Oral products

Abstract

The present disclosure relates to oral products, methods for manufacturing oral products, and uses of oral products. A first embodiment of the oral product comprises a combination of active ingredients, including (i) maca root or an extract thereof, (ii) a combination of B vitamins including at least two selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) ginseng or an extract thereof, and (iv) coenzyme Q10, wherein the weight ratio of maca root or an extract thereof to coenzyme Q10 is about 50:1 to about 1:10, and the oral product is caffeine-free. A second embodiment of the oral product comprises a combination of active ingredients, including (i) maca root or an extract thereof, (ii) a combination of B vitamins including at least three selected from vitamin B2, vitamin B6, vitamin B9, and vitamin B12, and (iii) ginseng or an extract thereof, and the oral product is caffeine-free.

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 easy to administer orally and can provide beneficial effects on specific mood states in humans or animals have gained popularity in recent years. For example, confectionery-type products (e.g., gummies or lozenges) containing vitamins or other mood-enhancing active ingredients 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 an 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, the products comprising a combination of active ingredients. The oral product may be in any form suitable for oral use, such as in tablet or lozenge form, as a loose powder, or in liquid form (e.g., as a beverage such as a shot).

[0007]

[0007] According to some embodiments described herein, there is provided an oral product comprising a combination of active ingredients, the combination including: (i) maca root; (ii) a combination of at least three B vitamins selected from vitamin B2, vitamin B6, vitamin B9, and vitamin B12; and (iii) ginseng. As will be understood by those skilled in the art, the terms "maca root" and "ginseng" include extracts thereof.

[0008]

[0008] According to some embodiments described herein, there is provided an oral product comprising a combination of active ingredients, the combination including: (i) maca root; (ii) a combination of at least two B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) ginseng; and (iv) coenzyme Q10, wherein the weight ratio of maca root to coenzyme Q10 is from about 50:1 to about 1:10, preferably from about 10:1 to about 1:10. As previously stated, the terms "maca root" and "ginseng" include extracts thereof.

[0009]

[0009] According to some preferred embodiments described herein, there is provided a caffeine-free oral product comprising a combination of active ingredients, the combination comprising: (i) maca root or an extract thereof; (ii) a combination of at least two B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) ginseng or an extract thereof; and (iv) coenzyme Q10, wherein the weight ratio of maca root or an extract thereof to coenzyme Q10 is from about 50:1 to about 1:10.

[0010]

[0010] According to some embodiments described herein, there is provided a method of preparing an oral product, comprising: (a) combining active ingredients, the active ingredients including (i) maca root, (ii) a combination of at least three B vitamins selected from vitamin B2, vitamin B6, vitamin B9, and vitamin B12, and (iii) ginseng; (b) contacting the active ingredients with water; and (c) mixing the active ingredients with water to prepare the oral product. As previously mentioned, the terms "maca root" and "ginseng" include extracts thereof.

[0011]

[0011] According to some embodiments described herein, there is provided a method for preparing an oral product, comprising: (a) combining active ingredients, the active ingredients including (i) maca root, (ii) a combination of at least two B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) ginseng, and (iv) coenzyme Q10, wherein the weight ratio of maca root to coenzyme Q10 is about 50:1 to about 1:10, preferably about 10:1 to about 1:10; (b) contacting the active ingredients with water; and (c) mixing the active ingredients with water to prepare the oral product. As previously mentioned, the terms "maca root" and "ginseng" include extracts thereof.

[0012]

[0012] According to some embodiments described herein, there is provided a use of a combination of active ingredients for increasing alertness and / or energy levels in a human or animal, the combination of active ingredients comprising maca root, (ii) a combination of at least three B vitamins selected from vitamin B2, vitamin B6, vitamin B9, and vitamin B12, and (iii) ginseng. As already mentioned, the terms "maca root" and "ginseng" include extracts thereof.

[0013]

[0013] According to some embodiments described herein, there is provided a use of a combination of active ingredients for increasing alertness and / or energy levels in a human or animal, the combination of active ingredients comprising maca root; (ii) a combination of at least two B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) ginseng; and (iv) coenzyme Q10, preferably in a weight ratio of maca root to coenzyme Q10 of about 50:1 to about 1:10, preferably about 10:1 to about 1:10. As already mentioned, the terms "maca root" and "ginseng" include extracts thereof. In a preferred embodiment, the combination of active ingredients is caffeine-free.

[0014]

[0014] According to some embodiments described herein, there is provided a use of a combination of active ingredients for increasing mental and / or physical energy in a human or animal, the combination of active ingredients comprising maca root, (ii) a combination of at least three B vitamins selected from vitamin B2, vitamin B6, vitamin B9, and vitamin B12, and (iii) ginseng. As already mentioned, the terms "maca root" and "ginseng" include extracts thereof.

[0015]

[0015] According to some embodiments described herein, there is provided a use of a combination of active ingredients for increasing mental and / or physical energy in a human or animal, the combination of active ingredients comprising maca root; (ii) a combination of at least two B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) ginseng; and (iv) coenzyme Q10, preferably in a weight ratio of maca root to coenzyme Q10 of about 50:1 to about 1:10, preferably about 10:1 to about 1:10. As previously mentioned, the terms "maca root" and "ginseng" include extracts thereof. In a preferred embodiment, the combination of active ingredients is caffeine-free.

[0016]

[0016] According to some embodiments described herein, there is provided an oral product in liquid form containing a combination of active ingredients, the combination of active ingredients including: (i) maca root; (ii) a combination of B vitamins including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; and (iii) ginseng. As previously mentioned, the terms "maca root" and "ginseng" include extracts thereof.

[0017]

[0017] According to some embodiments described herein, there is provided an oral product in liquid form comprising a combination of active ingredients, the combination of active ingredients comprising: (i) maca root; (ii) a combination of B vitamins including vitamin B1, vitamin B2, vitamin B6, and vitamin B7; (iii) ginseng; and (iv) coenzyme Q10. The weight ratio of maca root to coenzyme Q10 may be as defined herein. As previously stated, the terms "maca root" and "ginseng" include extracts thereof.

[0018]

[0018] 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 (i.e., a liquid having a volume of up to about 100 mL). The combination of active ingredients is preferably caffeine-free.

[0019] 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 set forth 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.

[0020] 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

[0021]

[0021] 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.

[0022] As used in this specification and 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 indicated, references to "wt %" (or "wt %") of a product or composition reflect the total wet weight (i.e., including water) of the product or composition.

[0023]

[0023] As used herein, unless otherwise specified, the term "about" modifying the amount of an ingredient in an oral product of the invention or used in a method of the invention refers to variations in the numerical amount that may occur, for example, through typical measuring and liquid handling procedures used to make concentrates or use solutions in the real world, through inadvertent errors in these procedures, through differences in the manufacture, source, or purity of the ingredients used to make the oral product or perform the method. "About" also encompasses amounts that differ due to different equilibrium conditions for a product or composition resulting from a particular initial mixture. Whether modified by the term "about," the claims include equivalents to these amounts.

[0024] Oral products

[0024] As described herein, an oral product containing a combination of active ingredients is provided, the combination including (i) maca root, (ii) a combination of at least three B vitamins selected from vitamin B2, vitamin B6, vitamin B9, and vitamin B12, and (iii) ginseng. Also provided is an oral product containing a combination of active ingredients, the combination including (i) maca root, (ii) a combination of at least two B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) ginseng, and (iv) coenzyme Q10, wherein the weight ratio of maca root to coenzyme Q10 is about 50:1 to about 1:10, preferably about 10:1 to about 1:10. Maca root and ginseng, including extracts thereof, are included in the oral product. References herein to an "oral product" refer to any of these products.

[0025]

[0025] The oral product is preferably caffeine-free, ie, there is no caffeine present in the oral product.

[0026] Oral products are configured for oral use and therefore for insertion into the mouth (i.e., oral cavity) of a user. As used herein, unless otherwise specified, the term "oral" in reference to a product refers to a product that, in normal use, is suitable for ingestion or placement 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 consumed by the user, or the product may be placed in the mouth (e.g., in the form of a tablet, lozenge, pouch, etc.). In a preferred embodiment, the oral product is in the form of a liquid.

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

[0028] Active ingredient combination

[0028] The products disclosed herein include an active ingredient. The active ingredient may be naturally occurring or synthetically derived. The combination of active ingredients includes suitable active ingredients that elicit 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.

[0029]

[0029] According to a first aspect of the present invention, the combination of active ingredients comprises at least (i) maca root, (ii) a combination of at least three B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9 and vitamin B12, and (iii) ginseng.

[0030]

[0030] According to a second aspect of the present invention, a combination of active ingredients includes at least (i) maca root, (ii) a combination of at least two B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) ginseng, and (iv) coenzyme Q10, wherein the weight ratio of maca root to coenzyme Q10 is about 50:1 to about 1:10, preferably about 10:1 to about 1:10. In a preferred embodiment of the second aspect of the present invention, the oral product is caffeine-free. While the oral product is caffeine-free, the product provides a boosting or stimulating effect in the subject. In this regard, each of the active ingredients may be present in an amount suitable to provide a desired biological response in humans or animals. The inventors have discovered that certain combinations of active ingredients included in oral products provide a rapid onset of mental and / or physical energy. The combination of active ingredients has been found to provide the user with a short-term, medium-term, or long-term mental and / or physical energy boost, among other things. In particular, it has been found that certain combinations of active ingredients in oral products increase mental energy (i.e., improve cognitive performance, increase energy (alertness, wakefulness), or reduce mental fatigue, increasing the consumer's motivation to perform mental tasks) and increase physical energy (i.e., improve endurance performance and capacity). The inventors have found that certain combinations of active ingredients of the present invention can improve energy levels over short or long periods of time. Increased energy levels can also increase the user's overall feelings of enjoyment and enthusiasm, resulting in increased feelings of confidence, motivation, joy, and excitement. The inventors have also found that there is improvement in cognitive performance for at least 90 minutes after consumption.

[0031] 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.

[0032] Maca, or Lepidium meyenii, is an edible herbaceous biennial plant of the Brassicaceae family native to South America. It is also known as "Peruvian ginseng" and is cultivated primarily for its root consumption. Traditionally, maca is processed by boiling, baking, and drying the root, then grinding the dried root material into a powder. Various maca root powders are commercially available. Maca root contains numerous phytochemicals, including zinc, calcium, iron, manganese, copper, phosphorus, and vitamins such as vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, and vitamin C. However, the amounts of such components can vary depending on factors including source and storage conditions. Any B vitamins and / or zinc contributed by maca root to the oral product are in addition to the specific total B vitamin and / or zinc components defined herein. In particular, maca root or an extract thereof may be a source of B vitamins, but the B vitamin combination according to feature (ii) defined in the aspects and embodiments disclosed herein is preferably derived from an independent source and not from maca root. Maca root may be used for its putative benefits, including increased fertility, boosting energy and endurance, improving mood, lowering blood pressure, and improving learning and memory.

[0033]

[0033] Fresh maca root comes in a variety of colors due to genetic variation. Colors include yellow, red, purple, blue, black, and green. Yellow maca is the sweetest tasting and is the most commonly cultivated for consumption, while red and black maca are generally considered to have more medicinal properties. The maca root included in the oral product may be black maca root, yellow maca root, red maca root, or any combination thereof. Maca root may be provided in the form of an extract or in the form of a powder (e.g., a powdered extract). Thus, in any of the aspects and embodiments disclosed herein, reference to "maca root" includes the extract thereof.

[0034] Maca root can be present in any suitable amount, such as at least about 0.001%, at least about 0.005%, at least about 0.01%, or at least about 0.05% by weight of the oral product. In some embodiments, maca root can be present in an amount of no more than about 15%, no more than about 10%, no more than about 5%, or no more than about 1% by weight of the oral product.

[0035] Alternatively, maca root may be present in an amount of at least about 0.01%, at least about 0.1%, or at least about 0.5% by weight of the oral product. In some embodiments, maca root may be present in an amount of no more than about 35%, no more than about 20%, or no more than about 10% by weight of the oral product.

[0036] Maca root may be present in an amount of about 0.001% to about 15% by weight of the oral product. In some embodiments, maca root is present in an amount of about 0.005% to about 10% by weight of the oral product. Maca root may preferably be present in an amount of about 0.01% to about 5% by weight of the oral product. Amounts of maca root of about 0.05% to about 1% by weight of the oral product are particularly preferred.

[0037]

[0037] In some embodiments (e.g., when the oral product is a liquid dosage form as discussed herein), maca root is present in an amount of about 0.01% to about 10% by weight of the oral product, for example, about 0.01% to about 5% by weight of the oral product, for example, about 0.05% to about 5% by weight of the oral product, for example, about 0.05% to about 1% by weight of the oral product.

[0038]

[0038] The combination of active ingredients further comprises a combination of B vitamins. In a first embodiment, the combination comprises at least three B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12. In a second embodiment, the combination comprises at least two B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12. Preferably, the combination of B vitamins in the second embodiment 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.

[0039] The term "B vitamins" includes a group of eight water-soluble vitamins that have effects on cellular function, e.g., cellular metabolism and synthesis of red blood cells. B vitamins act as coenzymes in a significant proportion of enzymatic processes for the physiological function of cells. B vitamins can generally be divided into two categories: those that act as coenzymes for catabolic enzyme reactions (resulting in the production of energy) and those that act as coenzymes for anabolic enzyme reactions (resulting in enhanced brain function).

[0040] 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 support anabolic metabolism and enhance brain function. Vitamins B1, B2, B3, B5, and B7 have been found to support catabolic metabolism and enhance energy levels.

[0041]

[0041] In a preferred embodiment of the first aspect, the oral product comprises at least three of the B vitamins that support anabolic metabolism. In other words, according to the first aspect, the combination of at least three B vitamins is selected from vitamins B2, B3, B6, B9, and B12. It has been found that the inclusion of at least three of 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 the 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 tiredness and fatigue, and the inclusion of all five B vitamins can provide a synergistic effect in this regard.

[0042] In some embodiments, the B vitamin combination consists essentially of a combination of all anabolic vitamins, i.e., vitamins B2, B3, B6, B9, and B12. In some embodiments, the B vitamin combination consists essentially of a combination of all anabolic vitamins, i.e., vitamins B2, B3, B6, B9, and B12. The term "anabolic B vitamins" refers to B vitamins that have effects on anabolic pathways, and the term "catabolic B vitamins" refers to B vitamins that have effects on catabolic pathways.

[0043]

[0043] In a preferred embodiment of the second aspect, the oral product comprises at least two of the B vitamins that support anabolic metabolism. In other words, according to the second 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 two of 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 vitamins B2 and B6, which support anabolic metabolism. Each of these B vitamins can contribute to reducing tiredness and fatigue, and the inclusion of these two specific B vitamins can provide a synergistic effect in this regard.

[0044] 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.

[0045]

[0045] In some preferred embodiments, (ii) the B vitamin combination further comprises one or more of vitamin B1 or vitamin B7, and more preferably, (ii) the B vitamin combination further comprises vitamin B1 and vitamin B7.

[0046] In another preferred embodiment, the B vitamin combination consists essentially of vitamin B1, vitamin B2, vitamin B6, and vitamin B7.

[0047] 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.

[0048]

[0048] 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 consume and has reduced side effects.

[0049] 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 / or 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 preferably be from about 0.01% to about 0.5% by weight of the oral product.

[0050] When present, the total amount of catabolic B vitamins (i.e., the total amount of the combination of vitamins B1, B5, and / or 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, this amount can be from about 0.01% to about 0.5% by weight of the oral product.

[0051] 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, e.g., about 0.05% to about 2% by weight, preferably about 0.05% to about 1% by weight of the oral product.

[0052] 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.

[0053] In some embodiments, vitamin B2 may be present in an amount of about 1% to about 30% 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 25% by weight of the total amount of B vitamins in the oral product.

[0054] 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.

[0055] 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.

[0056] In some embodiments, vitamin B6 may be present in an amount of about 5% to about 75% 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 15% to about 60% by weight of the total amount of B vitamins in the oral product.

[0057] 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.

[0058] 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.

[0059] 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., may contain 0.0001% or less by weight of vitamin B1) or may contain no vitamin B1 (i.e., may contain 0% vitamin B1).

[0060] When present, vitamin B1 may be present in an amount of about 1% to about 35% 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 5% to about 30% by weight of the total amount of B vitamins in the oral product.

[0061] 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.

[0062] 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 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.

[0063]

[0063] The combination of active ingredients further includes ginseng. Ginseng is the root of plants of the genus Panax and is characterized by the presence of unique steroidal saponin phytochemicals (ginsenosides) and gintonin. The putative major active components of ginseng include over 100 specific triterpene saponins or "ginsenosides." Ginseng and ginseng extracts also contain a range of other potentially bioactive components, including alkaloids, phytosterols, sesquiterpenes, and polyphenols. Ginseng has found use as a dietary supplement in energy drinks or herbal teas, and in traditional medicine.

[0064]

[0064] Ginseng may include any suitable form of ginseng, such as Panax ginseng (Korean ginseng), Panax notoginseng (Chinese ginseng), and Panax quinquefolius (American ginseng). Those skilled in the art will understand that the ginseng in the active ingredient combination is not Peruvian ginseng, i.e., maca root, so that the oral product contains a distinct active ingredient. Ginseng may include Ashwagandha (Withania somnifera), commonly known as Indian ginseng. Ginseng comes from the Panax family, such as Panax ginseng (Korean ginseng), Panax notoginseng (Chinese ginseng) and / or Panax quinquefolius (American ginseng).

[0065]

[0065] The ginseng may be present in the form of ginseng extract, chopped ginseng, shredded ginseng, or powdered ginseng. Preferably, the ginseng is included in the form of ginseng extract or powdered ginseng extract. Thus, in aspects and embodiments disclosed herein, reference to "ginseng" includes the extract. The ginseng may be white ginseng, fresh 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 result in enhanced brain function and / or increased cognitive benefits. It has been found that the inclusion of ginseng is beneficial for improving the cognitive benefits of the composition and reducing mental and physical fatigue in the user.

[0066] Ginseng can be included in any suitable amount to achieve the desired function, for example, 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, ginseng can be present in an amount of about 20% or less, about 10% or less, about 5% or less, or about 1% or less by weight of the oral product.

[0067] In some embodiments, ginseng is present in an amount of about 0.001% to about 20% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.01% to about 10% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.1% to about 5% by weight of the oral product. In some preferred embodiments, the active ingredient combination further comprises ginseng in an amount of about 0.01% to about 5% by weight of the oral product, preferably about 0.1% to about 1% by weight of the oral product.

[0068] Ginseng may be present in some embodiments (e.g., when the oral product is a liquid oral dosage form) in an amount of about 0.01% to about 1% 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, and preferably about 0.1% to about 0.5% by weight.

[0069]

[0069] In addition to maca root or an extract thereof, a combination of B vitamins, and ginseng or an extract thereof, the active ingredient combination may include one or more additional active ingredients. The additional active ingredients may be any suitable active ingredient that provides an increase in physical and / or mental energy levels and / or increased alertness, and may be selected from, for example, additional nutraceuticals, nootropics, and psychoactive substances. The additional active ingredients may be naturally occurring or synthetically obtained. Non-limiting examples of additional active ingredients include those in the categories of botanicals (e.g., Bacopa monnieri or Rhodiola rosea), stimulants (e.g., theacrine, matcha), amino acids or analogs (e.g., L-tyrosine, L-theanine), and / or nutraceutical and / or medicinal ingredients (e.g., additional vitamins such as 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.

[0070] 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, echinacea, cannabinoids, choline, alpha GPC, guayusa, matcha green tea, methylliberin, nitrates or beetroot 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, theacrine, or components, derivatives, or combinations thereof.

[0071] In a second aspect of the present invention, the combination of active ingredients further comprises coenzyme Q10, also known as ubiquinone-10, which is a 1,4-benzoquinone, where Q refers to the quinone chemical group and 10 refers to the number of isoprenyl chemical subunits in the tail, and has the following chemical formula: [ka] It has.

[0072] Coenzyme Q10 or CoQ 10 Coenzyme Q10 is a crystalline powder. Coenzyme Q10 acts as an antioxidant, protecting cells from damage. Coenzyme Q10 also plays an important role in human metabolism and has been used to treat many different conditions, including heart failure.

[0073] When present, Coenzyme Q10 can be included in the active ingredient combination in any suitable amount, such as about 0.001%, at least about 0.01%, or at least about 0.1% by weight of the oral product. In some embodiments, Coenzyme Q10 can be present in an amount of about 30% by weight or less, about 20% by weight or less, or about 10% by weight or less.

[0074] In some embodiments, Coenzyme Q10 is present in an amount of about 0.001% to about 30% by weight of the oral product. In some embodiments, Coenzyme Q10 is present in an amount of about 0.01% to about 20% by weight of the oral product. In some embodiments, Coenzyme Q10 is present in an amount of about 0.1% to about 10% by weight of the oral product. In some preferred embodiments, Coenzyme Q10 is present in an amount of about 0.01% to about 5% by weight of the oral product, with about 0.1% to about 1% by weight being particularly preferred.

[0075] Coenzyme Q10 may be present in an amount of about 0.01% to about 5% by weight of the oral product in some embodiments (e.g., when the oral product is a liquid oral dosage form). In some embodiments (e.g., when the oral product is a liquid oral dosage form), Coenzyme Q10 is present in an amount of about 0.1% to about 1% by weight of the oral product, such as about 0.1% to about 0.75% by weight, and preferably about 0.1% to about 0.5% by weight.

[0076] 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. Vitamin C 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 tiredness and fatigue and improve energy metabolism.

[0077] 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 50%, no more than about 20%, or no more than about 10% by weight of the oral product.

[0078] When present, vitamin C may be present in an amount of about 0.001% to about 50%, or about 0.01% to about 20% by weight of the oral product. Vitamin C may preferably be present in an amount of about 0.1% to about 15% by weight of the oral product. In some embodiments, vitamin C is present in an amount of about 0.2% to about 10%, preferably about 0.5% to about 5% by weight of the oral product.

[0079] In some embodiments, the active ingredient combination further includes theacrine (1,3,7,9-tetramethyluric acid). Theacrine is a purine alkaloid found in Theobroma grandiflorum (a tropical rainforest tree related to cocoa, commonly known as cupuaçu) and the Chinese tea known as bitter tea. Theacrine exhibits anti-inflammatory and analgesic effects and appears 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 a carbamide group as a result of an additional carbonyl group at the 8th position. The inclusion of theacrine can reduce tiredness and fatigue and improve energy metabolism.

[0080] 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 30%, no more than about 20%, or no more than about 15% by weight of the oral product.

[0081] When present, theacrine may be present in an amount of about 0.001% to about 30%, or about 0.01% to about 20% by weight of the oral product. Theacrine is preferably present in an amount of about 0.1% to about 15% 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.

[0082] In some embodiments, the active ingredient combination further includes theobromine (also known as xantheose or 3,7-dihydro-3,7-dimethyl-1H-purine-2,6-dione). Theobromine is the major alkaloid found in Theobroma cacao (the cocoa plant). Theobromine does not have a significant stimulating effect on the human central nervous system and, compared to caffeine, exhibits weaker inhibition of cyclic nucleotide phosphodiesterase and weaker antagonism of adenosine receptors. Structurally, theobromine is similar to caffeine, lacking the methyl groups at positions 4 and 9 and the carbonyl group at position 8. The latter indicates that the second ring is an imidazole.

[0083] When present, theobromine 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, theobromine can be present in an amount of no more than about 10%, no more than about 5%, or no more than about 1% by weight of the oral product.

[0084] When present, theobromine may be present in an amount of about 0.001% to about 10%, or about 0.01% to about 5% by weight of the oral product. Theobromine is preferably present in an amount of about 0.1% to about 1% by weight of the oral product. In some embodiments, theobromine 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.

[0085]

[0085] In some preferred embodiments, the combination of active ingredients includes maca root, a B vitamin combination, vitamin C, and ginseng.

[0086]

[0086] In some preferred embodiments, the combination of active ingredients includes maca root, a B vitamin combination, ginseng, and theacrine.

[0087]

[0087] In some preferred embodiments, the combination of active ingredients includes maca root, a B vitamin combination, ginseng, vitamin C, and theacrine.

[0088]

[0088] In some preferred embodiments, the combination of active ingredients includes maca root, a B vitamin combination, ginseng, and coenzyme Q10.

[0089]

[0089] In some preferred embodiments, the combination of active ingredients includes maca root, a B vitamin combination, ginseng, coenzyme Q10, and vitamin C.

[0090]

[0090] In some preferred embodiments, the combination of active ingredients includes maca root, a B vitamin combination, ginseng, coenzyme Q10, and theobromine.

[0091]

[0091] In some preferred embodiments, the combination of active ingredients includes maca root, a B vitamin combination, ginseng, coenzyme Q10, vitamin C, and theobromine.

[0092] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.001% to about 15% by weight of the oral product, (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.001% to about 10% by weight of the oral product, and (iii) ginseng in an amount of about 0.001% to about 20% by weight of the oral product. In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.005% to about 20% by weight of the oral product, (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.001% to about 5% by weight of the oral product, and (iii) ginseng in an amount of about 0.01% to about 10% by weight of the oral product.

[0093]

[0093] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.01% 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, and (iii) ginseng in an amount of about 0.1% to about 5% by weight of the oral product.

[0094]

[0094] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.05% to about 1% by weight of the oral product, (ii) a B vitamin combination in which the total amount of B vitamins is about 0.025% to about 3% by weight of the oral product, and (iii) ginseng in an amount of about 0.1% to about 5% by weight of the oral product.

[0095] In a second aspect of the present invention, the active ingredient combination includes coenzyme Q10. In some embodiments of the second aspect, the active ingredient combination includes (i) maca root in an amount of from about 0.01% to about 35% by weight of the oral product, (ii) a B vitamin combination, wherein the total amount of B vitamins is from about 0.001% to about 10% by weight of the oral product, (iii) ginseng in an amount of from about 0.001% to about 20% by weight of the oral product, and (iv) coenzyme Q10 in an amount of from about 0.001% to about 30% by weight of the oral product.

[0096]

[0096] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.1% to about 20% by weight of the oral product; (ii) a B vitamin combination, the total amount of B vitamins being about 0.001% to about 5% by weight of the oral product; (iii) ginseng in an amount of about 0.01% to about 10% by weight of the oral product; and (iv) coenzyme Q10 in an amount of about 0.01% to about 20% by weight of the oral product.

[0097]

[0097] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.5% to about 10% by weight of the oral product; (ii) a B vitamin combination, the total amount of B vitamins being about 0.01% to about 4% by weight of the oral product; (iii) ginseng in an amount of about 0.1% to about 5% by weight of the oral product; and (iv) coenzyme Q10 in an amount of about 0.1% to about 10% by weight of the oral product.

[0098] In any of these embodiments of the first or second aspect, the active ingredient combination may further comprise vitamin C in an amount of about 0.1% to about 15% by weight of the oral product. In any of these embodiments, the active ingredient combination may further comprise theacrine in an amount of about 0.1% to about 15% by weight of the oral product. In any of these embodiments, the active ingredient combination may further comprise theobromine in an amount of about 0.001% to about 10% by weight. In any of these embodiments, the active ingredient combination may further comprise theacrine in an amount of about 0.1% to about 15% by weight of the oral product and vitamin C in an amount of about 0.1% to about 15% by weight of the oral product. In any of these embodiments, the active ingredient combination may further comprise 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. Alternatively, the active ingredient combination may further comprise theobromine in an amount of about 0.01% to about 5% by weight of the oral product, and vitamin C in an amount of about 0.1% to about 15% by weight of the oral product. In any of these embodiments, the active ingredient combination may further comprise vitamin C in an amount of about 0.1% to about 5% by weight of the oral product, and theobromine in an amount of about 0.1% to about 1% by weight of the oral product.

[0099]

[0099] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.001% to about 15% 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) ginseng in an amount of about 0.001% to about 20% 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.

[0100]

[0100] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.005% to about 10% by weight of the oral product, (ii) a B vitamin combination in which the total amount of B vitamins is about 0.001% to about 5% by weight of the oral product, (iii) ginseng in an amount of about 0.01% to about 5% 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.

[0101]

[0101] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.01% to about 5% by weight of the oral product; (ii) a B vitamin combination, the total amount of B vitamins being about 0.01% to about 4% by weight of the oral product; (iii) ginseng in an amount of about 0.1% to about 5% 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.

[0102]

[0102] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.05% to about 1% by weight of the oral product; (ii) a B vitamin combination, the total amount of B vitamins being about 0.0025% to about 3% by weight of the oral product; (iii) ginseng in an amount of about 0.1% to about 1% 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.

[0103]

[0103] In any of these embodiments, the active ingredient combination may further include vitamin C in an amount of about 0.1% to about 20% by weight of the oral product.

[0104]

[0104] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.001% to about 15% by weight of the oral product; (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.001% to about 10% by weight of the oral product; (iii) ginseng in an amount of about 0.001% to about 20% by weight of the oral product; (iv) theacrine in an amount of about 0.001% to about 30% by weight of the oral product; and (v) vitamin C in an amount of about 0.001% to about 50% by weight of the oral product.

[0105]

[0105] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.005% to about 10% by weight of the oral product; (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.001% to about 5% by weight of the oral product; (iii) ginseng in an amount of about 0.01% to about 10% by weight of the oral product; (iv) theacrine in an amount of about 0.01% to about 20% by weight of the oral product; and (v) vitamin C in an amount of about 0.01% to about 20% by weight of the oral product.

[0106]

[0106] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.01% to about 5% by weight of the oral product; (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.01% to about 4% by weight of the oral product; (iii) ginseng in an amount of about 0.1% to about 5% by weight of the oral product; (iv) theacrine in an amount of about 0.1% to about 15% by weight of the oral product; and (v) vitamin C in an amount of about 0.1% to about 15% by weight of the oral product.

[0107]

[0107] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.01% to about 5% by weight of the oral product; (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.025% to about 3% by weight of the oral product; (iii) ginseng in an amount of about 0.1% to about 5% by weight of the oral product; (iv) theacrine in an amount of about 0.05% to about 5% by weight of the oral product; and (v) vitamin C in an amount of about 0.2% to about 5% by weight of the oral product.

[0108]

[0108] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.01% to about 35% by weight of the oral product; (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.001% to about 10% by weight of the oral product; (iii) ginseng in an amount of about 0.001% to about 20% by weight of the oral product; (iv) coenzyme Q10 in an amount of about 0.001% to about 30% by weight of the oral product; and (v) vitamin C in an amount of about 0.001% to about 50% by weight of the oral product.

[0109]

[0109] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.1% to about 20% by weight of the oral product; (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.001% to about 5% by weight of the oral product; (iii) ginseng in an amount of about 0.01% to about 10% by weight of the oral product; (iv) coenzyme Q10 in an amount of about 0.01% to about 20% by weight of the oral product; and (v) vitamin C in an amount of about 0.01% to about 20% by weight of the oral product.

[0110]

[0110] In some embodiments, the active ingredient combination includes (i) maca root in an amount of about 0.5% to about 10% by weight of the oral product; (ii) a B vitamin combination, wherein the total amount of B vitamins is about 0.01% to about 4% by weight of the oral product; (iii) ginseng in an amount of about 0.1% to about 5% by weight of the oral product; (iv) coenzyme Q10 in an amount of about 0.1% to about 10% by weight of the oral product; and (v) vitamin C in an amount of about 0.1% to about 15% by weight of the oral product.

[0111] The inventors have found that the above amounts of active ingredients provide beneficial effects of increasing energy levels and enhancing brain function while providing a safe product with reduced side effects. These amounts can be adjusted to ensure high efficacy while ensuring consumer safety and avoiding overdosing on the active ingredients. These amounts have been found to be particularly effective when used before physical exercise.

[0112]

[0112] In addition to the additional active ingredients described above, other suitable additional active ingredients are described below.

[0113]

[0113] L-theanine is a compound obtained by combining 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.

[0114] In some embodiments, the active ingredient combination further comprises a botanical active ingredient. As used herein, the term "botanical ingredient" or "botanical substance" 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 substance" includes, but is not limited to, "herbal material," which refers to seed-bearing plants that do not develop persistent woody tissue and are often valued for their medicinal or sensory properties (e.g., tea or tisane). Botanical materials useful in the present disclosure can include any of the compounds and sources set forth herein, including, but not limited to, mixtures thereof. Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemicals," or "functional foods." Certain botanical substances, either as plant material or extracts thereof, are used in traditional herbal medicine and are further described herein.Non-limiting examples of botanical substances or plant-derived materials include ashwagandha, Bacopa monniera, baobab, basil, Centella asiatica, Chai-hu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus fruits, cloves, cocoa, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba, Griffonia simplicifolia, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thai ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha green tea, Nardostachys chinensis (sweet pine), Viola odorata (oil extract), peppermint, quercetin, resveratrol, Rhizoma gastrodiae (Rhizoma gastrodiae), passionflower, guayusa (guayusa), maca, matcha green tea, beetroot juice, Rhodiola rosea (Rhodiola), rooibos, rose essential oil, rosemary, Sceletium tortuosum (Schisandra), skullcap, spearmint extract, spikenard, terpenes, tisane, turmeric, Turnera aphrodisiaca (Turnera aphrodisiaca), valerian, white mulberry (Mulberry), echinacea, and yerba mate (Yerba mate) As stated herein, oral products are caffeine-free.

[0115] 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, preferably from about 0.01% to about 1% by weight of the oral product.

[0116] 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 optionally further comprises vitamin D in an amount of about 0.001% to about 1% by weight of the oral product.

[0117] The active ingredient combination may further comprise an amino acid selected from the group consisting of an amino acid such as alanine, arginine, asparagine, aspartic acid, beta-alanine, 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.

[0118] 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) that inhibit the release of neurotransmitters in the brain. Cannabinoids are cyclic molecules that exhibit certain properties, such as the ability to easily cross the blood-brain barrier. Cannabinoids may be naturally occurring from plants such as cannabis (phytocannabinoids), from animals (endocannabinoids), or artificially produced (synthetic cannabinoids). Cannabis species represent at least 85 different plant cannabinoids, which may be divided into subclasses including cannabigerol, cannabichromene, cannabidiol, tetrahydrocannabinol, cannabinol, and cannabinodiol, as well as 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), tetrahydrocannabivarinic acid (THCV A), and mixtures thereof. In some embodiments, the cannabinoid is or comprises at least tetrahydrocannabinol (THC). In some embodiments, the cannabinoid is or includes at least cannabidiol (CBD).

[0119]

[0119] In some embodiments, the active ingredient combination comprises a cannabinoid (such as cannabidiol) in an amount of at least about 0.001% by weight of the oral product, for example, in the range of about 0.001% to about 10% by weight of the oral product, for example, about 0.01% to about 5% by weight, for example, about 0.1% to about 2.5% by weight, for example, 0.5% to about 1% by weight.

[0120] 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.

[0121] In some embodiments, the active ingredient combination includes an electrolyte. An electrolyte is an ion-containing medium that conducts electricity through the movement of ions. Electrolytes include most soluble salts, acids, and bases dissolved in a polar solvent, 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 levels after dehydration caused, for example, by exercise, excessive alcohol consumption, dialysis, diarrhea, vomiting, intoxication, or starvation. In some embodiments, the active ingredient combination includes an electrolyte, and optionally the electrolyte comprises a sodium salt and / or a potassium salt. When present, electrolytes may be present in an amount of 0.01% to about 30% by weight of the oral product, e.g., 0.1% to about 20% by weight, or about 0.5% to about 10% by weight of the oral product.

[0122] For the avoidance of doubt, combinations of the above endpoints are expressly contemplated by this disclosure, as are any of the ranges disclosed herein.

[0123] Ratio of active ingredients

[0123] The ratio of active ingredients in an oral product may be selected to enhance the effectiveness of the oral product for the consumer.

[0124] The ratio of ginseng in the product may also provide benefits for improving cognition and mental focus. In some embodiments, maca root and ginseng are present in a weight ratio of about 10:1 to about 1:10, such as about 5:1 to about 1:5, and preferably about 3:1 to about 1:3. In particularly preferred embodiments, maca root and ginseng may be present in a weight ratio of about 2:1 to about 1:3.

[0125]

[0125] Ginseng may be present in an amount such that the weight ratio of ginseng to total B vitamins is from about 15:1 to about 1:15, for example, from about 10:1 to about 1:10. Preferably, ginseng may be present in an amount such that the weight ratio of ginseng to total B vitamins is from about 5:1 to about 1:1.

[0126] Alternatively, ginseng may be present in an amount such that the weight ratio of ginseng to total B vitamins is from about 60:1 to about 1:1, for example, from about 40:1 to about 1:1. Preferably, ginseng may be present in an amount such that the weight ratio of ginseng to total B vitamins is from about 35:1 to about 1:1.

[0127] In some embodiments, the total amount of maca root and B vitamins is present in a weight ratio of about 10:1 to about 1:10, such as about 5:1 to about 1:5. In preferred embodiments, the total amount of maca root and B vitamins is present in a weight ratio of about 3:1 to about 1:3.

[0128] In another embodiment, the total amount of maca root and B vitamins is present in a weight ratio of about 100:1 to about 10:1, such as about 90:1 to about 15:1. In a preferred embodiment, the total amount of maca root and B vitamins is present in a weight ratio of about 85:1 to about 20:1.

[0129] In a further embodiment, the total amount of maca root and B vitamins is present in a weight ratio of about 85:1 to about 1:10, such as about 60:1 to about 1:5. In a preferred embodiment, the total amount of maca root and B vitamins is present in a weight ratio of about 15:1 to about 1:3.

[0130] When present, theacrine may be included in a weight ratio of maca root to theacrine of about 10:1 to about 1:10, e.g., about 5:1 to about 1:5. In preferred embodiments, the weight ratio of maca root to theacrine is about 3:1 to about 1:3. The weight ratio of total B vitamins to theacrine may be about 10:1 to about 1:10. In some preferred embodiments, the weight ratio of total B vitamins to theacrine may be about 5:1 to about 1:10, more preferably about 1:1 to about 1:10. The weight ratio of theacrine to ginseng may be about 10:1 to about 1:10. In some preferred embodiments, the weight ratio of theacrine to ginseng may be about 5:1 to about 1:5, more preferably about 3:1 to about 1:1.

[0131] When present, coenzyme Q10 (CoQ10) is included in a weight ratio of maca root to CoQ10 of about 50:1 to about 1:10. In some embodiments, the weight ratio of maca root to CoQ10 is about 30:1 to about 1:10. In preferred embodiments, the weight ratio of maca root to CoQ10 is about 10:1 to about 1:10. The weight ratio of CoQ10 to total B vitamins can be about 50:1 to about 1:1. In some preferred embodiments, the weight ratio of CoQ10 to total B vitamins can be about 40:1 to about 1:5, more preferably about 35:1 to about 1:3. The weight ratio of CoQ10 to ginseng can be about 10:1 to about 1:20. In some preferred embodiments, the weight ratio of CoQ10 to ginseng can be about 5:1 to about 1:10, more preferably about 4:1 to about 1:10.

[0132] When present, vitamin C may be included in a weight ratio of maca root to vitamin C of about 10:1 to about 1:10, e.g., about 5:1 to about 1:10, preferably about 2:1 to about 1:10. The weight ratio of total B vitamins to vitamin C may be about 10:1 to about 1:10, e.g., about 5:1 to about 1:10, preferably about 1:1 to about 1:10. The weight ratio of total B vitamins to vitamin C may be about 1:1 to about 1:100, e.g., about 1:5 to about 1:100, preferably about 1:10 to about 1:50.

[0133]

[0133] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, and (iii) ginseng, wherein the weight ratio of maca root to ginseng is about 10:1 to about 1:10, the weight ratio of maca root to total B vitamins is about 10:1 to about 1:10, and the weight ratio of ginseng to total B vitamins is about 15:1 to about 1:15, and the B vitamin combination is as described in any of the embodiments herein above.

[0134]

[0134] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, and (iii) ginseng, wherein the weight ratio of maca root to ginseng is about 5:1 to about 1:5, the weight ratio of maca root to total B vitamins is about 5:1 to about 1:5, and the weight ratio of ginseng to total B vitamins is about 10:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0135]

[0135] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, and (iii) ginseng, wherein the weight ratio of maca root to ginseng is from about 3:1 to about 1:3, the weight ratio of maca root to total B vitamins is from about 3:1 to about 1:3, and the weight ratio of ginseng to total B vitamins is from about 5:1 to about 1:1, and the B vitamin combination is as described in any of the embodiments herein above.

[0136]

[0136] In any of the above embodiments, the oral product may further comprise (iv) theacrine, wherein the weight ratio of maca root to theacrine is from about 10:1 to about 1:10, for example from about 5:1 to about 1:5, preferably from about 3:1 to about 1:3.

[0137]

[0137] In a second aspect of the present invention, the oral product further comprises (iv) CoQ10, wherein the weight ratio of maca root to CoQ10 is about 50:1 to about 1:10, about 30:1 to about 1:10, preferably about 10:1 to about 1:10.

[0138] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, and (iv) theacrine, wherein the weight ratio of maca root to ginseng is from about 10:1 to about 1:10, the weight ratio of maca root to total B vitamins is from about 10:1 to about 1:10, the weight ratio of ginseng to total B vitamins is from about 15:1 to about 1:15, and the weight ratio of maca root to theacrine is from about 10:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0139] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, and (iv) theacrine, wherein the weight ratio of maca root to ginseng is from about 5:1 to about 1:5, the weight ratio of maca root to total B vitamins is from about 5:1 to about 1:5, the weight ratio of ginseng to total B vitamins is from about 10:1 to about 1:10, and the weight ratio of maca root to theacrine is from about 5:1 to about 1:5, and the B vitamin combination is as described in any of the embodiments herein above.

[0140] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, and (iv) theacrine, wherein the weight ratio of maca root to ginseng is from about 3:1 to about 1:3, the weight ratio of maca root to total B vitamins is from about 3:1 to about 1:3, the weight ratio of ginseng to total B vitamins is from about 5:1 to about 1:1, and the weight ratio of maca root to theacrine is from about 3:1 to about 1:3, and the B vitamin combination is as described in any of the embodiments herein above.

[0141]

[0141] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, and (iv) CoQ10, wherein the weight ratio of maca root to ginseng is from about 10:1 to about 1:10, the weight ratio of maca root to total B vitamins is from about 85:1 to about 1:10, the weight ratio of ginseng to total B vitamins is from about 60:1 to about 1:1, and the weight ratio of maca root to CoQ10 is from about 50:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0142]

[0142] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, and (iv) CoQ10, wherein the weight ratio of maca root to ginseng is from about 5:1 to about 1:5, the weight ratio of maca root to total B vitamins is from about 60:1 to about 1:5, the weight ratio of ginseng to total B vitamins is from about 40:1 to about 1:1, and the weight ratio of maca root to CoQ10 is from about 30:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0143]

[0143] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, and (iv) CoQ10, wherein the weight ratio of maca root to ginseng is from about 3:1 to about 1:3, the weight ratio of maca root to total B vitamins is from about 15:1 to about 1:3, the weight ratio of ginseng to total B vitamins is from about 35:1 to about 1:1, and the weight ratio of maca root to CoQ10 is from about 10:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0144] In any of the above embodiments, the oral product may further comprise (v) vitamin C, wherein the weight ratio of maca root to vitamin C is about 10:1 to about 1:10. In some preferred embodiments, the weight ratio of maca root to vitamin C is about 5:1 to about 1:10, more preferably about 2:1 to about 1:10. The weight ratio of total B vitamins to vitamin C may be about 10:1 to about 1:10, preferably about 5:1 to about 1:10, more preferably about 1:1 to about 1:10. In some embodiments, the weight ratio of total B vitamins to vitamin C may be about 1:1 to about 1:100, preferably about 1:5 to about 1:100, more preferably about 1:10 to about 1:50.

[0145] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, and (v) vitamin C, wherein the weight ratio of maca root to ginseng is about 10:1 to about 1:10, the weight ratio of maca root to total B vitamins is about 10:1 to about 1:10, the weight ratio of ginseng to total B vitamins is about 15:1 to about 1:15, and the weight ratio of maca root to vitamin C is about 10:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0146]

[0146] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, and (v) vitamin C, wherein the weight ratio of maca root to ginseng is from about 5:1 to about 1:5, the weight ratio of maca root to total B vitamins is from about 5:1 to about 1:5, the weight ratio of ginseng to total B vitamins is from about 10:1 to about 1:10, and the weight ratio of maca root to vitamin C is from about 5:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0147]

[0147] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, and (v) vitamin C, wherein the weight ratio of maca root to ginseng is from about 3:1 to about 1:3, the weight ratio of maca root to total B vitamins is from about 3:1 to about 1:3, the weight ratio of ginseng to total B vitamins is from about 5:1 to about 1:1, and the weight ratio of maca root to vitamin C is from about 1:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0148] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, (iv) theacrine, and (v) vitamin C, wherein the weight ratio of maca root to ginseng is about 10:1 to about 1:10, the weight ratio of maca root to total B vitamins is about 10:1 to about 1:10, the weight ratio of ginseng to total B vitamins is about 10:1 to about 1:15, the weight ratio of maca root to theacrine is about 10:1 to about 1:10, and the weight ratio of maca root to vitamin C is about 10:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0149] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, (iv) theacrine, and (v) vitamin C, wherein the weight ratio of maca root to ginseng is about 5:1 to about 1:5, the weight ratio of maca root to total B vitamins is about 5:1 to about 1:5, the weight ratio of ginseng to total B vitamins is about 10:1 to about 1:10, the weight ratio of maca root to theacrine is about 5:1 to about 1:5, and the weight ratio of maca root to vitamin C is about 5:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0150] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, (iv) theacrine, and (v) vitamin C, wherein the weight ratio of maca root to ginseng is from about 3:1 to about 1:3, the weight ratio of maca root to total B vitamins is from about 3:1 to about 1:3, the weight ratio of ginseng to total B vitamins is from about 5:1 to about 1:1, the weight ratio of maca root to theacrine is from about 3:1 to about 1:3, and the weight ratio of maca root to vitamin C is from about 1:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0151] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, (iv) CoQ10, and (v) vitamin C, wherein the weight ratio of maca root to ginseng is about 10:1 to about 1:10, the weight ratio of maca root to total B vitamins is about 85:1 to about 1:10, the weight ratio of ginseng to total B vitamins is about 60:1 to about 1:1, the weight ratio of maca root to CoQ10 is about 50:1 to about 1:10, and the weight ratio of maca root to vitamin C is about 10:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0152] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, (iv) CoQ10, and (v) vitamin C, wherein the weight ratio of maca root to ginseng is about 5:1 to about 1:5, the weight ratio of maca root to total B vitamins is about 60:1 to about 1:5, the weight ratio of ginseng to total B vitamins is about 40:1 to about 1:1, the weight ratio of maca root to CoQ10 is about 5:1 to about 1:5, and the weight ratio of maca root to vitamin C is about 30:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0153] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a B vitamin combination, (iii) ginseng, (iv) CoQ10, and (v) vitamin C, wherein the weight ratio of maca root to ginseng is about 3:1 to about 1:3, the weight ratio of maca root to total B vitamins is about 15:1 to about 1:3, the weight ratio of ginseng to total B vitamins is about 35:1 to about 1:1, the weight ratio of maca root to CoQ10 is about 10:1 to about 1:10, and the weight ratio of maca root to vitamin C is about 2:1 to about 1:10, and the B vitamin combination is as described in any of the embodiments herein above.

[0154] In each of the above embodiments, the weight ratio of total B vitamins to vitamin C can be defined as about 10:1 to about 1:10, preferably about 5:1 to about 1:10, and more preferably about 1:1 to about 1:10. Alternatively, the weight ratio of total B vitamins to vitamin C can be defined as about 1:1 to about 1:100, preferably about 1:5 to about 1:100, and more preferably about 1:10 to about 1:50.

[0155]

[0155] In each of the above embodiments, the active ingredient combination may further include theobromine. The weight ratio of maca to theobromine may be about 10:1 to about 1:10, preferably about 5:1 to about 1:5, and more preferably about 3:1 to about 1:3. The weight ratio of CoQ10 to theobromine may be about 10:1 to about 1:10, preferably about 5:1 to about 1:5, and more preferably about 4:1 to about 1:4.

[0156] additives Depending on the type of oral product being processed, the product may contain one or more additional components in addition to the combination of active ingredients. For example, the oral product may further comprise 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 comprises one or more additives selected from the group consisting of flavoring agents, sweeteners, acidifying agents, thickeners, fillers, binders, humectants, preservatives, and mixtures thereof.

[0157] Filler Depending on the product form, oral products may contain fillers, which may serve multiple functions, such as improving certain organoleptic properties, such as texture and mouthfeel, or improving the cohesiveness or compressibility of the product.

[0158] In some embodiments, the filler is a porous granular material and is cellulosic. For example, the filler or bulking agent can be a non-tobacco plant material or 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, grass 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.

[0159] 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, semi-synthetic, or 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.

[0160]

[0160] 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 starch (e.g., from potato, wheat, rice, corn), natural cellulose, and modified cellulose materials. Further examples of possible fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Combinations of these fillers can also be used.

[0161]

[0161] 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, shoots, fruits, grains, and stems). Starches can vary in composition and granule shape and size. Often, starches from different sources have different chemical and physical properties. A particular starch can be selected for inclusion in a product based on the ability of the starch material to impart particular organoleptic properties to the product. Starch from a variety of sources can be used. For example, major sources of starch include grains (e.g., rice, wheat, and corn) and root vegetables (e.g., potato and cassava). Other examples of starch sources include acorns, arrowroot, arracacha, bananas, barley, beans (e.g., fava beans, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnut, taro, potato starch, kudzu, malanga, millet, oats, oka, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, salo, tobacco, water chestnut, and yam. Certain starches are modified starches. Modified starches often have one or more structural modifications designed to alter their high thermal properties. Some starches are developed through genetic engineering and are considered "modified" starches. Other starches are obtained and then processed. For example, modified starches can be starches that have been subjected to chemical reactions such as esterification, etherification, oxidation, depolymerization (thinning), bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), crosslinking, enzyme treatment, acetylation, hydroxypropylation, and / or partial hydrolysis by acid catalysis or oxidation in the presence of a base. Other starches are processed by heat treatment, e.g., pregelatinization, dextrinization, and / or cold water swelling processes.Certain modified starches include monostarch phosphate, didarch glycerol, didarch phosphate esterified with sodium trimetaphosphate, didarch phosphate, acetylated didarch phosphate, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated didarch adipate, acetylated didarch glycerol, hydroxypropyl starch, hydroxypropyl didarch glycerol, and starch sodium octenylsuccinate.

[0162] water

[0162] The moisture content (eg, water content) of an oral product prior to consumer use of the product can vary according to the desired properties.

[0163] Typically, for solid oral products, prior to insertion into the user's mouth, the water content is less than about 60% by weight of the oral product, generally from about 1 to about 60% by weight of the oral product, 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, with a water content of at least about 5%, at least about 10%, at least about 15%, and at least about 20% by weight of the oral product.

[0164] 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.

[0165] Flavoring agents As used herein, the term "flavoring agent" (or "flavor" or "flavoring") 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 properties that may be modified by a flavoring agent include taste, mouthfeel, 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.

[0166] Flavoring agents may be naturally occurring flavoring materials, botanicals, extracts of botanicals, synthetically derived materials, or combinations thereof (e.g., tobacco, cannabis, licorice, hydrangea, eugenol, magnolia leaf, chamomile, fenugreek, clove, maple, matcha green tea, menthol, Japanese mint, aniseed, cinnamon, turmeric, Indian spices, Asian spices, herbs, wintergreen, cherry, berry, red berry, cranberry, raspberry, strawberry, peach, apple, orange, mango). , pineapple, 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, coconut, celery, cascarilla, nutmeg, sandalwood, bergamot, geranium, khat, eggplant, betel nut, shisha, pine, honey essence, rose oil, vanilla, lemon oil, orange oil, orange blossom, cherry blossom , cassia, caraway, cognac, jasmine, ylang-ylang, 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, blackcurrant, 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., honey, sucralose, acesulfame potassium, aspartame, saccharin, cyclamate, lactose, sucrose, glucose, fructose, sorbitol, or mannitol), and charcoal, chlorophyll, minerals, plant substances,or other additives such as breath fresheners. They may be imitation, synthetic or natural ingredients, or blends thereof. They may be in any suitable form, for example, a liquid such as an oil, a solid such as a powder, or a gas.

[0167]

[0167] In some embodiments, the flavoring agent comprises a natural flavoring agent such as berry (e.g., raspberry, blueberry, or strawberry), honey, citrus (such as lemon, bergamot, orange, or lime), or other botanical material.

[0168] 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.

[0169] 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.

[0170] 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.

[0171] Binder In some embodiments, the oral product may further comprise at least one binder. A binder (or combination of binders) may be used in the product in certain embodiments in an amount sufficient to provide the product with desired physical attributes and physical integrity.

[0172]

[0172] The binder may be organic or inorganic, or a combination thereof. Representative binders include cellulose derivatives, povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof. The amount of binder utilized in the product may vary but may be up to about 30% by weight, with certain embodiments featuring 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.

[0173] In some embodiments, the binder comprises a cellulose derivative. In certain embodiments, the 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 certain embodiments comprise from about 1% to about 5% by weight of the cellulose derivative (such as HPC), based on the weight of the product.

[0174] moisturizer 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 propylene glycol. The amount of humectant utilized in the oral product can vary but can 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.

[0175] sweeteners

[0175] To improve the sensory properties of oral products, one or more sweeteners may be added. The sweetener may be any sweetener or combination of sweeteners, in natural or artificial form, or as 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.

[0176] In some embodiments, the sweetener comprises one or more sugar alcohols. The sugar alcohol may comprise erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, or a combination 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.

[0177] 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 may be sucralose and / or acesulfame K. When present in an oral product, the sweetener (such as sucralose and / or acesulfame K) may 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.

[0178] 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 included in an amount less than about 5% by weight of the oral product, e.g., about 0.5% to about 5% by weight, e.g., about 0.75% to about 4% by weight, about 0.75% to about 3% by weight, or about 1% to about 2% by weight, based on the total weight of the oral product.

[0179] 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 particular mixture component, as opposed to being inherently present merely as a constituent of another mixture component (e.g., a small amount of an 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 neat (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.

[0180] In some embodiments, the organic acid is a carboxylic acid or a sulfonic acid. The carboxylic acid or sulfonic acid functional group may, for example, have 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.

[0181] In some embodiments, the organic acid is an alkyl carboxylic acid. Non-limiting examples of alkyl carboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, etc. In some embodiments, the organic acid is an alkyl sulfonic acid. Non-limiting examples of alkyl sulfonic acids include propane sulfonic acid and octanesulfonic acid.

[0182] 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.

[0183] 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 of the carboxylic acid groups may be esterified. Non-limiting examples include succinic acid monoethyl ester, monomethyl fumarate, monomethyl citrate, or dimethyl citrate.

[0184] 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.

[0185] 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.

[0186] Further non-limiting examples of suitable organic acids include 2,2-dichloroacetic acid, 2-hydroxyethanesulfonic acid, 2-oxoglutaric acid, 4-acetamidobenzoic acid, 4-aminosalicylic acid, acetic acid, adipic acid, ascorbic acid (L), aspartic acid (L), camphoric acid (+), camphor-10-sulfonic acid (+), capric acid, caproic acid, caprylic acid, cinnamic acid, cyclamic acid, decanoic acid, dodecyl sulfuric acid, ethane-1,2-disulfonic acid, These include 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.

[0187] 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 comprises citric acid or a salt thereof.

[0188]

[0188] In some embodiments, the organic acid is or includes anhydrous citric acid.

[0189] The amount of organic acid present in the product can vary. The oral product can contain 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 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. When a salt of the organic acid is added (e.g., anhydrous citric acid), the weight percentage is calculated based on the weight of the free acid, without any counterion that may be present.

[0190] 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.

[0191]

[0191] In another embodiment, a mineral acid (eg, hydrochloric acid, sulfuric acid, phosphoric acid, etc.) is added to adjust the pH of the product to a desired value.

[0192]

[0192] 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.

[0193] thickener

[0193] 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).

[0194]

[0194] 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.

[0195] coloring agent

[0195] Colorants can be used in an amount sufficient to provide the product with the desired physical attributes. Examples of colorants include various dyes and pigments, such as caramel color and titanium dioxide. Natural colorants, such as curcumin, beet juice extract, and spirulina, as well as various synthetic pigments, can also be used. The amount of colorant utilized in oral products can vary, but, when present, is typically up to about 3% by weight, 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.

[0196] 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 desired control of the physical attributes of the oral product, such as by providing loss of physical integrity and dispersion of the various component materials upon contact of the formulation with water (e.g., by undergoing swelling upon contact with water).

[0197]

[0197] Additional examples of additives include zinc or magnesium salts, or combinations thereof, selected to be relatively water-soluble for compositions with higher water solubility (e.g., magnesium gluconate or zinc gluconate), or relatively water-insoluble for compositions with reduced water solubility (e.g., magnesium oxide or zinc oxide). See, for example, U.S. Pat. No. 9,237,769 to Mua et al., U.S. Pat. No. 7,861,728 to Holton, Jr. et al., U.S. Pat. App. Pub. No. 2010 / 0291245 to Gao et al., and U.S. Pat. App. Pub. No. 2007 / 0062549 to Holton, Jr. et al., each of which is incorporated herein by reference, for their representative components, combinations of components, relative amounts of these components, and modes and methods for using these components. Typical inclusion 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 include, for example, a range of 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.

[0198] 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.

[0199] In some preferred embodiments, the oral product comprises zinc or zinc gluconate in an amount of about 0.001% to about 5%, or about 0.01% to about 2%, preferably about 0.01% to about 0.1%, by weight of the oral product.

[0200]

[0200] 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). Furthermore, 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, previously incorporated herein by reference.

[0201] Oral products

[0201] 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 of the product's components (e.g., active ingredients) into the user's mouth. In certain embodiments, the product is adapted to deliver the active ingredient(s) and optional flavoring agent(s) to the user through the mucous membranes of the user's mouth, the user's digestive system, or both. In some cases, the active ingredient(s) and optional flavoring agent(s) may be absorbed through the mucous membranes in the mouth or may be absorbed through the digestive tract when the product is used.

[0202] 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, or 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, 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 15% by weight or less of the oral product.

[0203] 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 15% by weight of the oral product, more preferably about 1% to about 10% by weight of the oral product.

[0204] Oral products can be in any form suitable for application to the oral cavity of a human or animal. Oral products described herein can be in a variety of forms, including gels, melts, tablets, lozenges, powders, pouches, and liquids (e.g., beverages). 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.

[0205]

[0205] In some preferred embodiments, the oral product is a liquid oral dosage form. The term "liquid" does not include gels.

[0206] Liquid oral dosage forms

[0206] In some preferred embodiments, the oral product is in the form of a liquid dosage form, which is suitable for oral consumption, such that it can be ingested (i.e., drunk) by the user and may be referred to as a beverage.

[0207]

[0207] 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 two sips. Formulating an oral product in the form of a shot can be advantageous because it takes up less space during storage (e.g., in a refrigerator or cupboard) and provides a convenient, easy-to-use mode of administration that can be easily carried by the user and taken on the go. A shot can also provide an efficient delivery vehicle for the active ingredient, thereby delivering a sufficient level of the active ingredient to the user to provide good efficacy without the need to consume large amounts of liquid. Furthermore, a shot can be formulated to have a pleasant taste. Drinking a shot can be considered more palatable and easier for the user than, for example, swallowing a tablet.

[0208]

[0208] Liquid oral dosage forms may also be in the form of larger beverages that are consumed more slowly over several sips. 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.

[0209]

[0209] The liquid oral dosage form may 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 may be considered a shot. For example, the volume of the liquid may be about 60 mL or about 30 mL.

[0210] 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.

[0211]

[0211] When present, water may include tap water, rainwater, mineralized water, or distilled water.

[0212] The liquid oral dosage form may comprise a combination of active ingredients in an amount of about 0.1% to about 15% by weight of the oral product, and water in an amount of about 85% 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 12% by weight of the oral product, and water in an amount of about 88% to about 99.5% by weight of the oral product.

[0213] In some embodiments, the combination of active ingredients in the liquid oral dosage form includes (i) maca root, (ii) a B vitamin combination as defined hereinabove, (iii) ginseng, and optionally (iv) theacrine and / or (v) vitamin C. The combination of active ingredients in the liquid oral dosage form can include (i) maca root, (ii) a B vitamin combination as defined hereinabove, (iii) ginseng, (iv) theacrine, and (v) vitamin C.

[0214] In some embodiments, the combination of active ingredients in the liquid oral dosage form includes (i) maca root, (ii) a B vitamin combination as defined hereinabove, (iii) ginseng, (iv) CoQ10, and optionally (v) vitamin C. The combination of active ingredients in the liquid oral dosage form may include (i) maca root, (ii) a B vitamin combination as defined hereinabove, (iii) ginseng, (iv) CoQ10, and (v) vitamin C. The combination of active ingredients may further include theobromine.

[0215]

[0215] In any of the above embodiments, the liquid oral dosage form may optionally further comprise zinc or zinc gluconate in an amount of about 0.01% to about 2% by weight of the oral product.

[0216]

[0216] A liquid oral dosage form (e.g., in the form of a shot having a volume of 25 mL to 75 mL) may contain maca root in an amount of about 5 mg to about 50 mg, preferably about 10 mg to about 40 mg, and more preferably about 15 mg to about 30 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) may contain maca root in an amount of about 10 mg to about 500 mg, preferably about 15 mg to about 400 mg, and more preferably about 25 mg to about 375 mg.

[0217]

[0217] A liquid oral dosage form (e.g., in the form of a shot 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 10 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, B3, B5, B6, B7, B9, and B12, with a total amount of B vitamins being about 10 mg to about 50 mg.

[0218] In some 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 a total amount of B vitamins in an amount of about 1 mg to about 50 mg, preferably about 2 mg to about 35 mg, and more preferably about 2 mg to about 25 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 being about 1 mg to about 50 mg.

[0219]

[0219] A liquid oral dosage form (eg, 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.

[0220]

[0220] In some embodiments, 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 1 mg to about 500 mg, preferably about 5 mg to about 300 mg, and more preferably about 10 mg to about 250 mg.

[0221] 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.

[0222]

[0222] 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 CoQ10 in an amount of about 5 mg to about 500 mg, for example, about 10 mg to about 300 mg, for example, about 15 mg to about 200 mg.

[0223] 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.

[0224]

[0224] In some 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 5 mg to about 50 mg of maca root, (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, (iii) about 1 mg to about 500 mg of ginseng, and optionally (iv) about 10 mg to about 500 mg of theacrine, and / or optionally (v) about 10 mg to about 500 mg of vitamin C.

[0225]

[0225] In some 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) from about 10 mg to about 40 mg of maca root, (ii) from about 10 mg to about 75 mg of a B vitamin combination including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) from about 10 mg to about 300 mg of ginseng, and optionally (iv) from about 50 mg to about 500 mg of theacrine, and / or optionally (v) from about 50 mg to about 500 mg of vitamin C.

[0226]

[0226] In some 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 15 mg to about 30 mg of maca root, (ii) about 10 mg to about 50 mg of a B vitamin combination including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) about 25 mg to about 200 mg of ginseng, and optionally (iv) about 75 mg to about 300 mg of theacrine, and (v) about 200 mg to about 400 mg of vitamin C.

[0227]

[0227] In some 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 15 mg to about 30 mg of maca root, (ii) about 10 mg to about 50 mg of a B vitamin combination including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) about 50 mg to about 150 mg of ginseng, and optionally (iv) about 75 mg to about 200 mg of theacrine, and (v) about 250 mg to about 350 mg of vitamin C.

[0228]

[0228] In some 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) from about 10 mg to about 500 mg of maca root, (ii) from about 1 mg to about 50 mg of a B vitamin combination including at least two selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) from about 1 mg to about 500 mg of ginseng, (iv) from about 5 mg to about 500 mg of CoQ10, and optionally (v) from about 10 mg to about 500 mg of vitamin C.

[0229]

[0229] In some 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) from about 15 mg to about 400 mg of maca root, (ii) from about 2 mg to about 35 mg of a B vitamin combination including at least two selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) from about 5 mg to about 300 mg of ginseng, (iv) from about 10 mg to about 300 mg of CoQ10, and optionally (v) from about 50 mg to about 500 mg of vitamin C.

[0230]

[0230] In some 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 25 mg to about 375 mg of maca root, (ii) about 2 mg to about 25 mg of a B vitamin combination including at least two selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) about 10 mg to about 250 mg of ginseng, (iv) about 15 mg to about 200 mg of CoQ10, and (v) about 200 mg to about 400 mg of vitamin C.

[0231]

[0231] In any of the above embodiments, the liquid oral dosage form (eg, in the form of a shot having a volume of 25 mL to 75 mL) can contain from about 10 mg to about 500 mg of theobromine.

[0232]

[0232] The inventors have found that the amounts of active ingredients listed above provide beneficial effects of increasing energy levels and enhancing brain function, particularly before physical exercise, while providing a safe product with reduced side effects. These amounts can be adjusted to ensure the product is highly effective while ensuring consumer safety and avoiding overdosing on the active ingredients.

[0233] In any of the above embodiments, the liquid oral dosage form may optionally further comprise zinc, e.g., zinc gluconate, in an amount of from about 1 mg to about 150 mg. In a preferred embodiment, the liquid oral dosage form may further comprise zinc in an amount of from about 10 mg to about 50 mg.

[0234]

[0234] 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 above.

[0235] solid oral dosage forms

[0235] 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 moist snuff, loose dry snuff, pelletized pieces, extruded or formed strips, pieces, rods, or sticks, finely divided ground powders, powdered pieces, and finely divided or ground agglomerates of components, flaked pieces, molded pieces, films, readily water-soluble or water-dispersible films or strips, encapsulated materials, tablets, or lozenges. In some embodiments, the oral product is a tablet or lozenge. In some embodiments, the oral product is in the form of moist snuff or snus, which may or may not contain tobacco.

[0236] 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. While the cross-sectional shape of the product can vary, exemplary cross-sectional shapes include round, square, oval, rectangular, etc. Such shapes can be formed in a variety of ways using equipment such as moving belts, nips, extruders, granulators, and compactors.

[0237]

[0237] In some embodiments, the solid oral product is in a form selected from the group consisting of a melt, a tablet, or a lozenge.

[0238] melt

[0238] In some embodiments, the product may be meltable, for example, as discussed in US Patent Application Publication No. 2012 / 0037175 to Cantrell et al., which is incorporated herein by reference in its entirety.

[0239]

[0239] 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.

[0240]

[0240] The application of heat for the products disclosed herein is provided by the internal temperature of the user's mouth. Thus, the term "meltable" refers to products that can be liquefied in the user's mouth as the product changes phase from solid to liquid, and is intended to distinguish from products that simply disintegrate in the oral cavity due to loss of cohesion within the product, which simply dissolves in the oral cavity when the water-soluble components of the product interact with moisture.

[0241]

[0241] 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., plant-derived fats) and typically contain 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") when exposed to the temperature of a user's mouth. Exemplary plant-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.

[0242] 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, beechnut oil, ben oil, bitter melon oil, black seed oil, blackcurrant seed oil, borage seed oil, tianqiao 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, palm oil, corn oil, cohune palm oil, coriander seed oil, cottonseed oil, date palm seed oil, zika oil, egus seed oil, evening primrose oil, camellia oil, linseed oil, grape seed oil, grapefruit seed oil, hazelnut oil, hemp seed oil, kapok seed oil, kenaf seed oil, rallemantia 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, Groundnut oil, Pecan oil, Perilla seed oil, Perilla seed oil, Pequi oil, Pili nut oil, Pine nut oil, Pistachio oil, Pomegranate seed oil, Poppy seed oil, Prakash oil, Plum kernel oil, Pumpkin seed oil, Quinoa oil, Rapeseed oil, Rice bran oil, Roil oil, Sacha inchi oil, Safflower oil, Sapote oil, Ceje oil, Sesame oil, Sichuan nut oil, butter, 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 oil.

[0243]

[0243] In certain embodiments, the plant-derived fats of the present disclosure include palm oil (including fractionated palm oil), palm kernel 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 may 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.

[0244] 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.).

[0245]

[0245] 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 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 dry weight. Exemplary lipid weight ranges include about 10 to about 70% dry weight, e.g., about 35 to about 50% 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.

[0246] 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, and 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.

[0247]

[0247] In some 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 is 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 the 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.

[0248] tablet In certain embodiments, the product is in the form of a compressed or molded tablet. Exemplary tablet dosage forms have a weight of about 250 mg to about 1500 mg, e.g., about 250 mg to about 700 mg, or about 700 mg to about 1500 mg. The tablet can have any of a variety of shapes, including traditional pill or tablet shapes.

[0249]

[0249] Generally, the tablet-form product comprises a glucose-polysaccharide blend and a sugar alcohol. In some embodiments, the glucose-polysaccharide blend is present in an amount of about 35 to about 50% by weight, based on the total weight of the product, and the sugar alcohol is present in an amount of about 30 to about 45% by weight, based on the total weight of the product. In some embodiments, the sugar alcohol is 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.

[0250]

[0250] When in tablet form, the product may be dissolvable. As used herein, the terms "dissolve," "dissolution," and "dissolvable" refer to a product having water-soluble components that interact with the moisture in the oral cavity to form a solution, thereby causing gradual consumption of the product. According to one aspect, a dissolvable product can remain in the user's mouth for a given period of time until completely dissolved. The dissolution rate can vary over a wide range, from about 1 minute or less to about 60 minutes. For example, rapid-release products typically dissolve and / or release the desired components (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 by disruption of interactions between the product's components. In other embodiments, the product does not dissolve while the product remains in the user's mouth.

[0251] Lozenges In some embodiments, the products disclosed herein may be in the form of a dissolvable lozenge product configured for oral use. Exemplary lozenge-type products of the present invention have the form of a lozenge, tablet, microtab, or other tablet-type product. See, for example, U.S. Patent Nos. 4,967,773 to Shaw, 5,110,605 to Acharya, 5,733,574 to Dam, 6,280,761 to Santus, 6,676,959 to Andersson et al., 6,248,760 and 7,374,779 to Wilhelmsen, and U.S. Patent Application Publication No. 2001 / 00165, all of which are incorporated herein by reference. See US Pat. No. 6,993, US Pat. No. 6,993 to Liu et al., US Pat. No. 6,994 to McNeight, US Pat. No. 6,994 to Chau et al., US Pat. No. 6,994 to Gin et al., US Pat. No. 6,994 to Axelsson et al. for descriptions of types of nicotine-containing lozenges, lozenge formulations, lozenge formats and configurations, lozenge properties, and techniques for formulating or manufacturing lozenges.

[0252]

[0252] Lozenge products are generally described as "hard" and are 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.

[0253]

[0253] The lozenge-shaped product, in some embodiments, 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 (or nephelometry) and colorimetry can be used to quantify the opacity (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 diffuses and passes through the material or product.

[0254]

[0254] 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.

[0255]

[0255] 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 is typically present in an amount of about 0.1% to about 10% by weight, for example, about 0.1% to about 10% by weight, for example, 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% 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.

[0256]

[0256] In some embodiments, the lozenge product comprises a sugar substitute. The sugar substitute is typically provided in a pure solid form (e.g., granulated or powdered form). In certain embodiments, the sugar substitute is dry and comprises a very low moisture content. For example, the sugar substitute may comprise 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.

[0257] 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 benefit of reducing the tendency of the lozenge product to stick when exposed to humidity. The sugar substitute can be any sugar-free material (i.e., a material that does not contain sucrose) and can be natural or synthetically produced. The 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.

[0258]

[0258] In certain embodiments, the sugar substitute comprises one or more sugar alcohols. For example, in one embodiment, the sugar substitute is isomalt.

[0259]

[0259] In some embodiments, the sugar substitute is one or more of allulose, soluble tapioca fiber, and inulin. Such sugar substitutes may be a substitute for sugar alcohols or may be used in combination with one or more sugar alcohols.

[0260]

[0260] 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 aqueous solution of a sugar alcohol, e.g., having greater than about 40% solids, preferably greater than about 50% solids, greater than about 60% solids, greater than about 70% solids, or greater than about 80% solids. 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).

[0261]

[0261] The syrup, e.g., sugar alcohol syrup, can desirably affect the recrystallization of the melted sugar substitute. One exemplary sugar alcohol syrup that is 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 sugar alcohol syrups. For example, in some embodiments, corn syrup, golden syrup, and / or molasses can be used.

[0262]

[0262] The amount of sugar alcohol syrup added to the lozenge composition mixture is typically the amount necessary to slow the recrystallization of the sugar substitute in molten form. It should be noted that it may be possible to vary the amount of sugar alcohol syrup depending on the composition of the remaining ingredients to ensure that recrystallization is sufficiently slow to provide a material with the desired properties (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% by weight of the lozenge product mixture, often from about 0.5% to about 1.5% by weight, and more often about 1% by weight. In certain embodiments, the amount of sugar alcohol syrup is greater, e.g., up to about 2% by weight of the mixture, up to about 5% by weight of the mixture, up to about 10% by weight of the mixture, or up to about 20% by weight of the mixture.

[0263] Representative lozenge compositions and 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 flavoring agents in an amount up to about 5% by weight, and salt in an amount of 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.

[0264] Oral products of the present disclosure in the form of lozenges may contain varying amounts of water. The moisture content of the lozenges described herein, prior to consumer use of the product, may vary within such ranges depending on the desired properties and characteristics, as well as determining the final form of the product. For example, lozenge-shaped products typically have moisture contents ranging from about 0.1 to about 5% by weight of the product. Preferably, the moisture content of the lozenge product, present within a single unit of the product 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 moisture 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.

[0265] Powder or pouch products

[0265] 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 loose form in a container and thus may be used in a form similar to tobacco snuff, where the user pinches the powder from the container and places it in the mouth. 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 for insertion into the mouth of the user, i.e., a pouch oral product.

[0266] In some embodiments, the products of the present disclosure are in the form of a pouch oral product. 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.

[0267]

[0267] Such compositions in the form of moisture-permeable pouches are typically used by placing one pouch containing the composition in the mouth of a human subject / user. Generally, the pouch is placed somewhere in the user's oral cavity, for example, under the lip, similar to how moist snuff products are commonly used. The pouch is preferably neither chewed nor swallowed. Then, upon exposure to saliva, some of the components of the composition therein (e.g., active ingredient(s) and / or any flavor) pass through, for example, the moisture-permeable pouch, providing the user with a flavor and a satisfying sensation 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.

[0268] 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 fabrics that are neither woven nor knitted. Methods for manufacturing nonwoven materials are generally known in the art. Further information regarding nonwovens can be found in "Handbook of Nonwovens" by S. Russell, published by 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).

[0269] 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.

[0270]

[0270] 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 can be contained and packaged in the pouch in a manner and using the types of components used in the manufacture of conventional snus-type products. The pouch provides a moisture-permeable container of a type that can be considered similar in characteristics to the mesh-type materials used in the construction of tea bags. The components of the composition readily diffuse through the pouch into the user's mouth. Non-limiting examples of suitable types of pouches are shown, for example, in U.S. Pat. Nos. 5,167,244 to Kjerstad and 8,931,493 to Sebastian et al., as well as U.S. Patent Application Publication Nos. 2016 / 0000140 to Sebastian et al., 2016 / 0073689 to Sebastian et al., 2016 / 0157515 to Chapman et al., and 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 from the one-piece strand or matrix of pouches for use.

[0271]

[0271] Exemplary pouches can be manufactured from materials that undergo controlled dispersion or dissolution during use by the user. Such pouch materials can have the form of mesh, screen, perforated paper, permeable fabric, etc. For example, pouch materials manufactured from mesh-like or perforated rice paper can dissolve in the user's mouth. As a result, the pouch and composition can each completely disperse in the user's mouth during normal use conditions, and thus both the pouch and the composition can be ingested by the user. Other examples of pouch materials can be manufactured using materials in combination with water-dispersible film-forming materials (e.g., binders such as alginate, carboxymethylcellulose, xanthan gum, pullulan, etc.) and 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 components may be incorporated into or applied to the pouch material.

[0272] The amount of oral product contained in each pouch product unit, e.g., pouch, can vary. In some embodiments, the weight of the composition in each pouch is at least about 50 mg, e.g., about 50 mg to about 1 gram (1,000 mg), e.g., about 100 mg to about 900 mg, e.g., about 200 mg to about 800 mg, e.g., about 500 mg to about 700 mg. In some smaller embodiments, the weight of the composition in each pouch can be about 100 mg to about 300 mg. In larger embodiments, the weight of the composition in each pouch can be about 300 mg to about 700 mg. If desired, other components can be included in each pouch.

[0273] The moisture content of an oral product may vary depending on the format in which the composition is provided. In some embodiments described above, 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, e.g., at least 50% by weight. In some embodiments (e.g., in the case of snus-type products, e.g., non-pouch or pouch 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, e.g., from about 40% to about 55% by weight.

[0274] In some embodiments, the oral product may be a "dry" snus- or snuff-type product. In such embodiments, the moisture content of the oral product may be about 10% or less, e.g., about 5% or less, by weight of the oral product. For example, the moisture content may be about 0.1% to about 10%, e.g., about 1% to about 5%, by weight of the oral product.

[0275] When in the form of a pouch oral product, the oral product typically includes a filler. The filler may preferably be a cellulosic material selected from the suitable materials described above. In some preferred embodiments, the filler is or includes at least MCC. The amount of filler can vary, but typically is 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.

[0276] package According to some embodiments described herein, there is provided a package containing the oral product described herein. For example, the package may contain the oral product in powdered form. In such embodiments, the package may be in the form of a tin 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, tin, or plastic container containing such oral dosage forms.

[0277] According to some embodiments described herein, a package containing at least one pouch oral product described herein is provided. The pouch products described herein can be packaged in any suitable interior material and / or outer container. See, for example, U.S. Patent Nos. 7,014,039 to Henson et al., 7,537,110 to Kutsch et al., 7,584,843 to Kutsch et al., 8,397,945 to Gelardi et al., D592,956 to Thiellier, D594,154 to Patel et al., and D625,178 to Bailey et al., U.S. Patent Application Publication Nos. 2008 / 0173317 to Robinson et al., 2009 / 0014343 to Clark et al., and 2009 / 00144 to Bjorkholm, all of which are incorporated herein by reference. See also various types of containers for smokeless products shown in US Pat. No. 50, Bellamah et al., US Pat. No. 2009 / 0250360, Gelardi et al., US Pat. No. 2009 / 0266837, Gelardi et al., US Pat. No. 2009 / 0223989, Thiellier, US Pat. No. 2009 / 0230003, Gelardi, US Pat. No. 2010 / 0084424, and Bailey et al., US Pat. No. 2010 / 0133140, Bailey et al., US Pat. No. 2010 / 0264157, and Bailey et al., US Pat. No. 2011 / 0168712. For example, the package can be a tin or plastic container containing multiple pouch oral products.

[0278]

[0278] 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 can be a bottle containing a desired volume of the liquid oral dosage form.

[0279] method

[0279] The method of combining the various components of the composition (e.g., active ingredient and optional additives) can vary. Thus, for example, the overall product including the powdered composition components can be relatively uniform (e.g., homogeneous) in nature. The components, which can be in liquid or dry solid form, can be blended 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.

[0280] 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 brings the product ingredients into intimate contact can be used, such as a mixing device characterized by an impeller or other structure 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 shown in U.S. Pat. Nos. 4,148,325 to Solomon et al., 6,510,855 to Korte et al., and 6,834,654 to Williams, each of which is incorporated herein by reference. In some embodiments, the components that form the product are prepared so that the mixture can be used in the starch molding process to form the product.The manner and method of compounding the product will be clear to those skilled in the art.See, for example, the methodology of the kind shown 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, U.S. Patent No. 4,725,440 to Ridgway et al., and U.S. Patent No. 6,077,524 to Bolder et al., each of which is incorporated herein by reference.

[0281] Method for preparing a liquid oral dosage form

[0281] According to some embodiments described herein, (a) combining active ingredients; (b) contacting the active ingredient with water; (c) mixing the active ingredient with water to prepare an oral product; There is provided a method for preparing the oral products described herein, comprising:

[0282]

[0282] The combinations of active ingredients may be as described above. The combinations of active ingredients may also be as described below in relation to "Further Broad Embodiments."

[0283]

[0283] 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.

[0284] 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 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.

[0285]

[0285] The method may include the step of 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. 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.

[0286] 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 additive(s). 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.

[0287]

[0287] The resulting liquid product may be in the form of a solution or dispersion of the active ingredient in water.

[0288] Method for preparing a tablet product In some embodiments, the product is in the form of compressed pellets or tablets. In one embodiment, the method for making pellets or tablets includes first blending a bulk filler (e.g., EMDEX®) and the active ingredient. The remaining composition components (e.g., sugar alcohol and any other desired components, such as binders, colorants, sweeteners, flavors, etc.) are then added. Optionally, a colorant may be added to one of the composition components in a separate step before blending with the remaining components of the composition. Blending of the composition can be accomplished using any blending equipment. 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 a composition including any relevant formulation components 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. Equipment for providing an outer coating layer to a compacted pelletized composition is available from Thomas Engineering as CompuLab 24, CompuLab 36, Accela-Cota 48, and Accela-Cota 60.

[0289]

[0289] When present, the coating typically comprises a film-forming polymer, such as a cellulose polymer, an optional plasticizer, and optional flavorings, colorings, salts, sweeteners, or other additives of the type set forth 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. Exemplary film-forming polymers include cellulose polymers such as methylcellulose, hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethyl cellulose, and carboxymethylcellulose. Exemplary plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate. Additional potential coatings include food-grade shellac, waxes such as carnauba wax, and combinations thereof.

[0290] Method for Preparing Lozenge Products

[0290] The manner and methods used to formulate and manufacture the above lozenge products can vary. For example, the compositions can be prepared by any method commonly used to prepare hard-boiled confections. Exemplary methods for preparing hard confections can be found, for example, in LFRA Ingredients Handbook, Sweeteners, Janet M. Dalzell, Ed., Leatherhead Food RA (Dec. 1996), pp. 21-44, which is incorporated herein by reference.

[0291] Typically, a first mixture of ingredients is prepared. The composition of the first mixture of ingredients can vary, but 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 first mixture of ingredients 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 include an active ingredient, although in some embodiments, an active ingredient may be incorporated into the first mixture of ingredients.

[0292] A first mixture of ingredients is heated until melted, after which the mixture is heated to or above 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 can 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 allowed to cool. Heating can be carried out at atmospheric pressure or under vacuum. Typically, the methods of the present invention are carried out at atmospheric pressure.

[0293] In one exemplary embodiment, the first mixture of ingredients includes a high proportion of isomalt, and the mixture is heated to about 143° C. Once all components are dissolved, the temperature is increased beyond the hard crack stage (e.g., to about 166° C.). The mixture is heated to this temperature, and then removed from the heat and the mixture is allowed to cool.

[0294] In certain embodiments, the active ingredient(s) and optionally the additional components described above (e.g., additional sweeteners, fillers, flavoring agents, and water) are combined separately into 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., in certain embodiments, to about 132°C). In certain embodiments, one or more flavoring agents are added to the second mixture just before adding the mixture to the first heated 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 components, including, but not limited to, flavorings. Other methods of making lozenges are also intended to be encompassed herein.

[0295] 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 ingredients during the manufacturing process, and other similar types of factors. Additionally, the various process steps involved in product manufacture may involve the selection of certain solvents and processing aids, the use of heat and radiation, refrigeration and cryogenic conditions, ingredient mixing rates, etc. Manufacturing conditions may also be controlled by the selection of the form of the various ingredients (e.g., solid, liquid, or gas), the particle size or crystallinity 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.

[0296] 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 clarity such that the material may be classified as exhibiting "transparency" or "transparency," which is defined as a material that allows light to pass freely through it without significant diffusion. The clarity of the lozenge product is such that there is some level of translucency, as opposed to opacity, which refers to a material that does not allow light to pass through.

[0297]

[0297] 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 colorimetry can be used to quantify the opacity (light scattering) and color (light absorption), respectively, of the lozenge products provided herein. Translucency can also be confirmed by visual inspection by simply holding the material (e.g., extract) or product up to a light source and determining whether light diffuses through the product.

[0298] Method for preparing a molten product

[0298] In some embodiments, the product is in a meltable form. To prepare a meltable product, the lipid is typically heated slightly above its melting temperature so that the lipid is liquefied. Optionally, active ingredients, flavorings, and / or lecithin can be added to the liquefied lipid at this stage. All or a portion of the liquefied lipid can then be blended with the dry blend and mixed until the product reaches a desired level of homogeneity or until the desired textural characteristics are achieved. The mixture is milled (e.g., in a dry roll mill) until the particle size is less than about 20 microns. The milled isomalto-palm oil is combined with any remaining lipids and mixed with the dry ingredients and flavors. The base is generally warmed to a fluid consistency.

[0299]

[0299] In some embodiments, a sugar alcohol (eg, isomalt) is added to a mixer bowl, along with salt and an emulsifier, and a portion of the total lipid (eg, melted palm oil).

[0300]

[0300] Additional lipid is added with mixing until a cohesive mass forms. The agglomerated mixture is transferred in portions to a three-roll mill and processed to a particle size of less than 50 microns, or about 20 microns. 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.

[0301] The sweetener, flavor, 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 depositing 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.

[0302] The molten composition may be held in the mold (with or without starch) for a predetermined time, for example, from about 1 to about 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.

[0303]

[0303] According to another aspect of the present disclosure, rather than using a mold to prepare the molten product, an extrusion process can be used in which the final molten product is extruded. In some cases, the molten composition in slurry form can be formed into a sheet and dried to a moisture content of, for example, about 15% to about 25% water by weight to form a sticky or pasty material in a physically handleable form. The material can then be chopped or 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 cases, 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 may be subjected to a coextrusion process with another composition.

[0304]

[0304] 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 set forth in U.S. Patent Nos. 3,098,492 to Wursburg, 4,874,000 to Tamol et al., 4,880,018 to Graves et al., 4,989,620 to Keritsis et al., 5,072,744 to Luke et al., 5,829,453 to White et al., and 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 a Model TP 200 / 300 available from Emiliomiti, LLC, Italy. In some cases, a single machine may be capable of accomplishing multiple steps of the processes described herein, such as a kneader system available from Buss AG.

[0305]

[0305] While the above discussion focuses on a uniform composition throughout each product unit, products can also be formed with multiple different formulations with different properties within the same product unit. For example, two different compositions could be deposited in a single mold to produce a layered product. Furthermore, two different compositions could be co-extruded to form a product with different properties across its cross-section. Such a process could 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.

[0306] Method for preparing a pouch oral product

[0306] When the product is in the form of a pouch oral product, the method comprises: (a) combining active ingredients; (b) contacting the active ingredient combination and at least one filler to obtain an oral product; may include:

[0307]

[0307] The combinations of active ingredients may be as described above. The combinations of active ingredients may also be as described below in relation to "Further Broad Embodiments."

[0308] In some embodiments, step (b) comprises mixing the active ingredient combination with at least one filler. In some embodiments, the active ingredient combination is in solid form (e.g., powder form). The active ingredient combination may be mixed directly with the filler to obtain the 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 period of time. Preferably, the drying step comprises leaving the product at room temperature for 1 hour to 48 hours to remove the solvent.

[0309]

[0309] The method may then further comprise the step of pouching the oral product using the pouch material described above.

[0310] use

[0310] According to some embodiments described herein, there is provided the 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) maca root; (ii) a combination of at least three B vitamins selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9 and vitamin B12; and (iii) ginseng.

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

[0312]

[0312] In some embodiments, the combination of active ingredients is as defined above. In such embodiments, the combination may further include any of the additional active ingredients described above. For example, the combination of active ingredients may further include theacrine and / or vitamin C. The combination of active ingredients may, in particular, further include vitamin C. The combination of active ingredients may further include CoQ10 and optionally vitamin C.

[0313]

[0313] Alternatively, the combination of active ingredients may be as described below in any of the "Further Broad Aspects." For example, the combination of active ingredients may include (i) maca root, (ii) a combination of B vitamins including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) ginseng. Alternatively, or in addition, the combination of active ingredients may include (i) maca root, (ii) a combination of B vitamins including vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, and (iii) vitamin C.

[0314]

[0314] The combination of active ingredients may provide improved effects in increasing mental focus 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 increase physical and / or mental energy levels, as well as enhance cognitive benefits such as improved reaction times and reduced fatigue during cognitive tasks.

[0315] Further broad aspects According to some embodiments described herein, there is provided an oral product comprising a combination of active ingredients, the combination of active ingredients including (i) maca root, (ii) ginseng, and (iii) vitamin C. Alternatively, there is provided an oral product comprising a combination of active ingredients including (i) maca root, (ii) theacrine, and (iii) vitamin C.

[0316]

[0316] The amounts of maca root, vitamin C, theacrine, and ginseng (and any other active ingredients and / or additives) described above with respect to the first aspect are equally applicable to such an embodiment and will not be repeated here for the sake of brevity. All amounts and combinations described above apply equally to this embodiment in which the inclusion of a B vitamin combination is not required.

[0317]

[0317] In any of the above embodiments, the oral product may further comprise additional active ingredients as described above with respect to the first aspect. In particular, the oral product may further comprise at least one B vitamin and / or coenzyme Q10. The above ranges and combinations of these additional active ingredients 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 comprise a combination of at least vitamins B6, B9, and B12. In some embodiments, the oral product may comprise a combination of at least vitamins B2 and B6. Suitable ranges of amounts for these B vitamins are as described above.

[0318]

[0318] The above methods and uses are equally applicable to the above embodiments in which the combination of active ingredients comprises (i) maca root, (ii) ginseng, and (iii) vitamin C. [Example]

[0319]

[0319] 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.

[0320] Example 1 - Caffeine-Free Liquid Dosage Form An oral product in liquid form is prepared containing the following ingredients:

[0321] [Table 1]

[0322] Oral products have a volume of 30 or 60 mL per serving.

[0323] All active ingredients are added to water and the resulting mixture is stirred until a homogeneous dispersion or clear solution is obtained. The product is then packaged in bottles, with each serving containing 30 or 60 mL of liquid.

[0324] Example 2 - Caffeine-Free Liquid Dosage Form Containing a 1:4 Ratio of Maca Root:Ginseng An oral product in liquid form is prepared containing the following ingredients: ·water Vitamins B2, B3, B6, B9, and B12 Maca root Ginseng extract Vitamin C

[0325] Each serving contains approximately 30 mg of maca root and 120 mg of ginseng. Each serving contains approximately 2.4 mg of vitamin B6 and 2 mg of vitamin B2. The oral product has a volume of 60 mL per serving.

[0326] The oral product is prepared as shown in Example 1.

[0327] Example 3 - Caffeine-Free Liquid Dosage Form Containing Coenzyme Q10 An oral product in liquid form is prepared containing the following ingredients:

[0328] [Table 2]

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

[0330] Example 4 - Caffeine-Free Liquid Dosage Form Containing Coenzyme Q10 in a Weight Ratio of Maca Root to Coenzyme Q10 of Approximately 1:1 An oral product in liquid form is prepared containing the following ingredients: ·water Vitamins B1, B2, B6, and B7 Maca root Ginseng Coenzyme Q10

[0331] Each serving contains approximately 200 mg of maca root and 150 mg of ginseng. Each serving contains approximately 2.4 mg of vitamin B6 and 1 mg of vitamin B2. The oral product has a volume of 60 mL per serving and a 1:1 maca root to coenzyme Q10 weight ratio.

[0332] Example 5 - Caffeine-Free Liquid Dosage Form Containing Coenzyme Q10 in a Weight Ratio of Maca Root to Coenzyme Q10 of Approximately 30:1 An oral product in liquid form is prepared containing the following ingredients: ·water Vitamins B1, B2, B6, and B7 Maca root Ginseng Coenzyme Q10

[0333] Each serving contains approximately 400 mg of maca root and 150 mg of ginseng. Each serving contains approximately 2.4 mg of vitamin B6 and 1 mg of vitamin B2. The oral product has a volume of 60 mL per serving and a maca root to coenzyme Q10 weight ratio of approximately 30:1.

[0334] The oral product is prepared as shown in Example 1.

[0335] Example 6 - Caffeine-Free Liquid Dosage Form Containing Coenzyme Q10 An oral product in liquid form is prepared containing the following ingredients:

[0336] [Table 3]

[0337] Oral products have a volume of 30 or 60 mL per serving.

[0338] All active ingredients are added to water and the resulting mixture is stirred until a homogeneous dispersion or clear solution is obtained. The product is then packaged in bottles, with each serving containing 30 or 60 mL of liquid.

[0339] Example 7 - Caffeine-Free Liquid Dosage Form Containing Coenzyme Q10 in a Maca Root to Coenzyme Q10 Weight Ratio of Approximately 30:1 and a Maca Root to B Vitamins Weight Ratio of 50:1 An oral product in liquid form is prepared containing the following ingredients: ·water Vitamins B1, B2, B6, B7 - total weight 8mg Maca root Ginseng Coenzyme Q10

[0340] Each serving contains approximately 400 mg of maca root and 150 mg of ginseng. Each serving contains approximately 2.4 mg of vitamin B6 and 1 mg of vitamin B2. The oral product has a volume of 60 mL per serving and a maca root to coenzyme Q10 weight ratio of approximately 30:1. The maca root to B vitamin weight ratio is 50:1.

[0341] The oral product is prepared as shown in Example 1.

[0342] The various embodiments described herein are presented solely to aid in the understanding and teaching of the claimed features. These embodiments are provided only as a representative sample of embodiments and are not intended to be exhaustive and / or exclusive. The advantages, embodiments, examples, functions, features, structures, and / or other aspects described herein should not be construed as limitations on the scope of the invention as defined by the claims or limitations on the equivalents of the claims, and it should be understood that other embodiments may be utilized and modifications may be made without departing from the scope of the claimed invention. Various embodiments of the present invention may suitably comprise, consist of, or consist essentially of any suitable combination of the disclosed elements, components, features, parts, steps, means, etc., other than those specifically described herein. Furthermore, the present disclosure may include other inventions not currently claimed but which may be claimed in the future.

Claims

1. An oral product comprising a combination of active ingredients, said combination comprising: (i) maca root or an extract thereof; (ii) a combination of B vitamins including at least two selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) ginseng or an extract thereof; (iv) Coenzyme Q10, wherein the weight ratio of said maca root or extract thereof to said coenzyme Q10 is from about 50:1 to about 1:10, and the oral product is caffeine-free.

2. 10. The oral product of claim 1, wherein the (ii) B vitamin combination further comprises one or more of vitamin B1, vitamin B5, or vitamin B7.

3. 3. The oral product of claim 1 or 2, wherein the (ii) combination of B vitamins comprises a combination of vitamin B1, vitamin B2, vitamin B6, and vitamin B7.

4. 2. The oral product of claim 1, wherein the (ii) combination of B vitamins comprises vitamin B2 and vitamin B6.

5. 5. The oral product of claim 4, wherein the (ii) B vitamin combination further comprises one or more of vitamin B1 or vitamin B7, preferably the (ii) B vitamin combination further comprises vitamin B1 and vitamin B7.

6. 6. The oral product of claim 4 or 5, wherein the (ii) 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 the B vitamins in the combination is from about 0.005% to about 1% by weight of the oral product.

8. 8. The oral product of any one of claims 1 to 7, wherein the maca root or extract thereof is present in an amount of about 0.01% to about 35% by weight of the oral product.

9. 9. The oral product of any one of claims 1 to 8, wherein the ginseng or extract thereof is present in an amount of about 0.01% to about 20% by weight of the oral product.

10. 10. The oral product of any one of claims 1 to 9, wherein the maca root or extract thereof and the ginseng or extract thereof are present in a weight ratio of about 10:1 to about 1:10, preferably, the weight ratio is about 5:1 to about 1:

1.

11. 11. The oral product of any one of claims 1 to 10, wherein the total amount of the maca root or extract thereof and the B vitamins is present in a weight ratio of about 100:1 to about 10:

1.

12. 12. The oral product of any one of claims 1 to 11, wherein the total amount of the ginseng or extract thereof and the B vitamins is present in a weight ratio of about 60:1 to about 1:

1.

13. 13. The oral product of any one of claims 1 to 12, wherein the Coenzyme Q10 is present in an amount of about 0.01% to about 20% by weight of the oral product.

14. 14. The oral product of any one of claims 1 to 13, wherein the maca root or extract thereof and the coenzyme Q10 are present in a weight ratio of about 30:1 to about 1:

10.

15. 15. The oral product of any one of claims 1 to 14, wherein the combination of active ingredients further comprises (v) vitamin C, optionally wherein the vitamin C is present in an amount of from about 0.001% to about 50% by weight of the oral product.

16. 16. The oral product of any one of claims 1 to 15, comprising the combination of active ingredients in an amount of from about 0.5% to about 10% by weight of the oral product.

17. 17. The oral product of any one of claims 1 to 16, further comprising one or more additives selected from the group consisting of flavoring agents, sweetening agents, acidifying agents, thickening agents, fillers, binders, humectants, preservatives, and mixtures thereof.

18. 18. The oral product of any one of claims 1 to 17, further comprising zinc or zinc gluconate, optionally wherein the zinc or zinc gluconate is present in an amount of from about 0.001% to about 2% by weight of the oral product.

19. 19. The oral product of any one of claims 1 to 18, further comprising theobromine, optionally wherein the theobromine is present in an amount of from about 0.1% to about 2% by weight of the oral product.

20. 20. The oral product of any one of claims 1 to 19, which is a liquid dosage form, optionally said liquid oral dosage form having a volume of liquid from about 1 mL to about 200 mL, optionally said liquid oral dosage form having a volume of liquid from about 20 mL to about 100 mL.

21. The combination of active ingredients is (i) maca root or an extract thereof; (ii) a combination of at least vitamin B2, vitamin B6, and vitamin B7; (iii) ginseng or an extract thereof; (iv) Coenzyme Q10, (v) Vitamin C; and 21. The oral product of claim 20, comprising:

22. 22. The oral product of any one of claims 1 to 21, further comprising 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 10 mg to about 500 mg of maca root or an extract thereof; (ii) about 1 mg to about 50 mg of a combination of B vitamins including at least two selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12; (iii) about 1 mg to about 500 mg of ginseng or an extract thereof; (iv) about 5 mg to about 500 mg of coenzyme Q10, and optionally, (iv) about 10 mg to about 500 mg of vitamin C; 23. The oral product of any one of claims 1 to 22, comprising:

24. (a) combining active ingredients, the active ingredients including (i) maca root or an extract thereof, (ii) a combination of B vitamins including at least two selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin B12, (iii) ginseng or an extract thereof, and (iv) coenzyme Q10, wherein the weight ratio of the maca root or extract thereof to the coenzyme Q10 is about 50:1 to about 1:10; (b) contacting the active ingredient with water; (c) mixing the active ingredient with the water to prepare an oral product; A method for preparing the oral product of any one of claims 1 to 23, comprising:

25. Use of a combination of active ingredients for increasing alertness and / or energy levels in humans or animals, the combination of active ingredients comprising: (i) maca root or an extract thereof; (ii) a combination of B vitamins comprising at least two selected from vitamin B2, vitamin B3, vitamin B6, vitamin B9 and vitamin B12; (iii) ginseng or an extract thereof; and (iv) coenzyme Q10.

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