FR3101540A1 - Combination product to relieve the bronchi and make it easier to fall asleep - Google Patents

Abstract

The present invention relates to a combination product comprising, as active substances, at least thyme, marshmallow, poppy and vitamin B6 to relieve the bronchi and facilitate falling asleep. Finally, the invention relates to the use of a combination product as defined above for relieving the symptoms of cough and making it easier to fall asleep.

Description

Combination product to relieve the bronchial tubes and facilitate falling asleep

The subject of the present invention is a combination product comprising, as active substances, at least thyme, marshmallow, poppy and vitamin B6 to relieve the bronchial tubes and facilitate falling asleep. The invention finally relates to the use of a combination product as defined above for relieving the symptoms of coughing and facilitating falling asleep.

BACKGROUND

Coughing is a natural defense reflex to expel mucus or irritating agents from the respiratory tract. It can be acute, chronic, dry or oily. It is most often due to a viral infection but can be caused by other diseases: gastroesophageal reflux, asthma, allergy...

Cough is the sudden, loud exhalation of air from the lungs caused by irritation of the airways.

It is a natural defense reflex that must be respected. Indeed, receptors, located in the mucosa of the trachea and bronchi, react to the slightest irritation, and trigger contractions of the muscles involved in breathing (diaphragm, intercostal muscles, etc.). The resulting cough then frees the airways of phlegm and sources of aggression.

Not all coughs are the same. If the person has been coughing for less than three weeks, the cough is acute. If it continues beyond three weeks, the cough becomes chronic.

An irritating cough without sputum is said to be dry. If the person spits, the cough is oily or productive: it is accompanied by translucent or thick sputum of variable yellowish or greenish color.

The cough can manifest itself in the form of fits that are difficult to stop or, on the contrary, episodes of coughing of short duration. It can be present during the day, at night, when falling asleep or permanently. Lying down promotes its occurrence and coughing often interferes with falling asleep. The cough can be brought on by exertion or present even at rest. It can be isolated or associated with other symptoms: fever, difficulty breathing, vomiting...

In the vast majority of cases, the cough reveals a viral or more rarely bacterial infection of the respiratory tract:

nasopharyngitis;

laryngitis;

bronchiolitis;

acute bronchitis ;

sinusitis;

pneumonia;

whooping cough.

The cough is present, chronically when the person has chronic rhinitis with discharge in the back of the throat (chronic posterior rhinorrhea); in case of gastroesophageal reflux in adults and infants; in asthma ( a chronic cough may be the only manifestation of asthma) both in babies (asthma in infants), children (asthma in children) and adults; in chronic obstructive pulmonary disease or chronic bronchitis; in whooping cough because the cough usually lasts more than 3 weeks when taking certain medicines such as angiotensin converting enzyme inhibitors or certain angiotensin II inhibitors (sartans) beta-blockers (including those present in eye drops), inhaled treatments; in case of active or passive smoking or in case of atmospheric pollution.

Cough can significantly alter the quality of life, especially when it is nocturnal, causing insomnia. Also, coughing irritates the airways, which can make the cough worse. This vicious circle is often responsible for persistent coughs, especially after a cold or a seasonal respiratory infection.

It is therefore important not to leave a cough "dragging", even if it seems trivial. In addition, certain signs of seriousness can accompany the dry cough and should lead to consulting a doctor as soon as possible:

deterioration of general condition

difficulty breathing, feeling of tightness

presence of blood in the sputum

appearance or change of cough in a smoker

In order to help the body relieve coughs and facilitate falling asleep, the Applicant has developed a combination product comprising, as active substances, at least thyme, marshmallow, poppy and vitamin B6 .

There are a number of products on the market to relieve the bronchial tubes. Among these products, mention may be made, by way of example, of Bronches from the Giphar laboratory, which contains: dry extract of primrose roots (primula veris), dry extract of cape geranium rhizomes (pelargonium sidoides), dry extract of aerial parts of andrographis (andrographis paniculata), dry extract of deglycyrrhizinated liquorice roots (glycyrrhiza glabra), dry extract of climbing ivy leaves (hedera helix), dry extract of plantain leaves (plantago lanceolata), essential oil of thyme leaves (thymus vulgaris ), essential oil of eucalyptus leaves (eucalyptus globulus). The Phytosun Aroms Capsules Bronches product from Omega Pharma contains essential oils of Eucalyptus globulus (Eucalyptus globulus), Rosemary ABV (Rosmarinus off.), Marjoram, Thyme, Fine Lavender.

None of the products offered contains the combination that is the subject of the present invention.

These products contain essential oils that may cause side effects, such as, for example, seizures.

The combination product of the present invention soothes the airways, helps thin cough mucus and aids in falling asleep. The product of the present invention has no side effects or addiction and has an acceptable taste despite the presence of plants.

The presence of a natural verbena flavor has a double role: masking bad tastes and increasing the feeling of softening the bronchial tubes.

The product according to the present invention also has the advantage of preferably not containing any allergen and of being, preferably, lactose- or gluten-free and is free of preservatives.

The product of the present invention is preferably in the form of tablets.

The present invention relates to a combination product, comprising as active substances, at least:

thyme,

marshmallow,

poppy and

vitamin B6
to relieve the bronchial tubes and facilitate falling asleep.

The present invention also relates to a combination product, comprising, as active substances, at least:

thyme,

marshmallow,

poppy and

vitamin B6
for its use in relieving the symptoms of cough and facilitating sleep.
In certain embodiments, the combination product according to the invention comprises, in addition to thyme, marshmallow, poppy and vitamin B6, as active substances:

Plants or plant extracts, such as for example primrose or climbing ivy

Vitamins and minerals, such as, for example, group B vitamins, and/or zinc, iron or selenium

In certain 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:

thyme,

marshmallow,

poppy and

vitamin B6
in a physiologically acceptable medium.

In certain embodiments, the combination product of the invention is characterized in that thyme, marshmallow, poppy and vitamin B6 are administered in the form of a tablet containing:
- 20 to 200 mg, preferably 50 to 150 mg of thyme
- 50 to 300 mg, preferably 75 to 200 mg of marshmallow
- from 5 to 100 mg, preferably 10 to 60 mg of poppy
- from 0.01 to 10 mg, preferably from 1 to 5 mg of vitamin B6
per dry form unit

According to a particular embodiment of the invention, the combination product is characterized in that the active ingredients (i), (ii), (iii), (iv) are in a medium suitable for oral administration. The suitable environment is a dry environment. Preferably, the combination product is a tablet or a capsule. Thus, in the sense of "dry form unit", we mean a tablet or a capsule.

The various embodiments of the invention are particularly described in the detailed description below. These embodiments can be taken separately or in combination with each other.

In the present invention, the applicant has demonstrated that the combination of at least (i) thyme, (ii) marshmallow, (iii) poppy, (iv) vitamin B6 exhibited a synergistic effect for help maintain the body's natural defences.

By synergistic effect, it is understood according to the present invention that the combination of at least (i) thyme, (ii) marshmallow, (iii) poppy, (iv) vitamin B6 has an effect on the relief of the bronchial tubes and facilitates falling asleep, during the treatment which is superior to the cumulative effects of a treatment (a) comprising the administration of thyme, not associated with marshmallow, poppy and vitamin B6, and vice versa d a treatment (b) comprising the administration of marshmallow, not associated with thyme, poppy and vitamin B6 or a treatment (c) comprising the administration of poppy, not associated with thyme, marshmallow and with vitamin B6.

Thyme

Thymus is a genus of plants (commonly called thyme or wild thyme) of the Lamiaceae family. These plants are rich in essential oils and as such are part of the aromatic plants. The main essential oil of common thyme (Thymus vulgaris) is a terpenoid which owes its name, thymol, a bactericidal substance.

Thymol and carvacrol are the main components, as well as para-cymene, 1,8-cineol (eucalyptol), linalool and other monoterpenes, triterpenes, flavonoids.

In the context of the present invention, thyme is present in the composition in an amount of 20 to 200 mg, preferably 50 to 150 mg of thyme. Its quantities of thyme represent in plant equivalent from 100 to 1000 mg, preferably 200 to 700 mg.

Thyme is preferably present in the form of a plant extract.

There marshmallow

Marshmallow officinalis

Marshmallow officinalis (Althaea officinalis L.), also called Wild Marshmallow or White Mallow, is a perennial herbaceous plant of the Malvaceae family, common in Europe. It is cultivated as a medicinal plant for its emollient properties, as an ornamental plant for its flowers and sometimes as a vegetable plant mainly for its roots.

This plant, rich in mucilages, has softening, emollient, bechic, laxative and aperitif properties.

In the context of the present invention, the marshmallow represents from 50 to 300 mg, preferably 75 to 200 mg of marshmallow. Its quantities of marshmallow represent in plant equivalent from 100 to 2000 mg, preferably 250 to 750 mg.

Marshmallow is preferably present in the form of a plant extract.

The poppy

The poppy ( Papaver rhoeas ) is a species of dicotyledonous plant in the family Papaveraceae , native to Eurasia.

It is an annual herbaceous plant, very abundant in freshly disturbed soils from spring onwards, which is distinguished by the red color of its flowers and by the fact that it often forms large colored carpets visible from a great distance. It belongs to the group of so-called messicole plants because it has been associated with agriculture since very ancient times, thanks to its biological cycle adapted to cereal crops, flowering and setting seeds occurring before harvest.

Like all poppies, the poppy has narcotic effects due to the alkaloids it contains.

In herbal medicine, its dried petals are used, which take on a wine-red color on drying and are most often made into herbal teas. Its soothing effects are felt on adults, but especially on young children (in the past poppy was mixed with children's porridge to help them sleep). By its emollient, light sedative and bechic properties, the poppy is a soothing agent for coughs and throat irritations. It is then used in the form of lozenges to be sucked.

The composition according to the present invention comprises 5 to 100 mg, preferably 10 to 60 mg of poppy. Its quantities of poppy represent in plant equivalent from 50 to 1000 mg, preferably 100 to 500 mg.

The poppy is preferably present in the form of a plant extract.

Vitamin B6

Vitamin B6 is a water-soluble vitamin existing in several forms, pyridoxal phosphate being its biologically active form, as a cofactor involved in several reactions of amino acid metabolism, in particular transaminations, deaminations and decarboxylations. Pyridoxal phosphate is also involved in the reaction of hydrolysis of glycogen to glucose.

Vitamin B6 is known in seven different forms, interconvertible between them except for the last one:
1. pyridoxine (PN), the form in which vitamin B6 is administered as a dietary supplement,
2. pyridoxine phosphate (PNP),
3. pyridoxal (PL),
4. pyridoxal phosphate (PLP), biologically active form (distributed as vitamin supplement "P-5-P"),
5. pyridoxamine (PM),
6. pyridoxamine phosphate (PMP),
7. 4-pyridoxic acid (PA), catabolite excreted in the urine.

Vitamin B6 participates in the transformation of tryptophan into vitamin B3, and in the metabolism of lipids and amino acids (decarboxylation and transamination). Pyridoxal phosphate enables the conversion of glycogen into glucose (Glucose-1-Phospate) by Glycogen phosphorylase.

Vitamin B6 also participates in the biosynthesis of serotonin.

It is present in large quantities in poultry, livers (beef, lamb, veal), bananas, different forms of cabbage, tomatoes, spinach, potatoes, etc.

The composition according to the present invention comprises from 0.01 to 10 mg, preferably from 1 to 5 mg of vitamin B6.

Physiologically acceptable medium

A physiologically acceptable medium is one having no toxic or harmful effects under the conditions of use and inert with respect to the active ingredients of the combination product. Such a medium can for example comprise various adjuvants depending on its therapeutic or cosmetic purpose, such as, in a non-limiting manner, flavorings, colorants, fillers, diluents, wetting or suspending agents, etc. Such media can also allow immediate, modified or delayed release of one or the other of the active ingredients.

The physiologically acceptable medium can be composed of texturizers, colorants, flavorings, sugar or sugars.

By "texturizers" is meant the compounds which modify the texture of the products in which they are incorporated. Examples of texturizers are: guar and carob flours; gum arabic, xanthan and gellan; carrageenans; starches (native or modified); microcrystalline cellulose; gelatin; pectin; alginates (E400 to E405); agar agar; and their mixtures. The term “dyes” is understood to mean compounds of natural or synthetic origin capable of conferring coloring on the composition on their own. Examples of food colors are known in Europe under the codes E100 to E180.

By “flavourings”, is meant compounds of natural or synthetic origin capable on their own of modifying the taste of the composition. Examples of flavors are apricot, pineapple, banana, black currant, cherry, lemon, lime, strawberry, raspberry, passion fruit, tangerine, mint, orange , pistachio, pear, liquorice, rose, anise, blueberry, cinnamon, ginger, grapefruit, apple, kiwi, lychee, melon, coconut, peach, gooseberry, guava, grenadine, mango, blackberry, papaya, vanillin, natural vanilla extract, essential oils and mixtures thereof.

By sugar or sugars is meant, within the meaning of the present invention, any sweetening carbohydrate, preferably glucose syrup, sucrose, glucose, fructose, invert sugar, honey, maltose, or mixtures thereof. In the context of the present invention, the sugars used are sorbitol.

Advantageously, the composition according to the present invention does not contain preservatives.

In the context of the present invention, the combination product is in a dry form. By dry form is meant within the meaning of the present invention, a form free of liquid, having a residual moisture content, when measured by the method of loss on drying, of less than 20%, preferably less than 10%, more preferably less than 5%.

Additional asset(s)

Any additional active ingredient having a nutritional benefit and/or helping to maintain the body's natural defenses can also be added to the combination products of the invention in pharmaceutical or cosmetic form. The combination product may include, for example, vitamins, mineral salts, essential amino acids, essential fatty acids, trace elements, various plant extracts, fibers, antioxidants, flavonoids.

Advantageously, such an additional active ingredient can be intended to reinforce the desired effect as described above.

Of course, those skilled in the art will take care to choose the additional active agents as well as their quantity in such a way that the advantageous properties of the composition in accordance with the invention are not, or substantially not, altered by the addition envisaged.

As an additional active ingredient that can be used, we can cite:

- 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 (Pellagra Preventive), vitamin B5 (pantothenic acid), vitamin B8 or H (biotin), vitamin B9 (folic acid) and vitamin B12 (cobalamin). Examples of fat-soluble vitamins present in the syrupy product prepared according to the invention are in particular: vitamin A (retinol), vitamin E (mixture of tocopherols and tocotrienols) and vitamin K (phylloquinone).

- antioxidants, such as curcuminoids; carotenoids, in particular 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; chilli extracts; soy extracts; Cocoa ; the grenade ; the Emblica; CoenzymeQ10; selenium,

- minerals, such as zinc, calcium, copper, iron, iodine, manganese, selenium, chromium (III),

- amino acids, in particular sulfur amino acids, such as glutathione precursors, selenium amino acids, citrulline,

- phytosterols, resveratrol, hesperidin, neohesperidin, orthosilicic acid, monomethylsilanetriol, and mixtures thereof.

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. Tablets, powders, granules, lyophilisates constitute the currently preferred pharmaceutical or cosmetic form adapted to the oral route.

The preferred form is the tablet.

Example 1 of composition according to the invention

Manufacturing process :
All the compounds are mixed, then the tablets are shaped and placed in blister packs.

Claims (7)

Combination product comprising, as active substances, at least:
(i) thyme,
(ii) marshmallow,
(iii) poppy and
(iv) Vitamin B6
to relieve the bronchial tubes and facilitate falling asleep Combination product according to Claim 1, characterized in that it is in the form of a single composition containing at least:
(i) thyme,
(ii) vitamin C, and
(iii) white broth
in a physiologically acceptable medium. Combination product according to the preceding claims, characterized in that thyme, marshmallow, poppy and vitamin B6 are administered in an amount:
- 20 to 200 mg, preferably 50 to 150 mg of thyme
- 50 to 300 mg, preferably 75 to 200 mg of marshmallow
- from 5 to 100 mg, preferably 10 to 60 mg of poppy
- from 0.01 to 10 mg, preferably from 1 to 5 mg of vitamin B6
per dry form unit Combination product according to one of the preceding claims, characterized in that the physiologically acceptable medium is suitable for oral administration. Combination product according to one of the preceding claims, characterized in that it is in the form of a tablet or a capsule. Combination product according to one of the preceding claims, characterized in that the thyme, marshmallow and poppy are in the form of a plant extract. Use of a product according to claim 6 to help soothe the bronchi and facilitate falling asleep.