IT201800003804A1 - Composition for the treatment of respiratory and oropharyngeal diseases - Google Patents

Description

"Composition for the treatment of respiratory and oropharyngeal diseases" FIELD OF THE INVENTION

The present invention refers to a composition that contains Propolis, Matricaria recutita extract and β-glucans for the prevention and / or treatment of respiratory and oropharyngeal diseases. This invention is based on the synergistic action of the aforementioned active ingredients.

STATE OF THE ART

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 the cellular processes of the organism, that is, for its life.

Anatomically, two macro areas are distinguished which are the upper and lower airways. The former consist of the nose, pharynx and associated structures, while the latter consist of the larynx, trachea, bronchi and lungs, whose actual respiratory surface is constituted by 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 deviate the direction of the air. The mucus is stratified 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 hair cells characterize the airways from the trachea to the terminal bronchioles. From their apical surface the cilia protrude which have the task of moving with a cleaning effect on the mucus and on any inhaled particles.

The mucipar calciform cells which are responsible for the secretion of mucus, useful for maintaining the correct humidity of the epithelium and for trapping particulate matter. They are present in the larger tracts of the airways under the small bronchi but have not been found in the bronchioles.

All the 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. The object of the present invention is to provide a composition for use in the prevention and / or treatment of respiratory and oropharyngeal pathologies.

SUMMARY OF THE INVENTION

The present invention is based on the research and identification of a new combination of active ingredients which exert both prevention and treatment effects of respiratory and oropharyngeal pathologies.

The present invention relates to compositions comprising or consisting of a mixture of Propolis, Matricaria recutita extract and β-glucans and to their use in the treatment of respiratory and / or oropharyngeal pathologies. The compositions according to the present invention allow to obtain at the same time:

• Anti-inflammatory effect;

• Antimicrobial effect;

• Immunostimulating effect;

• Antioxidant effect.

Other advantages and features of the present invention will become apparent from the following detailed description.

DETAILED DESCRIPTION OF THE INVENTION

The present invention describes a composition comprising as main active ingredients, Propolis, Matricaria recutita extract and βglucans.

Propolis is a resinous substance that bees collect from the exudate of plants and which they use to seal holes in the hive. Propolis is mainly composed of resin (50%), wax (30%), essential oils (10%), pollen (5%) and other organic compounds (5%). The main organic compounds present in propolis are phenolic compounds, esters, flavonoids in all forms (flavonols, flavones, flavonones, dihydroflavonones, chalcones), terpenes, beta-steroids, alcohols and aromatic aldehydes, sesquiterpenes and stilbenes. The chemical composition of propolis varies according to several factors, such as the source of the exudates, the climate and environmental conditions. The phenethyl ester of caffeic acid (CAPE, Caffeic Acid Phenetyl Ester) is a biologically active ingredient with several interesting properties, including induction of apoptosis of cancer cells and the prevention of metastasis. Polyphenols are chemical compounds associated with numerous pharmacological properties: antioxidant, antibacterial, antiviral, anti-inflammatory. From a chemical point of view, phenols can be defined as substances that possess an aromatic ring to which one or more hydroxyl groups are bonded. The presence of phenols in foods can change their oxidative and microbiological stability: hence the interest in the extraction of these compounds as natural antioxidant and antimicrobial substances. In propolis, phenolic compounds are mainly present as flavonoids, the concentration of which depends on various factors, such as the species of plants, the season and environmental factors. The antioxidant capacity of propolis is mainly due to the polyphenols and flavonoids it contains and there is a high degree of correlation between these chemical compounds and the antioxidant capacity of this substance. Other compounds that could contribute to the antioxidant action of propolis belong to the classes of terpenes, steroids, aldehydes and ketones and it is not excluded that all these chemical compounds can synergize to determine the overall antioxidant effect of propolis. The mechanisms of action that contribute to the antioxidant capacity of propolis are the following: sequestration of free radicals, hydrogen donation, chelation of metal ions or their action, interference with propagation reactions and inhibition of the enzyme systems involved in initiation reactions. The greater the quantity of hydroxyl groups of these compounds, the greater the reactivity and the ability to undergo oxidation reactions.

Propolis also has a good anti-inflammatory activity. Among the various compounds present in propolis, the one of greatest interest is undoubtedly galangin, which is able to inhibit cyclooxygenase, lipoxygenase and inhibit the expression of COX-2. Another compound, the phenethyl ester of caffeic acid (CAPE) has the ability to inhibit the release of arachidonic acid from the cell membrane. Chrysin is able to suppress the activity of COX-2 and iNOS, further contributing to the anti-inflammatory mechanism of propolis. Propolis also exhibits antimicrobial activities. It has the ability to block the spread of viruses. Several studies have demonstrated the ability of propolis to inhibit the multiplication of various viruses, including Herpes simplex type 1 and 2, vesicular stomatitis virus and type 2 poliovirus. Furthermore, propolis exhibits antibacterial activity, mainly against Gram-negative bacteria. The chemical compounds responsible for this activity are pinocembrin, galangin, CAPE and other phenolic acids and esters. In the compositions of the present invention, propolis prepared according to the procedures known to those skilled in the art or commercially available products can be used. According to an embodiment, propolis enriched in one or more of the above compounds can be used. The composition may comprise for example an amount of propolis ranging from 1 mg to 1000 mg, preferably from 400 to 800 mg.

Chamomile (common name of Matricaria recutita) is one of the plants most used by man since ancient times, to which a variety of beneficial health effects have been attributed. This plant belongs to the Asteraceae family and is commonly represented by two types of main varieties such as German chamomile (Chamomilla recutita) and Roman chamomile (Chamaemelum nobile).

Various bioactive components have been isolated and characterized in chamomile which are responsible for the numerous uses in preparations for medical or cosmetic use. About 128 secondary metabolites have been identified in this plant and in particular about 28 compounds classifiable as terpenes and 36 as flavonoids. The main components of the essential oil extracted from the flowers are terpenes such as α-bisabolol and azulenes such as chamazulene. In addition to these main compounds, they constitute classes of compounds abundantly present in chamomile flowers, lactonic sesquiterpenes, glycosides, hydrocumarins, flavonoids, coumarins and mucilages.

Among the flavonoids, apigenin is the most interesting compound and in flowers it is mainly found not in free form but in glycosylated form. Other flavonoids present in chamomile are luteolin, patuletin and quercetin. Traditionally, chamomile has anti-inflammatory properties attributed to the presence of α-bisabolol and flavonoids. These compounds could lead to inhibition of the release of prostaglandin E2 induced by lipopolysaccharides (LPS) and attenuation of the inducible isoform of cyclooxygenase (COX-2) without acting on the constitutive isoform COX-1.

In particular, in vitro studies on the individual components have shown how apigenin is able to reduce the adhesion of leukocytes to human endothelial cells and inhibit the synthesis of prostaglandins, tumor necrosis factor, interleukin-1 and nitric oxide. Camazulene, on the other hand, proved to be able to inhibit the synthesis of leukotriene B4 and the peroxidation of arachidonic acid.

As reported in the monograph of the European Medical Agency (EMA), the ethanolic and aqueous extracts of chamomile possess antimicrobial activity. More specifically, the former have greater efficacy on bacteria such as Pseudomonas aeruginosa, beta hemolytic Streptococci, Enterobacter agglomerans, Escherichia coli and Staphylococcus aureus, while the aqueous extracts are more active against molds and yeasts. Other important components in the chamomile flower extract are mucilage, hydrophilic components present in most plants where they are essential for the preservation of nutrient water, for the germination of seeds and the thickening of the membranes.

Chamomile has a high quantity of mucilage which, thanks to their mucoadhesive properties, could guarantee physical protection at the level of the throat and pharynx, relieving inflammatory symptoms in patients with cough and colds. The beneficial action of chamomile as an adjuvant treatment in inflammatory and infectious syndromes of the upper respiratory tract could be expressed thanks to its anti-inflammatory, antimicrobial and soothing and emollient properties of mucilage. In the compositions of the present invention it is possible to use a chamomile extract prepared according to the procedures known to those skilled in the art or the products available on the market. According to an embodiment, an extract enriched in one or more of the above compounds can be used. The composition may comprise for example an extract amount comprised between 0.1 mg and 150 mg, preferably between 10 and 50 mg.

Β-glucans are a class of long-chain polysaccharides consisting of a chain of β-D-glucopyranosyl units joined by β- (1-3) type bonds and with side chains joined by β- (1-4) and β- (1-6). These are polymers that are found abundantly in nature, mainly in cereals such as barley and oats, but also in the wall of bacteria and yeasts such as Saccharomyces cerevisiae. They have several pharmacological activities, including protection against infection, reduction of plasma lipid concentrations, inhibition of tumor development and metastasis. It is believed that asthma and allergies are associated with an excessive Th2 response. Β-1,3-glucans can stimulate macrophages, which produce prostaglandin E2, tumor necrosis factor and IL-10 and can inhibit the Th2 response.

Β-glucans are known biological response modifiers. Their effects have been investigated following administration through different routes: these polymers are able to exert a good pharmacological activity even when administered orally and show an enhanced effect when administered with other immunological therapies. These polymers act by activating the entire immune system.

Β-glucans can be derived from different sources and exhibit structural differences and their pharmacological activities are determined by their molecular structure, chain length, degree of branching, any structural changes, conformation and solubility. Since mammalian cells do not synthesize β-glucans, these are recognized as Pathogen Associated Molecular Patterns (PAMPs) by the innate immunity receptors PRR (Pattern Recognition Receptors) present on the surface of the immune system cells. . PRRs that recognize β-glucans include toll-like receptors (TLRs), C-domain lectins (CLRs) such as dectin-1, complement system receptors (CR3), lactosylceramide, and scavenger receptors. Receptors for β-glucan have been identified on the surface of cells of the immune system, including neutrophils, eosinophils, natural killer cells, endothelial cells, alveolar epithelial cells and various types of macrophages, as well as cells that are not part of the immune system. including epithelial cells, vascular endothelial cells, fibroblasts. Β-glucans are potent activators of macrophages, monocytes and neutrophils and are primarily responsible for the stimulation of the reticuloendothelial system. The recognition of β-glucans as non-self molecules by mammalian cells induces the innate and adaptive immune response. The initial response to β-glucans occurs through innate immunity. This response is rapid and non-specific and mainly involves phagocytic cells, such as macrophages and neutrophils. Β-glucans interact with the mucosal immune system in the intestine (Peyer's plaques) and this induces the production of cytokines and resistance to infections. Β-glucans are transported by intestinal macrophages to organs of the immune system (spleen, lymph nodes, bone marrow, etc.) via the lymphatic system. In the bone marrow, the higher molecular weight β-glucans are broken down into smaller fragments by macrophages. The signaling mechanism induced by β-glucans does not derive from the internalization of these macromolecules. Β-glucans induce phagocytosis, stimulate bactericidal mechanisms such as respiratory outbreak and induce the production of components of the innate immune system, such as TNF-α, Interleukin-1, the MIP-2 protein (macrophage inflammatory protein 2-alpha ), eicosanoids. Other cells are recruited to the site of infection and activate the adaptive immune response. In the compositions of the present invention β-glucans prepared according to the procedures known to those skilled in the art or commercially available products can be used. The composition may comprise for example an amount of β-glucans comprised between 0.1 mg and 2000 mg, preferably between 10 and 500 mg.

The compositions according to the present invention can be formulated in any form suitable for the indicated administration and associated with any other suitable component, in a variety of ways, for example they will be formulated for nasal or inhalation administration as liquids, solutions, suspensions, solutions in bottles. for nebulization, aerosols, ointments, ointments. The compositions can be formulated with excipients and / or diluents. These excipients can be selected for example from those normally known in the state of the art and include, but are not limited to: a) carriers, b) fillers c) humectants d) disintegrating agents e) binders etc. In the formulations according to the present invention in liquid forms, diluents, carriers, excipients known to those skilled in the art can be used. According to an embodiment, the compositions will be formulated for oral use, for example as capsules, soft capsules, tablets, pills, jellies, powders or granules. Such excipients can be selected for example among those normally known in the state of the art and include, but are not limited to them: a) carriers, such as for example sodium citrate and calcium phosphate, b) fillers such as for example starch, lactose, microcrystalline cellulose, sucrose, glucose, mannitol and colloidal silica, c) humectants, such as glycerol, d) disintegrating agents, such as alginates, calcium carbonate, starches, starch derivatives, cellulose and polyvinylpyrrolidone, silicates and carbonate sodium e) binders such as carboxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, sucrose, polymeric derivatives of cellulose, starch derivatives f) retardants such as paraffin, cellulose polymers, esters of fatty acids g) accelerators of absorption, such as compounds of quaternary ammonium, h) wetting agents and surfactants such as cetyl alcohol and glycerol monostearate, i) adsorbents, such as benthic clays and kaolin, k) l lubricants such as talc, calcium stearate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, sodium stearyl fumarate j) glidants such as talc, colloidal silica. The solid dosage forms, such as tablets, capsules, soft capsules, gelatins, pills and granules, may be coated with enteric, gastric or other coatings known in the state of the art. They may contain opacifying agents and may be of the type to allow the release of the active ingredients only or preferably in a certain tract of the intestine, possibly in a delayed manner. Substances which may permit such delayed use include, but are not limited to, polymers and waxes. The soft capsules can house the antioxidant active substances in liquid form alone or in solutions, suspensions or emulsions of the active substances in a liquid solvent. The soft capsules may be characterized by a shell qualitatively similar to that of the rigid but thicker and softer. Liquid forms suitable for oral administration are for example emulsions, solutions, prepared or extemporaneous suspensions, syrups and elixirs. Excipients suitable for the formulations according to the present invention in liquid forms for oral use include, but are not limited to them, diluents such as water or other solvents, solubilizing and emulsifying agents selected from ethyl alcohol, polyalcohols, propylene glycol, glycerol, polyethylene glycol and esters of sorbitan. These formulations may also contain sweeteners and flavorings.

The compositions may be for example a medical device, food supplement, a nutraceutical, dietary, nutritional composition, a food product, a beverage, a nutraceutical, a medicament, a medicated food, a food for special medical purposes, a food. The compositions will mainly be intended for use by humans, but they can also be used on animals.

The combination of the above-mentioned active ingredients can be used formulated in a single composition according to the various embodiments described above or in a kit that contains the different separate ingredients, for example in single compositions such as capsules, pills, tablets for sequential or simultaneous administration. of the different ingredients. According to an embodiment, the compositions according to the present invention will be in the form of a spray comprising for example a bottle, a metering pump and a dispenser.

Preferably, regardless of the type of formulation used, the combination of active ingredients according to the present invention will be administered with a daily dosage regimen according to the concentrations mentioned above, i.e. Propolis in an amount ranging from 1 mg to 1000 mg, the extract of Matricaria recutita in an amount ranging from 0.1 mg to 150 mg and β-glucans are present in an amount ranging from 0.1 mg to 2000 mg.

The compositions according to the present invention will be used for the prevention and / or treatment of respiratory or oropharyngeal pathologies, in particular for a pathology chosen among rhinitis, sinusitis, pharyngitis, epiglottitis, laryngitis, bronchiolitis, cystic fibrosis, bronchiectasis.

Below is a brief description of some of the specific pathologies that can be treated with the combination of the three active ingredients according to the present invention.

Diseases Of The Upper Respiratory Tract

Rhinitis

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 caused by viruses, including Rhinovirus, Coronavirus, influenza and parainfluenza viruses, RSV, Coxsackie virus, ECHO virus, and adenovirus. The contagion occurs by direct contact with the sick subject who, in the peak of maximum contagiousness (generally on 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, hypertrophic adenoids. Allergic rhinitis is due to the subject's exposure to substances that cause an IgE-mediated 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.

Sinusitis

Sinusitis is inflammation of the mucosa that lines the paranasal sinuses, bony cavities located in the facial massif and which are in communication with the nasal cavities, and therefore can become infected for the same causes that determine rhinitis. Sinusitis can be divided into acute viral or acute 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 breast 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, 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. Certain genera of fungi such as Candida, Aspergillus, Blastomyces, Coccidioides, Rizophus, 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 self-resolves, and 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, that of 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 (pharyngotonsillitis)

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. The infection can be caused by viruses (such as Epstein-Barr) and by bacteria, in particular group A beta-haemolytic Streptococcus pyogenes is the most frequent in pediatric forms, but Mycoplasma pneumoniae, Chlamydia pneumoniae are also found in adults and in 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. Treatment 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, GERD. Laryngitis has symptoms that last 3-4 days and, unless bacteria are present, no antibiotics are used.

Lower Respiratory Tract Diseases Bronchiolitis

Bronchiolitis, a frequently pediatric disease, is characterized by extensive inflammation of the airways accompanied by intense mucus production and epithelial cell necrosis. Primarily it is caused by a viral infection, in particular by RSV (respiratory syncytial virus), but also by adenoviruses, influenza and parainfluenza viruses, human metapneumovirus and rhinovirus, while the bacteria most frequently involved are of the genus Chlamydia. In pediatric age, the main clinical manifestations are tachypnea, breathlessness, or crackles on auscultation, which generally follow an upper respiratory tract infection. Treatment may include hospitalization if the oxygen saturation is between 92 and 94%, together with other clinical manifestations such as poor nutrition, dehydration and a history of dyspnea.

Cystic fibrosis

This disease is caused by a mutation in the gene that codes for the CFTR protein, an anion channel expressed in skin cells throughout the body. Although it functions primarily as a chloride ion channel, it is also able to regulate the function of other membrane proteins, such as the epithelial sodium channel (ENaC), whose activity is inhibited. Among other many functions, CFTR also regulates the intracellular secretion of bicarbonate, which is reduced and determines a lowering of the epithelial pH with a consequent reduced protection from microbes and an increase in the viscoelasticity of the mucus. The dysfunction of the CFTR channel in the lung therefore leads to an excessive absorption of sodium and a reduced active secretion of chlorine with a consequent reduction of the liquid layer on the surface of the mucosa. This leads to an abnormal muco-ciliary clearance, with retention of viscous mucus which favors infections and inflammation and therefore lung damage. Several studies support the hypothesis that lung damage is also caused by the vulnerability of the dehydrated mucosa, based on this, it has been hypothesized that hypertonic saline solutions could constitute a new option to increase mucosal hydration and to improve mucociliary clearance. .

Bronchiectasis

It is a disease characterized by an irreversible dilation of a portion of the bronchial tree in the lungs. Bronchial dilation can be the result of a structural defect of the wall, exposure to abnormal pressure, or damage to the cartilage or elastic tissue following inflammation. It involves the bronchi and bronchioles where a vicious circle of infection and inflammation can be established, also with the release of mediators. Common symptoms are mucus-producing cough and chest pain. The mucus has an increased amount of elastase, and of TNF α, IL-8 and prostanoids. It can present as a local or diffuse obstructive process in both lobes, also accompanied by sinusitis or asthma. The causes are various, for example, especially in children, even mycotic infections that leave permanent damage. Or primary ciliary dyskinesia, in which there is a marked retention of secretions followed by infections. Cystic fibrosis as immunodeficient conditions can be predisposing factors. It has also been observed that respiratory tract infections and bronchiectasis are present in patients with ulcerative colitis. The treatment involves the use of antimicrobials to fight infections caused by both bacteria and fungi. In addition, it is particularly useful to perform airway washes for

increase the removal of secretions, making use of

of saline solutions and to keep the patient, in

general line, well hydrated.

EXAMPLES

As previously stated, in the present invention the synergistic action occurs between Propolis, Matricaria recutita extract and β-glucans. The synergy occurs when Propolis is present in an amount between 1 mg and 1000 mg, the extract of Matricaria recutita is present in an amount between 0.1 mg and 150 mg and β-glucans are present in an amount between 0.1 mg and 2000 mg.

Below are some non-limiting examples of daily dosages of the combination of active ingredients used in the compositions of the present invention

EXAMPLE 1

Active ingredient Daily dose Propolis 26.6 mg

β-glucans 1.9 mg

Matricaria recutita, 1.5 mg

o.e.

Pharmaceutical form: Bottle, with dosing pump and dispenser.

EXAMPLE 2

Active ingredient Daily dose

β-glucans 250 mg

Propolis 26.6 mg

Matricaria recutita 15 mg

Pharmaceutical form: Capsule.

EXAMPLE 3

Active ingredient Daily dose

β-glucans 250 mg

Propolis 50 mg

Matricaria recutita 15 mg

Pharmaceutical form: Tablets.

EXAMPLE 4

Active ingredient Daily dose Propolis 50 mg

β-glucans 25 mg

Matricaria recutita, 1.5 mg

o.e.

Pharmaceutical form: Bottle, with dosing pump and dispenser.

Claims (10)

CLAIMS 1.Composition comprising Propolis, Matricaria recutita extract and β-glucans. 2. Composition according to claim 1 for oral, nasal or inhalation administration. 3. Composition according to claim 1 or 2 comprising per dosing unit: - propolis in an amount of between 1 mg and 1000 mg; and / or - extract of Matricaria recutita in an amount between 0.1 mg and 150 mg; and / or - β-glucans in an amount of between 0.1 mg and 2000 mg. 4. Composition for oral administration according to any one of claims 1 to 3 in a form chosen from capsule, soft capsule, tablet, pill, gelatin, powder, granule, emulsion, solution, suspension, syrup. Composition for oral, nasal or inhalation administration according to any one of claims 1 to 3 in a form selected from liquid, solution, suspension, ointment, ointment, powder, solution for nebulization, aerosol. Composition according to any one of claims 1 to 5 further comprising one or more carriers and / or excipients. Composition according to any one of claims 1 to 6 wherein said composition is a medical device, a food supplement, a nutraceutical, dietary and nutritional composition, a food product, a beverage, a nutraceutical, a medicament, a medicated food or a food for special medical purposes. Composition according to any one of claims 1 to 7 for use in the prevention and / or treatment of a respiratory and / or oropharyngeal pathology. 9. Composition according to any one of claims 1 to 7 for use in the prevention and / or treatment of a respiratory and / or oropharyngeal pathology in which said pathology is selected from among rhinitis, sinusitis, pharyngitis, epiglottitis, laryngitis, bronchiolitis, cystic fibrosis , bronchiectasis. 10. Oral or nasal spray comprising a composition to be dispensed according to any one of claims 1 to 9.