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EP3551206A1 - Combination product that helps relax and fall asleep - Google Patents

Combination product that helps relax and fall asleep

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Publication number
EP3551206A1
EP3551206A1 EP16809803.6A EP16809803A EP3551206A1 EP 3551206 A1 EP3551206 A1 EP 3551206A1 EP 16809803 A EP16809803 A EP 16809803A EP 3551206 A1 EP3551206 A1 EP 3551206A1
Authority
EP
European Patent Office
Prior art keywords
sleep
combination product
rhodiola
valerian
hawthorn
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16809803.6A
Other languages
German (de)
French (fr)
Inventor
Tiphaine BRICOUT
Marilyn GENTILHOMME
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Urgo Recherche Innovation et Developpement
HCP Healthcare Asia Pte Ltd
Original Assignee
Urgo Recherche Innovation et Developpement
HCP Healthcare Asia Pte Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Urgo Recherche Innovation et Developpement, HCP Healthcare Asia Pte Ltd filed Critical Urgo Recherche Innovation et Developpement
Publication of EP3551206A1 publication Critical patent/EP3551206A1/en
Withdrawn legal-status Critical Current

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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)
    • A61K36/84—Valerianaceae (Valerian family), e.g. valerian
    • 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
    • A61P25/22—Anxiolytics

Definitions

  • the subject of the present invention is a combination product comprising, as active substances, at least valerian, passionflower, rhodiola and hawthorn or a bioequivalent compound of the latter to aid relaxation and / or to fall asleep.
  • the invention finally relates to the use of a combination product as previously defined for the treatment or prevention of stress and somnipathies.
  • Stress is a normal reaction of the body to environmental stresses. If it is temporary the stress can be positive, but if it lasts too long it can play on the health.
  • stressors The origin of stress can be multiple, it is due to what are called stressors or "stressors". It is a feeling of normal physical or emotional tension. There are two types of stress:
  • Chronic stress that lasts for a while. It is due to deeper problems. Any stress lasting several weeks or months is called chronic stress.
  • the body reacts to stress through the release of hormones that will play on the brain, muscles and heartbeat. In the short term, these reactions are beneficial to the body and protect it because they allow humans to manage and overcome the stress situation. On the other hand, if the stress persists, the human body remains perpetually in a state of alert despite the absence of danger.
  • 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
  • sleepwalking an activity that is physically and unconsciously engaged during sleep; Somniphobia, afraid to sleep; sleep apnea
  • sleep apnea 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.
  • clinics and laboratories devoted themselves to the study of sleep accompanied by its troubles.
  • Sleep medicine is now adapted in internal medicine, family medicine, pediatrics, otolaryngology, psychiatry and neurology.
  • the present invention relates to a composition for assisting stress management, relaxation and sleep in adults or children, preferably in adults.
  • 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 for 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.
  • 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 teenager 14 years. 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.
  • 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
  • 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 allergen 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 relates to a combination product comprising as active substances at least:
  • hawthorn or a bioequivalent compound of valerian, passionflower, rhodiola and / or hawthorn to assist with stress management, relaxation and / or sleep.
  • the present invention also relates to a combination product comprising as active substances at least:
  • hawthorn or a bioequivalent compound of valerian, passionflower, rhodiola and / or hawthorn for use in the treatment or prevention of stress and somnipathy.
  • the combination product according to the invention comprises, in addition to valerian, passionflower, rhodiola and / or hawthorn, as active substances: (i) Plants or extracts of plants, such as, for example, orange blossom, lavender, marjoram, hops, gentian and / or lemon balm,
  • Vitamins and minerals such as for example vitamin D, B vitamins, such as vitamin B6, magnesium and / or calcium
  • the combination product of the invention is characterized in that valerian, passionflower, rhodiola and hawthorn are in the form of plant extracts and are administered at a daily dose of 500 mg / day, preferably 100 to 300 mg / day of valerian extracts of 5 to 200 mg / day, preferably 50 to 150 mg / day of passionflower extracts of 20 to 200 mg / day, preferably 50 to 150 mg / day of rhodiola extracts of 5 to 100 mg / day, preferably 20 to 80 mg / day of hawthorn extracts
  • 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 according to the invention may be in the form of a single composition containing at least as active substances: from 50 to 500 mg, preferably 100 to 300 mg valerian extracts of 5 to 200 mg, preferably 50 to 150 mg of passionflower extracts from 20 to 200 mg, preferably 50 to 150 mg of rhodiola extracts of 5 to 100 mg, preferably 20 to 80 mg of hawthorn extracts
  • 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 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.
  • Valerian, passionflower, rhodiola, and hawthorn may be present as ingredients (i), (ii), (iii) or (iv) in a combination product of the invention in more or less form. purified, especially in the form of a plant extract.
  • the applicant has demonstrated that the combination of at least (i) valerian, (ii) passionflower, (iii) rhodiola, and (iv) hawthorn has a synergistic effect to help the management of stress relaxation and / or falling asleep.
  • the combination of at least (i) valerian, (ii) passionflower, (iii) rhodiola, and (iv) hawthorn has an effect on the aid in relaxation and / or sleep during treatment which is superior to the cumulative effects of a treatment (a) comprising the administration of valerian, not associated with passionflower, rhodiola and hawthorn, and conversely a treatment (b) comprising the administration of passionflower, not associated with valerian, rhodiola and hawthorn or a treatment (c) comprising the administration of rhodiola, not associated with valerian, hawthorn and passion flower or treatment (d) comprising the administration of hawthorn, not associated with valerian, passionflower and rhodiola.
  • a treatment comprising the administration of valerian, not associated with passionflower, rhodiola and hawthorn
  • a treatment comprising the administration of passionflower, not associated with valerian, rhodiola
  • Valerian Valerian or Valerian Hills or Valerian small leaves (Valeriana officinalis L.), also known under the vernacular names of Grass-au (x) -chat (s), Herb of Saint-Georges, or Bruised grass is a perennial herb of the family Valerianaceae. In the West its roots are traditionally used for their sedative and anxiolytic effects. They would promote sleep and reduce anxiety and are therefore considered a natural alternative to sleeping pills and chemical anxiolytics.
  • Passionflower 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.
  • Passiflora incarnata The aerial parts of the officinal passionflower (Passiflora incarnata) are known in herbal medicine for their anxiolytic and sedative action. Indeed, Passiflora incarnata has several alkaloids including inhibitors of monoamine oxidase (MAOI) and light sedatives.
  • MAOI monoamine oxidase
  • the Pink Orpin, Rhodiola, Rhodiola, Golden Root or Arctic Root (Rhodiola rosea, synonym Lignum rhodium or Sedum roseum) is a plant species of the family Crassulaceae. It grows in cold regions such as the Arctic, the mountains of Central Asia, the Rocky Mountains, and the mountainous regions of Europe, such as the Alps, the Pyrenees, and the Carpathians, Scandinavia, Iceland, the Kingdom United Kingdom and Ireland. This perennial grows up to 2,280 meters above sea level.
  • Rhodiola rosea can improve depressive states. Pilot studies conducted on patients show improved physical and mental performance, and can reduce fatigue.
  • Rhodiola rosea would alter serotonin and dopamine levels through the inhibition of monoamine oxidase and its Opioid peptides, such as beta-endorphins, although these specific neurochemical mechanisms have not been clearly defined by scientific studies.
  • Rhodiola is classified as an adaptogen, which differs from stimulants such as nicotine and amphetamine.
  • the adaptogenic factor has less efficacy and different physiological effects of the stimulants.
  • Rhodiola rosea Extracts of Rhodiola rosea have an anti-fatigue effect that increases mental performance, especially concentration skills in healthy subjects and in burnout patients with fatigue syndrome. Rhodiola reduces fatigue symptoms and improves attention after four weeks of intake. hawthorn
  • hawthorn used for pharmacological purposes are one-style hawthorn (Crataegus monogyna) and thorny hawthorn (Crataegus laevigata) (the latter being considered less effective). Both are commonly small trees of 2 to 4 meters, of the genus Crataegus and the Rosaceae family, very common in hedgerows of the European countryside. Their white flowers bloom in May.
  • hawthorn In herbal medicine, hawthorn, or hawthorn flowers, are valued for their ability to regulate heart rhythm, improve coronary circulation and nutrition of the heart muscle. It is a hypotensive, cardiotonic and antispasmodic, which calms palpitations, reduces stress and facilitates sleep, thanks to flavonoids, sterols and triterpenes that contains the plant. Non-toxic, it could, in excessive doses, have a depressive action on the heart and affect the liver cell. It is therefore necessary to avoid prolonged cures and to cut them from rest intervals.
  • a physiologically acceptable medium is a medium having no toxic or detrimental effect under the conditions of use and inert with respect to the active ingredients of the combination product.
  • a medium may, for example, comprise various adjuvants according to its therapeutic or cosmetic purpose, as in a nonlimiting manner, flavors, dyes, fillers, preservatives, diluents, wetting agents or suspension, 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.
  • Textturizers 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.
  • emulsifiers amphiphilic compounds characterized by their HLB (Hydrophilic Lipophilic Balance) value, in particular capable of stabilizing oil-in-water emulsions (particularly advantageous if it is desired to add, for example, liposoluble active agents such as Liposoluble vitamins
  • liposoluble active agents such as Liposoluble vitamins
  • food emulsifiers are lecithin and its derivatives present in particular in egg yolk, mono- and diglycerides of fatty acids, and polysorbate 80.
  • dye is meant compounds of natural or synthetic origin capable of conferring on their own a coloration to the composition.
  • Examples of food colorants are 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.
  • 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 them, such as goji berries; polyphenol compounds, flavonoids such as catechins; proanthocyanidins, anthocyanins, OPCs (procyanidolic oligomers); ubiquinones; coffee extracts containing polyphenols and / or diterpenes; chicory extracts; ginkgo biloba extracts; grape extracts rich in proanthocyanidins; chili extracts; soy extracts; Cocoa ; the grenade ; the Emblica; CoenzymeQ10; selenium,
  • amino acids especially sulfur-containing amino acids, such as precursors of glutathione, 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 fat-soluble 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, lyophilisers, drinkable solutions and syrups constitute the pharmaceutical or cosmetic form adapted to 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 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) in powder form and pouring the resulting mixture into soft or hard gelatin capsules.
  • Example of composition according to the invention (Table 1):
  • 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 valerian, Passiflora, Rhodiola and hawthorn or a bioequivalent compound of same for helping with stress management, relaxation and/or falling asleep. The invention further relates to the use of a combination product as defined above for the treatment or prevention of stress and 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 valériane, de la passiflore, de la rhodiola et de l'aubépine 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 ou la prévention du stress et des somnipathies. The subject of the present invention is a combination product comprising, as active substances, at least valerian, passionflower, rhodiola and hawthorn or a bioequivalent compound of the latter to aid relaxation and / or to fall asleep. The invention finally relates to the use of a combination product as previously defined for the treatment or prevention of stress and somnipathies.

ARRIERE PLAN BACKGROUND

Le stress est une réaction normale du corps à des contraintes de l'environnement. S'il est temporaire le stress peut être positif, mais s'il dure trop longtemps il peut jouer sur la santé. Stress is a normal reaction of the body to environmental stresses. If it is temporary the stress can be positive, but if it lasts too long it can play on the health.

L'origine d'un stress peut être multiple, il est dû à ce qu'on appelle des facteurs de stress ou «stresseurs». C'est un sentiment de tension physique ou émotionnelle normal. Il existe deux types de stress : The origin of stress can be multiple, it is due to what are called stressors or "stressors". It is a feeling of normal physical or emotional tension. There are two types of stress:

Le stress aigu qui disparait rapidement. C'est le stress qui, par exemple, aide le corps à augmenter ses performances ou à s'adapter à une situation nouvelle. Acute stress that quickly disappears. It is stress that, for example, helps the body to increase its performance or adapt to a new situation.

Le stress chronique qui, lui, dure un certain temps. Il est dû à des problèmes plus profonds. Tout stress durant plusieurs semaines ou mois est qualifié de stress chronique. Chronic stress that lasts for a while. It is due to deeper problems. Any stress lasting several weeks or months is called chronic stress.

Le corps réagit au stress via la libération d'hormones qui vont jouer sur le cerveau, les muscles et les battements cardiaques. A court terme, ces réactions sont bénéfiques pour le corps et le protègent car elles permettent à l'être humain de gérer et de surmonter la situation due au stress. Par contre, si le stress perdure, le corps humain reste perpétuellement en état d'alerte malgré l'absence de danger. The body reacts to stress through the release of hormones that will play on the brain, muscles and heartbeat. In the short term, these reactions are beneficial to the body and protect it because they allow humans to manage and overcome the stress situation. On the other hand, if the stress persists, the human body remains perpetually in a state of alert despite the absence of danger.

La libération continue des hormones et l'activation du cerveau, des muscles et du cœur peuvent alors engendrer des risques pour la santé comme une forte tension, des problèmes cardiaques, de l'anxiété, de la dépression, ou des problèmes de peau. 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. 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. Continuous release of hormones and activation of the brain, muscles, and heart can lead to health risks such as high blood pressure, heart problems, anxiety, depression, or skin problems. 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. 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 ; -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); - bruxism, creaking or involuntary clanging of the teeth during sleep; -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 ; -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;

-la terreur nocturne, pavor nocturnus, trouble nocturne caractérisée par une forte peur et anxiété ; - nocturnal terror, pavor nocturnus, nocturnal disorder characterized by strong fear and anxiety;

-le somnambulisme, activité engagée physiquement et inconsciemment durant le sommeil ; -la somniphobie, peur de dormir ; -les apnées du sommeil. 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. sleepwalking, an activity that is physically and unconsciously engaged during sleep; Somniphobia, afraid to sleep; sleep apnea 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, lOtolaryngologie, 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 gestion du stress, à la relaxation et à l'endormissement chez l'adulte ou chez l'enfant, de préférence chez l'adulte. 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. The present invention relates to a composition for assisting stress management, relaxation and sleep in adults or children, preferably in adults. 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 for 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 Disrupted sleep also entails risks for the cognitive development of the child with the occurrence of behavioral disorders As for adults, it seems that there is an association between obstructive apnea sleep 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 teenager 14 years. 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 aprèsDuring 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 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

I ' endormissement. I fall asleep.

II 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 Sanofi sous la dénomination commerciale Nova Nuit Sommeil à base de passiflore, mélatonine, pavot de Californie, mélisse et vitamine B6 ou le produit Somdor+ Mélatonine de Granions qui 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. There are on the market a number of products to overcome the problems of falling asleep or relaxation. Among these products, there may be mentioned, for example, the products marketed by Sanofi under the trade name Nova Nuit Sommeil made from passionflower, melatonin, California poppy, lemon balm and vitamin B6 or the product Somdor + Melatonin from Granions which contains melatonin, an extract of lemon balm, hawthorn, passionflower, hops and valerian. None of the products proposed contains the association object of the present invention.

Ces produits, bien que contenant de la valériane en association avec de la passiflore et de l'aubépine, 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. Le produit selon la présente invention présente également l'avantage de ne contenir, de préférence, aucun allergène et d'être, préférentiellement, sans lactose ou gluten. These products, although containing valerian in combination with passionflower and hawthorn, 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. The product according to the present invention also has the advantage of preferably containing no allergen 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. RESUME DE L'INVENTION The product of the present invention has a galenic adapted to the child and the adult, preferably in the form of a capsule. SUMMARY OF THE INVENTION

La présente invention se rapporte à un produit de combinaison, comprenant à titre de substances actives, au moins : The present invention relates to a combination product comprising as active substances at least:

(i) de la valériane, (i) valerian,

(ii) de la passiflore, (iii) de la rhodiola, et (ii) passionflower, (iii) rhodiola, and

(iv) de l'aubépine ou un composé bioéquivalent de la valériane, de la passiflore, de la rhodiola et/ou de l'aubépine pour aider à la gestion du stress, à la relaxation et/ou à l'endormissement. (iv) hawthorn or a bioequivalent compound of valerian, passionflower, rhodiola and / or hawthorn to assist with stress management, relaxation and / or sleep.

La présente invention se rapporte également à un produit de combinaison, comprenant à titre de substances actives, au moins : The present invention also relates to a combination product comprising as active substances at least:

(i) de la valériane, (i) valerian,

(ii) de la passiflore, (ii) passionflower,

(iii) de la rhodiola, et (iii) rhodiola, and

(iv) de l'aubépine ou un composé bioéquivalent de la valériane, de la passiflore, de la rhodiola et/ou de l'aubépine pour son utilisation dans le traitement ou la prévention du stress et des somnipathies. (iv) hawthorn or a bioequivalent compound of valerian, passionflower, rhodiola and / or hawthorn for use in the treatment or prevention of stress and somnipathy.

Dans certains modes de réalisation, le produit de combinaison selon l'invention comprend, en plus de la valériane, de la passiflore, de la rhodiola et/ou de l'aubépine, à titre de substances actives : (i) Des plantes ou extraits de plantes, tels que par exemple de la fleur d'oranger, la lavande, la marjolaine, le houblon, la gentiane et/ou la mélisse, In certain embodiments, the combination product according to the invention comprises, in addition to valerian, passionflower, rhodiola and / or hawthorn, as active substances: (i) Plants or extracts of plants, such as, for example, orange blossom, lavender, marjoram, hops, gentian and / or lemon balm,

(ii) Des vitamines et minéraux, tels que par exemple la vitamine D, les vitamines du groupe B, telles que la vitamine B6, le magnésium et/ou le calcium  (ii) Vitamins and minerals, such as for example vitamin D, B vitamins, 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 valériane, la passiflore, la rhodiola et l'aubépine se présentent sous forme d'extraits végétaux et sont administrés à une dose quotidienne : de 50 à 500 mg/jour de préférence 100 à 300 mg/jour d'extraits de valériane de 5 à 200 mg/jour, de préférence 50 à 150 mg/jour d'extraits de passiflore de 20 à 200 mg/jour, de préférence 50 à 150 mg/jour d'extraits de rhodiola de 5 à 100 mg/jour, de préférence 20 à 80 mg/jour d'extraits d'aubépine In certain embodiments, the combination product of the invention is characterized in that valerian, passionflower, rhodiola and hawthorn are in the form of plant extracts and are administered at a daily dose of 500 mg / day, preferably 100 to 300 mg / day of valerian extracts of 5 to 200 mg / day, preferably 50 to 150 mg / day of passionflower extracts of 20 to 200 mg / day, preferably 50 to 150 mg / day of rhodiola extracts of 5 to 100 mg / day, preferably 20 to 80 mg / day of hawthorn extracts

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 valériane, (i) valerian,

(ii) de la passiflore, (ii) passionflower,

(iii) de la rhodiola, et (iii) rhodiola, and

(iv) de l'aubépine dans un milieu physiologiquement acceptable. (iv) hawthorn in a physiologically acceptable medium.

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 contenant au moins à titre de substances actives : de 50 à 500 mg, de préférence 100 à 300 mg d'extraits de valériane de 5 à 200 mg, de préférence 50 à 150 mg d'extraits de passiflore de 20 à 200 mg, de préférence 50 à 150 mg d'extraits de rhodiola de 5 à 100 mg, de préférence 20 à 80 mg d'extraits d'aubépine In some embodiments of the invention, the combination product according to the invention may be in the form of a single composition containing at least as active substances: from 50 to 500 mg, preferably 100 to 300 mg valerian extracts of 5 to 200 mg, preferably 50 to 150 mg of passionflower extracts from 20 to 200 mg, preferably 50 to 150 mg of rhodiola extracts of 5 to 100 mg, preferably 20 to 80 mg of hawthorn extracts

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 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 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 valériane, la passiflore, la rhodiola, et l'aubépine pourront être présents en tant qu'ingrédients (i), (ii), (iii) ou (iv) dans un produit de combinaison de l'invention sous forme plus ou moins purifiée, notamment sous forme d'extrait végétal. Valerian, passionflower, rhodiola, and hawthorn may be present as ingredients (i), (ii), (iii) or (iv) in a combination product of the invention in more or less form. purified, 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 valériane, (ii) la passiflore, (iii) la rhodiola, et (iv) l'aubépine présentait un effet synergique pour aider à la gestion du stress relaxation et/ou à l'endormissement. In the present invention, the applicant has demonstrated that the combination of at least (i) valerian, (ii) passionflower, (iii) rhodiola, and (iv) hawthorn has a synergistic effect to help the management of stress relaxation and / or falling asleep.

Par effet synergique, il est entendu selon la présente invention que l'association d'au moins (i) la valériane, (ii) la passiflore, (iii) la rhodiola, et (iv) l'aubépine 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 valériane, non associé à la passiflore, à la rhodiola et à l'aubépine, et inversement d'un traitement (b) comprenant l'administration de la passiflore, non associé à la valériane, à la rhodiola et à l'aubépine ou d'un traitement (c) comprenant l'administration de la rhodiola, non associé à la valériane, à l'aubépine et à la passiflore ou d'un traitement (d) comprenant l'administration de l'aubépine, non associé à la valériane, à la passiflore et à la rhodiola. La valériane By synergistic effect, it is understood according to the present invention that the combination of at least (i) valerian, (ii) passionflower, (iii) rhodiola, and (iv) hawthorn has an effect on the aid in relaxation and / or sleep during treatment which is superior to the cumulative effects of a treatment (a) comprising the administration of valerian, not associated with passionflower, rhodiola and hawthorn, and conversely a treatment (b) comprising the administration of passionflower, not associated with valerian, rhodiola and hawthorn or a treatment (c) comprising the administration of rhodiola, not associated with valerian, hawthorn and passion flower or treatment (d) comprising the administration of hawthorn, not associated with valerian, passionflower and rhodiola. Valerian

La Valériane officinale ou Valériane des collines ou Valériane à petites feuilles (Valeriana officinalis L.), connue aussi sous les appellations vernaculaires d'Herbe-au(x)-chat(s), d'Herbe de Saint-Georges, ou d'Herbe à la meurtrie est une plante herbacée vivace de la famille des Valerianaceae. En Occident ses racines sont traditionnellement utilisées pour leurs effets sédatif et anxiolytique. Elles permettraient de favoriser le sommeil et d'atténuer l'anxiété et sont donc considérées comme une alternative naturelle aux somnifères et aux anxiolytiques chimiques. Valerian Valerian or Valerian Hills or Valerian small leaves (Valeriana officinalis L.), also known under the vernacular names of Grass-au (x) -chat (s), Herb of Saint-Georges, or Bruised grass is a perennial herb of the family Valerianaceae. In the West its roots are traditionally used for their sedative and anxiolytic effects. They would promote sleep and reduce anxiety and are therefore considered a natural alternative to sleeping pills and chemical anxiolytics.

La passiflore 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. Passionflower 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.

Les parties aériennes de la passiflore officinale (Passiflora incarnata) sont connues en phytothérapie pour leur action anxiolytique et sédative. En effet, la Passiflora incarnata possède plusieurs alcaloïdes notamment des inhibiteurs de la monoamine-oxydase (IMAO) et des sédatifs légers. The aerial parts of the officinal passionflower (Passiflora incarnata) are known in herbal medicine for their anxiolytic and sedative action. Indeed, Passiflora incarnata has several alkaloids including inhibitors of monoamine oxidase (MAOI) and light sedatives.

La rhodiola Rhodiola

L'Orpin rose, rhodiola, rhodiole, racine d'or ou racine arctique (Rhodiola rosea, synonyme Lignum rhodium ou Sedum roseum) est une espèce de plante de la famille des crassulaceae. Elle pousse dans les régions froides telles l'Arctique, les montagnes d'Asie centrale, les montagnes Rocheuses, et les régions montagneuses d'Europe, telles les Alpes, les Pyrénées, et les Carpates, la Scandinavie, l'Islande, le Royaume-Uni et l'Irlande. Cette plante vivace pousse jusqu'à 2 280 mètres d'altitude. The Pink Orpin, Rhodiola, Rhodiola, Golden Root or Arctic Root (Rhodiola rosea, synonym Lignum rhodium or Sedum roseum) is a plant species of the family Crassulaceae. It grows in cold regions such as the Arctic, the mountains of Central Asia, the Rocky Mountains, and the mountainous regions of Europe, such as the Alps, the Pyrenees, and the Carpathians, Scandinavia, Iceland, the Kingdom United Kingdom and Ireland. This perennial grows up to 2,280 meters above sea level.

Rhodiola rosea peut améliorer les états dépressifs. Des études pilotes menées sur des patients montrent l'amélioration des performances physique et mentale, et peut réduire la fatigue. Rhodiola rosea can improve depressive states. Pilot studies conducted on patients show improved physical and mental performance, and can reduce fatigue.

L'hypothèse est que les effets de la Rhodiola rosea modifieraient les niveaux de sérotonine et dopamine grâce à l'inhibition qu'engendre la monoamine oxidase et ses influences sur les peptides Opioïdes, telles les beta-endorphines, bien que ces mécanismes neurochimiques spécifiques n'aient pas été clairement définis par des études scientifiques. The hypothesis is that the effects of Rhodiola rosea would alter serotonin and dopamine levels through the inhibition of monoamine oxidase and its Opioid peptides, such as beta-endorphins, although these specific neurochemical mechanisms have not been clearly defined by scientific studies.

Rhodiola est classée comme adaptogène, qui diffère donc des stimulants comme la nicotine et l'amphétamine. Le facteur adaptogène a moins d'efficacité et des effets physiologiques différents des stimulants. Rhodiola is classified as an adaptogen, which differs from stimulants such as nicotine and amphetamine. The adaptogenic factor has less efficacy and different physiological effects of the stimulants.

Les extraits de Rhodiola rosea ont un effet anti-fatigue qui augmente les performances mentales, particulièrement l'habileté à la concentration chez les sujets sains et chez les patients en 'burnout' ayant un syndrome de fatigue. La Rhodiola réduit bien les symptômes de fatigue et améliore l'attention, au bout de quatre semaines de prise. L'aubépine Extracts of Rhodiola rosea have an anti-fatigue effect that increases mental performance, especially concentration skills in healthy subjects and in burnout patients with fatigue syndrome. Rhodiola reduces fatigue symptoms and improves attention after four weeks of intake. hawthorn

Les aubépines utilisées à des fins pharmacologiques sont l'Aubépine à un style (Crataegus monogyna) et l'Aubépine épineuse (Crataegus laevigata) (cette dernière étant considérée comme moins efficace). Toutes deux sont couramment des petits arbres de 2 à 4 mètres, du genre Crataegus et de la famille des rosacées, très fréquents dans les haies des campagnes européennes. Leurs fleurs blanches s'épanouissent en mai. The hawthorn used for pharmacological purposes are one-style hawthorn (Crataegus monogyna) and thorny hawthorn (Crataegus laevigata) (the latter being considered less effective). Both are commonly small trees of 2 to 4 meters, of the genus Crataegus and the Rosaceae family, very common in hedgerows of the European countryside. Their white flowers bloom in May.

En phytothérapie, l'aubépine, ou plutôt les fleurs de l'aubépine, sont appréciées pour leurs qualités de régulation du rythme cardiaque, d'amélioration de la circulation coronarienne et de la nutrition du muscle cardiaque. C'est un hypotenseur, un cardiotonique et un antispasmodique, qui calme les palpitations, diminue le stress et facilite le sommeil, grâce aux flavonoïdes, aux stérols et aux triterpènes que contient la plante. Non toxique, elle pourrait, à doses excessives, avoir une action dépressive sur le cœur et nuire à la cellule hépatique. Il faut donc éviter les cures trop prolongées et les couper d'intervalles de repos. In herbal medicine, hawthorn, or hawthorn flowers, are valued for their ability to regulate heart rhythm, improve coronary circulation and nutrition of the heart muscle. It is a hypotensive, cardiotonic and antispasmodic, which calms palpitations, reduces stress and facilitates sleep, thanks to flavonoids, sterols and triterpenes that contains the plant. Non-toxic, it could, in excessive doses, have a depressive action on the heart and affect the liver cell. It is therefore necessary to avoid prolonged cures and to cut them from rest intervals.

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 various adjuvants according to its therapeutic or cosmetic purpose, as in a nonlimiting manner, flavors, dyes, fillers, preservatives, diluents, wetting agents or suspension, etc. Such media may also allow immediate, modified or delayed release of either active ingredient.

Le milieu physiologiquement acceptable peut être composé d'eau, de purée et/ou jus de fruits, des texturants, des émulsifiants, des colorants, des conservateurs, des arômes, du sucre ou des sucres. The physiologically acceptable medium may be water, mash and / or fruit juice, texturizers, emulsifiers, colorants, preservatives, flavorings, 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 filtration) 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 « émulsifiants », 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 liposolubles tels que les vitamines liposolubles. Des exemples d'émulsifiants 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, liposoluble active agents such as Liposoluble vitamins Examples of food emulsifiers are lecithin and its derivatives present in particular 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. By "preservatives" is meant 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 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 them, such as goji berries; polyphenol compounds, flavonoids such as catechins; proanthocyanidins, anthocyanins, OPCs (procyanidolic oligomers); ubiquinones; coffee extracts containing polyphenols and / or diterpenes; chicory extracts; ginkgo biloba extracts; grape extracts rich in proanthocyanidins; chili extracts; soy extracts; Cocoa ; the grenade ; the Emblica; CoenzymeQ10; selenium,

- les minéraux, tels que le zinc, le calcium, le cuivre, le fer, l'iode, le manganèse, le sélénium, le chrome (III), - les acides aminés, notamment les acides aminés soufrés, tels que des précurseurs de glutathion, les acides aminés du sélénium, la citrulline, minerals, such as zinc, calcium, copper, iron, iodine, manganese, selenium, chromium (III), amino acids, especially sulfur-containing amino acids, such as precursors of glutathione, 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 liposoluble, 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 fat-soluble 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 lyophilisais, les solutés buvables et les sirops. Les comprimés, poudres, les granulés, les lyophilisais, 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, lyophilisers, drinkable solutions and syrups constitute the pharmaceutical or cosmetic form adapted to the currently preferred oral route. In the case of the 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 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.

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. Exemple de composition selon l'invention (Tableau 1) : 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. Example of composition according to the invention (Table 1):

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 valériane,  (i) valerian, (ii) de la passiflore,  (ii) passionflower, (iii) de la rhodiola, et  (iii) rhodiola, and (iv) de l'aubépine ou un composé bioéquivalent de la valériane, de la passiflore, de la rhodiola ou de la rhodiola pour aider à la gestion du stress, à la relaxation et/ou à l'endormissement.  (iv) hawthorn or a bioequivalent compound of valerian, passionflower, rhodiola or rhodiola to aid in stress management, relaxation and / or sleep. 2. 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 : 2. 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 valériane, (i) valerian, (ii) de la passiflore, (ii) passionflower, (iii) de la rhodiola, et (iv) de l'aubépine dans un milieu physiologiquement acceptable. (iii) rhodiola, and (iv) hawthorn in a physiologically acceptable medium. 3. Produit de combinaison selon l'une des revendications précédentes caractérisé en ce que le milieu physiologiquement acceptable est adapté à radministration par voie orale. 3. Combination product according to one of the preceding claims characterized in that the physiologically acceptable medium is suitable for oral administration. 4. 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. 4. 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. 5. Produit de combinaison selon l'une des revendications précédentes caractérisé en ce que la valériane, la passiflore, la rhodiola et l'aubépine sont sous forme d'extraits végétaux 5. Combination product according to one of the preceding claims characterized in that valerian, passionflower, rhodiola and hawthorn are in the form of plant extracts 6. Produit de combinaison selon l'une au moins des revendications précédentes, pour le traitement des sujets présentant une somnipathie. 6. Combination product according to at least one of the preceding claims, for the treatment of subjects with somnipathy.
EP16809803.6A 2016-12-12 2016-12-12 Combination product that helps relax and fall asleep Withdrawn EP3551206A1 (en)

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