EP3672589A1 - Kombinationsprodukt zur linderung von mit infektionen der oberen atemwege verbundenen symptomen - Google Patents
Kombinationsprodukt zur linderung von mit infektionen der oberen atemwege verbundenen symptomenInfo
- Publication number
- EP3672589A1 EP3672589A1 EP18750212.5A EP18750212A EP3672589A1 EP 3672589 A1 EP3672589 A1 EP 3672589A1 EP 18750212 A EP18750212 A EP 18750212A EP 3672589 A1 EP3672589 A1 EP 3672589A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- eucalyptus
- combination product
- erysimum
- zinc
- upper respiratory
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/30—Zinc; Compounds thereof
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
- A61K35/644—Beeswax; Propolis; Royal jelly; Honey
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- 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)
- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
-
- 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)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
-
- 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)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
-
- 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
- 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
- A61P11/02—Nasal agents, e.g. decongestants
-
- 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
- A61P11/04—Drugs for disorders of the respiratory system for throat disorders
Definitions
- the present invention relates to a combination product comprising as active substances, at least zinc, eucalyptus and erysimum or a bioequivalent compound thereof to help relieve symptoms related to respiratory tract infections. higher.
- the invention finally relates to the use of a combination product as previously defined for the treatment of symptoms related to upper respiratory tract infections.
- Upper respiratory tract infections are a medical term for a specific infection in the nose, throat or sinuses. These types of infections are usually characterized by cold symptoms and are most often caused by viruses. However, in some cases, bacteria are also responsible for triggering these infections.
- Upper respiratory tract infections include rhinitis, nasopharyngitis, laryngitis and sinusitis.
- Rhinitis is the medical term describing the irritation and inflammation (acute or chronic) of the mucous membranes of the nasal cavity. Rhinitis can be allergic or not. When they are chronic, they strongly affect the quality of life of those who are victims, to the point that the WHO published in 2001 a new classification of the disease.
- Rhinitis is often accompanied by other disorders such as asthma and / or sinusitis and is a cause of insomnia and fatigue. Fifty percent (50%) of patients with rhinitis have non-specific bronchial hyperreactivity, and therefore an increased risk of asthma. Inversely, asthmatics almost all have rhinitis (more or less acute) associated with asthma attacks. The symptoms are: - flowing (rhinorrhea);
- Acute non-allergic rhinitis can be induced by an infection (bacterial or more often viral). In the latter case, acute viral rhinitis can lead to a loss of smell (35% of cases of dysosmia) when an overabundant mucus covers the olfactory epithelium to the point of preventing the recognition of odors by the brain8).
- nasolabial polyposis nasal duct more or less closed by polyps.
- pregnancy rhinitis or "pregnancy rhinitis” occurring in about 30% of pregnant women with a "stuffy nose” sensation. This usually occurs after the first trimester and worsens during the third trimester and disappears most often two weeks after delivery.
- Rhinopharyngitis is a very common infection of the respiratory tract, specifically the nasopharynx, the cavity that extends from the nasal cavity to the pharynx.
- the symptoms of rhinopharyngitis similar to those of colds, usually persist between 7 and 10 days. Very common in young children from the age of 6 months, it appears mostly in autumn and winter. A child may have between 7 and 10 episodes of nasopharyngitis per year.
- Laryngitis is often infectious laryngeal inflammation of viral or bacterial origin. Laryngitis can be more or less dangerous depending on the seat of the condition. There are also chronic irritating laryngitis due to tobacco or the misuse of his voice.
- the diagnosis of laryngitis is clinical and associates a dysphonic syndrome (hoarseness of the voice, gradual extinction of the voice) and a dyspneic syndrome (especially in the child because of the narrowness of the laryngeal die, inspiratory bradypnea with draw, or whirling).
- a dysphonic syndrome haarseness of the voice, gradual extinction of the voice
- a dyspneic syndrome especially in the child because of the narrowness of the laryngeal die, inspiratory bradypnea with draw, or whirling.
- the dyspnoeic syndrome dominates.
- the dysphonic syndrome dominates.
- laryngitis chronic laryngitis, acute subglottic laryngitis of the child, striatal laryngitis, pseudo-myxomatous laryngitis.
- Sinusitis is an inflammation or infection of one or more of the four sinuses (maxillary, frontal, sphenoidal or ethmoidal) that the human body has.
- Rhinovirus The main viruses involved are: Rhinovirus, Myxovirus and Adenovirus.
- the main bacteria responsible for sinus superinfections are: Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, Staphylococcus aureus.
- Sinusitis can be of two types:
- Acute in most cases caused by a viral infection of the cold type, it is treated between 7 and 12 days. It can also be caused by allergies or dental abscesses. Chronic: they can be the consequence of insufficiently treated infectious episodes and are often favored by anatomical or allergic factors. Sinusitis is described as chronic when it lasts beyond 2 weeks and up to 4-8 weeks. However, acute sinusitis can be described as chronic if it is repeated 2 to 4 times during the same year.
- compositions because of the presence of active molecules such as paracetamol, pseudoephedrine, chlorphenamine, diphenhydramine, ibuprofen have the disadvantage of not being able to be used by the entire population. Indeed,
- liver failure should not be used in the following cases: liver failure; risk of closed angle glaucoma; risk of blockage of urine (adenoma of the prostate); arterial hypertension not controlled by a specific treatment; severe coronary heart disease; history of seizures, history of stroke; in combination with a non-selective MAOI antidepressant or for at least 15 days after taking it; in association with
- Arkopharma Duoflash® Respiratory Comfort product which contains sunflower oil, Ravintsara leaf essential oil (Cinnamomum Camphora), essential oil. Thymol Thyme (Thymus Vulgaris) thymus aerial part, Eucalyptus leaf extract (Eucalyptus Globulus), and Pelargonium root extract (Pelargonium Sidoides).
- Actirub® product marketed by the Green Health Laboratory which contains echinacea dry extract (Echinacea purpurea) titrated with 4% echinacosides, dry extract
- Andrographis Angrographis paniculata titrated to 6% of andrographolides, astragalus dry extract (Astragalus membranaceus) titrated to 16% polysaccharides, N-acetylcysteine, vitamin C, dry extract white broth (Verbascum thapsus), dry extract of thyme (Thymus vulgaris), dry extract of White willow (salix alba) titrated with 25% of salicin, dry extract of camomillie (Tanacetum) parthenium) titrated with 0.5% parthenolides, dry extract of elderberry
- the Applicant has developed, and it is the object of the present invention, a combination product comprising as active substances, at least zinc, eucalyptus and erysimum or a bioequivalent compound thereof. last to help relieve L5-related symptoms to upper respiratory infections.
- relieveving the symptoms associated with upper respiratory tract infections is meant in the context of the present invention, a product that makes it possible to soften the throat, to provide tone for the day, to clear the upper respiratory tract, especially the nose, bringing a feeling of freshness, but also to facilitate falling asleep at bedtime.
- Such a product thus makes it possible to relieve the symptoms associated with upper respiratory tract infections with products of natural origin and to treat a greater number of people.
- the product according to the present invention also has the advantage of preferably containing no artificial dyes, allergens and preferably being lactose or gluten-free.
- the product of the present invention has a galenic adapted to the adult, preferably in the form of a tablet to be sucked or swallowed.
- the product according to the present invention although containing products of natural origin has a pleasant taste and smell.
- the present invention relates to a combination product comprising, as active substances, at least zinc, eucalyptus and erysimum or a bioequivalent compound of eucalyptus and erysimum to help relieve symptoms related to to infections of the upper respiratory tract.
- the present invention also relates to a combination product comprising as active substances at least zinc, eucalyptus and erysimum or a bioequivalent compound of eucalyptus and erysimum for its use. in the treatment of symptoms related to upper respiratory tract infections.
- the combination product according to the invention comprises, in addition to zinc, eucalyptus and erysimum, as active substances:
- vitamins and minerals such as for example vitamin C
- the combination product of the invention is characterized in that L5 eucalyptus and erysimum are in the form of plant extracts in a tablet comprising: from 3 to 15%, preferably from 6 to 10% % of eucalyptus solids of 3 to 10, preferably 4 to 8%, of erysimum solids of 0.01 to 0.2%, preferably 0.05 to 0.1% of zinc
- the combination product of the invention is characterized in that the tablet comprises, according to a first alternative: from 3 to 15%, preferably from 6 to 10%, of eucalyptus solids of 3 to 10%. preferably 4 to 8% of dry extracts of erysimum
- composition will be taken, preferably, before the sleep phase of the subject having an infection of the upper respiratory tract.
- the combination product of the invention is characterized in that the tablet comprises, according to a second alternative: from 3 to 15%, preferably 6 to 10%, of eucalyptus solids of 3 to 10%. %, preferably 4 to 8% of dry extracts of erysimum of 0.01 to 0.2%, preferably 0.05 to 0.1% of zinc of 0.01 to 2%, preferably 0.05 to 0.5% of 1% propolis of 1 to 20%, preferably 5 to 10% of vitamin C as a percentage by weight relative to the total weight of the composition
- the composition will be taken, preferably during the "active" phase, that is to say at least 4 hours before the sleep phase of the subject having an infection of the upper respiratory tract.
- the combination product according to the invention may be in the form of a single (or combined) composition containing at least as active substances:
- the combination product is characterized in that the active ingredients (i), (ii), (iii), (iv), (v) and (vi) or a bioequivalent compound of these are in a medium suitable for oral administration.
- the suitable medium is a solid medium.
- the combination product is in the form of a tablet.
- the eucalyptus, the erysimum, and the poppy may be present as ingredients (ii), (iii) or (iv) in a combination product of the invention in more or less purified form, especially in the form of vegetable extract.
- the Applicant has demonstrated that the combination of zinc, eucalyptus and erysimum has a synergistic effect to help relieve symptoms related to upper respiratory tract infections.
- the combination of zinc, eucalyptus and erysimum has an effect on the relief of symptoms related to upper respiratory tract infections, during treatment which is superior the cumulative effects of a treatment (a) comprising the administration of zinc, not associated with eucalyptus, with erysimum, and conversely with a treatment (b) comprising the administration of eucalyptus, not associated with zinc and erysimum or a treatment (c) including the administration of erysimum, not associated with zinc and eucalyptus.
- European aromatherapy mainly uses the essential oil of four species of eucalyptus. • Lemon eucalyptus (E. citriodora). Preferred for topical applications (arthritis, tendonitis, itching, mosquito repellent, etc.).
- Eucalyptus radish (E. radiata). Better tolerated by the mucous membranes and the skin; good for children Not recommended during the first three months of pregnancy.
- the European Commission has approved the use of the leaves (internal route) and the essential oil (internal and external route) of Eucalyptus globulus, to treat inflammation of the respiratory tract.
- the World Health Organization recognizes the traditional use of eucalyptus leaves (E. globulus) to relieve fever and symptoms of asthma, inflammation of the airways, bronchial tubes or throat.
- composition according to the present invention comprises from 3 to 15%, preferably from 6 to 10%, of dry extracts of eucalyptus in percentage by weight relative to the total weight of the composition.
- Erysimum is a genus of dicotyledonous plants of the family Brassicaceae. This genus includes wallflowers, which include both cultivated ornamental species and various wild forms. Erysimum has pain-canceling effects as well as active principles similar to those of promethazine. With expectorant properties, velar leaves can calm coughs and inflammation of the larynx. They are therefore recommended in hoarseness of the voice. Since these same leaves are mucolytic, they can also facilitate the expulsion of mucus. They also prevent the disease called scurvy and stimulates the whole body. The flowering tops of this plant have the same properties as these leaves.
- composition according to the present invention comprises from 3 to 10, preferably from 4 to 8% of dry extracts of erysimum in percentage by weight relative to the total weight of the composition.
- Zinc is a trace element essential for low doses to animal and human life
- zinc in assimilable form is an important trace element, essential for plant and animal organisms. Duly assimilated by the organisms, it activates in particular the enzymes, influences the growth, favors the reactions and biochemical controls on the level of the pulmonary surfaces.
- the human body contains 2 g to 4 g. Daily requirements can be estimated at a minimum of 15 mg for a normal man, and up to twice as much for a breastfeeding woman.
- Zinc is contained in various yeasts (up to 100 mg per kilogram) and in red meat (in the range of 50 mg to 120 mg per kilogram), but also in a multitude of marketed foods.
- composition according to the present invention comprises from 0.01 to 0.2%, preferably from 0.05 to 0.1%, of zinc as a percentage by weight relative to the total weight of the composition.
- the poppy (Papaver rhoeas) is a dicotyledonous plant species of the family Papaveraceae, native to Eurasia.
- the poppy has narcotic effects due to the alkaloids it contains.
- composition according to the present invention comprises from 1 to 10, preferably 2 to 5% dry L0 extracts of poppy in percentage by weight relative to the total weight of the composition.
- Propolis refers to both a resinous material produced by certain plants and a complex material made by bees from this plant resin and wax
- Plant propolis refers to a series of resinous, gummy and balsamic L5 substances present on plants.
- the main tree species producing propolis are conifers (pine bark, fir, spruce) and the buds of several species of alder, willow, birch, plum, ash, oak and elm. , poplars (which seem to be the most important source) and horse chestnut.
- Bees propolis is a complex made by the bee from its secretions and the plant propolis that it has harvested.
- the propolis collected in the hive is composed of: resins and balms: 50 to 55% wax: 30 to 40% volatile or essential oils: 5 to 10% 15 pollen: 5% various materials: 5%
- This propolis also contains many other elements such as organic acids, many flavonoids, trace elements, many vitamins. It also contains paraben, whose antibacterial and antifungal properties help fight pathogens in the hive.
- propolis has multiple uses. It is a mortar used to seal cracks or gaps, to seal against moisture and mold growth, to reinforce racks or defective parts of the hive and to protect the colony by reducing entrance to the hive. It is also a sanitizing varnish deposited in a thin layer inside the cells before the laying of the queen, or to smooth the inner walls of the hive. It also serves to mummify dead intruder animals (rats and mice for example), too big to be evacuated by the bees, thus avoiding their decomposition.
- Raw propolis or in the form of mother tincture is an anti-infective (antifungal, antiseptic, antibiotic). It also has anesthetic, healing and anti-inflammatory power and increases cellular metabolism.
- propolis is a complex material made by bees from plant propolis and wax
- composition according to the present invention comprises 0.01 to 2%, preferably 0.05 to 1% of propolis as a percentage by weight relative to the total weight of the composition.
- Vitamin C is a water-soluble, heat-sensitive vitamin and light that plays an important role in the metabolism of humans and many other mammals. Chemically speaking, it is L-ascorbic acid, one of the stereoisomers of ascorbic acid, and its salts, ascorbates. The most common are sodium ascorbate and calcium ascorbate. Vitamin C is an enzymatic cofactor involved in a number of physiological reactions (hydroxylation). It is required in the synthesis of collagen and red blood cells and contributes to the immune system. It also plays a role in the metabolism of iron as a promoter of its absorption; its use is therefore not recommended in patients with iron overload and particularly hemochromatosis. In oxidized form (dehydroascorbic acid), it crosses the blood-brain barrier to access the brain and several organs with a high concentration of vitamin C.
- This vitamin is widely used in self-medication in the common cold. It seems to shorten the duration of symptoms and improve them in adults.
- composition according to the present invention comprises from 1 to 20%, preferably from 5 to 10% of vitamin C as a percentage by weight relative to the total weight of the composition.
- a physiologically acceptable medium is a medium having no toxic or detrimental effect under the conditions of use and inert with respect to the active ingredients of the combination product.
- a medium may, for example, comprise various adjuvants according to its therapeutic or cosmetic purpose, such as, but not limited to, flavors, dyes, fillers, preservatives, diluents, wetting or suspending agents, etc.
- Such media may also allow immediate, modified or delayed release of either active ingredient.
- the physiologically acceptable medium may be water, mash and / or fruit juice, texturizers, emulsifiers, colorants, preservatives, flavorings, sugar or sugars.
- mash and / or fruit juice is meant a more or less liquid preparation, in particular according to the nature of the fruit and / or the fineness of the grinding, prepared by grinding, pressing or other extraction process of one or more several fruits and optionally the concentration of the ground material obtained and / or the separation (in particular filtration) of the seeds, achenes and / or all or part of the pulp, and / or flash pasteurisation.
- the fruits can be chosen from: apple, banana, strawberry, peach, raspberry, blackberry, mango, kiwi, blueberry, blackcurrant, currant, orange, cherry, fig, pear, apricot, coconut, passion fruit, guava, papaya, melon, lychee, pineapple, lemon, mandarin, plum, grapefruit, grape, rhubarb and their mixtures, without this list being exhaustive.
- Textturizers means compounds that modify the texture of the products in which they are incorporated. Examples of texturants are: guar and carob flour; the erasers
- emulsifiers amphiphilic compounds characterized by their HLB (Hydrophilic Lipophilic Balance) value, in particular capable of stabilizing oil-in-water emulsions (particularly advantageous if it is desired to add, for example, liposoluble active agents).
- HLB Hydrophilic Lipophilic Balance
- L0 such as fat soluble vitamins.
- food emulsifiers are lecithin and its derivatives present in particular in egg yolk; mono- and diglycerides of fatty acids; and polysorbate 80.
- dye is meant compounds of natural or synthetic origin capable of conferring on their own a coloration to the composition.
- Examples of food colorants are L5 known in Europe under the codes E100 to E180.
- Preservatives means compounds that inhibit the proliferation of microorganisms, in particular yeasts and / or molds and / or bacteria, in particular Staphylococcus aureus, in the composition.
- Examples of food preservatives are sorbic acid and its salts (E200 to E203: benzoic acid and its salts (E210 to E219), sulfites and derivatives (E220 to E228), natamycin, nisin;
- the composition according to the invention does not comprise any preservative.
- flavors compounds of natural or synthetic origin capable alone to change the taste of the composition.
- flavors are apricots, pineapples, bananas, blackcurrants, cherries, lemons, lime, strawberries, raspberries, passion fruits, tangerines, peppermint, mint orange, pistachio, pear, licorice, rose, anise, blueberry, cinnamon, ginger, grapefruit, apple, kiwi, lychee, melon, coconut, peach, currant, guava, grenadine, mango, blackberry, papaya, tea, vanillin, natural vanilla extract, essential oils and mixtures thereof.
- sugar or sugar is understood to mean any sweetening carbohydrate, preferably glucose syrup, sucrose, glucose, fructose, invert sugar, honey, maltose, polyol or mixtures thereof.
- sugar used is a polyol, preferably sorbitol.
- the combination product may include, by way of example, vitamins, mineral salts, essential amino acids, essential fatty acids, trace elements, various plant extracts, fibers, antioxidants, flavonoids.
- such additional asset may be intended to enhance the desired effect as described above.
- water-soluble vitamins and fat-soluble vitamins examples include vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid) also called vitamin PP (preventive pellagra), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B8 or H (biotin), vitamin B9 (folic acid) and vitamin B12 (cobalamin).
- vitamin B1 thiamine
- vitamin B2 riboflavin
- vitamin B3 nicotinic acid
- vitamin PP preventive pellagra
- vitamin B5 pantothenic acid
- vitamin B6 pyridoxine
- vitamin B8 or H biotin
- vitamin B9 folic acid
- vitamin B12 cobalamin
- liposoluble vitamins present in the syrupy product prepared according to the invention are in particular: vitamin A (retinol), vitamin D3 (cholecalciferol), vitamin E (mixture of tocopherols and tocotrienols) and vitamin K (phylloquinon
- antioxidants such as curcuminoids; carotenoids, especially chosen from beta-carotene, astaxanthin, zeaxanthin, lutein or compounds containing them, such as goji berries; polyphenol compounds, flavonoids such as catechins; proanthocyanidins, anthocyanins, OPCs (procyanidolic oligomers); ubiquinones; coffee extracts containing polyphenols and / or diterpenes; chicory extracts; ginkgo biloba extracts; grape extracts rich in proanthocyanidins; chili extracts; soy extracts; Cocoa ; the grenade ; the Emblica; CoenzymeQ10; selenium, minerals, such as magnesium, calcium, copper, iron, iodine, manganese, selenium, chromium (III),
- amino acids especially sulfur-containing amino acids, such as glutathione precursors, the amino acids of selenium, citrulline,
- phytosterols resveratrol, hesperidin, neohesperidin, orthosilicic acid, monomethylsilanetriol, and mixtures thereof.
- a combination product according to the invention is administered orally.
- suitable forms for the oral route are, for example, tablets, capsules, lozenges, powders, granules, lyophilisates, oral solutes and syrups. Tablets, powders, granules, lyophilisers, oral solutes and syrups are the currently preferred oral pharmaceutical form.
- a solid composition in tablet form it is possible for example to mix the main active ingredients (i), (ii), (iii), (iv), (v) or (vi) with a Physiologically acceptable vehicle such as gelatin, starch, magnesium stearate, calcium stearate, talc, gum arabic or analogies.
- the tablets may be varied in nature, immediate release, controlled or delayed and optionally in effervescent or orodispersible form.
- a tablet preparation is obtained by mixing the active ingredient (i), (ii), (iii), (iv), (v) or (vi) as a powder.
- composition is obtained by mixing the various compounds according to the methods conventionally used for this type of preparation.
- the composition is then preferably in the form of a tablet.
- This tablet will be taken, preferably, by the subjects presenting an infection of the upper respiratory tracts, before the phase of sleep (at the time of the bedtime).
- composition is obtained by mixing the various compounds according to the methods conventionally used for this type of preparation.
- the composition is then preferably in the form of a bilayer tablet.
- This tablet will be taken, preferably, by the subject having an infection of the upper respiratory tract, during the "active" phase, preferably the subject will take 2 tablets during this "active" phase.
- Example 3 Tablet perception survey according to Examples 1 and 2
- Example 4 Observational study evaluating the efficacy of the tablets according to Examples 1 and 2
- the study was proposed to men and women, aged 18 to 65, with discomfort in the nose and / or throat characterized by symptoms such as runny nose, stuffy nose, sore throat or sneezing.
- the primary endpoint is the evolution of the Wisconsin upper respiratory symptom survey. It is an internationally validated questionnaire for assessing cold symptoms and their impact on quality of life. It has 21 questions rated from 0 to 7 and ranges from 0 to 147, the higher the score, the more severely ill the patient is.
- the particularity of the study is to document every day, from very accurately, the evolution of their symptoms by asking these people to describe them on a secure data collection system. This study also highlights the perceived improvement over inclusion in the criteria of respiratory comfort, throat softening, sleep, and fatigue. On the other hand, the overall satisfaction of the people at the end of the study is also evaluated.
- the results of the study include 93 people, 92 of whom completed the elements daily to assess the evolution of their symptoms. They are on average 38 years old and 81.5% female. At baseline, nose or throat symptoms and their impacts on daily life are relatively high with a Wurss score of 63 on average.
- the persons taking the study take two tablets each day following example 2 (one in the morning and one at midday) and one tablet according to example 1 in the evening. Under the effect of the product, from the first day, the overall inconvenience decreases rapidly and regularly as shown in Figure 1 with reductions reaching 45% from the second day, 65.4% on the 3rd day and disappear gradually thereafter. It is the same when we specifically analyzes the evolution of the score of clinical symptoms of the common cold (-42.4% on the second day) and improving the quality of life (-40.8% from the 2nd day).
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Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR1770885A FR3070261B1 (fr) | 2017-08-23 | 2017-08-23 | Produit de combinaison pour soulager les symptomes lies aux infections des voies respiratoires superieures |
| PCT/EP2018/071673 WO2019038100A1 (fr) | 2017-08-23 | 2018-08-09 | Produit de combinaison pour soulager les symptômes liés aux infections des voies respiratoires supérieures |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP3672589A1 true EP3672589A1 (de) | 2020-07-01 |
Family
ID=60765960
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP18750212.5A Pending EP3672589A1 (de) | 2017-08-23 | 2018-08-09 | Kombinationsprodukt zur linderung von mit infektionen der oberen atemwege verbundenen symptomen |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP3672589A1 (de) |
| FR (1) | FR3070261B1 (de) |
| WO (1) | WO2019038100A1 (de) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR3101540B1 (fr) * | 2019-10-04 | 2023-06-02 | Urgo Rech Innovation Et Developpement | Produit de combinaison pour soulager les bronches et faciliter l’endormissement |
| FR3101539B1 (fr) * | 2019-10-04 | 2023-06-02 | Urgo Rech Innovation Et Developpement | Produit de combinaison pour soulager les bronches |
| FR3165167A1 (fr) * | 2024-08-02 | 2026-02-06 | Urgo Recherche Innovation Et Developpement | Produit de combinaison pour soulager les symptômes liés aux infections des voies respiratoires supérieures |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2365283B1 (es) * | 2010-03-16 | 2012-08-07 | Primo Mendoza S.L. | Jarabe de miel y método para su elaboración. |
-
2017
- 2017-08-23 FR FR1770885A patent/FR3070261B1/fr active Active
-
2018
- 2018-08-09 EP EP18750212.5A patent/EP3672589A1/de active Pending
- 2018-08-09 WO PCT/EP2018/071673 patent/WO2019038100A1/fr not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| WO2019038100A1 (fr) | 2019-02-28 |
| FR3070261A1 (fr) | 2019-03-01 |
| FR3070261B1 (fr) | 2025-12-26 |
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