WO2021084058A1

WO2021084058A1 - Composition for the prevention and treatment of diseases of the respiratory system

Info

Publication number: WO2021084058A1
Application number: PCT/EP2020/080488
Authority: WO
Inventors: Umberto DI MAIO
Original assignee: Neilos S.r.l.
Priority date: 2019-10-31
Filing date: 2020-10-30
Publication date: 2021-05-06
Also published as: EP4051300A1; IT201900020154A1

Abstract

A composition is described which includes a synergistic combination of snail extract and Karaya gum for the prevention and / or treatment of respiratory tract diseases.

Description

"Composition for the prevention and treatment of diseases of the respiratory system"

DESCRIPTION

The present invention relates to a composition comprising an association of a snail extract and Karaya gum useful for the prevention and treatment of diseases of the respiratory system. The composition is particularly effective thanks to the synergistic action of its components.

Background of the invention

RESPIRATORY SYSTEM AND RESPIRATORY PATHOLOGIES

The respiratory system is made up of different anatomical structures that serve its correct function.

It is, in fact, responsible for the exchange of gas, oxygen and carbon dioxide, between the tissues and the external environment which is fundamental for all cellular processes of the body.

Anatomically, two macro areas are distinguished which are the upper and lower airways. The former are made up of the nose, pharynx and associated structures, while the latter are made up of the larynx, trachea, bronchi and lungs, whose real respiratory surface is made up of the alveoli. This complex system of organs serves to prepare the air for its entry into the lungs, by filtering any particulate matter, heating and humidification. Particles larger than 10-15 microns can be blocked at the level of the nasal cavities, thanks to the whiskers and the presence of mucus that traps these particles in addition to the precipitation by turbulence, mediated by the turbinates that divert the direction of the air. The mucus stratifies above the peri-ciliary fluid, in which the vibrating cilia of the cells of the epithelium are immersed. Particles of about 10 microns arrive in the trachea, are trapped in the mucus and then eliminated by the ciliary movement. Particles of 2-5 microns settle in the terminal bronchioles by gravitational precipitation, while those smaller than 2 microns are removed by the alveolar macrophages and removed from the pulmonary lymphatic system.

The entire respiratory tract is made up of epithelial cells that differ in type and function along the tracheobronchial tree. Columnar ciliated cells characterize the airways from the trachea to the terminal bronchioles. From their apical surface the cilia protrude having the task of moving with a cleaning effect on the mucus and on any inhaled particles. The mucous goblet cells are responsible for the secretion of mucus, which is useful for maintaining the correct humidity of the epithelium and for trapping particulate matter. They are present in the broader tracts of the airways below the small bronchi but have not been found in the bronchioles.

All components of the respiratory system can be exposed to a series of diseases, of different etiology, often supported by different pathogenic microorganisms which, becoming predominant in the microenvironment and on the flora normally present, determine the disease and, consequently, lead to a reduced functionality. EXAMPLES OF AFFECTIONS OF THE RESPIRATORY TRACT Depending on the area of the respiratory system concerned, different pathological conditions can be distinguished characterized by inflammation due to viruses, bacteria or fungi.

Cough

One of the main symptoms in respiratory diseases is cough.

From a physiological point of view, the cough reflex in itself is an important defense capable of promoting the elimination from the respiratory tract of particulate matter that could contain allergens or pathogenic microorganisms. Under normal conditions, cough plays a primary role in protecting the airways and lung parenchyma.

When this process increases in frequency and intensity due to various factors, it no longer plays a beneficial role and becomes one of the symptoms that require medical consultation for patients.

Cough is commonly classified into acute, subacute and chronic cough.

In the first case the duration is up to 3 weeks and in most patients, it is due to upper respiratory tract infections, acute bronchitis or tracheobronchitis due to bacterial or viral infections. This type of cough usually passes within a couple of weeks along with the complete resolution of the infection.

Subacute cough is characterized by a duration of between 3 and 8 weeks and is generally related to specific infections (such as M. pneumoniae) where a greater response at the bronchial level can persist for longer even after the infection has resolved.

Chronic and persistent cough, on the other hand, is usually due to other types of causes such as cigarette smoking, the use of ACE inhibitors, asthma, gastroesophageal reflux disease and cystic fibrosis. There are several pharmacological treatments to relieve cough such as codeine or dextromethorphan which act centrally by inhibiting the cough center, N-acetylcysteine which acts as a mucolytic by increasing the smoothness and therefore the elimination of mucus, anticholinergic drugs such as tiotropium and ipatropium which are taken by inhalation and inhibit bronchoconstriction and mucus hypersecretion by antagonizing the binding of acetylcholine to muscarinic receptors in the lung.

Pharmacological treatment must be well thought out and evaluated based primarily on the cause that led to the appearance of the cough as well as on the severity and persistence of the symptom. However, all pharmacological treatments, especially if used for prolonged periods, can cause side effects of varying degrees and importance that reduce patient compliance.

Rhinitis, allergic rhinitis and nasopharyngitis (cold)

Rhinitis is an inflammatory process that affects the mucous membrane of the nasal cavities and is divided into acute and chronic. Acute rhinitis is generally supported by viruses, including Rhinovirus, Coronavirus, influenza and parainfluenza viruses, RSV, Coxsackie virus, ECHO virus, and adenovirus. Contagion occurs by direct contact with the sick subject who, in the peak of maximum contagiousness (generally the first day), has 500-1000 virions per ml of secretion, which he emits through coughing and sneezing. Bacterial superinfections are possible leading to complications such as ear infections and sinusitis. The common Rhinovirus cold causes acute symptoms in the first 3-4 days, while cough and other symptoms persist for 7-10 days. There is an excess of mucous secretions which are fluid and transparent, and become purulent and foul-smelling in the case of bacterial overlap.

The chronic form is generally secondary to sinusitis, deviations of the nasal septum and hypertrophic adenoids.

Allergic rhinitis is due to the subject's exposure to substances that cause a mediated IgE reaction, characterized by excessive production of fluids, intranasal itching, sneezing and obstruction. In fact, IgE binds to mast cells which release large quantities of histamine, responsible for all the morbid manifestations.

Recent studies have shown that allergic rhinitis and asthma are concurrent and to be considered as two manifestations of the entire respiratory tract, rather than placing them one in the upper tract and the other in the lower tract of the respiratory tree. In fact, it appears that between 20% and 50% of patients with allergic rhinitis also have asthma and that 30% to 90% of patients with asthma have concomitant rhinitis. Therefore, allergic rhinitis could be a predisposing factor for the development of allergic asthma and, specifically, sensitization to aeroallergens (pollen or animal hair) would seem an important risk factor in the association of asthma and rhinitis.

The common cold, on the other hand, is known as nasopharyngitis, an inflammation of the mucous membranes of the nose and pharynx that may be due to flu or parainfluenza viruses or cold viruses such as adenoviruses. Cold can also be a trigger of the disease as it reduces the effectiveness of immune processes.

Sinusitis

Sinusitis is inflammation of the mucous membrane that lines the paranasal sinuses, bony cavities located in the facial massif that are in communication with the nasal cavities and, therefore, can become infected for the same causes that cause rhinitis. Sinusitis can be divided into acute viral or bacterial (up to 4 weeks), chronic (over 12 weeks) and recurrent acute (at least 4 episodes per year with resolution).

When sinusitis involves the nasal cavity, it is called rhinosinusitis. Generally, a healthy nasal sinus is sterile, characterized by appropriate drainage of mucus and free passage of air. Ciliary abnormality or immobility result in inhibition of drainage resulting in sinusitis. Predisposing factors for this pathology are an immunocompromised state, deviation of the nasal septum, nasal polyps, tumors, trauma and fractures, cocaine abuse and the presence of foreign bodies.

An acute viral form can be prone to bacterial superinfection. The bacteria commonly responsible for these infections are Streptococcus pneumoniae, non-typable Haemophilus influenzae, Moraxella catarrhalis. Pseudomonas aeruginosa is most frequently present in sinus infections from HIV and cystic fibrosis. Some genera of fungi such as Candida, Aspergillus, Blastomyces, Coccidioides, Rhizopus, Histoplasma and Cryptococcus can cause sinusitis in immunocompromised patients. The signs and symptoms of acute rhinosinusitis consist of: mucopurulent discharge from the nose, nasal obstruction, congestion, facial pain, pressure in the sinuses involved, hyposmia, anosmia, fever, feeling of pressure or “plug” in the ears, pain in the teeth.

Generally, in the first 3-5 days it is not possible to distinguish a viral form from a bacterial one, so the use of antibiotics is not recommended. If the disease persists beyond 10 days then it will most likely be supported by bacteria and antibiotic treatment is indicated. Chronic forms have a slower onset, longer duration and frequency. Symptoms are similar to those of the acute form with, in addition, bad breath, laryngitis, bronchitis and worsening of asthma.

Sinusitis often resolves spontaneously and the treatment is predominantly symptomatic. In particular, the decongestant treatment serves to reduce edema, improve the drainage of excess mucus and maintain the patency of the sinus ostia. A good result can be obtained from the local application of hypertonic saline solution both in the treatment of the acute bacterial form and in the acute recurrent one and in the chronic one and also in prevention.

The choice of antibiotics must take into account the production of beta lactamase and the presence of drug-resistant pneumococci.

Pharyngitis (pharynqotonsillitis)

It is an inflammatory process of the pharynx, hypopharynx, uvula and tonsils, which is generally transmitted by direct contact with respiratory secretions. It is more frequent in pediatric age (5-15 years) and, although it is frequently self-limiting, the swelling of the parts involved can cause a reduced patency of the airways or in any case preclude the ingestion of adequate amounts of fluids with consequent dehydration.

Infection can be caused by viruses (such as Epstein-Barr) and bacteria, in particular group A beta-haemolytic Streptococcus pyogenes is the most frequent in pediatric forms, but Mycoplasma pneumoniae and Chlamydia pneumoniae are also found in adults and children. The forms transmitted by sexual contact and sustained by Neisseria gonorrhoeae and those by Corynebacterium dyphtheriae (form reduced by the use of the vaccine) must also be considered.

Epiglottitis

It is an inflammation of the epiglottis, resulting from a viral or bacterial infection, which causes swelling of the organ with possible obstruction of the airways.

It is mainly caused by H. influenzae type b, but also by streptococci, staphylococci or thermal trauma. It is manifested by pain in the ears (in adults), dysphonia, while fever is absent in up to 50% of cases and can develop in a late stage. T reatment is antibiotic when bacteria are the cause of the disease, while intubation may be required in the case of severe airway obstruction.

Laryngitis

Inflammation of the larynx manifesting as aphonia and hoarseness, mainly caused by viruses, but up to 10% of cases also by bacteria (including streptococci and C. dyphtheriae). Non-infectious causes can be tumors, thermal or caustic trauma, and gastroesophageal reflux disease (GERD). Laryngitis has symptoms that last 3-4 days and, unless bacteria are present, no antibiotics are used.

Bronchitis

Bronchitis is a frequent inflammation of the bronchi which manifests itself as cough, shortness of breath, and chest pain. Bronchitis is divided into acute and chronic. In the first case, the cough lasts about three weeks and is caused in 90% of cases by a viral infection that can occur as a result of contagion with other infected people. Predisposing risk factors can be cigarette smoke or other sources of environmental pollution. Chronic bronchitis is characterized by coughing for three months a year for at least two episodes a year and cigarette smoking together with other genetic or environmental causes are the main triggers. As a rule, except in special cases, no antibiotics are used but steroid anti-inflammatory drugs, paracetamol to compensate for a possible increase in temperature and bronchodilators such as salbutamol to improve breathing.

It has now been surprisingly found that a combination of snail extract and Karaya gum is particularly effective in the prevention and / or treatment of respiratory tract diseases thanks to the synergistic action of its components.

Detailed description of the invention

Therefore, the subject of the present invention is a composition comprising an association of snail extract and Karaya gum for the prevention or treatment of respiratory diseases.

The components of the association according to the present invention are all known components, widely used in therapy.

SNAIL EXTRACT

The slug, or snail, is an animal belonging to the family of Molluscs, Class of Gastropods (in Greek, gaster = belly, pus = foot). This mollusk moves by means of an expanded foot, on which the entire body rests and which represents its only locomotor structure.

The snail has an external shell (limacella) (element having a protective function and useful to distinguish the various species) in the shape of a spiral, hence the name "Helix".

Over the years, the consumption of snails in the gastronomic and commercial sectors has increased in various areas, including those related to health. The Helix genus is the one of greatest gastronomic and commercial interest. The main farmed species are: Helix Aspersa Muller, Helix Pomatia L, Helix Vermiculata.

The snail extract (snail meat) which is obtained from the entire body of the mollusk with the exception of the external limacella is known for its consumption in the food sector. The composition includes about 80% water, about 13% protein, 4% carbohydrates and low fat (0,6%).

Among the essential amino acids lysine, leucine and valine are present in higher concentrations while glutamic acid, alanine and aspartic acid are the most abundant non-essential amino acids. There are vitamins A, E, B1 , B2, B3 and B6.

Another derivative / extract of considerable interest is snail mucopolysaccharide, commonly called "slime" which is a secretion produced by some glands located in the foot. It has been used for several years in medicine and in the cosmetic industry, due to its strong nourishing and moisturizing properties. The substance used in the cosmetic sector is the slime produced by the Helix Aspersa variety, the most common species of snail in the Mediterranean basin, including the Italian peninsula. The substance is a clear, limpid or slightly opalescent liquid; it is completely miscible in water, insoluble in vegetable or mineral oils, dispersible in oil-in-water emulsions. The snail slime is suitably collected, filtered, concentrated and dried and is used for various therapeutic activities. In the cosmetic field it is widely used for its ability to stimulate the formation of collagen, elastin and dermal components that repair marks of photoaging. It also minimizes the damage generated by free radicals, thanks to its content in proteins, high and low molecular weight hyaluronic acid and antioxidants. Substances contained within the slime such as allantoin, collagen, elastin, helicidin, Helix pomatia agglutinin, natural antibiotics, glycolic acid, have important pharmacological activities. Allantoin is widely used in cosmetics for its moisturizing and keratolytic effects, for its ability to increase the amount of water in the extracellular matrix and to improve the flaking of the upper layers of dead skin, and for its ability to promote cell proliferation and wound healing. The component rich in hyaluronic acid and glycoproteins justifies the moisturizing and soothing effect of the slime which in the context of this composition can be useful to recall water, thus thinning the mucus and forming a protective film on the throat mucosa that protects it from external agents. Helicidin, on the other hand, is a mucoglycoprotein from the drool used as a cough suppressant, therefore of particular interest for the present invention. An in vitro study shows that helicidin has a spasmolytic effect on tracheal smooth muscle isolated from guinea pigs, in part due to the induction of prostaglandin E2 production. An in vivo study conducted on cats, through the evaluation of the stimulation of the superior laryngeal nerve, shows how helicidin produces an antitussive action similar to codeine phosphate. Another in vivo study conducted on mice demonstrates how helicidin produces an antitussive effect, preventing cough caused by inhalation of 0,5 N sulfuric acid aerosol, similar to alimemazine, a phenothiazine compound capable of suppressing the cough reflex. A double-blind clinical study conducted in various hospitalized cough patients showed that significantly fewer cough episodes were found in patients treated with helicidin than in patients treated with placebo. A further double-blind clinical study confirmed the antitussive effect of helicidin through polysomnograph evaluation of nocturnal coughing episodes in patients with chronic obstructive pulmonary disorders. The study lasted 5 days; in the first two nights, patients were analyzed to recruit those with more than 20 coughing episodes. From the third day, the administration of helicidin syrup at 10% or placebo in two doses of 15 ml 3 times a day for 3 consecutive days was started and coughing episodes on the fourth and fifth night were then evaluated. The number of coughing episodes recorded on the second night before administration was used as a control. In conclusion, there was a significant reduction in both the duration and number of nocturnal cough episodes in patients treated with helicidin syrup compared to those treated with placebo. Hence this substance contained in the drool is recommended for the treatment of cough, especially for patients in whom opioid agents and antitussive antihistamines are contraindicated. In the context of the present invention, the moisturizing and antitussive action of snail extract appears to be of interest in order to alleviate signs and symptoms typical of upper respiratory tract diseases.

KARAYA GUM

Karaya gum is obtained from the exudates of Sterculia urens, a large and bushy tree belonging to the Sterculiaceae family, which grows in the dry and rocky forests of central and northern India. Karaya gum has the appearance of a fine powder, a gray- pink color and a slightly acetic smell and taste; combined with some compounds such as glycols, it has the ability to form thin films when plasticized with these compounds. Most of the Karaya gum on the market is obtained from Sterculia urens, all parts of the tree have this soft gum when cut. Karaya gum is made by carbonizing or scarring the tree trunk and removing a piece of bark or drilling holes in the trunk. The gum seeps from the cuts and is collected, washed, dried and then evaluated. Rubber is not digested and absorbed systemically and its main use is as a mass laxative due to its ability to form a mucilaginous gel in contact with water. In fact, in contact with water it does not dissolve, but swells forming a viscous colloidal solution, swelling due to the presence of acetyl groups in its structure. It has also been used to a limited extent as a desiccant or adsorbent additive in the production of paper in combination with starches. It is used in various industries for its water absorption capacity, moisture absorption, ability to form gel and film and for its adhesiveness. It is highly resistant to hydrolysis by weak acids and degradation carried out by most microorganisms. From the point of view of medicinal uses, it is used in case of constipation, liver disease and as a laxative. Even in case of wounds or sores, gum powder is useful because it increases the normal granulation of the tissue, ensuring normal epidermal growth. It is also used to treat throat infections, of particular interest for the present composition. Its ability to form an adhesive film appears interesting for the present composition, in order to create an adhesive barrier on the mucous membrane of the throat, which removes any microorganisms, allergens or dust that can give rise to the typical symptoms of respiratory tract diseases.

Therefore, an object of the present invention is a composition comprising the association of snail extract and Karaya gum mixed with one or more suitable acceptable carriers.

The snail extract can be present in an amount between 10 mg and 20000 mg, preferably between 50 mg and 10000 mg, even more preferably between 100 mg and 8000 mg.

Karaya gum can be present in an amount ranging from 1 mg to 10000 mg, preferably from 10 mg to 7000 mg, even more preferably from 20 mg to 5000 mg.

In a preferred embodiment, the composition object of the present invention comprises the association of snail extract and Karaya gum in admixture with one or more suitable acceptable carriers.

Suitable acceptable carriers are those commonly known to those skilled in the art for the preparation of compositions for oral administration such as syrups, solutions, suspensions, powders or granulates, tablets, capsules, pellets.

By way of non-limiting example, such acceptable carriers may consist of binders, diluents, lubricants, glidants, disintegrating agents, solubilizers (wetting agents), stabilizers, dyes, anti-caking agents, emulsifiers, thickeners and gelling agents, coating agents, humectants, sequestrants and sweeteners. Specifically, examples of diluents can be: magnesium carbonate, microcrystalline cellulose, starch, lactose and sucrose. The main lubricants used are magnesium stearate, stearic acid and sodium stearyl fumarate. As glidants colloidal silica and magnesium silicate can be mentioned; as disaggregating agents, cross-linked polyvinylpyrrolidones and sodium glycolate starch can be mentioned; as solubilizers, surfactants such as TWEEN or sodium lauryl sulfate can be mentioned and, as stabilizers, all classes of preservatives (sorbic acid and derivatives, benzoic acid and derivatives, parabens), antioxidants (ascorbic acid and derivatives, tocopherol) and acidifiers (phosphoric acid, tartaric acid) can be mentioned. The thickeners and gelling agents can be carrageenan, pectins and starches; coating agents may include, for example, waxes and derivatives; anti-caking agents can include calcium or magnesium carbonate; humectants can include sorbitol and mannitol; sequestrants can include EDTA and derivatives; sweeteners can include aspartame and acesulfame potassium.

The composition object of the present invention is preferably a liquid or solid composition for oral use, even more preferably a syrup, an aqueous solution, a suspension, a powder or granulate, a tablet, a capsule or pellet.

The composition object of the present invention can be a medical device, a food supplement, a nutraceutical, dietary and nutritional composition, a food product, a beverage, a nutraceutical, a medicament, a medicated food, a pharmaceutical composition or a food for special medical purposes or even in the form of simple, complementary, complete feed, intended for particular nutritional or medicated purposes.

The compositions referred to in the present invention are particularly effective in counteracting the pathologies of the respiratory system thanks to the synergistic action of their components.

The composition object of the present invention exhibits a valid synergistic effect, in particular, when the snail extract is present in an amount between 10 mg and 10000 mg, and Karaya gum is present in an amount between 10 mg and 5000 mg.

A further object of the present invention is therefore a composition comprising the association of snail extract and Karaya gum in admixture with one or more suitable carriers acceptable for use in the prevention and / or treatment of respiratory tract diseases in humans as well as in animals. The compositions object of the present invention are particularly effective in the treatment of cough, rhinitis, allergic rhinitis, nasopharyngitis or cold, rhinosinusitis, sinusitis, pharyngitis, epiglottitis, laryngitis and bronchitis, allowing at the same time to obtain an anti-inflammatory, antioxidant and antimicrobial effect thanks to the action synergistic of their components.

Effectiveness and synergy of action

The natural compounds extracted from snail and Karaya gum of the association object of the present invention are essential to obtain the desired effectiveness in the prevention and treatment of respiratory tract diseases.

In particular, the composition object of the present invention allows to obtain simultaneously a film-forming effect and an antibacterial effect.

Without being tied to a specific theory, the inventors believe that the synergistic effect of the association present in the composition object of this invention derives from the following activities of the components of the association:

- Snail extract: thanks to the moisturizing effect that some of its components are able to exert, it thins the excess mucus and thanks to the presence of mucoglycoproteins, including helicidin which also has documented antitussive properties, exerts film forming properties.

- Karaya gum: enhances the film-forming effect as it forms a barrier on the mucous membrane of the throat, shielding it from any pathogens and therefore also exerting an antibacterial action.

The synergistic activity of the aforesaid active ingredients can be studied by using any in vitro and / or in vivo test known in literature capable of evaluating the film-forming and antibacterial activity of the compositions according to the present invention and / or of the compositions of comparison.

In order to demonstrate the film-forming efficacy of the composition according to the present invention, of particular interest for the prevention and / or treatment of respiratory tract diseases, in vitro assays such as those determining the traction force, the shear stress, the adhesion weight method, fluorescent probe method, flow channel method, mechanical spectroscopic methods, liquid film drop method, viscometer test, adhesion number, in vitro substance release studies.

In particular, an in vitro model proposes to test the present composition for its mucoadhesive and film-forming effect. The protocol involves using liposomes coated with 4 different polymers, namely alginate, snail extract, Karaya gum and a blend of snail extract and Karaya gum. Mucoadhesive is evaluated using a new in vitro method that allows liposomes to interact with a mucus-producing HT29-MTX cell line without applying any external force, and then determine mucoadhesive capacity by fluorescence intensity. The aim is to demonstrate that liposomes coated by the mixture of snail extract polymers and Karaya gum achieve higher mucoadhesivity than alginate coated and single component liposomes.

To evaluate the synergistic effect on mucoadhesion, the inclined plane model can also be used. The steel top is positioned horizontally and the temperature is set at 60 ^eC before the start of the run. A few ml of sample (or deionized water for the controls) are placed at the predefined distance on the table and left to rest for a few minutes. To perform the test, the table is tilted at 45 °C and the sample detached at the end of the run is weighed. The sample falls into a petri dish and is weighed with automatic recordings at set intervals (e.g. 60 seconds).

On the other hand, to demonstrate the antibacterial efficacy of the composition according to the present invention, in vitro assays are suitable such as broth-dilution (by calculating the MIC, minimum inhibitory concentration and MBC, minimum bactericidal concentration) and diffusion in agar (where a standardized concentration of the sample is applied in a culture broth of bacteria and the diffusivity of the sample within the medium is calculated).

An in vivo model proposes to test the present invention to evaluate its antitussive effect on animal models (e.g. guinea pigs or others) with cough caused by inhalation of irritating agents such as capsaicin, citric acid or others. Anesthetized animals are exposed to a nebulized aqueous solution of the irritating agent and during exposure they are constantly observed to assess the number of tussive episodes. After establishing how soon the tussive episodes occur, the duration of exposure to the irritant agent is fixed. This model proposes to pre-treat animals with the single active ingredients or their combination (object of the present invention) orally, 30 minutes before inhalation with capsaicin, to demonstrate how the number of tussive episodes is significantly reduced by the synergistic action of the components compared to the same tested individually.

Examples

For illustrative purposes, some non-restrictive examples of quantities for single administration of the active components of the compositions object of the present invention are now provided. The single dose quantities are intended to be administered in suitable dosage form. Modifications or variations of the embodiments exemplified herein, obvious to one skilled in the art, are included in the appended claims.

EXAMPLE 1 (orosoluble tablets)

EXAMPLE 2 (tablets)

EXAMPLE 3 (oral vial)

EXAMPLE 4 (oral vial)

EXAMPLE 5 (oro-pharyngeal spray)

EXAMPLE 6 (sachets)

The compositions are prepared according to conventional techniques such as mixing.

Claims

1) A composition comprising an association of at least a snail extract and Karaya gum in admixture with one or more suitable acceptable carriers.

2) Composition according to claim 1 wherein the at least a snail extract is an extract from the whole snail body and/or snail slime.

3) Composition according to claim 1 or 2 in form of a liquid or solid composition for oral use.

4) Composition according to any of the preceding claims wherein the snail extract is present in an amount between 10 mg and 20000 mg, preferably between 50 mg and 10000 mg, still more preferably between 100 mg and 8000 mg.

5) Composition according to any of the preceding claims wherein Karaya gum is present in an amount between 1 mg and 10000 mg, preferably between 10 mg e 7000 mg, still more preferably between 20 mg and 5000 mg.

6) Composition according to any of the previous claims wherein the composition is a medical device, a food supplement, a nutraceutical, dietetic and nutritional composition, a food product, a beverage, a nutraceutical product, a medicament, a medicated food, a pharmaceutical composition or a food for special medical purposes, or is also in the form of simple, complementary, complete, for particular nutritional purposes or medicated animal feed.

7) A composition according to any of the previous claims for use in the prevention or treatment of respiratory tract diseases in humans as well as in animals.

8) Composition according to claim 7 for use in the prevention or treatment of cough, rhinitis, allergic rhinitis, rhinolaryngitis or cold, rhinosinusitis, sinusitis, pharyngitis, epiglottitis, laryngitis and/or bronchitis.