EP4281095A1 - Extrait de parties aeriennes de basilic sacre et compositions cosmetiques, ou dermatologiques le comprenant - Google Patents

Extrait de parties aeriennes de basilic sacre et compositions cosmetiques, ou dermatologiques le comprenant

Info

Publication number
EP4281095A1
EP4281095A1 EP22705429.3A EP22705429A EP4281095A1 EP 4281095 A1 EP4281095 A1 EP 4281095A1 EP 22705429 A EP22705429 A EP 22705429A EP 4281095 A1 EP4281095 A1 EP 4281095A1
Authority
EP
European Patent Office
Prior art keywords
extract
skin
holy basil
advantageously
weight
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22705429.3A
Other languages
German (de)
English (en)
French (fr)
Inventor
Sophie LECLERE- BIENFAIT
Stéphanie BREDIF
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.)
Laboratoires Expanscience SA
Original Assignee
Laboratoires Expanscience SA
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 Laboratoires Expanscience SA filed Critical Laboratoires Expanscience SA
Publication of EP4281095A1 publication Critical patent/EP4281095A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/18—Antioxidants, e.g. antiradicals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/04—Topical preparations for affording protection against sunlight or other radiation; Topical sun tanning preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/007—Preparations for dry skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/52—Stabilizers
    • A61K2800/522—Antioxidants; Radical scavengers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the invention relates to a composition comprising an extract of aerial parts of holy basil (Ocimum sanctum), green or purple variety.
  • the composition is advantageously cosmetic, pharmaceutical or dermatological.
  • the invention also relates to a process for extracting an extract of aerial parts of holy basil, as well as the extract that can be obtained by said process.
  • the invention also relates to such a composition or such an extract for its use in the prevention or treatment of disorders or pathologies of the skin, mucous membranes or appendages, and in the prevention or treatment of vascular disorders.
  • the invention finally relates to a cosmetic care process for the skin, appendages or mucous membranes, with a view to improving their condition or their appearance, consisting in administering such a composition or such an extract.
  • Ocimum sanctum (or ocimum tenuiflorum) commonly known as "holy basil” or “tulsi” is an aromatic plant from the lamiaceae family. It has an erect habit 30 to 60 cm high with hairy stems. The leaves are green or purple depending on the variety. They are simple, petiolate and up to 5 cm long. The small purplish flowers are placed on elongated racemes. There are two varieties of holy basil: green basil and purple basil. Both varieties have a similar phytochemical composition.
  • Holy basil is cultivated in Asia for its religious and medicinal uses, particularly in Ayurvedic medicine where it is considered an “elixir of life”.
  • Holy basil leaves are also used in Thai cooking and as an insect repellent.
  • composition of Ocimum sanctum Protein: 174.5 g/kg dry plant Fibre: 90.7 g/kg dry plant Ash: 135.6 g/kg dry plant
  • Sugars are composed of xylose and polysaccharides. Stems and leaves contain saponins, flavonoids, triterpenoids and tannins.
  • Table 1 Mineral composition of Ocimum sanctum (ppm)
  • the subject of the invention is an extract rich in polyphenols of holy basil, in particular an extract rich in polyphenols of aerial parts of holy basil.
  • the terms “holy basil” and “Ocimum sanctum” have the same meaning and can be used interchangeably. There are two varieties of holy basil: the green variety and the purple variety. Unless otherwise indicated, in the context of the present invention, the term “holy basil” or “Ocimum sanctum” means the two existing varieties, that is to say the green and purple varieties.
  • the "aerial parts" of Ocimum sanctum include the leaves, stems and flowers, preferably the leaves and stems.
  • extract rich in polyphenols is meant an extract comprising mainly or essentially polyphenols.
  • the extract according to the invention thus comprises at least 6% by weight of polyphenols, relative to the total weight of the dry extract, i.e. at least 1.2 mg of polyphenols per mL of liquid extract (in gallic acid equivalent) .
  • the extract according to the invention comprises at least 9% by weight, more advantageously at least 11% by weight, more advantageously at least 15% by weight, of polyphenols, relative to the total weight of the dry extract.
  • the extract according to the invention comprises between 6% and 17%, more advantageously between 9% and 17%, more advantageously between 11% and 17%, more advantageously between 15% and 17% by weight of polyphenols.
  • the percentages are expressed relative to the total weight of said dry extract (before any addition of a drying medium) and are determined according to the Folin Ciocalteu method.
  • polyphenol within the meaning of the present invention, is meant a molecule which comprises at least two hydroxyl functions carried by one or more benzene rings.
  • the polyphenols according to the invention contain or consist of hydroxycinnamic derivatives and flavonoids.
  • the extract according to the invention comprises at least 5% by weight of hydroxycinnamic derivatives, more advantageously at least 7% by weight of hydroxycinnamic derivatives, that is to say at least 1.0 mg of hydroxycinnamic derivatives per mL of liquid extract. More advantageously, the extract according to the invention comprises at least 10% by weight, more advantageously at least 15% by weight, of hydroxycinnamic derivatives.
  • the extract according to the invention comprises between 5% and 20% by weight, more advantageously between 7% and 20% by weight, more advantageously between 10% and 20% by weight, more advantageously between 15% and 20% by weight, of hydroxycinnamic derivatives. The percentages are expressed in relation to the total weight of said dry extract (before optional addition of a drying medium), in chlorogenic acid equivalent and are determined according to the Arnow method.
  • the extract according to the invention comprises at least 2.5% by weight of flavonoids, expressed as rutin equivalent, relative to the total weight of said dry extract, more advantageously at least 3.5% by weight.
  • the extract according to the invention comprises between 2.5% and 6% by weight, more advantageously between 3.5% and 6% by weight of flavonoids, expressed as rutin equivalent, relative to the total weight of said dry extract.
  • the flavonoid content is determined according to the Loots method (AlCb).
  • the extract according to the present invention comprises at least 6% by weight of polyphenols relative to the total weight of the dry extract, i.e. at least 1.2 mg of polyphenols per mL of liquid extract (in equivalent gallic acid), in particular at least 5% by weight of hydroxycinnamic derivatives relative to the total weight of the dry extract, and at least 2.5% by weight of flavonoids, expressed as rutin equivalent, relative to the total weight of the 'dry extract.
  • hydroxycinnamic derivatives within the meaning of the present invention is meant the molecules which include in their structure the following unit: it being understood that the hydrogens of the unit can be substituted by any other group.
  • the hydroxycinnamic derivatives within the meaning of the invention include in particular hydroxycinnamic acids, esters and glycosylated derivatives.
  • hydroxycinnamic derivatives As examples of hydroxycinnamic derivatives according to the present invention, mention may be made of: chicoric acid, caffeic acid, rosmarinic acid or caffaric acid, and mixtures thereof.
  • flavonoids is meant within the meaning of the present invention, the molecules which include in their structure the following unit:
  • flavonoids As examples of flavonoids according to the present invention, mention may be made of apigenin, apigenin-7-glucuronide or luteolin-7-glucuronide, and mixtures thereof.
  • flavonoids and hydroxycinnamic derivatives are typically polyphenols.
  • the extract according to the invention is essentially devoid of eugenol and methyl eugenol which are allergenic compounds and which are phenols, and not polyphenols within the meaning of the present invention.
  • eugenol and methyl eugenol are not classified in the family of polyphenols due in particular to their physicochemical properties. Indeed, these compounds are part of the main constituents of the essential oil of holy basil and are compounds which can be steamed, unlike the polyphenols according to the present invention.
  • the extract according to the present invention does not comprise eugenol and methyl eugenol or comprises less than 50 ppm in eugenol and less than 100 ppm in methyl eugenol.
  • the extract is not an essential oil, in fact the constituents of the extract cannot be steamed.
  • the extract rich in polyphenols described above is advantageously obtained by solid/liquid extraction of the aerial parts of holy basil, in a solvent chosen from water, glycols or glycerol, and their mixtures.
  • the extraction solvent according to the invention is a non-toxic solvent and is more particularly chosen from binary water/glycol or water/glycerol mixtures, advantageously in a proportion of between 30% and 90%, typically between 50% and 80 %, more advantageously between 60% and 70% of glycol or glycerol in water, by volume relative to the total volume of solvent used (water+glycol or water+glycerol).
  • the extraction solvent is chosen from binary mixtures water/propanediol, water/propylene glycol, water/glycerin, in particular water/propanediol, more particularly water/1,3-propanediol or water/glycerin.
  • the glycols mentioned above are glycols of plant origin, in particular propanediol and/or propylene glycol, more particularly propanediol, in particular 1,3-propanediol.
  • the glycerol mentioned above is of plant origin.
  • the invention also relates to a method for preparing an extract rich in polyphenols from aerial parts of holy basil, comprising at least one solid/liquid extraction step in a mixture of suitable solvents, in particular as defined in paragraph above, and under the optimum conditions of pH, time and temperature, known to those skilled in the art.
  • the method for preparing an extract rich in polyphenols from aerial parts of holy basil comprises the following successive steps: a) grinding the aerial parts of holy basil; b) extraction of the ground aerial parts in a solvent chosen from water, glycols, glycerol, and mixtures thereof, advantageously chosen from binary water/glycol or water/glycerol mixtures, under optimal conditions of duration, pH and temperature ; c) separation of the solid phase and the liquid phase by decantation and/or centrifugation and/or successive filtration; and d) optionally, drying the extract obtained in step c).
  • the process for preparing the extract contains a stage of elimination of eugenol or methyl eugenol or of substantial reduction of the eugenol and methyl eugenol content, typically by evaporation under vacuum or deodorization.
  • Step a) of grinding the plant can be carried out by methods known to those skilled in the art, in particular using a knife mill, a hammer mill, etc.
  • the extraction is preferably carried out in the presence of an extraction solvent chosen from binary water/glycol or water/glycerol mixtures.
  • an extraction solvent chosen from binary water/glycol or water/glycerol mixtures.
  • the extraction solvent used in step b) is chosen from binary water/glycol or water/glycerol mixtures in a proportion of between 30% and 90%, typically between 50% and 80%, more advantageously between 60 % and 70% of glycol or glycerol in water, by volume relative to the total volume of solvent used (water + glycol or water + glycerol).
  • the extraction solvent is chosen from binary mixtures water/propanediol, water/propylene glycol or water/glycerin, in particular water/propanediol, more particularly water/1,3-propanediol or water/glycerin.
  • the glycols are glycols of plant origin, in particular propanediol and/or propylene glycol, more particularly propanediol, in particular 1,3-propanediol.
  • the glycerol is of vegetable origin.
  • step b) of solid/liquid extraction is preferably carried out at a temperature of between 20°C and 90°C, in particular between 30°C and 80°C, more particularly between 30°C and 75°C. °C, typically 60°C.
  • the extraction time has the advantage of being short. It is advantageously between 30 minutes and 4 h, in particular between 1 h and 3 h, advantageously it is approximately 2 hours.
  • Step c) of separating the solid phase and the liquid phase is carried out by methods known to those skilled in the art, in particular by decantation, centrifugation and/or successive filtrations, preferably by filtration.
  • the liquid phase obtained is advantageously purified and concentrated, for example by ultrafiltration and/or sterilizing filtration.
  • Step c) is carried out until perfect clarity and microbiological cleanliness of a degree less than or equal to 100 CFU/g in total germ.
  • the extract rich in polyphenols according to the invention can be stabilized by the drying step d), by methods known to those skilled in the art.
  • Step d) of drying can, for example, be carried out in the presence of a support of the maltodextrin or acacia fiber type (Fibregum® company CNI).
  • the carrier content typically varies according to a ratio ranging from 0% to 80% carrier relative to the percentage of dry matter obtained in the liquid form of the extract.
  • the extract can optionally be dried by freeze-drying in order to obtain a final powder.
  • the final powder advantageously comprises 30 to 70% by weight of dry matter of the extract, the balance at 100% being the freeze-drying support. More advantageously, the final powder comprises 50% dry matter from the extract and 50% freeze-drying support.
  • the method according to the invention does not include step d).
  • the extract as obtained is preserved in the extraction solvent, the solvent being in sufficient quantity to exhibit bacteriostatic/bactericidal activity, in particular the solvent being in an amount greater than or equal to 50% by weight relative to the total weight of extract and solvent.
  • the extraction process according to the invention advantageously makes it possible to obtain an extract concentrated in polyphenols in a single main extraction step with a process that is simple to implement. In other words, it makes it possible to obtain concentrated extracts without multiplying the successive extraction steps as during fractionation.
  • the extract rich in polyphenols according to the invention can be obtained according to the following process: i. Grinding the aerial parts of holy basil; ii. Dissolution of the ground aerial parts at 10% (w/w) in a 1,3-propanediol/water mixture (60/40) or in a glycerin/water mixture (60/40); iii. Extraction with stirring for 2 h at 60° C.; iv. Purification by stages of successive filtrations; v. Advantageously elimination of eugenol and methyl eugenol, typically by vacuum evaporation or deodorization; and v. Sterile filtration.
  • extract according to the invention designate the extract as such, as defined above, or the extract capable of being obtained by the process according to invention as described above.
  • the extract obtainable by the process according to the invention as described above has the same composition as the extract according to the invention as such, as defined above.
  • a subject of the invention is also a composition
  • a composition comprising an extract according to the invention and a water/solvent mixture in a water/solvent ratio (v/v) of between 50/50 and 0/100, advantageously between 30/70 and 10 /90, more advantageously 20/80, said solvent being chosen from glycols, vegetable glycerin and mixtures thereof, preferably from glycols of vegetable origin, and preferably from 1,3-propanediol.
  • the composition comprises from 0.001 to 30% by weight, advantageously 0.001% to 10% by weight, of an extract according to the invention (expressed by weight of dry extract relative to the total weight of the composition) and between 70 % and 99.999% by weight, advantageously between 90% and 99.999% by weight, of a water/solvent mixture, relative to the total weight of the composition, the water/solvent ratio being between 50/50 and 0/100, advantageously between 30/70 and 10/90, more advantageously 20/80, and the solvent being chosen from glycols, vegetable glycerin and mixtures thereof, preferably from glycols of vegetable origin, and preferably from 1,3- propanediol.
  • the solvent is in an amount effective for a physical and microbiological stabilizing action of the composition according to the invention and in particular of the extract according to the invention.
  • a subject of the invention is also a composition comprising an extract rich in polyphenols from the aerial parts of Ocimum sanctum according to the invention, as active principle, and where appropriate a suitable excipient.
  • the extract according to the invention is as defined in the paragraphs above relating to the extract as such and those relating to the extract capable of being obtained by the process according to the invention.
  • composition is advantageously cosmetic, pharmaceutical or dermatological.
  • Said composition is preferably formulated to be administered by external topical route.
  • composition according to the invention comprises from 0.001 to 10%, typically from 0.01 to 5%, by weight of extract according to the invention, the weight of the extract being expressed as dry extract, relative to the weight composition total.
  • composition according to the invention may also comprise one or more other active principles.
  • composition according to the invention can be formulated in the form of various preparations suitable for topical administration and include in particular creams, emulsions, milks, ointments, lotions, oils, aqueous or hydroalcoholic or glycolic solutions, powders, patches, sprays, shampoos, varnishes or any other product for external application.
  • composition according to the invention may also comprise at least one cosmetically, pharmaceutically or dermatologically acceptable excipient.
  • composition according to the present invention may also comprise at least one cosmetically, pharmaceutically or dermatologically known adjuvant to those skilled in the art, chosen from surfactants, thickeners, preservatives, perfumes, dyes, chemical filters or minerals, moisturizing agents, thermal waters, etc.
  • surfactants chosen from surfactants, thickeners, preservatives, perfumes, dyes, chemical filters or minerals, moisturizing agents, thermal waters, etc.
  • compositions according to the invention can be determined according to the criteria generally taken into account in the establishment of a pharmacological, dermatological or cosmetic treatment adapted to a patient or to an animal, such as for example the age or body weight of the patient or animal, the severity of his general condition, tolerance to treatment, side effects observed, type of skin.
  • a subject of the invention is also an extract according to the invention or a composition according to the invention for its use for preventing and/or treating disorders or pathologies of the skin and/or mucous membranes (gums, periodontium, genital mucous membranes) and / or appendages (hair and nails) immature(s), normal(s) or mature/aged(s), advantageously inflammatory reactions, oxidation reactions, disorders linked to intrinsic or extrinsic stresses (such as psychological stress, stress linked to a state of anxiety, stress linked to free radical attacks linked or not to pollution (in particular chemical or atmospheric pollution) and/or linked to exposure to UV or IR ), barrier or homeostasis disorders, aging, in particular chronological and/or actinic aging, photosensitized skin, and/or mechanical or thermal attacks.
  • a subject of the invention is also an extract according to the invention or a composition according to the invention for its use for preventing and/or treating vascular disorders, in particular redness and rosacea.
  • a subject of the invention is also an extract according to the invention or a composition according to the invention for its use for preventing and/or treating imbalances and/or disorders linked to the imbalance of the microbiota of the skin and/or mucous membranes ( gums, periodontium, genital mucosa) and/or appendages and/or their appendages, immature(s), normal(s) or mature/aged.
  • the extract according to the invention has a protective activity of the skin and / or mucous membranes (gums, periodontium, genital mucous membranes) and / or appendages and / or their annexes, immature (s), normal (s) or mature(s)/aged(s), against mechanical, microbial, thermal and radical attacks.
  • the extract according to the invention acts for the defense of the microbiota and therefore makes it possible to fight against the microbiota imbalance.
  • the extract according to the invention makes it possible to stimulate the immune defenses of the skin and the cutaneous antioxidant system.
  • a subject of the invention is also the use of an extract according to the invention or of a composition according to the invention for the manufacture of a cosmetic, pharmaceutical or dermatological composition for preventing and/or treating disorders or pathologies of immature, normal or mature/aged skin and/or mucous membranes (gums, periodontium, genital mucosa) and/or appendages (hair and nails), advantageously inflammatory reactions, oxidation reactions, disorders linked to intrinsic or extrinsic stresses (such as psychological stress, stress linked to a state of anxiety, stress linked to radical attacks linked or not to pollution (in particular chemical pollution or atmospheric) and/or related to exposure to UV or IR), barrier or homeostasis disorders, aging, in particular chronological and/or actinic aging, photosensitized skin, and/or aggressions mechanical or thermal.
  • a cosmetic, pharmaceutical or dermatological composition for preventing and/or treating disorders or pathologies of immature, normal or mature/aged skin and/or mucous membranes (gums, periodontium
  • a subject of the invention is also the use of an extract according to the invention or of a composition according to the invention for the manufacture of a pharmaceutical, cosmetic or dermatological composition for preventing and/or treating vascular disorders, in especially redness and blotches.
  • a subject of the invention is also the use of an extract according to the invention or of a composition according to the invention for the manufacture of a pharmaceutical, cosmetic or dermatological composition for preventing and/or treating imbalances and/or disorders related to the imbalance of the microbiota of the skin and/or mucous membranes (gums, periodontium, genital mucous membranes) and/or appendages and/or their appendages, immature(s), normal(s) or mature(s)/aged (s).
  • the invention further relates to a method for preventing and/or treating disorders or pathologies of the skin and/or mucous membranes (gums, periodontium, genital mucous membranes) and/or appendages (hair and nails) immature(s), normal(s) or mature/aged(s), advantageously inflammatory reactions, oxidation reactions, disorders linked to intrinsic or extrinsic stresses (such as psychological stress, stress linked to a state of anxiety, stress linked to radical attacks linked or not to pollution (in particular chemical or atmospheric pollution) and/or linked to exposure to UV or IR), barrier or homeostasis disorders, aging, in particular chronological and/or actinic aging, photosensitized skin, and/or mechanical or thermal attacks, comprising the administration, in particular topical administration, of a effective amount of an extract according to the invention or of a composition according to the invention, to a subject in need thereof.
  • mucous membranes gaums, periodontium, genital mucous membranes
  • appendages hair
  • the invention also relates to a method for preventing and/or treating vascular disorders, in particular redness and rosacea, comprising the administration, in particular topical administration, of an effective quantity of an extract according to invention or a composition according to the invention, to a subject in need thereof.
  • the invention also relates to a method for preventing and/or treating for preventing and/or treating imbalances and/or disorders related to the imbalance of the microbiota of the skin and/or mucous membranes (gums, periodontium, genital mucous membranes) and /or appendages and/or their appendages, immature(s), normal(s) or mature/aged(s), comprising the administration, in particular the topical administration, of an effective amount of an extract according to the invention or of a composition according to the invention, to a subject in need thereof.
  • composition or the extract according to the invention is intended for the prevention and/or treatment of inflammatory or irritative reactions or pathologies or disorders of the barrier or of the homeostasis of the skin, skin appendages (hair and nails) and/or mucous membranes (gums, periodontium, genital mucous membranes) immature(s), normal(s) or mature/aged(s).
  • the inflammatory, irritative reactions, disorders or pathologies or disorders of the barrier or homeostasis of the skin are: acne, rosacea or erythrocouperosis, vascular disorders, in particular redness and rosacea, dermatitis diaper, atopic dermatitis, eczema, contact dermatitis, irritative dermatitis, allergic dermatitis, seborrhoeic dermatitis (cradle cap), sensitive skin, reactive skin, dry skin (xerosis), skin dehydrated skin, skin with redness, skin erythema, aged or photo-aged skin, photosensitized skin, pigmented skin (melasma, postinflammatory pigmentation...), skin with stretch marks, sunburn, irritation by agents chemical, physical (for example tension stress for pregnant women), bacteriological, fungal, skin aging, in particular photoaging and disorders linked to free radical attacks linked to chemical pollution ic or atmospheric, and/or related to exposure to UV or IR.
  • the reactions, disorders or inflammatory or irritative pathologies or disorders of the barrier or homeostasis of the mucous membranes are gingivitis (sensitive gums newborns, hygiene problems, due to smoking or other), and irritation of the external or internal male or female genital spheres.
  • the inflammatory or irritative reactions, disorders or pathologies or disorders of the barrier or of the homeostasis of the appendages are brittle nails, fragile nails, weakened hair, brittle hair, dry hair, alopecia, seborrheic dermatitis, and folliculitis dermatitis.
  • composition or the extract according to the invention is intended as an anti-ageing agent, against skin aging, in particular chronological and actinic aging, for example linked to sun exposure or to phenomena of inflammation, or to act on irritated skin.
  • the extract according to the invention is used to prevent and/or treat:
  • disorders or pathologies of the skin and/or mucous membranes and/or appendages advantageously inflammatory reactions, disorders linked to intrinsic or extrinsic stresses, such as psychological stress, stress linked to a state of anxiety, stress linked to free radical attacks linked or not to chemical or atmospheric pollution, and/or linked to exposure to UV or IR, advantageously chosen from sensitive skin, reactive skin and/or reactive mucous membranes, skin irritated, inflamed skin, barrier or homeostasis disorders, photosensitized skin, mechanical and/or thermal attacks; and or
  • vascular disorders preferably redness or rosacea and/or
  • microbiota imbalances advantageously chosen from atopic dermatitis, eczema, development of bad axillary odors, weakening of the skin barrier, acne, psoriasis, hidradenitis suppurativa, folliculitis, cradle cap, dandruff, itching in particular of the scalp, irritations, candidiasis and bacterial vaginosis and/or for its use as a healing agent.
  • a subject of the invention is also the cosmetic use of an extract according to the invention or of a composition according to the invention in the treatment and/or prevention of dehydrated skin; the skin with redness; aged skin; skin aging.
  • a subject of the invention is also the cosmetic use of an extract according to the invention or of a composition according to the invention for caring for skin appendages, in particular for preventing brittle nails; brittle nails; weakened hair; brittle hair; and dry hair.
  • the invention also relates to a cosmetic care process for the skin and/or appendages and/or mucous membranes, with a view to improving their condition and/or their appearance, consisting in administering a composition or an extract according to the present invention; especially in view to improve the firmness, the elasticity or the tonicity of the skin, with a view to reinforcing the mechanical properties of the skin and of the mucous membranes, in particular to combat withered, soft, distended and/or sagging skin, and/or with a view to reinforcing and/or restoring the elasticity or firmness of the skin, or else for treating wrinkles and fine lines.
  • the invention relates to a cosmetic care process for the skin and/or mucous membranes and/or superficial body growths, with a view to preventing alterations of the barrier and its dehydration or with a view to moisturizing the skin and/or or the mucous membranes, consisting in applying to the skin and/or the integuments and/or the mucous membranes a composition or an extract according to the present invention.
  • the invention also relates to a cosmetic care process for the skin and/or the appendages, with a view to preventing its aging, consisting in applying to the skin and/or the appendages a composition or an extract according to the present invention.
  • the invention also relates to the cosmetic use of a composition or of an extract or of a composition according to the invention for moisturizing the skin and/or the mucous membranes, for acting on the elasticity or the firmness of the skin, in particular as a tightening or anti-wrinkle agent, to act on sensitive skin.
  • the invention relates to the cosmetic use of a composition or an extract according to the invention in the treatment and/or prevention of dehydrated skin; the skin with redness; aged skin; the homogeneity of the complexion; the reduction of spots on the skin or skin ageing, in particular chronological and/or actinic ageing.
  • the cosmetic uses and methods of cosmetic care according to the present invention are typically carried out on healthy skins or healthy parts of the body and are not therapeutic.
  • Figure 1 describes the measurement of NO production by keratinocytes subjected to cortisol stress.
  • Fig. 2 Figure 2 depicts the effects of holy basil extract on cellular bioenergetics in pollutant-stressed fibroblasts, specifically the effects on oxygen consumption FIG. 2A, ATP production FIG. 2B, lactate production FIG. 2C and the NAD/NADH ratio FIG. 2D (*p ⁇ 0.05; ** p ⁇ 0.01 vs untreated control; #p ⁇ 0.05; ##p ⁇ 0.01 vs pollutant).
  • Figure 3 describes the percentage of damaged mitochondria per cell (%) (###p ⁇ 0.0001 vs. pollutant).
  • FIG. 4 demonstrates the lysosomal density (intensity/pm 2 ) (***p ⁇ 0.0001 vs control; #p ⁇ 0.05;###p ⁇ 0.0001 vs pollutant).
  • Fig. 5 Mitophagy (% of lysosomes co-localized with damaged mitochondria) (*** p ⁇ 0.0001 vs control; ###p ⁇ 0.0001 vs pollutant).
  • FIG. 6 Figure 6 demonstrates the percentage of fibroblast migration between T0 and T40h.
  • Example 1 extract according to the invention
  • a holy basil extract is obtained according to the following process: a) dissolution of 10% (w/w) of the aerial parts of Ocimum sanctum - purple variety - ground in a water/propanediol mixture 40/60 w/w b) extraction 2 h at 60° C. c) solid/liquid separation by successive filtrations.
  • the polyphenol-rich liquid extract thus obtained has the following characteristics (% by weight of molecules/dry extract of the extract obtained):
  • Example 2 extract according to the invention
  • a holy basil extract is obtained according to the following process: a) dissolution of 10% (w/w) of the aerial parts of Ocimum sanctum - green variety - ground in a water/propanediol mixture 40/60 w/w b) extraction 3 h at 60° C. c) solid/liquid separation by successive filtrations.
  • the polyphenol-rich liquid extract thus obtained has the following characteristics (% by weight of molecules/dry extract of the extract obtained):
  • Example 3 Tests of biological activities of the extract according to the invention
  • the keratinocytes were then stimulated with hydrogen peroxide (H 2 O 2 ) at 100 ⁇ M for 20 minutes.
  • H 2 O 2 hydrogen peroxide
  • ROS The production of ROS was evaluated by measuring the fluorescence emitted by the probe in contact with the ROS.
  • Reconstructed human epidermis were pre-treated with a formulation containing 3% basil extract obtained according to example 1 or its placebo for 24 hours. The skins were then irradiated with 30J/cm 2 of UVA.
  • the antioxidant activity of holy basil extract was investigated by evaluating the quantity of ROS produced by keratinocytes or fibroblasts subjected to oxidative stress induced by menadione. has. Material and method
  • ROS were labeled with the CellRox® probe; intracellular fluorescence, proportional to the amount of ROS was measured.
  • ROS are the main activators of lipid peroxidation, having as their main targets polyunsaturated lipids bound to the cell membrane.
  • the anti-lipid peroxidation activity of holy basil extract was investigated in keratinocytes or fibroblasts subjected to oxidative stress induced by cumene hydroperoxide. has. Material and method
  • the lipid peroxides were revealed by labeling using the BODIPY® 581/591 C11 probe; intracellular fluorescence was measured.
  • Glutathione is the main endogenous antioxidant peptide capable of neutralizing ROS. Intracellular GSH depletion is responsible for damage induced by oxidative stress, associated with mitochondrial toxicity.
  • Skin aging is characterized by an alteration of the dermal matrix with, in particular, a reduction in the quality and quantity of matrix fibers, mainly collagen and elastin.
  • the anti-aging activity of holy basil was evaluated by its ability to stimulate the expression and production of dermal matrix markers under standard conditions and under conditions of inflammatory stress modeling chronic inflammation, also called " inflamm'aging” or low-grade inflammation.
  • Collagen I The gene expression of Collagen I, Elastin, Dermatopontin and MMP1 (Matrix-Metalloproteinase-1) was evaluated by real-time quantitative PCR.
  • Human dermal fibroblasts were treated for 48 hours with the holy basil extract obtained according to Example 1 at 0.001% and 0.005% ms or with a mixture of Vitamin C at 10 ⁇ M and TGFB at 5 ng/mL, used as a positive reference. .
  • CLN3 encodes a lysosomal/endosomal transmembrane protein (neural ceroid-lipofuscinosis 3) involved in the regulation of the autophagy process.
  • Autophagy is an intracellular detoxification process allowing the degradation and recycling of damaged proteins and organelles. This process is essential for the maintenance of cell function and homeostasis. Stimulation of autophagy is of interest in slowing down aging and extending the lifespan of cells.
  • PXN encodes a focal adhesion molecule (paxillin), whose expression decreases with age and therefore represents a target for anti-aging action. Due to its crucial role in cell-matrix connections and mechanotransduction between the fibroblast and its matrix, the loss of paxillin with age could compromise cell function, resulting in the appearance or aggravation of skin aging. Inducing its expression could help restore age-related loss of collagen and dermal contractility.
  • paxillin focal adhesion molecule
  • Table 12 Genes modulated significantly by the 3% formulation of holy basil extract compared to the placebo (fixed at 1.00)
  • Reconstructed epidermis were treated topically with a formulation (cream) containing 3% holy basil extract obtained according to example 1 or its placebo, or systemically with dexamethasone at 1 ⁇ M, an anti-inflammatory reference. After 24 hours of pre-incubation, the epidermis were stimulated with 0.5 ⁇ g/mL of PMA and incubated again for 24 hours.
  • the culture subnatants were collected, an ILIa assay was carried out on the one hand and, on the other hand, these subnatants (conditioned media) were deposited on cultures of normal human dermal fibroblasts.
  • Table 14 Genes modulated by the 3% formula of holy basil in the Inflamm'aging model: gene expression in the fibroblasts incubated in the presence of conditioned media (Level of expression in relative quantity; % change compared to PMA)
  • the skin is daily exposed to different types of exogenous and/or endogenous stresses, likely to alter its functioning and quality, and which can ultimately lead to irreversible damage.
  • Nitric oxide is a reactive species involved in the regulation of skin homeostasis. This very unstable molecule is synthesized and released by many cell types to regulate physiological and homeostatic reactions, such as melanogenesis, healing, regulation of inflammation, immunomodulation, vasodilation...
  • Glucocorticoids such as cortisol.
  • HPA hypothalamic-pituitary-adrenal
  • Numerous studies have described the negative effects of psychological stress on cutaneous homeostasis, leading to an alteration of immune and inflammatory responses.
  • the inflammatory response includes the activation of free radicals, among which, NO.
  • Camptothecin is a genotoxic compound, inhibitor of toposiomerase I, used for the induction of double strand breaks in DNA.
  • Double-strand breaks were detected by immunostaining of yH2AX (phosphorylation of histone H2AX which occurs early in response to double-strand breaks) and quantified by image analysis.
  • Table 15 Expression of yH2AX in keratinocytes in the presence of camptothecin stress
  • UV, Pollution Environmental factors
  • Intracellular ROS are mainly formed by dysfunction of the mitochondrial electron transfer chain.
  • Mitochondrial DNA is particularly sensitive to ROS, resulting in the following phenomena which ultimately contribute to the aging process: decrease in energy production, increase in oxidative stress, increase in mitochondrial functions.
  • Normal human dermal fibroblasts were incubated for 120 minutes in the presence of the mixture of urban pollutants at 0.1% and the holy basil extract obtained in example 1 at 0.001% and 0.005% ms.
  • the analysis of autophagy and mitophagy was evaluated via a lysosomal marker and a specific dye of damaged mitochondria: Damaged mitochondria were visualized by a red fluorescence produced by reaction of a fluorochrome bound by covalent bond to the membrane mitochondrial which emits when damage to the mitochondrial membrane takes place. A lysosomal dye was used to label lysosomes and assess the colocalization of damaged mitochondria to lysosomes.
  • Mitophagy is represented by the percentage of lysosomes co-localized with a signal of damaged mitochondria. Pollution increased the frequency of lysosomes containing damaged mitochondria, demonstrating an increase in the process of mitophagy. Pollution increases mitochondrial and endoplasmic reticulum stress, both of which induce damage to the mitochondrial membrane. The increase in mitophagy observed under the effect of stress is linked to cells trying to eliminate damaged mitochondria and/or malformed proteins or lipids. Holy basil extract reduced and normalized pollutant stress-induced mitophagy (fig.5).
  • Aquaporin 3 plays an important role in preserving skin hydration: this transmembrane protein is involved in transporting water and glycerol into keratinocytes to maintain epidermal hydration a.
  • the anti-aging clinical efficacy of the holy basil extract according to the present invention was evaluated by an in vivo clinical study.
  • composition of the placebo is as follows:
  • the active ingredient significantly reduces the area and length of the wrinkle detected on D56 with a significant difference compared to the placebo.
  • Table 20 measurement results - crow's feet wrinkles b. Results on forehead wrinkles
  • the active ingredient significantly improves forehead wrinkles on D28 and does not induce any variation on D56.
  • the placebo does not induce any significant variation on D28 and globally induces a significant worsening on D56. Overall, this leads to significant differences in favor of the asset at D28 and D56 on all the topographic parameters evaluated.
  • the active improves tonicity (Ur and Ua) at D56 whereas the placebo causes a significant worsening.
  • the difference between the active and the placebo is significant in favor of the active for the 2 parameters.
  • the active improves the raw elasticity Ur/Uf at D56.
  • the difference is significant compared to the placebo which causes a worsening.
  • the active ingredient significantly improves the biological elasticity Ua/Uf on D28 and D56. The difference is significant compared to the placebo at D56 which causes a worsening.
  • the active improves the net elasticity Ur/Ue at D56.
  • the difference is significant compared to the placebo at D56 which causes a worsening.
  • the active improves on D28 and significantly on D56 Q1 viscoelastic recovery. The difference is significant compared to the placebo at D56 which causes a worsening.
  • the active improves elastic recovery Q2 at D56.
  • the difference is significant compared to the placebo at D56 which causes a worsening.
  • the active ingredient significantly improves Q3 viscous recovery on D28 and D56. The difference is significant compared to the placebo at D56 which does not cause any significant variation.
  • the active ingredient improves the biomechanical properties of the skin, significantly compared to the placebo, with an improvement in skin tone and elasticity.
  • the active ingredient significantly reduces redness a* on D28 and D56.
  • the difference is in favor of the active ingredient on D28 and D56 compared to the placebo, which also reduces redness on D28 and significantly on D56.
  • the active ingredient decreases hemoglobin on D28 and D56.
  • the active ingredient significantly improves the evenness of the complexion H76 to D56.
  • the active ingredient significantly improves the luminosity, redness and evenness of the complexion.
  • the active has an anti-aging effect observed instrumentally on wrinkles in the upper part of the face, namely crow's feet and forehead wrinkles. Significant differences compared to the placebo are observed according to the times in favor of the active ingredient.
  • the active ingredient significantly improves the tone and elasticity of the skin on D28 and D56 according to the parameters considered with significant differences with the placebo in favor of the active ingredient.
  • the active improves the homogeneity of the complexion at D56 with a difference compared to the placebo in favor of the active.

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EP22705429.3A 2021-01-20 2022-01-20 Extrait de parties aeriennes de basilic sacre et compositions cosmetiques, ou dermatologiques le comprenant Pending EP4281095A1 (fr)

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