Oral products for the delivery of active ingredients

Abstract

This disclosure relates to an oral product comprising a combination of active ingredients, a method for manufacturing the oral product, and the use of the oral product to increase sexual urges and / or desire for sexual activity in humans or animals.

Description

Technical Field

[0001]

[0001] This disclosure relates to oral products, methods of manufacturing oral products, and uses of oral products.

Background Art

[0002]

[0002] This disclosure relates to products and compositions intended for use in humans. 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 have beneficial effects on a particular mood state of a human or animal have become popular in recent years. For example, confectionery-type products (e.g., gummies or troches) containing vitamins or other mood-enhancing active ingredients provide a convenient and comfortable dosing mode for such active ingredients. Other convenient dosing modes are foods and beverages, such as nutritional drinks. Such products may contain active ingredients that are delivered to a user to cause a biological response in the user that can enhance the user's physical or mental capabilities.

[0004]

[0004] Beverages containing theanine and caffeine are described in U.S. Patent No. 5,780,086 and U.S. Patent No. 6,268,009. More recently, European Patent No. 1819241 describes beverages 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]

[0005] It is desirable to provide an oral product configured for oral use that can deliver an active ingredient to a consumer in an effective form that can be enjoyed, for example, in the form of a liquid shot.

Summary of the Invention

[0006]

[0006] The disclosure generally provides products configured for oral use, comprising a combination of active ingredients. The oral product may be in any form suitable for oral use, such as tablets or lozenges, loose powder, or liquid form (e.g., a beverage such as a shot). Preferably, the oral product is in liquid form, such as a beverage such as a shot.

[0007]

[0007] According to some embodiments described herein, there is an oral product comprising a combination of active ingredients, the combination comprising (i) maca root, (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6, (iii) ginseng, and (iv) ashwagandha, wherein the maca root, ginseng, and ashwagandha are different from each other.

[0008]

[0008] According to some embodiments described herein, a method for preparing an oral product is provided, comprising: (a) a step of combining active ingredients, wherein the active ingredients comprise (i) maca root, (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6, (iii) ginseng, and (iv) ashwagandha, provided that the maca root, ginseng, and ashwagandha are different from each other; (b) a step of bringing the active ingredients into contact with water; and (c) a step of mixing the active ingredients with water to prepare an oral product.

[0009]

[0009] According to some embodiments described herein, the use of a combination of active ingredients for increasing sexual desire and / or sexual activity in humans or animals is provided, wherein the combination of active ingredients comprises (i) maca root, (ii) a combination of B vitamins including at least vitamin B2 and vitamin B6, (iii) ginseng, and (iv) ashwagandha, provided that the maca root, ginseng, and ashwagandha are different from each other.

[0010]

[0010] According to some embodiments described herein, the combination of active ingredients comprises (i) maca root, (ii) a combination of B vitamins including at least vitamin B2 and vitamin B6, (iii) ginseng, and (iv) ashwagandha, wherein the maca root, ginseng, and ashwagandha are different from each other, and the use of such a combination of active ingredients for increasing mental and / or physical energy for sexual activity in humans or animals is provided.

[0011]

[0011] According to some embodiments described herein, an oral product is provided comprising a combination of active ingredients, wherein the combination of active ingredients comprises (i) maca root, (ii) a combination of B vitamins consisting of vitamin B1, vitamin B2, vitamin B6, and vitamin B7, (iii) ginseng, and (iv) passionflower, provided that the maca root and ginseng are different from each other.

[0012]

[0012] In a preferred embodiment, each of the oral products of the above embodiment may be provided in the form of a liquid dosage form, such as a shot (i.e., a liquid having a maximum volume of about 100 mL).

[0013]

[0013] These and other features, aspects, and advantages of the Disclosure will become apparent by reading the following detailed description. The Invention includes any combination of two, three, four, or more of the above-described embodiments, and any combination of two, three, four, or more features or elements described herein, whether such features or elements are expressly combined in the description of the particular embodiments herein. The Disclosure is intended to be read in whole so that, in any of the various aspects and embodiments, any separable feature or element of the disclosed Invention should be considered to be intended to be combinable unless the context clearly indicates otherwise.

[0014]

[0014] For ease of reference, these and further aspects of the present invention are discussed here under appropriate section headings. However, the teachings under each section are not necessarily limited to each specific section.

[0015]

[0015] Next, embodiments of the present invention will be described as merely examples with reference to the attached drawings. [Brief explanation of the drawing]

[0016] [Figure 1] Figure 1 is a graph showing the results of the dyadic score, evaluated by the Sexual Desire Inventory (SDI), over time (weekly), comparing the placebo group with Example 5. [Figure 2] Figure 2 is a graph showing the average Visual Analog Scale (VAS) results over time (weekly), comparing placebo with Example 5. This represents the average score for combinations of intimacy, pleasure, sensation, arousal, "the moment," and motivation, presenting an overall need score. [Figure 3] Figure 3 is a graph showing the results of the Feeling Scale (FS) over time (weekly), comparing the placebo group with Example 5. [Figure 4] Figure 4 is a graph showing the results of the Subjective Anxiety State Trait Anxiety Scale (STAI-S) over time (weekly), comparing the placebo group with Example 5. This provides a measure of overall satisfaction (lower anxiety). [Figure 5] Figure 5 is a graph showing the results of the Mood Profile Scale (POMS) for Subjective Negative Mood over time (weekly), comparing placebo with Example 5. This represents the average score for combinations of tension or anxiety, depression or discouragement, anger or hostility, vitality or activity, fatigue or apathy, confusion or bewilderment, and presents an overall mood state score. [Modes for carrying out the invention]

[0017]

[0021] The present invention is not limited to the specific configurations, steps of the method, and materials disclosed herein, and it should be understood that such configurations, steps of the method, and materials may vary to some extent. The scope of the present invention is limited only by the appended claims and their equivalents, and it should also be understood that the terms used herein are used solely for the purpose of describing specific embodiments and are not intended to limit them.

[0018]

[0022] Where used herein and in the claims, the singular forms "a," "an," and "the" refer to multiple subjects unless otherwise specified. References to "dry weight %" or "based on dry weight" or "dry weight" refer to the weight based on dry components (i.e., all components except water). References to "wet weight" refer to the weight of the product or composition including water. Unless otherwise specified, references to "weight %" (or "weight %") of a product or composition reflect the total wet weight (i.e., including water) of the product or composition.

[0019]

[0023] In this specification, unless otherwise specified, the term “about” modifying the amount of an ingredient in the oral product of the present invention or used in the method of the present invention refers to variations in quantity that may occur, for example, due to typical measurement and liquid handling procedures used in the real world to produce concentrates or working solutions, careless errors in these procedures, differences in the manufacture, source or purity of the ingredients used for the production of the oral product or the implementation of the method. The term “about” also encompasses different amounts resulting from different equilibrium conditions for a product or composition arising from a particular initial mixture. Whether modified by the term “about” or not, the claims include equivalents of quantities.

[0020] Oral products

[0024] As described herein, an oral product comprising a combination of active ingredients, wherein the combination comprises (i) the root of maca, (ii) a combination of vitamin B group including at least vitamin B2 and vitamin B6, (iii) ginseng, and (iv) ashwagandha, provided that the root of maca, ginseng, and ashwagandha are different from each other, is provided. The oral product preferably does not contain caffeine, that is, caffeine does not exist in the oral product.

[0021]

[0025] The oral product is configured for oral use and thus for insertion into the user's mouth (i.e., the oral cavity). As used herein, unless otherwise specified, the term "oral" in relation to a product refers, in normal use, to a product suitable for being ingested or placed anywhere 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 beverage) that can be orally ingested by the user, or the product may be placed in the mouth (e.g., in the form of a tablet, lozenge, pouch, etc.). Preferably, the product may be in the form of a liquid (i.e., in the form of a beverage, particularly in the form of a liquid shot) that can be orally ingested by the user.

[0022]

[0026] The scope provided herein can provide preferred embodiments of the present invention alone or in combination with one or more other component ranges.

[0023]

[0027] Combination of active ingredients The products disclosed herein contain active ingredients. The active ingredients may be naturally occurring or synthetically obtained. The combination of active ingredients includes suitable active ingredients that cause a biological response in humans or animals. The active ingredients used herein may be physiologically active materials that are materials intended to achieve or enhance a physiological response.

[0024]

[0028] According to one aspect of the present invention, the combination of active ingredients comprises at least (i) maca root, (ii) a combination of B vitamins including at least vitamin B2 and vitamin B6, (iii) ginseng, and (iv) ashwagandha, wherein the maca root, ginseng, and ashwagandha are distinct from each other. The oral product does not contain caffeine, but the product provides a stimulating effect on the subject. In this regard, each of the active ingredients may be present in an amount suitable for producing a desired biological response in humans or animals. The inventors have found that certain combinations of active ingredients contained in the oral product result in an increase in sexual urges or desire for sexual activity, also known as "libido." The combination of active ingredients has been found to produce, in particular, short-term, medium-term, or long-term enhancement of mental and / or physical sexual energy in the user. In particular, certain combinations of active ingredients in the oral product have been found to increase mental energy (i.e., arousal) or physical energy (i.e., improved endurance performance and ability) for sexual activity. The inventors have found that certain combinations of the active ingredients of the present invention can improve the desire for sexual activity over a short or sustained period. The increase in desire or urge can also increase feelings of confidence, motivation, pleasure, and excitement, as well as the user's overall feelings of enjoyment and enthusiasm.

[0025]

[0029] The oral products described herein have been found to be particularly effective in female subjects. As shown by the examples, ingestion of the oral products of the present invention results in increased desire and satisfaction levels and decreased overall mood levels in female subjects compared to placebo. Thus, the oral products of the present invention can provide relaxation while increasing sexual urges and / or desire for sexual activity in female subjects compared to placebo. Accordingly, in some embodiments, the uses described herein are provided in which the human or animal is female. In preferred embodiments, the subjects are human and female. The term “improve” is defined herein. In preferred embodiments, the improvement or increase in sexual urges and / or desire for sexual activity is compared to placebo, where placebo does not contain the combination of active ingredients of the oral products of the present invention.

[0026]

[0030] The oral products of the present invention have been found to be effective for short-term, medium-term, or long-term use. Such use may include daily use of the oral product. For example, a single dosage form of the oral product may be taken by the user once a day, and the oral product may be used for at least 14 days, at least 21 days, or at least 28 days.

[0027]

[0031] It has also been found that the combinations of active ingredients described herein can provide safe products with desirable pharmacokinetics (Tmax, Cmax, half-life), bioavailability, and metabolism.

[0028]

[0032] Maca, or Lepidium meyenii, is an edible biennial herbaceous plant belonging to the Brassicaceae family, native to South America. It is also known as "Peruvian ginseng" and is cultivated primarily for its roots. Traditionally, maca is processed by boiling, roasting, and drying the roots, and then grinding the dried root material into a powder. Various maca root powders are commercially available. Maca root may be used for its estimated benefits, including increased fertility, enhanced energy and endurance, improved mood, lowered blood pressure, and improved learning and memory.

[0029]

[0033] Fresh maca roots come in a variety of colors due to genetic variation. These colors include yellow, red, purple, blue, black, and green. Yellow maca is the sweetest and most commonly cultivated for food, while red and black maca are generally considered to have more medicinal properties. Maca roots contained in oral products may be black maca root, yellow maca root, red maca root, or any combination thereof. Maca roots may be provided in the form of an extract or powder (e.g., powdered extract).

[0030]

[0034] Maca extract is a concentrated form of maca that can be obtained by standard extraction techniques well known in the art. For example, maca extract can be obtained by taking dried maca roots cut into pieces or, preferably, ground into a powder, and immersing them in a solution. To minimize safety concerns, maca roots can be extracted in an organic solution such as chloroform, but the extract is preferably an aqueous solution or more preferably an aqueous / alcoholic solution, such as a water and ethanol solution. The extract is usually provided in excess. Preferably, the extraction temperature is from room temperature to below the boiling point of the solution, for example, from about 20°C to about 100°C, or from about 25°C to about 80°C. Techniques such as sonication may be used to increase extraction efficiency. Techniques such as filtration are preferably used to reduce fine particles in the maca extract. The extract can then be dried, preferably in powder form, to obtain a concentrated maca extract. The maca root of the present invention may be in a ratio of concentrated maca extract to filler. For example, a 10:1 purity of maca root components may be obtained by using 300 mg of concentrated maca extract to obtain 3 grams of maca root components. The type of extract is not limited in this disclosure.

[0031]

[0035] Maca root may be present in any preferred amount, such as at least about 0.01% by weight, at least about 0.1% by weight, or at least about 0.25% by weight of the oral product. In some embodiments, maca root may be present in an amount of about 20% by weight or less, about 15% by weight or less, or about 10% by weight or less of the oral product.

[0032]

[0036] Maca root may be present in an amount of about 0.01% to about 20% by weight of the oral product. In some embodiments, maca root may be present in an amount of about 0.1% to about 15% by weight of the oral product. Preferably, maca root may be present in an amount of about 0.25% to about 10% by weight of the oral product.

[0033]

[0037] With respect to the dry weight of the active ingredient combination, maca root may be present in any preferred amount, for example, at least about 20% by weight, at least about 30% by weight, or at least about 35% by weight of the dry weight of the combination. The term “dry weight” is as defined above. “Dry weight of combination” refers to the total dry weight of the active ingredient combination, excluding water. In some embodiments, maca root may be present in an amount of about 90% by weight or less, about 85% by weight or less, or about 80% by weight or less of the dry weight of the combination.

[0034]

[0038] Maca root may be present in an amount of about 20% to about 90% by weight of the dry weight of the combination. In some embodiments, maca root may be present in an amount of about 30% to about 85% by weight of the dry weight of the combination. Preferably, maca root may be present in an amount of about 35% to about 80% by weight of the dry weight of the combination.

[0035]

[0039] In some embodiments (for example, when the oral product is in liquid dosage form as discussed herein), maca root is present in an amount of about 0.01% to about 20% by weight of the oral product, for example, about 0.1% to about 15% by weight of the oral product, preferably about 0.25% to about 10% by weight of the oral product.

[0036]

[0040] The combination of active ingredients further includes a combination of B vitamins. The combination of B vitamins includes at least vitamin B2 and vitamin B6.

[0037]

[0041] The term "B vitamins" encompasses eight water-soluble vitamins that affect cellular functions (e.g., cellular metabolism and red blood cell synthesis). B vitamins act as coenzymes in a significant proportion of enzymatic processes in cellular physiological functions. B vitamins can generally be divided into two categories: those that act as coenzymes in catabolic reactions (which lead to energy production) and those that act as coenzymes in anabolic reactions (which lead to enhanced brain function).

[0038]

[0042] The B vitamins are thought to play a role in 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 pantothenate, e.g., calcium pantothenate), vitamin B6 (pyridoxine hydrochloride), vitamin B7 (biotin), vitamin B9 (folate or folic acid), and vitamin B12 (cyanocobalamin). Vitamins B2, B3, B6, B9, and B12 have been found to aid in anabolic metabolism and enhance brain function. Vitamins B1, B3, B5, and B7 have been found to aid in catabolism and increase energy levels. The term "anabolic vitamin B" refers to vitamin B that affects the anabolic pathway, while the term "catabolic vitamin B" refers to vitamin B that affects the catabolic pathway.

[0039]

[0043] Oral products contain at least two B vitamins, namely vitamins B2 and B6, which aid in anabolic metabolism. It has been found that the inclusion of these B vitamins can reduce perceived physical and mental fatigue, as well as enhance psychological and cognitive function.

[0040]

[0044] In some embodiments, the vitamin B group combination further includes at least one catabolic vitamin B selected from the group consisting of vitamin B1, vitamin B5, vitamin B7, and combinations thereof. In preferred embodiments, the vitamin B group combination further includes one or more of vitamin B1 or vitamin B7.

[0041]

[0045] In a particularly preferred embodiment, the combination of B vitamins consists of vitamin B2, vitamin B6, vitamin B1, and vitamin B7, or vitamin B2, vitamin B6, and vitamin B1. In any such embodiment, the ratio of the total amount of vitamins B2 and B6 to the total amount of vitamins B1 and B7 may be about 5:1 to about 1:5, preferably about 3:1 to about 1:3.

[0042]

[0046] The amount of B vitamins contained in the composition can be any suitable amount that produces the desired effect, while also providing a product that is safe to consume and has reduced side effects. In particular, the total amount of B vitamins contained in the combination can be any suitable amount that produces the desired effect of increasing sexual desire or the desire for sexual activity. In some embodiments, the total amount of vitamins B2 and B6 may be at least about 0.0001% by weight of the oral product, preferably at least about 0.001% by weight. For example, the total amount of vitamins B2 and B6 may be about 0.0001% to about 5% by weight of the oral product, preferably about 0.001% to about 1% by weight.

[0043]

[0047] If present, the total amount of vitamins B1, B5, and / or B7 may be at least about 0.0001% by weight of the oral product, preferably at least about 0.001% by weight. For example, the total amount of vitamin B1 and optionally vitamin B7 may be about 0.0001% to about 5% by weight of the oral product, preferably about 0.001% to about 1% by weight.

[0044]

[0048] The total amount of B vitamins included in the combination may be any suitable amount that produces the desired effect of increasing sexual desire or the urge to engage in sexual activity. 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 may be about 0.005% to about 2% by weight of the oral product, preferably about 0.005% to about 0.1% by weight.

[0045]

[0049] In some embodiments, vitamin B2 may be present in an amount of about 5% to about 50% by weight of the total amount of B vitamins in the oral product. For example, vitamin B2 may be present in an amount of about 10% to about 40% by weight of the total amount of B vitamins in the oral product.

[0046]

[0050] In some embodiments, vitamin B6 may be present in an amount of about 10% to about 60% 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 50% by weight of the total amount of B vitamins in the oral product. In other examples, vitamin B6 may be present in an amount of about 15% to about 55% by weight of the total amount of B vitamins in the oral product.

[0047]

[0051] In some embodiments, vitamin B2 may be present in an amount of about 5% to about 50% by weight of the total amount of B vitamins in the oral product, and vitamin B6 may be present in an amount of about 10% to about 60% by weight of the total amount of B vitamins in the oral product. In some embodiments, vitamin B2 may be present in an amount of about 10% to about 60% by weight of the total amount of B vitamins in the oral product, and vitamin B6 may be present in an amount of about 10% to about 60% by weight of the total amount of B vitamins in the oral product. In some embodiments, vitamin B2 may be present in an amount of about 5% to about 50% by weight of the total amount of B vitamins in the oral product, and vitamin B6 may be present in an amount of about 15% to about 50% by weight of the total amount of B vitamins in the oral product. In some embodiments, vitamin B2 may be present in an amount of about 10% to about 60% by weight of the total amount of B vitamins in the oral product, and vitamin B6 may be present in an amount of about 15% to about 50% by weight of the total amount of B vitamins in the oral product. In some embodiments, vitamin B2 may be present in an amount of about 10% to about 40% by weight of the total amount of B vitamins in the oral product, and vitamin B6 may be present in an amount of about 15% to about 55% by weight of the total amount of B vitamins in the oral product.

[0048]

[0052] If present in any of the above embodiments, vitamin B1 may be present in an amount of about 5% to about 40% by weight of the total amount of B vitamins in the oral product. For example, if present, vitamin B1 may be present in an amount of about 10% to about 35% by weight of the total amount of B vitamins in the oral product.

[0049]

[0053] In some embodiments, vitamin B1 may be present in an amount of about 5% to about 40% by weight in the oral product, vitamin B2 may be present in an amount of about 5% to about 50% by weight of the total amount of B vitamins in the oral product, and vitamin B6 may be present in an amount of about 10% to about 60% of the total amount of B vitamins in the oral product. In some embodiments, vitamin B1 may be present in an amount of about 10% to about 35% by weight in the oral product, vitamin B2 may be present in an amount of about 10% to about 40% by weight of the total amount of B vitamins in the oral product, and vitamin B6 may be present in an amount of about 15% to about 55% of the total amount of B vitamins in the oral product. In such embodiments, the total amount of B vitamins may be about 0.0001% to about 5% by weight of the oral product, preferably about 0.001% to about 1% by weight of the oral product.

[0050]

[0054] In some embodiments, the oral product may be substantially free of vitamin B3 (i.e., containing 0.0001% by weight or less) or may not contain vitamin B3 at all (i.e., containing 0% by weight). In some embodiments, the oral product may be substantially free of vitamin B5 (i.e., containing 0.0001% by weight or less) or may not contain vitamin B5 at all (i.e., containing 0% by weight).

[0051]

[0055] If 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, if 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 (i.e., containing 0.0001% by weight or less) or may not contain vitamin B7 at all (i.e., containing 0% by weight).

[0052]

[0056] The combination of active ingredients further includes ginseng. Ginseng is the root of the plant Panax, characterized by the presence of unique steroid saponin phytochemicals (ginsenosides) and gintonin. The estimated major active ingredients of ginseng include more than 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 been found in nutritional drinks or herbal teas, and as a health supplement in traditional medicine.

[0053]

[0057] Ginseng may include any preferred form of ginseng, such as Panax ginseng (Korean ginseng), Panax notoginseng (Panax notoginseng), and Panax quinquefolius (American ginseng). Those skilled in the art will understand that the ginseng in the combination of active ingredients is not Peruvian ginseng, i.e., maca root, or Indian ginseng, i.e., ashwagandha, so that the oral product contains an identifiable active ingredient. In other words, maca root, ginseng, and ashwagandha are distinct from one another. Ginseng may exist in the form of ginseng extract, coarse ginseng, finely chopped ginseng, or powdered ginseng. Preferably, ginseng is included in the form of ginseng extract or powdered ginseng extract. Ginseng may be white ginseng, fresh ginseng, or red ginseng. In some embodiments, ginseng is red ginseng, such as red ginseng extract or powdered red ginseng extract. The addition of ginseng has been found to potentially enhance sexual drive and / or increase sexual desire in humans or animals.

[0054]

[0058] Ginseng may be included in any suitable amount to achieve the desired function, for example, at least about 0.01% by weight, at least about 0.05% by weight, or at least about 0.1% by weight of the oral product. In some embodiments, ginseng may be present in an amount of about 5% by weight or less, about 2% by weight or less, or about 1% by weight or less of the oral product.

[0055]

[0059] In some embodiments, ginseng is present in an amount of about 0.01% to about 5% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.05% to about 2% by weight of the oral product. In some embodiments, ginseng is present in an amount of about 0.1% to about 1% by weight of the oral product.

[0056]

[0060] With respect to the dry weight of the active ingredient combination, ginseng may be present in any preferred amount, for example, at least about 1% by weight, at least about 2% by weight, or at least about 5% by weight of the combination. In some embodiments, ginseng may be present in an amount of about 30% by weight or less, about 25% by weight or less, or about 20% by weight or less of the dry weight of the combination.

[0057]

[0061] Ginseng may be present in an amount of about 1% to about 30% by weight of the dry weight of the combination. In some embodiments, ginseng may be present in an amount of about 2% to about 25% by weight of the dry weight of the combination. Preferably, ginseng may be present in an amount of about 5% to about 20% by weight of the dry weight of the combination.

[0058]

[0062] In some embodiments (for example, when the oral product is in liquid oral dosage form), ginseng may be present in an amount of about 0.01% to about 5% by weight of the oral product. In some embodiments (for example, when the oral product is in liquid oral dosage form), ginseng may be present in an amount of about 0.05% to about 2% by weight, preferably about 0.1% to about 1% by weight of the oral product.

[0059]

[0063] The combination of active ingredients further includes ashwagandha. As used herein, ashwagandha refers to the root of Withania somnifera, an evergreen shrub belonging to the Solanaceae or Nightshadeaceae family. This root has been used for centuries in traditional medicine to reduce stress and anxiety and improve general health. Ashwagandha is particularly used as a dietary or tea supplement, and its biologically active components include alkaloids, steroid lactones, saponins, and withanolides.

[0060]

[0064] Ashwagandha may be present in the combination of active ingredients in the form of an extract, coarsely chopped or finely ground or powdered ashwagandha. Preferably, ashwagandha is included in the form of an extract or powder. KSM-66 ashwagandha is an example of an ashwagandha extract that can be used, but this disclosure is not limited thereto.

[0061]

[0065] The addition of ashwagandha has been found to enhance sexual drive or increase sexual desire in humans or animals. Therefore, ashwagandha may be included in any suitable amount to achieve this desired function, for example, at least about 0.01% by weight, at least about 0.05% by weight, or at least about 0.1% by weight of the oral product. In some embodiments, ashwagandha may be present in amounts of about 10% by weight or less, about 5% by weight or less, or about 2% by weight or less of the oral product.

[0062]

[0066] In some embodiments, ashwagandha is present in an amount of about 0.01% to about 10% by weight of the oral product. In some embodiments, ashwagandha is present in an amount of about 0.05% to about 5% by weight of the oral product. In some embodiments, ashwagandha is present in an amount of about 0.1% to about 2% by weight of the oral product.

[0063]

[0067] With respect to the dry weight of the active ingredient combination, ashwagandha may be present in any preferred amount, for example, at least about 1% by weight, at least about 2% by weight, or at least about 5% by weight of the dry weight of the combination. In some embodiments, ashwagandha may be present in an amount of about 40% by weight or less, about 35% by weight or less, or about 30% by weight or less of the dry weight of the combination.

[0064]

[0068] Ashwagandha may be present in an amount of about 1% to about 40% by weight of the dry weight of the combination. In some embodiments, ashwagandha may be present in an amount of about 2% to about 35% by weight of the dry weight of the combination. Preferably, ashwagandha may be present in an amount of about 5% to about 30% by weight of the dry weight of the combination.

[0065]

[0069] In some embodiments (for example, when the oral product is in liquid oral dosage form), ashwagandha may be present in an amount of about 0.01% to about 10% by weight of the oral product. In some embodiments (for example, when the oral product is in liquid oral dosage form), ashwagandha may be present in an amount of about 0.05% to about 5% by weight, preferably about 0.1% to about 2% by weight of the oral product.

[0066]

[0070] In addition to maca root, a combination of B vitamins, ginseng, and ashwagandha, the combination of active ingredients may include one or more additional active ingredients. The additional active ingredients may be any suitable active ingredients that increase sexual desire or the urge for sexual activity, and may be selected from, for example, further nutritional supplements, nootropics, or psychoactive substances. The additional active ingredients may be naturally occurring or obtained synthetically. Non-limiting examples of additional active ingredients include those falling into the categories of plant components (e.g., Bacopa monieri or Rhodiola rosea), stimulants (e.g., theacrine, matcha), amino acids or analogs (e.g., L-tyrosine, L-theanine), and / or nutritional supplements and / or medicinal components (e.g., further vitamins, e.g., A, C, D, E, or K, and / or cannabinoids, e.g., tetrahydrocannabinol (THC) and cannabidiol (CBD)). In some embodiments, additional active ingredients are selected from plant-based ingredients, stimulants, further vitamins, and combinations thereof.

[0067]

[0071] Additional active ingredients may be selected from, for example, L-tyrosine, L-theanine, thein, vitamins such as vitamin A, vitamin C, vitamin D, vitamin E, and vitamin K, echinacea, cannabinoids, choline, alpha-GPC, guayusa, matcha, methylriverine, nitrates or beetroot juice, yerba mate, glucose, theacrine, or their components, derivatives, or combinations. In some embodiments, additional active ingredients may be selected from vitamins such as vitamin A, vitamin C, vitamin D, vitamin E, and vitamin K, theacrine, or their components, derivatives, or combinations.

[0068]

[0072] In some preferred embodiments, the combination of active ingredients further includes passionflower (Passiflora incarnate). Passionflower is a herbal supplement that has historically been used to treat anxiety, insomnia, seizures, and hysteria. Passionflower is available as a decoction, tea, liquid extract, and tincture, and the herbal supplement typically consists of the flowers, leaves, and stems of the plant. Passionflower may be present in oral products in any of these forms. In some embodiments, passionflower may be present in the form of passionflower extract, coarse or finely chopped passionflower (whether derived from the flowers, leaves, and / or stems of the plant), or in powder form. In some embodiments, passionflower is not used in the form of a tincture. Preferably, if present, passionflower may be in the form of a passionflower extract. The addition of passionflower has been found to result in an enhancement of sexual drive or increased sexual desire in humans or animals. It has also been found that the addition of passionflower may enhance relaxation in humans or animals. While we do not wish to be bound by theory, the relaxing effects of passionflower, combined with the effects of maca root, ginseng, and ashwagandha on increasing sexual arousal and / or sexual desire, are considered particularly complementary in the manufacture of effective oral products.

[0069]

[0073] If present, passionflower may be present in any suitable amount to achieve the desired function, for example, at least about 0.01% by weight, at least about 0.05% by weight, or at least about 0.1% by weight of the oral product. In some embodiments, passionflower may be present in an amount of about 10% by weight or less, about 5% by weight or less, or about 2% by weight or less of the oral product.

[0070]

[0074] If present, passionflower may be present in an amount of about 0.01% to about 10% by weight, or about 0.05% to about 5% by weight, of the oral product. Preferably, passionflower may be present in an amount of about 0.1% to about 2% by weight, of the oral product.

[0071]

[0075] With respect to the dry weight of the active ingredient combination, passionflower may be present in any preferred amount, for example, at least about 1% by weight, at least about 2% by weight, or at least about 5% by weight of the dry weight of the combination. In some embodiments, passionflower may be present in an amount of about 40% by weight or less, about 35% by weight or less, or about 30% by weight or less of the dry weight of the combination.

[0072]

[0076] Passionflower may be present in an amount of about 1% to about 40% by weight of the dry weight of the combination. In some embodiments, passionflower may be present in an amount of about 2% to about 35% by weight of the dry weight of the combination. Preferably, passionflower may be present in an amount of about 5% to about 30% by weight of the dry weight of the combination.

[0073]

[0077] In some embodiments, the combination of active ingredients further includes vitamin C (ascorbic acid). Vitamin C acts as an antioxidant, helping to protect cells from damage caused by free radicals. Vitamin C also produces collagen, a protein that can be used by the body to aid in wound healing. Furthermore, vitamin C improves the absorption of iron from plant-based foods and helps the immune system function properly to protect the body from disease. By including vitamin C, fatigue and lethargy can be reduced and energy metabolism can be improved.

[0074]

[0078] If present, vitamin C may be present in any suitable amount, for example, at least about 0.001% by weight, at least about 0.01% by weight, or at least about 0.1% by weight of the oral product. In some embodiments, vitamin C may be present in an amount of about 50% by weight or less, about 20% by weight or less, or about 10% by weight or less of the oral product.

[0075]

[0079] If present, vitamin C may be present in an amount of about 0.001% to about 50% by weight, or about 0.01% to about 20% by weight, of the oral product. Preferably, vitamin C may 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% by weight, preferably about 0.5% to about 5% by weight, of the oral product.

[0076]

[0080] In some preferred embodiments, the combination of active ingredients includes maca root, a combination of B vitamins as defined herein, ginseng, ashwagandha, and passionflower.

[0077]

[0081] In some preferred embodiments, the combination of active ingredients includes maca root, a combination of B vitamins, ginseng, ashwagandha, passionflower, and vitamin C.

[0078]

[0082] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.01% to about 20% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.001% to about 10% by weight, (iii) ginseng in an oral product of about 0.01% to about 5% by weight, and (iv) ashwagandha in an oral product of about 0.01% to about 10% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0079]

[0083] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.01% to about 20% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.001% to about 5% by weight, (iii) ginseng in an oral product of about 0.01% to about 5% by weight, and (iv) ashwagandha in an oral product of about 0.01% to about 10% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0080]

[0084] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.01% to about 20% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.001% to about 10% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, and (iv) ashwagandha in an oral product of about 0.01% to about 10% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0081]

[0085] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.01% to about 20% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.001% to about 10% by weight, (iii) ginseng in an oral product of about 0.01% to about 5% by weight, and (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0082]

[0086] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.1% to about 15% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.001% to about 5% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, and (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0083]

[0087] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.1% to about 15% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 0.1% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, and (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0084]

[0088] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.1% to about 15% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.001% to about 5% by weight, (iii) ginseng in an oral product of about 0.1% to about 1% by weight, and (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, where vitamin B is defined according to any of the embodiments discussed above.

[0085]

[0089] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.1% to about 15% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.001% to about 5% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, and (iv) ashwagandha in an oral product of about 0.1% to about 2% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0086]

[0090] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.25% to about 10% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 0.1% by weight, (iii) ginseng in an oral product of about 0.1% to about 1% by weight, and (iv) ashwagandha in an oral product of about 0.1% to about 2% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0087]

[0091] In any of these embodiments, the combination of active ingredients may further contain vitamin C in an amount of about 0.1% to about 15% by weight of the oral product.

[0088]

[0092] In any of these embodiments, the combination of active ingredients may further contain passionflower in an amount of about 0.01% to about 10% by weight of the oral product. Passionflower is a preferred additional active ingredient in this disclosure.

[0089]

[0093] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.01% to about 20% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.001% to about 10% by weight, (iii) ginseng in an oral product of about 0.01% to about 5% by weight, (iv) ashwagandha in an oral product of about 0.01% to about 10% by weight, and (v) passionflower in an oral product of about 0.01% to about 10% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0090]

[0094] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.1% to about 15% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.001% to about 5% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, and (v) passionflower in an oral product of about 0.01% to about 10% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0091]

[0095] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.25% to about 10% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 2% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, and (v) passionflower in an oral product of about 0.01% to about 10% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0092]

[0096] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.25% to about 10% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 0.1% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, and (v) passionflower in an oral product of about 0.01% to about 10% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0093]

[0097] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.25% to about 10% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 0.1% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, and (v) passionflower in an oral product of about 0.05% to about 5% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0094]

[0098] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.25% to about 10% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 0.1% by weight, (iii) ginseng in an oral product of about 0.1% to about 1% by weight, (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, and (v) passionflower in an oral product of about 0.05% to about 5% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0095]

[0099] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.25% to about 10% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 0.1% by weight, (iii) ginseng in an oral product of about 0.1% to about 1% by weight, (iv) ashwagandha in an oral product of about 0.1% to about 2% by weight, and (v) passionflower in an oral product of about 0.05% to about 5% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0096]

[0100] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.25% to about 10% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 0.1% by weight, (iii) ginseng in an oral product of about 0.1% to about 1% by weight, (iv) ashwagandha in an oral product of about 0.1% to about 2% by weight, and (v) passionflower in an oral product of about 0.1% to about 2% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0097]

[0101] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.1% to about 15% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 0.1% by weight, (iii) ginseng in an oral product of about 0.1% to about 1% by weight, (iv) ashwagandha in an oral product of about 0.1% to about 2% by weight, and (v) passionflower in an oral product of about 0.1% to about 2% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0098]

[0102] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.01% to about 20% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 0.1% by weight, (iii) ginseng in an oral product of about 0.1% to about 1% by weight, (iv) ashwagandha in an oral product of about 0.1% to about 2% by weight, and (v) passionflower in an oral product of about 0.1% to about 2% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0099]

[0103] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.01% to about 20% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 2% by weight, (iii) ginseng in an oral product of about 0.1% to about 1% by weight, (iv) ashwagandha in an oral product of about 0.1% to about 2% by weight, and (v) passionflower in an oral product of about 0.1% to about 2% by weight, where vitamin B is defined according to any of the embodiments discussed above.

[0100]

[0104] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.01% to about 20% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 2% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, (iv) ashwagandha in an oral product of about 0.1% to about 2% by weight, and (v) passionflower in an oral product of about 0.1% to about 2% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0101]

[0105] In some embodiments, the combination of active ingredients includes (i) maca root in an oral product of about 0.01% to about 20% by weight, (ii) a combination of B vitamins in a total amount of B vitamins of about 0.005% to about 2% by weight, (iii) ginseng in an oral product of about 0.05% to about 2% by weight, (iv) ashwagandha in an oral product of about 0.05% to about 5% by weight, and (v) passionflower in an oral product of about 0.1% to about 2% by weight, where the B vitamins are defined according to any of the embodiments discussed above.

[0102]

[0106] In any of these embodiments, the combination of active ingredients may further contain vitamin C in an amount of about 0.1% to about 20% by weight of the oral product.

[0103]

[0107] The inventors have found that the amount of active ingredient described above provides a safe product with reduced side effects while simultaneously producing the beneficial effect of increased sexual desire or increased desire for sexual activity. The amount can be adjusted to ensure the safety of the user and avoid excessive intake of the active ingredient, while still providing a highly effective product.

[0104]

[0108] In addition to the above-mentioned additional active ingredients, other suitable additional active ingredients are listed below.

[0105]

[0109] L-theanine is L-γ-glutamylethylamide and N 5 It is an amino acid analog also known as ethyl-L-glutamine. If present, L-theanine may be present in an amount of about 0.01% to about 10% by weight of the oral product. Preferably, L-theanine may be present in an amount of about 0.1% to about 5% by weight of the oral product.

[0106]

[0110] In some embodiments, the combination of active ingredients further includes botanical active ingredients. As used herein, the terms “botanical ingredients” or “botanical” refer to any botanical or fungal material, including plant materials in their natural forms and botanical materials derived from natural plant materials, e.g., extracts or isolates from plant materials or processed plant materials (e.g., plant materials subjected to heat treatment, fermentation, bleaching, or other processing processes that can alter the physical and / or chemical properties of the material). For the purposes of this disclosure, “botanical” includes, but is not limited to, “herbal materials,” which refer to seed-producing plants that do not develop persistent woody tissue and are often valued for their medicinal or sensory properties (e.g., tea or herbal tea). Botanical materials useful in this disclosure may include, but is not limited to, any compounds and sources (including mixtures thereof) described herein. Certain botanical materials of this type may be called health supplements, nutritional supplements, “phytochemicals” or “functional foods.” Certain botanical raw materials as botanical materials or extracts of botanical materials are used in traditional herbal medicine and are described herein further.

[0107]

[0111] Non-exclusive examples of plant-based raw materials or plant-derived materials include Bacopa monniera, baobab, basil, Centella asiatica, Chai-hu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus fruits, clove, cocoa, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba, Griffonia simplicifolia, cannabis, hemp, hops, jasmine, and Kaempferia tinctoria. Parviflora (Thai ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein, matcha, spikenard (Nardostachys chinensis), sweet violet (Viola odorata) oil extract, peppermint, quercetin, resveratrol, piperine, Rhizoma gastrodiae, guayusa, matcha tea, beetroot juice, Rhodiola, rooibos, rose essential oil, rosemary, Sceletium tortuosum, Schisandra, skullcap, spearmint extract, spikenard, terpenes, chisan, turmeric, Turnera aphrodisiaca, valerian, mulberry, echinacea and yerba mate Examples include mate. As described herein, oral products are preferably caffeine-free.

[0108]

[0112] In some embodiments, the combination of active ingredients further includes piperine. Piperine is an alkaloid found in the fruits of the genus Piper of the family Piperaceae, such as black pepper (Piper nigrum), long pepper (Piper longum), red long pepper (Piper retrofactum), and voiteperiferi pepper (Piper borbonense). Piperine may be beneficial to include in oral products due to its ability to enhance the bioavailability of one or more compounds contained in the oral product. In some embodiments, the oral product may contain about 0.0001% to about 0.1% by weight of piperine, based on the total weight of the oral product. In preferred embodiments, the oral product may contain about 0.0005% to about 0.05% by weight of piperine, based on the total weight of the oral product.

[0109]

[0113] In some preferred embodiments, the combination of active ingredients includes maca root, a combination of B vitamins as defined herein, ginseng, ashwagandha, and piperine.

[0110]

[0114] In some embodiments, the combination of active ingredients further includes echinacea, a genus of herbaceous flowering plants in the Asteraceae family, commonly known as cornflower. If present, echinacea may be present in an amount of about 0.001% to about 3% by weight of the oral product, and preferably about 0.01% to about 1% by weight of the oral product.

[0111]

[0115] The combination of active ingredients may further include vitamins selected from vitamin A, vitamin D, vitamin E, and vitamin K, or mixtures thereof. In some preferred embodiments, the combination of active ingredients may further include vitamin D in an amount of about 0.00001% to about 0.1% by weight of the oral product.

[0112]

[0116] The combination of active ingredients may further include amino acids selected from the group consisting of 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 combination of active ingredients includes L-tyrosine.

[0113]

[0117] In some embodiments, the combination of active ingredients includes cannabinoids. Cannabinoids may be derivatives or extracts of cannabis. Cannabinoids are a class of naturally occurring 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). The cannabis species represents at least 85 different phytocannabinoids, which can be classified into subclasses including cannabigerol, cannabichromene, cannabidiol, tetrahydrocannabinol, cannabinol, cannabinodiol, and other cannabinoids. In some embodiments, the cannabinoid is selected from the group consisting of cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), and cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabiclomevalin (CBCV), cannabigerovalin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerol acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabimolic acid (THCA), tetrahydrocannabivaric acid (THCV A), and mixtures thereof. In some embodiments, the cannabinoid is tetrahydrocannabinol (THC) or comprises at least tetrahydrocannabinol (THC). In some embodiments, the cannabinoid is cannabidiol (CBD) or comprises at least cannabidiol (CBD).

[0114]

[0118] In some embodiments, the combination of active ingredients includes at least about 0.001% by weight of cannabinoids (such as cannabidiol) in an amount ranging from about 0.001% to about 10% by weight, 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 of the oral product.

[0115]

[0119] In some embodiments, the combination of active ingredients includes magnesium glycinate. If present, magnesium glycinate may be included in the oral product in an amount of about 0.1% to about 10% by weight, for example, about 0.5% to about 5% by weight, or about 0.5% to about 1% by weight.

[0116]

[0120] In some embodiments, the active ingredient combination includes electrolytes. Electrolytes are media that contain ions and conduct electricity through the movement of these ions. Electrolytes include most soluble salts, acids, and bases dissolved in polar solvents such as water. Upon dissolution, substances separate into cations and anions and disperse uniformly throughout the solvent. In oral rehydration therapy, electrolyte beverages containing sodium and potassium salts replenish the body's water and electrolyte concentration after dehydration caused, for example, by exercise, excessive alcohol intake, sweating, diarrhea, vomiting, poisoning, or starvation. In some embodiments, the active ingredient combination includes electrolytes, and the electrolytes may include sodium and / or potassium salts. If present, electrolytes may be included in amounts ranging from 0.01% to about 30% by weight of the oral product, for example, from 0.1% to about 20% by weight, or from about 0.5% to about 10% by weight of the oral product.

[0117]

[0121] To avoid misunderstanding, the above combinations of endpoints are expressly assumed by this disclosure. This applies to any scope disclosed herein.

[0118]

[0122] Ratio of active ingredients The ratio of active ingredients in an oral product may be selected to increase the effect of the oral product on the person taking it. This is a particularly preferred embodiment of the present disclosure.

[0119]

[0123] In some embodiments, maca root and ginseng are present in a weight ratio of about 30:1 to about 1:1, for example, about 15:1 to about 1:1, preferably about 10:1 to about 1:1.

[0120]

[0124] In some embodiments, maca root and ashwagandha are present in a weight ratio of about 20:1 to about 1:10, for example, about 20:1 to about 1:5, preferably about 15:1 to about 1:5.

[0121]

[0125] Ginseng may be present in an amount such that the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, for example, approximately 40:1 to approximately 5:1. Preferably, ginseng may be present in an amount such that the weight ratio of ginseng to the total amount of B vitamins is approximately 35:1 to approximately 10:1.

[0122]

[0126] In some embodiments, the total amount of maca root and B vitamins is present in a weight ratio of about 900:1 to about 10:1, for example, about 700:1 to about 15:1. In preferred embodiments, the total amount of maca root and B vitamins is present in a weight ratio of about 550:1 to about 25:1.

[0123]

[0127] In some embodiments, the total amount of ashwagandha and B vitamins is present in a weight ratio of about 150:1 to about 1:1, for example, about 120:1 to about 10:1, preferably about 100:1 to about 20:1.

[0124]

[0128] In some embodiments, ashwagandha and ginseng are present in a weight ratio of about 10:1 to about 1:10, for example, about 10:1 to about 1:5, preferably about 5:1 to about 1:5.

[0125]

[0129] If present, passionflower may be included such that the weight ratio of maca root to passionflower is about 20:1 to about 1:10, for example, about 15:1 to about 1:5. In a preferred embodiment, the weight ratio of maca root to passionflower is about 10:1 to about 1:5. The weight ratio of passionflower to total B vitamins may be about 50:1 to about 1:10, for example, about 40:1 to about 1:1, preferably about 35:1 to about 5:1. The weight ratio of passionflower to ginseng may be about 10:1 to about 1:10, for example, about 5:1 to about 1:5, preferably about 3:1 to about 1:3. The weight ratio of passionflower to ashwagandha may be about 10:1 to about 1:10, for example, about 5:1 to about 1:5, preferably about 4:1 to about 1:4.

[0126]

[0130] If present, vitamin C may be included such that its weight ratio to vitamin C in maca root is approximately 10:1 to 1:10, for example, approximately 5:1 to 1:10, preferably approximately 1:1 to 1:10. The weight ratio of total B vitamins to vitamin C may be approximately 10:1 to 1:10, for example, approximately 5:1 to 1:10, preferably approximately 1:1 to 1:10.

[0127]

[0131] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is about 30:1 to about 1:1, the weight ratio of maca root to the total amount of B vitamins is about 900:1 to about 10:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is about 50:1 to about 1:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0128]

[0132] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 15:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 900:1 to approximately 10:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0129]

[0133] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is about 10:1 to about 1:1, the weight ratio of maca root to the total amount of B vitamins is about 900:1 to about 10:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is about 50:1 to about 1:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0130]

[0134] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 700:1 to approximately 15:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0131]

[0135] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 15:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 700:1 to approximately 15:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0132]

[0136] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 550:1 to approximately 25:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0133]

[0137] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 700:1 to approximately 15:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is approximately 40:1 to approximately 5:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0134]

[0138] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 700:1 to approximately 15:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is approximately 35:1 to approximately 10:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0135]

[0139] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 550:1 to approximately 25:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is approximately 35:1 to approximately 10:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0136]

[0140] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 15:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 550:1 to approximately 25:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is approximately 35:1 to approximately 10:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0137]

[0141] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is about 10:1 to about 1:1, the weight ratio of maca root to the total amount of B vitamins is about 550:1 to about 25:1, and optionally the weight ratio of ginseng to the total amount of B vitamins is about 35:1 to about 10:1, and the combination of B vitamins is as described in any of the embodiments described herein.

[0138]

[0142] In any of the above embodiments, the weight ratio of maca root to ashwagandha may be about 20:1 to about 1:10, for example, about 20:1 to about 1:5, preferably about 15:1 to about 1:5.

[0139]

[0143] For example, in some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 900:1 to approximately 10:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0140]

[0144] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 15:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 900:1 to approximately 10:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0141]

[0145] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 10:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 900:1 to approximately 10:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0142]

[0146] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 700:1 to approximately 15:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0143]

[0147] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 15:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 700:1 to approximately 15:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0144]

[0148] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 550:1 to approximately 25:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 50:1 to approximately 1:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0145]

[0149] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 700:1 to approximately 15:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 40:1 to approximately 5:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0146]

[0150] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 700:1 to approximately 15:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 35:1 to approximately 10:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0147]

[0151] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 30:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 550:1 to approximately 25:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 35:1 to approximately 10:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0148]

[0152] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 15:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 550:1 to approximately 25:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 35:1 to approximately 10:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0149]

[0153] In some embodiments, the oral product comprises a combination of active ingredients including (i) maca root, (ii) a combination of B vitamins, (iii) ginseng, and (iv) ashwagandha, where the weight ratio of maca root to ginseng is approximately 10:1 to approximately 1:1, the weight ratio of maca root to the total amount of B vitamins is approximately 550:1 to approximately 25:1, the weight ratio of ginseng to the total amount of B vitamins is approximately 35:1 to approximately 10:1, and the weight ratio of maca root to ashwagandha is approximately 20:1 to approximately 1:10, and the combination of B vitamins is as described in any of the embodiments described herein.

[0150]

[0154] In any of the above embodiments, the oral product may further contain (iv) passionflower, where the weight ratio of maca root to passionflower is about 20:1 to about 1:10, for example, about 15:1 to about 1:5, preferably about 10:1 to about 1:5.

[0151]

[0155] In any of the above embodiments, the oral product may further contain (v) vitamin C, with the weight ratio of maca root to vitamin C being approximately 10:1 to approximately 1:10.

[0152]

[0156] additives Depending on the type of oral product being processed, the product may contain one or more additional ingredients in addition to the combination of active ingredients. For example, an oral product may further contain additives selected from the group consisting of flavoring agents, sweeteners, buffering agents, acidifying agents, thickeners, fillers, binders, humectants, preservatives, salts, colorants, oral care additives, disintegrants, antioxidants, water, or mixtures thereof. In some embodiments, the oral product further contains one or more additives selected from the group consisting of flavoring agents, sweeteners, acidifying agents, thickeners, fillers, binders, humectants, preservatives, and mixtures thereof.

[0153]

[0157] Filler Depending on the product form, oral products may contain fillers. Fillers can perform multiple functions, such as improving certain sensory perception characteristics like texture and mouthfeel, or improving the cohesiveness or compressibility of the product.

[0154]

[0158] In some embodiments, the filler is a porous granular material and is cellulosic. For example, the filler or bulking agent may be a non-tobacco plant material or a derivative of a non-tobacco plant material, and may include cellulosic materials derived from such sources. Examples of cellulosic non-tobacco plant materials include cereals (e.g., corn, oats, barley, rye, buckwheat, etc.), sugar beets (e.g., FIBREX® brand fillers available from International Fiber Corporation), bran fibers, 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, plant 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.

[0155]

[0159] In some embodiments, the filler is derived from wood pulp fibers. One filler particularly suitable for use in the products described herein is microcrystalline cellulose ("MCC"). MCC may be synthetic, semi-synthetic, or obtained entirely from natural cellulose. 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, as well as mixtures thereof.

[0156]

[0160] In some embodiments, the filler is a non-tobacco plant material or a derivative of a non-tobacco plant material. Non-limiting examples of derivatives of non-tobacco plant materials include starch (e.g., potato, wheat, rice, corn), natural cellulose, and modified cellulose materials. Further examples of potential fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Combinations of these fillers can also be used.

[0157]

[0161] As used herein, “starch” may refer to pure starch, modified starch, or starch derivatives from any source. Starch is typically present in granular form in almost all green plants and various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, sprouts, fruits, grains, and stems). Starch can vary in composition, as well as in granular form and size. Often, starches from different sources have different chemical and physical characteristics. Certain starches can be selected for inclusion in a product based on their ability to impart specific sensory properties to the product. Starches from a variety of sources can be used. For example, major sources of starch include grains (e.g., rice, wheat, and corn) and root vegetables (e.g., potatoes and cassava). Other examples of starch sources include acorns, arrowroot, arakacha, bananas, barley, legumes (e.g., broad beans, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnut, taro, dogtooth violet, kudzu, maranga, millet, oats, wood sorrel, taro, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnut, and yam. Certain starches are modified starches. Modified starches undergo one or more structural modifications, often designed to alter the high thermal properties of modified starches. Some starches are developed through genetic modification and are considered “modified” starches. Other starches are obtained and subsequently processed. For example, modified starch may be starch subjected to chemical reactions such as esterification, etherification, oxidation, depolymerization (dilution) by oxidation in the presence of an acid catalyst or a base, bleaching, glycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), crosslinking, enzymatic treatment, acetylation, hydroxypropylation, and / or partial hydrolysis. Other starches are processed by heat treatments such as gelatinization, dextrinization, and / or cold water swelling processes.Specific modified starches include phosphorylated starch, glycerol cross-linked starch, phosphate cross-linked starch esterified with sodium trimetaphosphate, phosphorylated phosphate cross-linked starch, acetylated phosphate cross-linked starch, acetate starch esterified with acetic anhydride, acetate starch esterified with vinyl acetate, acetylated adipic acid cross-linked starch, acetylated glycerol cross-linked starch, hydroxypropyl starch, hydroxypropyl glycerol cross-linked starch, and sodium octenyl succinate starch.

[0158]

[0162] water The water content (e.g., water content) of an oral product before use by the consumer may vary according to the desired characteristics.

[0159]

[0163] Typically, for solid oral products, the water content before insertion into the user's mouth is less than 50% by weight, generally ranging from about 1% to about 50% by weight, for example, about 5% to about 45% by weight, about 10% to about 40% by weight, and about 20% to about 35% by weight, containing at least about 5% by weight, at least about 10% by weight, at least about 15% by weight, and at least about 20% by weight of water in the oral product.

[0160]

[0164] In the case of liquid oral products, the water content may be higher, and may be at least about 50% by weight of the oral product, for example, at least about 60% by weight, for example, 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 about 60% to about 99.5% by weight of the oral product, for example, about 75% to about 99% by weight, for example, about 80% to about 98% by weight.

[0161]

[0165] Flavoring As used herein, the term “flavoring agent” (or “flavor” or “flavoring agent”) refers to any material that may be used to create a desired taste, aroma, or other somatic sensation in a product intended for adult consumption, where local regulations permit it. Examples of sensory characteristics that may be modified by flavoring agents include taste, texture, moisture, coolness / heat, and / or aroma / fragrance. Flavoring agents may be natural or synthetic, and the flavor characteristics they impart may be described as, but are not limited to, fresh, sweet, herbal, confectionery, floral, fruity, or spicy.

[0162]

[0166] Flavorings include naturally occurring flavorings, plant-based ingredients, extracts of plant-based ingredients, synthetically obtained materials, or combinations thereof (e.g., tobacco, cannabis, licorice, hydrangea, eugenol, magnolia leaf, chamomile, fenugreek, clove, maple, matcha, menthol, Japanese mint, anise, cinnamon, turmeric, Indian spices, Asian spices, herbs, wintergreen, cherry, berries, red berries, cranberries, raspberries, strawberries, peaches, apples, oranges, mangoes, pineapples). Apple, clementine, lemon, lime, tropical fruit, papaya, rhubarb, grape, 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, kurt, eggplant, betel nut, shisha, pine, honey essence, rose oil, vanilla, lemon oil, orange oil, orange blossom, cherry blossom, oak A, caraway, cognac, jasmine, ylang-ylang, sage, fennel, wasabi, bell pepper, ginger, coriander, coffee, hemp, peppermint oil from any of the Mentha species, eucalyptus, star anise, cocoa, lemongrass, rooibos, flax, ginkgo, hazelnut, hibiscus, bay leaf, mate, orange peel, rose, tea such as green or black tea, thyme, juniper, elderflower, basil, bay leaf, cumin, oregano, paprika, rosemary, saffron, lemon peel, mint, shiso, curcuma, cilantro, myrtle, oak (Valeriana, 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), as well as charcoal, chlorophyll, minerals, and plant-based ingredients.Alternatively, it may be selected from the group consisting of other additives such as breath fresheners. The flavoring agent may be an imitation, synthetic, or natural ingredient, or a blend thereof. The flavoring agent may be in any suitable form, such as a liquid like oil, a solid like powder, or a gas.

[0163]

[0167] In some embodiments, the flavoring agent includes natural flavoring agents such as berries (e.g., raspberries, blueberries, or strawberries), honey, citrus fruits (such as lemons, bergamots, oranges, or limes), or other plant-based materials.

[0164]

[0168] In some embodiments, the flavoring agent includes menthol, spearmint, and / or peppermint. In some embodiments, the flavoring agent includes flavor components of cucumber, blueberry, citrus, and / or red berry. 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.

[0165]

[0169] In some embodiments, the flavoring agent may include a sensory stimulant, which is intended to achieve somatosensory effects that are normally chemically induced and perceived by stimulation of the fifth cranial nerve (trigeminal nerve) in addition to, or instead of, the aroma or taste nerves, and may include agents that produce heating, cooling, tingling, or numbing effects. A preferred thermal agent may be, but is not limited to, vanillyl ethyl ether, and a preferred cooling agent may be, but is not limited to, eucalyptol or WS-3.

[0166]

[0170] If present, flavoring agents may be included in the oral product in an amount of up to about 10% by weight of the oral product, for example, up to about 5% by weight, for example, up to about 1% by weight. In some embodiments, flavoring agents are present in an amount of about 0.01% to about 5% by weight, preferably about 0.1% to about 2.5% by weight of the oral product, and more preferably about 0.25% to about 1% by weight of the oral product.

[0167]

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

[0168]

[0172] The binder may be organic, inorganic, or a combination thereof. Typical binders include cellulose derivatives, povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and combinations thereof. The amount of binder used in the product may vary, but can be up to approximately 30% by weight, and specific embodiments are characterized by a binder content of at least approximately 0.1% by weight, for example, approximately 1% to approximately 30% by weight, or approximately 1% to approximately 10% by weight, based on the total weight of the oral product.

[0169]

[0173] In some embodiments, the binder includes a cellulose derivative. In certain embodiments, the cellulose derivative is a cellulose ether (including carboxyalkyl ethers), meaning a cellulose polymer in which one or more hydrogens of hydroxyl groups in the cellulose structure are replaced by alkyl, hydroxyalkyl, or aryl groups. Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethylcellulose, and carboxymethylcellulose ("CMC"). In some embodiments, the cellulose derivative is HPC or includes HPC. In some embodiments, the cellulose derivative is a combination of HPC and HPMC. In some embodiments, the oral product contains about 1% to about 10% by weight of the cellulose derivative (such as HPC) of the oral product, and in certain embodiments, it contains about 1% to about 5% by weight of the cellulose derivative (such as HPC), based on the weight of the product.

[0170]

[0174] Humectant In some embodiments, the oral product contains at least one wetting agent. Examples of suitable wetting agents 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, and mannitol. In some embodiments, the wetting agent is glycerin or contains glycerin. In some embodiments, the oral product contains glycerin. In some embodiments, the wetting agent is propylene glycol or contains propylene glycol. In some embodiments, the oral product contains propylene glycol. The amount of wetting agent used in the oral product may vary, but may be up to about 5% by weight, and certain embodiments may be characterized by a wetting agent content of at least about 1% by weight, for example, about 2% to about 5% by weight, in the oral product. In some embodiments, a wetting agent (such as glycerin and / or propylene glycol) may be present in an amount of about 0.01% to about 25% by weight of the oral product, for example, about 0.1% to about 20% by weight of the oral product, for example, about 0.5% to about 15% by weight of the oral product, for example, about 1% to about 10% by weight of the oral product, for example, about 5% to about 10% by weight of the oral product.

[0171]

[0175] sweetener One or more sweeteners may be added to improve the sensory characteristics of an oral product. The sweeteners may be any sweetener or combination of sweeteners, either 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, and honey. Examples of artificial sweeteners include sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, and neotame.

[0172]

[0176] In some embodiments, the sweetener comprises one or more sugar alcohols. Examples of sugar alcohols include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof. In some embodiments, the sweetener is selected from the group consisting of fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and mixtures thereof.

[0173]

[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 the oral product, the sweetener (such as sucralose and / or acesulfame K) may be present in an amount of about 0.001% to about 5% by weight, for example, about 0.01% to about 3% by weight, preferably about 0.01% to about 1% by weight, of the oral product.

[0174]

[0178] cushioning agent Non-limiting examples of suitable buffers 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 where a buffer is present, the buffer 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 buffer is sodium bicarbonate and / or sodium carbonate. If present, the buffer (e.g., sodium bicarbonate and / or sodium carbonate) may be included in amounts less than about 5% by weight of the oral product, for example, about 0.5% to about 5% by weight based on the total weight of the oral product, for example, about 0.75% to about 4% by weight, about 0.75% to about 3% by weight, or about 1% to about 2% by weight.

[0175]

[0179] organic acid In some embodiments, the product contains organic acids. As used herein, the term “organic acid” refers to an organic (i.e., carbon-based) compound characterized by its 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 (-CO2H) or sulfonic acids (-SO2OH). As used herein, references to organic acids mean organic acids that are intentionally added. In this regard, organic acids may be intentionally added as a specific component of a mixture, rather than simply existing as a component of another mixture (e.g., small amounts of organic acids that may be essentially present in a mixture of components such as tobacco materials). In some embodiments, one or more organic acids are added as is (i.e., in the form of free acids, natural solids or liquids) or as a solution, for example, in water. In some embodiments, one or more organic acids are added in the form of salts.

[0176]

[0180] In some embodiments, the organic acid is a carboxylic acid or sulfonic acid. The carboxylic acid or sulfonic acid functional group is, for example, 1 to 20 carbon atoms (C1 to C20). 20It may be bonded to any alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl group having ). In some embodiments, the organic acid is an alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroarylcarboxylic acid or sulfonic acid.

[0177]

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

[0178]

[0182] In some embodiments, the alkylcarboxylic acid or sulfonic acid is substituted with one or more hydroxyl groups. Non-limiting examples include glycolic acid, 4-hydroxybutyric acid, and lactic acid.

[0179]

[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 carboxylic acid groups may be esterified. Non-limiting examples include monoethyl succinate, monomethyl fumarate, monomethyl citrate, or dimethyl citrate.

[0180]

[0184] In some embodiments, the organic acid may comprise two or more carboxylic acid groups and one or more hydroxyl groups. Non-limiting examples of such acids include tartaric acid and citric acid. In some preferred embodiments, the organic acid is citric acid, sodium citrate, calcium citrate, or a combination thereof.

[0181]

[0185] In some embodiments, the organic acid is an arylcarboxylic acid or an arylsulfonic acid. Non-limiting examples of arylcarboxylic acids and sulfonic acids include benzoic acid, tolueneic acid, salicylic acid, benzenesulfonic acid, and p-toluenesulfonic acid.

[0182]

[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 sulfate, ethane-1,2-disulfonic acid, ethanol Examples include sulfonic acid, formic acid, fumaric acid, galactaric acid, gentisic acid, glucoheptonic acid, gluconic acid, glucuronic acid, glutamic acid, glycerophosphate, 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.

[0183]

[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 citric acid or a citrate, or comprises citric acid or a citrate.

[0184]

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

[0185]

[0189] The amount of organic acids present in the product may vary. An oral product may contain about 0.01% to about 10% by weight of organic acids (e.g., citric acid or citrate) present as one or more organic acids, based on the total weight of the oral product. In some embodiments, an oral product may contain at least about 0.01% by weight, at least about 0.1% by weight, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight, about 0.9% by weight, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, or at least about 10% by weight of organic acids, based on the total weight of the oral product. In some preferred embodiments, an oral product may contain about 0.01% to about 5% by weight of organic acids (e.g., citric acid or citrate), based on the weight of the oral product. For example, oral products contain organic acids in amounts ranging from approximately 0.1% to 2.5% by weight of the oral product. If a salt of an organic acid is added (e.g., anhydrous citric acid), the weight percentage is calculated based on the weight of the free acid, excluding any counterions that may be present.

[0186]

[0190] In certain embodiments, the organic acid content is sufficient to provide a product pH of about 4.0 to about 9.0, for example, 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 organic acid content is sufficient to provide a product pH of about 4.5 to about 6.5, for example, 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, for example, 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.

[0187]

[0191] In other embodiments, mineral acids (e.g., hydrochloric acid, sulfuric acid, phosphoric acid, etc.) are added to adjust the product pH to a desired value.

[0188]

[0192] Organic acids (e.g., citric acid) can be added either as is (i.e., as a solid) or in solution, for example, in water. In some embodiments, the organic acid is added as a 50% aqueous solution.

[0189]

[0193] Thickening agent In some embodiments, oral products may contain thickeners. Suitable thickeners include hydrophilic colloids 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 a composition when added during low-temperature processing (i.e., when no heat is applied).

[0190]

[0194] If present, a thickening agent (e.g., xanthan gum) may be included in the oral product in an amount of about 0.001% to about 5% by weight, preferably about 0.01% to about 1% by weight.

[0191]

[0195] Coloring agents Colorants may be used in amounts sufficient to impart the desired physical attributes to the product. Examples of colorants include caramel colorants and various dyes and pigments such as titanium dioxide. Natural colorants such as curcumin, beet juice extract, and spirulina, as well as various synthetic pigments, may also be used. The amount of colorant used in oral products may vary, but if present, it is typically up to about 3% by weight, e.g., about 0.1% by weight, about 0.5% by weight, or about 1% to about 3% by weight, based on the total weight of the oral product.

[0192]

[0196] Other additives Other ingredients such as preservatives (e.g., potassium sorbate), disintegrants (e.g., croscarmellose sodium, crospovidone, sodium starch glycolate, pregelatinized corn starch, etc.), and / or antioxidants may also be used. Typically, such ingredients, when used, are used in amounts 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. Disintegrants may be used in amounts sufficient to bring about control of the desired physical attributes of the oral product, for example, by causing loss of physical integrity and dispersion of various component materials upon contact with water (e.g., by undergoing swelling upon contact with water).

[0193]

[0197] Further examples of additives include zinc or magnesium salts, or combinations thereof, selected to be relatively water-soluble for compositions with higher water solubility (e.g., magnesium gluconate or zinc gluconate), or selected to be relatively water-insoluble for compositions with reduced water solubility (e.g., magnesium oxide or zinc oxide). See, for example, U.S. Patent No. 9,237,769 by Mua et al., U.S. Patent No. 7,861,728 by Holton, Jr. et al., U.S. Patent Application Publication No. 2010 / 0291245 by Gao et al., and U.S. Patent Application Publication No. 2007 / 0062549 by Holton, Jr. et al. (each of which is incorporated herein by reference), for typical components of additives, combinations of components, relative amounts of components of additives, and forms and methods for using the components of additives. The typical range of such additional additives can vary depending on the properties and functions of the additive, as well as the intended effect on the final product. For example, based on the total weight of the oral product, the range may be up to approximately 10% by weight (e.g., approximately 0.1% to approximately 5% by weight).

[0194]

[0198] In some embodiments, the oral product contains a magnesium salt. A non-limiting example of a suitable magnesium salt is magnesium gluconate. In some embodiments, the oral product contains magnesium in an amount of about 0.1% to about 2% by weight, or about 0.2% to about 1% by weight, based on the element magnesium.

[0195]

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

[0196]

[0200] The aforementioned additives can be used together (for example, as an additive formulation) or separately (for example, individual additive components can be added at different stages involved in the preparation of the final product). Furthermore, the aforementioned types of additives may be encapsulated so as to be provided in the final product or composition. Exemplary encapsulated additives are described, for example, in Atchley's International Publication 2010 / 132444, which is previously incorporated herein by reference.

[0197]

[0201] Oral products The products or compositions described herein are configured for oral use. As used herein, “configured for oral use” means that the product is provided in such a form that, during use, the saliva in the user’s mouth allows one or more components of the product (e.g., the active ingredient) to pass through the user’s mouth. In certain embodiments, the product is adapted to deliver the active ingredient and optionally flavoring agents to the user through the mucous membranes of the user’s mouth, the user’s digestive system, or both. In some examples, the active ingredient and optionally flavoring agents may be absorbed through the mucous membranes of the mouth or through the digestive tract when the product is used.

[0198]

[0202] In some embodiments, the oral product comprises a combination of active ingredients in an amount of at least about 0.01% by weight, for example, at least about 0.1% by weight, or preferably at least about 1% by weight of the oral product. The oral product may comprise a combination of active ingredients in an amount of 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 of the oral product, for example, about 40% by weight or less, for example, about 30% by weight or less, for example, about 20% by weight or less, for example, about 15% by weight or less.

[0199]

[0203] The combination of active ingredients may be present in an amount of about 0.01% to about 20% by weight. For example, the combination of active ingredients may be present in an amount of about 0.05% to about 15% by weight of the oral product, for example, about 0.1% to about 10% by weight, or about 0.5% to about 5% by weight. Preferably, the combination of active ingredients 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.

[0200]

[0204] Oral products can take any form suitable for administration to the oral cavity of humans or animals. 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. Oral products described herein can take various forms including gels, melts, tablets, lozenges, powders, pouches, and liquids (e.g., beverages). In some preferred embodiments, the oral product is a liquid oral dosage form.

[0201]

[0205] Liquid oral dosage form In some preferred embodiments, the oral product is in the form of a liquid dosage form. Since the liquid dosage form is suitable for oral administration and can be ingested (i.e., drunk) by the user, it is sometimes referred to as a beverage.

[0202]

[0206] Liquid oral dosage forms may also be in the form of shots, i.e., beverages that can be taken quickly, for example, in one or several doses. Formulating oral products in shot form may be preferable because it provides a convenient and easy-to-use mode of administration, taking up less space during storage (e.g., in a refrigerator or cupboard) and being easily portable by the user, allowing for consumption while on the go. Shots can also provide an efficient delivery medium for the active ingredient, thereby delivering a sufficient level of the active ingredient to the user to produce good efficacy without the need to ingest a large amount of liquid. Furthermore, shots may be formulated to have a pleasant taste. Drinking shots may be considered more palatable and easier for the user than, for example, swallowing tablets.

[0203]

[0207] 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 supplied in packaging such as cartons, cups, cans, or liquid bottles.

[0204]

[0208] 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.

[0205]

[0209] When in the form of a liquid oral dosage form, the oral product may further contain water in an amount of about 50% to about 99.9% by weight of the oral product. In some embodiments, the oral product contains water in an amount of about 75% to about 99.5% by weight of the oral product, for example, about 80% to about 99% by weight, for example, about 90% to about 97.5% by weight of the oral product. In some embodiments, the oral product contains 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.

[0206]

[0210] If present, water may include tap water, rainwater, mineral-rich water, or distilled water.

[0207]

[0211] A liquid oral dosage form may contain 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. A liquid oral dosage form may contain 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.

[0208]

[0212] In some embodiments, the combination of active ingredients in the liquid oral dosage form includes (i) maca root, (ii) a combination of B vitamins as defined herein above, (iii) ginseng, (iv) ashwagandha, and optionally (v) passionflower and / or (vi) vitamin C. The combination of active ingredients in the liquid oral dosage form may include (i) maca root, (ii) a combination of B vitamins as defined herein above, (iii) ginseng, (iv) ashwagandha, and (v) passionflower.

[0209]

[0213] In any of the above embodiments, the liquid oral dosage form may further contain, optionally, about 0.01% to about 2% by weight of zinc or zinc gluconate in the oral product.

[0210]

[0214] The liquid oral dosage form (for example, in the form of shots with a volume of 25 mL to 75 mL) may contain an amount of maca root of about 50 mg to about 1000 mg, for example, about 100 mg to about 800 mg, preferably about 150 mg to about 500 mg.

[0211]

[0215] In other embodiments, the liquid oral dosage form (for example, in the form of shots with a volume of 25 mL to 75 mL) may contain an amount of maca root of about 500 mg to about 3000 mg, for example, about 1000 mg to about 3000 mg, preferably about 2000 mg to about 3000 mg.

[0212]

[0216] The liquid oral dosage form (for example, in the form of shots with a volume of 25 mL to 75 mL) may contain the total amount of B vitamins in an amount of about 1 mg to about 50 mg, for example, about 1 mg to about 30 mg, preferably about 1 mg to about 20 mg. In some preferred embodiments, the liquid oral dosage form (for example, in the form of shots with a volume of 25 mL to 75 mL) contains vitamins B1, B2, B6, and B7 or a combination of vitamins B1, B2, and B6, and the total amount of B vitamins is about 1 mg to about 30 mg, preferably about 1 mg to about 15 mg.

[0213]

[0217] Liquid oral dosage forms (for example, in the form of shots with a volume of 25 mL to 75 mL) may contain ginseng in an amount of about 10 mg to about 500 mg, for example, about 25 mg to about 300 mg, preferably about 50 mg to about 250 mg.

[0214]

[0218] Liquid oral dosage forms (for example, in the form of shots with a volume of 25 mL to 75 mL) may contain ashwagandha in an amount of about 10 mg to about 500 mg, for example, about 25 mg to about 400 mg, preferably about 50 mg to about 350 mg.

[0215]

[0219] In other embodiments, a liquid oral dosage form (for example, in the form of a shot with a volume of 25 mL to 75 mL) may contain an amount of ashwagandha of about 10 mg to about 600 mg, for example, about 50 mg to about 600 mg, preferably about 100 mg to about 600 mg.

[0216]

[0220] If present, the liquid oral dosage form (for example, in the form of a shot with a volume of 25 mL to 75 mL) may contain an amount of passionflower of about 10 mg to about 800 mg, for example, about 25 mg to about 700 mg, preferably about 50 mg to about 600 mg.

[0217]

[0221] If present, the liquid oral dosage form (e.g., in the form of shots with a volume of 25 mL to 75 mL) may contain an amount of vitamin C of about 10 mg to about 500 mg, for example, about 50 mg to about 500 mg, or for example, about 200 mg to about 400 mg. In some preferred embodiments, the liquid oral dosage form (e.g., in the form of shots with a volume of 50 mL to 100 mL) may contain an amount of vitamin C of about 250 mg to about 350 mg.

[0218]

[0222] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 50 mg to about 1000 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0219]

[0223] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 100 mg to about 800 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0220]

[0224] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 150 mg to about 500 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0221]

[0225] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 50 mg to about 1000 mg of maca root, (ii) about 1 mg to about 30 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0222]

[0226] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 50 mg to about 1000 mg of maca root, (ii) about 1 mg to about 20 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0223]

[0227] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 50 mg to about 1000 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 25 mg to about 300 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0224]

[0228] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 50 mg to about 1000 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 50 mg to about 250 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0225]

[0229] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 50 mg to about 1000 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 25 mg to about 400 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0226]

[0230] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 50 mg to about 1000 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 50 mg to about 250 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0227]

[0231] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 100 mg to about 800 mg of maca root, (ii) about 1 mg to about 30 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0228]

[0232] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 100 mg to about 800 mg of maca root, (ii) about 1 mg to about 30 mg of a combination of B vitamins as defined above, (iii) about 25 mg to about 300 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0229]

[0233] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 100 mg to about 800 mg of maca root, (ii) about 1 mg to about 30 mg of a combination of B vitamins as defined above, (iii) about 50 mg to about 250 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0230]

[0234] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 100 mg to about 800 mg of maca root, (ii) about 1 mg to about 30 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 25 mg to about 400 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0231]

[0235] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 100 mg to about 800 mg of maca root, (ii) about 1 mg to about 30 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 50 mg to about 250 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0232]

[0236] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 150 mg to about 500 mg of maca root, (ii) about 1 mg to about 20 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0233]

[0237] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 150 mg to about 500 mg of maca root, (ii) about 1 mg to about 20 mg of a combination of B vitamins as defined above, (iii) about 25 mg to about 300 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0234]

[0238] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 150 mg to about 500 mg of maca root, (ii) about 1 mg to about 20 mg of a combination of B vitamins as defined above, (iii) about 50 mg to about 250 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0235]

[0239] In some embodiments, the liquid oral dosage form (e.g., in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 150 mg to about 500 mg of maca root, (ii) about 1 mg to about 20 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 50 mg to about 250 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0236]

[0240] In some embodiments, the liquid oral dosage form (e.g., in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 150 mg to about 500 mg of maca root, (ii) about 1 mg to about 20 mg of a combination of B vitamins as defined above, (iii) about 50 mg to about 250 mg of ginseng, (iv) about 25 mg to about 400 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0237]

[0241] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 150 mg to about 500 mg of maca root, (ii) about 1 mg to about 20 mg of a combination of B vitamins as defined above, (iii) about 50 mg to about 250 mg of ginseng, (iv) about 50 mg to about 250 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0238]

[0242] In any of the above embodiments, passionflower may be present in an amount of about 25 mg to about 700 mg, preferably about 50 mg to about 600 mg.

[0239]

[0243] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 500 mg to about 3000 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 500 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0240]

[0244] In some embodiments, the liquid oral dosage form (e.g., in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 50 mg to about 1000 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 600 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0241]

[0245] In some embodiments, the liquid oral dosage form (for example, in the form of shots having a volume of 25 mL to 75 mL) comprises (i) about 500 mg to about 3000 mg of maca root, (ii) about 1 mg to about 50 mg of a combination of B vitamins as defined above, (iii) about 10 mg to about 500 mg of ginseng, (iv) about 10 mg to about 600 mg of ashwagandha, and optionally (v) about 10 mg to about 800 mg of passionflower.

[0242]

[0246] The inventors have found that the amount of active ingredient described above provides a safe product with reduced side effects while simultaneously producing the beneficial effect of increased sexual desire or increased desire for sexual activity. The amount can be adjusted to ensure the safety of the user and avoid excessive intake of the active ingredient, while still providing a highly effective product.

[0243]

[0247] In any of the above embodiments, the liquid oral dosage form may further contain, optionally, about 5 mg to about 150 mg of zinc, such as zinc gluconate. In a preferred embodiment, the liquid oral dosage form may further contain about 10 mg to about 50 mg of zinc.

[0244]

[0248] The liquid oral dosage form may contain any further suitable additives. Suitable additives are described in more detail above, and all additives described herein may be included in the liquid oral dosage form. In some embodiments, the liquid oral dosage form may further contain additives selected from the group consisting of flavoring agents, sweeteners, acidifying agents, thickeners, wetting agents, preservatives, and mixtures thereof. Examples of each of these forms of additives are described above herein.

[0245]

[0249] Solid oral dosage form In some embodiments, the oral product is in 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, the product can be considered solid, solid-like, solid-form, or solid-like-form at room temperature. To avoid misunderstanding, a solid product remains substantially solid up to 30°C. In some embodiments, the oral product is in solid form, such as loose wet snuff, loose dry snuff, pelletized pieces, extruded or molded strips, pieces, rods or sticks, finely ground powder, powdered pieces and finely ground or pulverized aggregates of components, flake-like pieces, molded pieces, films, films or strips that readily dissolve or disperse in water, capsule-like materials, tablets, lozenges, etc. In some embodiments, the oral product is a tablet or lozenge. In some embodiments, the oral product is in the form of wet snuff or snus, which may or may not contain tobacco.

[0246]

[0250] The oral products disclosed herein can be formed into a variety of shapes, including pills, tablets, spheres, strips, films, sheets, coins, cubes, beads, oval shapes, obloids, cylinders, bean shapes, sticks, or rods. The cross-sectional shapes of the products can vary, with exemplary cross-sectional shapes including circular, square, elliptical, and rectangular shapes. Such shapes can be formed in various ways using devices such as moving belts, nip devices, extruders, granulators, and compressors.

[0247]

[0251] In some embodiments, the solid oral product is in a form selected from the group consisting of a melt, a tablet, or a lozenge.

[0248]

[0252] Molten material In some embodiments, the product may be meltable, for example, as discussed in Cantrell et al., U.S. Patent Application Publication 2012 / 0037175, which is incorporated herein by reference in whole.

[0249]

[0253] As used herein, “melt,” “melting,” and “meltable” refer to the ability of a product to change from a solid state to a liquid state. That is, melting occurs when a substance (e.g., the products disclosed herein) changes from a solid to a liquid, usually by the application of heat.

[0250]

[0254] The application of heat to the products disclosed herein is provided by the internal temperature of the user's mouth. Therefore, the term “meltable” refers to a product that can be liquefied in the user's mouth when the product undergoes a phase change from solid to liquid, and is intended to distinguish between a product that simply disintegrates in the oral cavity due to the loss of cohesiveness within the product and a product that simply dissolves in the oral cavity as its water-soluble components interact with moisture.

[0251]

[0255] Generally, meltable products contain lipids. In some embodiments, the composition contains lipids. Lipids are typically fats, oils, or waxy substances derived from animal or plant materials (e.g., plant-derived fats), and typically contain mostly triglycerides, along with smaller 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 at least partially liquefy (i.e., “melt”) when exposed to the temperature of the user’s mouth. Exemplary plant-derived fats consist mainly of saturated or unsaturated fatty acid chains (most of which are bonded within 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.

[0252]

[0256] In some embodiments, lipids include oils, particularly food-grade oils including fractionated oils. Such oils include vegetable oils (e.g., acai oil, almond oil, amaranth oil, apricot oil, apple seed oil, argan oil, avocado oil, babassu oil, beech nut oil, bean oil, bitter melon oil, black seed oil, blackcurrant seed oil, borage seed oil, talc oil, bottle gourd oil, Brazil nut oil, buffalo pumpkin oil, butternut squash seed oil, Cape chestnut oil, canola oil, carob cashew oil) - Oil, cocoa butter, burdock oil, coconut oil, corn oil, kaffir lime oil, coriander seed oil, cottonseed oil, date seed oil, dika oil, egus seed oil, evening primrose oil, linseed oil, flaxseed oil, grape seed oil, grapefruit seed oil, hazelnut oil, hemp seed oil, kapok seed oil, kenaf seed oil, larlemanthia oil, lemon oil, flaxseed oil, macadamia oil, muffler oil, marula oil, meadowfoam seed oil, mongongo nut Oils, mustard oil, niger seed oil, nutmeg butter, okra seed oil, olive oil, orange oil, palm oil, papaya seed oil, peanut oil, pecan oil, perilla seed oil, oyster seed oil, pequi oil, pili nut oil, pine nut oil, pistachio oil, pomegranate seed oil, poppy seed oil, pracaxi oil, plum kernel oil, pumpkin seed oil, quinoa oil, ramuchil oil, rapeseed oil, rice bran oil, royal oil, sacha inchi oil, safflower oil, sapote oil, sage oil, sesame oil, Examples of animal oils include, but are not limited to, shea butter, soybean oil, sunflower oil, tarami 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., bovine fat, buffalo fat, sheep fat, goat fat, porcine fat, lard, camel fat, animal fat, liquid margarine, fish oil, fish liver oil, whale oil, seal oil, and combinations thereof), and mineral oils.

[0253]

[0257] In certain embodiments, the plant-derived fats of this 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 unhydrogenated. Exemplary embodiments of the lipid can be purchased from Aarhus Karlshamn USA Inc. under the trademarks CEBES®, CISAO®, or CONF AO®.

[0254]

[0258] The melting point of lipids is typically above about 29°C, for example, 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 a melting point below about 36°C is unsuitable due to melting that may occur during product storage or handling. One test for determining the melting point of lipids is the Mettler dropping point method (ASTM D3954-15, Standard Test Method for Dropping Point of Waxes, ASTM International (West Concho Hocken, Pennsylvania), 2015, www.astm.org).

[0255]

[0259] If present, the amount of lipids in the composition may vary. In certain embodiments, the amount of lipids is at least about 10% by weight, at least about 20% by weight, or at least about 30% by weight on a dry weight basis of the composition. In certain embodiments, the amount of lipids is less than about 70% by weight, less than about 60% by weight, or less than about 50% by weight on a dry weight basis. Exemplary lipid weight ranges include about 10% by weight to about 70% by weight on a dry weight basis, for example, about 35% by weight to about 50% by weight on a dry weight basis. In some embodiments, the amount of lipids is about 35% by weight, about 40% by weight, about 45% by weight, or about 50% by weight of the total oral product.

[0256]

[0260] In some embodiments, the oral product contains lipids. In one embodiment, the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil, and combinations thereof, wherein the oil may be hydrogenated, partially hydrogenated, or unhydrogenated. In one embodiment, the lipid is a medium-hardness trans-hydrogenated filled fat such as Confao® 5, available from Aarhus Karlshamn USA Inc. (131 Marsh Street, Port Newark, New Jersey (07114)).

[0257]

[0261] In some embodiments, the product in a molten form contains about 35% to about 50% by weight of lipids and about 35% to about 55% by weight of sugar alcohols. In some embodiments, sugar alcohols may include isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or combinations thereof. In some embodiments, the sugar alcohol is isomalt or contains isomalt. In some embodiments, sugar substitutes may be substitutes for sugar alcohols or may be used in combination with one or more sugar alcohols. Suitable sugar substitutes include allulose, soluble tapioca fiber, inulin, and combinations thereof.

[0258]

[0262] tablet In certain embodiments, the product is in the form of compressed or molded tablets. Exemplary tablet dosage forms have a weight of about 250 mg to about 1500 mg, for example, about 250 mg to about 700 mg, or about 700 mg to about 1500 mg. The tablets may have any of a variety of shapes, including traditional pill or tablet shapes.

[0259]

[0263] Generally, the tablet-form product contains a glucose-polysaccharide blend and a sugar alcohol. In some embodiments, the glucose-polysaccharide blend is present in an amount of about 35% to about 50% by weight based on the total weight of the product, and the sugar alcohol is present in an amount of about 30% to about 45% by weight based on the total weight of the product. In some embodiments, the sugar alcohol may be isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof. In some embodiments, the sugar alcohol is isomalt or contains isomalt.

[0260]

[0264] When in tablet form, the product may be dissolvable. As used herein, the terms “dissolve,” “dissolving,” and “dissolvable” refer to a product having water-soluble components that interact with oral moisture to enter a solution, thereby causing gradual ingestion of the product. In one embodiment, a dissolvable product can remain in the user’s mouth for a given period of time until the dissolvable product is completely dissolved. The rate of dissolution can vary over a wide range from about 1 minute or less to about 60 minutes. For example, a fast-release product typically dissolves and / or releases the desired components (e.g., active ingredients, flavorings, 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 destruction (e.g., chewing), enzymatic or other chemical decomposition, or disruption of interactions between components of the product. In other embodiments, the product does not dissolve while it remains in the user’s mouth.

[0261]

[0265] Lozenges In some embodiments, the products disclosed herein may be in the form of a soluble lozenge product configured for oral use. Exemplary lozenge-type products of the present invention may be in the form of lozenges, tablets, microtabs, or other tablet-type products. For example, U.S. Patent No. 4,967,773 by Shaw, U.S. Patent No. 5,110,605 by Acharya, U.S. Patent No. 5,733,574 by Dam, U.S. Patent No. 6,280,761 by Santus, U.S. Patent No. 6,676,959 by Andersson et al., U.S. Patent No. 6,248,760 and U.S. Patent No. 7,374,779 by Wilhelmsen, U.S. Patent Application Publication 2001 / 0016593 by Wilhelmsen, and U.S. Patent Application Publication 2004 / 01015 by Liu et al. See Patent No. 43, U.S. Patent Application Publication No. 2006 / 0120974 of Mcneight, U.S. Patent Application Publication No. 2008 / 0020050 of Chau et al., U.S. Patent Application Publication No. 2009 / 0081291 of Gin et al., and U.S. Patent Application Publication No. 2010 / 0004294 of Axelsson et al. (these are incorporated herein by reference) for descriptions of nicotine-containing lozenges, lozenge formulations, lozenge forms and compositions, lozenge characteristics, and techniques for formulating or manufacturing lozenges.

[0262]

[0266] Lozenge products are generally labeled "hard" to distinguish them from soft lozenges (i.e., troches). Hard lozenges are amorphous mixtures of sugars and / or carbohydrates. Although hard lozenges are made from aqueous syrup, the water initially present evaporates as the syrup boils during processing, resulting in a very low moisture content in the final product, for example, 0.5% to 1.5% by weight. To obtain hard, non-sticky lozenges, the temperature of the molten material must reach the hard crack stage, generally within the exemplary temperature range of 149°C to 154°C.

[0263]

[0267] Lozenge-type products may exhibit translucency or transparency in some embodiments. The desired transparency or translucency of a product can be quantified by any known method. For example, optical methods such as turbidity measurement (or turbidimetry) and colorimetry may be used to quantify the cloudiness (light scattering) and color (light absorption) of the product, respectively. Translucency can also be confirmed by visual inspection, simply by lifting the product to a light source and determining whether light passes through the material or product in a diffuse manner.

[0264]

[0268] The lozenge-type products of this disclosure may incorporate various different additives in addition to the combination of active ingredients, and may be prepared according to various different methods commonly known in the art for preparing lozenge-type products. Exemplary compositions, products, and methods for preparing such products are described in detail below herein.

[0265]

[0269] The lozenge products of this 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 ingredients discussed herein are suitable for use as active ingredients in the lozenge products provided herein. In some embodiments, the active ingredients may be provided in liquid form or in dry powder or particle form. As described above, the active ingredient may typically be present in amounts ranging from about 0.1% to about 10% by weight, based on the total weight of the product, 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. In some embodiments, the active ingredient may be present in amounts 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.

[0266]

[0270] In some embodiments, the lozenge product includes a sugar substitute. The sugar substitute is typically provided in a pure solid form (e.g., granular or powdery form). In certain embodiments, the sugar substitute is dry and contains a very low water content. For example, the sugar substitute may contain less than about 5% by weight of water, less than about 3% by weight of water, less than about 2% by weight of water, or less than about 1% by weight of water. In certain embodiments, the sugar substitute can form a glassy matrix. The formation of a glassy matrix is ​​generally characterized by a translucent / transparent appearance.

[0267]

[0271] 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 offer the advantage of reducing the tendency of lozenge products to stick when exposed to humidity. Sugar substitutes can be materials that do not contain any sugar (i.e., materials that do not contain sucrose) and can be produced naturally or synthetically. Sugar substitutes used in the products described herein can be nutrient-rich or non-nutrient-rich. 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, treitol, 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 may vary, but is typically at least about 75% by weight, at least about 80% by weight, at least about 85% by weight, at least about 90% by weight, or at least about 95% by weight of the product.

[0268]

[0272] In certain embodiments, the sugar substitute comprises one or more sugar alcohols. For example, in one embodiment, the sugar substitute is isomalt.

[0269]

[0273] In some embodiments, the sugar substitute is one or more of allulose, soluble tapioca fiber, and inulin. Such sugar substitutes may be substitutes for sugar alcohols, or may be used in combination with one or more sugar alcohols.

[0270]

[0274] In some embodiments, the lozenge products of this disclosure may comprise syrups, such as sugar syrups or sugar alcohol syrups. As used herein, “sugar alcohol syrup” is intended to refer to a concentrated solution of a sugar alcohol having, for example, more than about 40% solid content, preferably more than about 50% solid content, more than about 60% solid content, more than about 70% solid content, or more than about 80% solid content. Typically, the solid content of a sugar alcohol syrup consists mainly of a specified sugar alcohol (i.e., maltitol syrup typically contains more than about 80% by weight, more than about 85% by weight, or more than about 90% by weight of maltitol 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 syrups are typically characterized by a relatively high concentration of sugar alcohol and relatively high stability (i.e., sugar alcohols typically do not crystallize from solution at room temperature, for example).

[0271]

[0275] A syrup, such as a sugar alcohol syrup, can preferably influence the recrystallization of the molten sugar substitute. An example of a sugar alcohol syrup particularly useful according to this disclosure is maltitol syrup. Other sugar alcohol syrups can be used, but are not limited to corn syrup, golden syrup, molasses, xylitol, mannitol, glycerol, erythritol, treitol, arabitol, ribitol, mannitol, sorbitol, dulciitol, iditol, isomalt, lactitol, and polyglycitol syrup. Such sugar alcohol syrups can be prepared or obtained from commercially available sources. For example, maltitol syrup is commercially available from suppliers such as Corn Products Specialty Ingredients. While sugar alcohol syrups may be preferred, in certain embodiments, sugar syrups can be used instead of or in combination with sugar alcohol syrups. For example, in some embodiments, corn syrup, golden syrup, and / or molasses can be used.

[0272]

[0276] The amount of sugar alcohol syrup added to the lozenge composition mixture is typically the amount necessary to slow down the recrystallization of the sugar substitute in molten form. It should be noted that the amount of sugar alcohol syrup may be varied depending on the composition of the remaining components so that recrystallization is sufficiently slowed in order to provide a material with desired characteristics (e.g., a desired level of translucency / transparency). Thus, although the amount of sugar alcohol syrup may vary, it is typically in the range of about 0.1% to about 2% by weight of the lozenge product mixture, often 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, for example, 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.

[0273]

[0277] Typical lozenge compositions and lozenge products may incorporate, based on the total weight of the product, a combination of active ingredients of about 10% by weight or less, about 0.01% to about 2% by weight of artificial sweeteners, about 1% to about 5% by weight of humectants, about 1% to about 5% by weight of natural sweeteners, at least about 80% by weight of sugar substitutes, about 0.1% to about 10% by weight of sugar alcohol syrup, one or more flavoring agents in an amount of up to about 5% by weight, and up to about 3% by weight of salt. The specific proportions and selection of ingredients will vary depending on the desired flavor, texture, and other characteristics.

[0274]

[0278] Oral products of this disclosure in the form of lozenges may contain varying amounts of water. The water content of the lozenges described herein may vary within such ranges according to desired properties and characteristics, in addition to defining the final form of the product before use by the ingestor. For example, lozenge-type products typically have a water content ranging from about 0.1% by weight to about 5% by weight of the product. Preferably, the water content of the lozenge product, when present in a single product unit before insertion into the user's mouth, is less than about 5% by weight, less than 3% by weight, less than 2% by weight, or less than 1% by weight of the product. In some embodiments, the water content of the lozenge product described herein may be in the range of about 0.1% by weight to about 5% by weight, about 0.5% by weight to about 3% by weight, or about 1% by weight to about 2% by weight of the product.

[0275]

[0279] Powder or pouch product In some embodiments, the oral product may be in powder form. The powder may be a free-flowing powder. The powder may be contained in a loose form in a container and thus used in a form similar to a snuff cigarette, where the user picks up the powder from the container and places it in their mouth. Alternatively or additionally, the powder may be incorporated into a moisture-permeable (e.g., saliva-permeable) pouch, similar to a snus-type product. The pouch product may be configured to be inserted into the user's mouth, i.e., it may be a pouch oral product.

[0276]

[0280] In some embodiments, the products of the Disclosure are in the form of pouch oral products. Such pouch products include the oral products described herein, disposed within a moisture-permeable container (e.g., a water-permeable pouch or a saliva-permeable pouch). For example, a pouch product may include an oral product in powder form incorporated within a saliva-permeable pouch.

[0277]

[0281] Such compositions in a breathable pouch form are typically used by placing one pouch containing the composition into the mouth of a human subject / user. Generally, the pouch is placed somewhere in the user's mouth, for example, under the lips, in a manner similar to how wet snuff products are generally used. The pouch is preferably not chewed or swallowed. Then, upon exposure to saliva, some of the components of the composition in the breathable container (e.g., active ingredients and / or any flavors) pass through, for example, the breathable pouch, providing the user with flavor and satisfaction, and the user does not need to spit out any part of the composition. After use / enjoyment for about 10 to 60 minutes, typically about 15 to 45 minutes, a considerable amount of the composition has been ingested by the human subject, and the pouch can be removed from the human subject's mouth for disposal.

[0278]

[0282] 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 bonded nonwovens comprising viscose rayon fibers (i.e., regenerated cellulose) and an acrylic polymer that acts as a binder in the nonwoven material and provides heat sealing of the pouch during manufacturing. The pouch material may also contain synthetic fibers (e.g., polyester) in addition to viscose fibers. Viscose nonwoven materials commonly used in smokeless tobacco pouches are similar to the fabrics used in tea bags. Nonwovens are fabrics that are not woven or knitted. Methods for manufacturing nonwoven materials are generally known in the art. Further information on nonwovens can be found in "Handbook of Nonwovens" by S. Russell, Woodhead Pub I. Ltd., 2007. In some embodiments, the pouch material is fleece material. In some embodiments, the pouch material is nonwoven material. In some embodiments, the pouch material is a nonwoven fleece material. In some embodiments, the pouch material includes viscose, such as viscose rayon fibers. In some embodiments, the pouch material includes regenerated cellulose fibers. In some embodiments, the pouch material includes polyester fibers, which may constitute the pouch material or be included in combination with viscose (such as regenerated cellulose fibers).

[0279]

[0283] In some embodiments, the pouch material includes a binder that provides heat sealing of the pouch during manufacturing. In some embodiments, the pouch material includes an acrylic binder. In some embodiments, the pouch material includes an acrylic binder in combination with viscose and / or polyester fibers.

[0280]

[0284] Suitable packets, pouches, or containers of the type used in the manufacture of smokeless tobacco products are available under the trade names CatchDry, Ettan, General, Granit, Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf, and TreAnkrare. The composition may be contained and packaged in a pouch in a manner that uses the type of ingredients used in the manufacture of conventional snus-type products. The pouch provides a type of breathable container that can be considered to have characteristics similar to the mesh-type materials used in the manufacture of tea bags. The ingredients of the composition readily diffuse into the user's mouth through the pouch. Non-limiting examples of preferred types of pouches are described, for example, in U.S. Patent No. 5,167,244 of Kjerstad and U.S. Patent No. 8,931,493 of Sebastian et al., as well as in U.S. Patent Application Publications 2016 / 0000140, 2016 / 0073689, 2016 / 0157515, and 2016 / 0192703 of Sebastian et al., each of which is incorporated herein by reference. The pouches may be supplied as individual pouches, or multiple pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25, or 30 pouches) may be connected or linked to one another (e.g., ends to ends) so that one pouch or individual part can be easily removed for use from a single strip or matrix-shaped pouch.

[0281]

[0285] Exemplary pouches may be manufactured from materials in such a manner that the pouch undergoes controlled dispersion or dissolution during use by the user. Such pouch materials may take the form of mesh, screen, perforated paper, permeable fabric, etc. For example, a pouch material manufactured from rice paper or perforated rice paper in a mesh form may dissolve in the user's mouth. As a result, the pouch and composition can be completely dispersed in the user's mouth during normal use conditions, and thus both the pouch and composition can be ingested by the user. Other examples of pouch materials may be manufactured using water-dispersible film-forming materials (e.g., binders such as alginates, carboxymethylcellulose, xanthan gum, and pullulan), as well as in combination with materials such as pulverized cellulose (e.g., fine-grained wood pulp). Preferred pouch materials are water-dispersible or soluble, but may be designed and manufactured so that a considerable amount of composition contents permeates the pouch material before the pouch loses its physical integrity under normal use conditions. If desired, flavoring agents, disintegrants, and other desired components may be incorporated into the pouch material or applied to the pouch material.

[0282]

[0286] The amount of oral product contained in each pouch product unit, for example, within the pouch, may vary. In some embodiments, the weight of the composition in each pouch is at least about 50 mg, for example, about 50 mg to about 1 gram (1,000 mg), for example, about 100 mg to about 900 mg, for example, about 200 mg to about 800 mg, for example, about 500 mg to about 700 mg. In some smaller embodiments, the weight of the composition in each pouch may be about 100 mg to about 300 mg. In larger embodiments, the weight of the composition in each pouch may be about 300 mg to about 700 mg. Other components may be included in each pouch if desired.

[0283]

[0287] The moisture content of the oral product can vary depending on the form in which the composition is provided. In some embodiments described above herein, the oral product may be in the form of a wet snuff or snus, and / or may be provided in a pouch form. In some embodiments (e.g., in the case of a snus-type product), the moisture content of the composition (before inserting the product into the user's mouth) can 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, such as at least 50% by weight. In some embodiments (e.g., in the case of a snus-type product, e.g., a non-pouch or pouch snus product), the moisture content of the composition (before inserting the product into the user's mouth) can be from about 20% to about 70% by weight of the oral product, such as from about 30% to about 60% by weight, such as from about 40% to about 55% by weight.

[0284]

[0288] In some embodiments, the oral product can be a "dry" form of a snus-type or snuff-type product. In such embodiments, the moisture content of the oral product can be about 10% by weight or less of the oral product, such as about 5% by weight or less. For example, the moisture content can be from about 0.1% to about 10% by weight of the oral product, such as from about 1% to about 5% by weight.

[0285]

[0289] When in the form of a pouch oral product, the oral product typically contains a filler. The filler can preferably be a cellulose material selected from the suitable materials described above in this specification. In some preferred embodiments, the filler is at least MCC or contains MCC. The amount of the filler can vary, but typically it 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 (such as a cellulose material like MCC) can be present in the oral product in an amount of about 5% to about 95% by weight of the oral product, such as about 10% to about 90% by weight, such as about 15% to about 85% by weight, such as about 20% to about 80% by weight, such as about 25% to about 75% by weight, such as about 30% to about 70% by weight, such as about 35% to about 65% by weight, such as about 40% to about 60% by weight. In some embodiments, the filler (such as a cellulose material like MCC) can be present in the oral product in an amount of about 45% to about 55% by weight.

[0286]

[0290] Package According to some embodiments described herein, a package containing the oral product described herein is provided. For example, the package can contain an oral product in powder form. In such embodiments, the package can be in the form of a can or a plastic container. Alternatively or additionally, the package can contain an oral product in the form of a lozenge, tablet, etc. The package can be in the form of a blister pack, a can, or a plastic container containing such an oral dosage form.

[0287]

[0291] According to some embodiments described herein, a package containing at least one of the pouch oral products described herein is provided. The pouch products described herein can be packaged in any suitable inner material and / or outer container. Also, for example, U.S. Patent No. 7,014,039 by Henson et al., U.S. Patent No. 7,537,110 by Kutsch et al., U.S. Patent No. 7,584,843 by Kutsch et al., U.S. Patent No. 8,397,945 by Gelardi et al., Design Patent No. D592,956 by Thiellier, Design Patent No. D594,154 by Patel et al., and Design Patent No. D625,178 by Bailey et al., U.S. Patent Publication No. 2008 / 0173317 by Robinson et al., U.S. Patent Publication No. 2009 / 0014343 by Clark et al., U.S. Patent Publication No. 2009 / 0014450 by Bjorkholm, and U.S. Patent No. See the various types of containers for smokeless products described in U.S. Patent Publication No. 2009 / 0250360, U.S. Patent Publication No. 2009 / 0266837 by Gelardi et al., U.S. Patent Publication No. 2009 / 0223989 by Gelardi, U.S. Patent Publication No. 2009 / 0230003 by Thiellier, U.S. Patent Publication No. 2010 / 0084424 by Gelardi, and U.S. Patent Publication No. 2010 / 0133140 by Bailey et al., U.S. Patent Publication No. 2010 / 0264157 by Bailey et al., U.S. Patent Publication No. 2011 / 0168712 by Bailey et al. (these are incorporated herein by reference). For example, the package may be a can or plastic container containing multiple pouches of oral product.

[0288]

[0292] In some preferred embodiments where the oral product is in liquid form, a package in the form of a bottle or can containing the liquid oral dosage form is provided. The package may be a bottle containing a desired volume of the liquid oral dosage form.

[0289]

[0293] process The way in which the various components of a composition (e.g., active ingredients and any additives) are combined can vary. Therefore, the overall product containing, for example, powdered composition components may be relatively homogeneous in nature. The components, which may be in liquid or dry solid form, can be mixed in a pretreatment step before mixing with any remaining components of the product, or they can simply be mixed together with all other liquid or dry components.

[0290]

[0294] Various components of the product may be brought into contact, combined, or mixed together using any mixing technique or apparatus known in the art. Any mixing method that brings the product components into close contact may be used, such as mixing apparatus featuring an impeller or other agitable structure. Examples of mixing apparatus include casing drums, conditioning cylinders or drums, liquid spraying devices, conical blenders, ribbon blenders, mixers available from Littleford Day, Inc. as FKM130, FKM600, FKM1200, FKM2000 and FKM3000, plow-sear type mixer cylinders, and Hobart mixers. See also, for example, the types of methodologies described in U.S. Patent No. 4,148,325 by Solomon et al., U.S. Patent No. 6,510,855 by Korte et al., and U.S. Patent No. 6,834,654 by Williams et al. (each of which is incorporated herein by reference). In some embodiments, the components forming the product are prepared such that their mixture can be used in a starch molding process to form the product. The forms and methods for formulating the product will be apparent to those skilled in the art. See also, for example, the types of methodologies described in U.S. Patent No. 4,148,325 by Solomon et al., U.S. Patent No. 6,510,855 by Korte et al., and U.S. Patent No. 6,834,654 by Williams et al., U.S. Patent No. 4,725,440 by Ridgway et al., and U.S. Patent No. 6,077,524 by Bolder et al. (each of which is incorporated herein by reference).

[0291]

[0295] Method for preparing liquid oral products According to some embodiments described herein, the oral product is preferably in liquid form. (a) The step of combining the active ingredients, (b) The step of bringing the active ingredient into contact with water, (c) A step of preparing an oral product by mixing the active ingredient with water, A method for preparing the oral product described herein, including the above, is provided.

[0292]

[0296] The combinations of active ingredients may be as described above in this specification. The combinations of active ingredients may also be as described below in relation to “further broader embodiments”.

[0293]

[0297] The active ingredient may be provided in the form of a liquid extract, liquid oil, or powder. If it is in the form of a powder, step (c) may include mixing the active ingredient with water until the active ingredient is dissolved in water.

[0294]

[0298] Step (b) and / or step (c) may preferably be carried out at ambient temperature or room temperature (20-25°C). Alternatively, the temperature may be raised to aid in the dispersion or dissolution of the active ingredient in water. For example, step (b) may include contacting the active ingredient with water at a temperature of about 20-100°C, for example, about 30-90°C, or about 40-80°C. Step (b) may include mixing the active ingredient with water at a temperature of about 20-100°C, for example, about 30-90°C, or about 40-80°C.

[0295]

[0299] This method may include steps of adding any additional additives at any stage. For example, any additive may be added to the active ingredient before and / or after the active ingredient has been combined with water. Alternatively, an additive may be added to the water before it comes into contact with the combination of active ingredients. Step (a) may include an optional step of combining any additive (e.g., an acidifying agent) with the combination of active ingredients. Step (b) may include an optional step of bringing the active ingredient into contact with water and the additive. Step (c) may include an optional step of adding the additive to the mixture and mixing the additive with the combination of active ingredients and water.

[0296]

[0300] In some embodiments, the oral product further comprises one or more additives selected from thickeners, organic acids, or mixtures thereof. In such embodiments, one or more additives may be combined with water before the addition of the active ingredient. Optionally, the step of combining one or more additives with water may include heating the combination to a temperature, for example, about 60°C to about 80°C, to achieve dissolution of the additives. Further additives, such as sweeteners, humectants, and colorants, may be added at this stage, or during and / or after the step of combining the active ingredient with water.

[0297]

[0301] The resulting liquid product may be in the form of a solution or dispersion of the active ingredient in water.

[0298]

[0302] Method for preparing tablet products In some embodiments, the product is in the form of compressed pellets or tablets. In one embodiment, the process for producing the pellets or tablets first involves mixing a bulk filler (e.g., EMDEX®) with the active ingredient. Then, the remaining composition ingredients (e.g., sugar alcohols and any other desired ingredients, e.g., binders, colorants, sweeteners, flavorings, etc.) are added. Optionally, a colorant may be added to one of the composition ingredients in a separate step before being mixed with the remaining components of the composition. The mixing of the composition can be achieved using any mixing apparatus. The final composition is then compressed into the form of pellets or tablets using conventional tableting techniques and optionally coated. Compressed composition pellets can be produced by compressing a composition containing any relevant compounding ingredients into pellet form and optionally coating each pellet with an overcoat material. Exemplary compression devices, such as compression presses, are available from Vector Corporation as Colton 2216 and Colton 2247, and from Fette Compacting as 1200i, 2200i, 3200, 2090, 3090, and 4090. Devices for providing an outer coating layer to the compressed pelletized composition are available from Thomas Engineering as CompuLab 24, CompuLab 36, Accela-Cota 48, and Accela-Cota 60.

[0299]

[0303] If present, the coating typically comprises a film-forming polymer such as a cellulosic polymer, any plasticizer, and any flavorings, colorants, salts, sweeteners, or other additives of the kind described herein. The coating composition is usually aqueous in nature and can be applied using any pellet or tablet coating technique known in the art, such as bread coating. Exemplary film-forming polymers include cellulosic polymers such as methylcellulose, hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose, 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.

[0300]

[0304] Method for preparing lozenge products The forms and methods used to formulate and manufacture the lozenge products described herein may vary. For example, the compositions may be prepared by any method commonly used for the preparation of hard confectionery. Exemplary methods for the preparation of hard confectionery can be found, for example, in the LFRA Ingredients Handbook, Sweeteners, Janet M. Dalzell, Ed., Leatherhead Food RA (Dec. 1996), pp. 21-44, which is incorporated herein by reference.

[0301]

[0305] Typically, a first mixture of components is prepared. The composition of the first mixture of components may vary, but typically includes a sugar substitute and may contain various additional substances (e.g., sugar alcohol syrup, NaCl, preservatives, further sweeteners, water, and / or flavoring agents). In certain embodiments, the mixture includes a sugar substitute, salt, and vanillin. In other embodiments, the first mixture includes a sugar substitute and sugar alcohol syrup. Typically, the first mixture of components does not contain an active ingredient, but in some embodiments, an active ingredient may be incorporated into the first mixture of components.

[0302]

[0306] The first mixture of components is heated until melted, and then the mixture is heated to or beyond the hard crack stage. In confectionery, the hard crack stage is defined as the temperature at which a string of the heated mixture (obtained by pulling a cooled syrup sample between the thumb and index finger) becomes brittle, or the temperature at which cracks appear when attempting to mold the syrup. According to this method, the temperature at which the hard crack stage is achieved may vary depending on the specific composition of the product mixture, but is generally between approximately 145°C and approximately 170°C. Typically, the mixture is not heated above approximately 171°C, the temperature at which caramelization begins. In the method of this disclosure, the mixture is typically heated above the hard crack stage temperature and then cooled. Heating may be carried out under atmospheric pressure or vacuum. Typically, the method of the present invention is carried out under atmospheric pressure.

[0303]

[0307] In one exemplary embodiment, the first mixture of components contains a high proportion of isomalt, and the mixture is heated to approximately 143°C. Once all components have dissolved, the temperature is raised beyond the hard cracking stage (e.g., to approximately 166°C). The mixture is heated to this temperature and then removed from the heat to cool.

[0304]

[0308] In certain embodiments, the active ingredient and optionally the additional ingredients described above (e.g., additional sweeteners, fillers, flavorants, 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 heat. In some embodiments, the addition of the second mixture can occur only after the heated first mixture of ingredients has been cooled to a predetermined temperature (e.g., in certain embodiments, up to about 132 °C). In certain embodiments, one or more flavorants are added to the second mixture immediately prior to adding the mixture to the heated first mixture of ingredients. Certain flavorants are volatile and thus are preferably added after the mixture has been somewhat cooled. The combined mixture is then formed into the desired shape. In certain embodiments, the mixture is either directly injected into a mold, formed (e.g., rolled or pressed) into the desired shape, or extruded. If desired, the mixture can be extrusion molded or injection molded. In certain embodiments, the mixture is formed or extrusion molded into a mold of the desired shape within a closed system, which may require a temperature decrease and may limit the evaporation of certain mixture components. For example, such a system may limit the evaporation of volatile components, including flavorants. Other methods of manufacturing lozenges are also intended to be encompassed herein.

[0305]

[0309] Typical conditions related to 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 components are exposed during manufacture and the temperature of the manufacturing environment), moisture content (e.g., the degree of moisture present in individual components and in the final composition), humidity in the manufacturing environment, atmosphere control (e.g., nitrogen atmosphere), airflow to which the various components are subjected during the manufacturing process, and other similar factors. Furthermore, steps in the various methods involved in product manufacturing may include the selection of specific solvents and processing aids, the use of heat and radiation, refrigeration and cryogenic conditions, and component mixing rates. Manufacturing conditions can also be controlled by the selection of the forms of the various components (e.g., solid, liquid, or gas), the particle size or crystalline properties of components in solid form, and the concentration of components in liquid form. Components can be processed into the desired composition by techniques such as extrusion, compression, and spraying.

[0306]

[0310] In certain embodiments, the lozenge product may be transparent or translucent. As used herein, “translucent” or “translucent” refers to a material that allows a certain level of light to pass through diffusely. In certain embodiments, the lozenge product of this disclosure may have a degree of transparency such that the material may be classified as exhibiting “transparency” or “translucency,” which is defined as a material that allows light to pass through freely without significant diffusion. The transparency of the lozenge product is such that it has a degree of translucency, as opposed to opaque (a material that does not allow light to pass through).

[0307]

[0311] Transparency / transparency can be determined by any means commonly used in the art, but is generally measured by spectral photometric light transmission over a range of wavelengths (e.g., about 400–700 nm). Alternatively, the cloudiness (light scattering) and color (light absorption) of the lozenge products provided herein can be quantified, respectively, using optical methods such as turbidity measurement (or turbidimetry) and colorimetry. Transparency can also be confirmed by visual inspection, simply by lifting the product to a light source and determining whether light passes through the material (e.g., extract) or product in a diffuse manner.

[0308]

[0312] Method for preparing a molten product In some embodiments, the product is in a molten form. For the preparation of a molten product, the lipids are typically heated to a temperature slightly above their melting point so that the lipids liquefy. Optionally, active ingredients, flavorings, and / or lecithin may be added to the liquefied lipids at this stage. All or part of the liquefied lipids are then blended with the dry blend and mixed until the product reaches a desired level of homogeneity or until the desired texture characteristics are achieved. The mixture is ground (e.g., in a dry roll mill) until the particle size is less than about 20 micrometers. The ground isomaltpalm oil is combined with any remaining lipids, and the dry ingredients and flavorings are mixed in. The base is generally heated to a fluid consistency.

[0309]

[0313] In some embodiments, a sugar alcohol (e.g., isomalt) is added to the mixer bowl, along with salt and an emulsifier, and a portion of the total lipids (e.g., molten palm oil).

[0310]

[0314] Add additional lipids while mixing until adhesive clumps form. Transfer the aggregated mixture partially to a 3-roll mill and process to a particle size of less than 50 micrometers or about 20 micrometers. Transfer the purified mixture to a mixer bowl and add the remaining lipids while mixing. Heat the mixture as needed to maintain fluid consistency.

[0311]

[0315] Sweeteners, flavorings, and active ingredients are added while mixing. Mixing is continued until a homogeneous composition is obtained. The mixture is allowed to stand for a certain period of time, for example, about 10 to 15 minutes. The composition can be divided into separate parts, for example, by injecting the composition into a sheet-like structure, cooling it, and then cutting the structure into individual parts, or by pouring the composition into a mold and allowing it to cool. The mold may be a starch mold or a starch-free mold. In certain embodiments, the mold is starch-free.

[0312]

[0316] The molten composition may be held in a mold (with or without starch) for a predetermined time, for example, about 1 to about 15 minutes, to cool and solidify. If necessary, the mold containing the molten product may be cooled by refrigeration to accelerate solidification.

[0313]

[0317] According to other aspects of this disclosure, an extrusion process may be used in which the final molten product is extruded, rather than using a mold to prepare the molten product. In some examples, a molten composition in slurry form may be formed into a sheet and dried to, for example, a moisture content of about 15% to about 25% by weight to form a sticky or other paste-like material in a physically handleable form. The material may then be roughly chopped, for example, using a mixer, or otherwise cut into smaller pieces. The chopped material may then be extruded through an extruder into any desired shape / size, including shapes that may be difficult or impossible to achieve with a mold. In some examples, the extruded product may then be dried to achieve a desired moisture content. Similar types of processes are described, for example, in U.S. Patent No. 3,806,617 by Smylie et al., which is incorporated herein by reference in whole. Furthermore, the molten composition may be subjected to a co-extrusion process with another composition.

[0314]

[0318] For example, shapes such as rods and cubes can be formed by first extruding the material through a die having a desired cross-section (e.g., circular or square), and then optionally cutting the extruded material to the desired length. Techniques and apparatus for extruding tobacco material are described in U.S. Patent No. 3,098,492 by Wursburg, U.S. Patent No. 4,874,000 by Tamol et al., U.S. Patent No. 254,880,018 by Graves et al., U.S. Patent No. 4,989,620 by Keritsis et al., U.S. Patent No. 5,072,744 by Luke et al., U.S. Patent No. 5,829,453 by White et al., and U.S. Patent No. 6,182,670 by White et al., each of which is incorporated herein by reference. Suitable exemplary extruders for use include food or gum extruders, or industrial pasta extruders such as the Model TP 200 / 300 available from Emiliomiti, LLC of Italy. In some cases, it may be possible to accomplish multiple steps of the method described herein using a single machine, such as a compounding machine available from Buss AG, for example.

[0315]

[0319] While the above description focuses on a uniform composition throughout each product unit, products can also be formed from multiple different formulations having different properties within the same product unit. For example, two different compositions can be poured into a single mold to produce a layered product. Furthermore, two different compositions can be co-extruded to form a product having different properties across its cross-section. Such a method can be used to provide a product having two different compositions characterized by different dissolution rates, such that a first portion of the product dissolves at a first rate (e.g., a faster rate) and a second portion dissolves at a second, slower rate.

[0316]

[0320] Method for preparing pouch oral products If the product is in the form of an oral pouch product, this method is used. (a) The step of combining the active ingredients, (b) A step of providing an oral product by bringing a combination of active ingredients into contact with at least one filler, It may include.

[0317]

[0321] The combinations of active ingredients may be as described above in this specification. The combinations of active ingredients may also be as described below in relation to “further broader embodiments”.

[0318]

[0322] In some embodiments, step (b) includes mixing at least one filler with a combination of active ingredients. In some embodiments, the combination of active ingredients is in solid form (e.g., powder form). The combination of active ingredients may be mixed directly with the filler to provide an oral product. In some embodiments, the combination of active ingredients may be dissolved in a hydrophilic solvent (e.g., water and / or alcohol) before contact with the filler. For example, the combination of active ingredients may be dissolved in water or alcohol (e.g., ethanol or propylene glycol) before being mixed with the filler. In such embodiments, the method may include 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 specific period of time. Preferably, the drying step includes leaving the product at room temperature for 1 to 48 hours to remove the solvent.

[0319]

[0323] The method may further include the step of packaging an oral product into a pouch using the pouch material described above in this specification.

[0320]

[0324] use According to some embodiments described herein, the use of a combination of active ingredients for increasing sexual desire and / or sexual activity in humans or animals is provided, wherein the combination of active ingredients comprises (i) maca root, (ii) a combination of B vitamins including at least vitamin B2 and vitamin B6, (iii) ginseng, and (iv) ashwagandha, provided that the maca root, ginseng, and ashwagandha are different from each other.

[0321]

[0325] In some embodiments, use may involve the combination of active ingredients increasing or enhancing the sexual drive and / or desire for sexual activity in the subject to whom it is administered. Use may also involve increasing the subject's mental energy (e.g., arousal) or physical energy.

[0322]

[0326] In some embodiments, the combination of active ingredients is as defined above herein. In such embodiments, the combination may further include any of the additional active ingredients described above herein. For example, the combination of active ingredients may include passionflower and / or vitamin C. The combination of active ingredients may further include passionflower in particular.

[0323]

[0327] Alternatively, the combination of active ingredients may be as described below in any of the “further broader embodiments.”

[0324]

[0328] The combination of active ingredients may provide improved efficacy compared to previously known products and / or placebos.

[0325]

[0329] Further broader aspects According to some embodiments described herein, an oral product is provided comprising a combination of active ingredients including (i) maca root, (ii) ginseng, and (iii) passionflower. Alternatively, an oral product is provided comprising a combination of active ingredients including (i) maca root, (ii) ashwagandha, and (iii) passionflower. Alternatively, an oral product is provided comprising a combination of active ingredients including (i) maca root, (ii) ginseng, and (iii) ashwagandha, wherein the active ingredients optionally further comprise passionflower. In such embodiments, a combination of B vitamins is not an essential element.

[0326]

[0330] Alternatively, an oral product is provided comprising a combination of active ingredients comprising (i) maca root, (ii) a combination of B vitamins including vitamin B2, vitamin B6, and vitamin B7, (iii) ginseng, and (iv) passionflower. Alternatively or additionally, the combination of active ingredients may comprise (i) maca root, (ii) vitamins B1, B2, B3, B6, and B7, or a combination of B vitamins including vitamin B1, B2, B3, and B6, and (iii) passionflower. In other words, the combination of active ingredients may include passionflower as an essential element instead of ashwagandha.

[0327]

[0331] Details herein, including the forms and amounts of the above-mentioned maca root, ginseng, ashwagandha, vitamin B, and passionflower (and all other active ingredients and / or additives), are equally applicable to such embodiments and are not repeated here for the sake of brevity. All details herein, including the above-mentioned forms, amounts, and combinations, are equally applicable to this embodiment. The above-mentioned methods and uses may also be equally applicable to the above-mentioned embodiments.

[0328]

[0332] Examples Aspects of the present invention are more fully illustrated by the following embodiments, which are described to illustrate specific aspects of the invention and should not be construed as limitations thereof.

[0329] Example 1 - Liquid Dosage Form Prepare an oral product in liquid form containing the following ingredients:

[0330] [Table 1]

[0331] Oral products come in doses of 30 mL or 60 mL.

[0332] All active ingredients are added to water, and the resulting mixture is stirred until a uniform dispersion or clear solution is obtained. The product is then packaged in bottles containing 30 mL or 60 mL of liquid per serving.

[0333] Examples 2-5: Liquid dosage form containing maca root:ashwagandha in a ratio of 1:1 Prepare an oral product in liquid form containing the following ingredients: ·water • Vitamins B2, B6, B1, and B7 in some cases. Maca root Ginseng extract Ashwagandha

[0334] Each serving contains approximately 400 mg of maca root and 80 mg of ashwagandha. Each serving contains approximately 1.7 mg of vitamin B6 and 1 mg of vitamin B2. The oral product has a volume of 60 mL per serving.

[0335] The oral product is prepared as described in Example 1.

[0336] Example 3-1: Liquid dosage form containing Maca root:Ashwagandha in a 1:1 ratio Prepare an oral product in liquid form containing the following ingredients: ·water • Vitamins B2, B6, B1, B7 Maca root Ginseng extract Ashwagandha Passionflower

[0337] Each serving contains approximately 200 mg of maca root and 200 mg of ashwagandha. Each serving also contains approximately 2 mg of vitamin B6 and 2 mg of vitamin B2. The oral product has a volume of 60 mL per serving.

[0338] The oral product is prepared as described in Example 1.

[0339] Example 4-2: Liquid dosage form containing maca root:passionflower in a 1:1 ratio Prepare an oral product in liquid form containing the following ingredients: ·water • Vitamins B2, B6, B1, and B7 in some cases. Maca root Ginseng extract Depending on the circumstances, Ashwagandha Passionflower

[0340] Each serving contains approximately 400 mg of maca root and 200 mg of passionflower extract. Each serving contains approximately 2 mg of vitamin B6 and 1 mg of vitamin B2. Each serving contains approximately 100 mg of ginseng extract. The oral product has a volume of 60 mL per serving.

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

[0342] Example 5 - Liquid Dosage Form An oral product in liquid form is prepared according to Example 1, containing the following ingredients. ·water Vitamin B2 (1.3 mg), B6 ​​(1.6 mg), B1 (1 mg): Total 3.9 mg Maca root: 300mg Ginseng extract: 60mg Ashwagandha: 200mg Passionflower: 100mg

[0343] The oral product has a volume of 60 mL per dose and is prepared as described in Example 1.

[0344] Example 6 - Results of the Intake Test A study was conducted to compare an oral product prepared according to Example 5 with a placebo (a shot with a uniform flavor but without the active ingredient of Example 5). A blind study was conducted in which one group of participants received the shot of Example 5, and the second group of participants received the placebo product. This study investigated the effects of the liquid dosage form on subjective levels of desire and related mood areas over 21 days. Baseline was obtained before the study (T0), measurements were taken weekly (T7, T14, T21), and retrospective measurements were taken after the study (T21). These measurements led to an assessment of the effects of the liquid dosage form on sexual desire and / or desire for sexual activity.

[0345] The following elements were evaluated. [Table 2]

[0346] In this study, all participants (n=48 for product in Example 5, n=44 for placebo product) were women aged 25-40, in a stable relationship of at least 12 months, with no self-reported sexual difficulties, and with a baseline SDI-Dyadic score of less than 53. Exclusion criteria included: recreational drug use, prescription drug use (excluding oral contraceptives), pregnancy, within 12 months postpartum, breastfeeding or lactation, self-reported moderate to severe anxiety or depression, self-reported sleep disturbances, and major life events affecting mood (trauma, bereavement, etc.).

[0347] Each participant was given 21 liquid oral products and instructed to take one per day for 21 consecutive days.

[0348] The following results were obtained. • Dyadic Score - Sexual Desire Inventory (SDI) - The SDI is widely used to assess sexual desire in men and women, including dyadic sexual desire. The questionnaire categorizes sexual desire into two aspects: dyadic sexual desire and unisexual sexual desire. Participants who ingested the product of Example 5 showed significantly higher dyadic scores than participants who ingested a placebo (Yuend P-value = 0.002 for week 3 vs. week 1). This indicates that the oral product of the present invention elicits a higher level of desire compared to placebo. The results are shown in Figure 1.

[0349] • Average Need Score - Visual Analog Scale (VAS) - VAS is often used in epidemiological and clinical studies to measure the intensity or frequency of various symptoms. In this study, the average score of a combination of scores for intimacy, pleasure, sensation, arousal, "the moment," and motivation presents the overall need score. Participants who ingested the product of Example 5 showed significantly higher average VAS scores than participants who ingested a placebo (Yuend P-value = 0.026, week 3 vs. week 1). This indicates that the oral product of the present invention resulted in a higher level of need compared to placebo. The results are shown in Figure 2.

[0350] • The Emotional Valence-Feeling Scale (FS) is an 11-point scale ranging from -5 ("Very Bad") to +5 ("Very Good"). The FS is widely used to assess emotions during exercise and correlates with other measures of emotional valence. Participants who ingested the product of Example 5 showed significantly higher emotional valence scores than participants who ingested a placebo (Yuend P-value = 0.013, Week 3 vs. Week 1). This indicates that the oral product of the present invention resulted in a better mood compared to placebo. The results are shown in Figure 3.

[0351] • Satisfaction (lower anxiety) - State Trait Anxiety Scale State (STAI-S) - The STAI-S is a commonly used scale for trait anxiety and state anxiety. This result is state-related, with lower scores indicating a higher level of satisfaction. Participants who ingested the product of Example 5 showed significantly lower anxiety scores than participants who ingested a placebo (Yuend P-value = 0.021 for week 3 vs. week 1). This indicates that the oral product of the present invention results in higher satisfaction compared to placebo. The results are shown in Figure 4.

[0352] • Overall Mood State - Mood Profile Inventory (POMS) - The POMS is a psychological rating scale used to assess transient, distinct mood states. The POMS is a self-reported assessment that measures six aspects of mood fluctuations that change over time, namely tension or anxiety, depression or discouragement, anger or hostility, vitality or activity, fatigue or apathy, confusion or bewilderment, and presents the mean of a combination of overall mood states. Participants who took the product of Example 5 showed significantly lower mean scores than participants who took a placebo (Yuend P-value = 0.016 for week 3 vs. week 1). This indicates that the oral product of the present invention results in lower mood states compared to placebo. The results are shown in Figure 5.

[0353] Significant improvement was observed in all evaluation items with the ingestion of the present oral product compared to placebo. Interestingly, specific measures of both sexual drive and / or desire for sexual activity (SDI and VAS) showed that the present oral product resulted in increased desire. These results, coupled with increased satisfaction levels and reduced mood, demonstrate that the present oral product increases sexual drive and / or desire for sexual activity while providing relaxation. While not bound by theory, it is thought that the combination of maca root, the B vitamins as defined herein, ginseng, ashwagandha, and passionflower, coupled with the observed desire and satisfaction and / or more stable mood, enables the achievement of a balanced effect.

[0354] Example 7 - Liquid Dosage Form A liquid oral product containing the following ingredients is prepared according to Example 1. ·water • Vitamins B2, B6, B1 Maca root Ginseng extract Ashwagandha • Piperine Depending on the circumstances, passionflower

[0355] The amount of maca root is approximately 300 mg, the amount of ginseng is 120 mg, and the amount of passionflower (if present) is approximately 100 mg. All amounts are per serving. The total amount of B vitamins is approximately 8 mg per serving. The amount of piperine is approximately 12 mg. The oral product has a volume of 60 mL per serving.

[0356] The oral product is prepared as described in Example 1.

[0357] The various embodiments described herein are presented solely to aid in understanding and teaching the claimed features. These embodiments are provided only as representative examples of embodiments and are not exhaustive and / or exclusive. The advantages, embodiments, examples, functions, features, structures, and / or other aspects described herein should not be considered limitations to the scope of the invention as defined by the claims or to equivalents of the claims, and it should be understood that other embodiments may be used and modified without departing from the scope of the claimed invention. Various embodiments of the invention may suitably include, consist of, or essentially consist of, appropriate combinations of disclosed elements, components, features, parts, steps, means, etc., other than those specifically described herein. Furthermore, this disclosure may include other inventions that are not currently claimed but may be claimed in the future.

Claims

1. An oral product containing a combination of active ingredients, wherein the combination is (i) Maca root and (ii) A combination of B vitamins including at least vitamin B2 and vitamin B6, (iii) Ginseng and, (iv) Ashwagandha and An oral product comprising, provided that the maca root, the ginseng, and the ashwagandha are different from each other.

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

3. The oral product according to claim 1 or 2, wherein the combination of vitamin B group (ii) is vitamin B2, vitamin B6, vitamin B1, and vitamin B7, or vitamin B2, vitamin B6, and vitamin B1.

4. The oral product according to any one of claims 1 to 3, wherein the total amount of B vitamins contained in the combination is about 1% to about 5% by weight of the dry weight of the combination, or about 0.001% to about 10% by weight of the oral product.

5. The oral product according to any one of claims 1 to 4, wherein the maca root is present in an amount of about 20% to about 90% by weight of the dry weight of the combination, or the maca root is present in an amount of about 0.01% to about 20% by weight of the oral product.

6. The oral product according to any one of claims 1 to 5, wherein the ginseng is present in an amount of about 1% to about 30% by weight of the dry weight of the combination, or the ginseng is present in an amount of about 0.01% to about 5% by weight of the oral product.

7. The oral product according to any one of claims 1 to 6, wherein the ashwagandha is present in an amount of about 1% to about 40% by weight of the dry weight of the combination, or the ashwagandha is present in an amount of about 0.01% to about 10% by weight of the oral product.

8. The oral product according to any one of claims 1 to 7, wherein the maca root and the ginseng are present in a weight ratio of about 30:1 to about 1:1, preferably in a weight ratio of about 15:1 to about 1:

1.

9. The oral product according to any one of claims 1 to 8, wherein the total amount of maca root and the vitamin B group is present in a weight ratio of about 900:1 to about 10:1, preferably, the total amount of maca root and the vitamin B group is present in a weight ratio of about 550:1 to about 25:

1.

10. The oral product according to any one of claims 1 to 9, wherein the total amount of ginseng and the vitamin B group is present in a weight ratio of about 50:1 to about 1:1, preferably, the total amount of ginseng and the vitamin B group is present in a weight ratio of about 35:1 to about 10:

1.

11. The oral product according to any one of claims 1 to 10, wherein the maca root and the ashwagandha are present in a weight ratio of about 20:1 to about 1:10, preferably about 15:1 to about 1:

5.

12. The oral product according to any one of claims 1 to 11, wherein the ashwagandha and ginseng are present in a weight ratio of about 10:1 to about 1:10, preferably about 5:1 to about 1:

5.

13. The oral product according to any one of claims 1 to 12, wherein the combination of the active ingredients further comprises (v) passionflower, and optionally the passionflower is present in an amount of about 1% to about 40% by weight of the dry weight of the combination, or the passionflower is present in an amount of about 0.01% to about 10% by weight of the oral product.

14. The oral product according to claim 13, wherein the maca root and the passionflower are present in a weight ratio of about 20:1 to about 1:10, preferably about 10:1 to about 1:

5.

15. The oral product according to claim 13 or 14, wherein the passionflower and the ashwagandha are present in a weight ratio of about 10:1 to about 1:10, preferably about 5:1 to about 1:

5.

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

17. An oral product according to any one of claims 1 to 16, further comprising one or more additives selected from the group consisting of flavoring agents, sweeteners, acidifying agents, thickeners, fillers, binders, wetting agents, preservatives, and mixtures thereof.

18. The oral product according to any one of claims 1 to 17, wherein the oral product is in liquid dosage form, and optionally the liquid oral dosage form has a volume of liquid of about 1 mL to about 200 mL, and optionally the liquid oral dosage form has a volume of liquid of about 20 mL to about 100 mL.

19. The oral product according to any one of claims 1 to 18, wherein the oral product further contains water in an amount of about 50% to about 99.9% by weight of the oral product.

20. The above combination of active ingredients is (i) Maca root and (ii) at least a combination of vitamin B2 and vitamin B6, (iii) Ginseng and, (iv) Ashwagandha and, (v) Passionflower and An oral product according to claim 18 or 19, comprising:

21. The oral product is in liquid dosage form, (i) Approximately 50 mg to 1000 mg of maca root, (ii) A combination of B vitamins in an amount of approximately 1 mg to approximately 50 mg, including at least vitamin B2 and vitamin B6, (iii) Approximately 10 mg to approximately 500 mg of ginseng, (iv) Approximately 10 mg to 500 mg of ashwagandha, and in some cases (v) Approximately 10 mg to 800 mg of passionflower An oral product according to any one of claims 1 to 20, comprising:

22. (a) A step of combining active ingredients, wherein the active ingredients include (i) the maca root, (ii) a combination of B vitamins including at least vitamin B2 and vitamin B6, (iii) ginseng, and (iv) ashwagandha, provided that the maca root, ginseng, and ashwagandha are different from each other. (b) The step of bringing the active ingredient into contact with water, (c) The step of mixing the active ingredient with water to prepare an oral product. A method for preparing the oral product according to any one of claims 1 to 21, including the method described in any one of claims 1 to 21.

23. Use of a combination of active ingredients for increasing sexual urges and / or desire for sexual activity in a human or animal, wherein the combination of active ingredients comprises (i) maca root, (ii) a combination of B vitamins including at least vitamin B2 and vitamin B6, (iii) ginseng, and (iv) ashwagandha, wherein the maca root, ginseng, and ashwagandha are different from each other, and preferably the combination of active ingredients is as described in any one of claims 1 to 21.

24. The combination of active ingredients is (i) Maca root and (ii) Vitamin B1, vitamin B2, vitamin B6, and vitamin B7, or a combination of vitamin B group consisting of vitamin B1, vitamin B2, and vitamin B6, (iii) Ginseng and, (iv) Passionflower and An oral product comprising a combination of active ingredients, wherein the maca root and the ginseng are different from each other.

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