FOOD SUPPLEMENT, ITS USES, PROCEDURE FOR FOOD SUPPLEMENTATION AND ORAL SPRAY

Abstract

The present invention relates to a food supplement containing minerals and / or vitamins, a wetting agent, and, for example, essential oils. The food supplement is formulated as an oral spray. In particular, the present invention relates to a concentrated food supplement in the form of an oral spray, containing a combination of magnesium ions, panthenol (vitamin B5), caffeine, menthol and / or peppermint flavoring, and a wetting agent. The food supplement is particularly suitable for use during sports and in situations of high physical exertion.

Description

[0001] Dietary supplements. Uses thereof. Methods for dietary supplementation and oral spray.

[0002] The present invention relates to a dietary supplement containing minerals and / or vitamins, a humectant, and, for example, essential oils. The dietary supplement is formulated as an oral spray. In particular, the present invention relates to a concentrated dietary supplement in the form of an oral spray containing a combination of magnesium ions, panthenol (vitamin B5), caffeine, menthol flavoring and / or peppermint flavoring, and a humectant.

[0003] This dietary supplement is particularly suitable for use during sports and stressful situations.

[0004] Various dietary supplements are known from current technology. Concentrated forms are mostly available as powders. In most cases, known dietary supplements are portioned so that one unit, e.g., a capsule, a powder sachet, an ampoule, etc., contains a single dose of at least 15% of the recommended daily allowance of vitamins and / or minerals.

[0005] Furthermore, there are also application methods in the form of a concentrate, e.g., filled into bottles, from which an aliquot is then mixed with 50 to 100 ml of water before ingestion.

[0006] In physically and mentally stressful situations such as exams, presentations, speeches, etc., a feeling of dryness in the mouth can quickly develop. One reason for this is that saliva production is controlled by the autonomic nervous system. During sports, dry mouth is further exacerbated by mouth breathing.

[0007] Particularly in the situations mentioned above, the application of a powdered dietary supplement is disadvantageous. Taking a powder in these situations is not only inconvenient, but also leads to an unpleasant feeling due to dry mouth.

[0008] Based on the prior art cited above, the object of the present invention is therefore to provide a dietary supplement containing a combination of selected active ingredients (i) to support endurance activity or during periods of exertion in a highly concentrated manner, (ii) to provide long-lasting moisturization of the oral mucosa and pharynx to prevent dry mouth, and (iii) simultaneously to promote free breathing, which also enhances concentration and performance. The active ingredients should be easily absorbed by the body. The system can be conveniently transported, e.g., in a trouser pocket, and used quickly.

[0009] The aforementioned problem is solved by the features of the independent patent claims. The respective dependent patent claims describe advantageous embodiments of the invention.

[0010] In a first aspect, the present invention thus relates to a food supplement comprising or consisting of an aqueous solution or emulsion of

[0011] a) at least one mineral selected from the group consisting of magnesium, potassium, calcium, iron, zinc, selenium, manganese-containing minerals and mixtures and combinations thereof, and / or b) at least one vitamin and / or at least one provitamin selected from the group consisting of pantothenic acid, dexpanthenol, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin E, niacin, riboflavin, biotin and mixtures and combinations thereof,

[0012] c) at least one component for moisturizing and maintaining the moisture content of the oral mucosa and / or the pharynx (humidifying agent), as well as

[0013] d) at least one component that conveys the feeling of free breathing, preferably an essential oil, e.g., menthol and / or peppermint oil, aroma, and / or crystals

[0014] in the form of a mouth spray.

[0015] The term "food supplement" within the meaning of the present invention is understood as defined by the German Food Supplements Regulation (NemV) of May 24, 2004 (Federal Law Gazette I p. 1011), as last amended by Article 11 of the Regulation of July 5, 2017 (Federal Law Gazette I p. 2272). Accordingly, a food supplement is a foodstuff that

[0016] - is intended to supplement the general diet,

[0017] - represents a concentrate of nutrients or other substances with a nutritional or physiological effect, alone or in combination and

[0018] - in metered form, in particular in the form of capsules, lozenges, tablets, pills and other similar dosage forms, powder sachets, liquid ampoules, bottles with dropper inserts and similar dosage forms of liquids and powders for ingestion in measured small quantities, is placed on the market.

[0019] In accordance with the Food Supplements Regulation, nutrients within the meaning of the present invention are understood to be vitamins and minerals, including trace elements. The food supplement according to the present invention thus represents a combination formulation containing

[0020] - one or more components for dietary supplementation, i.e., important vitamins and / or minerals that, for example, promote concentration, wakefulness, performance enhancement, or have antispasmodic effects,

[0021] - one or more components for sustainable, continuous mouth moisturization to eliminate dry mouth caused, for example, by increased breathing, especially mouth breathing, during sports, lectures, etc., reduced saliva production controlled by the autonomic nervous system in stressful, tense, and anxiety situations, etc.

[0022] - one or more components that facilitate free and deep breathing (e.g., through the mouth and / or nose and throat) and thereby have a tension-relieving, focusing, and performance-enhancing effect.

[0023] Surprisingly, it was found that the effects of increasing performance, improving concentration and focus, as well as overcoming fatigue and stress, are significantly enhanced by the described combination compared to administering at least one vitamin and / or at least one mineral alone.

[0024] The formula, thanks to a component like menthol, facilitates and encourages free and deep breathing. Consequently, the brain and muscles are effectively supplied with oxygen. The pleasant cooling and moisturizing effect on the oral cavity further supports breathing and well-being. A dry mouth leads to a tickly cough and discomfort.

[0025] Surprisingly, it was found that using this dietary supplement can create optimal performance conditions and improve focus, for example, during sports, stressful situations, exams, or anxiety-provoking situations, while also offering optimal ease of use. The supplement supports increased mental and physical performance, focus, and concentration in stressful, tense, and anxious situations, such as those experienced by athletes, individuals facing exams or other demanding situations, and high-achievers (e.g., executives, surgeons, etc.). Simultaneously, it contributes to improved mental and physical well-being and the optimization of physical parameters during and after stressful situations, as well as during rehabilitation.The formulation is therefore also suitable for relieving tension, stress and anxiety situations, and for improving mental and physical well-being.

[0026] The oral spray formulation allows the dietary supplement to be dispensed as a spray or aerosol, specifically as a metered spray with a predefined volume, which can range from 20 to 500 ml, but preferably from 50 to 200 ml. The oral spray application allows the formulation to be administered in several small doses, even multiple times throughout the day. This portioned delivery of the substances ensures effective absorption and utilization. Due to the application in small doses, the active ingredients are preferably present in a highly concentrated form, so that at least 15% of the recommended daily dose can be achieved with just a few sprays. However, the formulation cannot be considered a concentrate in the conventional sense, as it is not diluted before ingestion; rather, the undiluted formulation is applied directly into the oral cavity from the spray system.This also presents a challenge for the flavor preparation of the highly concentrated formulation.

[0027] The active ingredients, such as minerals and vitamins, are absorbed by the body more quickly and effectively through two routes of absorption: via the oral mucosa they enter the bloodstream directly and / or via the gastrointestinal tract.

[0028] This multiple application in several small doses spread throughout the day increases absorption efficiency.

[0029] At the same time, the application as an oral spray enables even wetting and distribution of at least one oral moisturizing component throughout the entire oropharynx.

[0030] Accordingly, essential oil components, which, for example, promote free breathing, also have an effect in the nasal area when applied and distributed in the oropharynx, since the pharynx forms the connection between the oral and nasal cavities. Consequently, such components then convey the feeling of free breathing through the mouth and nose.

[0031] However, the formulation to be patented is not used for oral hygiene and oral care, as a mouth deodorant, and / or for dental hygiene and health maintenance.

[0032] Surprisingly, it has been shown that the dietary supplement according to the invention contributes to the reduction of tiredness, fatigue, and exhaustion, and has a wake-promoting, concentration-enhancing, and performance-enhancing effect. Furthermore, the dietary supplement alleviates or prevents dry mouth. It also contributes to the body's electrolyte balance, normal muscle function, and normal protein synthesis. Due to the formulation according to the invention as an oral spray, it is easy to take during sports, while driving, or during an exam by spraying a few times; the dietary supplement according to the invention can, for example, be carried in a trouser pocket or belt bag during sports activities.

[0033] The absorption of the active ingredients in volume-defined doses (i.e., one or more sprays) is more effective than a single large dose. It also avoids unwanted side effects that some substances cause when applied in high quantities. Furthermore, it can be perfectly integrated into a training plan or running workout, as the spray also contributes to oral moisturization and improved breathing.

[0034] The food supplement may either contain at least one of the minerals mentioned in feature a) and be free of the vitamins and / or provitamins mentioned in feature b).

[0035] Alternatively, the food supplement may contain at least one of the vitamins and / or provitamins listed in feature b) and be free of the minerals listed in feature a). It is also possible for the food supplement to contain at least one of the minerals listed in feature a) and at the same time at least one of the vitamins and / or provitamins listed in feature b).

[0036] Regarding minerals a), it is preferred if the food supplement contains no other minerals besides those mentioned a).

[0037] Alternatively or additionally, it is also preferred if the food supplement contains no further vitamins and / or provitamins besides the aforementioned vitamins and / or provitamins.

[0038] The present invention overcomes the disadvantages of prior art dietary supplements, particularly those formulated as powders or liquid ampoules. Administering a dietary supplement during exercise as a powder from a sachet without liquid, especially when the mouth is already dry, is more difficult and unpleasant than applying a single spray from an oral spray. The oral spray can be applied with one hand; opening a sachet or unscrewing an ampoule requires both hands. The substances can be administered in precisely measured, small amounts (sprays) throughout the day by applying them as an oral spray. This contrasts with powders and liquid solutions in ampoules that are taken once daily and are not designed for dose-controlled, portioned administration.However, administering the medication in smaller portions ensures better absorption and utilization of the administered substances. Furthermore, such portion-based administration can avoid undesirable side effects associated with larger, single doses, such as those of magnesium, which can cause stomach irritation and / or diarrhea.

[0039] The present invention combines highly concentrated dietary supplements in liquid application form with a component for long-lasting moisturizing of the mouth and throat and a component that facilitates breathing through the mouth and nose. Thus, the dietary supplement according to the present invention is ideally suited to support endurance sports activities and / or situations of physical or mental stress.

[0040] The dietary supplement contains the previously described components in concentrated, liquid form. The required recommended daily amount of minerals and vitamins can thus be achieved by administering precisely defined small amounts of liquid throughout the day, for example, in small portions using a few sprays of the oral spray formulation.

[0041] The minerals, vitamins, and other active ingredients contained in the dietary supplement are thus quickly available. In particular, magnesium or, for example, caffeine (preferably 1 to 120 mg, more preferably 22 to 100 mg, particularly preferably 25 to 80 mg caffeine in an application amount of 0.1 to 6 ml, more preferably 0.5 to 5 ml, more preferably 1 to 4 ml) can be quickly added to the body as needed.

[0042] The faster availability of the ingredients contained in the dietary supplement, especially the minerals, vitamins, provitamins and other components, occurs particularly with mouth spray, which is distributed and nebulized over a wide area of ​​the oral cavity through two different absorption pathways, namely:

[0043] - via the gastrointestinal tract, and

[0044] - are absorbed through the oral mucosa and from there pass directly into the bloodstream.

[0045] The formulation of the dietary supplement according to the invention results in a particularly advantageous and rapid absorption of the active ingredients contained in the supplement, since both of the aforementioned absorption mechanisms can be optimally utilized. The full potential of the present invention is particularly realized when applied as an oral spray. Preferably, viscosity enhancers also ensure mucoadhesive retention in the oral cavity and thus further increase the absorption rate.

[0046] In particular, the preferred combination of menthol, magnesium and caffeine, optionally also pantothenic acid or dexpanthenol, in high concentration and a moisturizing agent (e.g. glycerin) increases concentration and performance, influences neuromuscular processes, has a muscle-relaxing and antispasmodic effect, allows free breathing, eliminates dry mouth and provides a long-lasting feeling of moisture and freshness in the mouth.

[0047] The oral spray contains at least one mineral or at least one vitamin and / or at least one provitamin, preferably in highly concentrated form. It is advantageous if the at least one mineral a) and / or the at least one vitamin b) is each concentrated enough to provide at least 15% and at most 140% of the recommended daily allowance (RDA) according to Annex I of Commission Directive 2008 / 100 / EC of 28 October 2008, administered in portions throughout the day in a total application quantity of 0.1 to 10 ml, preferably 0.5 to 8 ml, particularly preferably 1 to 4 ml for the oral spray. The aforementioned RDA values ​​may vary by up to 50% and -20% according to the “Guidance Document for Competent Authorities for Control of Compliance with EU Legislation on Regulation (EU No. 1169 / 2011, table 2)” and for minerals by +45% and -20%.The quantities mentioned refer to the amount of the respective metal (i.e., the total content of magnesium, potassium, calcium, iron, zinc, selenium, manganese) as such – regardless of the type of compound of this metal contained.

[0048] A preferred content of the at least one humectant is from 0.01 to 15 wt.%, preferably 0.05 to 10 wt.%, particularly preferably 0.1 to 5 wt.%, based on the food supplement.

[0049] A first option regarding component d), which conveys the feeling of free breathing, stipulates that it is selected from the group consisting of crystalline menthol, menthol oil, menthol aroma, as well as mixtures and combinations thereof.

[0050] It is preferred that the aforementioned component d) is preferably contained in an amount of 1 to 500 mg, preferably 20 to 400 mg, particularly preferably 50 to 250 mg in an application amount of 0.1 to 10 ml, preferably 0.5 to 8 ml, particularly preferably 1 to 4 ml for the oral spray of the formulation.

[0051] Alternatively, and equally preferred, the component d), which provides the feeling of free breathing, may be selected from the group consisting of peppermint extract, peppermint oil, peppermint flavouring, as well as mixtures and combinations thereof.

[0052] In this case, component d) is preferably 0.0003 to 30 mg, preferably 0.001 to 10 mg, particularly preferably 0.01 to 5 mg in an application quantity of 0.1 to 6 ml, preferably 0.5 to 5 ml, particularly preferably 1 to 4 ml.

[0053] However, it is also possible that component d) in the food supplement contains both a substance selected from the group consisting of crystalline menthol, menthol oil, menthol flavoring, and mixtures and combinations thereof, and a component selected from the group consisting of peppermint extract, peppermint oil, peppermint flavoring, and mixtures and combinations thereof. In this case, where both of the aforementioned substance groups are present, the respective individual components are included within the limits of the previously mentioned preferred quantities.

[0054] The minerals preferably contained in the food supplement a) – with the exception of selenium – are present in particular as inorganic or organic salts of the aforementioned metal cations, especially as acetates, carbonates, chlorides, citrates, gluconates, glycerophosphates, orthophosphates, lactates, hydroxides, hydrogen sulfates and / or sulfates. Selenium is preferably present as sodium selenite, sodium hydrogen selenite and sodium selenate.

[0055] Preferably, the at least one mineral is selected from the group consisting of inorganic or organic magnesium salts, in particular magnesium acetate, magnesium carbonate, magnesium chloride, magnesium salts of citric acid, magnesium gluconate, magnesium glycerophosphate, magnesium salts of orthophosphoric acid, magnesium lactate, magnesium hydroxide, magnesium oxide, and / or magnesium sulfate. It is possible that one or more of the aforementioned magnesium salts constitute the only mineral contained in the dietary supplement according to the invention.

[0056] The aforementioned magnesium-based mineral is contained in a corresponding amount, preferably containing 35 to 450 mg of magnesium ions, preferably 40 to 250 mg of magnesium ions, particularly preferably 50 to 100 mg of magnesium ions in an application amount of 0.1 to 6 ml, preferably 0.5 to 5 ml, particularly preferably 1 to 4 ml for the oral spray or 3 to 30 ml, preferably 5 to 25 ml, particularly preferably 10 to 20 ml for the oral solution.

[0057] A preferably included humectant is in particular selected from the group consisting of polyhydroxy compounds comprising sorbitol, 1,2-propanediol, glycerol, cellulose derivatives such as carmellose (carboxymethylcellulose), methylcellulose, hydroxypropylmethylcellulose, and carbomer, as well as mixtures and combinations thereof.

[0058] In particular, the dietary supplement according to the invention contains dexpanthenol, preferably in an application amount of 0.5 to 15 mg in an application amount of 0.1 to 6 ml, preferably 0.5 to 5 ml, particularly preferably 1 to 4 ml for the oral spray or 3 to 30 ml, preferably 5 to 25 ml, particularly preferably 10 to 20 ml for the oral solution.

[0059] To enhance the wakefulness effect and increase attention, performance and reaction time, the food supplement may additionally contain caffeine, preferably 10 to 120 mg, preferably 22 to 100 mg, particularly preferably 25 to 80 mg of magnesium ions in an application amount of 0.1 to 6 ml, preferably 0.5 to 5 ml, particularly preferably 1 to 4 ml for the oral spray.

[0060] Furthermore, it is advantageous if the dietary supplement contains at least one viscosity enhancer, in particular alginate, xanthan gum, and / or gum arabic and / or glycosaminoglycans, e.g., hyaluronic acid and / or chondroitin sulfate, as well as mixtures and combinations thereof, preferably in a concentration of 0.01 to 5% by weight, particularly preferably 0.1 to 1% by weight. The viscosity enhancers preferably contained in the dietary supplement, through the resulting film formation, provide a longer residence time on the oral mucosa and thus more effective absorption of the ingredients. The oral spray is compact, therefore easy to carry, handy, and can be used at any time by spraying it into the open mouth. It can be easily applied by spraying, especially during sports, exams, or while driving.

[0061] Other additives that may be contained in the food supplement are specifically selected from the group consisting of emulsifiers, such as polysorbates, sorbate esters and lecithins; oils, e.g. MCT oils; C-8 fatty acids (caprylic acid), C-10 fatty acids (capric acid) and mixtures thereof; carbohydrates, in particular glucose, fructose, dextrose, maltose, xylitol and / or sorbitol; essential oils (e.g. lavender, orange, vanilla, jasmine, lemongrass, mandarin, citrus) and / or extracts, e.g. peppermint, orange, lemon, lime, blackcurrant (cassis), aronia, papaya, vanilla; flavorings, e.g. vanillin, bitter almond, bitter masking flavor, citrus, lemongrass, ginger; Sweeteners, such as saccharin and its sodium, potassium, and calcium salts (E 954), aspartame (E 951), acesulfame K (E 950), sucralose (E 955), thaumatin (E 957), steviol glycosides (E 960), aspartame-acesulfame salt (E 962), and advantame (E 969); humectants; expectorants, such as essential oils or extracts from, for example,Anise, licorice, primrose; buffers; complexing agents, such as EDTA and / or citric acid, and excipients for food supplements, preferably in a concentration of 0.001 to 22 wt.%, more preferably of 1 to 21 wt.%, more preferably of 5 to 19%, particularly preferably 10 to 17 wt.%.

[0062] In particular, the presence of caffeine and / or a mood-enhancing component, such as extracts and / or essential oils, can effectively support and increase alertness, concentration and performance, and reduce tension, stress and anxiety.

[0063] In a preferred embodiment, the dietary supplement contains only a single emulsifier, for example, polysorbate 80, soy lecithin, etc. Co-emulsifiers are not included in this case. A particularly preferred embodiment provides that the dietary supplement contains at least one medium-chain triglyceride (MCT oil), selected from the group consisting of medium-chain triglycerides (MCT oils) whose fatty acids are at least 90 mol% C-8 fatty acid (caprylic acid) and C-10 fatty acid (capric acid), e.g., 60-80 mol% C-8 fatty acid (caprylic acid) and 40-20 mol% C-10 fatty acid (capric acid); or vegetable medium-chain triglycerides (MCT oils), in particular MCTs based on coconut oil and / or palm oil, as well as mixtures and combinations thereof, for example, in the amounts mentioned above for the additives.

[0064] The dietary supplement according to the present invention is, in particular, self-preserving and can therefore be formulated without preservatives. A self-preserving formulation is provided, in particular, by an embodiment in which the dietary supplement is filled into a so-called airless spray bottle or device. Preservatives used in the present invention are those commonly used in dietary supplements, such as...Potassium sorbate, sorbic acid, calcium sorbate, benzoic acid, sodium benzoate, potassium benzoate, calcium benzoate, ethyl 4-hydroxybenzoate, ethyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, methyl 4-hydroxybenzoate, methyl 4-hydroxybenzoate, sulfur dioxide / sulfurous acid, sodium sulfite, sodium hydrogen sulfite, sodium disulfite, potassium disulfite, calcium sulfite, calcium hydrogen sulfite, potassium hydrogen sulfite, orthophenylphenol, sodium orthophenylphenol, nisin, natamycin, formic acid, sodium formate, potassium formate, urotropin, dimethyl dicarbonate, ethyl laurylarginate, potassium nitrite, sodium nitrite, sodium nitrate, potassium nitrate, acetic acid, potassium acetate, sodium acetate, sodium diacetate, calcium acetate, lactic acid, propionic acid sodium propionate, calcium propionate, potassium propionate, boric acid, sodium tetraborate, carbon dioxide, malic acid, fumaric acid and / or lysozyme are understood.Preservative-free means that the substances mentioned are present in a concentration of less than 0.001% by weight, based on the food supplement.

[0065] Alternatively, the dietary supplement may also contain one or more of the aforementioned preservatives. Preferred preservatives are sorbic acid, potassium sorbate, and / or calcium sorbate, with potassium sorbate being particularly preferred.

[0066] Furthermore, the dietary supplement is preferably free of cyclodextrins.

[0067] The emulsion underlying the dietary supplement can be a microemulsion or a nanoemulsion.

[0068] The present invention also relates to the use of the dietary supplement according to the invention for non-therapeutic nutritional supplementation, in particular before, during and / or after a sporting activity, in stressful situations, examination situations and / or while driving.

[0069] Furthermore, the present invention relates to a method for dietary supplementation in which a dietary supplement according to one of the preceding claims is applied in the form of a spray into the mouth of a person, in particular before, during and / or after a sporting activity (e.g. endurance sports, in particular cycling, running, e.g. marathon, skiing or mountaineering), in stressful situations, in examination situations, in stressful, tense and anxious situations, in cases of fatigue, lack of sleep, and / or exhaustion (e.g. in examination situations, when driving a car, e.g. professional drivers) to relieve tension and to improve mental and physical well-being.

[0070] When applying the spray, the dietary supplement is atomized into the mouth and / or throat of a person, particularly using a suitable atomizing device. Application preferably occurs several times a day, in particular 3 to 50 times, more preferably 5 to 20 times, with 1 to 10 sprays of 10 to 500 ml, preferably 50 to 200 ml, being applied each time.

[0071] Furthermore, the present invention relates to a method for non-therapeutic refreshment, non-therapeutic support of free breathing, non-therapeutic performance enhancement, non-therapeutic moisturization of the oral mucosa, and / or non-therapeutic reduction of tiredness and / or exhaustion, in which a dietary supplement according to the invention is applied to a person's mouth in the form of a spray or ingested as an oral solution. The application of the spray is carried out according to the procedure described above.

[0072] Furthermore, medical and therapeutic aspects of the dietary supplement according to the present invention are described. In particular, the dietary supplement is suitable for the treatment of mucus buildup; in this case, the dietary supplement is used as an expectorant. The dietary supplement is also suitable for use in the prevention and / or treatment of muscle cramps.

[0073] As with non-therapeutic uses, the dietary supplement is applied to the mouth in the form of a spray. Application is preferably several times a day, in particular 3 to 50 times, more preferably 5 to 20 times, with 1 to 10 sprays of 10 to 500 ml, preferably 50 to 200 ml, being applied each time.

[0074] The present invention further relates to an oral spray comprising a reservoir in which a food supplement according to the invention is stored, and a spray head connected or connectable to the reservoir, which enables the food supplement to be dispensed as a spray. The spray head can be designed as a pump head, which is operated manually by a user, for example. Alternatively, the oral spray can also be designed such that the food supplement in the reservoir is pressurized and flows out of the spray head automatically when the spray head is activated. The pump spray can be designed as an airless or non-airless system, with the airless system being preferred.

[0075] The present invention has been described in more detail with reference to the following exemplary formulation.

[0076] The dietary supplements in examples 1 to 5 are particularly suitable for use in sports and stressful situations to enhance mental and physical performance and can be used for these purposes. The dietary supplements in examples 6 to 8 are particularly suitable for relieving tension, stress, and anxiety, while simultaneously improving well-being and mental performance, and can be used for these purposes.

[0077] Example 1:

[0078]

[0079] Example 2:

[0080]

[0081] Example 3

[0082]

[0083] Example 4:

[0084] Example 5:

[0085] Example 6

[0086]

[0087] Example 7

[0088]

[0089] Example 8

[0090]

Claims

URSAPHARM Arzneimittel GmbH 189PCT 4108 Patent claims 1. Food supplements, comprising or consisting of a aqueous solution or emulsion of a) at least one mineral selected from the group of Magnesium, potassium, calcium, iron, zinc, selenium, manganese-containing minerals, as well as mixtures and combinations thereof, and / or b) at least one vitamin and / or at least one provitamin selected from the group consisting of pantothenic acid, dexpanthenol, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin E, niacin, folic acid, thiamin, riboflavin, biotin, and mixtures and combinations thereof; c) at least one component for moisturizing and maintaining the moisture content of the oral mucosa and / or the pharynx (humectant); and d) at least one component that promotes free and deep breathing, preferably an essential oil, e.g. menthol and / or peppermint oil, aroma and / or crystals, in the form of a mouth spray.

2. Food supplement according to claim 1, characterized in that the at least one mineral a) is concentrated such that the magnesium, potassium, calcium, iron, zinc, selenium and / or manganese are each contained in an amount of at least 15% and at most 140% of the recommended daily allowance according to Annex 1 of Commission Directive 2008 / 100 / EC of 28 October 2008 (Recommended Daily Allowance, “RDA”) in an application amount of 0.1 to 10 ml, preferably 0.5 to 8 ml, particularly preferably 1 to 4 ml.

3. Food supplement according to one of the preceding claims, characterized in that the at least one vitamin b) is concentrated to provide at least 15% and at most 140% of the recommended daily intake according to Annex 1 to Commission Directive 2008 / 100 / EC of 28 October 2008 (Recommended Daily Intake). Allowance, “RDA”) in an application amount of 0.1 to 10 ml, preferably 0.5 to 8 ml, particularly preferably 1 to 4 ml.

4. Food supplement according to one of the preceding claims, characterized in that it contains at least one moisturizing agent c) in an amount of 0.01 to 15 wt.%, preferably 0.05 to 10 wt.%, particularly preferably 0.1 to 5 wt.%, based on the food supplement.

5. A food supplement according to one of the preceding claims, characterized in that the at least one component d), which provides the feeling of free breathing, is selected from the group consisting of crystalline menthol, menthol oil, menthol aroma and mixtures and combinations thereof and is preferably contained in an amount of 1 to 500 mg, preferably 20 to 400 mg, particularly preferably 50 to 250 mg in an application amount of 0.1 to 10 ml, preferably 0.5 to 8 ml, particularly preferably 1 to 4 ml for the oral spray.

6. A food supplement according to any of the preceding claims, characterized in that the at least one component d), which provides the feeling of free breathing, is selected from the group consisting of peppermint extract, peppermint oil, peppermint flavoring and mixtures and combinations thereof and is preferably contained in an amount of 0.0003 to 30 mg, preferably 0.001 to 10 mg, particularly preferably 0.01 to 5 mg in an application amount of 0.1 to 10 ml, preferably 0.5 to 8 ml, particularly preferably 1 to 4 ml. A food supplement according to one of the preceding claims, characterized in that the at least one mineral is selected from the group consisting of inorganic or organic magnesium, potassium, calcium, iron, zinc, and / or manganese. gan salts, in particular acetates, carbonates, chlorides, citrates, gluconates, glycerophosphates, orthophosphates, lactates, hydroxides, hydrogen sulfates and / or sulfates; in the case of selenium as sodium selenite, sodium hydrogen selenite and sodium selenate.

8. Food supplement according to one of the preceding claims, characterized in that the at least one mineral is selected from the group consisting of inorganic or organic magnesium salts, in particular magnesium acetate, magnesium carbonate, magnesium chloride, magnesium salts of citric acid (e.g. magnesium hydrogen citrate, trimagnesium dicitrate), magnesium gluconate, Magnesium glycerophosphate, magnesium salts of Orthophosphoric acid, magnesium lactate, magnesium hydroxide, magnesium oxide, and / or magnesium sulfate, wherein preferably 35 to 450 mg magnesium ions, preferably 40 to 250 mg magnesium ions, particularly preferably 50 to 100 mg magnesium ions are contained in an application amount of 0.1 to 10 ml, preferably 0.5 to 8 ml, particularly preferably 1 to 4 ml.

9. Food supplement according to one of the preceding claims, characterized in that the humectant is selected from the group consisting of polyhydroxy compounds comprising sorbitol, 1,2-propanediol, glycerol, cellulose derivatives, such as carmellose (carboxymethylcellulose), methylcellulose, Hydroxypropylmethylcellulose and carbomer, as well as mixtures and combinations thereof.

10. Food supplement according to one of the preceding claims, characterized in that it contains at least one vitamin and / or at least one provitamin pantothenic acid or Dexpanthenol is preferably present in an application amount of 0.5 to 15 mg in an application amount of 0.1 to 10 ml, preferably 0.5 to 8 ml, particularly preferably 1 to 4 ml.

11. A food supplement according to any of the preceding claims, characterized in that it additionally contains caffeine, preferably 1 to 120 mg, preferably 22 to 100 mg, particularly preferably 25 to 80 mg caffeine in an application amount of 0.1 to 6 ml, preferably 0.5 to 5 ml, particularly preferably 1 to 4 ml.

12. Food supplement according to one of the preceding claims, characterized in that it contains at least one viscosity increaser, in particular alginate, xanthan gum, and / or gum arabic and / or glycosaminoglycans, e.g. hyaluronic acid and / or chondroitin sulfate, as well as mixtures and combinations thereof, preferably in a concentration of 0.01 to 5% by weight, particularly preferably 0.1 to 1% by weight.

13. Food supplement according to one of the preceding claims, characterized in that at least one additive selected from the group consisting of emulsifiers, such as e.g. Polysorbates, sorbate esters and lecithins; oils, e.g., MCT oils; C-8 fatty acids (caprylic acid), C-10 fatty acids (capric acid) and mixtures thereof; carbohydrates, in particular glucose, fructose, dextrose, maltose, xylitol and / or sorbitol; essential oils and / or extracts, e.g., peppermint, orange, lemon, lime, blackcurrant (cassis), aronia, papaya, vanilla; flavorings, e.g., vanillin, bitter almond, bitter masking flavor, citrus, lemongrass, ginger; sweeteners, such as saccharin and its sodium, potassium, and calcium salts (E 954), aspartame (E 951), acesulfame K (E 950), sucralose (E 955), thaumatin (E 957). Steviol glycosides (E 960), aspartame-acesulfame salt (E 962) and Advantam (E 969); humectant; expectorant, e.g. essential oils or extracts of e.g. anise, licorice, primrose; buffer; complexing agents, such as EDTA and / or citric acid, and excipients for food supplements, preferably in a concentration of 0.001 to 22 wt.%, more preferably of 1 to 21 wt.%, more preferably of 5 to 19%, particularly preferably 10 to 17 wt.%.

14. Food supplement according to one of the preceding claims, characterized in that at least one additive is used. Medium-chain triglyceride (MCT oil), selected from the group consisting of medium-chain triglycerides (MCT oils) whose fatty acids are at least 90 mol% C-8 fatty acid (caprylic acid) and C-10 fatty acid (capric acid), e.g. 60-80 mol% C-8 fatty acid (caprylic acid) and 40-20 mol% C-10 fatty acid (capric acid); vegetable medium-chain triglycerides (MCT oils), in particular MCTs based on coconut oil and / or palm oil, as well as mixtures and combinations thereof.

15. Food supplement according to one of the preceding claims, characterized in that it is free of cyclodextrins.

16. Food supplement according to one of the preceding claims, characterized in that the emulsion is a microemulsion or a nanoemulsion.

17. Food supplement according to one of the preceding claims, characterized in that it has the following composition:

18. A food supplement according to one of the preceding claims, characterized in that it is preservative-free, preferably self-preserving.

19. A method for non-therapeutic food supplementation, in which a Dietary supplements are applied in the form of a spray into a person's mouth, in particular before, during and / or after a sporting activity (e.g. endurance sports, especially cycling, running, e.g. marathon, Skiing or mountaineering), in stressful situations, in exam situations, in stressful, tense and anxiety situations, in cases of fatigue, lack of sleep, and / or exhaustion (e.g. in exam situations, when driving, e.g. professional drivers) to relieve tension and improve mental and physical well-being.

20. Use of a food supplement according to any of claims 1 to 18 for non-therapeutic food supplementation, in particular before, during and / or after sporting activity, in stressful situations, examination situations and / or while driving.

21. Use according to the preceding claim to support the production of increased mental and physical performance; focus and concentration in stressful, tense and anxiety situations, such as those occurring in athletes, persons in examination and stressful situations, high performers (e.g. managers, surgeons, etc.), etc.; to improve mental and physical well-being and optimize physical parameters during, in and after stressful situations; for rehabilitation; suitable for relieving tension, stress and anxiety situations and for improving mental and physical well-being.

22. Composition comprising or consisting of an aqueous solution or emulsion of a) at least one mineral selected from the group of Magnesium, potassium, calcium, iron, zinc, selenium, manganese-containing minerals, as well as mixtures and combinations thereof, and / or b) at least one vitamin and / or at least one provitamin selected from the group consisting of pantothenic acid, dexpanthenol, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin E, niacin, folic acid, thiamin, riboflavin, biotin and mixtures and combinations thereof, c) at least one component for moisturizing and maintaining the moisture content of the oral mucosa and / or the pharynx (Be- moisturizing agents), as well as d) at least one component that promotes free and deep breathing, preferably an essential oil e.g. menthol and / or peppermint oil, aroma and / or crystals, in the form of an oral spray for use in the treatment of mucus congestion; in the treatment and / or prevention of muscle cramps.