Classifications

• • 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)
  • A61K36/577—Malvaceae (Mallow family)
• • 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
  • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
• • 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
  • 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)
  • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system
  • A61P25/20—Hypnotics; Sedatives

Definitions

• the subject of the present invention is a combination product comprising, as active substances, at least lemon balm, linden, chamomile and magnesium, or a bioequivalent compound thereof, to aid relaxation and / or sleep.
• the invention finally relates to the use of a combination product as previously defined for the treatment of somnipathies.
• a sleep disorder is a disorder related to the sleep habits of an individual. Some sleep disorders are serious enough to interfere with physical, mental and emotional functioning. A test commonly used for sleep disorders is polysomnography.
• Sleep dysfunction can be caused by a variety of problems, from grinding of teeth (bruxism) to night terrors. When an individual has difficulty falling asleep without apparent cause, it is insomnia. In addition, sleep disorders can lead the individual to sleep enormously, a situation known as hypersomnia. Other conditions of the sleep disorder may be related to substantial abuse. Sleep disorders include:
• hypopnoea respiratory or cardiac abnormality during sleep
• -narcolepsy sudden sleep often spontaneous at any time of the day
• Sleep medicine is now adapted in internal medicine, family medicine, pediatrics, otolaryngology, psychiatry and neurology.
• the present invention relates to a composition for assisting relaxation and sleep, particularly in children.
• the duration and organization of sleep are subject to changes during development. Basic knowledge helps distinguish true sleep disorders from variations in the norm. As an indication the approximate values of sleep duration in 24 hours are: 16 hours for the newborn term, 13 hours for the child of 2 years, 11 hours to 5 years, 10 hours to 9 years and about 9 hours for a 14 year old. Young adults still need about 8 hours, a fact often forgotten. The variability of these values is quite important and corresponds to the distribution of genetic traits in the population. Individual sleep needs are more easily established during weekends and holidays when the body is allowed to sleep for as long as needed.
• a sleep cycle includes a passage through the three states.
• REM sleep rapid eye movement sleep
• non-REM sleep slow sleep
• a sleep cycle includes a passage through the three states.
• In deep sleep can come different parasomnias (non-REM parasomnias): for example nocturnal terrors of small children, which are replaced by somnambulism at the bigger child. Since sleep cycles with deep phases occur in the first half of the night, it is usual to observe these parasomnias during the first hours after falling asleep.
• Passiflora a homeopathic preparation of Boiron which contains: Passiflora incarnata, Ignatia amara, Coffea cruda, Nyckterinia, Tellurium metallicum, Phosphoricum acidum, Palladium metallicum, Magnesium metallicum.
• Quietness which is also a homeopathic preparation of Boiron, which contains: Chamomilla vulgaris, Gelsemium, Hyoscyamus niger, Kalium bromatum, Passiflora incarnata, Stramonium.
• the product Pédiakid Sleep of Ineldea is based on magnesium, manganese, phosphorus, orange blossom extract, lavender extract, chamomile extract, melissa extract, extract of marjoram, hawthorn extract.
• the product Pédiakid Nervesse d'Ineldea contains hydroglycerinated extracts of plants (hops, lemon balm, orange blossom, passionflower, gentian), magnesium, vitamin B6, and phosphate.
• Euphytocalm from Bayer contains a dry extract of lemon balm and magnesium. None of the products proposed contains the association object of the present invention.
• the combination product of the present invention provides a soothing effect to facilitate falling asleep, especially for children, and help them to naturally recover a restful sleep, without nocturnal awakening.
• the product of the present invention has a good taste. It has no side effects or addiction.
• the combination product of the present invention helps to help you fall asleep, soothes, relaxes and helps maintain a healthy sleep. It also contributes to the proper functioning of the nervous system.
• 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 child, preferably in the form of a syrup.
• the present invention relates to a combination product comprising as active substances at least: (i) melissa,
• the present invention also relates to a combination product comprising as active substances at least: (i) melissa,
• the combination product according to the invention comprises, in addition to lemon balm, linden, chamomile and / or magnesium, as active substances:
• Plants or extracts of plants such as, for example, orange blossom, lavender, hawthorn, marjoram, hops, gentian, valerian, passionflower and / or rhodiola,
• Vitamins and minerals such as for example vitamin D, vitamins of group B, such as vitamin B6 and / or calcium
• the combination product of the invention is characterized in that lemon balm, linden and chamomile are in the form of plant extracts and are administered in a daily dose of 0.5 to 5 g. per day, preferably 1 to 3 g / day of melissa of 50 to 500 mg / day, preferably 50 to 200 mg / day of linden of 10 to 200 mg / day, preferably 20 to 80 mg / day of chamomile.
• the combination product of the invention is characterized in that the magnesium is administered at a daily dose of 10 to 200 mg / day, preferably 20 to 80 mg / day.
• 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) or a bioequivalent compound thereof are in a medium adapted to oral administration.
• the suitable medium is a liquid medium.
• the combination product is a syrup or capsule containing said syrup.
• the combination product according to the present invention is especially intended for children.
• Melissa, linden and chamomile may be present as ingredients (i), (ii) or (iii) in a combination product of the invention in more or less purified form, in particular in the form of a plant extract. .
• Magnesium may be present as an ingredient (iv) in a combination product of the invention in more or less purified form. It may also be in free form or in the form of derivatives.
• the acceptable magnesium derivatives according to the invention include in particular the complexed, protected forms or salts.
• the synergistic effect is understood to mean that the combination of at least (i) lemon balm, (ii) linden, (iii) chamomile and (iv) magnesium has an effect on the aid for relaxation and / or sleep, during treatment which is superior to the cumulative effects of a treatment (a) comprising the administration of lemon balm, not associated with linden, to chamomile and magnesium, and conversely a treatment (b) including the administration of lime, not associated with lemon balm, chamomile and magnesium or a treatment (c) including the administration of chamomile, not associated with lemon balm, lime blossom or magnesium or a treatment (d) magnesium, not associated with lemon balm, chamomile and linden.
• Melissa Melissa or Melissa officinalis is a perennial herb of the Lamiaceae family. Its name comes from the Greek melissophullon which means “bee leaf”. It is also known as lemon balm or simply lemongrass, not to be confused with lemongrass (Cymbopogon citratus) used in Asian cooking. It is a plant native to the eastern Mediterranean basin, which has spread throughout Europe since ancient times. Lemon balm, or lemongrass balm, has been cultivated in gardens since ancient times. Originally from Europe, it was introduced in North America. The stems and leaves are still used as a tonic and mild stimulant. The taste is astringent and the aroma is light. The alcohol is obtained by distillation of its fresh leaves: melissa water has antispasmodic properties. Lemon balm can also be consumed as herbal teas.
• Melissa is most often used for its soothing and relaxing virtues. In fact, it regulates nerve impulses, which has a beneficial effect on tachycardia, but also reduces spasms of the stomach and colon (it also has antifungal properties). In infusion, lemon balm has a slightly sedative effect, and further promotes sweating, so it is recommended in cases of insomnia, or hot weather in infants and the elderly.
• the linden
• the lime tree is a wild and ornamental tree whose fragrant flowers and bracts are used in soothing and calming infusions.
• the common linden flowers contain mucilage, essential oils (38%, including farnesol) tannins, glucosides, gums, sugars, manganese and vitamin C.
• essential oils 38%, including farnesol
• glucosides gums
• sugars manganese
• vitamin C vitamin C
• mother tincture as infusion they are recommended in many cases of nervous disorders (fatigue, anxiety attacks, neurasthenia), migraines, influenza, and insomnia.
• These flowers are antidepressants, euphoria and sedatives. They would also be antispasmodic, diaphoretic and make the blood more fluid and promote circulation.
• Wild Chamomile, Chamomile Chamomile, Chamomile, (Matricaria recutita) is an annual herbaceous plant of the family Asteraceae and genus Matricaria. It is sometimes called German Chamomile or True Chamomile or Truncated Matricaria.
• Matricaria recutita differs from the other two medicinal chamomiles in that it is an annual plant, consisting of a single upright erect stem.
• a number of chamomile chamomile activities have been demonstrated by in vitro and in vivo studies:
• -Anti-inflammatory this property can be attributed to chamazulene, its precursor matricin, (-) - a-bisabolol and its oxide. Good anti-inflammatory activity has been clearly established on rat paw induced edema, induced arthritis and radio-induced erythema26. (-) - a-bisabolol is resistant to gastric ulceration induced by various agents (ethanol, stress, indomethacin, in rats, orally). A wound on the rat's tongue treated with a chamomile ointment heals faster (because it promotes epithelialization with a higher percentage of collagen fibers).
• -Spasmolytic the hydro-alcoholic extract of the flowers is spasmolytic. This activity could be due to apigenol which is more active than papaverine on isolated guinea pig ileum
• -Antibacterial, antifungal the essential oil of feverfew Chamomile is weakly antibacterial and antifungal. It stimulates biliary secretion in cats and dogs.
• -Sedative observations in humans have reported a sedative action of Chamomile chamomile.
• the chamomile feverfew is used as the Roman chamomile: it is known as tonic, stomachic, antispasmodic and analgesic.
• Magnesium is an alkaline earth metal. The recommended daily intake is estimated at 300 mg of magnesium a day (double for athletes or pregnant women) or 6 mg per kg of body weight.
• the body does not produce magnesium and must draw it from the diet. Excessive consumption of magnesium is eliminated in the urine, magnesium does not accumulate.
• Some disorders may be due to a lack of magnesium: depression, anxiety, diabetes, muscle spasms, cramps, cardiovascular disorders, high blood pressure, insomnia and osteoporosis.
• Magnesium in the form of hydrate, hydrated oxide, carbonate (MgCOs), chloride (MgCl 2 ), is used in medicine.
• Magnesium is used for the formation of bones and teeth, with calcium and phosphorus, promotes the fixation of calcium on the bone, an action on growth, the transmission of nerve impulses, promotes brain plasticity and avoids memory decline, muscle contraction, heart rate, contributes to the immune defense mechanisms, fight against stress, sedative effect (muscle relaxant), high concentration, fight against constipation by osmotic action and local motor stimulation, fight against oxalic calcium lithiasis, antiallergic, anti-inflammatory, platelet antiaggregant (protective role against thromboses), protective radio, thermal regulator, catalysis of numerous metabolic reactions (enzymatic catalysis, glycogen and protein synthesis, phosphate transfer, etc.).
• 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 different 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 several fruits and optionally the concentration of the ground material obtained and / or 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, mirabelle plum, grapefruit, grape, rhubarb and their mixtures, without this list being exhaustive.
• “Texturizers” means compounds that modify the texture of the products in which they are incorporated.
• emulsifiers amphiphilic compounds characterized by their HLB value (Hydrophilic Lipophilic Balance), in particular capable of stabilizing oil-in-water emulsions (particularly advantageous if it is desired to add, for example, liposoluble active agents such as fat-soluble vitamins.)
• HLB value Hydrophilic Lipophilic Balance
• 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 known in Europe under the codes El 00 to El 80.
• preservatives compounds inhibiting 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, and mixtures thereof
• the composition according to the invention does not comprise any preservative.
• “Aromas” means compounds of natural or synthetic origin which alone are capable of modifying the taste of the composition.
• the flavor used in the present invention is the vanilla aroma combined with the banana flavor.
• sugar or sugar is understood to mean any sweetening carbohydrate, preferably glucose syrup, sucrose, glucose, fructose, invert sugar, honey, maltose, or mixtures thereof.
• the sugars used are a mixture of glucose syrup, sucrose and honey.
• any additional active ingredient of nutritional interest and / or aiding in relaxation or asleep may also be added to the combination products of the invention in pharmaceutical or cosmetic form.
• 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 are in particular: 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), vitamin B12 (cobalamin) and vitamin C (ascorbic acid).
• 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
• vitamin C ascorbic acid
• 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 (phylloquinone) .
• antioxidants such as curcuminoids; carotenoids, especially chosen from beta. -carotene, astaxanthin, zeaxanthin, lutein or compounds containing it 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 zinc, 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,
• the combination of active ingredients comprises, as additional active ingredient, a fat-soluble vitamin, in particular vitamin D3, minerals such as potassium.
• 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, lyophilisates, oral solutes and syrups constitute the pharmaceutical or cosmetic form suitable for the currently preferred oral route.
• a physiologically acceptable vehicle such as gelatin, starch, magnesium 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 capsule preparation is obtained by mixing the active ingredient (i), (ii), (iii) or (iv) with a diluent and pouring the resulting mixture into soft or hard gelatin capsules.
• Vitamin D3 0.011
• Citric acid monohydrate 1.224

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• 2015
  • 2015-09-04 EP EP15767086.0A patent/EP3349765A1/de active Pending
  • 2015-09-04 WO PCT/EP2015/001785 patent/WO2017036488A1/fr not_active Ceased
• 2016
  • 2016-09-02 FR FR1601301A patent/FR3040628A1/fr not_active Withdrawn

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