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
  • A61K36/11—Pteridophyta or Filicophyta (ferns)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
  • A61K36/258—Panax (ginseng)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
  • A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
• • 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)
  • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
  • A61K36/738—Rosa (rose)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
  • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
  • A61K8/9783—Angiosperms [Magnoliophyta]
  • A61K8/9789—Magnoliopsida [dicotyledons]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
• • 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
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin

Definitions

• the present invention relates to topical compositions that contain at least one plant extract and that moisturize and nourish the skin for use in the treatment of stretch marks on the skin.
• the invention particularly relates to a topical composition that contains an extract of a plant selected from Chamomilla recutita, Rosa moschata, Prunus amygdalus dulcis, Malva sylvestris, Panax ginseng and Equisetum arvense and to the cosmetic use thereof.
• Stretch marks are pale, thin lines on skin surface. Although stretch marks may be seen in various areas of the body, they usually appear in the abdominal region, upper side of the arms, chest, hips and thighs. Pregnancy, sudden weight loss or gain, rapid growth, adolescence period, hormonal changes, heavy exercise or genetic factors may cause the formation of stretch marks. When the skin is too tense, collagen fibers that provide skin flexibility become impaired, then normal production cycle of collagen is interrupted and damaged. As a result of this damage, thin lines, i.e. stretch marks appear on the skin. ln state of the art, many synthetic and natural compositions have been developed in order to prevent stretch mark formation, eliminate or reduce the stretch marks that have appeared.
• Patent application no. US 8,765,198 B2 relates to cosmetic prevention or treatment of stretch marks.
• the composition according to this document contains an effective amount of a natural polymer called arabinogalactan.
• various plant-based oils such as sweet almond oil, macademia oil, corn oil and peanut oil are also used.
• WO 2013/072852 A1 describes a composition that contains sweet and/or bitter almond oil, avocado oil, grapefruit oil, lavender oil, chamomile oil, Turmeric root, Calendula and Neem for preventing stretch marks.
• the composition of the invention is applied topically.
• the application no. US 2012/0156272 A1 relates to a composition that contains a plant extract, carbohydrate, and phospholipid and the pharmaceutical, cosmetic or dietary application thereof ln the document, the plant extract is selected from the group that comprises Aloe [Aloe vera], Aspalathus Linnea s, Paullinia cupana, white tea, green tea, black tea, Hibiscus, Urticaceae, Rorippa amphibia, Water Cress, Horse Tail, Field Horsetail, Chamomile, Centella asiatica, Gingko, Ginseng, Cranberry ( Vaccinium macrocarpon), olive, Pomegranate or mixtures thereof.
• a plant-based active ingredient selected from Chamomilla recutita juice, Rosa moschata seed oil, Prunus amygdalus dulcis, Malva sylvestris extract, Panax ginseng extract and Equisetum arvense extract and that preferably contains a combination thereof was used.
• Chamomilla recutita that is used in the composition of the invention is used in various ways against acne and eczema, skin erythema and wounds in state of the art due to its antiinflammatory, antispasmodic and sedative effects.
• Rosa moschata seed that is used in the present invention contains retinol or vitamin A, Omega 6, Omega 9 fatty acids, a very strong antioxidant, i.e. lycopene, another very strong antioxidant, i.e. beta carotene and Vitamin C. ltis used against scars, psoriasis, early aging and aging of the skin.
• Prunus amygdalus dulcis that is mentioned in the invention have been used for skin beauty since the past and it is widely preferred today lt is used in the treatment of blemishes on the face, blackheads and scaly skin, it nourishes the skin, provides softness and meets the Vitamin E need.
• Malva sylvestris that is used in the present invention has many benefits for skin health in state of the art. lt is known that it facilitates reducing swelling in the skin lt provides a much more radiant appearance of the skin while rejuvenating skin cells lt delays skin aging and it is used for treatment purposes in wounds and burns on the skin.
• Panax ginseng in the present invention is a very strong antioxidant and has regenerative effects on all damaged tissues. Therefore, it has constructive and therapeutical effects in many skin problems. Ginseng contains insulin-containing substance that cannot be found in many plants and hence it preserves the existing moisture and vitamin balance of the skin thereby preventing skin aging.
• Equisetum arvense possesses antiseptic, antibacterial and astringent properties lt is used for gingival and oral infections as well as an oral rinse to treat throat inflammation.
• the mentioned natural oils should be formed into a topical dosage form in order to be easily applied on the skin by a patient.
• it is not always easy to obtain an effective and safe topical form due to the physical and chemical stability problems of the compositions known in the art that contain natural oils. Natural oils disintegrate when they are exposed to the atmosphere during production or before patient use or phase stability and homogeneity problems are encountered as oils do not readily dissolve in water.
• the topical composition should have suitable viscosity, phase stability and homogeneity in order to enable easy application of the composition on the area that will be treated.
• This composition which is made into a dosage form, should be compatible with the skin without causing any harm, and therefore it is preferred to have a pH value within a certain interval.
• Natural substances and especially plant-based materials are still needed in order to treat and eliminate stretch marks that are considered as one of the most important problems from the cosmetic aspect ln addition, the physicochemical properties of these substances and materials should be improved.
• the present invention offers novel plant-based compositions as described in the appended claims in order to provide a solution to these problems.
• the present invention essentially relates to the cosmetic use of at least one plant extract selected from Chamomilla recutita juice extract, Rosa moschata seed oil, Prunus amygdaius dulcis oil, Malva sylvestris extract, Panax ginseng root extract and Equisetum arvense extract in order to prevent and/or eliminate stretch marks.
• the inventors found that the mentioned plant extracts are beneficial in the cosmetic treatment of stretch marks, which was unpredictable from the prior art.
• the use in preferred embodiments of the invention contains the synergistic use of multiple combinations of the mentioned plant extracts.
• the invention more preferably provides the use of all of the mentioned extracts in a combination.
• composition should meet certain criteria such as suitable pH, viscosity and phase stability.
• a suitable preservative should be used in order to combine the oils of interest and make them into an effective and safe dosage form by meeting these criteria ln an embodiment of the present invention, cetearyl alcohol also known in the art as cetyl steaiyl alcohol or cetosteaiyl alcohol was used as a preservative in order to overcome the mentioned problems.
• cetearyl alcohol provides the desired viscosity value and phase stability while chemical stability is also preserved. Active ingredient in an effective and safe topical composition should be homogenously distributed within the composition lnsoluble substances or complexes lead to skin irritation. For such unstable topical compositions that exhibit phase separation, the active ingredient cannot be evenly distributed within the area of application. This causes penetration problems on the skin and reduces the effect of treatment ln the present invention, cetearyl alcohol is recommended to overcome phase stability and homogeneity problems.
• the mentioned topical composition should be easily applied by the patient on the area that will be treated. Therefore, studies about the amount of cetearyl alcohol have been conducted within the scope of the present invention.
• the amount of cetearyl alcohol is between 1-20%, preferably between 3-12% and more preferably around 5.1% by weight in the total composition ltwas observed that the desired viscosity value of the topical composition of the invention was achieved with this amount of cetearyl alcohol.
• Viscosity value of the composition of the present invention is 40.000-70.000 mPas. Hence, it was ensured that the patient easily applies the composition to the desired area and that the composition remains in a stable manner (without flowing) on the skin.
• cetearyl alcohol contains 25-35% cetyl alcohol and 60-75% steaiyl alcohol, preferably 30% cetyl alcohol and 70% stearyl alcohol by weight lt is already known in the art that cetearyl alcohol is comprised of cetyl alcohol and stearyl alcohol ln the present invention, it was observed that cetyl alcohol and stearyl alcohol used in these amounts were effective in reaching the desired viscosity.
• composition of the invention may also contain dicaprylyl ether lt was found that colloidal precipitation and crystallization were prevented due to the excellent solubilizing effect of this component on plant extracts of the invention.
• the mentioned composition is provided in a form that is selected from the group that comprises ointment, pomade, soap, gel, emulsion, spray, shampoo, mousse, balm, cream and lotion.
• the composition of the invention is particularly in cream or lotion form.
• topical composition of the invention may also contain at least one excipient selected from skin care agents, emollients, solvents, emulsifiers, preservatives, surfactants, humectants, chelating agents, viscosity agents, buffers, antioxidants, perfumes and antimicrobial preservatives.
• Suitable skin care agents can be selected from the group that contains glycerin, tocopherol, bisabolol, panthenol, olive oil hydrolyzed wheat protein, caprylyl glycol and mixtures thereof.
• Suitable emollients can be selected from the group that contains glyceryl stearate, glyceryl stearate citrate, glyceryl oleate, polyglyceryl- 3 -stearate, CIO-18 triglycerides, glyceryl caprilate, glyceryl caprate, cetearyl alcohol, behenyl alcohol, Cera Alba (beeswax), shea butter, lanolin, lecithin, jojoba oil, argania spinosa kernel oil, rosmarinus officinalis oil, triticum vulgare (wheat germ) extract, fish oil, aloe vera oil, sunflower oil, rice bran oil, foeniculum vulgare oil, sesame oil, rosehip oil, avocado oil, centella asiatica extract, coconut-caprilate/caprate, fumatrice propolis extract, cremerlin pura and mixtures thereof.
• Suitable solvents can be selected from the group that contains water, dicapiylyl ether, glycerol, ethanol, methanol, propylene glycol, polyethylene glycol, 2-propanol, cetyl alcohol, steaiyl alcohol, dimethylsulfoxide, benzyl alcohol, 1-3 butylene glycol, polyoxyethylene, lauryl alcohol, 1-3 propanediol and mixtures thereof.
• Suitable emulsifiers can be selected from the group that contains carnauba, jojoba, beeswax ( Cera Alba), lanolin, xanthan gum, lecithin, glyceryl oleate, glyceryl stearate citrate, soapwort, candelilla, castile soap, yucca extract, quince seed extract, quillaja bark extract, rice bran, lanolin and mixtures thereof.
• Suitable preservatives may be selected from the group than contains rosmarinus officinalis (rosemary) leaf extract, Melaleuca alternifolia leaf oil, hamamelis virginiana (hamamelis) extract, tea tree essential oil, thyme essential oil, grapefruit seed extract, bitter orange extract, propolis extract, caprylhydroxamic acid, caprylyl glycol, glycerin and mixtures thereof.
• Suitable surfactants may be selected from the group that contains castile soap, yucca extract, soapwort extract, quillaja bark extract, lanolin, candelilla, carnauba, jojoba, rice bran, beeswax ( Cera Alba), lanolin, xanthan gum, quince seed, lechitin, glyceryl oleate, glyceryl stearate citrate and mixtures thereof.
• Suitable chelating agents can be selected from the group than contains tetrasodium glutamate diacetate, glutamic acid, ethylenediaminotetraacetic acid (EDTA) or any salt thereof, dimercaprol disodium, deferoxamine and mixtures thereof.
• Suitable viscosity agents can be selected from the group that contains glycerin, acacia, agar, alginic acid, bentonite, carbomer copolymer, carbomer homopolymer, carbomer interpolymer, carboxymethylcellulose calcium, carboxymethylcellulose sodium, carboxymethylcellulose, carrageenan, microciystalline cellulose, carboxymethylcellulose sodium, dextrin, gelatin, gellan gum, guar gum, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, maltodextrin, methylcellulose, pectin, polyethylene oxide, polyvinyl alcohol, povidone, propylene glycol alginate, pullulan, hydrophobic colloidal silica, silicone dioxide, sodium alginate, corn starch, xanthan gum and mixtures thereof.
• Suitable buffers can be selected from the group than contains citric acid, epolamine, triethanolamine, diethanolamine, tromethamine and mixtures thereof.
• Suitable antioxidants are selected from the group that contains lecithin, ascorbyl palmitate, tocopherol, sunflower oil, ascorbic acid (vitamin C) or ascorbyl palmitate, propolis extract, allium cepae (onion) bulb extract, vitamin E (tocopheryl acetate/tocopherol), licorice (organic licorice) extract and mixtures thereof.
• Suitable antimicrobial preservatives can be selected from the group that contains propylene glycol, phenoxyethanol, methyl paraben, propyl paraben and salts thereof (sodium, potassium), sodium benzoate, citric acid, benzoic acid, butylated hydroxytoluene, boric acid, sorbic acid, benzyl alcohol, benzalconium chloride, parahydroxybenzoic acids or butylated hydroxyanisole and mixtures thereof.
• Topical composition of the present invention is intended for use in the treatment of stretch marks on the skin lt is suitable to use as of the early months of pregnancy to achieve an effective treatment.
• Topical composition of the invention can be applied by massaging on the abdominal region, chest and hips.
• the mentioned topical composition can be used twice a day, i.e. in the morning and evening.
• the most effective cosmetic treatment is achieved by using the composition of the invention twice a day.
• Another embodiment of the present invention provides a method for producing the topical composition of the invention. This process contains the following steps:
• the mentioned method contains the following steps: a) Mixing water, Chamomilla recutita juice, Malva sylvestris extract, Equisetum arvense extract, Panax ginseng extract and tetrasodium glutamate diacetate in a turbo emulsifier,
• composition was stored at various temperatures (4 °C, 25 °C, 40 °C and in thermal shock 4 °C / 40 °C) for 3 months and its stability was evaluated at certain times (t: 0, day 15, month 1, month 3). 4 samples that correspond to control days were analyzed for each environmental status. Samples were evaluated at each control time by keeping one sample sealed all the time and others open. Thermal shock was applied once a week in two stages starting in the cooler followed by cooler/heater.
• organoleptic and chemical-physical properties at room temperature [25 °C) remained unchanged.
• Expected and usual changes inherent in the raw materials were observed under hot and cold conditions.
• the composition was sealed tightly in order to prevent it from oxidation and possible chemical-physical or temperature-related changes and stored at room temperature.
• composition is stable under reasonable storage conditions (room temperature: 25 °C) in a commercial business or in its container for more than 30 months (preserves its chemical and physical properties and microbiological compatibility until the date of expiry).
• test was applied to 25 male-female patients between the ages 18-70 that were selected according to the inclusion criteria, i.e. a) well general state of health b) absence of dermatopathy c) absence of ongoing pharmacological treatment d) acceptance of not changing the ordinary daily routine and e) absence of atopy in anamnesis, in order to provide outpatient treatment.
• the composition According to the ordinary use of the composition, it was applied as a leave on or 10% standard concentration rinse-off composition.
• Liquid composition was applied to the skin at 20 m ⁇ dose.
• Solid and semi solid compositions were applied at a dose of 20 pg.
• Finn chamber plastic that contains 7 mm aluminum disc and absorbent paper discs
• Finn chamber contains blotting papers that were immersed in a certain amount (20 m ⁇ ) of the sample that will be tested.
• the compositions (20 pg) that will be tested are directly applied to the skin.
• the relevant area on the skin was cleansed using 70% alcoholic solution.
• composition was applied at an amount of 0,02 g or ml/cm 2 skin.
• the relevant area of the skin was covered by the Finn chamber. Composition was maintained in contact with the skin for 24 hours.

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• Health & Medical Sciences (AREA)
• Natural Medicines & Medicinal Plants (AREA)
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• Animal Behavior & Ethology (AREA)
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• 2019
  • 2019-04-17 EP EP19840745.4A patent/EP3787654A4/de active Pending
  • 2019-04-17 WO PCT/TR2019/050254 patent/WO2020022991A2/en unknown

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