WO2021221577A2

WO2021221577A2 - Formulations of food supplement comprising natural sweetener

Info

Publication number: WO2021221577A2
Application number: PCT/TR2020/051064
Authority: WO
Inventors: Ali Turkyilmaz; Gulay YELKEN DEMIREL; Mustafa MARASLI
Original assignee: Montero Gida Sanayi Ve Ticaret Anonim Sirketi
Priority date: 2020-04-27
Filing date: 2020-11-09
Publication date: 2021-11-04
Also published as: WO2021221577A3

Abstract

The invention relates to a food supplement comprising at least one herbal extract and natural sweetener which is luo han guo.

Description

FORMULATIONS OF FOOD SUPPLEMENT COMPRISING NATURAL SWEETENER

Field of the invention

Background of the invention

The term ‘food supplement’ describes a broad and diverse category of products that you eat or drink to support good health and supplement the diet. Food supplements can be vitamins, minerals, herbal or botanical substances, extracts, amino acids, fatty acids, and other substances delivered in the form of pills, tablets, capsules, liquid, etc. Supplements are available in a range of doses, and in different combinations.

Particularly following the end of the 1990s, the positive effects of food supplements on human health were discovered. The demand for food supplement is increased, besides, especially food supplement comprising natural and herbal products are preferred for users.

In recent years, the use of various herbs and/or herbal medical products for the prevention and treatment of diseases and alleviating the effects thereof have been gradually increasing in all societies. Throughout human history, there have been and still are attempt for treating many diseases (diabetes, jaundice, dyspnea, etc.) by using some herbs. According to the records of the World Health Organization (WHO), a large proportion of the world's population (70-80%) make use of herbs for therapeutic or prophylactic purposes. Additionally, around 25% of prescription drugs in developed countries are composed of plant-based active agents (vinblastine, reserpine, quinine, aspirin, etc.).

Pelargonium sidoides (African Geranium, Umckaloabo) is a plant species widely used in the treatment and prevention of, or in the alleviation and/or elimination of the symptoms of cold and respiratory tract disease (pharyngitis, sinusitis, acute bronchitis, tonsillitis). It was determined to be effective in increasing the generation of natural killer cells and tumor necrosis factor alpha, and to enhance the release of interferon beta. Pelargonium sidoides has antiviral properties strengthening the immune system. It further has both antibacterial effects and antioxidative properties against some bacteria. Apart from that, it was also reported to boost the immune system of the respective organism and to have expectorant action by increasing the ciliary beat frequency of respiratory epithelial cells. In a multicenter study conducted by the Pneumology Department of a German University Hospital (2000) on acute bronchitis patients, including adults, children, and infants, it was determined that an extract of the roots of Pelargonium sidoides reduced the severity of the symptoms after 7 days treatment from 6.3 to 0.9 according to the average bronchitis severity score. A study published in "Acta Paediatrica" in April 2010, showed that preparations extracted from herbal roots were much more effective in the treatment of acute bronchitis as compared to placebo. A study group of children aged 6 to 18 years, taking the herbal extracts experienced less coughing, sputum, and bed rest times versus placebo. By assessing the results of four placebo-controlled clinic trials, the researchers at the Medical Center, the University of Pittsburgh, concluded that a standardized extract of Pelargonium sidoides showed a much better performance in alleviating the bronchitis symptoms versus placebo in a 7-day treatment period.

In the prior art, there are also several patents which disclose food supplement comprising natural and herbal products.

US8227013 B2 discloses nutritional dietary combination with selected herbs and spices. The formulation comprises sweeteners which are sucralose and stevia.

However, the formulations of a food supplement comprising natural and herbal products taken for support to human body are also very important. In the prior art, we see that there are formulations for food supplement comprising natural and herbal products but, when the formulations were examined, we see that used excipients especially sweeteners cause some side effects in the formulation.

In the prior art, traditional sugar is used like sucrose, but the sugars provide the most desirable taste to consumers, it is caloric and unhealthy, also having a high glycemic index.

Therefore, there is still a need for a food supplement which overcomes the above described problems in prior art and has additive advantages over them. The selection of excipients, especially sweeteners, has more importance to overcome the above described problems.

Luo Han Guo (luohanguo) refers to the fruit of Siraitia grosvenori, formerly called Momordica grosvenori, a member of the Curcubitaceae. The plant is cultivated for its fruit Luo Han Guo, whose extract is nearly 300 times sweeter than sugar and has been used in China as a natural low-calorie sweetener and in traditional Chinese medicine to treat diabetes and obesity. Luo Han Guo is popularly considered a longevity aid and is used to balance heat buildup caused by internal conditions, life-forces, or external heat. It is used as an expectorant and antitussive to treat lung congestion, cough, other respiratory ailments, and sore throat. It also is used for constipation and chronic enteritis. Luo Han Guo is a low- caloric, low-glycemic food used as a natural sweetener in beverages and food.

Luo Han Guo is collected as a round green fruit that turns brown upon drying. The sweet taste of Luo Han Guo comes primarily from mogrosides, a group of terpene glycosides, the present at the level of about 1% of the fleshy part of the fruit. Both the fresh and dried fruits are extracted to yield a powder that is 80% or more mogrosides. The mogrosides have been numbered, 1-5, and the main component is called mogroside-5, previously known as esgoside. Other, similar compounds from Luo Han Guo have been labeled siamenoside and neomogroside. The mixed mogrosides are estimated to be about 300 times as sweet as sugar by weight, so that the 80% extracts are nearly 250 times sweeter than sugar; pure mogrosides 4 and 5 may be 400 times as sweet as sugar by weight.

A process for making a useful sweetener from Luo Han Guo was patented in 1995 by Procter and Gamble Company in U.S. patent 5,411 ,755. As described in the patent application, the fruit itself, though sweet, has too many additional flavors that would make it unsuitable for widespread use as a sweetener, so P&G developed a method for processing it to eliminate the undesired flavors. In the P&G process, the fresh fruit is picked before ripening and allowed to complete its ripening during storage so that processing begins with the just-ripe fruit. The peel and seeds are then removed, and the mashed fruit becomes the basis of a concentrated fruit juice or puree that can be used in food manufacturing. Further processing involves using solvents to remove volatile and off-flavor components. Numerous sugar substitutes derived from Luo Han Guo by similar processes that isolate the sweet compounds are now readily available for manufacturing and for kitchen use.

Recent work on Luo Han Guo includes investigation of the antioxidant activity of the mogrosides (Shi H, et al., Antioxidant property of fructus momordicae extract, 1996 Biochemistry and Molecular Biology International 1996; 40 (6): 1111-1121.) and their potential use as cancer prevention compounds (Konoshima T and Takasaki M, Cancer- chemopreventive effects of natural sweeteners and related compounds, Pure Applied Chemistry 2002; 74(7): 1309-1316.). This suggested effect is based on the understanding that antioxidants can produce significant reversal or suppression of the early stage of cancer development, which has been an area of particular interest for tea drinking (Katiyar SK and Mukhtar H, Tea antioxidants in cancer chemoprevention, Journal of Cellular Biochemistry, Supplement 1997; 27: 59-67.). Further, Luo Han Guo and its sweetening component are often mentioned in relation to diabetes and obesity, because it can substitute for caloric sugars normally consumed in the diet.

In this present invention, food supplements comprising Pelargonium sidoides and Luo Han Guo is combined together to overcomes the above described problems in the prior art and to provide healthy and effective treatment.

Detailed description of the Invention

The main object of the present invention is to obtain a food supplement comprising Pelargonium sidoides and Luo Han Guo as a natural sweetener which overcomes the above described problems in the prior art and has additive advantages over them. The natural sweetener Luo Han Guo does not carry any glycemic index potential. Thus, a product is obtained which can be used by those who are in diets or by the diabetics. The product also provides the desired taste in the food supplement.

In the present invention, the phrase “Luo Han Guo” includes any Luo Han Guo product that is solid comprising “extract”, “concetrated extract”, “dried fruit”, “de-juiced fruit”, “lyophilized”, “spray dried”, “crystallized” or mixtures thereof.

Health trends have promoted an increased use of natural sweeteners in consumer diets. Amongst the many possibilities available to product developers is the option to enrich foods with "healthy ingredients" or perhaps to exchange one or more ingredients of the recipe in order to optimize the nutritional profile.

Of increasing nutritional and physiological importance to today's consumer is the glycemic index (Gl) that is much lower for fructose compared to that of glucose. Using glucose as the standard base, with a Gl of 100, fructose has only a Gl of around 20. The Gl measures the glycemic response (an indication of the rate at which the blood glucose level rises and how it is sustained over time) after ingestion of carbohydrate foods. The consumption of food with low Gl, such as fruit and vegetables, results in a slow increase in the blood glucose level. Food with a high Gl, such as sucrose and white bread, results in a quick response of blood glucose insulin levels and therefore should not only be avoided by diabetics, but also by the growing number of health conscious consumers as there is growing evidence that over long time, a diet based on high-carbohydrate low-glycemic foods is beneficial towards health by preventing chronic diseases such as diabetes, coronary heart disease and possibly cancer.

For instance, foods, which do not include additives or sugar, are perceived by the consumer, as natural and healthy. Despite their immense popularity, sweeteners and particularly sucrose recently gained bad publicity because of health concerns. That's why natural sweeteners are becoming more and more important as a natural alternative to sucrose as they contain the plant's own sugar spectrum.

According to one embodiment of the present invention, a food supplement comprises Pelargonium sidoides and Luo Han Guo as natural sweetener. Luo Han Guo is a healthy sugar substitution. Luo Han Guo at a certain rate, which extracts have almost no calorie (noncaloric) but has about 300-400 times sugar content compared with cane sugar.

According to one embodiment of the present invention, the food supplement comprises natural sweetener composition that has sweeter taste because of the synergy between Luo Han Guo concentrate and/or any other sweeteners. Furthermore, the natural sweetener composition is process friendly with virtually the same sweetening power as traditional sugar.

Another embodiment of the present invention is to combine Pelargonium sidoides and Luo Han Guo as natural sweetener in stable dosage form with desired dissolution profiles while maintaining a synergistic therapeutic effect with a reduced side effect. Thus, a product is obtained which can be used by those who are in diets or by the diabetics.

Supplements are available in a range of doses, and in different combinations. However, only a certain amount of each nutrient is needed for our bodies to function, and higher amounts are not necessarily better. At high doses, some substances may have adverse effects, and may become harmful. Therefore, ratios of each substance are very important for the formulation.

According to one embodiment of the present invention, the amount of Pelargonium sidoides in the composition is between 0.005% and 30.0% by weight or between 0.005% and 20.0% by weight or between 0.1 % and 15.0% by weight or between 0.2% and 10.0% by weight.

In this invention it is surprisingly found that, the specific amount of Luo Han Guo changes the taste balance of a food supplement. They are slower in onset and longer in duration than the sweet taste produced by sucrose. According to one embodiment of the present invention, the amount of Luo Han Guo in the composition is between 0.005% and 20.0% by weight or between 0.005% and 10.0% by weight or between 0.001% and 5.0% by weight or between 5.0% and 10.0% by weight.

According to one embodiment of the present invention, optionally, the food supplement further comprises a natural sweetener which is honey.

Honey is the natural product processed by honeybees from flower nectars or plant secretions, by the aid of their own secretions. Honey is a nutritious, sweet and healthy food, and minor components of honey include proteins (0.25-0.5%), organic acids, aminoacids, vitamins, flavonoids and water. The amount of water in honey is between 15.00% and 30.00% by weight.

Honey has been used for the treatment of microbial infections since ancient times. In recent years there has been a resurgence of interest in the therapeutic efficacy of honey. While it may naturally have a long shelf life, heating and cooling the spread too many times can cause it to lose its color and aroma. Shelf-life of honey depends on botanical origin as well as processing.

In one embodiment, the food supplement further comprises at least one extract which is selected from the group comprising hedera helix extract, zingiber officinale, propolis extract, echinacea purpurea, berberis vulgaris, panax ginseng (only for adult compositions), glycyrrhiza glabra or mixtures thereof. Moreover, the efficacy of the formulation is enhanced by the therapeutic effects of each herbal extract used here.

According to one embodiment of the present invention, the food supplement further comprises at least one extract which is glycyrrhiza glabra, berberis vulgaris, zingiber officinale or mixtures thereof.

According to one embodiment of the present invention, the food supplement comprises

• Pelargonium sidoides

• Luo Han Guo

• Glycyrrhiza glabra extract

According to one embodiment of the present invention, the food supplement comprises • Pelargonium sidoides

• Luo Han Guo

• Berberis vulgaris

• Pelargonium sidoides

• Luo Han Guo

• Zingiber officinale

• Pelargonium sidoides

• Luo Han Guo

• Glycyrrhiza glabra

• Berberis vulgaris

• Zingiber officinale

According to one embodiment of the present invention, the food supplement further comprises at least one extract which is propolis extract.

• Pelargonium sidoides

• Luo Han Guo

• Propolis extract

• Pelargonium sidoides

• Luo Han Guo

• Hedera helix

• Pelargonium sidoides

• Luo Han Guo

• Glycyrrhiza glabra extract

• Hedera helix

• Pelargonium sidoides

• Luo Han Guo • Hedera helix

• Propolis extract

• Pelargonium sidoides

• Luo Han Guo

• Glycyrrhiza glabra extract

• Hedera helix

• Propolis extract

Hedera helix (English Ivy) is one of the plant species used in the production of herbal products for the treatment and prevention of diseases, and/or for the alleviation and/or elimination of the symptoms thereof. Hedera helix, comprising saponins, phenol, and alkaloids, is known to be used for the treatment of cough, parasites, skin diseases, bronchitis, and chronic respiratory tract diseases. Various studies have been performed to demonstrate the effect of Hedera helix on said diseases. For instance, Erik van Wyk and Michael Wink stated in "Medicinal Plants of the World" that the expectorant action of Hedera Helix works by stimulating the "nervus vagus" in the stomach, causing a cough response. A study by S. Fazio et al. published in the January 2009 issue of "Phytomedicine" tested a dried leaf extract on 9657 patients with acute and chronic bronchitis, including children. Accordingly, it was observed that following one week, cough and chest pain disappeared or improved in 95% of patients.

Ginger (Zingiber officinale) is also called "warming herb" and used for a long time as an important medical herb. It comprises essential oils with ether comprising Zingiberene, Zingiberol, Gingerol and Shogol. The essential oils contained which are mixed with terpenoids give the special taste and scent of ginger. The bitter substances without essential oils which make the mouth feel warm are gingerol and zingeron.

Ginger has a wide area of usage. Ginger is preventive against cancer based on stopping the Epstein-barr virus activity. 6-gingerol and 6-paradol, among the active substances of ginger, are effective in stopping promyelocytic leucaemia by disturbing the DNA synthesis. It also has anti-inflammatory effect, is effective against arthritis and headache, and is bacteriostatic. It is used against nausea, spasm and fever in kids. Based on its antiseptic effect, it is used against stomach and intestine infections and even against food poisoning. It also prevents the coagulation of the blood and has blood thinning effect. It supports the cardiovascular system by making the platelets less adherent, this in turn causes a decrease in the problems of the circulation system. It is appetizing and can also be used against constipation. In addition to these, it has a warming and sedative effect in cough, flu, cold and other respiratory system diseases.

Propolis is one of the most important bee products. Besides its antibacterial, antifungal, antiviral features, a great number of beneficial biological activities such as anti-inflammatory, anti-ulcer, local anesthetic, anti-tumor and immunity stimulant properties popularizes its usage in medicine, apitherapy, health nutrition and biocosmetic fields. It comprises 150 chemical compounds, more than 20 mineral substances, beeswax, resin and pollen. In chemical terms, propolis comprises a wide variety of extremely complex and potent terpenes, benzoic acids, caffeic acids, cinnamic acids, and phenolic acids. It has a high flavonoid content.

Propolis is one of the most powerful antibiotics found in nature. It is rich in terms of amino acids and trace metals, has a very high vitamin content and contains at least 38 valuable bioflavonoids. It is an invaluable antioxidant based on its high bioflavonoid content. It was demonstrated to inactivate at least 21 bacteria species, 9 fungi species, 3 protozoa (including giardia), and a wide spectrum of viruses.

Echinacea purpurea, the purple coneflower, is a plant species widely used in the prophylaxis and/or treatment of infection, cold, cough, bronchitis, flu, in the treatment of infection of the urinary system, in the treatment of the sore throat and toothache, in boosting the immune system, and externally, in the treatment of snakebite, eczema, psoriazis, acne, wounds and burns. Echinacea purpurea is known to have immunostimulant, anti-inflammatory, antibacterial, antiviral, antifungal, anticancer, cicatrizant activities. The compounds accounting for these activities are thought to be polysaccharides, glycoproteins, alkylamides, and caffeic acid derivatives (cichoric acid, echinacoside). Echinacea purpurea supports the production of interferon, thereby strengthening the defense system of the respective organism. Interferon activates the natural killer cells and induces these cells to bind to and destroy infected cells or tumor bearing cells. Interferon is effective in releasing the enzymes destroying the genetic structure of viruses and inhibiting their reproductive and spreading capabilities.

Berberis vulgaris berries are edible and rich in vitamin C. Berberine is the main active alkaloid with a benzyl tetra hydroxy quinoline chemical structure which can be found in all part of berberis vulgaris especially in its fruit (barberry). It is odorless but with a bitter taste powder which is sparingly soluble in methanol, slightly soluble in ethanol and very slightly soluble in water.

Ginseng root is harvested after a cultivation period of 6 years and this part of the plant is used for therapeutic purposes. It comprises saponins (dammaran and oleanan derivatives; ginsenosites), polyacetylene derivatives and polysaccarides. The effects of Ginseng on the body are not local, and thus, one of the benefits of Ginseng is that it strengthens the entire body and helps in balancing entire body systems. Ginseng (Panax ginseng) is an antioxidant and an important immunity system improver which increases the number of immunity system cells in the body. It is useful in the treatment of bronchitis, asthma and circulation problems. According to a study conducted by American scientists, the flu risk of people who are administered 200mg ginseng root capsules twice a day reduced by 31%. In the laboratory and animal experiments, it is found that it is effective against prostate, stomach, kidney, liver, large intestine, brain and lung cancers. In the animals with prostate cancer, it prevented the development of cancer.

According to one embodiment of the present invention, ginseng is used only for adult compositions.

Glycyrrhiza glabra a native of Southeastern Europe and Middle East, besides being used extensively in confectionary is also particularly well known for its medicinal properties. The dried licorice roots find extensive use in treating coughs, consumption and chest complaints and bronchitis. In the traditional system of medicine, the roots and rhizomes of Glycyrrhiza glabra have been employed clinically for centuries for their anti-inflammatory, antiulcer, expectorant, antimicrobial and anxiolytic activities.

According to one embodiment of the present invention, the food supplement further comprises pharmaceutically acceptable excipients which are selected from the group comprising solvents, flavors, preservatives, acidulants, stabilizers or mixtures thereof.

Suitable solvents are selected from the group comprising propanol, water, ethanol, propylene glycol, 1 -butanol, 2-butanol, ethyl acetate, ethyl ether, heptane, pentane, 1-pentanol, 1- propanol, 2-propanol, methylene chloride, acetone, dichloromethane, n-hexane, dioxane or mixtures thereof.

Suitable flavors are selected from the group comprising eucalyptus, ammonium glycyrrhizinate, menthol, peppermint, cinnamon, chocolate, vanillin or fruit essences such as cherry, orange, strawberry, grape, black currant, raspberry, banana, red fruits, wild berries or mixtures thereof. According to one embodiment of the present invention, the flavor is eucalyptus, optionally, ammonium glycyrrhizinate can be used.

Eucalyptus species which have analgesic and anti-inflammatory activities are also widely used in modern cosmetics, food, and pharmaceutical industries. Since eucalyptus has antibacterial and antiseptic qualities, it has been shown to protect against microbial growth that can promote a host of different symptoms and diseases in the body. In this invention, one important reason that the inventors preferably use eucalyptus is that it creates a cooling and refreshing effect.

When eucalyptus is used as the flavoring agent, it is observed that it shows a supporting effect for said formulation due to the refreshing, cooling and smoothening effect of scent and the patients administered with said formulation feels instant relief and alleviation of symptoms, thus, it helped them feel better within a shorter period of time.

Suitable preservatives are selected from the group comprising sodium benzoate, potassium sorbate, methyl paraben, propyl paraben, benzyl alcohol, citric acid, benzoic acid, m-cresol, phenol or mixtures thereof.

According to one embodiment of the present invention, the preservative is sodium benzoate or potassium sorbate.

Suitable acidulants are selected from the group comprising citric acid monohydrate, sodium citrate dihydrate, sodium maleates, potassium maleate, calcium maleates, sodium adipate, potassium adipate, sodium fumarate, potassium fumarate, calcium fumarate, nicotinamide, triammonium citrate, ammonium iron citrate, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, ammonium carbonate, ammonium bicarbonate, magnesium carbonate, magnesium bicarbonate or mixtures thereof.

According to one embodiment of the present invention, the acidulant is citric acid monohydrate or sodium citrate dihydrate or mixtures thereof.

Suitable stabilizers are selected from the group comprising glycerol, sorbitol, fumaric acid, tartaric acid, sodium citrate, sodium dihydrogen phosphate, calcium carbonate, meglamine, ascorbic acid, gallic acid esters or the mixtures thereof.

According to one embodiment of the present invention, the stabilizer is glycerol or sorbitol or mixtures thereof. According to one embodiment of the present invention, the food supplement comprises pharmaceutically acceptable excipients which are selected from the group comprising propanol, water, ethanol, propylene glycol, eucalyptus, ammonium glycyrrhizinate, sodium benzoate, potassium sorbate, citric acid monohydrate, sodium citrate dihydrate, glycerol, sorbitol or mixtures thereof.

According to one embodiment of the present invention, the food supplement comprises luo han guo, pelargonium sidoides extract, eucalyptus, glycerol, sorbitol or mixtures thereof.

According to one embodiment of the present invention, the form of the food supplement is liquid or solid or semi-solid.

The food supplement of the present invention is formulated in a liquid formulation to be administered orally, said components are diluted in purified water. Example 1 : The liquid food supplement comprising natural sweetener

Example 2: The liquid food supplement comprising natural sweetener

Example 3: The liquid food supplement comprising natural sweetener

Example 4: The liquid food supplement comprising natural sweetener

Example 5: The liquid food supplement comprising natural sweetener

Example 6: The liquid food supplement comprising natural sweetener

Example 7: The liquid food supplement comprising natural sweetener

Example 8: The liquid food supplement comprising natural sweetener

Example 9: The liquid food supplement comprising natural sweetener

q.s.: quantity sufficient Example 10: The liquid food supplement comprising natural sweetener

q.s.: quantity sufficient Example 11 : The liquid food supplement comprising natural sweetener

q.s.: quantity sufficient Example 12: The liquid food supplement comprising natural sweetener

q.s.: quantity sufficient Example 13: The liquid food supplement comprising natural sweetener

q.s.: quantity sufficient One example of the process of the liquid food supplement

Dissolving Luo Han Guo extract with water,

- Adding sorbitol, glycerol, honey, then mixing,

- Adding other extracts and mixing,

- Adding preservatives and acidulants and then mixing, Adding flavors and then mixing,

Completing to the final volume.

Homogenizing the bulk product and sieving Filling the bottles and packaging appropriately.

Example 14: The solid food supplement comprising natural sweetener

Claims

1 . A food supplement comprising Pelargonium sidoides and Luo Han Guo as natural sweetener.

2. The food supplement according to claim 1 , wherein the amount of Pelargonium sidoides in the composition is between 0.005% and 30.0% by weight.

3. The food supplement according to claim 1 , wherein the amount of Luo Han Guo in the composition is between 0.005% and 20.0% by weight.

4. The food supplement according to claim 1 , wherein further comprises a natural sweetener which is honey.

5. The food supplement according to claim 1 , further comprising at least one extract which is selected from the group comprising hedera helix extract, zingiber officinale, propolis extract, echinacea purpurea, berberis vulgaris, panax ginseng, glycyrrhiza glabra or mixtures thereof.

6. The food supplement according to claim 1 or 5, wherein at least one extract is glycyrrhiza glabra, berberis vulgaris, zingiber officinale or mixtures thereof.

7. The food supplement according to claim 1 or 5, wherein at least one extract is hedera helix extract.

8. The food supplement according to claim 1 or 5, wherein at least one extract is propolis extract.

9. The food supplement according to claim 1 , further comprising pharmaceutically acceptable excipients which are selected from the group comprising solvents, flavors, preservatives, acidulants, stabilizers or mixtures thereof.

10. The food supplement according to claim 9, wherein the pharmaceutically acceptable excipient is propanol, water, ethanol, propylene glycol, eucalyptus, ammonium glycyrrhizinate, sodium benzoate, potassium sorbate, citric acid monohydrate, sodium citrate dihydrate, glycerol, sorbitol or mixtures thereof.

11. The food supplement according to claim 10 wherein the pharmaceutically acceptable excipient is eucalyptus, glycerol, sorbitol or mixtures thereof.

12. The food supplement according to claim 1 , wherein the form of the composition is liquid or solid or semi-solid.

13. The food supplement according to claim 12, wherein the form of the composition is liquid.