg, and more preferably about 1 mg to about 25 mg. In some embodiments, the B vitamins in the oral chew product (e.g., having a total weight of about 1 g to about 5 g) consist of a combination of vitamins B2, B3, B6, B9, and B12, and the total amount of B vitamins is about 1 mg to about 25 mg.

[0198] When present, an oral chew product (e.g., having a total weight of about 1 g to about 5 g) may contain ginseng in an amount of about 0.01 mg to about 5 mg, preferably about 0.01 mg to about 2 mg, more preferably about 0.01 mg to about 1 mg. The amount of ginseng in the oral chew product may be about 2 mg or less, e.g., about 1 mg or less, e.g., about 0.1 mg or less. The amount of ginseng in the oral chew product may be about 0.01 mg to about 1 mg.

[0199] When present, an oral chew product (e.g., having a total weight of about 1 g to about 5 g) may contain vitamin C in an amount of about 1 mg to about 300 mg, e.g., about 10 mg to about 200 mg. In some preferred embodiments, an oral chew product (e.g., having a total weight of about 1 g to about 5 g) may contain vitamin C in an amount of about 25 mg to about 100 mg.

[0200] In some embodiments, the oral chew product (e.g., having a total weight of about 1 g to about 5 g) comprises: (i) about 1 mg to about 250 mg of caffeine; (ii) about 0.1 mg to about 100 mg of a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) about 1 mg to about 200 mg of taurine, optionally (iv) about 1 mg to about 300 mg of vitamin C, and / or Optionally, (v) about 0.01 mg to about 5 mg of ginseng.

[0201] In some embodiments, the oral chew product (e.g., having a total weight of about 1 g to about 5 g) comprises: (i) about 10 mg to about 100 mg of caffeine, (ii) about 1 mg to about 25 mg of a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) about 5 mg to about 50 mg of taurine, optionally (iv) about 25 mg to about 100 mg of vitamin C, and / or Optionally, (v) about 0.01 mg to about 5 mg of ginseng.

[0202] In some embodiments, the oral chew product (e.g., having a total weight of about 1 g to about 5 g) comprises: (i) about 10 mg to about 100 mg of caffeine, (ii) about 5 mg to about 25 mg of a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) about 5 mg to about 50 mg of taurine, optionally (iv) about 25 mg to about 100 mg of vitamin C, and / or Optionally, (v) about 0.01 mg to about 5 mg of ginseng.

[0203] In some embodiments, the oral chew product (e.g., having a total weight of about 1 g to about 5 g) comprises: (i) about 10 mg to about 100 mg of caffeine, (ii) about 1 mg to about 25 mg of a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) about 5 mg to about 50 mg of taurine, (iv) about 25 mg to about 100 mg of vitamin C, and (v) about 0.01 mg to about 5 mg of ginseng.

[0204] In some embodiments, the oral chew product (e.g., having a total weight of about 1 g to about 5 g) comprises: (i) about 10 mg to about 100 mg of caffeine, (ii) about 5 mg to about 25 mg of a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) about 5 mg to about 50 mg of taurine, (iv) about 25 mg to about 100 mg of vitamin C, and (v) about 0.01 mg to about 5 mg of ginseng.

[0205] The inventors have found that the amounts of active ingredients described above provide the beneficial effects of increasing energy levels and enhancing brain function while providing a safe product with reduced side effects. The amounts can be adjusted to ensure the product is highly effective while ensuring consumer safety and avoiding any overdose of the active substance.

[0206] In any of the above embodiments, the active ingredient combination in the oral chew product may optionally further comprise magnesium glycinate in an amount of about 0.1% to about 10% by weight of the oral product, e.g., about 0.5% to about 5% by weight, or about 0.5% to about 1% by weight. If present, the amount of magnesium glycinate in the oral chew product may be about 1 mg to about 50 mg, preferably about 10 mg to about 30 mg.

[0207] The oral chew product may contain any additional suitable additives. Suitable additives are described in more detail above, and all of the additives described herein may be included in the oral chew product. In some embodiments, the oral chew product may further contain an additive selected from the group consisting of a flavoring agent, a sweetener, an acidifying agent, a preservative, and mixtures thereof. Examples of these types of additives are described hereinabove.

[0208] In some embodiments, the chew may further comprise a coating, such as a coating oil. The coating may comprise an oil or wax, for example, sunflower oil and / or carnauba wax. Suitable coatings are described in more detail with respect to lozenge products, and this description applies entirely to the chews as well.

[0209] For example, the chew may be coated with an overcoat material. Devices for providing an outer coating layer to compressed pelletized compositions are available from Thomas Engineering as CompuLab 24, CompuLab 36, Accela-Cota 48, and Accela-Cota 60.

[0210] If present, the coating may include a film-forming polymer such as a cellulose-based polymer, an optional plasticizer, and any flavoring, coloring, salt, sweetener, or other additive of the type described herein. The coating composition may be aqueous in nature and may be applied using any pellet or tablet coating technique known in the art, such as pan coating. Exemplary film-forming polymers include cellulose polymers such as methylcellulose, hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethyl cellulose, and carboxymethylcellulose. Exemplary plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate. Additional potential coatings include food-grade shellac, oils such as sunflower oil, waxes such as carnauba wax, and combinations thereof.

[0211] Lozenges In some embodiments, the products disclosed herein may be in the form of a dissolvable, lightly chewable lozenge product for oral use. As used herein, the term "lozenge" refers to a dissolvable oral product made by solidifying a liquid or gel composition, such as a composition containing a gelling agent or binder, so that the final product becomes a solidified solid gel. Alternatively, a lozenge product may be referred to as a soft lozenge. In certain embodiments, the lozenge products of the present disclosure are characterized by sufficient cohesion to withstand light chewing in the oral cavity without rapidly disintegrating. The lozenge products of the present disclosure typically do not exhibit the highly deformable chewing qualities found in conventional chewing gums. For example, smokeless tobacco lozenges, lozenge formulations, lozenge configurations, lozenge characteristics, and lozenge formulation or manufacturing techniques are described in U.S. Patents 9,204,667 and 9,775,376 to Cantrell et al. and U.S. Patent 10,357,054 to Marshall et al., which are incorporated herein by reference. Particular products may exhibit, for example, one or more of the following characteristics: crispy, granular, chewy, syrupy, pasty, fluffy, smooth, and / or creamy. In certain embodiments, the desired texture characteristic may be selected from the group consisting of adhesiveness, cohesiveness, density, dryness, friability, granularity, gumminess, hardness, weight, moisture absorption, moisture release, mouthcoating, roughness, slipperiness, smoothness, viscosity, wettability, and combinations thereof.

[0212] Lozenge products of the present disclosure typically comprise a combination of active ingredients, a binder, and a sugar alcohol and / or sugar (e.g., as a filler component) in an amount of about 0.1% to about 10% by weight of the oral product. Any active ingredient discussed herein is meant to be suitable for use as an active ingredient in lozenge products according to the present disclosure.

[0213] In some embodiments, the active ingredients may be provided in the lozenge in liquid form or in dry powder or particulate form, hi some embodiments, each active ingredient in the active ingredient combination is provided within the lozenge in dry powder form.

[0214] A binder (or a combination of two or more binders) may be used in the product in an amount sufficient to provide the lozenge product with desired physical attributes and physical integrity. In some embodiments, the binder in the lozenge may include pectin or a gum. A representative amount of binder (e.g., pectin or gum) may comprise at least about 5% or at least about 10% of the total weight of the lozenge product. In certain embodiments, the binder (e.g., pectin or gum) will be present in an amount of at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% by weight, based on the total weight of the oral product. In some embodiments, the binder (e.g., pectin or gum) may be present in an amount of about 35% to about 55% by weight of the oral product. Preferably, the total amount of binder (e.g., pectin or gum) in the lozenge product will not exceed about 55% by weight of the oral product. In many cases, the amount of binder (eg, pectin or gum) in a desirable product will not exceed about 65% by weight of the oral product, and often will not exceed about 60% by weight.

[0215] In some embodiments, the binder may include or be pectin. The lozenge product may include pectin as the only binder, or pectin may be included in combination with a gum.

[0216] In certain embodiments, the binder is or includes a gum. The gum may include a natural gum. In particular, a natural gum (e.g., gum arabic, etc.) may be incorporated into the lozenge product as a softener. Advantageously, the use of a natural gum as a softener provides the desired texture qualities necessary for forming the lozenge product, particularly as described herein. In particular, it is noted that increasing the amount of natural gum (e.g., gum arabic) and then decreasing the amount of sugar alcohol and / or sugar can advantageously increase the softness of the resulting lozenge product. As used herein, natural gum refers to a naturally occurring polysaccharide material useful as a softener. Representative natural gums derived from plants, which are typically somewhat water-soluble, include xanthan gum, guar gum, gum arabic, gum ghatti, gum tragacanth, gum karaya, locust bean gum, gellan gum, and combinations thereof. Preferably, gum arabic may be used as an exemplary natural gum that provides the above-mentioned softening properties when incorporated into the lozenge product of the present disclosure.

[0217] As noted above, the lozenge products of the present disclosure may include at least one sugar, or at least one sugar alcohol, or a combination of at least one sugar and at least one sugar alcohol (e.g., in the form of a filler component). Sugar alcohols are particularly advantageous as filler components in the lozenges of the present disclosure because such materials contribute some sweetness without disrupting the desired chewable characteristics of the final product. In some embodiments, the sugar alcohol may be selected from the group consisting of maltitol, sorbitol, erythritol, mannitol, lactitol, xylitol, and isomalt. In some embodiments, isomalt may be incorporated as the only filler component. The sugar alcohol and / or sugar are typically added to the products of the present disclosure in the form of an aqueous solution or suspension, such as a solution or suspension having a solids content of about 50% to about 90% by weight. Combinations of sugar alcohols and / or sugars with additional filler components can also be used. Filler components often serve multiple functions, such as improving certain organoleptic properties, such as texture and mouthfeel, and improving the cohesiveness or compressibility of the product. In some embodiments, the filler comprises a sugar substitute, such as one or more of allulose, soluble tapioca fiber, and inulin. Such sugar substitutes may be substitutes for sugar alcohols or may be used in combination with one or more sugar alcohols.

[0218] melt In some embodiments, the product may be meltable, for example, as described in U.S. Patent Application Publication No. 2012 / 0037175 to Cantrell et al., which is incorporated herein by reference in its entirety.

[0219] As used herein, "melt," "melt," and "meltable" refer to the ability of a product to change from a solid state to a liquid state. That is, melting occurs when a substance (e.g., a product disclosed herein) changes from a solid to a liquid, usually by the application of heat.

[0220] The application of heat for the products disclosed herein is provided by the temperature in the user's mouth. Thus, the term "meltable" refers to a product that can liquefy in the user's mouth as the product changes phase from solid to liquid, and is intended to distinguish between products that simply disintegrate in the oral cavity due to loss of cohesion within the product and products that simply dissolve in the oral cavity as the water-soluble components of the product interact with moisture.

[0221] Generally, meltable products include lipids. In some embodiments, the composition includes lipids. Lipids are fats, oils, or waxy substances typically derived from animal or plant materials (e.g., vegetable-derived fats) and typically comprise mostly triglycerides, with lesser amounts of free fatty acids and mono- or diglycerides. In certain embodiments, lipids are solid or semi-solid at room temperature (i.e., 25°C) and can be at least partially liquefied (i.e., "melted") when exposed to the temperature of a user's mouth. Exemplary vegetable-derived fats are primarily composed of saturated or unsaturated fatty acid chains (the majority of which are bonded in triglyceride structures) having carbon lengths of about 10 to about 26 carbon atoms, or about 14 to about 20 carbon atoms, or about 14 to about 18 carbon atoms.

[0222] In some embodiments, the lipid comprises an oil, particularly a food-grade oil, including fractionated oils. Such oils include vegetable oils (e.g., acai oil, almond oil, amaranth oil, apricot oil, apple seed oil, argan oil, avocado oil, babassu oil, beech nut oil, ben oil, bitter melon oil, black seed oil, blackcurrant seed oil, borage seed oil, Borneo tallow nut oil, bottle gourd oil, Brazil nut oil, buffalo pumpkin oil, butternut squash seed oil, Cape chestnut oil, canola oil, carob cashew oil, and the like). Oil, cocoa butter, cocklebur oil, coconut oil, corn oil, cosne oil, coriander seed oil, cottonseed oil, date palm oil, zika oil, egus seed oil, evening primrose oil, camelina oil, linseed oil, grape seed oil, grapefruit seed oil, hazelnut oil, hemp oil, kapok seed oil, kenaf seed oil, lalemantia oil, lemon oil, linseed oil, macadamia oil, mafra oil, marula oil, meadowfoam seed oil, mongongo nut oil, mustard oil , niger seed oil, nutmeg butter, okra seed oil, olive oil, orange oil, palm oil, papaya seed oil, peanut oil, pecan oil, shiso seed oil, persimmon seed oil, pequi oil, pili nut oil, pine seed oil, pistachio oil, pomegranate seed oil, poppy seed oil, prakashi oil, prune kernel oil, pumpkin seed oil, quinoa oil, ramucil oil, rapeseed oil, rice bran oil, roil oil, saccha inchi oil, safflower oil, sapote oil, seje oil, sesame oil, ciabatta oils (e.g., beef fat, soybean oil, sunflower oil, tarramilla oil, tea seed oil, thistle oil, tiger nut oil, tobacco seed oil, tomato seed oil, walnut oil, watermelon seed oil, wheat germ oil, and combinations thereof), animal oils (e.g., beef fat, buffalo fat, sheep fat, goat fat, swine fat, lard, camel fat, tallow, liquid margarine, fish oil, fish liver oil, whale oil, seal oil, and combinations thereof), and mineral oils.

[0223] In certain embodiments, the plant-derived fats of the present disclosure include palm oil, palm kernel oil (including fractionated palm oil), soybean oil, cottonseed oil, and mixtures thereof. In one embodiment, the lipid is a blend of palm oil and palm kernel oil. The lipid can be, for example, hydrogenated, partially hydrogenated, or non-hydrogenated. Exemplary embodiments of the lipid can be purchased under the trade names CEBES®, CISAO®, or CONF AO®, available from AarhusKarlshamn USA Inc.

[0224] The melting point of the lipid is typically about 29°C or higher, e.g., about 29°C to about 49°C, or about 36°C to about 45°C, or about 38°C to about 41°C. In some embodiments, the use of lipids with melting points below about 36°C is not advantageous due to potential melting during product storage or handling. One test for determining the melting point of a lipid is the Mettler dropping point method (ASTM D3954-15, Standard Test Method for Dropping Point of Waxes, ASTM International, West Conshohocken, PA, 2015, www.astm.org).

[0225] When present, the amount of lipid in the composition can vary. In certain embodiments, the amount of lipid is at least about 10%, at least about 20%, or at least about 30% by weight, based on the dry weight of the composition. In certain embodiments, the amount of lipid is less than about 70%, less than about 60%, or less than about 50% by weight, based on the dry weight. Exemplary lipid weight ranges include about 10% to about 70% by weight, e.g., about 35% to about 50% by weight, based on the dry weight. In some embodiments, the amount of lipid is about 35%, about 40%, about 45%, or about 50% by weight of the total oral product.

[0226] In some embodiments, the oral product comprises a lipid. In one embodiment, the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil, and combinations thereof, wherein the oil may be hydrogenated, partially hydrogenated, or non-hydrogenated. In one embodiment, the lipid is a medium-hardness trans-hydrogenated filling fat such as Confao® 5, available from AarhusKarlshamn USA Inc. (131 Marsh Street, Port Newark, NJ 07114).

[0227] In some embodiments, the dissolvable form of the product comprises lipids in an amount of about 35% to about 50% by weight of the oral product and sugar alcohols in an amount of about 35% to about 55% by weight of the oral product. In some embodiments, the sugar alcohol may include isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof. In some embodiments, the sugar alcohol is or includes isomalt. In some embodiments, a sugar substitute may be a substitute for a sugar alcohol or may be used in combination with one or more sugar alcohols. Suitable sugar substitutes include allulose, soluble tapioca fiber, inulin, and combinations thereof.

[0228] tablet In certain embodiments, the product is in the form of a compressed or molded tablet. Exemplary tablet dosage forms have a weight of about 250 mg to about 1500 mg, e.g., about 250 mg to about 700 mg, or about 700 mg to about 1500 mg. The tablet can have any of a variety of shapes, including traditional pill or tablet shapes.

[0229] Generally, the tablet-form product comprises a glucose-polysaccharide blend and a sugar alcohol. In some embodiments, the glucose-polysaccharide blend is present in an amount of about 35% to about 50% by weight based on the total weight of the product, and the sugar alcohol is present in an amount of about 30% to about 45% by weight based on the total weight of the product. In some embodiments, the sugar alcohol may include isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof. In some embodiments, the sugar alcohol is or comprises isomalt.

[0230] Lozenges In some embodiments, the products disclosed herein can be in the form of a dissolvable lozenge product for oral use. Exemplary lozenge-type products of the present invention have the form of lozenges, tablets, microtabs, or other tablet-type products. For example, see U.S. Patent No. 4,967,773 to Shaw, U.S. Patent No. 5,110,605 to Acharya, U.S. Patent No. 5,733,574 to Dam, U.S. Patent No. 6,280,761 to Santus, U.S. Patent No. 6,676,959 to Andersson et al., U.S. Patent No. 6,248,760 and U.S. Patent No. 7,374,779 to Wilhelmsen, U.S. Patent Application Publication No. 2001 / 0016593 to Wilhelmsen, U.S. Patent Application Publication No. 2004 / 01015 to Liu et al. 43, U.S. Patent Application Publication No. 2006 / 0120974 to Mcneight, U.S. Patent Application Publication No. 2008 / 0020050 to Chau et al., U.S. Patent Application Publication No. 2009 / 0081291 to Gin et al., and U.S. Patent Application Publication No. 2010 / 0004294 to Axelsson et al., which are incorporated herein by reference, for the nicotine-containing lozenges, lozenge formulations, lozenge formats and configurations, lozenge characteristics, and techniques for formulating or manufacturing lozenges.

[0231] Lozenge products are generally described as "hard" and thus distinguished from soft lozenges (i.e., troches). Hard lozenges are a mixture of sugars and / or carbohydrates in an amorphous state. Hard lozenges are made from aqueous syrup; however, the water initially present evaporates as the syrup boils during processing, resulting in a very low moisture content in the final product, e.g., 0.5% to 1.5% by weight. To obtain a hard, non-sticky lozenge, the temperature of the melt must generally reach the hard crack stage, with an exemplary temperature range of 149°C to 154°C.

[0232] In some embodiments, the lozenge-shaped product may exhibit translucency or transparency. The desired transparency or translucency of the product can be quantified by any known method. For example, optical methods such as turbidity measurement (or nephelometry) and colorimetry can be used to quantify the haze (light scattering) and color (light absorption) of the product, respectively. Translucency can also be confirmed by visual inspection by simply holding the product up to a light source and determining whether light passes through the material or product in a diffuse manner.

[0233] The lozenge-shaped products of the present disclosure can incorporate a variety of different additives in addition to the combination of active ingredients and can be prepared according to a variety of different methods generally known in the art for preparing lozenge-shaped products. Exemplary compositions, products, and methods for preparing such products are detailed herein below.

[0234] The lozenge products of the present disclosure typically comprise a composition comprising a combination of an active ingredient in an amount of less than about 2% by weight, a sugar substitute in an amount of at least about 80% by weight, and a sugar alcohol syrup. Any active ingredient discussed herein is suitable for use as an active ingredient in the lozenge products provided herein. In some embodiments, the active ingredient may be provided in liquid form or in dry powder or particulate form. As noted above, the active ingredient may typically be present in an amount of about 0.1% to about 10% by weight, e.g., about 0.1% to about 10% by weight, e.g., about 0.1%, about 0.5%, about 1%, about 1.5%, about 2%, about 2.5%, about 3%, about 3.5%, about 4%, or about 4.5% by weight, up to about 5.5%, about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%, about 9.5%, or about 10% by weight, based on the total weight of the product. In some embodiments, the active ingredient may be present in an amount of less than about 10% by weight, less than about 9% by weight, less than about 8% by weight, less than about 7% by weight, less than about 6% by weight, less than about 5% by weight, less than about 4% by weight, less than about 3% by weight, less than about 2% by weight, or less than about 1% by weight, based on the total weight of the product.

[0235] In some embodiments, the lozenge product comprises a sugar substitute. The sugar substitute is typically provided in a pure solid form (e.g., granular or powdered form). In certain embodiments, the sugar substitute is dry and has a very low moisture content. For example, the sugar substitute may contain less than about 5% water by weight, less than about 3% water by weight, less than about 2% water by weight, or less than about 1% water by weight. In certain embodiments, the sugar substitute is capable of forming a glassy matrix. The formation of a glassy matrix is ​​generally characterized by a translucent / transparent appearance.

[0236] Typically, sugar substitutes are substantially non-hygroscopic. Non-hygroscopic materials typically do not absorb, adsorb, and / or retain significant amounts of moisture from the air. Non-hygroscopic materials can provide the advantage of reducing the tendency of the lozenge product to stick when exposed to humidity. Sugar substitutes can be any sugar-free material (i.e., a material that does not contain sucrose) and can be naturally or synthetically produced. Sugar substitutes used in the products described herein can be nutritive or non-nutritive. For example, sugar substitutes are generally sugar alcohols. Sugar alcohols that may be useful according to the present invention include, but are not limited to, erythritol, threitol, arabitol, xylitol, ribotol, mannitol, sorbitol, dulcitol, iditol, isomalt, maltitol, lactitol, polyglycitol, and mixtures thereof. For example, in certain embodiments, the sugar alcohol is selected from the group consisting of erythritol, sorbitol, and isomalt. The amount of sugar substitute in the lozenge product can vary, but is typically at least about 75%, at least about 80%, at least about 85%, or at least about 90%, or at least about 95% by weight of the product.

[0237] In certain embodiments, the sugar substitute comprises one or more sugar alcohols, for example, in one embodiment, the sugar substitute is isomalt.

[0238] In some embodiments, the sugar substitute is one or more of allulose, soluble tapioca fiber, and inulin. Such sugar substitutes may be substitutes for sugar alcohols or may be used in combination with one or more sugar alcohols.

[0239] In some embodiments, the lozenge products of the present disclosure may contain a syrup, such as a sugar syrup or a sugar alcohol syrup. As used herein, "sugar alcohol syrup" is intended to refer to a concentrated solution of a sugar alcohol, e.g., having a solids content of greater than about 40%, preferably greater than about 50%, greater than about 60%, greater than about 70%, or greater than about 80%. Typically, the solids content of a sugar alcohol syrup comprises primarily the specified sugar alcohol (i.e., maltitol syrup typically contains greater than about 80%, greater than about 85%, or greater than about 90% maltitol by weight on a dry basis). Sugar alcohol syrups are generally prepared by heating an aqueous solution of a sugar alcohol and cooling the mixture to obtain a viscous composition. The resulting syrup is typically characterized by a relatively high concentration of sugar alcohol and a relatively high stability (i.e., the sugar alcohol typically does not crystallize from solution, e.g., at room temperature).

[0240] The syrup, e.g., sugar alcohol syrup, can desirably affect the recrystallization of the melted sugar substitute. One example of a sugar alcohol syrup particularly useful in accordance with the present disclosure is maltitol syrup. Other sugar alcohol syrups can be used, including, but not limited to, corn syrup, golden syrup, molasses, xylitol, mannitol, glycerol, erythritol, threitol, arabitol, ribitol, mannitol, sorbitol, dulcitol, iditol, isomalt, lactitol, and polyglycitol syrup. Such sugar alcohol syrups can be prepared or obtained from commercially available sources. For example, maltitol syrup is commercially available from suppliers such as Corn Products Specialty Ingredients. While sugar alcohol syrups may be preferred, in certain embodiments, sugar syrups can be used in place of or in combination with the sugar alcohol syrup. For example, in some embodiments, corn syrup, golden syrup, and / or molasses can be used.

[0241] The amount of sugar alcohol syrup added to the lozenge composition mixture is typically the amount necessary to slow the recrystallization of the sugar substitute in molten form. It should be noted that it may be possible to vary the amount of sugar alcohol syrup depending on the composition of the remaining ingredients so that recrystallization is sufficiently slowed to provide a material with desired characteristics (e.g., a desired level of translucency / transparency). Thus, the amount of sugar alcohol syrup can vary, but typically ranges from about 0.1% to about 2%, often about 0.5% to about 1.5%, and more often about 1% by weight of the lozenge product mixture. In certain embodiments, the amount of sugar alcohol syrup is greater, e.g., up to about 2%, up to about 5%, up to about 10%, or up to about 20% by weight of the mixture.

[0242] Representative lozenge compositions and lozenge products may incorporate up to about 10% by weight of a combination of active ingredients, about 0.01% to about 2% by weight of an artificial sweetener, about 1% to about 5% by weight of a humectant, about 1% to about 5% by weight of a natural sweetener, at least about 80% by weight of a sugar substitute, about 0.1% to about 10% by weight of a sugar alcohol syrup, one or more flavorings in an amount up to about 5% by weight, and salt in an amount up to about 3% by weight, based on the total weight of the product. The specific proportions and selection of ingredients will vary depending on the desired flavor, texture, and other characteristics.

[0243] Oral products of the present disclosure in the form of lozenges may contain various amounts of water. The water content of the lozenges described herein may vary within such ranges according to the desired properties and characteristics, in addition to defining the final form of the product prior to consumer use. For example, lozenge-shaped products typically have a water content ranging from about 0.1% to about 5% by weight of the product. Preferably, the water content of the lozenge product, when present in a single product unit prior to insertion into a user's mouth, is less than about 5%, less than about 3%, less than about 2%, or less than about 1% by weight of the product. In some embodiments, the water content of the lozenge products described herein may be within the range of about 0.1% to about 5%, about 0.5% to about 3%, or about 1% to about 2% by weight of the product.

[0244] Powder or pouch products In some embodiments, the oral product may be in the form of a powder. The powder may be a free-flowing powder. The powder may be contained in a loose form in a container and thus may be used in a form similar to snuff tobacco, where the user pinches the powder from the container and places it in the oral cavity. Alternatively or additionally, the powder may be incorporated into a moisture-permeable (e.g., saliva-permeable) pouch, similar to snus-type products. The pouch product may be configured to be inserted into the oral cavity of the user, i.e., it may be a pouch oral product.

[0245] In some embodiments, the products of the present disclosure are in the form of pouched oral products. Such pouch products include an oral product described herein disposed within a moisture-permeable container (e.g., a water-permeable pouch or a saliva-permeable pouch). For example, the pouch product may include the oral product in powder form incorporated within a saliva-permeable pouch.

[0246] Such compositions in the form of a moisture-permeable pouch are typically used by placing one pouch containing the composition in the subject's / user's mouth. Generally, the pouch is placed somewhere in the user's oral cavity, e.g., under the lips, in a manner similar to how moist snuff products are commonly used. The pouch is preferably not chewed or swallowed. Then, upon exposure to saliva, some of the components of the composition therein (e.g., active ingredients and / or any flavors) pass through, e.g., the moisture-permeable pouch, providing the user with a flavor and a satisfying sensation, without the user having to expel any portion of the composition. After about 10 to about 60 minutes, typically about 15 to about 45 minutes, of use / enjoyment, a substantial amount of the composition is ingested by the human subject, and the pouch can be removed from the human subject's mouth for disposal.

[0247] In some embodiments, the pouch is saliva-permeable. This means that the pouch is made of a saliva-permeable pouch material. Pouch materials used in oral pouch products are typically dry-laid adhesive nonwovens containing viscose rayon fibers (i.e., regenerated cellulose) and an acrylic polymer, which acts as a binder in the nonwoven material and provides a heat seal for the pouch during its manufacture. The pouch material may also contain synthetic fibers (e.g., polyester) in addition to viscose fibers. The viscose nonwoven material typically used in smokeless tobacco pouches is similar to the fabric used in tea bags. Nonwovens are nonwoven, not woven, fabrics. Methods for manufacturing nonwoven materials are generally known in the art. Further information regarding nonwovens can be found in "Handbook of Nonwovens" by S. Russell, Woodhead Pub I. Ltd., 2007. In some embodiments, the pouch material is a fleece material. In some embodiments, the pouch material is a nonwoven material. In some embodiments, the pouch material is a nonwoven fleece material. In some embodiments, the pouch material comprises viscose, e.g., viscose rayon fibers. In some embodiments, the pouch material comprises regenerated cellulose fibers. In some embodiments, the pouch material comprises polyester fibers, which may comprise the pouch material or may be included in combination with viscose (e.g., regenerated cellulose fibers).

[0248] In some embodiments, the pouch material includes a binder that provides heat sealing of the pouch during manufacturing. In some embodiments, the pouch material includes an acrylic binder. In some embodiments, the pouch material includes an acrylic binder in combination with viscose and / or polyester fibers.

[0249] Suitable packets, pouches, or containers of the type used in the manufacture of smokeless tobacco products are available under the trade names CatchDry, Ettan, General, Granit, Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf, and TreAnkrare. The composition may be contained in a pouch and packaged in a manner that uses ingredients of the type used in the manufacture of conventional snus-type products. The pouch provides a moisture-permeable container of a type that can be considered similar in characteristics to the mesh-type material used in the manufacture of tea bags. The ingredients of the composition easily diffuse through the pouch into the user's mouth. Non-limiting examples of suitable types of pouches are described, for example, in U.S. Pat. No. 5,167,244 to Kjerstad and U.S. Pat. No. 8,931,493 to Sebastian, as well as U.S. Patent Application Publication No. 2016 / 0000140 to Sebastian et al., U.S. Patent Application Publication No. 2016 / 0073689 to Sebastian et al., U.S. Patent Application Publication No. 2016 / 0157515 to Chapman et al., and U.S. Patent Application Publication No. 2016 / 0192703 to Sebastian et al., each of which is incorporated herein by reference. The pouches can be provided as individual pouches, or multiple pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25, or 30 pouches) can be connected or linked together (e.g., in an end-to-end manner) so that single pouches or individual portions can be easily removed for use from the unitary strand or matrix of pouches.

[0250] Exemplary pouches can be manufactured from materials in a manner that allows the pouch to undergo controlled dispersion or dissolution during use by the user. Such pouch materials can have the form of mesh, screen, perforated paper, permeable fabric, etc. For example, pouch materials manufactured from mesh-like or perforated rice paper can dissolve in the user's mouth. As a result, the pouch and composition can each completely disperse in the user's mouth during normal use conditions, and thus both the pouch and the composition can be ingested by the user. Other examples of pouch materials can be manufactured using water-dispersible film-forming materials (e.g., binders such as alginate, carboxymethylcellulose, xanthan gum, pullulan, etc.) in combination with materials such as comminuted cellulose (e.g., fine-particle-sized wood pulp). Preferred pouch materials are water-dispersible or soluble, but can be designed and manufactured so that a significant amount of the composition contents can permeate the pouch material under normal use conditions before the pouch loses its physical integrity. If desired, flavoring ingredients, disintegration aids, and other desired ingredients may be incorporated into or applied to the pouch material.

[0251] The amount of oral product contained in each pouched product unit, e.g., pouch, can vary. In some embodiments, the weight of the composition in each pouch is at least about 50 mg, e.g., about 50 mg to about 1 gram (1,000 mg), e.g., about 100 mg to about 900 mg, e.g., about 200 mg to about 800 mg, e.g., about 500 mg to about 700 mg. In some smaller embodiments, the weight of the composition in each pouch can be about 100 mg to about 300 mg. In larger embodiments, the weight of the composition in each pouch can be about 300 mg to about 700 mg. If desired, other ingredients can be included in each pouch.

[0252] The moisture content of the oral product may vary depending on the format in which the composition is provided. In some embodiments described hereinabove, the oral product may be in the form of moist snuff or snus and / or may be provided in a pouch format. In some embodiments (e.g., in the case of snus-type products), the moisture content of the composition (before the product is inserted into the user's mouth) may be at least about 20% by weight of the oral product, such as at least 30% by weight, such as at least 40% by weight, for example at least 50% by weight. In some embodiments (e.g., in the case of snus-type products, e.g., non-pouched or pouched snus products), the moisture content of the composition (before the product is inserted into the user's mouth) may be about 20% to about 70% by weight of the oral product, such as about 30% to about 60% by weight, for example about 40% to about 55% by weight.

[0253] In some embodiments, the oral product may be a snus- or snuff-type product in a "dry" form. In such embodiments, the moisture content of the oral product may be about 10% or less, e.g., about 5% or less, by weight of the oral product. For example, the moisture content may be about 0.1% to about 10%, e.g., about 1% to about 5%, by weight of the oral product.

[0254] When in the form of a pouch-like oral product, the oral product typically includes a filler. The filler may preferably be a cellulosic material selected from the suitable materials described hereinabove. In some preferred embodiments, the filler is or includes at least MCC. The amount of filler may vary, but typically comprises at least about 5% to about 95% by weight of the oral product, based on the total weight of the oral product. In some embodiments, the filler (e.g., a cellulosic material such as MCC) may be present in the oral product in an amount of about 5% to about 95% by weight of the oral product, e.g., about 10% to about 90% by weight, e.g., about 15% to about 85% by weight, e.g., about 20% to about 80% by weight, e.g., about 25% to about 75% by weight, e.g., about 30% to about 70% by weight, e.g., about 35% to about 65% by weight, e.g., about 40% to about 60% by weight. In some embodiments, the filler (e.g., a cellulosic material such as MCC) may be present in the oral product in an amount of about 45% to about 55% by weight of the oral product.

[0255] package According to some embodiments described herein, a package is provided that contains the oral product described herein. For example, the package can contain oral products in the form of chews, lozenges, etc. The package can be in the form of a blister pack, can, or plastic container that contains such oral dosage forms.

[0256] According to some embodiments described herein, there is provided a package comprising at least one pouch oral product described herein. The pouch products described herein can be packaged within any suitable inner packaging material and / or outer container. Also, see, for example, U.S. Pat. No. 7,014,039 to Henson et al., U.S. Pat. No. 7,537,110 to Kutsch et al., U.S. Pat. No. 7,584,843 to Kutsch et al., U.S. Pat. No. 8,397,945 to Gelardi et al., Design Patent No. D592,956 to Thiellier, Design Patent No. D594,154 to Patel et al., and Design Patent No. D625,178 to Bailey et al., U.S. Pat. Publication No. 2008 / 0173317 to Robinson et al., U.S. Pat. Publication No. 2009 / 0014343 to Clark et al., U.S. Pat. Publication No. 2009 / 0014450 to Bjorkholm, U.S. Pat. See U.S. Patent Publication No. 2009 / 0250360 to Gelardi et al., U.S. Patent Publication No. 2009 / 0266837 to Gelardi, U.S. Patent Publication No. 2009 / 0223989 to Thiellier, U.S. Patent Publication No. 2009 / 0230003 to Gelardi, U.S. Patent Publication No. 2010 / 0084424 to Gelardi, and U.S. Patent Publication Nos. 2010 / 0133140 to Bailey et al., 2010 / 0264157 to Bailey et al., and 2011 / 0168712 to Bailey et al., which are incorporated herein by reference. For example, the package may be a can or plastic container containing a plurality of pouch oral products.

[0257] process The manner in which the various components of the composition (e.g., active ingredient and optional additives) are combined can vary. Thus, for example, the overall product, including powdered composition components, can be relatively uniform (e.g., homogeneous) in nature. The above components, which can be in liquid or dry solid form, can be mixed in a pre-processing step before being mixed with any remaining components of the product, or can simply be mixed with all other liquid or dry ingredients.

[0258] The various components of the product can be contacted, combined, or mixed together using any mixing technique or device known in the art. Any mixing method that results in intimate contact of the product components can be used, such as a mixing device characterized by an impeller or other structure that allows for agitation. Examples of mixing devices include casing drums, conditioning cylinders or drums, liquid spray devices, cone-type blenders, ribbon blenders, mixers available from Littleford Day, Inc. as FKM130, FKM600, FKM1200, FKM2000, and FKM3000, plowshare-type mixer cylinders, Hobart mixers, and the like. See also, for example, the types of methodologies described in U.S. Patent No. 4,148,325 to Solomon et al., U.S. Patent No. 6,510,855 to Korte et al., and U.S. Patent No. 6,834,654 to Williams et al. (each of which is incorporated herein by reference). In some embodiments, the ingredients that form the product are prepared so that their mixture can be used in a starch molding process to form the product. The manner and method for formulating the product will be clear to those skilled in the art. See, for example, the type of methodology described in U.S. Patent No. 4,148,325 to Solomon et al., U.S. Patent No. 6,510,855 to Korte et al., U.S. Patent No. 6,834,654 to Williams et al., U.S. Patent No. 4,725,440 to Ridgway et al., and U.S. Patent No. 6,077,524 to Broder et al. (each of which is incorporated herein by reference).

[0259] Method for preparing chew products In some embodiments, the product is in a chewable form. In such embodiments, the process comprises: (a) contacting at least one binder with at least one sugar, or at least one sugar alcohol, or a combination of at least one sugar and at least one sugar alcohol, and optionally adding water; (b) heating a mixture of binder, sugar alcohol and / or sugar, and optionally water; (c) adding the combination of active ingredients; (d) solidifying the resulting mixture to obtain an oral chew product.

[0260] The combination of active ingredients may be as described herein above. The combination of active substances may also be as described below in relation to "Further Broad Aspects."

[0261] Step (b) of heating the mixture may include heating the mixture to a temperature of about 70° C. to about 150° C., such as about 80° C. to about 125° C., for example, about 90° C. to about 100° C. Step (b) may include heating, optionally while stirring the mixture, until the mixture boils.

[0262] Step (d) preferably includes a cooling step. In some embodiments, the mixture resulting from step (c) is cooled to solidify and obtain an oral chew product. For example, after the active ingredient is added in step (c), the resulting mixture can be poured into a mold and the heat removed. The mixture can be passively cooled to room temperature. Alternatively, the mixture can be placed in a cold water bath, refrigerator, or freezer to reduce the temperature. Preferably, cooling is performed at room temperature to solidify the product.

[0263] The active ingredient combination may be added during the heating step (b). In some embodiments, the active ingredient combination is added while the mixture of binder, sugar alcohol and / or sugar, and optionally water is boiling. Alternatively, the active ingredient combination may be added after the mixture of binder, sugar alcohol and / or sugar, and optionally water is boiling.

[0264] Optional additives may be added at any stage during the process. In some embodiments, an oxidizing agent is added after the mixture is removed from the heat, i.e., during step (c) or (d). In some embodiments, a flavoring agent and / or a coloring agent is added after the mixture is removed from the heat, i.e., during step (c) or (d). In some embodiments, a sweetener is added during step (a). Thus, a sweetener may be included in the mixture heated in step (b).

[0265] To prepare chewable products, a binder (e.g., pectin, agar, carrageenan, starch, or a combination thereof) is generally preblended with all or a portion of the sugar alcohol / sugar, sweetener, or combination thereof. Water is added, and the mixture is heated to a boil with stirring. The remaining sugar alcohol or sweetener is added to the boiling mixture along with the active ingredient, followed by the optional buffer. The mixture is cooked to about 50 to about 80 degrees Brix. The heat is removed, and optional acidifiers and / or flavorings are added along with optional coloring agents, and the mixture is thoroughly combined. The composition is then poured into molds for storage at ambient temperature.

[0266] In some embodiments, the composition is poured into a starch mold. A starch tray having a molded shape is prepared and preheated to 60°C for at least 1-2 hours. The starch can be any starch as disclosed hereinabove. In some embodiments, the starch is corn starch. In some starch-molded embodiments, the pectin binder is pre-blended with a portion of the sugar alcohol (e.g., isomalt or maltitol). Water is added, and the mixture is heated to a boil while stirring. Additional sugar alcohol (e.g., maltitol syrup and / or isomalt) is added to the boiling mixture along with the active ingredient. The mixture is cooked to approximately 78 Brix. The heat is removed, and optional sweeteners (e.g., sucralose or acesulfame K) and flavors are added along with optional colorants and acidifiers (e.g., citric acid solution), and the mixture is thoroughly combined. The hot mixture is poured into a starch mold for storage at ambient temperature. The resulting chew is removed from the starch mold and excess starch is removed.

[0267] In another starch formulation embodiment, gum powder (e.g., pectin, agar, carrageenan, starch, or a combination thereof) is mixed with water until no lumps remain. Sugar alcohols and / or sugars (e.g., isomalt and / or maltitol syrup) and an optional sweetener (e.g., sucralose) are mixed together, and the mixture is heated to 82-104°C. The gum powder solution is added to the sugar alcohol / sugar and mixed thoroughly. Active ingredients, as well as optional colors and flavors, are added to the solution and mixed thoroughly. The mixture is cooked at 93-104°C until the Brix is ​​50-80. An aqueous solution of an acidifying agent (e.g., citric acid and / or trisodium citrate dihydrate) is prepared and added to the hot mixture. Optional gelling agents (e.g., dicalcium phosphate solution) are then added to the mixture, if desired. The hot mixture is poured into the prepared starch molds and kept in a 60°C oven overnight, or until adequate solidification is achieved. The resulting chews are removed from the starch molds and excess starch is removed. In some embodiments, the chews are coated with, for example, a coating oil or CAPOL 410 (available from Centechem, Inc.). The coating process can be carried out in the same manner as described in detail below for lozenge products.

[0268] In another embodiment, the composition is poured into starch-free molds. In another such embodiment, gum powder (e.g., pectin, agar, carrageenan, starch, or a combination thereof) is mixed with water until no lumps remain. Maltitol syrup, sucralose, and optionally isomalt are mixed together, and the mixture is heated to 82-104°C. The gum powder solution is added to the maltitol solution and mixed thoroughly. The active ingredient(s), as well as any color and flavor, are added, and the mixture is mixed thoroughly. The mixture is cooked at 93-104°C until the Brix is ​​50-80. An aqueous solution of citric acid and, optionally, trisodium citrate dihydrate is prepared and added to the hot mixture to reach a pH of 2.5-4. An optional gelling agent (e.g., dicalcium phosphate solution) is then added to the mixture, if desired. The hot mixture is poured into starch-free molds and allowed to stand at room temperature until proper solidification is achieved.

[0269] The chew product may be held in the mold (with or without starch) for a predetermined period of time, such as, for example, from about 10 minutes to about 24 hours, or even 48 hours, to allow the chew product to harden and set.

[0270] According to another aspect of the present disclosure, rather than using a mold to prepare the chew product, an extrusion process may be used in which the final chew product is extruded as described below with respect to the lozenge extrusion method.

[0271] Method for preparing a lozenge product The manner and methods used to formulate and manufacture the lozenge products described herein can vary. For example, the composition forming the lozenge product can be prepared so that the mixture can be used in a starch molding process to form the lozenge product. Exemplary lozenge manufacturing processes are described in U.S. Patent No. 4,725,440 to Ridgway et al. and U.S. Patent No. 6,077,524 to Bolder et al., which are incorporated herein by reference. In some embodiments, the composition forming the lozenge product can be prepared so that the mixture can be used in a starchless molding process (e.g., no starch-based components are included in the molding process) to form the lozenge product.

[0272] In some embodiments, the process involves heating the gum, optionally hydrating the gum ingredients with water, and then stirring the active ingredient combination into the heated gum ingredients. Generally, the gum may be heated to a temperature ranging from about 60°C to about 80°C for a few seconds to a few minutes. In some embodiments, the gum may be heated to a temperature of about 71°C before stirring in the active ingredient combination to dissolve the active ingredients in the gum. In some examples, an aqueous mixture is formed in a separate container by mixing one or more additives (e.g., salt, sweeteners, humectants, emulsifiers, flavoring agents, etc.) with water to form an aqueous mixture.

[0273] The aqueous mixture may then be mixed with the heated gum (including at least one active ingredient added to the gum) to form a mixture in the form of a slurry. In some embodiments, at least one sugar alcohol / sugar component may be added separately to this mixture, or in other embodiments, the at least one sugar alcohol may be combined with the gum and active ingredient(s) before being added to the mixture. In some instances, the at least one sugar alcohol / sugar may be heated in a separate container and added separately to the mixture. For example, in some embodiments, the at least one sugar alcohol / sugar (optionally including isomalt / maltitol / erythritol) may be heated to a temperature in the range of about 160°C to about 190°C before being added to the mixture. In some embodiments, the at least one sugar alcohol / sugar may be heated to a temperature of at least about 160°C, at least about 170°C, at least about 180°C, or at least about 190°C. In some instances, the heated sugar alcohol / sugar may be cooled to a temperature in the range of about 120°C to about 160°C before being added to the mixture. In some embodiments, for example, the heated sugar alcohol / sugar may be cooled to a temperature of about 160°C or less, about 150°C or less, about 140°C or less, or about 130°C or less before being added to the mixture.

[0274] In some examples, the heated (and optionally cooled) sugar alcohol / sugar can be combined with a mixture (e.g., including the heated gum, at least one active ingredient, and an aqueous mixture) and agitated using a high-shear mixer or a Hobart mixing bowl equipped with a whisk attachment to provide a lozenge composition, which can also be in the form of a slurry. The lozenge composition is then heated at an elevated temperature for a period of time, e.g., from about 40°C to about 80°C, typically to about 71°C for about 1 to about 3 minutes, to dissolve any dry ingredients within the lozenge composition. The heating step can be characterized by heating at a temperature of at least about 50°C, at least about 60°C, or at least about 70°C. The lozenge composition can typically have a moisture content of at least about 40% by weight, based on the total weight of the composition.

[0275] According to some embodiments, the lozenge composition in the form of a slurry may optionally be subjected to a degassing step or process before being placed in a mold or subjected to other processing steps to reduce or eliminate air bubbles present in the slurry mixture. Air bubbles entrapped in the slurry can affect the final weight of the lozenge product and potentially lead to a lack of unit-to-unit weight uniformity in the final product. Therefore, any degassing method and system may be used to remove such air bubbles from the slurry material. For example, to remove air bubbles in the slurry mixture, the slurry may be placed under reduced pressure (i.e., below atmospheric pressure). In some examples, a vacuum degassing process may be used, in which the slurry mixture is placed in a vacuum degasser and degassed using reduced pressure. In some examples, the slurry mixture may be placed under vacuum for about 1 minute to about 10 minutes, typically about 3 minutes to about 5 minutes. The degassing step may be monitored and adjusted accordingly to controllably remove gaseous components from the slurry mixture.

[0276] The viscosity of the heated and deaerated slurry mixture can be measured, for example, using a Brookfield viscometer, HA series, SC4 water jacket, 27 / 13R sample chamber, and No. 27 spindle. The lozenge composition can have a viscosity of about 5.7 Pascal seconds (Pa·s) to about 6.2 Pa·s when heated to a temperature of about 38° C., about 4.9 Pa·s to about 5.4 Pa·s when heated to a temperature of about 43° C., and about 4.2 Pa·s to about 4.7 Pa·s when heated to a temperature of about 50° C. Optionally, additional water can be added to the lozenge composition to provide the desired viscosity.

[0277] Once the desired viscosity is achieved, the heated lozenge composition can then be poured into a mold, such as, for example, a starch mold. It is noted that although the process described further herein is directed to forming lozenge products using a starch mold, the process can be used with other types of molds, such as, for example, starch-free molds, pectin molds, plastic tray molds, silicone tray molds, metal tray molds, neoprene tray molds, etc.

[0278] When using a starch mold, the starch mold may be pre-dried to remove moisture from the starch mold itself. That is, the starch mold may be subjected to high temperatures to remove moisture within the starch mold before containing the slurry or viscous lozenge composition. For example, in some instances, the starch mold may initially have a moisture content of about 10-15% by weight. Moisture at such levels may affect the uniformity of the resulting product. In this regard, certain moisture levels in the starch mold may potentially have a wrinkling or shrinking effect on the product, resulting in the final product having a crinkled or otherwise wrinkled appearance. In such cases, the starch mold may be dried at high temperatures to reduce the moisture content of the starch mold to about 4% to about 10% by weight, preferably about 6% to about 8% by weight, based on the total weight of the starch mold. By performing such a step, the product may, in some cases, have a more uniform appearance. Additionally, the starch mold can be heated to an elevated temperature prior to containing the lozenge composition, so that the starch mold itself is at an elevated temperature when it contains the lozenge composition.

[0279] The lozenge composition can remain in the starch mold at an elevated temperature, such as about 40°C to about 80°C (e.g., at least about 40°C or at least about 50°C), typically about 60°C. The lozenge composition may be held at the elevated temperature for a predetermined duration, such as about 12 to 48 hours, typically about 24 hours, to bring the moisture content of the lozenge composition to a desired final moisture level while allowing the lozenge composition to harden and solidify into a lozenge form. As noted above, in some embodiments, the desired final moisture level of the lozenge product can be within a range of about 5% to about 25% by weight, or about 8% to about 20% by weight, or about 10% to about 15% by weight, based on the total weight of the product unit. In this regard, hardening generally refers to the solidification process during which moisture loss occurs, the viscosity of the composition increases, and chemical and physical changes (e.g., crystallization, crosslinking, gelation, film formation, etc.) begin to occur. The lozenge composition is cooled and then removed from the starch mold. In some instances, the lozenge composition may be refrigerated or cooled below ambient temperature. A blower / shaker device may be used to remove starch residue from the lozenge composition after it has been removed from the starch mold.

[0280] The lozenge product is then post-cured for a time and temperature suitable to equilibrate with the desired moisture, shape, and configuration. The time and temperature may vary without departing from this invention and may depend in part on the desired final properties of the product. In one embodiment, post-curing occurs at ambient temperature for at least about 20 hours after removal from the mold.

[0281] The lozenge product may be provided with individual pieces ranging from about 0.5 grams to about 5 grams, although the present disclosure is not limited to such weights.

[0282] The curing time and temperature of the lozenge product can be varied as needed. In this regard, such variables can affect the final visual appearance of the lozenge product. For example, a longer curing time and / or a lower curing temperature can affect the final external configuration or contour of the lozenge product. That is, the rate at which the product dries and / or cures can affect the final properties of the product. In some instances, for example, by lowering the curing temperature and extending the curing time, the lozenge product can have a relatively smooth outer surface. In contrast, curing at a higher temperature for a shorter period of time can result in a roughened or wrinkled appearance of the product.

[0283] According to another aspect of the present disclosure, rather than preparing a lozenge product using a mold, an extrusion process can be used in which the final lozenge product is extruded. In some examples, a lozenge composition in slurry form can be formed into a sheet and dried to a moisture content, e.g., about 15% to about 25% by weight, to form a sticky or other paste-like material in a physically manageable form. The material can then be chopped or otherwise cut into smaller pieces, e.g., using a mixer. The chopped material can then be extruded through an extrusion device into any desired shape / size, including shapes that may be difficult or impossible to achieve with a mold. In some examples, the extruded product can then be dried to achieve the desired moisture content. A similar type of process is described, for example, in U.S. Pat. No. 3,806,617 to Smylie et al., which is incorporated herein by reference in its entirety. Additionally, a lozenge composition can be subjected to a co-extrusion process with another composition.

[0284] For example, shapes such as rods and cubes can be formed by first extruding the material through a die having the desired cross-section (e.g., circular or square), and then optionally cutting the extruded material to the desired length. Techniques and equipment for extruding tobacco materials are described in U.S. Patent No. 3,098,492 to Wursburg, U.S. Patent No. 4,874,000 to Tamol et al., U.S. Patent No. 2,488,018 to Graves et al., U.S. Patent No. 4,989,620 to Keritsis et al., U.S. Patent No. 5,072,744 to Luke et al., U.S. Patent No. 5,829,453 to White et al., and U.S. Patent No. 6,182,670 to White et al., each of which is incorporated herein by reference. Exemplary extrusion equipment suitable for use includes a food or gum extruder, or an industrial pasta extruder, such as the Model TP 200 / 300 available from Emiliomiti, LLC, Italy. In some instances, a single machine may be capable of accomplishing multiple steps of the processes described herein, such as, for example, kneader systems available from Buss AG.

[0285] The lozenge product can be provided in any suitable predetermined shape or form, most preferably in a form having a common shape such as a pill, pellet, tablet, coin, bead, oval, obloid, cube, etc. The texture of the lozenge product preferably has a slightly chewable and dissolvable quality with a gentle elasticity or "springback" upon chewing, which gradually leads to greater malleability during use. According to one embodiment, the lozenge product can preferably last in the user's mouth for about 10-15 minutes until the product is completely dissolved. Preferably, the product does not leave any residue in the user's mouth and does not impart a smooth, waxy, or slimy feeling to the user's mouth to a substantial extent.

[0286] According to some embodiments, the lozenge composition may be coated with a coating material after removal from the starch mold and before drying. For example, a gloss or non-stick coating material, such as CAPOL 410 (available from Centechem, Inc.), may be applied to the lozenge composition to provide flow characteristics. The coating composition may include an oil or wax, such as sunflower oil and / or carnauba wax.

[0287] The outer coating can also help improve the storage stability of the lozenge products of the present disclosure, as well as improve the packaging process by reducing friability and dusting. Devices for applying the outer coating layer to the products of the present disclosure include pan coaters and spray coaters, particularly coating devices available from Thomas Engineering as CompuLab 24, CompuLab 36, Accela-Cota 48, and Accela-Cota 60. Exemplary coatings include a film-forming polymer, such as a cellulose-based polymer, an optional plasticizer, and optional flavors, colors, salts, sweeteners, or other additives of the type described herein. The coating composition is typically aqueous in nature and can be applied using any pellet or tablet coating technique known in the art, such as pan coating. Representative film-forming polymers include cellulose polymers such as methylcellulose, hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethyl cellulose, and carboxymethyl cellulose. Representative plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate.

[0288] In one embodiment, the coating composition comprises up to about 75 wt. % of a film-forming polymer solution (e.g., about 40 to about 70 wt. % based on the total weight of the coating formulation), up to about 5 wt. % of a plasticizer (e.g., about 0.5 to about 2 wt. %), up to about 5 wt. % of a sweetener (e.g., about 0.5 to about 2 wt. %), up to about 10 wt. % of one or more colorants (e.g., about 1 to about 5 wt. %), up to about 5 wt. % of one or more flavorings (e.g., about 0.5 to about 3 wt. %), up to about 2 wt. % of a salt such as NaCl (e.g., about 0.1 to about 15 wt. %), and the balance water. Exemplary coating compositions and application methods are described in U.S. Patent Application Serial No. 12 / 876,785, filed September 7, 2010, by Hunt et al., which is incorporated herein by reference.

[0289] While the preceding discussion focuses on a uniform composition throughout each product unit, products can also be formed with multiple different formulations with different properties within the same product unit. For example, two different compositions can be cast into a single mold to produce a layered product. Furthermore, two different compositions can be co-extruded to form a product with different properties across its cross-section. Such a process can be used to provide a product with 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, slower rate.

[0290] Method for preparing tablet products In some embodiments, the product is in the form of compressed pellets or tablets. In one embodiment, the process for making pellets or tablets involves first mixing a bulk filler (e.g., EMDEX®) with the active ingredient. Then, the remaining composition ingredients (e.g., sugar alcohol and any other desired ingredients, such as binders, colorants, sweeteners, flavors, etc.) are added. Optionally, a colorant can be added to one of the composition ingredients in a separate step before mixing with the remaining components of the composition. Composition mixing can be achieved using any mixing device. The final composition is then compressed into pellet or tablet form using conventional tableting techniques and optionally coated. Compressed composition pellets can be produced by compressing the composition, including any relevant formulation ingredients, into pellet form and optionally coating each pellet with an overcoat material. Exemplary compaction equipment, such as compaction presses, are available from Vector Corporation as Colton 2216 and Colton 2247, and from Fette Compacting as 1200i, 2200i, 3200, 2090, 3090, and 4090. Devices for providing an outer coating layer to compacted pelletized compositions are available from Thomas Engineering as CompuLab 24, CompuLab 36, Accela-Cota 48, and Accela-Cota 60.

[0291] If present, the coating typically comprises a film-forming polymer such as a cellulose-based polymer, an optional plasticizer, and optional flavors, colorants, salts, sweeteners, or other additives of the type described herein. The coating composition is usually aqueous in nature and can be applied using any pellet or tablet coating technique known in the art, such as pan coating. Representative film-forming polymers include cellulose polymers such as methylcellulose, hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethyl cellulose, and carboxymethylcellulose. Representative plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate. Additional potential coatings include food-grade shellac, waxes such as carnauba wax, and combinations thereof.

[0292] Method for preparing a lozenge product The manner and methods used to formulate and manufacture the lozenge products described herein can vary. For example, the compositions can be prepared by any method commonly used to prepare hard confections. Exemplary methods for preparing hard confections can be found, for example, in LFRA Ingredients Handbook, Sweeteners, Janet M. Dalzell, Ed., Leatherhead Food RA (December 1996), pp. 21-44, which is incorporated herein by reference.

[0293] Typically, a first mixture of ingredients is prepared. The composition of the first mixture of ingredients can vary, but it typically includes a sugar substitute and may contain various additional substances (e.g., sugar alcohol syrup, NaCl, preservatives, additional sweeteners, water, and / or flavorings). In certain embodiments, the mixture includes a sugar substitute, salt, and vanillin. In other embodiments, the first mixture includes a sugar substitute and a sugar alcohol syrup. Typically, the first mixture of ingredients does not contain an active ingredient, but in some embodiments, an active ingredient may be incorporated into the first mixture of ingredients.

[0294] A first mixture of ingredients is heated until melted, after which the mixture is heated to or through the hard crack stage. In confectionery, the hard crack stage is defined as the temperature at which a string of the heated mixture (obtained by pulling a cooled syrup sample between thumb and index finger) becomes brittle, or at which the syrup cracks when attempted to be molded. According to the present method, the temperature at which the hard crack stage is achieved may vary depending on the specific composition of the product mixture, but is generally between about 145°C and about 170°C. Typically, the mixture is not heated above about 171°C, the temperature at which caramelization begins to occur. In the process of the present disclosure, the mixture is typically heated to or above the hard crack stage temperature and then cooled. Heating can be performed at atmospheric pressure or under vacuum. Typically, the method of the present invention is performed at atmospheric pressure.

[0295] In one exemplary embodiment, a first mixture of ingredients includes a high percentage of isomalt, and the mixture is heated to about 143° C. Once all ingredients are dissolved, the temperature is increased beyond the hard crack stage (e.g., to about 166° C.). The mixture is heated to this temperature, then removed from the heat and the mixture is allowed to cool.

[0296] In certain embodiments, the active ingredients and optionally additional ingredients (e.g., additional sweeteners, fillers, flavoring agents, and water) are combined separately in a second mixture. The second mixture is typically added to the first mixture of ingredients after the first mixture of ingredients has been removed from the heat. In some embodiments, the addition of the second mixture can occur only after the heated first mixture of ingredients has cooled to a predetermined temperature (e.g., to about 132°C in certain embodiments). In certain embodiments, one or more flavoring agents are added to the second mixture just before adding the mixture to the heated first mixture of ingredients. Certain flavoring agents are volatile and therefore preferably added after the mixture has cooled somewhat. The combined mixture is then formed into a desired shape. In certain embodiments, the mixture is poured directly into a mold, formed (e.g., rolled or pressed) into a desired shape, or extruded. If desired, the mixture can be extruded or injection molded. In certain embodiments, the mixture is formed or extruded into a mold of the desired shape in a closed system, which may require a reduced temperature and may limit evaporation of certain mixture components. For example, such a system may limit evaporation of volatile ingredients, including, but not limited to, flavorings. Other methods of making lozenges are also intended to be encompassed herein.

[0297] Typical conditions associated with the manufacture of food-grade lozenge products as described herein include control of heat and temperature (i.e., the degree of heat to which the various ingredients are exposed during manufacture and the temperature of the manufacturing environment), moisture content (e.g., the degree of moisture present within the individual ingredients and in the final composition), humidity within the manufacturing environment, atmospheric control (e.g., nitrogen atmosphere), airflow experienced by the various raw materials during the manufacturing process, and other similar types of factors. Additionally, the various process steps involved in product manufacture may include the selection of specific solvents and processing aids, the use of heat and radiation, refrigeration and cryogenic conditions, ingredient mixing rates, etc. Manufacturing conditions may also be controlled by the selection of the form (e.g., solid, liquid, or gas) of the various ingredients, the particle size or crystalline nature of ingredients in solid form, the concentration of ingredients in liquid form, etc. The ingredients may be processed into the desired composition by techniques such as extrusion, compression, spraying, etc.

[0298] In certain embodiments, the lozenge product may be transparent or translucent. As used herein, "translucent" or "translucent" refers to a material that allows some level of light to pass through it diffusely. In certain embodiments, the lozenge products of the present disclosure may have a high degree of transparency such that the material may be classified as exhibiting "transparent" or "transparency," which is defined as a material that allows light to pass freely through it without significant diffusion. The transparency of the lozenge product is such that there is some degree of translucency, as opposed to opaque, which refers to a material that light cannot transmit through.

[0299] Transparency / translucency can be determined by any means commonly used in the art, but is generally measured by spectrophotometric light transmission over a range of wavelengths (e.g., approximately 400-700 nm). Alternatively, optical methods such as turbidity (or nephelometry) and colorimetry can be used to quantify the haze (light scattering) and color (light absorption) of a product, respectively. Translucency can also be confirmed by visual inspection by simply holding the product up to a light source and determining whether light passes through the material (e.g., extractables) or product in a diffuse manner.

[0300] Method for preparing molten products In some embodiments, the product is in a meltable form. To prepare a meltable product, lipids are typically heated to a temperature slightly above their melting temperature so that the lipids are liquefied. Optionally, active ingredients, flavorings, and / or lecithin can be added to the liquefied lipids at this stage. All or part of the liquefied lipids can then be blended with the dry blend and mixed until the product reaches a desired level of homogeneity or until the desired texture characteristics are achieved. The mixture is milled (e.g., in a dry roll mill) until the particle size is less than about 20 micrometers. The milled isomalt palm oil is combined with any remaining lipids, and the dry ingredients and flavorings are mixed. The base material is generally heated to a fluid consistency.

[0301] In some embodiments, a sugar alcohol (e.g., isomalt) is added to a mixer bowl, and a portion of the total fat (e.g., melted palm oil) is added along with salt and an emulsifier.

[0302] Additional lipid is added with mixing until a sticky mass forms. The agglomerated mixture is partially transferred to a three-roll mill and processed to a particle size of less than 50 micrometers, or about 20 micrometers. The refined mixture is transferred to a mixer bowl, and the remaining lipid is added with mixing. The mixture is warmed as needed to maintain a fluid consistency.

[0303] The sweetener, flavoring agent, and active ingredient are added while mixing. Mixing is continued until a homogeneous composition is obtained. The mixture is allowed to stand for a period of time, for example, about 10-15 minutes. The composition can be divided into separate portions, for example, by pouring the composition into a sheet-like structure, allowing it to cool, and then cutting the structure into individual portions, or by pouring the composition into a mold and allowing it to cool. The mold can be a starch mold or a starch-free mold. In certain embodiments, the mold is starch-free.

[0304] The molten composition may be held in a mold (with or without starch) for a predetermined period of time, e.g., about 1 to 15 minutes, to allow the molten composition to cool and solidify. Optionally, the mold containing the molten product may be cooled by refrigeration to accelerate solidification.

[0305] According to another aspect of the present disclosure, rather than using a die to prepare the molten product, an extrusion process may be used in which the final molten product is extruded as described above with respect to the lozenge extrusion method.

[0306] Method for preparing pouch oral products If the product is in the form of a pouched oral product, the process may include: (a) combining active ingredients; (b) contacting the combination of the active ingredient with at least one filler to obtain the oral product.

[0307] The combination of active ingredients may be as described herein above. The combination of active substances may also be as described below in relation to "Further Broad Aspects."

[0308] In some embodiments, step (b) comprises mixing the active ingredient combination with at least one filler. In some embodiments, the active ingredient combination is in solid form (e.g., in powder form). The active ingredient combination can be mixed directly with the filler to obtain an oral product. In some embodiments, the active ingredient combination can be dissolved in a hydrophilic solvent (e.g., water and / or alcohol) before contacting with the filler. For example, the active ingredient combination can be dissolved in water or alcohol (e.g., ethanol or propylene glycol) before mixing with the filler. This process, in such embodiments, can include a step of drying the product to remove the solvent. For example, the product can be dried by heating, freeze-drying, spray-drying, or simply leaving the product at room temperature for a specified period of time. Preferably, the drying step comprises leaving the product at room temperature for 1 hour to 48 hours to remove the solvent.

[0309] The process may then further comprise the step of pouching the oral product using a pouch material as described hereinabove.

[0310] use According to some embodiments described herein, there is provided a use of a combination of active ingredients for increasing alertness and / or energy levels in a human or animal, wherein the combination of active ingredients comprises: (i) caffeine; (ii) a combination of B vitamins including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine.

[0311] In some embodiments, the use includes increasing or enhancing the energy level of a subject to which the combination of active ingredients is administered. The use may include increasing alertness in a subject. Additionally or alternatively, the use may include increasing concentration and / or cognition in a subject.

[0312] In some embodiments, the combination of active ingredients is as defined hereinabove. In such embodiments, the combination may further comprise any of the additional active ingredients described hereinabove. For example, the combination of active ingredients may further comprise vitamin C and / or ginseng. The combination of active ingredients may further comprise ginseng, among others.

[0313] Alternatively, the combination of active ingredients may be as described below in any of the "further broad aspects." For example, the combination of active ingredients may include (i) caffeine, (ii) ginseng, and (iii) taurine. Alternatively or additionally, the combination of active ingredients may include (i) caffeine, (ii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) ginseng. Alternatively or additionally, the combination of active ingredients may include (i) caffeine, (ii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) taurine, and (iv) vitamin C.

[0314] Alternatively or additionally, the combination of active ingredients can include (i) caffeine and (ii) taurine, wherein the caffeine and taurine are present in a weight ratio of about 1:1, and the combination of active ingredients further includes one or more of: (iii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; or (iv) ginseng.

[0315] The combination of active ingredients may provide improved effects in increasing mental alertness in consumers compared to previously known products. The inventors have found that the specific combination of active ingredients of the present invention can improve alertness, increase physical and / or mental energy levels, and enhance cognitive effects such as reaction time and reduced fatigue during cognitive tasks.

[0316] Further broad aspects According to some embodiments described herein, (i) Caffeine (ii) ginseng, and (iii) a combination of active ingredients including taurine; at least one binder; and A chewable solid oral product is provided that includes at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar.

[0317] With respect to the first aspect, the amounts of caffeine, taurine, and ginseng (and all other active ingredients and / or additives) described hereinabove are equally applicable to such embodiments including (i) caffeine, (ii) ginseng, and (iii) taurine and will not be repeated here for the sake of brevity. All amounts and combinations described hereinabove apply equally to this embodiment in which the inclusion of a B vitamin combination is not required.

[0318] In some embodiments, the active ingredient combination includes: (i) caffeine in an amount of from about 0.1% to about 5% by weight of the oral product; (ii) ginseng in an amount of from about 0.01% to about 1% by weight of the oral product; and (iii) taurine in an amount of from about 0.01% to about 5% by weight of the oral product.

[0319] In some embodiments, the oral product comprises: A combination of active ingredients comprising: (i) caffeine, (ii) ginseng, and (iii) taurine; wherein the weight ratio of caffeine to taurine is about 5:1 to about 1:1; The weight ratio of caffeine to ginseng is about 50:1 to about 30:1, The weight ratio of taurine to ginseng is about 20:1 to about 10:1.

[0320] Preferably, the weight ratio of caffeine to taurine is about 3:1.

[0321] In some embodiments, the oral product comprises: A combination of active ingredients comprising: (i) caffeine, (ii) ginseng, and (iii) taurine; wherein the weight ratio of caffeine to taurine is about 5:1 to about 1:1; The weight ratio of caffeine to ginseng is about 60:1 to about 30:1, The weight ratio of taurine to ginseng is about 25:1 to about 10:1.

[0322] Preferably, the weight ratio of caffeine to taurine is from about 4:1 to about 1:1.

[0323] In some embodiments, the oral product comprises: Contains a combination of active ingredients including: (i) caffeine; (ii) ginseng; and (iii) taurine; Here, the weight ratio of caffeine to taurine is about 2:1 to about 4:1.

[0324] In some embodiments, the oral product comprises: Contains a combination of active ingredients including: (i) caffeine; (ii) ginseng; and (iii) taurine; Here, the weight ratio of caffeine to taurine is about 3:1.

[0325] In some embodiments, the oral product comprises: (i) about 1 mg to about 250 mg of caffeine; (ii) about 0.01 mg to about 5 mg of ginseng, and (iii) an oral chew product comprising about 1 mg to about 200 mg of taurine.

[0326] In some embodiments, the oral product comprises: (i) about 10 mg to about 100 mg of caffeine, (ii) about 0.01 mg to about 5 mg of ginseng, and (iii) an oral chew product comprising about 5 mg to about 50 mg of taurine.

[0327] In any of the above embodiments, the oral product may further comprise an additional active ingredient as described herein above for the first aspect. In particular, the oral product may further comprise at least one B vitamin and / or vitamin C. The ranges and combinations of these additional active ingredients described herein above apply equally to these embodiments. In some preferred embodiments, the oral product may further comprise at least one B vitamin selected from the group consisting of vitamins B2, B3, B6, B9, B12, and combinations thereof. In some embodiments, the oral product may comprise a combination of at least vitamins B6, B9, and B12. Suitable ranges of amounts for these B vitamins are as described above.

[0328] The processes and uses described herein above may also be equally applicable to the above embodiments in which the combination of active ingredients comprises (i) caffeine, (ii) ginseng, and (iii) taurine.

[0329] According to some embodiments described herein, (i) caffeine, (ii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) a combination of active ingredients, including ginseng; at least one binder, and A chewable solid oral product is provided that includes at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar.

[0330] According to some embodiments described herein, (i) caffeine, (ii) ginseng, and (iii) a combination of active ingredients including taurine; at least one binder, and A chewable solid oral product is provided that includes at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar.

[0331] According to some embodiments described herein, (i) caffeine, (ii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) taurine, (iv) a combination of active ingredients, including vitamin C; at least one binder; and A chewable solid oral product is provided that includes at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar.

[0332] With respect to the first aspect, all active ingredient and / or additive amounts set forth herein above are equally applicable to such embodiments and will not be repeated here for the sake of brevity.

[0333] The processes and uses herein above are equally applicable to the above embodiments.

[0334] Example Aspects of the present invention are more fully described by the following examples, which are set forth to illustrate certain aspects of the invention and are not to be construed as limitations thereof.

[0335] Example 1 - Oral Chew Product Prepared in a Starch Form A chewable product according to an embodiment of the present disclosure is prepared from a composition containing a mixture of fillers, taurine, a combination of caffeine, a combination of vitamins B2, B3, B6, B9, B12, ginseng, and vitamin C (as active ingredients), and additional ingredients disclosed herein (sucralose as a sweetener, flavoring, water, coloring, pectin as a binder, citric acid). The fillers include a combination of isomalt syrup and maltitol syrup.

[0336] The pectin binder is pre-blended with a portion of the isomalt. Water is added and the mixture is heated to a boil while stirring. Maltitol syrup and any remaining isomalt are added to the boiling mixture along with active ingredients (e.g., taurine, ginseng, caffeine, B vitamins, and vitamin C). The mixture is cooked to 78 Brix. The heat is removed, and the sweetener (e.g., sucralose), color, and flavor are added along with citric acid. The mixture is thoroughly combined, and the composition is poured into starch molds for storage at ambient temperature. Each chew weighs 2600 mg.

[0337] Example 2 - Oral Chew Product in a Starch-Free Format A chewable product according to an embodiment of the present disclosure is prepared from a composition containing a mixture of a filler, an active ingredient (see Example 1), and additional ingredients disclosed herein (sucralose as a sweetener, flavoring, water, coloring, pectin as a binder, and citric acid). The filler comprises a combination of isomalt and maltitol syrup.

[0338] The pectin is mixed with water until no lumps remain. The maltitol syrup, isomalt, and sucralose are mixed together and the mixture is heated to 82-104°C. The pectin solution is added to the maltitol / isomalt solution and mixed thoroughly. The active ingredients, colorants, and flavorings are added and the mixture is mixed thoroughly. The mixture is cooked at 93-104°C until the Brix is ​​50-80. An aqueous citric acid solution is prepared and added to the hot mixture to reach a pH of 2.5-4. The hot mixture is poured into starch-free molds and allowed to stand at room temperature until proper solidification is achieved.

[0339] Example 3 - Oral Lozenge Product An oral product in the form of a lozenge adapted for oral use is provided in the following manner.

[0340] An aqueous mixture is prepared by mixing water, salt, a sweetener (sucralose), a humectant (glycerin), and a flavoring agent. The gum (gum arabic) solution is then heated to a temperature of about 71°C, and a combination of active ingredients (e.g., including taurine, caffeine, a combination of vitamins B2, B3, B6, B9, and B12, ginseng, and optionally vitamin C) are stirred into the heated gum ingredients.

[0341] The heated gum (including at least one active ingredient therein) is then added to an aqueous composition to form a mixture. At least one sugar alcohol (including, for example, isomalt, maltitol, and erythritol) is then heated to a temperature of about 175° C. and then cooled to a temperature of about 150° C. The cooled sugar alcohol is then added to the mixture and stirred in a Hobart mixing bowl to form the lozenge composition and allowed to cool.

[0342] The lozenge composition is heated to about 71°C and then poured into a starch mold. The lozenge composition remains in the starch mold at about 60°C for about 24 hours. The lozenge composition is cooled and then removed from the starch mold. The oral product is then allowed to harden at ambient room temperature for about 24 hours to provide a lozenge product configured for oral use.

[0343] Example 4 - Oral Melt Compositions according to embodiments of the present disclosure in a dissolvable form are prepared from compositions containing as active ingredients a bulking agent (e.g., isomalt), a lipid (e.g., palm oil), taurine, a mixture of caffeine, a combination of vitamins B2, B3, B6, B9, and B12, ginseng, and optionally vitamin C, as well as additional ingredients (salt, sweeteners, flavorings) disclosed herein.

[0344] A portion of the palm oil is melted in a mixer and mixed with the isomalt. The mixture is transferred to a dry roll mill and milled until the particle size is less than about 20 micrometers. The milled isomalt-palm oil is combined with the remaining palm oil in a mixer. The base is warmed to a fluid consistency. Sunflower oil, dry ingredients, and flavors are mixed. The isomalt-palm oil component mixture is transferred to a heated pouring funnel. An appropriate weight of sample is poured into a starch-free mold. If necessary, place the mold on a vibrator to ensure uniform filling. The product is cooled and solidified, then removed from the mold. Each melt weighs 1300 mg.

[0345] Example 5 - Chew Dosage Form An oral product in the form of a chew is prepared containing the following ingredients: water Vitamin B2 - 0.88 mg Vitamin B3 (as niacinamide) - 4mg Vitamin B6 - 0.76 mg Vitamin B9 (as folic acid) - 6.66 μg Vitamin B12 - 0.006 mg Caffeine (green tea extract) - 40mg Taurine Vitamin C - 77mg Ginseng root extract Acidifying Agent Sucralose pectin Isomalt Maltitol syrup Flavoring agents

[0346] The total blend of caffeine, taurine and ginseng is present in an amount of 51 mg. The oral product has a mass of 4 g per serving.

[0347] The oral product is prepared as described in Example 2.

[0348] Example 6 - Consumer Test Results A study was conducted to compare the product prepared in Example 5 with a placebo (a chew containing no active substance) and a commercially available chew (OLLY® Daily Energy) that contained 150 mg of vitamin B12, 15 mg of coenzyme Q10, and 100 mg of goji berry per chew.

[0349] Five treatment groups taken by different groups of test subjects i) 3 placebo chews, ii) two chews of Example 5 and a placebo chew (total of three chews); iii) the three chews of Example 5; iv) the four chews of Example 5; or v) A blinded study was conducted with two commercially available energy chews and one placebo chew (3 chews total).

[0350] Subjects were assessed by completing a cognitively demanding task in the immediate post-ingestion period, and the following factors were assessed over a period of up to 90 or 110 minutes post-ingestion: Factors were part of a cognitive demand battery (CDB) or a self-reported psychological assessment.

[0351] The cognitive battery, administered using COMPASS (Computerized Mental Performance Assessment System), included rapid visual information processing (RVIP), serial subtraction by sevens, numerical working memory (NWM), and Corsi blocks. Each of these tasks assesses a different aspect of cognitive function, such as working memory, executive function, and sustained attention.

[0352] Self-reported measures on CompuSense (web-based software for consumer and sensory testing provided by CompuSense Inc) included the Profile of Mood States (POMS), Social Activity Measure (SAM), Visual Analogue Scale (VAS: mental alertness, distractibility, alertness, boredom, physical arousal, relaxation, stimulation and concentration) and the Caturra das Attitudina (CATA), all validated self-report questionnaires used to measure mood and emotions.

[0353] Pre-study screening for anxiety and depression was performed using the Zung scale, a validated self-report questionnaire.

[0354] The study population was assessed and bridged to other study populations using the Quality of Life Scale (QOLS), which, again, is a validated self-report questionnaire used to measure anxiety in adults.

[0355] End-of-study interviews were used for qualitative evaluation.

[0356] The following factors were evaluated: Cognitive accuracy - Consumers were tested using the Rapid Visual Information Processing (RVIP), the most demanding test within the cognitive battery. For RVIP, results showed that the product of Example 5 significantly outperformed placebo and the commercial product at both doses, maintaining cognitive (RVIP) accuracy during the challenging task for up to 90 minutes after ingestion. This is shown in Figure 1, where the corresponding letters indicate significant changes from placebo and the commercial product.

[0357] Mental Arithmetic - Mental arithmetic was assessed by timed and scored serial subtraction (by sevens and by threes). For example, as shown in Figure 2, the oral product of Example 5 generally outperformed placebo and the commercial product, demonstrating higher cognitive performance in serial subtraction (by sevens) over the time course of the demand battery (40-90 minutes after ingestion). This was particularly true between the 60-80 minute time point. Significant changes were demonstrated at two chew doses, with the corresponding letters indicating significant changes from placebo and the commercial product.

[0358] Overall Cognitive Accuracy - The post-ingestion composite scores of RVIP, Numeric Working Memory (NWM), and serial subtraction by 7 and by 3 provide a measure of overall cognitive accuracy. As shown in Figure 3, the oral product of Example 5 improved overall cognitive accuracy over placebo and the commercial product. Two chew doses showed significant changes relative to placebo (indicated by the corresponding letter designation).

[0359] Arousal - Perceived effect was measured using a visual analog scale (VAS) ranging from "least awake" to "most awake." As shown in Figure 4, perceived alertness for the oral product of Example 5 was significantly higher than that of the placebo and commercial product and was maintained over the 50-110 minute period after ingestion (corresponding letters indicate significant changes from placebo and commercial product).

[0360] Physical Energy—Perceived effects were measured using a visual analog scale (VAS) ranging from "most physically energetic" to "most physically energetic." As shown in Figure 5, perceived physical energy for the oral product of Example 5 was significantly higher than that of the placebo and commercial product and was maintained over the 50-110 minute period after ingestion (corresponding letters indicate significant changes from placebo and commercial product). The three chews of Example 5 showed a particular increase in energy.

[0361] Fatigue—Workers underwent a cognitively demanding task designed to induce fatigue. Perceived effect was measured using a visual analog scale (VAS) ranging from "least fatigued" to "most fatigued." As shown in Figure 6, perceived fatigue for the oral product of Example 5 was significantly reduced compared to placebo and the commercial product, and was maintained over a 50-90 minute period after ingestion (corresponding letters indicate significant changes from placebo and the commercial product).

[0362] Irritation—Perceived effect was measured using a visual analog scale (VAS) ranging from "least irritating" to "most irritating." As shown in Figure 7, perceived irritation for the oral product of Example 5 was significantly greater than placebo (as indicated by the corresponding letter designation) and tended to be greater than the commercial product for the three chews of Example 5. Increases relative to placebo were maintained from 30 to 110 minutes.

[0363] Physical tremors—Physical tremors may be perceived as beneficial in preparation for physical activity. Perceived effects were measured using a visual analog scale (VAS) ranging from "minimal physical tremors" to "maximal physical tremors." As shown in Figure 8, perceived physical tremors for the oral product of Example 5 were significantly higher than those for the placebo and commercial product (corresponding letters indicate significant changes from placebo and commercial product) and were maintained over the 30-110 minute period following ingestion. Although perceived physical tremors were elevated, the time course suggests smooth / sustained activation by the chew of Example 5.

[0364] Global Mood Maintenance - Global mood maintenance was assessed using the Profile of Mood States (POMS). The cognitively demanding tasks performed were, by design, difficult, tedious, and tiring, and would be expected to worsen mood over time. This is illustrated by the placebo results in Figure 9. However, the Example 5 chew alleviates / modulates this mood disturbance during the performance of the challenging task. The Example 5 chew was significantly better than the placebo in attenuating negative mood changes (indicated by the corresponding letter designation, i.e., "A"). The Example 5 chew also demonstrated improvement over the commercial product in the 30-75 minute time frame after ingestion.

[0365] The endpoints and methods can be summarized as follows:

[0366] [Table 1]

[0367] Study participants (n = 17, across groups) were aged 18–40 years and considered healthy adults. Inclusion criteria included non-smokers, non-nicotine users, self-reported good physical and mental health (using Zung and QOLS scales), self-reported positive stress-reducing lifestyle habits, and a positive attitude toward health and well-being products. Exclusion criteria included prescription and recreational drug users, CBD users, caffeine intake less than 120 mg or more than 400 mg per day, arrhythmia or other cardiac conditions, pregnancy or breastfeeding, self-reported moderate / severe anxiety and depression (using Zung and QOLS scales), self-reported sleep disorders, self-reported gastrointestinal problems, and dyscalculia. Participants were acclimated to the study one week prior to ingestion and abstained from physical activity and caffeine 10 hours before the test, as well as any food or drink 1 hour before the test.

[0368] The cognitive battery test was administered before any of the products (NWM, Corsi block, RVIP, serial subtraction by 7, serial subtraction by 3). Similarly, the mood battery test (COMPASS POMS and VAS) was administered before any of the products. These tests provided baseline results. Each participant then took the oral products as specified according to their assigned treatment arm, and these products were tested in a double-blind approach. Approximately 30 minutes after ingestion, participants underwent the same cognitive battery test as at baseline. These tests were then repeated several times over a period of up to 90 or 110 minutes after ingestion. A time-consuming documentary was screened during each test period.

[0369] As explained above, the results of the study are shown in Figures 1-9.

[0370] The results showed how each of the two and three chew doses of the present invention improved performance on cognitive tasks, with the two and three chew doses performing similarly. The two and three chew doses of the present invention also had improved performance on emotional measures, generally helping participants feel focused and alert / attentional while reducing negative mood changes during difficult tasks. Qualitative interviews after the study confirmed the quantitative measurements.

[0371] Example 7 - Chew Dosage Form An oral product in the form of a chew is prepared containing the following ingredients: water Vitamin B2 - 0.8 mg Vitamin B3 (as niacinamide) - 4mg Vitamin B6 - 0.6 mg Vitamin B9 (as folic acid) - 0.6mg Vitamin B12 - 0.5 mg Caffeine (green tea extract) - 30mg Taurine - 10mg Vitamin C Acidifying Agent Sucralose pectin Isomalt Maltitol syrup Flavoring agents

[0372] The oral product has a mass of 4g per serving.

[0373] The oral product is prepared as described in Example 2.

[0374] The various embodiments described herein are presented solely to aid in the understanding and teaching of the claimed features. These embodiments are provided only as a representative sample of embodiments and are not intended to be exhaustive and / or exclusive. The advantages, embodiments, examples, functions, features, structures, and / or other aspects described herein should not be construed as limitations on the scope of the invention as defined by the claims or limitations on the equivalents of the claims, and it should be understood that other embodiments may be utilized and modifications may be made without departing from the scope of the claimed invention. Various embodiments of the present invention may suitably comprise, consist of, or consist essentially of any suitable combination of the disclosed elements, components, features, parts, steps, means, etc., other than those specifically described herein. Furthermore, the present disclosure may include other inventions not currently claimed but which may be claimed in the future.

[0375] Terms 1. (i) caffeine, (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine, A combination of active ingredients comprising at least one binder, and A solid oral product comprising at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar. 2. The solid oral product of clause 1, wherein the total amount of B vitamins in the combination is from about 0.1% to about 5% by weight of the oral product. 3. The solid oral product of clauses 1-2, wherein the caffeine is present in an amount of about 0.1% to about 5% by weight of the oral product. 4. The solid oral product of any one of clauses 1-3, wherein the taurine is present in an amount of about 0.01% to about 5% by weight of the oral product. 5. The solid oral product of any one of clauses 1 to 4, wherein the caffeine and taurine are present in a weight ratio of about 5:1 to about 1:1. 6. The solid oral product of any one of clauses 1-5, wherein the caffeine and taurine are present in a weight ratio of about 3:1. 7. The solid oral product of any one of clauses 1 to 6, wherein the total amount of caffeine and B vitamins is present in a weight ratio of about 1:1 to about 10:1. 8. The solid oral product of any one of clauses 1 to 7, wherein the total amount of taurine and B vitamins is present in a weight ratio of about 5:1 to about 1:1. 9. The solid oral product of any one of clauses 1-8, wherein the combination of active ingredients further comprises (iv) vitamin C, optionally wherein the vitamin C is present in an amount of about 0.1% to about 5% by weight of the oral product. 10. The solid oral product of clause 9, wherein the total amount of vitamin C and B vitamins is present in a weight ratio of about 1:1 to about 10:1. 11. The solid oral product of any one of clauses 1-10, wherein the combination of active ingredients further comprises (v) ginseng, optionally present in an amount of about 0.001% to about 0.1% by weight of the oral product. 12. The solid oral product of any one of clauses 1 to 11, wherein the combination of active ingredients further comprises (vi) vitamin D. 13. The solid oral product of any one of clauses 1-12, wherein the oral product comprises the combination of active ingredients in an amount of about 0.5% to about 10% by weight of the oral product. 14. The solid oral product of any one of clauses 1-13, further comprising one or more additives selected from the group consisting of flavoring agents, sweeteners, acidifying agents, fillers, humectants, preservatives, and mixtures thereof. 15. A solid oral product according to clause 14, wherein the oral product comprises an acidifying agent. 16. The solid oral product of any one of clauses 1-15, wherein the oral product further comprises zinc or zinc gluconate, optionally wherein the zinc or zinc gluconate is present in an amount of about 0.001% to about 5% by weight of the oral product. 17. The solid oral product of any one of clauses 1-16, wherein the oral product comprises at least one sugar alcohol. 18. The solid oral product of any one of clauses 1 to 17, wherein at least one sugar alcohol is selected from the group consisting of erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof, and optionally wherein the at least one sugar alcohol is or comprises maltitol. 19. The solid oral product of any one of clauses 1-18, wherein the at least one sugar alcohol is present in an amount of about 40% to about 99% by weight of the oral product. 20. The solid oral product of any one of clauses 1-19, wherein the oral product comprises at least one sugar alcohol comprising a combination of isomalt and maltitol, and optionally the at least one sugar alcohol is present in an amount of about 50% to about 99% by weight of the oral product. 21. A solid oral product according to any one of clauses 1 to 20, wherein the oral product comprises a combination of at least one sugar alcohol and a sugar, and optionally the at least one sugar alcohol is or comprises maltitol. 22. The solid oral product of any one of clauses 1-21, wherein at least one binder is selected from the group consisting of cellulose derivatives, povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof, and optionally wherein at least one binder is or comprises pectin. 23. The solid oral product of any one of clauses 1-22, wherein the at least one binder is present in an amount of about 0.001% to about 5% by weight of the oral product. 24. A solid oral product according to any one of clauses 1 to 23, wherein the oral product is in the form of a dissolvable chew. twenty five. (a) contacting at least one binder with at least one sugar, or at least one sugar alcohol, or a combination of at least one sugar and at least one sugar alcohol, and optionally adding water; (b) heating a mixture of binder, sugar alcohol and / or sugar, and optionally water; (c) adding a combination of active ingredients including: (i) caffeine; (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine; (d) solidifying the resulting mixture to obtain the oral product. 26. (i) Caffeine (ii) ginseng, and (iii) taurine, A combination of active ingredients comprising at least one binder, and A solid oral product comprising at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar. 27. (i) caffeine, (ii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) a combination of active ingredients, including ginseng; at least one binder, and A chewable solid oral product comprising at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar. 28. (i) caffeine, (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine, and (iv) a combination of active ingredients, including vitamin C; at least one binder, and A chewable solid oral product comprising at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar.

Claims

1. (i) caffeine, (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine, A combination of active ingredients, including at least one binder; and A chewable solid oral product comprising at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar.

2. 10. The solid oral product of claim 1, wherein the total amount of B vitamins in the combination is from about 0.1% to about 5% by weight of the oral product.

3. 3. The solid oral product of claim 1 or 2, wherein the caffeine is present in an amount of about 0.1% to about 5% by weight of the oral product.

4. 4. The solid oral product of claim 1, wherein the taurine is present in an amount of about 0.01% to about 5% by weight of the oral product.

5. 5. The solid oral product of claim 1, wherein the caffeine and taurine are present in a weight ratio of about 5:1 to about 1:

1.

6. 6. The solid oral product of any one of claims 1 to 5, wherein the caffeine and taurine are present in a weight ratio of about 3:1 or about 2:

1.

7. 7. The solid oral product of any one of claims 1 to 6, wherein the total amount of caffeine and B vitamins is present in a weight ratio of about 1:1 to about 10:

1.

8. 8. The solid oral product of claim 1, wherein the total amount of taurine and B vitamins is present in a weight ratio of about 5:1 to about 1:1 or about 5:1 to about 1:

2.

9. 9. The solid oral product of any one of claims 1 to 8, wherein the combination of active ingredients further comprises (iv) vitamin C, optionally wherein the vitamin C is present in an amount of about 0.1% to about 5% by weight of the oral product.

10. 10. The solid oral product of claim 9, wherein the total amount of vitamin C and B vitamins is present in a weight ratio of about 1:1 to about 10:1 or about 1:1 to about 15:

1.

11. 11. The solid oral product of any one of claims 1 to 10, wherein the combination of active ingredients further comprises (v) ginseng, optionally present in an amount of about 0.001% to about 0.1% by weight of the oral product.

12. The solid oral product of any one of claims 1 to 11, wherein the combination of active ingredients further comprises (vi) vitamin D.

13. 13. The solid oral product of any one of claims 1 to 12, wherein the oral product comprises a combination of active ingredients in an amount of from about 0.5% to about 10% by weight of the oral product.

14. 14. The solid oral product of any one of claims 1 to 13, further comprising one or more additives selected from the group consisting of flavoring agents, sweeteners, acidifying agents, fillers, humectants, preservatives, and mixtures thereof, preferably wherein said oral product comprises an acidifying agent.

15. 15. The solid oral product of any one of claims 1 to 14, wherein the oral product further comprises zinc or zinc gluconate, optionally the zinc or zinc gluconate is present in an amount of about 0.001% to about 5% by weight of the oral product.

16. The solid oral product of any one of claims 1 to 15, wherein the oral product comprises at least one sugar alcohol.

17. 17. The solid oral product of any one of claims 1 to 16, wherein the at least one sugar alcohol is selected from the group consisting of erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof, and optionally the at least one sugar alcohol is or comprises maltitol.

18. 18. The solid oral product of any one of claims 1 to 17, wherein the at least one sugar alcohol is present in an amount of from about 40% to about 99% by weight of the oral product.

19. 19. The solid oral product of any one of claims 1-18, wherein the oral product comprises at least one sugar alcohol comprising a combination of isomalt and maltitol, and optionally the at least one sugar alcohol is present in an amount of from about 50% to about 99% by weight of the oral product.

20. 20. The solid oral product of any one of claims 1 to 19, wherein the oral product comprises a combination of at least one sugar alcohol and a sugar, and optionally the at least one sugar alcohol is or comprises maltitol.

21. 21. The solid oral product of any one of claims 1 to 20, wherein the at least one binder is selected from the group consisting of cellulose derivatives, povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof, and optionally the at least one binder is or comprises pectin.

22. 22. The solid oral product of any one of claims 1 to 21, wherein the at least one binder is present in an amount of about 0.001% to about 5% by weight of the oral product.

23. A solid oral product according to any one of claims 1 to 22, wherein the oral product is in the form of a dissolvable chew.

24. (a) contacting at least one binder with at least one sugar, or at least one sugar alcohol, or a combination of at least one sugar and at least one sugar alcohol, and optionally adding water; (b) heating a mixture of a binder, a sugar alcohol and / or a sugar, and optionally water; (c) adding a combination of active ingredients including: (i) caffeine; (ii) a combination of B vitamins including at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) taurine; (d) solidifying the resulting mixture to obtain the oral product.

25. (i) caffeine, (ii) ginseng, and (iii) taurine; at least one binder; and at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar; (i) caffeine, (ii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) a combination of active ingredients comprising ginseng; at least one binder; and at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar; (i) caffeine, (ii) at least one B vitamin selected from the group consisting of vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) taurine, and (iv) Vitamin C; at least one binder; and A chewable solid oral product comprising at least one bulking agent selected from the group consisting of a sugar alcohol, or a sugar, or a combination of at least one sugar alcohol and at least one sugar.

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