WO2019194775A2 - Composition de traitement de maladies du mamelon et de l'aréole - Google Patents

Composition de traitement de maladies du mamelon et de l'aréole Download PDF

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Publication number
WO2019194775A2
WO2019194775A2 PCT/TR2018/050873 TR2018050873W WO2019194775A2 WO 2019194775 A2 WO2019194775 A2 WO 2019194775A2 TR 2018050873 W TR2018050873 W TR 2018050873W WO 2019194775 A2 WO2019194775 A2 WO 2019194775A2
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WO
WIPO (PCT)
Prior art keywords
composition according
topical composition
group
composition
lanolin
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Application number
PCT/TR2018/050873
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English (en)
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WO2019194775A3 (fr
Inventor
Ahmet Toksöz
Zafer Toksöz
Original Assignee
Montero Gida Sanayi Ve Ticaret Anonim Sirketi
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Publication of WO2019194775A2 publication Critical patent/WO2019194775A2/fr
Publication of WO2019194775A3 publication Critical patent/WO2019194775A3/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • A61P39/06Free radical scavengers or antioxidants

Definitions

  • the present invention is related to the compositions which are suitable for use in diseases of nipple and areola. More specifically, the present invention is related to the compositions comprising lanolin, Chamomilla Recutita (Matricaria) juice, Mimosa Tenuiflora shell extract and Calendula Officinalis extract.
  • the said skin conditions occurs with the breastfeeding-related physical damage in the nipple or areola tissue.
  • Such physical damages can be accompanied by infections, however, there are times when they follow a course without any infection accompanied.
  • Rhagade a disease of nipple/areola without infection, is a manifestation of a postpartum inflammatory disease. Symptoms such as crack, abrasion, pain, rash, edema, scabbing occur in the area of inflammation.
  • Staphylococcus aureus is the most common cause of the bacterial infections. It settles in the milk duct due to the damage in the nipple and causes serious diseases such as mastitis or breast abscess.
  • Candida albicans overgrows in the affected tissue and leads to mastitis.
  • oral candidiasis is seen in the breastfed babies.
  • lanolin is known for its topical use based on the principle of moist wound healing in the treatment of traumatic nipples / areola. [ Riordan , J. (1985). The effectiveness of topical agents in reducing nipple soreness of breastfeeding mothers. J Hum Lact, 1, 36-41]. Lanolin is still practically used by women based on its extensive experience, proving its satisfactory results in terms of providing care. Furthermore, nurses and lactation experts continue to recommend the use of lanolin. However, as shown in recent studies, the predominant idea is that lanolin increases the risk for infection and causes more severe infections as mentioned [Sasaki, B. C., Pinkerton, K., & Leipeit, A. (2014). Does lanolin use increase the risk for infection in breastfeeding women? Clinical Lactation, 5(1), 28-32].
  • emollient selection is quite important for herbal formulations, particularly for the formulations in the emulsion form.
  • Emollients are advantageous for their physico chemical parameters such as viscosity, surface tension, spreadability and pour/blurring point and enable herbal oils to be used in the formulations easily with minimum effort.
  • compositions with antifungal and antibacterial features that can overcome the abovementioned problems, maintaining the efficacy and stability of the active pharmaceutical ingredients.
  • the said composition should comprise herbal supplements which do not exclude the useful features of lanolin and prevent lanolin-related infections.
  • the invention achieves those goals with the compositions according to claim 1.
  • the present invention is related to a topical composition
  • a topical composition comprising Lanolin, Chamomilla Recutita juice, Mimosa Tenuiflora shell extract and Calendula Officinalis extract.
  • the ratio of Lanolin ⁇ Chamomilla Recutita juice is in the range of 1 :10 and 1 :1 by weight, which is advantageous.
  • the said emulsifier agent is selected from a group comprising cetearyl alcohol, cetyl alcohol, polyglyceryl-3- stearate citrate and mixtures thereof. It is observed that the said stability is improved when a triglyceride is used.
  • the said glyceride is selected from a group comprising the oils of Shea, Helianthus Annuus, Zea Mays, Prunus Amigdalus Dulcis plants and mixtures thereof.
  • composition of the invention further comprise at least one additional agent selected from a group comprising moisturizer, thickener, humectant, antioxidant, preservative and pH regulator.
  • the said moisturizer agent can be selected from a group comprising behenyl alcohol, glyceryl caprate, glyceryl caprylate, caprylyl glycol and mixtures thereof.
  • the said thickener agent can be selected from a group comprising Cera Alba, xanthan gum or combinations thereof.
  • the said humectant is preferably glycerin.
  • the topical composition of the invention is presented in the form of cream, foam, gel, lotion or ointment.
  • the composition is preferably in the form of cream or ointment, more preferably in cream form.
  • composition of the invention can be present in the following ratios by weight:
  • composition of the invention More preferred formulation of the composition of the invention is disclosed in the present description.
  • the invention is related to the use of the above-mentioned topical composition for diseases or disorders of nipple and/or areola.
  • the said disease or disorder of nipple and areola can be selected from a group comprising dermatitis, eczema, vasospasm, mastitis and rhagade.
  • the invention is related to the method of preparation of the topical composition and consists of the following steps: a. Introducing of a hydrophilic phase comprising Chamomilla Recutita juice, b. Introduction of a lipophilic phase comprising Lanolin, Mimosa Tenuiflora shell extract and Calendula Officinalis extract,
  • an emulsifier which is used as part of the method and in particular an emulsifier which is selected from a group comprising cetearyl alcohol, cetyl alcohol, polyglyceryl-3-stereate, glyceryl stereate, citrate and mixtures thereof provides the desired stability.
  • the present invention presents a composition comprising lanolin as well as Mimosa Tenuiflora shell extract, Calendula Officinalis extract and Chamomilla Recutita juice with skin regeneration activities for use in skin disorders of nipple and areola especially in skin disorders of nipple and areola that are seen during lactation and breastfeeding periods.
  • composition of the present invention comprises Chamomilla Recutita juice.
  • Chamomilla Recutita juice as used in the present invention means any extract of Chamomilla Recutita or more preferably the extract derived from the flower thereof.
  • Chamomilla Recutita has antimicrobial and drying effects in the ulcers with discharge, accelerating the recovery process [Glowania, HJ., Raulin, C., Swoboda, M. (1987). Effect of chamomile on wound healing-a clinical double-blind study. Z Hautkr, Sep 1;62(17):1262, 1267-71 ]. Moreover, it is also proved that Chamomilla Recutita has antimicrobial activities against staphylococcus and Candida microorganisms that cause infected skin diseases of nipple and areola [Aggag, ME., Yousef, RT. (1972). Study of antimicrobial activity of chamomile oil. Planta Med. Sep;22(2):140-4].
  • Chamomilla Recutita and lanolin show complementary effects particularly in the infected ulcers when used in combination. Yet, these substances need to be developed with the following components to have the features of fighting the microorganisms with wider spectrum and treating the conditions such as irritation and edema. For this reason, the invention suggests additionally the use of Mimosa Tenuiflora shell extract and Calendula Officinalis extract in the composition presented herein. It is found that Mimosa Tenuiflora shell extract is beneficial for the skin diseases of nipple and areola. The shell extract of Mimosa Tenuiflora is a product of traditional South America medicine for healing ulcers and burns.
  • This plant shell comprises saponins, lipids, phytosterols, metoxichalcones, cuculcanins and tanins that are efficient against free radicals as well as providing antibacterial, antimycotic, astringent effects. Furthermore, in the microbiological activity profile studies the antibacterial and antimycotic features as well as the inhibition effect of Mimosa Tenuiflora shell extract on gram-positive (Staphylococcus aureus) and fungi proliferation are established. Calendula Officinalis extract has synergic interaction with M. tenuiflora extract due to the anti-inflammatory, anti-edema, antibacterial, antioxidant activities of triterpene diol esters that stimulate epithelium generation in skin lesions.
  • the inventors have found a composition providing wider-spectrum antimycotic, antibacterial and antimicrobial features, rapid wound healing features, preventing irritation and having stability when the said herbal supplements are used with lanolin within the combination presented herein.
  • the ratio of lanolin: Chamomilla Recutita juice is in the range of 1 :10 and 1 :1 by weight, which yielded outstanding results.
  • biological additives are used in the composition of the present invention considering the sensitive immune systems of newborns and mothers.
  • biological additive means any compound that is derived from a natural source such as animal, bacteria and yeast and has medical or beneficial effect.
  • biological additives might be the extracts and hydrous mixtures, oils and pollens of flowers, seeds, germs, shells or leaves of plants.
  • the composition may comprise biological additive which is lecithin.
  • Lecithin is a mixture of choline, choline esters, oil acids, glycerol, glycolipid, triglyceride, phosphoric acid and phosphatidylcholine which are the natural components of human milk. When used as additive, it is effective on clogged milk ducts.
  • Another herbal additive is Maiva Syivestris extract which is known as mallow and externally used in poultice form for the wound treatment in traditional medicine.
  • Aloe Barbadensis can also be used in the present invention.
  • the said composition further comprises at least one triglyceride.
  • triglyceride as used herein solely means any oil in solid or liquid form derived from the plants.
  • the triglycerides used in the present invention are selected to overcome emulsion difficulties. Furthermore, since they are “natural”, they provide advantage for using the compound safely.
  • the said trglyceride shea is selected from a group comprising Helianthus Annuus, Zea Mays, Prunus Amigdalus Dulcis oils and mixtures thereof.
  • triglycerides in the composition of the present invention are the emollient effect, however the chemical features of the said plants are also effective for healing the targeted diseases.
  • Shea oil melts down at body temperature and has good water-binding features.
  • Helianthus Annuus (Sunflower) is used for the wounds and skin lesions that usually take long to heal.
  • Prunus Amigdalus Dulcis (Almond) is usually topically applied for skin care and liniments. Prunus Amigdalus Dulcis is also used for the production of natural cosmetics as an ointment base.
  • the compound comprises at least one moisturizer (emollient) agent.
  • the said moisturizer agent is selected from a group comprising beheny alcohol, glyceryl caprate, glyceryl caprylate, caprylyl glycol and mixtures thereof.
  • These chemicals have moisturizing abilities as well as multifunctional cosmetic features such as wetting, viscosity regulator, antimicrobial, solubilizer.
  • Emulsification efficacy of moisturizing agents depends on their concentration. The moisturizing agents help reduce mechanic work load and heat energy, contributing to the production of a homogeneous and stable emulsion.
  • the composition further comprises a thickener agent.
  • a thickener agent i.e. rheological additives improves product in terms of production, storage stability and administration.
  • Rheological additives affect the stability and viscosity features of dosage form, thus are quite important in either liquid or semi-liquid formulations.
  • the features that are regulated with rheological additives include but is not limited to viscosity, flow rate, stability depending on the viscosity variations in time and ability to suspend the particles in such compositions.
  • the said thickener agent is selected from a group comprising Cera Alba, xanthan gum or combinations thereof. While Cera Alba is known as beeswax, it is a natural rheology regulator. Xanthan gum, on the other hand, is a polysaccharide of high molecular weight formed by pure culture fermentation between carbohydrate and Xanthomonas campestris.
  • the said thickener agent is Cera Alba.
  • Cera Alba (beeswax) is necessary for applications where non-toxicity and biodegradation is very important.
  • Cera Alba is preferably present in the range of 1% and 5% by weight of the total composition.
  • the composition further comprises an emulsifier.
  • Emulsifiers enhances kinetic stability of an emulsion.
  • the said emulsifier is selected from a group comprising cetearyl alcohol, cetyl alcohol, polyglyceryl-3-stearate, glyceryl stearate citrate and mixtures thereof. Cetearyl alcohol, cetyl alcohol in this group are classified as fatty alcohols and used in oil- in-water emulsions, providing a soft feeling for the skin.
  • the composition further comprises a humectant.
  • Humectants are composites that help keep skin moisturised. In cosmetics, humectants can be used in topical dosage forms to increase the solubility of the active components of the chemical compositions thus increasing the penetration abilities of the said active components to the skin along with their activity periods.
  • the composition of the present invention comprises a humectant which is glycerin.
  • the components present in the composition of the present invention is provided in Table 1 by their preferred ratios by weight.
  • composition of the present invention is preferably in a form intended for topical application.
  • preferred topical forms are cream, foam, gel, lotion and ointment.
  • the said composition is more preferably in the form of cream or ointment.
  • the composition of the present invention can be used for the treatment of diseases related to nipple and areola.
  • the said disease related to nipple and areola is selected from a group comprising dermatitis, eczema, vasospasm, mastitis, edema and rhagad.
  • the present invention is related to the production of a composition comprising Mimosa Tenuiflora shell extract, Calendula Officinalis extract and Chamomilla Recutita juice, combined with lanolin.
  • the method of the said production comprises the following steps: a. Introducing a hydrophilic phase comprising Chamomilla Recutita juice, b. Introducing a lipophilic phase comprising Lanolin, Mimosa Tenuiflora shell extract and Calendula Officinalis extract,
  • the emulsifying agent mentioned herein was selected from cetearyl alcohol, cetyl alcohol, polygyceryl-3-stereate and glyceryl stearate citrate, which was observed to be advantageous. Because it is important that the hydrophilic and lipophilic phases are homogeneously mixed to provide long-term physical stability and as shown in the examples the agents herein provide the desired stability.
  • hydrophilic phase components comprising Aloe Barbadensis leaf juice powder, chelating agent, Chamomilla Recutita juice, Maiva Syivestris extract, propanediol are mixed, while separately prepared another second phase comprising glycerin and xanthan gum is added to hydrophilic phase.
  • lipophilic phase components comprising Shea oil, Mimosa Tenuiflora shell extract, Calendula Officinalis extract, Prunus Amygdalus Dulcis oil, cetyl alcohol, cetearyl alcohol, lecithin, Polyglyceryl-3-Stearate, lanolin and cera alba are mixed in the dissolvent.
  • Hydrophilic phase second phase mixture and lipophilic phase is heated up to 70 °C. At this stage, two phases are combined and mixed for 10 minutes until emulsion is obtained. The product is cooled and the last phase components comprising caprylyl glycol, glyceryl caprylate, phenetyl alcohol are added below 40 °C.
  • composition is prepared so as to comprise the following components by weight (%):
  • Stability test Method: The composition was stored at various temperatures (4 °C, 25 °C, 40 °C and in weekly thermal shock 4 °C / 40 °C) for 3 months and its stability was evaluated at certain time points (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 remained unchanged.
  • Expected and usual changes inherent in the raw materials were not 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) while used for commercial purposes or in its container for more than 30 months (preserves its chemical and physical properties until the date of expiry).
  • room temperature 25°C
  • 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 pi dose.
  • Solid and semi solid composition was 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 pi) 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/cm2 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
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  • Organic Chemistry (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Plant Substances (AREA)
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Abstract

La présente invention concerne une composition topique comprenant de la lanoline, du jus de Chamomilla Recutita, un extrait de coque de Mimosa Tenuiflora et un extrait de Calendula Officinalis. La composition selon l'invention s'avère efficace pour le traitement de troubles liés au mamelon et à l'aréole. La présente invention concerne le procédé de fabrication de cette composition.
PCT/TR2018/050873 2017-12-27 2018-12-24 Composition de traitement de maladies du mamelon et de l'aréole WO2019194775A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2017/22083 2017-12-27
TR2017/22083A TR201722083A2 (tr) 2017-12-27 2017-12-27 Göğüs ucu ve areolaya i̇li̇şki̇n rahatsizliklarin tedavi̇si̇ne yöneli̇k bi̇leşi̇m

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WO2019194775A2 true WO2019194775A2 (fr) 2019-10-10
WO2019194775A3 WO2019194775A3 (fr) 2019-12-26

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PCT/TR2018/050873 WO2019194775A2 (fr) 2017-12-27 2018-12-24 Composition de traitement de maladies du mamelon et de l'aréole
PCT/TR2018/050890 WO2019209224A2 (fr) 2017-12-27 2018-12-25 Composition topique pour le traitement de la dermatite

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Application Number Title Priority Date Filing Date
PCT/TR2018/050890 WO2019209224A2 (fr) 2017-12-27 2018-12-25 Composition topique pour le traitement de la dermatite

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WO (2) WO2019194775A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3787654A4 (fr) * 2018-05-02 2022-04-20 Montero Gida Sanayi Ve Ticaret Anonim Sirketi Compositions topiques contre les vergetures sur la peau

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Publication number Priority date Publication date Assignee Title
IT1320192B1 (it) * 2000-05-12 2003-11-26 Giovanni Summo Composizione terapeutica per la cura della psoriasi.
US20030105445A1 (en) * 2001-11-30 2003-06-05 Kimberly-Clark Worldwide, Inc. Breast pad assembly containing a skin benefit ingredient
US7582307B2 (en) * 2003-11-26 2009-09-01 Harmony Labs, Inc. Dermatological composition
US8623335B2 (en) * 2007-09-10 2014-01-07 Tauna Ann Waddington Scar and rosacea and other skin care treatment composition and method
WO2013103944A1 (fr) * 2012-01-07 2013-07-11 Aloe Baby, Llc Compositions et méthodes de traitement d'affections cutanées
JP7313118B2 (ja) * 2014-10-31 2023-07-24 ポメガ インク ザクロ種子油、rosa canina果実油、およびinula viscosa含油樹脂または抽出物を含有する組成物
WO2017055943A1 (fr) * 2015-07-15 2017-04-06 Bakel Srl Composition cosmétique
US11571373B2 (en) * 2015-12-16 2023-02-07 Mattityahu AVSHALOMOV Skin care preparations for babies
CN106389582A (zh) * 2016-08-31 2017-02-15 肖涵 一种婴儿用万用膏及制备方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3787654A4 (fr) * 2018-05-02 2022-04-20 Montero Gida Sanayi Ve Ticaret Anonim Sirketi Compositions topiques contre les vergetures sur la peau

Also Published As

Publication number Publication date
TR201722083A2 (tr) 2019-07-22
WO2019209224A3 (fr) 2020-01-16
WO2019209224A2 (fr) 2019-10-31
WO2019194775A3 (fr) 2019-12-26
TR201806196A2 (tr) 2019-07-22

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