WO2019180635A1 - Composition à utiliser pour le traitement de maladies respiratoires et oropharyngées - Google Patents

Composition à utiliser pour le traitement de maladies respiratoires et oropharyngées Download PDF

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WO2019180635A1
WO2019180635A1 PCT/IB2019/052256 IB2019052256W WO2019180635A1 WO 2019180635 A1 WO2019180635 A1 WO 2019180635A1 IB 2019052256 W IB2019052256 W IB 2019052256W WO 2019180635 A1 WO2019180635 A1 WO 2019180635A1
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composition
respiratory
composition according
propolis
glucans
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PCT/IB2019/052256
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Umberto DI MAIO
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Neilos S.r.l.
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Publication of WO2019180635A1 publication Critical patent/WO2019180635A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to a composition including Propolis, extract of Matricaria recutita and b-glucans for the prevention and/or treatment of the respiratory and oropharyngeal diseases.
  • Such invention is based upon the synergic action of the above-mentioned active principles.
  • the respiratory apparatus consists of several anatomic structures which are useful for the function thereof.
  • Anatomically two macro areas are distinguished which are the upper and the lower respiratory tracts.
  • the first ones consist of nose, pharynx and associated structures, whereas the second ones consist of larynx, trachea, bronchi and lungs, the real respiratory surface is constituted by the alveoli.
  • This complex system of organs is useful to prepare air to enter the lungs, by means of filtration by possible particulate, heating and humidification.
  • the particles bigger than 10-15 micron can be locked, this thanks to whiskers and the presence of mucus entrapping these particles apart from precipitation by turbolence, mediated by the turbinates deviating the air direction.
  • the mucus stratifies above the peri- ciliary liquid, wherein the vibritile cilia of the epithelium cells are dipped. Particles of about 10 micron reach trachea, they are entrapped in the mucus and then removed by the ciliary motion. Particles of 2-5 micron settle in the terminal bronchioles by gravitational precipitation, whereas those having sizes lower than 2 microns are removed by the alveolar macrophages and taken away by the pulmonary lymphatic system.
  • the whole respiratory tract consists of epithelial cells differing by type and function along the tracheobronchial tree.
  • the ciliary columnar cells characterize the respiratory tracts from trachea as far as the terminal bronchioles. From their apical surface cilia protrude having the purpose of moving with cleaning effect on mucus and on possible inhaled particles .
  • the mucoid calcium-like cells which are assigned to the mucus secretion, useful to keep the correct humidity of epithelium and to entrap particulate. They are present in the widest tracts of the respiratory tracts below the small bronchi but they were not found in the bronchioles.
  • All components of the respiratory apparatus can be exposed to a series of diseases, of different aetiology, often sustained by different pathogenic microorganisms which, by becoming preponderant in the microenvironment and on the normally existing flora, determine the disease and, consequently, cause a reduced functionality.
  • the object of the present invention is to provide a composition for use in the prevention and/or treatment of the respiratory and oropharyngeal diseases .
  • the present invention is based upon the search for and identification of a new combination of active principles which exert both effects for preventing and treating the respiratory and oropharyngeal diseases .
  • the present invention relates to compositions comprising or consisting of a mixture of Propolis, extract of Matricaria recutita and b-glucans and to the use thereof in the treatment of the respiratory and/or oropharyngeal diseases.
  • the compositions according to the present invention allow to obtain at the same time:
  • the present invention describes a composition comprising as main active principles, Propolis, extract of Matricaria recutita and b-glucans.
  • Propolis is a resinous substance which bees collect from the plants' exudate and which they use to seal the holes in the hive.
  • Propolis mainly consists of resin (50%), wax (30%), essential oils (10%), pollen (5%) and other organic compounds (5%) .
  • the main organic compounds existing in Propolis are phenolic compounds, esters, flavonoids in all forms (flavonols, fl arms, flavonons, dihydroflavonons , chalcones), terpenes, beta-steroids, alcohols and aromatic aldeydes, sesquiterpenes and stilbenes.
  • the chemical composition of Propolis varies based upon several factors, such as the source of exudates, the climate and the environmental conditions.
  • the Caffeic Acid Phenetyl Ester is a biologically active ingredient with several interesting properties, thereamong induction of apoptosis of tumour cells and the prevention of metastasis.
  • the polyphenols are chemical compounds associated to several pharmacological properties: antioxidant, antibacterial, antiviral, anti-inflammatory. From a chemical point of view, the phenols can be defined as substances having an aromatic ring thereto one or more hydroxyl groups are bound. The presence of phenols in food can modify their oxidative and microbiological stability: the interest in the extraction of these compounds as antioxidant and antimicrobial natural substances derives therefrom.
  • the phenolic compounds are present mainly as flavonoids, the concentration thereof depends upon several factors, such as the plants' species, the season and the environmental factors.
  • the antioxidant capability of Propolis is mainly due to polyphenols and flavonoids it includes and there is a high level of correlation between these chemical compounds and the antioxidant capability of this substance.
  • Other compounds which could contribute in 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 could synergize to determine the overall antioxidant effect of Propolis.
  • the action mechanisms contributing in the antioxidant capability of Propolis are the following ones: seizure of free radicals, hydrogen donation, chelation of metal ions or the action thereof, the interference with the propagation reactions and the inhibition of enzymatic systems involved in the initiation reactions.
  • seizure of free radicals seizure of free radicals
  • hydrogen donation hydrogen donation
  • chelation of metal ions or the action thereof the interference with the propagation reactions and the inhibition of enzymatic systems involved in the initiation reactions.
  • Propolis has also a good anti-inflammatory activity.
  • the most interesting one is surely galangin, which is capable of inhibiting cyclo-oxygenase, lipoxygenase and of inhibiting the expression of COX-2.
  • Another compound, the caffeic acid phenetyl ester (CAPE) has the capability of inhibiting the release of arachidonic acid from the cellular membrane.
  • Chrysin is capable of suppressing the activity of COX-2 and of iNOS, by further contributing to the anti-inflammatory mechanism of Propolis.
  • Propolis further has antimicrobial activities. It has the capability of locking propagation of viruses.
  • Propolis has an anti-bacterial activity, mainly against Gram negative bacteria.
  • the chemical compounds responsible for this activity are pinocembrin, galangin, CAPE and other acids and phenol esters.
  • Propolis prepared according to the procedures known to the person skilled in the art or the products available on the market could be used.
  • Propolis enriched with one or more of the above-mentioned compounds could be used.
  • the composition could include for example an amount of Propolis ranging between 1 mg and 1000 mg, preferably between 400 and 800 mg.
  • Camomile (common name of Matricaria recutita) is one of the plants most used by man since ancient times, thereto a variety of beneficial effects on health were attributed. Such plant belongs to the family of Asteraceae and it is commonly represented by two types of main varieties such as German camomile (Chamomilla recutita) and Roman camomile (Chamaemelum nobile) .
  • camomile In camomile several bioactive components were insulated and characterized thereto the several uses in preparations for medical or cosmetic use are owed. About 128 secondary metabolites were identified in this plant and in particular about 28 compounds which can be classified as terpenes and 36 as flavonoids.
  • the main components of the essential oil extracted from flowers are terpenes such as -bisabolol and the azulenes such as chamazulene.
  • sesquiterpenes lactones, glycosides, hydrocoumarins , flavonoids, coumarins and mucilages constitute classes of compounds abundantly present in camomile flowers.
  • flavonoids apigenin is the most interesting compound and in the flowers it is present mainly not in free form but in glycosylated form.
  • Other flavonoids existing in camomile are luteolin, patuletin and quercetin.
  • apigenin is capable of reducing adhesion of leucocytes to the human endothelial cells and of inhibiting synthesis of prostaglandins, tumour necrosis factor, interleukin- 1 and nitric oxide.
  • chamazulene was found to be capable of inhibiting synthesis of leukotriene B4 and peroxidation of the arachidonic acid .
  • EMA ethanol and aqueous extracts of camomile have antimicrobial activity. More in details the first ones have more effectiveness on bacteria such as Pseudomonas aeruginosa, beta hemolytic Streptococci, Enterobacter agglomerans, Escherichia coli and Staphylococcus aureus, whereas the aqueous extracts are more active against moulds and yeasts.
  • camomile flowers Other important components in the extract of camomile flowers are mucilages, hydrophile components existing in most part of plants wherein they are fundamental for the preservation of water, nutrients, for germination of seeds and thickening of the membranes.
  • Camomile has a high amount of mucilages which, thanks to their mucoadhesive properties, could guarantee a physical protection at the level of the throat and the pharynx by alleviating the inflammatory symptoms in patients with cough and colds.
  • the beneficial action of camomile as adjuvant treatment in inflammatory and infective syndromes of upper respiratory tracts could be expressed thanks to its anti-inflammatory, antimicrobial and lenitive and emollient properties of mucilages .
  • an extract of camomile could be used prepared according to the procedures known to the person skilled in the art or the products available on the market. According to an embodiment an extract could be used enriched with one or more of the above-said compounds.
  • the composition could include for example an amount of extract ranging between 0.1 mg and 150 mg, preferably between 10 and 50 mg.
  • b-glucans are a class of long-chain polysaccharides constituted by a chain of b-D-glucopyranosyl units joined by bonds of b— ( 1—3 ) type and with side chains joined by b— ( 1—4 ) and b— ( 1— 6 ) bonds. They are polymers which can be found abundantly in nature, mainly in cereals such as barley and oat, but even in the wall of bacteria and yeasts such as Saccharomyces cerevisiae. They are provided with different pharmacological activities, thereamong protection from infections, decrease in the plasmatic concentrations of lipids, development inhibition and tumour metastasis. It is believed that asthma and allergies are associated to an excessive Th2 response, b-l , 3-glucans can stimulate macrophages, which produce prostaglandin E2, factor of tumour necrosis and IL-10 and they can inhibit Th2 response.
  • b-glucans are known modifiers in the biological response. Their effects were investigated after administration through several routes: these polymers are capable of carrying out a good pharmacological activity even when administered by oral route and show a strengthened effect when administered with other immunological therapies. These polymers act by activating the whole immune system.
  • b-glucans can be derived from several sources and show structural differences and their pharmacological activities are determined by their molecular structure, by the chain length, by the level of branches, by possible structural modifications, by shape and solubility.
  • PAMPs Pulthogen Associated
  • PRR Pattern Recognition Receptors
  • PRR which recognize b-glucans include the toll-like receptors (TLR) , Lectine with domain of type C ( CLR) such as dectin-1, receptors of the complement system (CR3), lactosylceramide and scavenger receptors.
  • the receptors for b-glucan were identified on the surface of the cells of the immune system, thereamong neutrophils, eosinophils, Natural Killer cells, endothelial cells, alveolar epithelial cells and various types of macrophages, as well as cells not belonging to the immune system, thereamong epithelial cells, vascular endothelium cells, fibroblasts, b-glucans are powerful activators of macrophages, monocytes and neutrophils and they are mainly responsible for the stimulation of the reticuloendothelial system.
  • the recognition of the b-glucans as not-self molecules by the mammal cells induces the innate and adaptive immune response.
  • b-glucans The initial response to b-glucans takes place through the innate immunity. This response is rapid and not specific and mainly involves the phagocytic cells, such as macrophages and neutrophils.
  • b-glucans interact with the mucosal immune system at intestinal level (Peyer plates) and this induces the production of cytokines and the resistance to infections.
  • b-glucans are transported by the intestinal macrophages to the organs of the immune system (spleen, lymph nodes, bone marrow, etc.) through the lymphatic system. In the bone marrow, the b-glucans having the highest molecular weight are degraded into smaller fragments by the macrophages.
  • b-glucans induce phagocytosis, they stimulate bactericidal mechanisms such as the respiratory burst and induce the production of components of the innate immune system, such as TNF- ci, Interleukin-1, protein MIP-2 (macrophage inflammatory protein 2-alpha), eicosanoids. Other cells are employed at the infection site and they activate the adaptive immune response.
  • b-glucans prepared according to the procedures known to the person skilled in the art or the products available on the market could be used.
  • the composition could include for example an amount of b-glucans ranging between 0.1 mg and 2000 mg, preferably between 10 and 500 mg.
  • compositions according to the present invention could be formulated in any form suitable to the designated administration and associated to any other suitable component, in a variety of ways, for example they will be formulated for the nasal or inhalatory administration such as liquids, solutions, suspensions, solutions in bottles for nebulization, aerosol, creams, ointments.
  • the compositions could be formulated with excipients and/or diluents.
  • excipients can be selected for example among those usually known in the state of art and include, but they are not limited thereto: a) carriers, b) fillers c) moistening agents d) disintegrating agents e) binders etc.
  • diluents carriers, excipients known to the person skilled in the art, could be used.
  • compositions will be formulated for oral use for example as capsules, soft capsules, tablets, pills, gelatines, powders or granules.
  • excipients can be selected for example among those usually known in the state of art and they include, but they are not limited thereto: 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) moistening agents, such as for example glycerol, d) disintegrating agents, such as alginates, calcium carbonate, starches, derivatives of starch, of cellulose and of polyvinylpyrrolidone, silicates and sodium carbonate e) binders such as carboxymethylcellulose, alginates, gelatine, polyvinylpyrrolidone, sucrose, polymeric derivatives of cellulose, starch derivatives f) retarding agents such as paraffin, cellulose poly
  • the forms of solid dosage such as tablets, capsules, soft capsules, gelatines, pills and granules, could be coated with enteric, gastric coatings or of any other type known in the state of art. They can include opacifiers and can be of the type to allow the release of the active ingredients only or preferably in a certain tract of intestine, in case, in delayed way. Substances which can allow such delayed use include, but they are not limited thereto, polymers and waxes.
  • the soft capsules could 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 could be characterized by a casing qualitatively similar to that of the hard ones, but thicker and softer.
  • Liquid forms suitable to an oral administration for example are emulsions, solutions, prepared or extemporaneous suspensions, syrups and elixirs.
  • Excipients suitable to the formulations according to the present invention in liquid forms for oral use include, but they are not limited thereto, diluents such as water or other solvents, solubilizing agents, and emulsifiers selected from ethyl alcohol, polyalcohols, propylene glycol, glycerol, polyethylene glycol and sorbitan esters. These formulations can even include sweeteners and aroma.
  • compositions could be for example a medical device, food supplement, a nutraceutical , dietary, nutritional composition, food product, a beverage, a neutraceutical product, a medicament, medicated food, food for special medical purposes, food.
  • the compositions mainly will be intended to be used by human beings, but they could also be used on animals.
  • the combination of above-mentioned active ingredients could be used formulated in one single composition according to the various above-described embodiments or in a kit including the several separate ingredients, for example in single compositions such as capsules, pills, tablets for sequential or contemporary administration of the different ingredients.
  • the compositions according to the present invention will be in form of a spray comprising for example a bottle, a dosing pump and a dispenser.
  • the combination of active ingredients according to the present invention will be administered with a daily dosage regime according to the above-mentioned concentrations, that is Propolis in an amount between 1 mg and 1000 mg, the extract of Matricaria recutita in an amount between 0.1 mg and 150 mg and b-glucans are present in an amount between 0.1 mg and 2000 mg.
  • compositions according to the present invention will be used for the prevention and/or treatment of the respiratory or oropharyngeal diseases, in particular for a disease selected from rhinitis, sinusitis, pharyngitis, epiglottitis, laryngitis, bronchiolitis, cystic fibrosis, bronchiectasis.
  • Rhinitis is an inflammatory process relating the mucosa of the nasal cavities and it is distinguished in acute and chronical.
  • Acute rhinitis generally are sustained by viruses, thereamong Rhinovirus, Coronavirus, influenza and parainfluenza viruses, RSV, Coxsackie virus, ECHO virus and adenovirus.
  • the contagion takes place by direct contact with the ill subject who, in the peak of maximum infectivity (generally on the first day) , has 500-1000 virions per ml of secretion, which he/she emits through cough and sneezing. Bacterial superinfections are possible which cause complications such as otitis and sinusitis.
  • Rhinovirus determines acute symptoms in the first 3-4 days, whereas for 7- 10 days cough and other symptoms persist. There is an excess in mucous secretions which are fluid and transparent, and become purulent and evil-smelling in case of bacterial superimposition.
  • the chronical form generally is secondary to sinusitis, deviations of the nasal septum, hypertrophic adenoids.
  • the allergic rhinitis is due to the exposure by the subject to substances which cause him/her a mediated IgE reaction, characterized by an excessive production of fluids, intranasal pruritus, sneezing and obstruction. IgE, in fact, bind to the mastocytes which release huge amounts of histamine, responsible for all morbid manifestations.
  • Sinusitis is the inflammation of the mucosa coating the paranasal sinuses, bone cavities placed in the facial bones and which are in communication with the nasal fossae, and therefore they can infect for the same causes which determine rhinitis.
  • Sinusitis can be distinguished in viral acute or bacterial acute (up to 4 weeks), chronical (beyond 12 weeks) and acute recurrent (at least 4 episodes per year with resolution) .
  • a healthy sinus is sterile, characterized by suitable drainage of the mucus, and free passage of air.
  • Ciliary abnormality or immobility determine an inhibition of the drainage resulting in sinusitis.
  • Factors predisposing to this disease are an immunocompromised state, deviation of the nasal septum, nasal polypuses, tumours , trauma and fractures, cocaine abuse, presence of foreign bodies .
  • a viral acute form can be subjected to bacterial superinfection.
  • the bacteria commonly responsible for these infections are Streptococcus pneumoniae, non-typeable Haemophilus influenzae, Moraxella catarrhalis.
  • Pseudomonas aeruginosa is most frequently present in sinusitis by HIV infections and cystic fibrosis.
  • Some kinds 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 in: mucopurulent discharges from the nose, nasal obstruction, congestion, facial pain, pressure to the involved sinuses, hyposmia, anosmia, fever, feel of pressure or "plug" in the ears, teeth pain.
  • mucopurulent discharges from the nose nasal obstruction, congestion, facial pain, pressure to the involved sinuses, hyposmia, anosmia, fever, feel of pressure or "plug" in the ears, teeth pain.
  • antibiotics Generally in the first 3-5 days one is not capable of distinguishing a viral form from a bacterial form, therefore the use of antibiotics is not recommended.
  • the chronical forms have a slower onset, longer duration and frequency.
  • the symptoms are similar to those of the acute form with, in addition, bad breath, laryngitis, bronchitis and asthma worsening.
  • the treatment is mainly symptomatic.
  • the decongestant treatment is useful to reduce oedema, to improve drainage of the excess mucus and keep patency of the sinus apertures.
  • a good result can be obtained from the local application of hypertonic saline solution both in the treatment of the acute bacterial form, and of the recurrent acute one and in the chronical one and even for prevention.
  • the selection of the antibiotics instead, has to take into consideration the production of beta lactamases and of the presence of pneumococci resistant to drugs.
  • Pharyngitis faringo-tonsillitis
  • the infection can be sustained by viruses (such as Epstein-Barr ) and by bacteria.
  • viruses such as Epstein-Barr
  • the beta-haemolytic Streptococcus pyogenes of group A is the most frequent one in the paediatric forms, but even Micoplasma pneumoniae, Clamidia pneumoniae are found in adults and children.
  • the forms transmitted by sexual contact and sustained by Neisseria gonorrhoeae and those by Corynebacterium dyphtheriae are further to be considered.
  • Inflammation of larynx which appears with aphonia and hoarseness, mainly caused by viruses, but up to 10% of cases even by bacteria (including streptococci and C. dyphtheriae) .
  • Not infective causes can be tumours, thermal or caustic trauma, GERD.
  • Laryngitis has symptoms lasting 3-4 days and, unless bacteria are present, antibiotics are not used .
  • Bronchiolitis frequently paediatric disease, is characterized by an extended inflammation of the respiratory tracts accompanied by an intense production of mucus and by necrosis of epithelial cells. Primarily it is caused by a viral infection, in particular by RSV (respiratory syncytial virus), but even adenovirus, influenza and parainfluenza virus, human metapneumovirus and rhinovirus, whereas the most frequently involved bacteria are of Clamidia genus.
  • RSV respiratory syncytial virus
  • adenovirus influenza and parainfluenza virus
  • human metapneumovirus and rhinovirus whereas the most frequently involved bacteria are of Clamidia genus.
  • the treatment can provide hospitalization in case saturation of oxygen is comprised between 92 and 94%, together with other clinical manifestations like poor nutrition, dehydration and dyspnea anamnesis .
  • This disease is caused by a mutation of the gene codifying for protein CFTR, an anionic channel expressed in the epithelial cells in the whole body. Although it acts above all as channel of the chloride ion, it is capable of regulating even the function of other membrane proteins, like the sodium epithelial channel (ENaC) , the activity thereof is inhibited.
  • CFTR adjusts even the intracellular secretion of bicarbonate, which is reduced and determines a lowering in epithelial pH with a consequent reduced protection from the microbes and an increase in the viscoelasticity of mucus.
  • the dysfunction of CFTR channel in the lung thus determines an excessive sodium absorption and a reduced active secretion of chlorine with a consequent reduction in the liquid layer of the mucosa surface.
  • Bronchiectasis It is a disease characterized by an irreversible dilation of a portion of the bronchial tree in the lungs.
  • the bronchial dilation can be the result of a structural defect of the wall, of the exposure to an abnormal pressure, or of a damage of cartilage or of the elastic tissue after inflammation. It involves bronchi and bronchioles wherein a vicious circle of infection and inflammation can be established, even with release of mediators.
  • Common symptoms are cough producing mucus and chest pain. Mucus has an increased quantity of elastase, and of TNF a, IL-8 and prostanoids. It can appear like a local obstructive process or widespread in a portion of both lobes, even accompanied by sinusitis or asthma.
  • the causes are various, for example, above all in paediatric age, even mycotic infections which leave a permanent damage. Or primary ciliary dyskinesia, wherein there is a marked retention of secretions followed by infections.
  • the cystic fibrosis as immunodeficiency conditions can be predisposing factors. It was further observed that in patients with ulcerative colitis there are infections of the respiratory tract and bronchiectasis .
  • the treatment provides the use of antimicrobial agents to fight against the infections sustained both by bacteria and fungi. Moreover, it results to be particularly useful to perform washing of respiratory tracts to increase the removal of secretions, by using saline solutions and to keep the patient, generally, well hydrated.
  • the synergic action takes place between Propolis, extract of Matricaria recutita and b- glucans .
  • 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
  • b-glucans are present in an amount between 0.1 mg and 2000 mg.
  • Bottle with dosing pump and dispenser .
  • Bottle with dosing pump and dispenser .

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Abstract

La présente invention concerne une composition comprenant de la propolis, un extrait de Matricaria recutita et des β-glucanes pour la prévention et/ou le traitement des maladies respiratoires et oropharyngées. L'invention repose sur l'action synergique des principes actifs susmentionnés.
PCT/IB2019/052256 2018-03-21 2019-03-20 Composition à utiliser pour le traitement de maladies respiratoires et oropharyngées WO2019180635A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021222987A1 (fr) * 2020-05-08 2021-11-11 Gretals Australia Pty Ltd Compositions et procédés pour la prophylaxie et le traitement d'affections fibrotiques et inflammatoires

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US20090196921A1 (en) * 2008-02-06 2009-08-06 The Procter & Gamble Company Compositions Methods and Kits For Enhancing Immune Response To A Respiratory Condition
US20090230013A1 (en) * 2008-03-17 2009-09-17 The Procter & Gamble Company User-Customizable Dosing System
US20130216574A1 (en) * 2012-02-20 2013-08-22 James Liu Kit providing multiple unmet therapeutic effects
US20140037688A1 (en) * 2011-03-01 2014-02-06 Quorum Innovations, Llc Materials and Methods for Treating Conditions Associated with Pathogenic Biofilm

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US20090196921A1 (en) * 2008-02-06 2009-08-06 The Procter & Gamble Company Compositions Methods and Kits For Enhancing Immune Response To A Respiratory Condition
US20090230013A1 (en) * 2008-03-17 2009-09-17 The Procter & Gamble Company User-Customizable Dosing System
US20140037688A1 (en) * 2011-03-01 2014-02-06 Quorum Innovations, Llc Materials and Methods for Treating Conditions Associated with Pathogenic Biofilm
US20130216574A1 (en) * 2012-02-20 2013-08-22 James Liu Kit providing multiple unmet therapeutic effects

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Title
DATABASE GNPD [online] MINTEL; 1 August 2010 (2010-08-01), ROXSPA AESTHETICS: "Correct Aging/Normal Skin Serum", XP002787233, Database accession no. 1378737 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021222987A1 (fr) * 2020-05-08 2021-11-11 Gretals Australia Pty Ltd Compositions et procédés pour la prophylaxie et le traitement d'affections fibrotiques et inflammatoires

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