WO2017109300A1 - Combination product that helps relax and fall asleep - Google Patents

Combination product that helps relax and fall asleep Download PDF

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Publication number
WO2017109300A1
WO2017109300A1 PCT/FR2015/053731 FR2015053731W WO2017109300A1 WO 2017109300 A1 WO2017109300 A1 WO 2017109300A1 FR 2015053731 W FR2015053731 W FR 2015053731W WO 2017109300 A1 WO2017109300 A1 WO 2017109300A1
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WO
WIPO (PCT)
Prior art keywords
sleep
melatonin
chamomile
combination product
passionflower
Prior art date
Application number
PCT/FR2015/053731
Other languages
French (fr)
Inventor
Marilyn GENTILHOMME
Séverine HERTLEIN
Original Assignee
Urgo Recherche Innovation Et Developpement
Hcp Healthcare Asia Pte Ltd
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Publication date
Application filed by Urgo Recherche Innovation Et Developpement, Hcp Healthcare Asia Pte Ltd filed Critical Urgo Recherche Innovation Et Developpement
Priority to PCT/FR2015/053731 priority Critical patent/WO2017109300A1/en
Priority to EP15837133.6A priority patent/EP3393471A1/en
Publication of WO2017109300A1 publication Critical patent/WO2017109300A1/en

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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)
    • A61K36/28—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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)
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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 present invention relates to a combination product comprising as active substances, at least melatonin, passionflower, chamomile and melissa or a bioequivalent compound thereof to help 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 an individual's sleep habits. 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; cataplexy, sudden weakness of the motor muscles that may result in a fall on the ground; - nocturnal terror, pavor nocturnus, nocturnal disorder characterized by strong fear and anxiety; sleepwalking, an activity that is physically and unconsciously engaged during sleep; Somniphobia, afraid to sleep; sleep apnea
  • 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 in adults and 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.
  • deep sleep may originate different parasomnias (non-REM parasomnias): for example the night terrors of small children, which are replaced by sleepwalking in the larger 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.
  • Valdispert such as Nuit Paisible, which contains melatonin, magnesium, zinc and vitamin B6, or Bonne Nuit, which contains melatonin alone.
  • SomniPhyt of Green Health contains melatonin associated with Griffonia Simplicifolia, Magnolia officinalis, Valeriana Offcinalis, Eschscholzia calfornica, L-tryptophan, L-glutamine, Hypericum perforatum and Vitamin B6.
  • Nova Night Sleep product from Sanofi is based on passionflower, melatonin, California poppy, lemon balm and vitamin B6.
  • Nutreov's OptiNuit Flash product contains melatonin and vitamin B6.
  • Somdor + Melatonin Granionin contains melatonin, lemon balm extract, hawthorn, passionflower, hops and valerian. 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 according to the present invention 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 and the adult, preferably in the form of a capsule.
  • the present invention also relates to a combination product comprising as active substances at least: (i) melatonin, (ii) passionflower, (iii) chamomile, and
  • the combination product according to the invention comprises, in addition to melatonin, passionflower, chamomile and / or lemon balm, as active substances:
  • Plants or extracts of plants such as, for example, orange blossom, lavender, hawthorn, marjoram, hops, gentian, valerian and / or rhodiola,
  • Vitamins and minerals such as for example vitamin D, vitamins of group B, such as vitamin B6, magnesium and / or calcium
  • the combination product of the invention is characterized in that passionflower, chamomile and lemon balm are in the form of plant extracts and are administered at a daily dose of 50 to 500 mg / day. preferably 50 to 200 mg / day of passionflower extracts of 5 to 200 mg / day, preferably 10 to 80 mg / day of chamomile extracts of 5 to 50 mg / day, preferably 10 to 30 mg / day of lemon balm extracts
  • the combination product of the invention is characterized in that melatonin is administered at a daily dose of 0.5 to 2.0 mg / day, preferably 1.0 to 1.5 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 in the form of powder or a capsule containing said powder.
  • the combination product according to the present invention is especially intended for adults or children.
  • Passionflower, chamomile and melissa 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 a plant extract .
  • the Applicant has demonstrated that the combination of at least (i) melatonin, (ii) passionflower, (iii) chamomile and (iv) lemon balm, has a synergistic effect to help relaxation and / or falling asleep
  • the combination of at least (i) melatonin, (ii) passionflower, (iii) chamomile and (iv) lemon balm has an effect on helping relaxation and / or asleep during treatment which is superior to the cumulative effects of a treatment (a) comprising the administration of melatonin, not associated with passionflower, chamomile and lemon balm, and conversely a treatment (b) comprising the administration of passionflower, not associated with melatonin, lemon balm and chamomile or a treatment (c) comprising the administration of chamomile, not associated with melatonin with lemon balm and passionflower or treatment (d) comprising the administration of lemon balm, not associated with melatonin, passionflower and chamomile.
  • Melatonin (or N-acetyl-5-methoxytryptamine), often referred to as sleep hormone, is best known as the central hormone regulating chronobiological rhythms by being synthesized especially at night. It regulates many hormonal secretions, in humans and in all mammals. This neurohormone is synthesized from a neurotransmitter, serotonin, which itself derives from tryptophan. It is secreted by the pineal gland (in the brain) in response to the absence of light.
  • Melatonin is also synthesized by the retina but also by bone marrow cells, lymphocytes and epithelial cells. Normally, the concentration of melatonin in these cells is greater than that found in the blood, but it does not appear to be regulated by photoperiod.
  • Nuts and hazelnuts are an important source of melatonin easily absorbed by the body. Melatonin is also found in corn, tomatoes and potatoes, but in much smaller amounts. The melatonin content of many foods is still poorly known. The body can also extract it from vegetable sources (rice, bananas, pineapples, etc.).
  • melatonin is secreted at night only (peak secretion at 5 am in humans, and on average because its production is inhibited by light) and it (partially) manages circadian rhythms.
  • Passiflora is a genus of plants, the passiflora, of more than 530 species of the family Passifloraceae. They are spectacular flowering climbers, but their abundance is only guaranteed in areas with mild climate.
  • the aerial parts of the officinal passionflower (Passiflora incarnata) are known in herbal medicine for their anxiolytic and sedative action.
  • Passiflora incarnata has several alkaloids including inhibitors of monoamine oxidase (MAOI) and light sedatives.
  • MAOI monoamine oxidase
  • Matricaria recutita differs from the other two medicinal chamomiles in that it is an annual plant, consisting of a single upright erect stem.
  • -Spasmolytic the hydro-alcoholic extract of 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.
  • 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.
  • 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 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.
  • the media may also allow immediate, modified or delayed release of any of the active ingredients.
  • Physiologically acceptable medium may be water, mash and / or fruit juice, texturizers, emulsifiers, colorants, preservatives, flavors, 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.
  • Textturizers means compounds that modify the texture of the products in which they are incorporated.
  • texturants are: guar and carob flour; gum arabic, xanthan and gellan; carrageenans; starches (native or modified); microcrystalline cellulose; gelatin; pectin; alginates (E400 to E405); agar-agar; and their mixtures.
  • 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, liposo-rich active ingredients).
  • HLB Hydrophilic Lipophilic Balance
  • examples of dietary emulsifiers are lecithin and its derivatives present especially 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 means compounds which 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, 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.
  • 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.
  • those skilled in the art will take care to choose the additional assets and their amount so that the advantageous properties of the composition according to the invention are not, or not substantially impaired by the addition envisaged.
  • water-soluble vitamins As additional assets that can be used, mention may be made of: - water-soluble vitamins and fat-soluble vitamins.
  • water-soluble vitamins present in the syrupy product prepared according to the invention 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).
  • 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,
  • 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.
  • the combination of active agents comprises, as additional active ingredient, a liposo-fucous vitamin, in particular vitamin D3, minerals such as potassium or magnesium.
  • 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 solid composition in the form of tablets it is possible, for example, to mix the main active ingredients (i), (ii), (iii) or (iv) with a physiologically acceptable carrier 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) in powder form and pouring the resulting mixture into soft or hard gelatin capsules.
  • composition is obtained by mixing the various compounds according to the methods conventionally used for this type of preparation.
  • the composition is then preferably injected into capsules.

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Abstract

The invention relates to a combination product comprising, as active substances, at least melatonin, passion flower, chamomile and lemon balm or a bioequivalent compound thereof for helping individuals relax and/or fall asleep. The invention further relates to the use of a combination product as defined above for the treatment of sleep disorders.

Description

Produit de combinaison pour aider à la relaxation et à l'endormissement  Combination product to help with relaxation and falling asleep
DOMAINE TECHNIQUE TECHNICAL AREA
La présente invention a pour objet un produit de combinaison comprenant à titre de substances actives, au moins de la mélatonine, de la passiflore, de la camomille et de la mélisse ou un composé bioéquivalent de ces derniers pour aider à la relaxation et/ou à l'endormissement. L'invention concerne enfin l'utilisation d'un produit de combinaison tel que précédemment défini pour le traitement des somnipathies. The present invention relates to a combination product comprising as active substances, at least melatonin, passionflower, chamomile and melissa or a bioequivalent compound thereof to help relaxation and / or sleep. The invention finally relates to the use of a combination product as previously defined for the treatment of somnipathies.
ARRIERE PLAN BACKGROUND
Un trouble du sommeil (somnipathie) est un trouble lié aux habitudes du sommeil d'un individu. Certains troubles du sommeil sont suffisamment sérieux pour interférer au fonctionnement physique, mental et émotionnel. Un test communément utilisé pour les troubles du sommeil est la polysomnographie. A sleep disorder (somnipathy) is a disorder related to an individual's sleep habits. Some sleep disorders are serious enough to interfere with physical, mental and emotional functioning. A test commonly used for sleep disorders is polysomnography.
Les dysfonctionnements du sommeil peuvent être causés par une variété de problèmes, des grincements de dents (bruxisme) aux terreurs nocturnes. Lorsqu'un individu souffre de difficultés à s'endormir sans cause apparente, il s'agit alors d'insomnie. En addition, les troubles du sommeil peuvent conduire l'individu à dormir énormément, une situation connue sous le terme d'hypersomnie. D'autres conditions du trouble du sommeil peuvent être liées à un abus substantiel. 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.
Les troubles du sommeil incluent : Sleep disorders include:
-l'insomnie primaire - difficulté chronique à s'endormir et/ou à maintenir un sommeil lorsqu'aucune autre cause symptomatique peut être perçue ; - primary insomnia - chronic difficulty falling asleep and / or maintaining sleep when no other symptomatic cause can be perceived;
-le bruxisme, grincement ou claquement involontaire des dents durant le sommeil ; - bruxism, creaking or involuntary clanging of the teeth during sleep;
-le syndrome de retard de phase du sommeil, incapacité à s'endormir ou à se réveiller durant des heures socialement acceptables mais ne causant aucun problème dans la maintenance du sommeil, un trouble du rythme circadien (symptôme similaire - syndrome hypernycthéméral); -Sleep phase delay syndrome, inability to fall asleep or to wake up for socially acceptable hours but not causing any problems in sleep maintenance, circadian rhythm disorder (similar symptom - hypernycthemeral syndrome);
-l'hypopnée, anormalité respiratoire ou cardiaque durant le sommeil ; hypopnoea, respiratory or cardiac abnormality during sleep;
-la narcolepsie, sommeil soudain souvent spontané à toute heure du jour ; -la cataplexie, soudaine faiblesse des muscles moteurs pouvant résulter à une chute sur le sol ; -la terreur nocturne, pavor nocturnus, trouble nocturne caractérisée par une forte peur et anxiété ; -le somnambulisme, activité engagée physiquement et inconsciemment durant le sommeil ; -la somniphobie, peur de dormir ; -les apnées du sommeil. -narcolepsy, sudden sleep often spontaneous at any time of the day; cataplexy, sudden weakness of the motor muscles that may result in a fall on the ground; - nocturnal terror, pavor nocturnus, nocturnal disorder characterized by strong fear and anxiety; sleepwalking, an activity that is physically and unconsciously engaged during sleep; Somniphobia, afraid to sleep; sleep apnea
Suite à l'évolution du savoir concernant le sommeil au XXe siècle, incluant la découverte de l'hypnologie et de l'apnée du sommeil, l'importance médicale du sommeil est reconnue. La communauté clinique s'intéresse de plus près aux troubles du sommeil, tels que l'apnée du sommeil, et du rôle ainsi que de la qualité du sommeil lors de différentes conditions. Durant les années 1970 aux États-Unis, les cliniques et laboratoires se dévouent pour l'étude du sommeil accompagné de ses troubles. Following the evolution of knowledge about sleep in the twentieth century, including the discovery of hypnology and sleep apnea, the medical importance of sleep is recognized. The clinical community is taking a closer look at sleep disorders, such as sleep apnea, and the role and quality of sleep under different conditions. During the 1970s in the United States, clinics and laboratories devoted themselves to the study of sleep accompanied by its troubles.
L'impact des troubles du sommeil, sur la vie des individus, peut être très important : une étude, en 2014, établit qu'un sommeil ressenti comme étant de mauvaise qualité est associé à une augmentation du risque de suicide chez la personne âgée (âge moyen dans l'étude, 74,9 ans plus ou moins 5,6 ans). The impact of sleep disorders on the lives of individuals can be very important: a study in 2014 found that sleep perceived as being of poor quality is associated with an increased risk of suicide in the elderly ( mean age in the study, 74.9 years plus or minus 5.6 years).
La médecine du sommeil est maintenant adaptée dans la médecine interne, la médecine familiale, la pédiatrie, l'otolaryngologie, la psychiatrie et la neurologie. Sleep medicine is now adapted in internal medicine, family medicine, pediatrics, otolaryngology, psychiatry and neurology.
La présente invention porte sur une composition pour aider à la relaxation et à l'endormissement chez l'adulte comme chez l'enfant. The present invention relates to a composition for assisting relaxation and sleep in adults and children.
En effet, une étude publiée dans la revue Paediatrica (vol 14 n°3 2003) fait le point sur les troubles du sommeil des enfants. Jusqu'à 25% des petits enfants et presque 50%> des enfants d'âge scolaire présentent des troubles du sommeil qui durent depuis au moins 6 mois. La prévalence est de 33% pour les adolescents. Hedger Archbold et coll. ont différencié ces troubles. Certains troubles du sommeil sont plus fréquents à un certain âge et liés à des situations particulières, d'autres peuvent survenir à tout âge (par exemple: le syndrome d'apnées du sommeil, les épilepsies associées au sommeil. Un trouble du sommeil n'est pas seulement un problème pour les parents. Un sommeil perturbé implique aussi des risques pour le développement cognitif de l'enfant avec la survenue de troubles du comportement. Comme pour l'adulte, il semble qu'il existe une association entre les apnées obstructives du sommeil et une prévalence plus élevée du syndrome métabolique chez l'enfant et l'adolescent. Indeed, a study published in Paediatrica (vol 14 no. 3 2003) takes stock of children's sleep disorders. Up to 25% of small children and almost 50%> of school-aged children have sleep disorders that have lasted at least 6 months. The prevalence is 33% for adolescents. Hedger Archbold et al. have differentiated these disorders. Some sleep disorders are more common at a certain age and related to particular situations, others can occur at any age (for example: sleep apnea syndrome, sleep-related epilepsies. is not only a problem for parents, disturbed sleep also involves risks for the cognitive development of the child with the occurrence of behavioral disorders. In adults, there appears to be an association between obstructive sleep apnea and a higher prevalence of metabolic syndrome in children and adolescents.
La durée et l'organisation du sommeil sont soumises à des changements au cours du développement. Des connaissances de base permettent de distinguer les vrais troubles du sommeil des variations de la norme. A titre d'indication les valeurs approximatives de durée du sommeil par 24 heures sont: 16 heures pour le nouveau-né à terme, 13 heures pour l'enfant de 2 ans, 11 heures à 5 ans, 10 heures à 9 ans et environ 9 heures pour un adolescent de 14 ans. Les jeunes adultes ont encore besoin d'à peu près 8 heures, un fait souvent oublié. La variabilité de ces valeurs est assez importante et correspond à la distribution des traits génétiques dans la population. Les besoins individuels de sommeil sont plus facilement établis pendant les fins de semaine et les vacances, lorsque le corps est autorisé à dormir aussi longtemps que nécessaire. 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.
Pendant la nuit on observe trois états: l'éveil, le sommeil paradoxal (rapid eye movement sleep ou REM sleep) et le sommeil lent (non-REM sleep). Un cycle de sommeil comprend un passage par les trois états. Dans le sommeil profond peuvent avoir origine différentes parasomnies (non- REM parasomnies): par exemple les terreurs nocturnes des petits enfants, lesquels sont remplacés par le somnambulisme chez l'enfant plus grand. Etant donné que les cycles de sommeil avec des phases profondes surviennent dans la première moitié de la nuit, il est habituel d'observer ces parasomnies pendant les premières heures après l'endormissement. During the night, three states are observed: wakefulness, REM sleep (rapid eye movement sleep) and non-REM sleep (slow sleep). A sleep cycle includes a passage through the three states. In deep sleep may originate different parasomnias (non-REM parasomnias): for example the night terrors of small children, which are replaced by sleepwalking in the larger 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.
Il existe sur le marché un certain nombre de produits pour pallier aux problèmes d'endormissement ou de relaxation. Parmi ces produits, on peut citer à titre d'exemple les produits commercialisés par Valdispert tel que Nuit Paisible, qui contient de la mélatonine, du magnésium, du zinc et de la vitamine B6, ou Bonne Nuit, qui contient de la mélatonine seule. SomniPhyt de Santé Verte contient de la mélatonine associée à Griffonia Simplicifolia, Magnolia officinalis, Valeriana Offîcinalis, Eschscholzia calfornica, L-tryptophane, L-glutamine, Hypericum perforatum et Vitamine B6. Le produit Nova Nuit Sommeil de Sanofi est à base de passiflore, mélatonine, pavot de Californie, mélisse et vitamine B6. Le produit OptiNuit Flash de Nutreov contient quant à lui de la mélatonine et de la vitamine B6. Le produit Somdor+ Mélatonine de Granions contient de la mélatonine, un extrait de mélisse, d'aubépine, passiflore, houblon et valériane. Aucun des produits proposés ne contient l'association objet de la présente invention. Ces produits, bien que contenant de la mélatonine en association avec de la passiflore, de la camomille et de la mélisse, n'apportent pas entière satisfaction en terme d'apaisement, de relaxation et/ou d'aide à l'endormissement. Le produit de combinaison de la présente invention apporte un effet apaisant pour faciliter l'endormissement, en particulier des enfants, et les aider à retrouver naturellement un sommeil réparateur, sans réveil nocturne. Le produit selon la présente invention est sans effet secondaire ni accoutumance. Le produit de combinaison selon la présente invention contribue à aider à l'endormissement, apaise, relaxe et aide à maintenir un sommeil sain. Il contribue également au bon fonctionnement du système nerveux. There are a number of products on the market to overcome the problems of falling asleep or relaxation. Among these products, there may be mentioned, for example, the products marketed by Valdispert such as Nuit Paisible, which contains melatonin, magnesium, zinc and vitamin B6, or Bonne Nuit, which contains melatonin alone. SomniPhyt of Green Health contains melatonin associated with Griffonia Simplicifolia, Magnolia officinalis, Valeriana Offcinalis, Eschscholzia calfornica, L-tryptophan, L-glutamine, Hypericum perforatum and Vitamin B6. Nova Night Sleep product from Sanofi is based on passionflower, melatonin, California poppy, lemon balm and vitamin B6. Nutreov's OptiNuit Flash product contains melatonin and vitamin B6. Somdor + Melatonin Granionin contains melatonin, lemon balm extract, hawthorn, passionflower, hops and valerian. None of the products proposed contains the association object of the present invention. These products, although containing melatonin in combination with passionflower, chamomile and lemon balm, do not provide complete satisfaction in terms of appeasement, relaxation and / or help with falling asleep. 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 according to the present invention 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.
Le produit selon la présente invention présente également l'avantage de ne contenir, de préférence, aucun colorant artificiel, allergènes et d'être, préférentiellement, sans lactose ou gluten. 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.
Le produit de la présente invention présente une galénique adaptée à l'enfant et à l'adulte, de préférence sous forme d'une gélule. The product of the present invention has a galenic adapted to the child and the adult, preferably in the form of a capsule.
RESUME DE L'INVENTION La présente invention se rapporte à un produit de combinaison, comprenant à titre de substances actives, au moins : SUMMARY OF THE INVENTION The present invention relates to a combination product comprising as active substances at least:
(i) de la mélatonine, (i) melatonin,
(ii) de la passiflore, (ii) passionflower,
(iii) de la camomille, et (iv) de la mélisse ou un composé bioéquivalent de la mélatonine, de la passiflore, de la camomille et/ou de la mélisse pour aider à la relaxation et/ou à l'endormissement. (iii) chamomile, and (iv) lemon balm or a bioequivalent compound of melatonin, passionflower, chamomile and / or lemon balm to aid relaxation and / or sleep.
La présente invention se rapporte également à un produit de combinaison, comprenant à titre de substances actives, au moins : (i) de la mélatonine, (ii) de la passiflore, (iii) de la camomille, et The present invention also relates to a combination product comprising as active substances at least: (i) melatonin, (ii) passionflower, (iii) chamomile, and
(iv) de la mélisse ou un composé bioéquivalent de la mélatonine, de la passiflore, de la camomille et/ou de la mélisse pour son utilisation dans le traitement des somnipathies. (iv) lemon balm or a bioequivalent compound of melatonin, passionflower, chamomile and / or lemon balm for use in the treatment of somnipathies.
Dans certains modes de réalisation, le produit de combinaison selon l'invention comprend, en plus de la mélatonine, de la passiflore, de la camomille et/ou de la mélisse, à titre de substances actives : In certain embodiments, the combination product according to the invention comprises, in addition to melatonin, passionflower, chamomile and / or lemon balm, as active substances:
(i) Des plantes ou extraits de plantes, tels que par exemple de la fleur d'oranger, la lavande, l'aubépine, la marjolaine, le houblon, la gentiane, la valériane et/ou la rhodiola, (i) Plants or extracts of plants, such as, for example, orange blossom, lavender, hawthorn, marjoram, hops, gentian, valerian and / or rhodiola,
(ii) Des vitamines et minéraux, tels que par exemple la vitamine D, les vitamines du goupe B, telles que la vitamine B6, le magnésium et/ou le calcium  (ii) Vitamins and minerals, such as for example vitamin D, vitamins of group B, such as vitamin B6, magnesium and / or calcium
(iii) Des acides aminés ou dérivés d'acides aminés, tels que par exemple le tryptophane  (iii) Amino acids or amino acid derivatives, such as, for example, tryptophan
Dans certains modes de réalisation, le produit de combinaison de l'invention est caractérisé en ce que la passiflore, la camomille et la mélisse se présentent sous forme d'extrait végétaux et sont administrés à une dose quotidienne : de 50 à 500 mg/jour de préférence 50 à 200 mg/jour d'extraits de passiflore de 5 à 200 mg/jour, de préférence 10 à 80 mg/jour d'extraits de camomille de 5 à 50 mg/jour, de préférence 10 à 30 mg/jour d'extraits de mélisse In some embodiments, the combination product of the invention is characterized in that passionflower, chamomile and lemon balm are in the form of plant extracts and are administered at a daily dose of 50 to 500 mg / day. preferably 50 to 200 mg / day of passionflower extracts of 5 to 200 mg / day, preferably 10 to 80 mg / day of chamomile extracts of 5 to 50 mg / day, preferably 10 to 30 mg / day of lemon balm extracts
Dans certains modes de réalisation, le produit de combinaison de l'invention est caractérisé en ce que la mélatonine est administrée à une dose quotidienne 0,5 à 2,0 mg/jour, de préférence 1,0 à 1,5 mg/jour. In some embodiments, the combination product of the invention is characterized in that melatonin is administered at a daily dose of 0.5 to 2.0 mg / day, preferably 1.0 to 1.5 mg / day. .
Dans certains modes de réalisation de l'invention, le produit de combinaison selon l'invention peut se présenter sous la forme d'une composition unique (ou combinée) contenant au moins à titre de substances actives : In some embodiments of the invention, the combination product according to the invention may be in the form of a single (or combined) composition containing at least as active substances:
(i) de la mélatonine, (i) melatonin,
(ii) de la passiflore, (iii) de la camomille, et (ii) passionflower, (iii) chamomile, and
(iv) de la mélisse dans un milieu physiologiquement acceptable. (iv) lemon balm in a physiologically acceptable medium.
Selon un mode de réalisation particulier de l'invention, le produit de combinaison est caractérisé en ce que les ingrédients actifs (i), (ii), (iii), (iv) ou un composé bioéquivalent de ces derniers sont dans milieu adapté à l'administration par voie orale. De préférence, le milieu adapté est un milieu liquide. De manière préférentielle, le produit de combinaison se présente sous la forme de poudre ou une gélule contenant ladite poudre. According to a particular embodiment of the invention, 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. Preferably, the suitable medium is a liquid medium. Preferably, the combination product is in the form of powder or a capsule containing said powder.
Lorsqu'il est utilisé pour le traitement thérapeutique des troubles du sommeil, le produit de combinaison suivant la présente invention, est notamment destiné à des adultes ou des enfants. When used for the therapeutic treatment of sleep disorders, the combination product according to the present invention is especially intended for adults or children.
La passiflore, la camomille et la mélisse pourront être présents en tant qu'ingrédients (ii), (iii) ou (iv) dans un produit de combinaison de l'invention sous forme plus ou moins purifiée, notamment sous forme d'extrait végétal. Passionflower, chamomile and melissa 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 a plant extract .
Les différents modes de réalisations de l'invention sont particulièrement décrits dans la description détaillée ci-après. Ces modes de réalisation peuvent être pris séparément ou en combinaison les uns avec les autres. The various embodiments of the invention are particularly described in the detailed description below. These embodiments may be taken separately or in combination with each other.
DESCRIPTION DETAILLEE DE L'INVENTION : DETAILED DESCRIPTION OF THE INVENTION
Dans la présente invention, la demanderesse a mis en évidence que l'association d'au moins (i) la mélatonine, (ii) la passiflore, (iii) la camomille et (iv) la mélisse, présentait un effet synergique pour aider à la relaxation et/ou à l'endormissement In the present invention, the Applicant has demonstrated that the combination of at least (i) melatonin, (ii) passionflower, (iii) chamomile and (iv) lemon balm, has a synergistic effect to help relaxation and / or falling asleep
Par effet synergique, il est entendu selon la présente invention que l'association d'au moins (i) la mélatonine, (ii) la passiflore, (iii) la camomille et (iv) la mélisse présente un effet sur l'aide à la relaxation et/ou à l'endormissement, au cours du traitement qui est supérieur aux effets cumulés d'un traitement (a) comprenant l'administration de la mélatonine, non associé à la passiflore, à la camomille et à la mélisse, et inversement d'un traitement (b) comprenant l'administration de la passiflore, non associé à la mélatonine, à la mélisse et à la camomille ou d'un traitement (c) comprenant l'administration de la camomille, non associé à la mélatonine, à la mélisse et à la passiflore ou d'un traitement (d) comprenant l'administration de la mélisse, non associé à la mélatonine, à la passiflore et à la camomille. By synergistic effect, it is understood according to the present invention that the combination of at least (i) melatonin, (ii) passionflower, (iii) chamomile and (iv) lemon balm has an effect on helping relaxation and / or asleep during treatment which is superior to the cumulative effects of a treatment (a) comprising the administration of melatonin, not associated with passionflower, chamomile and lemon balm, and conversely a treatment (b) comprising the administration of passionflower, not associated with melatonin, lemon balm and chamomile or a treatment (c) comprising the administration of chamomile, not associated with melatonin with lemon balm and passionflower or treatment (d) comprising the administration of lemon balm, not associated with melatonin, passionflower and chamomile.
La mélatonine Melatonin
La mélatonine (ou N-acétyl-5-méthoxytryptamine), souvent dénommée hormone du sommeil, est surtout connue comme étant l'hormone centrale de régulation des rythmes chronobiologiques en étant synthétisée surtout la nuit. Elle régule de nombreuses sécrétions hormonales, chez l'humain et chez tous les mammifères. Cette neurohormone est synthétisée à partir d'un neurotransmetteur, la sérotonine, qui dérive elle-même du tryptophane. Elle est sécrétée par la glande pinéale (dans le cerveau) en réponse à l'absence de lumière. Melatonin (or N-acetyl-5-methoxytryptamine), often referred to as sleep hormone, is best known as the central hormone regulating chronobiological rhythms by being synthesized especially at night. It regulates many hormonal secretions, in humans and in all mammals. This neurohormone is synthesized from a neurotransmitter, serotonin, which itself derives from tryptophan. It is secreted by the pineal gland (in the brain) in response to the absence of light.
La mélatonine est également synthétisée par la rétine mais aussi par les cellules de la moelle osseuse, les lymphocytes et les cellules épithéliales. Normalement, la concentration de mélatonine dans ces cellules est plus grande que celle trouvée dans le sang, mais elle ne semble pas régulée par la photopériode. Melatonin is also synthesized by the retina but also by bone marrow cells, lymphocytes and epithelial cells. Normally, the concentration of melatonin in these cells is greater than that found in the blood, but it does not appear to be regulated by photoperiod.
Les noix et les noisettes sont une source importante de mélatonine facilement absorbée par l'organisme. La mélatonine se retrouve également dans le maïs, les tomates et les pommes de terre, mais en quantités nettement inférieures. La teneur en mélatonine de plusieurs aliments serait encore très mal connue. L'organisme peut d'ailleurs l'extraire des sources végétales (riz, bananes, ananas, etc.). Nuts and hazelnuts are an important source of melatonin easily absorbed by the body. Melatonin is also found in corn, tomatoes and potatoes, but in much smaller amounts. The melatonin content of many foods is still poorly known. The body can also extract it from vegetable sources (rice, bananas, pineapples, etc.).
En temps normal, la mélatonine est sécrétée la nuit uniquement (pic de sécrétion à 5 heures du matin chez l'humain, et en moyenne, car sa production est inhibée par la lumière) et elle gère (en partie) les rythmes circadiens. Normally, melatonin is secreted at night only (peak secretion at 5 am in humans, and on average because its production is inhibited by light) and it (partially) manages circadian rhythms.
La prise de mélatonine facilite l'endormissement (endormissement 8 minutes plus tôt en moyenne) et allonge le sommeil (de 27 minutes en moyenne). L'association lumière et mélatonine a aussi diminué les comportements agressifs (-9 %), les phases d'agitation et de réveils nocturnes. Taking melatonin makes falling asleep easier (falling asleep 8 minutes earlier on average) and lengthening sleep (an average of 27 minutes). The combination of light and melatonin also decreased aggressive behavior (-9%), agitation and nocturnal awakenings.
L'administration de mélatonine chez le rat produirait un effet aussi anxiolytique qu'un médicament de référence, le diazépam (Valium), administré à la même dose (1 mg-kg-1). La passiflore The administration of melatonin in the rat would produce as anxiolytic effect as a reference drug, diazepam (Valium), administered at the same dose (1 mg-kg-1). Passionflower
Passiflora est un genre de plantes, les passiflores, de plus de 530 espèces de la famille des Passifloraceae. Ce sont des plantes grimpantes aux fleurs spectaculaires, mais leur abondance n'est garantie que dans les régions au climat doux. Les parties aériennes de la passiflore officinale (Passiflora incarnata) sont connues en phytothérapie pour leur action anxiolytique et sédative. Passiflora is a genus of plants, the passiflora, of more than 530 species of the family Passifloraceae. They are spectacular flowering climbers, but their abundance is only guaranteed in areas with mild climate. The aerial parts of the officinal passionflower (Passiflora incarnata) are known in herbal medicine for their anxiolytic and sedative action.
En effet, la Passiflora incarnata possède plusieurs alcaloïdes notamment des inhibiteurs de la monoamine-oxydase (IMAO) et des sédatifs légers. Indeed, Passiflora incarnata has several alkaloids including inhibitors of monoamine oxidase (MAOI) and light sedatives.
La camomille ou Matricaria recutita La Camomille sauvage, Matricaire camomille, Petite Camomille, (Matricaria recutita) est une plante herbacée annuelle de la famille des Astéracées et du genre Matricaria. Elle est parfois appelée Camomille allemande ou Camomille vraie ou Matricaire tronquée. Chamomile or Matricaria recutita Wild Camomile, 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.
C'est une plante médicinale utilisée depuis l'Antiquité gréco-latine, appelée simplement «camomille» en herboristerie. Matricaria recutita se distingue des deux autres camomilles médicinales, par le fait que c'est une plante annuelle, constituée d'une seule tige érigée dressée. It is a medicinal plant used since ancient Greek-Latin, simply called "chamomile" in herbalism. Matricaria recutita differs from the other two medicinal chamomiles in that it is an annual plant, consisting of a single upright erect stem.
Un certain nombre d'activités de la matricaire camomille ont été mises en évidence par des études in vitro et in vivo : A number of chamomile chamomile activities have been demonstrated by in vitro and in vivo studies:
-Anti-inflammatoire : cette propriété peut être attribuée au chamazulène, à son précurseur la matricine, au (-)-a-bisabolol et à son oxyde. Une bonne activité anti-inflammatoire a été clairement établie sur l'œdème induit de la patte du rat, l'arthrite induite et l'érythème radio induit26. Le (-)-a-bisabolol s'oppose à l'ulcération gastrique induite par différents agents (éthanol, stress, indométacine, chez le rat, par voie orale). Une blessure sur la langue du rat, traitée par un onguent de camomille guérit plus rapidement (car elle favorise l'épithélialisation avec un meilleur pourcentage de fibres de collagène). -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).
-Spasmolytique : l'extrait hydro-alcoolique des fleurs est spasmolytique. Cette activité pourrait être due à l'apigénol qui est plus actif que la papavérine sur l'iléon de Cobaye isolé -Antibactérien, antifongique : l'huile essentielle de la matricaire camomille est faiblement antibactérienne et antifongique. Elle stimule la sécrétion biliaire chez le chat et le chien. -Spasmolytic: the hydro-alcoholic extract of 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.
-Sédatif : des observations chez l'homme ont fait état d'une action sédative de la matricaire camomille. La matricaire camomille s'utilise comme la camomille romaine : elle est réputée tonique, stomachique, antispasmodique et analgésique. -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.
La mélisse Lemon balm
La Mélisse ou Mélisse officinale (Melissa officinalis) est une plante herbacée vivace de la famille des Lamiacées. Son nom vient du grec melissophullon qui signifie « feuille à abeilles ». On l'appelle aussi mélisse citronnelle ou simplement citronnelle, à ne pas confondre avec la citronnelle (Cymbopogon citratus) utilisée en cuisine asiatique. C'est une plante originaire de l'Est du bassin méditerranéen, qui s'est répandue dans toute l'Europe dès l'Antiquité. La mélisse officinale, ou mélisse citronnelle, est cultivée dans les jardins depuis des temps très anciens. Originaire d'Europe, elle a été introduite en Amérique du Nord. Les tiges et les feuilles sont encore utilisées comme tonique et stimulant léger. Le goût est astringent et l'arôme léger. L'alcool est obtenu par distillation de ses feuilles fraîches : l'eau de mélisse a des propriétés antispasmodiques. La mélisse peut aussi être consommée sous forme de tisanes. Melissa or Melissa officinalis (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.
La mélisse est le plus souvent utilisée pour ses vertus calmantes et relaxantes. De fait, elle régule l'influx nerveux, ce qui a une action bénéfique sur la tachycardie, mais réduit aussi les spasmes de l'estomac et du côlon (elle a également des propriétés antifongiques). En infusion, la mélisse a un effet légèrement sédatif, et favorise de plus la sudation, c'est pourquoi elle est recommandée dans des cas d'insomnie, ou par forte chaleur chez le nourrisson et les personnes âgées. 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.
Milieu physiologiquement acceptable Physiologically acceptable medium
Un milieu physiologiquement acceptable est un milieu n'ayant aucun effet toxique ou préjudiciable dans les conditions d'utilisation et inerte vis-à-vis des ingrédients actifs du produit de combinaison. Un tel milieu peut par exemple comprendre différents adjuvants selon sa finalité thérapeutique ou cosmétique, comme de façon non limitative, des arômes, des colorants, des charges, des conservateurs, des diluants, des agents mouillants ou de suspension, etc. De tels milieux peuvent également permettre une libération immédiate, modifiée ou retardée de l'un ou l'autre des ingrédients actifs. 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. Such 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 The media may also allow immediate, modified or delayed release of any of the active ingredients.
Le milieu physio logiquement acceptable peut être composé d'eau, de purée et/ou jus de fruits, des texturants, des émulsifïants, des colorants, des conservateurs, des arômes, du sucre ou des sucres. Physiologically acceptable medium may be water, mash and / or fruit juice, texturizers, emulsifiers, colorants, preservatives, flavors, sugar or sugars.
Par « purée et/ou jus de fruits », on entend une préparation plus ou moins liquide, en particulier selon la nature du fruit et/ou la finesse du broyage, préparée par broyage, pressage ou autre procédé d'extraction d'un ou plusieurs fruits et éventuellement concentration du broyât obtenu et/ou séparation (notamment fïltration) des pépins, akènes et/ou de tout ou partie de la pulpe, et/ou flash pasteurisation. By "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.
Les fruits peuvent être choisis parmi : la pomme, la banane, la fraise, la pêche, la framboise, la mûre, la mangue, le kiwi, la myrtille, le cassis, la groseille, l'orange, la cerise, la figue, la poire, l'abricot, la noix de coco, le fruit de la passion, la goyave, la papaye, le melon, le litchi, l'ananas, le citron, la mandarine, la mirabelle, le pamplemousse, le raisin, la rhubarbe et leurs mélanges, sans que cette liste soit exhaustive. 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.
Par « texturants », on entend les composés qui modifient la texture des produits dans lesquels ils sont incorporés. Des exemples de texturants sont : les farines de guar et de caroube ; les gommes arabique, de xanthane et de gellane ; les carraghénanes ; les amidons (natifs ou modifiés) ; la cellulose microcristalline ; la gélatine ; la pectine ; les alginates (E400 à E405) ; l'agar-agar ; et leurs mélanges. Par « émulsifïants », on entend des composés amphiphiles caractérisés par leur valeur de HLB (Hydrophile Lipophile Balance), notamment susceptibles de stabiliser des émulsions huile-dans-eau (particulièrement intéressant si l'on souhaite ajouter, par exemple, des actifs liposo lubies tels que les vitamines liposolubles. Des exemples d' émulsifïants alimentaires sont la lécithine et ses dérivés présents notamment dans le jaune d'œuf ; les mono- et diglycérides d'acides gras ; et le polysorbate 80. "Texturizers" means compounds that modify the texture of the products in which they are incorporated. Examples of texturants are: guar and carob flour; gum arabic, xanthan and gellan; carrageenans; starches (native or modified); microcrystalline cellulose; gelatin; pectin; alginates (E400 to E405); agar-agar; and their mixtures. By "emulsifiers" is meant 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, liposo-rich active ingredients). Examples of dietary emulsifiers are lecithin and its derivatives present especially in egg yolk, mono- and diglycerides of fatty acids, and polysorbate 80.
Par « colorants », on entend des composés d'origine naturelle ou synthétique susceptibles de conférer à eux seuls une coloration à la composition. Des exemples de colorants alimentaires sont connus en Europe sous les codes El 00 à El 80. By "dyes" 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.
Par « conservateurs », on entend des composés inhibant la prolifération des micro-organismes, en particuliers de levures et/ou moisissures et/ou bactéries, en particulier Staphylococcus Aureus, dans la composition. Des exemples de conservateurs alimentaires sont l'acide sorbique et ses sels (E200 à E203: l'acide benzoïque et ses sels (E210 à E219) ; les sulfites et dérivés (E220 à E228) ; la natamycine ; la nisine ; et leurs mélanges. De préférence, la composition selon l'invention ne comprend aucun conservateur. Par « arômes », on entend des composés d'origine naturelle ou synthétique susceptibles à eux seuls de modifier le goût de la composition. Des exemples d'arômes sont l'abricot, l'ananas, la banane, le cassis, la cerise, le citron, le lime, la fraise, la framboise, les fruits de la passion, la mandarine, la menthe, l'orange, la pistache, la poire, le réglisse, la rose, l'anis, la myrtille, la cannelle, le gingembre, le pamplemousse, la pomme, le kiwi, le lychee, le melon, la noix de coco, la pêche, la groseille, la goyave, la grenadine, la mangue, la mûre, la papaye, la vanilline, l'extrait naturel de vanille, les huiles essentielles et leurs mélanges. "Preservatives" means compounds which 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, and mixtures thereof Preferably, 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. apricot, pineapple, banana, blackcurrant, cherry, lemon, lime, strawberry, raspberry, passion fruit, mandarin, mint, orange, pistachio, pear, licorice, rose, anise, blueberry, cinnamon, ginger, grapefruit, apple, kiwi, lychee, melon, coconut, peach, currant, guava, grenadine, mango, blackberry, papaya, vanillin, natural vanilla extract, essential oils and their mixtures.
Par sucre ou sucres, on entend, au sens de la présente invention, tout hydrate de carbone édulcorant, de préférence du sirop de glucose, du saccharose, glucose, fructose, sucre inverti, miel, maltose, polyol ou leurs mélanges. Dans le cadre de la présente invention, le sucre utilisé est un polyol, de préférence le sorbitol. For the purposes of the present invention, sugar or sugar is understood to mean any sweetening carbohydrate, preferably glucose syrup, sucrose, glucose, fructose, invert sugar, honey, maltose, polyol or mixtures thereof. In the context of the present invention, the sugar used is a polyol, preferably sorbitol.
Actif(s) additionnel(s) Additional asset (s)
Tout actif additionnel présentant un intérêt nutritionnel et/ou aidant à la relaxation ou à l'endormissement peut également être ajouté aux produits de combinaison de l'invention sous forme pharmaceutique ou cosmétique. Le produit de combinaison pourra comprendre, à titre d'exemple, des vitamines, des sels minéraux, des acides aminés essentiels, des acides gras essentiels, des oligoéléments, divers extraits végétaux, des fibres, des antioxydants, des flavonoïdes. 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.
Avantageusement, un tel actif additionnel peut être destiné à renforcer l'effet souhaité tel que décrit précédemment. Bien entendu, l'homme du métier veillera à choisir les actifs additionnels ainsi que leur quantité de telle manière que les propriétés avantageuses de la composition conforme à l'invention ne soient pas, ou substantiellement pas, altérées par l'adjonction envisagée. Advantageously, such additional asset may be intended to enhance the desired effect as described above. Of course, those skilled in the art will take care to choose the additional assets and their amount so that the advantageous properties of the composition according to the invention are not, or not substantially impaired by the addition envisaged.
A titre d'actif additionnel utilisable, on peut citer : - les vitamines hydrosolubles et les vitamines liposolubles. Des exemples de vitamines hydrosolubles présentes dans le produit sirupeux préparé selon l'invention sont notamment : la vitamine Bl (thiamine), la vitamine B2 (riboflavine), la vitamine B3 (acide nicotinique) appelée également vitamine PP (Pellagra Préventive), la vitamine B5 (acide pantothénique), la vitamine B6 (pyridoxine), la vitamine B8 ou H (biotine), la vitamine B9 (acide folique), la vitamine B12 (cobalamine) et la vitamine C (acide ascorbique). Des exemples de vitamines liposolubles présentes dans le produit sirupeux préparé selon l'invention sont notamment : la vitamine A (rétinol), la vitamine D3 (cholécalciférol), la vitamine E (mélange de tocophérols et de tocotriénols) et la vitamine K (phylloquinone). - les antioxydants, tels que les curcuminoïdes ; les caroténoïdes, notamment choisis parmi le beta. -carotène, l'astaxanthine, la zéaxanthine, la lutéine ou les composés en contenant comme les baies de goji ; des composés polyphénols, les flavonoïdes tels que les catéchines ; les proanthocyanidines, les anthocyanines, les OPC (oligomères procyanidoliques) ; les ubiquinones ; les extraits de café contenant des polyphénols et/ou des diterpènes ; les extraits de chicorés ; les extraits de ginkgo biloba ; les extraits de raisins riches en proanthocyanidines; les extraits de piment ; les extraits de soja ; le cacao ; la grenade ; l'Emblica ; le CoenzymeQlO ; le sélénium, As additional assets that can be used, mention may be made of: - water-soluble vitamins and fat-soluble vitamins. Examples of water-soluble vitamins present in the syrupy product prepared according to the invention 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). Examples of 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,
- les minéraux, tels que le zinc, le calcium, le cuivre, le fer, l'iode, le manganèse, le sélénium, le chrome (III), minerals, such as zinc, calcium, copper, iron, iodine, manganese, selenium, chromium (III),
- les acides aminés, notamment les acides aminés soufrés, tels que des précurseurs de glutathion, les acides aminés du sélénium, la citrulline, amino acids, especially sulfur-containing amino acids, such as glutathione precursors, the amino acids of selenium, citrulline,
-les phytostérols, le resvératrol, l'hespéridine, la néohesperidine, l'acide orthosilicique, le monométhylsilanetriol, et leurs mélanges. phytosterols, resveratrol, hesperidin, neohesperidin, orthosilicic acid, monomethylsilanetriol, and mixtures thereof.
Dans un mode de réalisation particulièrement avantageux de l'invention, l'association d'actifs comprend, à titre d'actif additionnel, une vitamine liposo lubie, en particulier la vitamine D3, des minéraux tels que le potassium ou le magnésium. In a particularly advantageous embodiment of the invention, the combination of active agents comprises, as additional active ingredient, a liposo-fucous vitamin, in particular vitamin D3, minerals such as potassium or magnesium.
De façon préférée, un produit de combinaison selon l'invention est administré par voie orale. Les formes appropriées pour la voie orale sont par exemple les comprimés, les gélules, les pastilles, les poudres, les granulés, les lyophilisats, les solutés buvables et les sirops. Les comprimés, poudres, les granulés, les lyophilisats, les solutés buvables et les sirops constituent la forme pharmaceutique ou cosmétique adaptée à la voie orale actuellement préférée. Dans le cas de la préparation d'une composition solide sous forme de comprimés, on pourra par exemple mélanger les ingrédients actifs principaux (i), (ii), (iii) ou (iv) avec un véhicule physiologiquement acceptable tel que la gélatine, l'amidon, le stéarate de magnésium, le talc, la gomme arabique ou analogies. Les comprimés peuvent être de nature variée, à libération immédiate, contrôlée ou retardée et éventuellement sous forme effervescente ou orodispersible. Preferably, 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. In the case of preparation of a solid composition in the form of tablets, it is possible, for example, to mix the main active ingredients (i), (ii), (iii) or (iv) with a physiologically acceptable carrier 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.
On obtient une préparation en gélule en mélangeant l'ingrédient actif (i), (ii), (iii) ou (iv) sous forme de poudre et en versant le mélange obtenu dans des gélules molles ou dures. A capsule preparation is obtained by mixing the active ingredient (i), (ii), (iii) or (iv) in powder form and pouring the resulting mixture into soft or hard gelatin capsules.
Exemple de composition selon l'invention (Tableau 1) : Example of composition according to the invention (Table 1):
Figure imgf000014_0001
Figure imgf000014_0001
Cette composition est obtenue en mélangeant les différents composés selon les procédés classiquement utilisés pour ce type de préparation. La composition est ensuite préférentiellement injectée dans des gélules. This composition is obtained by mixing the various compounds according to the methods conventionally used for this type of preparation. The composition is then preferably injected into capsules.

Claims

REVENDICATIONS
1. Produit de combinaison comprenant à titre de substances actives, au moins : 1. Combination product comprising as active substances at least:
(i) de la mélatonine,  (i) melatonin,
(ii) de la passiflore,  (ii) passionflower,
(iii) de la camomille, et  (iii) chamomile, and
(iv) de la mélisse ou un composé bioéquivalent de la mélatonine, de la passiflore, de la camomille ou de la mélisse pour aider à la relaxation et/ou à l'endormissement.  (iv) lemon balm or a bioequivalent compound of melatonin, passionflower, chamomile or lemon balm to aid relaxation and / or sleep.
2. Produit de combinaison selon la revendication 1, caractérisé en ce que les substances actives consistent en : Combination product according to Claim 1, characterized in that the active substances consist of:
(i) de 0,5 à 2,0 mg/jour, de préférence 1,0 à l,5mg/jour de mélatonine  (i) 0.5 to 2.0 mg / day, preferably 1.0 to 1.5 mg / day of melatonin
(ii) de 50 à 500 mg/jour de préférence 50 à 200 mg/jour de passiflore  (ii) from 50 to 500 mg / day, preferably 50 to 200 mg / day of passionflower
(iii) de 5 à 200 mg/jour, de préférence 10 à 80 mg/jour de camomille  (iii) from 5 to 200 mg / day, preferably 10 to 80 mg / day of chamomile
(iv) de 5 à 50 mg/jour, de préférence 10 à 30 mg/jour de mélisse  (iv) from 5 to 50 mg / day, preferably from 10 to 30 mg / day of melissa
3. Produit de combinaison selon l'une des revendications 1 ou 2, caractérisé en ce qu'il est sous la forme d'une composition unique contenant au moins : 3. Combination product according to one of claims 1 or 2, characterized in that it is in the form of a single composition containing at least:
(i) de la mélatonine, (i) melatonin,
(ii) de la passiflore, (ii) passionflower,
(iii) de la camomille, et (iii) chamomile, and
(iv) de la mélisse dans un milieu physiologiquement acceptable. (iv) lemon balm in a physiologically acceptable medium.
4. Produit de combinaison selon l'une des revendications précédentes caractérisé en ce que le milieu physiologiquement acceptable est adapté à l'administration par voie orale. 4. Combination product according to one of the preceding claims characterized in that the physiologically acceptable medium is suitable for oral administration.
5. Produit de combinaison selon l'une des revendications précédentes caractérisé en ce qu'il se présente sous la forme d'une gélule comprenant les actifs sous forme de poudre. 2 5. Combination product according to one of the preceding claims characterized in that it is in the form of a capsule comprising the active form of powder. 2
6. Produit de combinaison selon l'une des revendications précédentes caractérisé en ce que la mélatonine, la passiflore, la camomille et la mélisse sont sous forme d'extraits végétaux 6. Combination product according to one of the preceding claims characterized in that melatonin, passionflower, chamomile and lemon balm are in the form of plant extracts
7. Produit de combinaison selon l'une au moins des revendications précédentes, pour le traitement des sujets présentant une somnipathie. 7. Combination product according to at least one of the preceding claims, for the treatment of subjects with somnipathy.
8. Utilisation d'un produit, selon la revendication 7 pour aider à la relaxation et/ou à 1 ' endormissement. 8. Use of a product according to claim 7 to aid relaxation and / or sleep.
PCT/FR2015/053731 2015-12-22 2015-12-22 Combination product that helps relax and fall asleep WO2017109300A1 (en)

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