Oral products

Abstract

The present disclosure relates to oral products, methods of making oral products, and uses of oral products containing a combination of active ingredients including caffeine, a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12, and beta-alanine.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE

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

[0002]

[0002] This 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]

[0003] Products that are easily administered 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 would be 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 liquid shot. Summary of the Invention

[0006]

[0006] The present disclosure generally provides products configured for oral use that include a combination of active ingredients. The oral product may be in any form suitable for oral use, such as a tablet or lozenge form, a loose powder, or a liquid form (e.g., a beverage such as a shot).

[0007]

[0007] According to some embodiments described herein, an oral product is provided that contains a combination of active ingredients including: (i) caffeine; (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; and (iii) β-alanine.

[0008]

[0008] According to some embodiments described herein, there is provided a method for preparing an oral product, comprising: (a) combining an active ingredient comprising (i) caffeine, (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12, and (iii) β-alanine; (b) contacting the active ingredient with water; and (c) mixing the active ingredient with water to prepare the oral product.

[0009]

[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, wherein the combination of active ingredients includes (i) caffeine, (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12, and (iii) β-alanine. In a preferred embodiment, the combination of active ingredients is ingested by the human or animal at least about 10 minutes before physical activity. This allows, for example, to increase alertness and / or energy levels before physical exercise.

[0010]

[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, wherein the combination of active ingredients includes (i) caffeine, (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12, and (iii) β-alanine. In a preferred embodiment, the combination of active ingredients is ingested by a human or animal at least about 10 minutes before physical activity. This allows, for example, to increase mental and / or physical energy before physical exercise.

[0011]

[0011] According to some embodiments described herein, there is provided an oral product comprising a combination of active ingredients including (i) caffeine, (ii) β-alanine, and (iii) ginseng.

[0012]

[0012] According to some embodiments described herein, there is provided an oral product in liquid form comprising a combination of active ingredients including: (i) caffeine; (ii) a combination of B vitamins including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) theacrine. In some embodiments, the β-alanine and caffeine are present in a weight ratio of about 1:1 to about 15:1.

[0013] In a preferred embodiment, each of the oral products of the above embodiments may be provided in the form of a liquid dosage form, such as a shot (ie, a liquid having a volume of up to about 100 mL).

[0014] 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.

[0015] For ease of reference, these and further aspects of the present invention are discussed herein under appropriate section headings, although the teachings under each section are not necessarily limited to each particular section. DETAILED DESCRIPTION OF THE INVENTION

[0016]

[0016] It is to be understood that the present invention is not limited to the particular configurations, process steps, and materials disclosed herein, and that such configurations, process steps, and materials may vary somewhat. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims and their equivalents.

[0017] 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.

[0018]

[0018] As used herein, unless otherwise indicated, 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 numerical quantities 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, through differences in the manufacture, source, or purity of ingredients used to make the oral product or carry out 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 quantities whether or not modified by the term "about."

[0019] Oral products As described herein, oral products are provided that contain a combination of active ingredients including: (i) caffeine; (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; and (iii) β-alanine.

[0020] 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 reference to a product refers to a product that, in normal use, is suitable for being ingested or placed somewhere in the user's oral cavity. For example, the product may be in the form of a liquid (i.e., in the form of a drink) that can be orally ingested by the user, or the product may be placed in the mouth.

[0021] 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.

[0022] Combination of active ingredients The products disclosed herein include active ingredients. The active ingredients may be naturally occurring or synthetically obtained. The combination of active ingredients includes suitable active ingredients that induce a biological response in humans or animals. As used herein, an active ingredient may be a physiologically active material, which is a material intended to achieve or enhance a physiological response.

[0023]

[0023] According to one aspect of the present invention, the combination of active ingredients includes at least (i) caffeine, (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9 and vitamin B12, and (iii) β-alanine.

[0024]

[0024] 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 the user with a short-, medium-, or long-term boost of 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, excitability), or reduce mental fatigue, increasing the consumer's motivation to perform mental tasks) and increase 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 an increase in the user's overall feelings of enjoyment and enthusiasm. The inventors have also found that there is an improvement in cognitive performance for at least 90 minutes after ingestion.

[0025] 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.

[0026]

[0026] 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. When ingested, caffeine is metabolized through 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.

[0027] 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.

[0028] Caffeine can be present in any suitable amount, such as at least about 0.01%, at least about 0.1%, at least about 1%, or at least about 2% by weight of the oral product. In some embodiments, caffeine can be present in an amount of no more than about 35%, no more than about 20%, no more than about 10%, or no more than about 5% by weight of the oral product.

[0029] Caffeine may be present in an amount of about 0.01% to about 35% by weight of the oral product. In some embodiments, caffeine is present in an amount of about 0.1% to about 20% by weight of the oral product. Caffeine is preferably present in an amount of about 0.1% to about 10% by weight of the oral product. Particularly preferred is an amount of caffeine of about 0.1% to about 5% by weight of the oral product. Alternatively, caffeine may be present in an amount of about 1% to about 35% by weight of the oral product.

[0030] In some embodiments (e.g., when the oral product is a liquid dosage form as discussed herein), caffeine is present in an amount of about 0.01% to about 10% by weight of the oral product, e.g., about 0.05% to about 8% by weight of the oral product, e.g., about 0.1% to about 5% by weight of the oral product. In some preferred embodiments, caffeine may be present in an amount of about 0.2% to about 5% by weight of the oral product.

[0031]

[0031] The combination of active ingredients further comprises a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9 and vitamin B12. Preferably, the combination of B vitamins comprises vitamin B2 and vitamin B6, and more preferably, the combination of B vitamins further comprises one or more of vitamin B1 or vitamin B7.

[0032] The term "B vitamins" includes a group of eight water-soluble vitamins that affect cellular function, such as cellular metabolism and red blood cell synthesis. B vitamins act as coenzymes in a significant proportion of enzymatic processes for cellular physiological function. 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).

[0033] B vitamins are thought to play a role in aspects of brain function and energy production. 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.

[0034]

[0034] In a preferred embodiment, the oral product comprises at least two B vitamins that support anabolic metabolism. In other words, according to a first aspect, the combination of at least two B vitamins is selected from vitamins B2, B3, B6, B9, and B12. It has been found that the inclusion of at least these B vitamins can reduce perceived physical and mental fatigue and enhance psychological and cognitive function. In a particularly preferred embodiment, the oral product comprises all five B vitamins that support anabolic metabolism. In other words, according to a first aspect, the active ingredient combination comprises a combination of vitamins B2, B3, B6, B9, and B12. Each of these B vitamins can contribute to reducing fatigue and tiredness, and the inclusion of all five B vitamins can provide a synergistic effect in this regard.

[0035] In some embodiments, the B vitamin combination consists essentially of all anabolic vitamins, i.e., a combination of vitamins B2, B3, B6, B9, and B12. In some embodiments, the B vitamin combination consists essentially of all anabolic vitamins, i.e., a combination of vitamins B2, B3, B6, B9, and B12. The term "anabolic B vitamins" refers to B vitamins that affect anabolic pathways, while the term "catabolic B vitamins" refers to B vitamins that affect catabolic pathways.

[0036] 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.

[0037]

[0037] In any such embodiment, the ratio of the total amount of anabolic B vitamins (i.e., vitamins B2, B3, B6, B9, and B12) to the total amount of catabolic B vitamins (i.e., vitamins B1, B5, and B7) can be from about 5:1 to about 1:5, preferably from about 2:1 to about 1:2, and more preferably from about 2:1 to about 1:1.

[0038] In other embodiments, the B vitamin combination may include at least vitamin B1 and vitamin B2, or at least vitamin B6 and vitamin B7, or at least vitamin B1 and B6, or at least vitamin B2 and vitamin B7, and preferably the B vitamin combination may include at least vitamin B1, vitamin B2, and vitamin B6. In such embodiments, the B vitamin combination may include at least vitamin B1, vitamin B2, vitamin B6, and vitamin B7, and preferably the B vitamin combination may consist essentially of vitamin B1, vitamin B2, vitamin B6, and vitamin B7.

[0039]

[0039] 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.

[0040] 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 anabolic B vitamins (i.e., the total amount of the combination of vitamins B2, B3, B6, B9, and B12) can be at least about 0.0001% by weight of the oral product, preferably at least about 0.001% by weight, and more preferably at least about 0.01% by weight. For example, the total amount of anabolic B vitamins can be from about 0.0001% to about 5% by weight of the oral product, preferably from about 0.001% to about 1% by weight. For example, this amount can be from about 0.01% to about 0.5% by weight of the oral product, or from about 0.05% to about 0.5% by weight of the oral product.

[0041] When present, the total amount of catabolic B vitamins (i.e., the total amount of the combination of vitamins B1, B5, and B7) can be at least about 0.0001% by weight of the oral product, preferably at least about 0.001% by weight, and more preferably at least about 0.01% by weight. For example, the total amount of catabolic B vitamins (e.g., where the catabolic B vitamins are vitamin B1, vitamin B2, vitamin B3, vitamin B5, and / or vitamin B7) can be from about 0.0001% to about 5% by weight of the oral product, preferably from about 0.001% to about 1% by weight. For example, the amount of catabolic B vitamins can be present in an amount of from about 0.01% to about 0.5% by weight of the oral product.

[0042] 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 is about 0.001% to about 10% by weight of the oral product, preferably about 0.001% to about 5% by weight. In some embodiments, the total amount of B vitamins can be about 0.01% to about 4% by weight of the oral product, e.g., about 0.025% to about 3% by weight, preferably about 0.05% to about 2% by weight.

[0043] 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. In other embodiments, vitamin B2 may be present in an amount of about 1% to about 40% 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 10% to about 40% by weight of the total amount of B vitamins in the oral product.

[0044] 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, preferably about 45% to about 60% by weight, of the total amount of B vitamins in the oral product. In other embodiments, the B vitamin combination does not include vitamin B3.

[0045] 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. In other embodiments, vitamin B6 may be present in an amount of about 1% to about 50% 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 50% by weight of the total amount of B vitamins in the oral product.

[0046] In some embodiments, vitamin B9 may be present in an amount of about 0.1% to about 10% 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 5% by weight of the total amount of B vitamins in the oral product.

[0047] In some embodiments, vitamin B12 may be present in an amount of about 0.01% to about 30% by weight, e.g., about 0.1% to about 25% by weight, e.g., about 1% to about 20% by weight, of the total amount of B vitamins in the oral product. For example, vitamin B12 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.

[0048] When present, vitamin B1 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. For example, when present, vitamin B1 may be present in an amount of about 2.5% to about 7.5% by weight of the total amount of B vitamins in the oral product. In some embodiments, the oral product may be substantially free of vitamin B1 (i.e., containing 0.0001% or less by weight) or may contain no vitamin B1 (i.e., containing 0% by weight). In other embodiments, vitamin B1 may be present in an amount of about 1% to about 40% by weight of the total amount of B vitamins in the oral product. For example, vitamin B1 may be present in an amount of about 5% to about 35% by weight of the total amount of B vitamins in the oral product.

[0049] When present, vitamin B5 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, when present, vitamin B5 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. In some embodiments, the oral product may be substantially free of vitamin B5, or may be free of vitamin B5.

[0050] When present, vitamin B7 may be present in an amount of about 0.01% to about 5% by weight of the total amount of B vitamins in the oral product. For example, when present, vitamin B7 may be present in an amount of about 0.01% to about 1% by weight or about 0.01% to about 2% by weight of the total amount of B vitamins in the oral product. In some embodiments, the oral product may be substantially free of vitamin B7, or may be free of vitamin B7.

[0051]

[0051] β-alanine, or 3-aminopropanoic acid, is a naturally occurring β-amino acid. There is evidence that β-alanine supplements can increase energy and cognitive performance and prevent muscle soreness and fatigue. β-alanine is converted into carnosine in muscle cells, which acts as a buffer for lactic acid produced during high-intensity exercise, thereby helping to delay the onset of neuromuscular fatigue.

[0052] The β-alanine can be present in any suitable amount, such as at least about 0.01% by weight, at least about 0.1% by weight of the oral product, or at least about 1% by weight of the oral product. In some embodiments, the β-alanine can be present in an amount of no more than about 60%, no more than about 50%, or no more than about 10% by weight of the oral product.

[0053] β-alanine can be present in an amount of about 0.01% to about 60% by weight of the oral product. In some embodiments, the β-alanine is present in an amount of about 0.1% to about 50% by weight of the oral product. In other embodiments (e.g., when the oral product is in liquid dosage form), the β-alanine is present in an amount of about 1% to about 10% by weight of the oral product.

[0054] In addition to caffeine, a B vitamin combination, and β-alanine, 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.

[0055] Non-limiting examples of additional active ingredients include those that fall into the categories of botanicals (e.g., ginseng, beetroot, bacopa monnieri, or rhodiola rosea), stimulants (e.g., theacrine, matcha), additional amino acids or analogs (e.g., L-tyrosine, L-theanine), and / or functional food 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)). In some embodiments, the additional active ingredient is selected from botanicals, stimulants, additional vitamins, and combinations thereof.

[0056] The additional active ingredient may be selected from, 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, guayusa, maca, matcha, methylliberin, nitrates, or beet root juice, yerba mate, glucose, theacrine, or components, derivatives, or combinations thereof. In some embodiments, the additional active ingredient may be selected from vitamins such as vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, ginseng, beet root juice, theacrine, or components, derivatives, or combinations thereof.

[0057] In some preferred embodiments, the active ingredient combination 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 make 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. The inclusion of vitamin C can reduce fatigue and tiredness and improve energy metabolism.

[0058] 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. In 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.

[0059] When present, vitamin C may be present in an amount of about 0.001% to about 20%, or about 0.01% 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.

[0060] In some embodiments, the combination of active ingredients further includes ginseng. Ginseng is the root of plants in the Panax genus and is characterized by the presence of unique steroidal saponin phytochemicals (ginsenosides) and gintonin. The putative primary 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.

[0061]

[0061] Ginseng may include any suitable form of ginseng, such as Panax ginseng (Korean ginseng), Sanshi ginseng (Chinese ginseng), and American ginseng (American ginseng). Ginseng may also include Ashwagandha (Withania somnifera), commonly known as Indian ginseng. Ginseng may be present in the form of ginseng extract, coarsely chopped ginseng, shredded ginseng, or powdered ginseng. Preferably, ginseng is included in the form of ginseng extract or powdered ginseng extract. 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.

[0062] When present, ginseng may be included in any suitable amount, such as at least about 0.0001% by weight, at least about 0.001% by weight, 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 10% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.001% to about 5% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.01% to about 4% by weight of the oral product. In some preferred embodiments, the active ingredient combination further comprises ginseng in an amount of about 0.001% to about 4% by weight of the oral product, preferably about 0.01% to about 1.5% by weight of the oral product.

[0063] When present, in some embodiments (e.g., when the oral product is a liquid oral dosage form), ginseng may be present in an amount of about 0.01% to about 1.5% by weight of the oral product. In some embodiments (e.g., when the oral product is a liquid oral dosage form), ginseng is present in an amount of about 0.02% to about 1% by weight of the oral product, such as about 0.05% to about 0.75% by weight, preferably about 0.1% to about 0.5% by weight.

[0064]

[0064] In some preferred embodiments, the combination of active ingredients further includes theacrine (1,3,7,9-tetramethyluric acid). Theacrine is a purine alkaloid found in Theobroma grandiflorum (a tropical rainforest tree related to cacao, commonly known as cupuaçu) and the Chinese tea known as kucha. Theacrine exhibits anti-inflammatory and analgesic effects and is thought to affect adenosine signaling in a manner similar to caffeine. Structurally, theacrine is similar to caffeine, possessing an additional methyl group at the 9th position and an additional carbonyl group at the 8th position, resulting in a carbamide moiety. The inclusion of theacrine can reduce fatigue and tiredness and improve energy metabolism.

[0065] When present, theacrine 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. In some embodiments, theacrine 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.

[0066] When present, theacrine may be present in an amount of about 0.001% to about 20%, or about 0.01% to about 10% by weight of the oral product. Theacrine is preferably present in an amount of about 0.1% to about 5% by weight of the oral product. In some embodiments, theacrine is present in an amount of about 0.05% to about 5%, preferably about 0.05% to about 1%, by weight of the oral product.

[0067] In some preferred embodiments, the combination of active ingredients includes caffeine, a combination of B vitamins, beta-alanine, and ginseng.

[0068] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, and theacrine.

[0069] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, ginseng, and theacrine.

[0070]

[0070] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.01% to about 35% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 10% by weight of the oral product, and (iii) beta-alanine in an amount of about 0.01% to about 60% by weight of the oral product.

[0071]

[0071] In some embodiments, the active ingredient combination includes (i) caffeine in an amount of about 0.01% to about 20% by weight of the oral product, (ii) a B vitamin combination in which the total amount of B vitamins is about 0.001% to about 5% by weight of the oral product, and (iii) beta-alanine in an amount of about 0.1% to about 50% by weight of the oral product.

[0072]

[0072] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.01% to about 10% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 5% by weight of the oral product, and (iii) beta-alanine in an amount of about 0.1% to about 10% by weight of the oral product.

[0073]

[0073] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.05% to about 10% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.01% to about 5% by weight of the oral product, and (iii) beta-alanine in an amount of about 1% to about 10% by weight of the oral product.

[0074]

[0074] In some embodiments, the active ingredient combination includes (i) caffeine in an amount of about 0.1% to about 10% 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 4% by weight of the oral product, and (iii) beta-alanine in an amount of about 1% to about 10% by weight of the oral product.

[0075]

[0075] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.1% to about 5% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.01% to about 4% by weight of the oral product, and (iii) beta-alanine in an amount of about 2% to about 8% by weight of the oral product.

[0076] 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 5% by weight of the oral product, or about 0.01% to about 1% by weight of the oral product.

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

[0079]

[0079] In some embodiments, the active ingredient combination includes (i) caffeine in an amount of about 0.01% to about 35% by weight of the oral product, (ii) a B vitamin combination in which the total amount of B vitamins is about 0.001% to about 10% by weight of the oral product, (iii) beta-alanine in an amount of about 0.01% to about 60% by weight of the oral product, and (iv) theacrine in an amount of about 0.001% to about 20% by weight of the oral product.

[0080]

[0080] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.01% to about 20% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 5% by weight of the oral product, (iii) beta-alanine in an amount of about 0.1% to about 50% by weight of the oral product, and (iv) theacrine in an amount of about 0.01% to about 10% by weight of the oral product.

[0081]

[0081] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.01% to about 10% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 5% by weight of the oral product, (iii) beta-alanine in an amount of about 0.1% to about 10% by weight of the oral product, and (iv) theacrine in an amount of about 0.05% to about 10% by weight of the oral product.

[0082]

[0082] In some embodiments, the active ingredient combination includes (i) caffeine in an amount of about 0.05% to about 10% 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 5% by weight of the oral product, (iii) beta-alanine in an amount of about 1% to about 10% by weight of the oral product, and (iv) theacrine in an amount of about 0.1% to about 5% by weight of the oral product.

[0083]

[0083] In some embodiments, the active ingredient combination includes (i) caffeine in an amount of about 0.1% to about 10% 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 4% by weight of the oral product, (iii) beta-alanine in an amount of about 1% to about 10% by weight of the oral product, and (iv) theacrine in an amount of about 0.1% to about 1% by weight of the oral product.

[0084]

[0084] 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 in which the total amount of B vitamins is about 0.01% to about 4% by weight of the oral product, (iii) beta-alanine in an amount of about 2% to about 8% by weight of the oral product, and (iv) theacrine in an amount of about 0.1% to about 1% by weight of the oral product.

[0085]

[0085] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.01% to about 35% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 10% by weight of the oral product, (iii) beta-alanine in an amount of about 0.01% to about 60% by weight of the oral product, and (v) ginseng in an amount of about 0.001% to about 5% by weight of the oral product.

[0086]

[0086] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.1% to about 20% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 5% by weight of the oral product, (iii) beta-alanine in an amount of about 0.1% to about 50% by weight of the oral product, and (v) ginseng in an amount of about 0.01% to about 5% by weight of the oral product.

[0087]

[0087] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.01% to about 10% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 5% by weight of the oral product, (iii) beta-alanine in an amount of about 0.1% to about 10% by weight of the oral product, and (v) ginseng in an amount of about 0.01% to about 2% by weight of the oral product.

[0088]

[0088] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.05% to about 10% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.01% to about 5% by weight of the oral product, (iii) beta-alanine in an amount of about 1% to about 10% 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.

[0089]

[0089] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.1% to about 10% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.01% to about 4% by weight of the oral product, (iii) beta-alanine in an amount of about 1% to about 10% by weight of the oral product, and (v) ginseng in an amount of about 0.1% to about 1% by weight of the oral product.

[0090]

[0090] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.1% to about 5% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.01% to about 4% by weight of the oral product, (iii) beta-alanine in an amount of about 2% to about 8% by weight of the oral product, and (v) ginseng in an amount of about 0.1% to about 1% by weight of the oral product.

[0091]

[0091] In some embodiments, the combination of active ingredients includes (i) caffeine in about 0.01% to about 35% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 10% by weight of the oral product, (iii) beta-alanine in about 0.01% to about 60% by weight of the oral product, (iv) theacrine in about 0.001% to about 20% by weight of the oral product, and (v) ginseng in about 0.001% to about 10% by weight of the oral product.

[0092]

[0092] In some embodiments, the combination of active ingredients includes (i) caffeine in about 0.1% to about 20% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 5% by weight of the oral product, (iii) beta-alanine in about 0.1% to about 50% by weight of the oral product, (iv) theacrine in about 0.01% to about 10% by weight of the oral product, and (v) ginseng in about 0.01% to about 10% by weight of the oral product.

[0093]

[0093] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.01% to about 10% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 5% by weight of the oral product, (iii) beta-alanine in an amount of about 0.1% to about 10% by weight of the oral product, (iv) theacrine in an amount of about 0.05% to about 10% by weight of the oral product, and (v) ginseng in an amount of about 0.01% to about 2% by weight of the oral product.

[0094]

[0094] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.05% to about 10% 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 5% by weight of the oral product, (iii) beta-alanine in an amount of about 1% to about 10% by weight of the oral product, (iv) theacrine in an amount of about 0.1% 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.

[0095]

[0095] In some embodiments, the combination of active ingredients includes (i) caffeine in about 0.1% to about 10% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.01% to about 4% by weight of the oral product, (iii) beta-alanine in about 1% to about 10% by weight of the oral product, (iv) theacrine in about 0.1% to about 1% by weight of the oral product, and (v) ginseng in about 0.1% to about 1% by weight of the oral product.

[0096]

[0096] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.1% to about 5% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.01% to about 4% by weight of the oral product, (iii) beta-alanine in an amount of about 2% to about 8% by weight of the oral product, (iv) theacrine in an amount of about 0.1% to about 1% by weight of the oral product, and (v) ginseng in an amount of about 0.1% to about 1% by weight of the oral product.

[0097]

[0097] In some embodiments, the combination of active ingredients includes (i) caffeine in an amount of about 0.1% to about 10% by weight of the oral product, (ii) a combination of B vitamins, the total amount of B vitamins being about 0.001% to about 5% by weight of the oral product, (iii) beta-alanine in an amount of about 1% to about 10% by weight of the oral product, and (v) ginseng in an amount of about 0.1% to about 1% by weight of the oral product.

[0098] The inventors have found that the amounts of active ingredients described above provide a safe product with reduced side effects while providing the beneficial effects of increasing energy levels and enhancing brain function. The amounts can be adjusted to ensure high efficacy while ensuring consumer safety and avoiding any overdose of the active substance. These amounts have been found to be particularly effective when used before physical activity.

[0099] In addition to the additional active substances described above, other suitable additional active ingredients are described below.

[0100]

[0100] L-theanine is a compound obtained by mixing 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.

[0101] 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 may 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-bearing 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 can include, but are not limited to, any of the compounds and sources described herein (including mixtures thereof). Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemicals," or "functional foods." Certain plant materials or plant-derived materials, such as plant materials or their extracts, have been found to be used in traditional herbal medicine, and will be 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, Chlorphyll, Cinnamon, Citrus Fruit, Clove, Cocoa, Cordyceps Sinensis, Curcumin, Damiana, Dorstenia Arifolia, Dorstenia Odorata, Essential Oils, Eucalyptus, Fennel, Galphimia Glauca, Ginger, Ginkgo, Ginseng (e.g., Panax Ginseng), Griffonia Simplicifolia, Guarana, Cannabis, Hemp, Hops, Jasmine, Black Ginger (Thai Ginseng), Kava, Lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha, nardostatis chinensis, oily extract of viola odorata, 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.

[0102]

[0102] In some embodiments, the combination of active ingredients further includes beet root, for example in the form of beet root extract. Beet root offers a wide range of potential health benefits, including lowered blood pressure, improved digestion, and reduced risk of diabetes. These benefits are associated with the high levels of nitrates, an antioxidant called alpha lipoic acid, and high levels of fiber in beet root. Beet root has also been suggested to improve the amount of oxygen absorbed by muscles during exercise, although research on its effects on athletic performance is limited.

[0103] When present, the active ingredient combination comprises beet root extract in an amount of at least about 0.01% by weight of the oral product, or at least about 0.1% by weight of the oral product. The active ingredient combination may comprise beet root extract in an amount of up to 30% by weight of the oral product, up to 20% by weight of the oral product, or up to 10% by weight of the oral product. In some embodiments, the active ingredient combination comprises beet root extract in an amount of from about 0.01% to about 30% by weight of the oral product, e.g., from about 0.01% to about 20% by weight of the oral product. In preferred embodiments, the active ingredient combination comprises beet root extract in an amount of from about 0.01% to about 10% by weight of the oral product, more preferably from about 0.1% to about 5% by weight of the oral product.

[0104]

[0104] In some preferred embodiments, the combination of active ingredients includes caffeine, a combination of B vitamins, beta-alanine, and beet root extract.

[0105]

[0105] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, ginseng, and beet root extract.

[0106]

[0106] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, theacrine, and beet root extract.

[0107]

[0107] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, ginseng, theacrine, and beet root extract.

[0108] In some embodiments, the active ingredient combination further includes 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.

[0109] 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.

[0110] The active ingredient combination may further include an additional 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, and hydroxyproline. In some embodiments, the active ingredient combination includes L-tyrosine.

[0111] In some embodiments, the active ingredient combination 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 readily 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 divided 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 includes at least cannabidiol (CBD).

[0112]

[0112] 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, for example, from about 0.001% to about 10% by weight, for example, from about 0.01% to about 5% by weight, for example, from about 0.1% to about 2.5% by weight, for example, from 0.5% to about 1% by weight.

[0113] In some embodiments, the active ingredient combination includes magnesium glycinate. When present, the magnesium glycinate 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.

[0114] In some embodiments, the active ingredient combination includes an electrolyte. Electrolytes are media that contain ions and conduct electricity through the movement of these ions. Electrolytes include most soluble salts, acids, and bases dissolved in polar solvents such as water. Upon dissolution, the substance separates into cations and anions, which are uniformly dispersed throughout the solvent. In oral rehydration therapy, electrolyte drinks containing sodium and potassium salts replenish the body's water and electrolyte concentrations after dehydration caused, for example, by exercise, excessive alcohol consumption, sweating, diarrhea, vomiting, intoxication, or starvation.

[0115] In some embodiments, the active ingredient combination includes an electrolyte, optionally comprising a sodium salt and / or a potassium salt. When present, the electrolyte may be included in an amount of from 0.01% to about 30% by weight of the oral product, e.g., from 0.1% to about 30% by weight of the oral product, or from about 0.5% to about 30% by weight of the oral product.

[0116]

[0116] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, and electrolytes.

[0117]

[0117] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, beet root extract, and electrolytes.

[0118]

[0118] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, ginseng, and electrolytes.

[0119]

[0119] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, ginseng, beet root extract, and electrolytes.

[0120]

[0120] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, theacrine, and electrolytes.

[0121]

[0121] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, theacrine, beet root extract, and electrolytes.

[0122]

[0122] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, ginseng, theacrine, and electrolytes.

[0123]

[0123] In some preferred embodiments, the combination of active ingredients includes caffeine, a B vitamin combination, beta-alanine, ginseng, theacrine, electrolytes, and beet root extract.

[0124] For the avoidance of doubt, combinations of the above endpoints are expressly contemplated by this disclosure, as are any of the ranges disclosed herein.

[0125]

[0125] Ratio of active ingredients The ratio of active ingredients in an oral product may be selected to increase the effectiveness of the oral product for the consumer.

[0126] In some embodiments, the β-alanine and caffeine are present in a weight ratio of about 1:25 to about 25:1, such as about 1:20 to about 10:1, preferably about 1:1 to about 15:1.

[0127] In some embodiments, the total amount of caffeine and B vitamins is present in a weight ratio of about 1:1 to about 50:1, such as about 1:1 to about 40:1. In preferred embodiments, the total amount of caffeine and B vitamins is present in a weight ratio of about 1:1 to about 35:1. In other preferred embodiments, the total amount of caffeine and B vitamins is present in a weight ratio of about 1:1 to about 10:1.

[0128] In some embodiments, the total amount of β-alanine and B vitamins is present in a weight ratio of about 10:1 to about 100:1, e.g., about 25:1 to about 75:1. In some preferred embodiments, the total amount of β-alanine and B vitamins is present in a weight ratio of about 25:1 to about 60:1. In other preferred embodiments, the total amount of β-alanine and B vitamins is present in a weight ratio of about 25:1 to about 50:1.

[0129]

[0129] Alternatively, the total amount of β-alanine and B vitamins is present in a weight ratio of about 100:1 to about 500:1.

[0130]

[0130] 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 15:1 to about 1:5, e.g., about 15:1 to about 1:1. Preferably, ginseng may be present in an amount such that the weight ratio of caffeine to ginseng is about 10:1 to about 1:1. When present, ginseng may be present in an amount such that the weight ratio of β-alanine to ginseng is about 1:25 to about 25:1, e.g., about 1:20 to about 10:1, preferably about 1:1 to about 15:1, more preferably about 10:1 to about 15:1.

[0131] When present, theacrine may be included such that the weight ratio of caffeine to theacrine is from about 15:1 to about 1:5. In some preferred embodiments, the weight ratio of caffeine to theacrine is from about 12:1 to about 1:1. The weight ratio of total B vitamins to theacrine may be from about 10:1 to about 1:10. In some preferred embodiments, the weight ratio of total B vitamins to theacrine may be from about 5:1 to about 1:10, more preferably from about 1:1 to about 1:10.

[0132] In some embodiments, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is from about 25:1 to about 1:25, the weight ratio of caffeine to the total amount of B vitamins is from about 1:1 to about 15:1, and the weight ratio of β-alanine to the total amount of B vitamins is from about 10:1 to about 100:1, and the combination of B vitamins is as described in any of the embodiments herein above.

[0133] In another embodiment, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) a B vitamin combination, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is from about 25:1 to about 1:25, the weight ratio of caffeine to the total amount of B vitamins is from about 1:1 to about 50:1, and the weight ratio of β-alanine to the total amount of B vitamins is from about 100:1 to about 500:1, and preferably the B vitamin combination includes at least vitamin B1 and vitamin B6, and more preferably the B vitamin combination includes vitamin B1, vitamin B2, vitamin B6, and vitamin B7.

[0134] In some embodiments, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is from about 20:1 to about 1:10, the weight ratio of caffeine to the total amount of B vitamins is from about 1:1 to about 50:1, and the weight ratio of β-alanine to the total amount of B vitamins is from about 25:1 to about 75:1, and the combination of B vitamins is as described in any of the embodiments herein above.

[0135] In some embodiments, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is from about 15:1 to about 1:1, the weight ratio of caffeine to the total amount of B vitamins is from about 1:1 to about 40:1, and the weight ratio of β-alanine to the total amount of B vitamins is from about 25:1 to about 60:1, and the combination of B vitamins is as described in any of the embodiments herein above.

[0136] In another embodiment, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is from about 15:1 to about 1:1, the weight ratio of caffeine to the total amount of B vitamins is from about 1:1 to about 40:1, and the weight ratio of β-alanine to the total amount of B vitamins is from about 100:1 to about 500:1, and the combination of B vitamins is as described in any of the embodiments herein above.

[0137] In some embodiments, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is from about 15:1 to about 1:1, the weight ratio of caffeine to the total amount of B vitamins is from about 1:1 to about 35:1, and the weight ratio of β-alanine to the total amount of B vitamins is from about 25:1 to about 50:1, and the combination of B vitamins is as described in any of the embodiments herein above.

[0138] In another embodiment, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) a combination of B vitamins, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is from about 15:1 to about 1:1, the weight ratio of caffeine to the total amount of B vitamins is from about 1:1 to about 35:1, and the weight ratio of β-alanine to the total amount of B vitamins is from about 100:1 to about 500:1, and the combination of B vitamins is as described in any of the embodiments herein above.

[0139] In any of the above embodiments, the oral product may further comprise (iv) theacrine, wherein the weight ratio of caffeine to theacrine is from about 15:1 to about 1:5. In some preferred embodiments, the weight ratio of caffeine to theacrine is from about 12:1 to about 1:1.

[0140] In any of the above embodiments, the oral product may further comprise (v) ginseng, wherein the weight ratio of caffeine to ginseng is from about 15:1 to about 1:5. In some preferred embodiments, the weight ratio of caffeine to ginseng is from about 15:1 to about 1:1, more preferably from about 10:1 to about 1:1.

[0141]

[0141] In any of the above embodiments, the oral product may further comprise electrolytes, as defined above. The weight ratio of caffeine to electrolytes may be about 5:1 to about 1:15, preferably about 2:1 to about 1:10. The weight ratio of β-alanine to electrolytes may be about 1:10 to 10:1, preferably about 1:5 to about 5:1. The weight ratio of total B vitamins to electrolytes is about 1:20 to 5:1, preferably about 1:20 to 1:1.

[0142]

[0142] 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.

[0143]

[0143] Filler Depending on the product form, oral products may contain fillers, 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.

[0144] 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 a derivative thereof, 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.

[0145] 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.

[0146] 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.

[0147]

[0147] As used herein, "starch" can 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). Starches 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. Starches 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.

[0148]

[0148] 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.

[0149] Typically, for solid oral products, prior to insertion into the user's mouth, the moisture 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 moisture 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.

[0150] For liquid oral products, the water content may be higher, such as at least about 50% by weight of the oral product, such as at least about 60% by weight, such as at least about 75% by weight. Preferably, the water content of the liquid oral product may be at least about 90% by weight of the oral product. Preferably, the water content of the liquid oral product may be from about 60% to about 99.5% by weight of the oral product, such as from about 75% to about 99% by weight, such as from about 80% to about 98% by weight.

[0151]

[0151] Flavoring agent 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.

[0152] Flavoring agents may be any naturally occurring flavoring material, plant matter, extracts of plant matter, synthetically derived materials, or combinations thereof (e.g., tobacco, cannabis, licorice, hydrangea, eugenol, magnolia leaf, chamomile, fenugreek, clove, maple, matcha green tea, 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 fruits, papaya, rhubarb, grapes, durian, dragon fruit, cucumber, blueberry, mulberry, citrus fruits, Drambuie, bourbon, scotch, whiskey, gin, tequila, rum, spearmint, peppermint, lavender, aloe vera, cardamom, 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, sage, fennel, wasabi, bell pepper, 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 , 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., 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.

[0153]

[0153] 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 material.

[0154] In some embodiments, the flavoring agent includes menthol, spearmint, and / or peppermint. In some embodiments, the flavoring agent includes cucumber, blueberry, citrus, and / or red berry flavor components. In some embodiments, the flavoring agent includes eugenol. In some embodiments, the flavoring agent includes flavor components extracted from tobacco. In some embodiments, the flavoring agent includes flavor components extracted from cannabis.

[0155] 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 these may include agents that produce heating, cooling, tingling, and 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.

[0156] 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, e.g., up to about 1% by weight. 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.

[0157] 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.

[0158] Binders can be organic or inorganic, or combinations 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 can 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.

[0159] 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"), hydroxyethylcellulose, 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 oral product of a cellulose derivative (such as HPC), and in certain embodiments, from about 1% to about 5% by weight of the product of a cellulose derivative (such as HPC).

[0160] 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.

[0161]

[0161] 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.

[0162] In some embodiments, the sweetener comprises one or more sugar alcohols. 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.

[0163] 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 from about 0.001% to about 5% by weight of the oral product, for example, from about 0.01% to about 3% by weight, preferably from about 0.01% to about 1% by weight.

[0164] 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.

[0165]

[0165] 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.

[0166] 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, a carboxylic acid or sulfonic acid functional group having 1 to 20 carbon atoms (C1 to C 20In some embodiments, the organic acid is an alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl carboxylic or sulfonic acid.

[0167] 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, and the like. In some embodiments, the organic acid is an alkyl sulfonic acid. Non-limiting examples of alkyl sulfonic acids include propane sulfonic acid and octanesulfonic acid.

[0168] 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.

[0169] 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.

[0170] 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.

[0171] 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.

[0172] 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, and ethane-1,2-disulfonic acid. , ethanesulfonic acid, formic acid, fumaric acid, galactaric acid, gentisic acid, glucoheptonic acid, gluconic acid, glucuronic acid, glutamic acid, glycerophosphoric acid, glycolic acid, hippuric acid, isobutyric acid, lactobionic acid, lauric acid, malonic acid, mandelic acid, methanesulfonic acid, naphthalene-1,5-disulfonic acid, naphthalene-2-sulfonic acid, oleic acid, palmitic acid, pamoic acid, pyroglutamic acid, sebacic acid, stearic acid, and undecylenic acid.

[0173] Preferably, the organic acid is selected from the group consisting of citric acid, malic acid, lactic acid, benzoic acid, tartaric acid, and mixtures thereof. In some preferred embodiments, the organic acid is or includes citric acid or a salt thereof.

[0174]

[0174] In some preferred embodiments, the organic acid is or includes citric acid anhydride.

[0175] 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.

[0176] 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.

[0177]

[0177] In another embodiment, a mineral acid (eg, hydrochloric acid, sulfuric acid, phosphoric acid, etc.) is added to adjust the product pH to a desired value.

[0178]

[0178] The organic acid (e.g., citric acid) can be added neat (i.e., as a solid) or in a solution, e.g., in water. In some embodiments, the organic acid is added as a 50% solution in water.

[0179]

[0179] 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).

[0180]

[0180] When present, thickening agents (eg, xanthan gum) may be included in an amount of from about 0.001% to about 5%, preferably from about 0.01% to about 1%, by weight of the oral product.

[0181]

[0181] Coloring agent Colorants may 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, may also be used. When beet juice is included as an active ingredient, it may serve the dual function of colorant and active ingredient. The amount of colorant utilized in oral products may vary, but when present, is typically up to about 3% by weight, e.g., about 0.1%, about 0.5%, or about 1% to about 3% by weight, based on the total weight of the oral product.

[0182]

[0182] 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).

[0183]

[0183] An example of a further type of additive includes 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 representative ingredients, combinations of ingredients, relative amounts of ingredients, and modes and methods for using these ingredients. 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.

[0184] In some embodiments, the oral product includes a magnesium salt. A non-limiting example of a suitable magnesium salt is magnesium gluconate. In some embodiments, the oral product includes 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.

[0185] 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.

[0186] 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 so as to be provided 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 herein by reference.

[0187]

[0187] 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.

[0188] 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, e.g., 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% by weight, at least about 0.3% by weight, at least about 0.5% by weight, at least about 0.75% by weight, at least about 1% by weight, at least about 1.5% by weight, at least about 2% by weight, at least about 3% by weight, at least about 4% by weight, 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, e.g., about 40% by weight or less, e.g., about 30% by weight or less, e.g., about 20% by weight or less, e.g., about 10% by weight or less.

[0189] 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 10% by weight, more preferably about 1% to about 10% by weight of the oral product.

[0190]

[0190] Oral products can be in any form suitable for application to the oral cavity of a human or animal. In some embodiments, the oral product is an oral dosage form in the form of a solid, gel, or liquid. In some embodiments, the oral product is a solid oral dosage form.

[0191]

[0191] In some preferred embodiments, the oral product is a liquid oral dosage form.

[0192]

[0192] The oral products described herein can take a variety of forms, including gels, melts, tablets, lozenges, powders, pouches, and liquids (eg, beverages).

[0193] Liquid oral dosage form In some preferred embodiments, the oral product is in the form of a liquid dosage form, which can be referred to as a beverage because it is suitable for oral consumption and can therefore be ingested (i.e., drunk) by the user.

[0194]

[0194] The liquid oral dosage form may be in the form of a shot, i.e., a beverage that can be consumed quickly, for example, in one or several doses. Formulating an oral product in the form of a shot may be advantageous because it provides a convenient and easy-to-use mode of administration that takes up less space during storage (e.g., in the refrigerator or cupboard) and can be easily carried by the user, allowing for consumption on the go. A shot may also provide an efficient delivery vehicle for the active agent, thereby delivering a sufficient level of the active agent to the user to provide good efficacy without the need to consume large amounts of liquid. Furthermore, a shot may be formulated to have a pleasant taste. Drinking a shot may be considered more palatable and easier for the user than, for example, swallowing a tablet.

[0195]

[0195] Liquid oral dosage forms may also be in the form of larger drinks that are taken more slowly over several doses. Liquid oral dosage forms may have a volume of about 1 mL to about 250 mL, for example, about 1 mL to about 200 mL. Liquid oral dosage forms may have a volume of about 100 mL to about 250 mL and may be provided in packages such as liquid cartons, cups, cans, or bottles.

[0196]

[0196] The liquid oral dosage form can have a volume of about 10 mL to about 100 mL, for example, about 25 mL to about 75 mL. In such embodiments, the liquid oral dosage form can be considered a shot. For example, the volume of the liquid can be about 60 mL or about 30 mL.

[0197] When in the form of a liquid oral dosage form, the oral product may further comprise water in an amount of about 50% to about 99.9% by weight of the oral product. In some embodiments, the oral product comprises water in an amount of about 75% to about 99.5% by weight of the oral product, e.g., about 80% to about 99% by weight, e.g., about 90% to about 97.5% by weight. In some embodiments, the oral product comprises water in an amount of about 90% to about 99.5% by weight of the oral product, which may be about 95% to about 99% by weight of the oral product.

[0198]

[0198] When present, water may include tap water, rainwater, mineralized water, or distilled water.

[0199] The liquid oral dosage form may comprise a combination of active ingredients in an amount of about 0.1% to about 10% by weight of the oral product, and water in an amount of about 90% to about 99.9% by weight of the oral product. The liquid oral dosage form may comprise a combination of active ingredients in an amount of about 0.5% to about 10% by weight of the oral product, and water in an amount of about 90% to about 99.5% by weight of the oral product.

[0200] In some embodiments, the combination of active ingredients in the liquid oral dosage form includes (i) caffeine, (ii) a B vitamin combination as defined hereinabove, (iii) beta-alanine, and optionally (iv) theacrine and / or (v) ginseng. The combination of active ingredients in the liquid oral dosage form can include (i) caffeine, (ii) a B vitamin combination as defined hereinabove, (iii) beta-alanine, (iv) theacrine, and (v) ginseng.

[0201]

[0201] In any of the above embodiments, the liquid oral dosage form may optionally further comprise zinc or zinc gluconate in an amount of about 0.1% to about 2% by weight of the oral product.

[0202]

[0202] In any of the above embodiments, the liquid oral dosage form may further comprise an electrolyte, as defined above. The electrolyte may be present in an amount of about 0.1% to about 10% by weight of the oral product. The liquid oral dosage form may further comprise beet root extract. The beet root extract may be present in an amount of about 0.01% to about 5% by weight of the oral product.

[0203]

[0203] A liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) may contain caffeine in an amount of about 50 mg to about 1500 mg, preferably about 100 mg to about 1500 mg. In some embodiments, a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) contains caffeine in an amount of about 100 mg to about 250 mg. In other embodiments, a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) contains caffeine in an amount of about 500 mg to about 1500 mg.

[0204]

[0204] A liquid oral dosage form (e.g., a shot form having a volume of 25 mL to 75 mL) can contain β-alanine in an amount of about 500 mg to about 2500 mg, preferably about 500 mg to about 2000 mg, and more preferably about 500 mg to about 1500 mg. In some embodiments, a liquid oral dosage form (e.g., a shot form having a volume of 25 mL to 75 mL) contains β-alanine in an amount of about 1000 mg to about 1500 mg.

[0205]

[0205] A liquid oral dosage form (e.g., a shot form having a volume of 25 mL to 75 mL) may contain a total amount of B vitamins in an amount of about 1 mg to about 100 mg, preferably about 10 mg to about 75 mg, and more preferably about 25 mg to about 50 mg. In some preferred embodiments, a liquid oral dosage form (e.g., a shot form having a volume of 25 mL to 75 mL) contains a combination of vitamins B1, B2, B3, B5, B6, B7, B9, and B12, and the total amount of B vitamins is about 10 mg to about 50 mg. In other embodiments, a liquid oral dosage form (e.g., a shot form having a volume of 25 mL to 75 mL) may contain a total amount of B vitamins in an amount of about 1 mg to about 100 mg, preferably about 1 mg to about 75 mg, and more preferably about 2 mg to about 50 mg. In some preferred embodiments, the liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) contains a combination of vitamins B1, B2, B6, and B7, with a total amount of B vitamins ranging from about 1 mg to about 100 mg, preferably from about 1 mg to about 75 mg, and more preferably from about 2 mg to about 50 mg.

[0206]

[0206] When present, a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 750 mL) may contain ginseng in an amount of about 10 mg to about 300 mg, preferably about 25 mg to about 200 mg, and more preferably about 50 mg to about 150 mg.

[0207] When present, the liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) may contain theacrine in an amount of about 10 mg to about 500 mg, e.g., about 50 mg to about 500 mg, e.g., about 75 mg to about 300 mg. In some preferred embodiments, the liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) may contain theacrine in an amount of about 75 mg to about 200 mg.

[0208] When present, the liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) may contain vitamin C in an amount of about 10 mg to about 500 mg, e.g., about 50 mg to about 500 mg, e.g., about 200 mg to about 400 mg. In some preferred embodiments, the liquid oral dosage form (e.g., in the form of a shot having a volume of 50 mL to 100 mL) may contain vitamin C in an amount of about 250 mg to about 350 mg.

[0209]

[0209] When present, a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) may contain beet root extract in an amount of about 10 mg to about 500 mg, for example, about 25 mg to about 250 mg, for example, about 50 mg to about 150 mg.

[0210]

[0210] When present, a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) may contain electrolytes in an amount of from about 10 mg to about 1000 mg, e.g., from about 100 mg to about 750 mg, e.g., from about 250 mg to about 700 mg.

[0211] In some embodiments, a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) contains (i) about 50 mg to about 1500 mg of caffeine, (ii) about 1 mg to about 100 mg of a B vitamin combination including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) about 500 mg to about 2500 mg of β-alanine, optionally (iv) about 100 mg to about 500 mg of theacrine, and / or optionally (v) about 10 mg to about 300 mg of ginseng. The oral product may further contain about 10 mg to about 500 mg of beet root extract and / or about 10 mg to about 1000 mg of electrolytes.

[0212] In some embodiments, a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) contains (i) about 100 mg to about 1500 mg of caffeine, (ii) about 10 mg to about 75 mg of a B vitamin combination including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) about 500 mg to about 2000 mg of β-alanine, optionally (iv) about 50 mg to about 500 mg of theacrine, and / or optionally (v) about 25 mg to about 200 mg of ginseng. The oral product may further contain about 25 mg to about 250 mg of beet root extract and / or about 100 mg to about 750 mg of electrolytes.

[0213] In some embodiments, a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) contains (i) about 100 mg to about 250 mg of caffeine, (ii) about 25 mg to about 50 mg of a B vitamin combination including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) about 500 mg to about 1500 mg of β-alanine, optionally (iv) about 75 mg to about 300 mg of theacrine, and (v) about 50 mg to about 150 mg of ginseng. The oral product may further contain about 50 mg to about 150 mg of beet root extract and / or about 250 mg to about 750 mg of electrolytes.

[0214] In some alternative embodiments, the liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) contains (i) about 500 mg to about 1500 mg of caffeine, (ii) about 25 mg to about 50 mg of a B vitamin combination including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) about 500 mg to about 1500 mg of β-alanine, optionally (iv) about 75 mg to about 300 mg of theacrine, and (v) about 50 mg to about 150 mg of ginseng. The oral product may further contain about 50 mg to about 150 mg of beet root extract and / or about 250 mg to about 750 mg of electrolytes.

[0215]

[0215] The inventors have found that the amounts of active ingredients described above provide a safe product with reduced side effects while providing the beneficial effects of increasing energy levels and enhancing brain function, particularly when taken before physical activity, e.g., at least about 10 minutes before physical activity. The amounts can be adjusted to ensure the product is highly effective while ensuring consumer safety and avoiding any overdose of the active substance.

[0216]

[0216] In any of the above embodiments, the liquid oral dosage form may optionally further comprise zinc, eg, zinc gluconate, in an amount of from about 10 mg to about 150 mg.

[0217]

[0217] The liquid oral dosage form 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 liquid oral dosage form. In some embodiments, the liquid oral dosage form may further contain an additive selected from the group consisting of a flavoring agent, a sweetener, an acidifying agent, a thickener, a humectant, a preservative, and mixtures thereof. Examples of each of these types of additives are described herein above.

[0218] Solid Oral Dosage Forms In some embodiments, the oral product is in a solid form. As used herein, the term "solid" means that the product can substantially maintain its physical shape when not supported by external means, such as packaging. Thus, a product is considered to be solid, solid-like, in solid form, or in 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 loose wet snuff, loose dry snuff, pelletized pieces, extruded or molded strips, pieces, rods or sticks, finely ground powders, finely ground or pulverized agglomerates of powdered pieces and ingredients, flake-like pieces, molded pieces, films, films or strips that are readily soluble or dispersible in water, capsule-like materials, tablets, lozenge forms, etc. In some embodiments, the oral product is a tablet or lozenge. In some embodiments, the oral product is in the form of wet snuff or snus, which may or may not contain tobacco.

[0219] 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 circles, squares, ovals, rectangles, and the like. Such shapes can be formed in a variety of ways using equipment such as moving belts, nips, extruders, granulating devices, compression devices, and the like.

[0220]

[0220] In some embodiments, the solid oral product is in a form selected from the group consisting of a melt, a tablet, or a lozenge.

[0221]

[0221] 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.

[0222]

[0222] As used herein, "melt," "melt," and "meltable" refer to the ability of a product to change from a solid 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.

[0223]

[0223] 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 be liquefied 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 mouth due to loss of cohesion within the product and products that simply dissolve in the mouth as the water-soluble components of the product interact with moisture.

[0224]

[0224] 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 include mostly triglycerides, along with lesser amounts of free fatty acids and mono- or diglycerides. In certain embodiments, the lipids are solid or semi-solid at room temperature (i.e., 25°C) and can be at least partially liquefied (i.e., "melted") upon exposure to the temperature of the 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.

[0225] 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 others). 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.

[0226]

[0226] 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 lipids can be purchased under the trade names CEBES®, CISAO®, or CONF AO®, available from AarhusKarlshamn USA Inc.

[0227] 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).

[0228]

[0228] 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.

[0229] 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, where 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).

[0230]

[0230] In some preferred embodiments, the dissolvable form of the product comprises lipid in an amount of about 35% to about 50% by weight of the oral product and a sugar alcohol 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.

[0231]

[0231] Tablets 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. Tablets can have any of a variety of shapes, including traditional pill or tablet shapes.

[0232]

[0232] Generally, the tablet form of the 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.

[0233]

[0233] When in tablet form, the product may be dissolvable. As used herein, the terms "dissolve," "dissolution," and "dissolvability" 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, immediate-release products typically dissolve and / or release the 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 (e.g., chewing), enzymatic or other chemical degradation, or disruption of interactions between the product's components. In other embodiments, the product does not dissolve while the product is in the user's mouth.

[0234]

[0234] Lozenge 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.

[0235]

[0235] 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.

[0236]

[0236] 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 colorimetric measurement 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.

[0237]

[0237] 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.

[0238]

[0238] The lozenge products of the present disclosure typically comprise a composition comprising a combination of active ingredients 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.

[0239] 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.

[0240] 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.

[0241]

[0241] In certain embodiments, the sugar substitute comprises one or more sugar alcohols. For example, in one embodiment, the sugar substitute is isomalt.

[0242]

[0242] 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.

[0243] In some embodiments, the lozenge products of the present disclosure may include 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).

[0244]

[0244] Syrups, such as sugar alcohol syrups, 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 commercial 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.

[0245] The amount of sugar alcohol syrup added to the lozenge composition mixture is typically the amount necessary to retard 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 retarded 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.

[0246]

[0246] 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.

[0247] Oral products of the present disclosure in the form of lozenges may contain varying 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.

[0248]

[0248] Powder or pouch product 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.

[0249] 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.

[0250]

[0250] Such compositions in the form of a moisture-permeable pouch are typically used by placing one pouch containing the composition in the subject / 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 ingredient(s) and / or any flavors) pass through, e.g., the moisture-permeable pouch, providing flavor and a satisfying sensation to the user, without the user having to expectorate 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.

[0251] 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, non-knitted fabrics. Methods for manufacturing nonwoven materials are generally known in the art. Further information on 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).

[0252] In some embodiments, the pouch material includes a binder that provides heat sealing of the pouch during manufacture. 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.

[0253] 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 the 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 the 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 readily 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.

[0254]

[0254] 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 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.

[0255] 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 5 grams (5,000 mg), e.g., about 100 mg to about 4,000 mg, e.g., about 200 mg to about 4,000 mg, e.g., about 500 mg to about 4,000 mg. If desired, other ingredients can be included in each pouch.

[0256] The moisture content of an 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 inserting the product into a 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 inserting the product into a user's mouth) may be from about 20% to about 70% by weight of the oral product, such as from about 30% to about 60% by weight, for example from about 40% to about 55% by weight.

[0257] 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 from about 0.1% to about 10%, e.g., from about 1% to about 5%, by weight of the oral product.

[0258] 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 is typically 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 (eg, a cellulosic material such as MCC) may be present in an amount of about 45% to about 55% by weight of the oral product.

[0259]

[0259] Package According to some embodiments described herein, a package containing the oral product described herein is provided. For example, the package may contain the oral product in powder form. In such embodiments, the package may be in the form of a can or plastic container. Alternatively or additionally, the package may contain the oral product in the form of a lozenge, tablet, or the like. The package may be in the form of a blister pack, can, or plastic container containing such oral dosage forms.

[0260]

[0260] 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.

[0261]

[0261] In some preferred embodiments where the oral product is in liquid form, a package in the form of a bottle or can containing the liquid oral dosage form is provided. The package may be a bottle containing a desired volume of the liquid oral dosage form.

[0262]

[0262] Method 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.

[0263] 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 mixing devices characterized by impellers or other structures capable of 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. Pat. No. 4,148,325 to Solomon et al., U.S. Pat. No. 6,510,855 to Korte et al., and U.S. Pat. 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).

[0264] Methods for preparing liquid oral dosage forms According to some embodiments described herein, there is provided a method for preparing the oral products described herein, the method comprising: (a) combining active ingredients; (b) contacting the active ingredient with water; (c) mixing the active ingredient with water to prepare an oral product.

[0265]

[0265] The combination of active ingredients may be as described hereinabove. The combination of active substances may also be as described below in relation to "Further Broad Embodiments."

[0266]

[0266] The active ingredient may be provided in the form of a liquid extract, a liquid oil or a powder. If in powder form, step (c) may comprise mixing the active ingredient with water until the active ingredient is dissolved in the water.

[0267] Step (b) and / or step (c) may preferably be carried out at ambient or room temperature (20-25°C). Alternatively, the temperature may be elevated to aid in the dispersion or dissolution of the active ingredient in the water. For example, step (b) may involve contacting the active ingredient with water at a temperature of about 20-100°C, e.g., about 30-90°C, or about 40-80°C. Step (b) may involve mixing the active ingredient with water at a temperature of about 20-100°C, e.g., about 30-90°C, or about 40-80°C.

[0268]

[0268] The method may include adding optional additional additives at any stage. For example, optional additives may be added to the active ingredients before combining with water and / or after combining the active ingredients with water. Also, additives may be added to the water before contacting the water with the active ingredient combination. Step (a) may include the optional step of combining optional additives (e.g., acidifying agents) with the active ingredient combination. Step (b) may include the optional step of contacting the active ingredients with water and additives. Step (c) may include the optional step of adding additives to the mixture and mixing the additives with the active ingredient and water combination.

[0269] In some embodiments, the oral product further comprises one or more additives selected from a thickening agent, an organic acid, or a mixture thereof. In such embodiments, the one or more additives may be combined with water prior to the addition of the active ingredient. Optionally, the step of combining the one or more additives with water may include heating the combination to a temperature of, for example, about 60°C to about 80°C to achieve dissolution of the additives. Additional additives, such as sweeteners, humectants, colorants, etc., may be added at this stage or may be added during and / or after the step of combining the active ingredient with water.

[0270]

[0270] The resulting liquid product may be in the form of a solution or dispersion of the active ingredient in water.

[0271] 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.

[0272]

[0272] When present, the coating typically comprises a film-forming polymer such as a cellulose-based polymer, an optional plasticizer, and optional flavorings, colorings, 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.

[0273] Method for Preparing Lozenge Products 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.

[0274] Typically, a first mixture of ingredients is prepared. While the composition of the first mixture of ingredients can vary, 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, although in some embodiments, an active ingredient may be incorporated into the first mixture of ingredients.

[0275] 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 sample of the cooled syrup 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 methods of the present disclosure, the mixture is typically heated to or above the hard crack stage temperature and then cooled. Heating can be carried out at atmospheric pressure or under vacuum. Typically, the methods of the present invention are carried out at atmospheric pressure.

[0276] In one exemplary embodiment, a first mixture of ingredients includes a high proportion of isomalt, and the mixture is heated to about 143° C. Once all ingredients are dissolved, the temperature is increased to above 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.

[0277] 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. The addition of the second mixture may, in some embodiments, 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, are preferably added after the mixture has cooled somewhat. The combined mixture is then formed into the desired shape. In certain embodiments, the mixture is poured directly into a mold, formed (e.g., rolled or pressed) into the 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.

[0278] 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 selection of specific solvents and processing aids, use of heat and radiation, refrigeration and cryogenic conditions, ingredient mixing rates, etc. Manufacturing conditions may also be controlled by 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.

[0279] 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 a degree of translucency, as opposed to opaque, which refers to a material that light cannot transmit through.

[0280]

[0280] 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., about 400-700 nm). Alternatively, optical methods such as turbidity (or nephelometry) and colorimetric measurements 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.

[0281] Method for preparing a molten product 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.

[0282]

[0282] In some embodiments, a sugar alcohol (eg, isomalt) is added to a mixer bowl, and a portion of the total lipid (eg, melted palm oil) is added along with salt and an emulsifier.

[0283] Additional lipid is added with mixing until a sticky mass is formed. 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.

[0284] The sweetener, flavoring agent, and active ingredient are added with 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 to 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.

[0285] 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.

[0286] According to other aspects of the present disclosure, rather than preparing a molten product using a mold, an extrusion process can be used in which the final molten product is extruded. In some examples, a molten composition in slurry form can be formed into a sheet and dried, for example, to a moisture content of about 15% to about 25% by weight to form a sticky or other paste-like material in a physically handleable form. The material can then be chopped or otherwise cut into smaller pieces, for example, 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, the molten composition can be subjected to a coextrusion process with another composition.

[0287]

[0287] 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 material 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 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.

[0288] While the preceding discussion has focused on a uniform composition throughout each product unit, products may also be formed with multiple different formulations having different properties within the same product unit. For example, two different compositions may be cast into a single mold to produce a layered product. Additionally, two different compositions may be coextruded to form a product with different properties across its cross-section. Such a process may 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.

[0289] Method for preparing a pouch oral product If the product is in the form of a pouched oral product, the method comprises: (a) combining active ingredients; (b) contacting the combination of the active ingredient with at least one filler to provide an oral product.

[0290]

[0290] The combination of active ingredients may be as described hereinabove. The combination of active substances may also be as described below in relation to "Further Broad Embodiments."

[0291] 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 may be mixed directly with the filler to provide an oral product. In some embodiments, the active ingredient combination may be dissolved in a hydrophilic solvent (e.g., water and / or alcohol) before contacting with the filler. For example, the active ingredient combination may be dissolved in water or alcohol (e.g., ethanol or propylene glycol) before mixing with the filler. The method may, in such embodiments, comprise a step of drying the product to remove the solvent. For example, the product may be dried by heating, freeze-drying, spray-drying, or simply by 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.

[0292]

[0292] The method may then further comprise the step of pouching the oral product using a pouch material as described hereinabove.

[0293]

[0293] 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 includes: (i) caffeine; (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; and (iii) β-alanine.

[0294] In some embodiments, the use includes increasing or enhancing the energy level of a subject to whom the combination of active ingredients is administered. The use may include increasing alertness in the subject. Additionally or alternatively, the use may include increasing concentration and / or cognition in the subject. In some embodiments, the combination of active ingredients is ingested by a human or animal a period of time prior to physical activity. The length of time prior to physical activity is not limited, but in some embodiments, may be at least about 5 minutes, or at least about 10 minutes, or at least about 15 minutes prior to physical activity.

[0295] In some embodiments, the combination of active ingredients is as defined hereinabove. In such embodiments, the combination may further include any of the additional active ingredients described hereinabove. For example, the combination of active ingredients may further include theacrine, ginseng, electrolytes, and / or beet root extract. The combination of active ingredients may further include ginseng, among others.

[0296] 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) β-alanine, and (iii) ginseng. Alternatively or additionally, the combination of active ingredients may include (i) caffeine and (ii) electrolytes, wherein the caffeine and electrolytes are present in a weight ratio of about 1:5 to about 5:1, 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 B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; or (iv) ginseng.

[0297] Alternatively or additionally, the combination of active ingredients may include (i) caffeine, (ii) a combination of B vitamins including 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) β-alanine, and (iv) theacrine.

[0298]

[0298] 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 and can increase physical and / or mental energy levels, as well as enhance cognitive effects such as reaction time and reduced fatigue during cognitive tasks.

[0299] Further broad aspects According to some embodiments described herein, there is provided an oral product comprising a combination of active ingredients including (i) caffeine, (ii) ginseng, and (iii) β-alanine.

[0300]

[0300] With respect to the first aspect, the amounts of caffeine, β-alanine, 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) β-alanine, 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.

[0301]

[0301] In some preferred embodiments, the oral product comprising (i) caffeine, (ii) ginseng, and (iii) β-alanine is a liquid oral dosage form.

[0302]

[0302] In some embodiments, the active ingredient combination includes (i) caffeine in an amount of from about 0.1% to about 10% by weight of the oral product, (ii) ginseng in an amount of from about 0.05% to about 10% by weight of the oral product, and (iii) beta-alanine in an amount of from about 0.1% to about 20% by weight of the oral product.

[0303]

[0303] In some embodiments, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) ginseng, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is about 1:1 to about 15:1, the weight ratio of caffeine to ginseng is about 15:1 to about 1:5, and the weight ratio of β-alanine to ginseng is about 25:1 to about 1:25.

[0304]

[0304] In some embodiments, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) ginseng, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is about 1:1 to about 15:1, the weight ratio of caffeine to ginseng is about 15:1 to about 1:1, and the weight ratio of β-alanine to ginseng is about 20:1 to about 1:20.

[0305]

[0305] In some embodiments, the oral product comprises a combination of active ingredients including (i) caffeine, (ii) ginseng, and (iii) β-alanine, wherein the weight ratio of β-alanine to caffeine is about 15:1 to about 1:1, the weight ratio of caffeine to ginseng is about 10:1 to about 1:1, and the weight ratio of β-alanine to ginseng is about 1:1 to about 15:1.

[0306]

[0306] In some embodiments, the oral product is a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL), wherein the liquid oral dosage form comprises (i) about 50 mg to about 1500 mg of caffeine, (ii) about 10 mg to about 300 mg of ginseng, and (iii) about 500 mg to about 2500 mg of β-alanine.

[0307]

[0307] In some embodiments, the oral product is a liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL), wherein the liquid oral dosage form comprises (i) about 100 mg to about 1200 mg of caffeine, (ii) about 25 mg to about 200 mg of ginseng, and (iii) about 500 mg to about 1500 mg of β-alanine.

[0308]

[0308] 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 theacrine and / or electrolytes and / or beet root extract. 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 B1, B2, B3, B5, B6, B7, B9, B12, and combinations thereof. In some embodiments, the oral product may include a combination of at least vitamins B6, B9, and B12. Suitable ranges of amounts for these B vitamins are described above.

[0309]

[0309] The methods and uses described herein above are also equally applicable to the above embodiments in which the combination of active ingredients comprises (i) caffeine, (ii) ginseng, and (iii) β-alanine.

[0310]

[0310] According to some embodiments described herein, an oral product in liquid form is provided that contains a combination of active ingredients, including: (i) caffeine; (ii) a combination of B vitamins including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) ginseng.

[0311]

[0311] 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.

[0312]

[0312] According to some embodiments described herein, oral products are provided that include a combination of active ingredients including: (i) caffeine; (ii) at least two B vitamins selected from the group consisting of vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; (iii) beta-alanine; and (iv) electrolytes.

[0313]

[0313] With respect to the first aspect, the amounts of caffeine, β-alanine, vitamin B and electrolytes (and all other active ingredients and / or additives) set forth herein above are equally applicable to such embodiments and will not be repeated here for the sake of brevity.

[0314]

[0314] The methods and uses described herein above are equally applicable to the above embodiments.

[0315]

[0315] 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.

[0316] Example 1 - Liquid Dosage Form An oral product in liquid form is prepared containing the following ingredients:

[0317] [Table 1]

[0318] Oral products have a volume of 30 mL or 60 mL per serving.

[0319] All active ingredients are added to water and the resulting mixture is stirred until a uniform dispersion or clear solution is obtained. The product is then packaged in bottles, each containing 30 mL or 60 mL of liquid.

[0320] Example 2-2 Liquid Dosage Form Containing a 5:2 Ratio of β-Alanine:Caffeine An oral product in liquid form is prepared containing the following ingredients: water Vitamins B1, B2, B3, B5, B6, B7, B9, and B12 Caffeine β-alanine Ginseng extract ·Electrolyte Beet root extract

[0321] Each serving contains approximately 120 mg of caffeine and 1.5 g of beta-alanine. Each serving contains approximately 2.4 mg of vitamin B6 and 1.5 mg of vitamin B1. Each oral product has a volume of 60 mL.

[0322] The oral product is prepared as described in Example 1.

[0323] Example 3 - Liquid dosage form containing a 5:1 ratio of caffeine:total B vitamins An oral product in liquid form is prepared containing the following ingredients: water Vitamins B1, B2, B3, B5, B6, B7, B9, and B12 Caffeine β-alanine Ginseng extract ·Electrolyte Beet root extract

[0324] Each serving contains approximately 200 mg of caffeine and 40 mg of total B vitamins. Each serving contains approximately 2 mg of vitamin B2 and 5 mg of vitamin B12. Each oral product has a volume of 30 mL.

[0325] The oral product is prepared as described in Example 1.

[0326] Example 4 - Liquid Dosage Form An oral product in liquid form is prepared containing the following ingredients:

[0327] [Table 2]

[0328] Oral products have a volume of 30 mL or 60 mL per serving.

[0329] All active ingredients are added to water and the resulting mixture is stirred until a uniform dispersion or clear solution is obtained. The product is then packaged in bottles, each containing 30 mL or 60 mL of liquid.

[0330] Examples 5-1 Liquid Dosage Forms Containing a 5:2 Ratio of β-Alanine:Caffeine An oral product in liquid form is prepared containing the following ingredients: water Vitamin B1, B2, B6, B7 - 6mg total weight of B vitamins Caffeine β-alanine Ginseng extract - 100mg Preservatives ·sweetener Acidifier Flavoring agents

[0331] Each serving contains approximately 120 mg of caffeine and 900 mg of beta-alanine. Each serving contains approximately 2.4 mg of vitamin B6 and 1.5 mg of vitamin B1. Each oral product has a volume of 60 mL.

[0332] The oral product is prepared as described in Example 4.

[0333] Example 6 - Liquid dosage form containing a 300:1 ratio of β-alanine:total B vitamins An oral product in liquid form is prepared containing the following ingredients: water Vitamin B1, B2, B6, B7 - 4mg Caffeine - 140mg β-alanine - 1.2g Ginseng extract - 120mg Preservatives ·sweetener Acidifier Flavoring agents

[0334] The amount of vitamin B2 per serving is approximately 1 mg, and the amount of vitamin B7 is approximately 0.15 mg. The oral product has a volume of 60 mL per serving.

[0335] The oral product is prepared as described in Example 4.

[0336] 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 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.

[0337] Numbered clauses 1.(i) Caffeine, (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; and (iii) an oral product comprising a combination of active ingredients, including β-alanine; 2.(ii) The oral product according to clause 1, wherein the combination of B vitamins comprises at least vitamin B2, vitamin B3, vitamin B6, vitamin B9 and vitamin B12. 3. (ii) The oral product of clause 2, wherein the B vitamin combination further comprises one or more of vitamin B1, vitamin B5, or vitamin B7. 4. (ii) The oral product of any one of clauses 1 to 3, wherein the combination of B vitamins comprises a combination of vitamin B2, vitamin B3, vitamin B6, vitamin B9, vitamin B12, vitamin B1, vitamin B5 and vitamin B7. 5. The oral product of any one of clauses 1 to 4, wherein the total amount of B vitamins in the combination is from about 0.01% to about 5% by weight of the oral product. 6. The oral product of any one of clauses 1-5, wherein caffeine is present in an amount of about 0.1% to about 10% by weight of the oral product. 7. The oral product of any one of clauses 1-5, wherein caffeine is present in an amount of about 1% to about 35% by weight of the oral product. 8. The oral product of any one of clauses 1-7, wherein the β-alanine is present in an amount of about 0.1% to about 60% by weight of the oral product. 9. The oral product of clause 8, wherein the β-alanine is present in an amount of about 1% to about 10% by weight of the oral product. 10. The oral product of any one of clauses 1 to 9, wherein the β-alanine and caffeine are present in a weight ratio of about 1:1 to about 15:1. 11. The oral product of any one of clauses 1 to 10, wherein the total amount of caffeine and B vitamins is present in a weight ratio of about 1:1 to about 35:1. 12. The oral product of any one of clauses 1 to 11, wherein the total amount of β-alanine and B vitamins is present in a weight ratio of about 10:1 to about 60:1. 13. The oral product of any one of clauses 1-12, wherein the combination of active ingredients further comprises (iv) theacrine, optionally wherein the theacrine is present in an amount of about 0.05% to about 5% by weight of the oral product. 14. The oral product of any one of clauses 1-13, wherein the combination of active ingredients further comprises (v) ginseng, optionally present in an amount of about 0.05% to about 10% by weight of the oral product. 15. The oral product of any one of clauses 1 to 14, wherein the combination of active ingredients further comprises (vi) electrolytes, optionally wherein the electrolytes comprise sodium salts and / or potassium salts. 16. The oral product of clause 15, wherein the electrolyte is present in an amount of about 0.1% to about 30% by weight of the oral product. 17. The oral product of any one of clauses 1-16, wherein the oral product comprises the combination of active ingredients in an amount of about 1% to about 15% by weight of the oral product. 18. The oral product of any one of clauses 1-17, further comprising one or more additives selected from the group consisting of flavoring agents, sweeteners, acidifying agents, thickeners, fillers, binders, humectants, preservatives, and mixtures thereof. 19. The oral product of any one of clauses 1-18, wherein the oral product further comprises zinc or zinc gluconate, optionally wherein the zinc or zinc gluconate is present in an amount of about 0.01% to about 1% by weight of the oral product. 20. The oral product of any one of clauses 1-19, wherein the oral product is a liquid dosage form, and optionally the liquid oral dosage form has a liquid volume of about 10 mL to about 100 mL. 21. The combination of active ingredients is (i) caffeine, (ii) a combination of at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) β-alanine, (iv) theacrine, and (v) an oral product according to clause 20, comprising ginseng; 22. The oral product of any one of clauses 1-21, wherein the oral product further comprises water in an amount of about 50% to about 99.9% by weight of the oral product. 23. The liquid dosage form is (i) about 50 mg to about 1500 mg of caffeine; (ii) about 1 mg to about 100 mg of a combination of B vitamins including at least two selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; and (iii) about 0.1 g to about 5 g of β-alanine; In some cases, the liquid dosage form is (iv) about 50 mg to about 500 mg of theacrine, and / or (v) about 10 mg to about 300 mg of ginseng. 24. (a) combining an active ingredient comprising: (i) caffeine; (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; and (iii) beta-alanine; (b) contacting the active ingredient with water; (c) mixing the active ingredient with water to prepare the oral product. 25. 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 at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12, and (iii) beta-alanine. 26. Use according to clause 25, wherein the combination of active ingredients is taken by a human or animal at least about 10 minutes before physical activity. 27.(i) Caffeine, (ii) β-alanine, and (iii) Oral products containing a combination of active ingredients, including ginseng.

Claims

1. (i) caffeine, (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; and (iii) an oral product comprising a combination of active ingredients including β-alanine.

2. 2. The oral product of claim 1, wherein the (ii) combination of B vitamins includes at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12.

3. 3. The oral product of claim 2, wherein the (ii) combination of B vitamins further comprises one or more of vitamin B1, vitamin B5, or vitamin B7.

4. 4. The oral product according to claim 1, wherein the (ii) combination of B vitamins comprises a combination of vitamin B2, vitamin B3, vitamin B6, vitamin B9, vitamin B12, vitamin B1, vitamin B5, and vitamin B7.

5. 2. The oral product of claim 1, wherein the (ii) combination of B vitamins comprises at least vitamin B1 and vitamin B2, or at least vitamin B6 and vitamin B7, or at least vitamin B1 and B6, or at least vitamin B2 and vitamin B7, and preferably the (i) combination of B vitamins comprises at least vitamin B1, vitamin B2, and vitamin B6.

6. 6. The oral product of claim 5, wherein the (i) combination of B vitamins comprises at least vitamin B1, vitamin B2, vitamin B6, and vitamin B7, and preferably the combination of B vitamins consists essentially of vitamin B1, vitamin B2, vitamin B6, and vitamin B7.

7. 7. The oral product of any one of claims 1 to 6, wherein the total amount of B vitamins in the combination is from about 0.001% to about 5% by weight of the oral product.

8. 8. The oral product of any one of claims 1 to 7, wherein the caffeine is present in an amount of about 0.1% to about 10% by weight of the oral product, or wherein the caffeine is present in an amount of about 1% to about 35% by weight of the oral product.

9. 9. The oral product of any one of claims 1 to 8, wherein the β-alanine is present in an amount of about 0.1% to about 60% by weight of the oral product.

10. 10. The oral product of claim 9, wherein the β-alanine is present in an amount of about 1% to about 10% by weight of the oral product.

11. 11. The oral product of any one of claims 1 to 10, wherein the β-alanine and caffeine are present in a weight ratio of about 1:1 to about 15:

1.

12. 12. The oral product of any one of claims 1 to 11, wherein the total amount of caffeine and B vitamins is present in a weight ratio of about 1:1 to about 35:

1.

13. 13. The oral product of any one of claims 1 to 12, wherein the total amount of β-alanine and B vitamins is present in a weight ratio of about 10:1 to about 60:1 or about 100:1 to about 500:

1.

14. 14. The oral product of any one of claims 1 to 13, wherein the combination of active ingredients further comprises (iv) theacrine, optionally present in an amount of from about 0.05% to about 5% by weight of the oral product.

15. 15. The oral product of any one of claims 1 to 14, wherein the combination of active ingredients further comprises (v) ginseng, optionally present in an amount of about 0.05% to about 10% by weight of the oral product.

16. 16. The oral product of any one of claims 1 to 15, wherein the active ingredient combination further comprises (vi) an electrolyte, optionally wherein the electrolyte comprises a sodium salt and / or a potassium salt.

17. 17. The oral product of claim 16, wherein the electrolyte is present in an amount of about 0.01% to about 30% by weight of the oral product.

18. 18. The oral product of any one of claims 1 to 17, wherein the oral product comprises a combination of active ingredients in an amount of from about 1% to about 15% by weight of the oral product.

19. 19. The oral product of any one of claims 1 to 18, wherein the oral product further comprises zinc or zinc gluconate, optionally present in an amount of from about 0.01% to about 1% by weight of the oral product.

20. 20. The oral product of any one of claims 1 to 19, wherein the oral product is in a liquid dosage form, optionally wherein the liquid oral dosage form has a liquid volume of about 10 mL to about 100 mL.

21. The combination of active ingredients is (i) caffeine, (ii) a combination of at least vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) β-alanine, (iv) theacrine, and (v) ginseng, or (i) caffeine, (ii) a combination of at least vitamin B1, vitamin B2, and vitamin B6, and vitamin B7; (iii) β-alanine, and (iv) ginseng, 21. The oral product of claim 20, comprising:

22. 22. The oral product of any one of claims 1 to 21, wherein the oral product further comprises water in an amount of about 50% to about 99.9% by weight of the oral product.

23. the liquid dosage form comprising: (i) about 50 mg to about 1500 mg of caffeine; (ii) about 1 mg to about 100 mg of a combination of B vitamins including at least two selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; and (iii) about 0.1 g to about 5 g β-alanine; Optionally, the liquid dosage form comprises: (iv) about 50 mg to about 500 mg of theacrine, and / or 23. The oral product of any one of claims 1 to 22, further comprising (v) about 10 mg to about 300 mg of ginseng.

24. (a) combining active ingredients including (i) caffeine, (ii) a combination of at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12, and (iii) β-alanine; (b) contacting the active ingredient with water; (c) mixing the active ingredient with water to prepare the oral product.

25. 1. 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 at least two B vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12; and (iii) β-alanine.

26. 26. The use of claim 25, wherein the combination of active ingredients is ingested by the human or animal at least about 10 minutes before physical activity.

27. An oral product comprising a combination of active ingredients, said combination comprising: (i) caffeine, (ii) β-alanine, and (iii) ginseng, wherein the β-alanine and caffeine are present in a weight ratio of about 1:1 to about 15:1.

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