WO2019209228A2

WO2019209228A2 - Solid oral compositions comprising dried honey and herbal extracts

Info

Publication number: WO2019209228A2
Application number: PCT/TR2018/050926
Authority: WO
Inventors: Ali TÜRKYILMAZ; Gülay Yelken; Mustafa MARASLI
Original assignee: Montero Gida Sanayi Ve Ticaret Anonim Sirketi
Priority date: 2017-12-29
Filing date: 2018-12-28
Publication date: 2019-10-31
Also published as: TR201722982A1; WO2019209228A3

Abstract

The present invention relates to a herbal composition comprising dried honey and at least one herbal extract for providing treatment in various respiratory diseases such as cold, cough, allergic asthma, seasonal allergic rhinitis, bronchitis, pharyngitis, laryngitis and pneumonitis.

Description

SOLID ORAL COMPOSITIONS COMPRISING DRIED HONEY AND HERBAL

EXTRACTS

Technical Field

Background of the Invention

Honey is the natural product processed by honeybees from flower nectars or plant secretions, by 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 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 colour and aroma. Shelf-life of honey depends on botanical origin as well as processing.

TR2014/02396B relates to process for producing solid honey which has water in an amount less than 1.00% by weight.

EP2387329B1 relates to a honey product comprising honey having a low moisture content.

Honey is an excellent source of easily digestible sugars. It is largely composed of glucose and fructose, monosaccharides that are rapidly absorbed and metabolized by the organism. It also contains volatile components which makes it a very palatable ingredient. Honey may contain enzymes, pollen and propolis which have been recognized as having excellent health benefits. 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 the human history, there have been and still are attempts for treating many diseases (diabetes, jaundice, dyspnea, etc.) by using some herbs. According to the records of the World Heath 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.).

Particularly following the end of the 1990s, the discovery of new areas of use for medical and aromatic herbs and the increasing demand for natural products have increased the use potential thereof day by day.

Herbal medical products have long been in use for the treatment or prophylaxis of respiratory diseases. In the treatment or prophylaxis of these diseases which are typically caused by viruses, bacteria, and/or fungi, it is quite significant both to eradicate these harmful organisms and to boost the immune system of the affected individual. This is because the immune system is comprised of processes providing protection against diseases, as well as recognizing and eliminating the pathogenic and tumor cells in a living being. The system scans the organism against any kind of foreign substances, entering or contacting the former, from viruses to parasitic worms of a wide variety, and distinguishes them from the organism's own healthy cells and tissues. The immune system can even distinguish substances with very similar features from each other to such an extent that even proteins having a different amino acid can be distinguished from the equivalents thereof. The function of the immune system is primarily to prevent harmful foreign substances from entering the respective organism, or upon entry, to retain the substances at the place of entry, or to prevent or delay their spreading therein.

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.

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.

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.

In the studies, a lot of advantages of propolis for health are demonstrated. Some of these studies are: 1 ) A clinical study conducted in Spain in 1988 on 138 individuals has shown that the usage of a propolis based supplement is as effective as the usage of antiprotozoal drug tinidazole which is extensively used in the treatment of infections caused by giardiasis parasite. 2) A study published in Nutrition and Cancer in 2003 has shown that propolis has revitalized apoptosis and provided the tissue decomposition of the lung cancer tumors in mouse. 3) According to National Institutes of Health, propolis may be used as an effective anti-inflammatory agent against aphtha and other gingiva wounds and peptic ulcer. 4) Blue Shield Complementary and Alternative Health has reported that propolis is two times more effective than acyclovir which is the conventional anti-viral drug in herpes treatment. 5) According to a study published in American Journal of Biochemistry and Biotechnology on February 2004, propolis kills the human breast cancer cells called MCF-7. 13% of the cancer cells of the participants were killed only within 24 hours following the administration of propolis extract.

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 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.

Berberis vulgaris berries are edible and rich in vitamin C. 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 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.

Products to be used for medical purposes have to incorporate the elements of quality, efficiency, and reliability. A product can be a "medical" product only by having these elements. In order for a product prepared from a herbal source to be a medical product, it has to be prepared from an efficient and standardized extract, to have established pharmacological, clinical outcomes and toxicological data, and a determined stability. Therefore, it bears great significance to have a good stability for a product, produced from herbal sources, to be used in the treatment and prevention of diseases, or in the alleviation and/or elimination of the symptoms thereof.

Physical, chemical, and microbiological factors play role in the stability of medicaments or other products prepared for medical purposes. The stability issue is not dependent on a simple cause only but emerges as a result of many factors. Factors such as the interaction of active agents contained in a product, the interaction of excipients among themselves or with active agents, pH, light, humidity, and temperature are among many elements which may influence the stability of such products.

Until recently, the researchers deemed considerable importance on the chemical stability of pharmaceutical products rather than the physical stability thereof and conducted many studies accordingly. In many instances, however, they could show how important the changes in the physical structures of products are for the product quality, and for the durability of the technologic, microbiologic, and biopharmaceutical properties thereof. Accordingly, it was shown that primarily the physical stability of a product has to be maintained in order to sustain its quality and other features thereof, and therefore ensuring the physical stability during the development of pharmaceutical products is as important as, or sometimes more important than ensuring the chemical stability thereof.

Additionally, the physical properties taken into account in the evaluation of the physical stability of a product, particularly the taste, scent, color, clarity, uniformity, etc. of a product, also considerably influence the patient compliance. For this reason, when a novel composition is developed, besides aiming a composition of good physical stability, the physical properties of this composition should be made ideal to provide high patient compliance.

However, it is quite difficult to provide the above described conditions in the composition comprising herbal substances. Due to some characteristic chemical, biological and physical properties of the herbal substances used in the composition, some problems are encountered in obtaining a composition comprising said substances as well as having a good physical stability and ideal physical properties in terms of patient compliance.

The physical properties and the physical stability of a composition are influenced directly from the characteristic properties of herbal agents contained therein. Some aspects of herbal agents contained in a composition, such as having a bad taste, a bad scent, a bad color and similar physical properties, becoming easily oxidized, and providing a suitable medium for the reproduction of microorganisms negatively influence the physical properties and physical stability of that composition. Additionally, in case a composition comprises a combination of herbal agents, a correct selection of the herbal agents bears great importance, since more than one herbal agent present in the same composition are capable to mutually affect their respective properties.

Even if there are composition comprising herbal extracts and honey in prior art, it would be desirable to provide a new composition, as well as a process for the preparation of this composition, comprising combinations of herbal agents, being capable to retain the physical stability for a long time, and having ideal physical properties in terms of patient compliance for the treatment of respiratory diseases. In detail, there is a need in the state of art for a composition comprising dried honey and herbal extracts, and having ideal physical properties to ensure high patient compliance and good physical stability, as well as to a method for preparing this composition, which is simple, cost-efficient and time-saving. In this invention, using honey in solidified form also increases the stability of the composition.

Object of the Invention

The main object of the present invention is to obtain solid oral compositions comprising dried honey and at least one herbal extract.

Another object of the present invention is to obtain solid oral compositions for providing treatment in various respiratory diseases such as cold, cough, allergic asthma, seasonal allergic rhinitis, bronchitis, pharyngitis, laryngitis and pneumonitis.

Yet another object of the present invention is to develop solid oral compositions which is capable of providing an easy administration accompanied by an increased patient compliance and convenience.

Another object of the present invention is to provide solid oral compositions wherein a significantly improved stability, as well as the excellent long-term stability is shown.

Another object of the present invention is to provide compositions which have increased quality, reliability, and shelf life as a result of an improved physical stability.

Detailed Description of the Invention

In order to achieve the aforementioned objects, the present invention discloses a novel, stable, bioavailable, oral compositions for the oral administration of herbal extracts as the active ingredient comprising dried honey.

The maintenance of the physical stability of a pharmaceutical product can be ensured if no change occurs in the physical structure of that product. Therefore, whether the physical stability is maintained or not is assessed by determining changes in various physical properties of the product during composition development process. Properties such as the color, scent, taste, pH, clarity, viscosity, homogeneity, density are among the physical properties of a pharmaceutical are the basic physical properties playing role in the assessment of the physical stability thereof.

In the physical stability studies conducted during the development of a composition comprising herbal extract for use in medicine, it was surprisingly found that adding dried honey into the composition, improved the physical stability of the product, and thus, the physical properties such as the color, scent, taste, pH, clarity, viscosity, uniformity, and the density thereof at the time the composition was prepared were maintained for a longer time such that the physical stability was maintained as well.

In this invention, the solid oral compositions comprise dried honey and at least one herbal extract.

According to this invention, the amount of dried honey is between 25.00% and 99.00%, preferably between 50.00% and 99.00%, more preferably between 75.00% and 99.00% by weight of the total composition.

When dried honey is used in especially these amounts, it is observed that the patient compliance is improved due to the pleasant taste of dried honey.

In one embodiment, the amount of the total herbal extracts is between 0.02% and 25.00%, preferably between 0.50% and 10.00%, more preferably between 1 .00% and 1.50% by weight of the total composition.

In one embodiment, the weight ratio of the total herbal extracts to the dried honey between 0.002 and 1 .00, preferably between 0.005 and 0.05.

When the herbal extracts and dried honey were used at a specific weight ratio in the composition according to the present invention, i.e. when the weight ratio of the total herbal extracts to the dried honey was between 0.002 and 1.00, it was surprisingly observed that this had a synergistic effect on the physical stability of said composition. Thus, by providing an improved physical stability; the quality, reliability, and the shelf life of the composition according to the present invention are increased.

All plant extracts comprised in the content of the composition within the scope of the present invention can be obtained from the shell, leaf, flower, root or seed of respective plants. Prior art methods are used for obtaining all the extracts according to the present invention.

In one embodiment, the composition is in the form of lozenge, tablets, capsules, effervescent tablets, effervescent sachets, orally disintegrating tablets, sublingual tablets, buccal tablets.

According to this embodimnet, the composition is in the form of lozenge.

In another embodiment, the composition is maintained in contact with the mouth and/or throat for a sufficient length of time that reduction of the severity or presence of one or more symptoms of the cold is achieved. The lozenges of this invention may be of any shape.

In another embodiment, the composition is maintained in contact with the mouth and/or throat for a sufficient length of time that infection by cold viruses is prevented.

According to these embodiments, the herbal extract is selected from the group comprising pelargonium sidoides, ginseng, berberis vulgaris, glycyrrhiza glabra, echinacea purpurea, tilia, zingiber officinale, citrus junos (yuzu), licorice, hedera helix, ginkgo biloba, turmeric, capsicum, sage, rosemary, maca, rhodiola or combinations thereof.

According to this embodiment, the herbal extract is preferably selected from pelargonium sidoides, ginseng, berberis vulgaris, glycyrrhiza glabra, echinacea purpurea, tilia, zingiber officinale, citrus junos (yuzu) or combinations thereof.

Since the stability and therapeutic effectiveness of the composition is influenced by the choice of the herbal extracts, the herbal extracts which are used in this invention, are very important. Furthermore, the therapeutic effectiveness of the composition is increased by the selection of the herbal extracts which are preferred herein.

In one preferred embodiment, herbal extracts are pelargonium sidoides, ginseng, berberis vulgaris, glycyrrhiza glabra, echinacea purpurea, tilia and zingiber officinale.

In one preferred embodiment, the composition further comprises propolis extract.

According to this embodiment, the amount of propolis extract is between 0.005% and 10.00%, preferably between 0.01 % and 5.00%, more preferably 0.01% and 1.00% by weight of the total composition. The efficacy of the composition is enhanced by the therapeutic properties of propolis extract.

In one preferred embodiment, the herbal extract is pelargonium sidoides.

According to this preferred embodiment, the amount of pelargonium sidoides is between 0.10% and 10.00%, preferably between 0.20% and 5.00%, more preferably between 0.20% and 2.00% by weight of the total composition.

In one preferred embodiment, the herbal extract is glycyrrhiza glabra.

According to this preferred embodiment, the amount of glycyrrhiza glabra is between 0.01 % and 10.00%, preferably between 0.05% and 5.00%, more preferably between 0.05% and 0.50% by weight of the total composition.

In one preferred embodiment, the herbal extract is echinacea purpurea.

According to this preferred embodiment, the amount of echinacea purpurea extract is between 0.01 % and 10.00%, preferably between 0.05% and 5.00%, more preferably between 0.05% and 0.50% by weight of the total composition.

In one preferred embodiment, the herbal extract is tilia.

According to this preferred embodiment, the amount of tilia extract is between 0.01% and 10.00%, preferably between 0.05% and 5.00%, more preferably between 0.05% and 0.50% by weight of the total composition.

In one preferred embodiment, the herbal extract is zingiber officinale.

According to this preferred embodiment, the amount of zingiber officinale is between 0.005% and 10.00%, preferably between 0.01% and 5.00%, more preferably between 0.01 % and 1.00% by weight of the total composition.

In one preferred embodiment, the herbal extract is berberis vulgaris.

According to this preferred embodiment, the amount of berberis vulgaris is between 0.005% and 10.00%, preferably between 0.01% and 5.00%, more preferably between 0.01 % and 0.50% by weight of the total composition.

Here, it was found that when the above indicated amounts of herbal extracts were added to a composition according to the present invention, the need to include a preservative in said composition was avoided due to the characteristic features of these extracts, particularly the antibacterial, antiviral, and/or antioxidative features of the same. Thus, when a composition according to the present invention contains the above indicated amounts of herbal extracts, the physical stability thereof can be maintained for a longer time without containing a preservative and a more natural composition can be obtained as compared to the composition comprising a preservative.

In one embodiment, the composition further comprises zinc sulfate monohydrate.

Zinc is used for treating the common cold and recurrent ear infections, and preventing lower respiratory infections. It can also help shorten the length of colds.

In one embodiment, the composition may further comprises silver solution.

Silver solution is used in the treatment and alleviation of the symptoms of cold.

Flavouring agent used according to the present invention is selected from the group comprising but not limited to, eucalyptus, menthol, peppermint, lime, apple, cinnamon, chocolate, vanillin and fruit essences such as cherry, orange, strawberry, grape, tutti frutti.

In one preferred embodiment, the flavouring agent is eucalyptus.

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

According to an embodiment of the present invention, said solid oral composition comprises; a) dried honey

b) at least one herbal extract According to an embodiment of the present invention, said solid oral composition comprises;

a) dried honey in an amount of between 25.00% and 99.00%,

b) propolis extract in an amount of between 0.005% and 10.00%, by weight of total composition.

According to an embodiment of the present invention, said solid oral composition comprises;

a) dried honey

b) propolis extract

c) at least one herbal extract

According to an embodiment of the present invention, said solid oral composition comprises

a) dried honey in an amount of between 25.00% and 99.00%,

b) propolis extract in an amount of between 0.005% and 10.00%,

c) pelargonium sidoides in an amount of between 0.10% and 10.00%, by weight of total composition.

b) at least one herbal extract

c) zinc sulfate monohydrate

d) eucalyptus

b) at least one herbal extract extract which are selected from the group comprising pelargonium sidoides, ginseng, glycyrrhiza glabra, echinacea purpurea, tilia, zingiber officinale, berberis vulgaris, citrus junos (yuzu) According to an embodiment of the present invention, said solid oral composition comprises;

a) dried honey

b) at least one herbal extract which are selected from the group comprising pelargonium sidoides, ginseng, glycyrrhiza glabra, echinacea purpurea, tilia, zingiber officinale, berberis vulgaris, citrus junos (yuzu)

c) propolis extract

d) zinc sulfate monohydrate

e) eucalyptus

a) dried honey

c) propolis extract

d) zinc sulfate monohydrate

e) silver solution (optionally)

f) eucalyptus

According to one embodiment of the present invention, said solid oral composition comprises:

a. dried honey 25.00-99.00%

b. pelargonium sidoides extract 0.10-10.00%

c. glycyrrhiza glabra extract 0.01 -10.00%

d. echinacea purpurea extract 0.01 -10.00%

e. ginseng extract 0.01 -10.00%

f. tilia extract 0.01 -10.00%

g. zingiber officinale extract 0.005-10.00%

h. propolis extract 0.005-10.00%

i. berberis vulgaris extract 0.005-10.00%

j. zinc sulfate monohydrate 0.05-5.00%

k. eucalyptus 0.05-5.00 According to one embodiment of the present invention, said solid oral composition comprises:

a. dried honey 25.00-99.00%

b. pelargonium sidoides extract 0.10-10.00%

c. glycyrrhiza glabra extract 0.01 -10.00%

d. echinacea purpurea extract 0.01 -10.00%

e. panax ginseng extract 0.01 -10.00%

f. tilia extract 0.01 -10.00%

g. zingiber officinale extract 0.005-10.00%

h. propolis extract 0.005-10.00%

i. berberis vulgaris extract 0.005-10.00%

j. citrus junos extract.05-10.00%

k. zinc sulfate monohydrate 0.05-5.00%

L. silver solution 0-0.50%

m. eucalyptus 0.05-5.00%

Example 1 : Lozenge

Example 2: Lozenge

Example 3: Lozenge

Example 4: Lozenge

Example 5: Lozenge

Example 6: Lozenge

The solid oral compositions mentioned above can be prepared by following these steps: a. Preparing dried honey by a physical method in which microwave or heat is used b. Weighing each herbal extract, zinc sulfate monohydrate, silver solution and

eucalyptus

c. Adding all ingredients to the dried honey and mixing

d. Transfering the mixture to the feed reservoir

e. Filling the mixture to the moulding machine to form lozenges

f. Cooling the lozenges

g. Packing the lozenges into suitable packaging In one embodiment, the solid oral composition further comprises one lubricant. According to this embodiment, the solid oral composition can be prepared by following these steps: a. Mixing all ingredients

b. Adding a lubricant to this mixture

c. Compressing this mixture to form lozenges

Claims

1. A solid oral composition comprising dried honey and at least one herbal extract.

2. The solid oral composition according to claim 1 , wherein the amount of dried honey is between 25.00% and 99.00% by weight of the total composition.

3. The solid oral composition according to claim 1 , wherein the amount of the total herbal extracts is between 0.02% and 25.00% by weight of the total composition.

4. The solid oral composition according to claim 3, wherein the the weight ratio of the total herbal extracts to the dried honey is between 0.002 and 1.00, preferably between 0.005 and 0.05.

5. The solid oral composition according to claim 4, wherein the composition is in the form of lozenge, tablets, capsules, effervescent tablets, effervescent sachets, orally disintegrating tablets, sublingual tablets, buccal tablets.

6. The solid oral composition according to claim 5, wherein the composition is in the form of lozenge.

7. The solid oral composition according to claim 1 , wherein the herbal extract is selected from the group comprising pelargonium sidoides, ginseng, berberis vulgaris, glycyrrhiza glabra, echinacea purpurea, tilia, zingiber officinale, citrus junos, licorice, hedera helix, ginkgo biloba, turmeric, capsicum, sage, rosemary, maca, rhodiola or combinations thereof.

8. The solid oral composition according to claim 7, wherein the herbal extract is preferably selected from pelargonium sidoides, ginseng, berberis vulgaris, glycyrrhiza glabra, echinacea purpurea, tilia, zingiber officinale, citrus junos or combinations thereof.

9. The solid oral composition according to claim 1 , wherein the composition further comprising propolis extract.

10. The solid oral composition according to claim 9, wherein the amount of propolis extract is between 0.005% and 10.00%, preferably between 0.01 % and 5.00%, more preferably 0.01% and 1.00% by weight of the total composition.

1 1. The solid oral composition according to any preceding claims, comprising a. dried honey in an amount of between 25.00% and 99.00%, b. propolis extract in an amount of between 0.005% and 10.00%, by weight of total composition.

12. The solid oral composition according to claim 8, wherein the herbal extract is pelargonium sidoides.

13. The solid oral composition according to claim 12, wherein the amount of pelargonium sidoides is between 0.10% and 10.00%, preferably between 0.20% and 5.00%, more preferably between 0.20% and 2.00% by weight of the total composition.

14. The solid oral composition according to claim 13, comprising a. dried honey in an amount of between 25.00% and 99.00%, b. propolis extract in an amount of between 0.005% and 10.00%, c. pelargonium sidoides in an amount of between 0.10% and 10.00%, by weight of total composition.

15. The solid oral composition according to claim 8, wherein the herbal extract is glycyrrhiza glabra.

16. The solid oral composition according to claim 8, wherein the herbal extract is zingiber officinale.

17. The solid oral composition according to claim 8, wherein the herbal extract is echinacea purpurea.

18. The solid oral composition according to claim 8, wherein the herbal extract is tilia.

19. The solid oral composition according to claim 8, wherein the herbal extract is berberis vulgaris.

20. The solid oral composition according to claim 1 , wherein the composition further comprising zinc sulfate monohydrate.

21. The solid oral composition according to claim 1 , wherein the composition further comprising one flavouring agent which is selected from a group comprising eucalyptus, menthol, peppermint, lime, apple, cinnamon, chocolate, vanillin and fruit essences such as cherry, orange, strawberry, grape, tutti frutti.

22. The solid oral composition according to claim 21 , wherein the flavouring agent is eucalyptus.

23. The solid oral compositin according to any of the preceding claims, wherein the composition comprising; a. dried honey 25.00-99.00%

b. pelargonium sidoides extract 0.10-10.00%

c. glycyrrhiza glabra extract 0.01 -10.00%

d. echinacea purpurea extract 0.01 -10.00%

e. ginseng extract 0.01 -10.00%

f. tilia extract 0.01 -10.00%

g. zingiber officinale extract 0.005-10.00%

h. propolis extract 0.005-10.00%

i. berberis vulgaris extract 0.005-10.00%

j. zinc sulfate monohydrate 0.05-5.00%

k. eucalyptus 0.05-5.00%

24. The solid oral compositin according to any of the preceding claims, wherein the composition comprising; a. dried honey 25.00-99.00%

b. pelargonium sidoides extract 0.10-10.00%

c. glycyrrhiza glabra extract 0.01 -10.00%

d. echinacea purpurea extract 0.01 -10.00%

e. panax ginseng extract 0.01 -10.00%

f. tilia extract 0.01 -10.00%

g. zingiber officinale extract 0.005-10.00%

h. propolis extract 0.005-10.00%

i. berberis vulgaris extract 0.005-10.00%

j. citrus junos extract 0.05-10.00%

k. zinc sulfate monohydrate 0.05-5.00%

L. silver solution 0-0.50%

m. eucalyptus 0.05-5.00%