WO2014025290A1 - Produit de traitement externe des malades souffrant de dermatite atopique - Google Patents

Produit de traitement externe des malades souffrant de dermatite atopique Download PDF

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Publication number
WO2014025290A1
WO2014025290A1 PCT/RU2013/000670 RU2013000670W WO2014025290A1 WO 2014025290 A1 WO2014025290 A1 WO 2014025290A1 RU 2013000670 W RU2013000670 W RU 2013000670W WO 2014025290 A1 WO2014025290 A1 WO 2014025290A1
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WO
WIPO (PCT)
Prior art keywords
mass
atopic dermatitis
patients
skin
remedy
Prior art date
Application number
PCT/RU2013/000670
Other languages
English (en)
Russian (ru)
Inventor
Николай Васильевич КУНГУРОВ
Екатерина Леонидовна ХАРСЕВИЧ
Наталья Владимировна ЗИЛЬБЕРБЕРГ
Муза Михайловна КОХАН
Андрей Станиславович ГАВРИЛОВ
Наталья Петровна ЕВСТИГНЕЕВА
Original Assignee
Федеральное Государственное Бюджетное Учреждение "Уральский Научно-Исследовательский Институт Дерматовенерологии И Иммунопатологии" Министерства Здравоохранения Российской Федерации (Фгбу "Урниидвии" Минздрава России)
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Application filed by Федеральное Государственное Бюджетное Учреждение "Уральский Научно-Исследовательский Институт Дерматовенерологии И Иммунопатологии" Министерства Здравоохранения Российской Федерации (Фгбу "Урниидвии" Минздрава России) filed Critical Федеральное Государственное Бюджетное Учреждение "Уральский Научно-Исследовательский Институт Дерматовенерологии И Иммунопатологии" Министерства Здравоохранения Российской Федерации (Фгбу "Урниидвии" Минздрава России)
Publication of WO2014025290A1 publication Critical patent/WO2014025290A1/fr

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Classifications

    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
    • 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
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders

Definitions

  • the invention relates to medicine, namely to dermatology and can be used to treat patients with atopic dermatitis.
  • One of such agents is an agent for atopic dermatitis, containing dry dropsy extract, a solution of 5% vitamin E oil, anhydrous lanolin, sunflower oil and distilled water at a certain ratio of components (RU, patent N ° 2028150, IPC A61K35 / 78, publ. 02/191995).
  • a known combination comprising pyrrolidone-5-carboxylic acid and at least one compound of citrulline, arginine and asparagine for the treatment of atopic dermatitis (RU, patent application N ° 2009147465/15, IPC A61KZ 1/198, publ. 27.06. 2011).
  • an anti-inflammatory and antipruritic cream for the treatment of dermatological diseases containing, as an active component, gamma-b-glutamylhistamine and a base comprising at least one of the oil components (olive oil, oil sunflower oil, vaseline oil), cosmetic stearin, emulsifier, emulsion wax, triethanolamine, vitamin A, distilled glycerin, antioxidant, preservative, tea tree oil and purified water at certain ratios (RU, patent N ° 2233152, IPC A61K7 / 48, A61K7 / 00, A61K9 / 06, A61K35 / 70, published on July 27, 2004).
  • oil components oil, oil sunflower oil, vaseline oil
  • cosmetic stearin emulsifier, emulsion wax, triethanolamine, vitamin A, distilled glycerin, antioxidant, preservative, tea tree oil and purified water at certain ratios (RU, patent N ° 2233152, IPC A61K7 / 48, A61
  • This composition is not effective enough due to the use of stearin as a base.
  • Stearin forms an impermeable film, thereby blocking the restoration of the skin’s own lipid balance, leaving a feeling of “greasy” skin, which reduces the compliance of the therapy.
  • the closest is a cream for external use - ZINOKAP (CINOCAP) 0.2%.
  • auxiliary substances includes macrogol cetostearate (emulsifier), cetostearyl alcohol (emulsifier), liquid paraffin (liquid paraffin) (propylene glycol (humectant), dexapanthenol (active substance), sodium dihydrogen phosphate dihydrate and sodium hydrogen phosphate) (Instructions for use of the drug TsINOKAP, Pharmstandard-Tomskkhimfarm OJSC, 201 1g., ATX code: D1 1AX12, registration JN LSR-010496/08, 12.24.08) - prototype.
  • This cream has anti-inflammatory, antibacterial and antifungal activity, however, the mechanism of anti-inflammatory action has not been studied, allergic reactions are possible.
  • the objective of the invention is to develop a cream for external use, providing a moisturizing, anti-inflammatory and softening effect on the skin of patients with atopic dermatitis in the inter-relapse period.
  • the technical result that will be achieved from the use of this invention is to eliminate side effects, restore the physiological properties of the skin and to ensure high patient satisfaction after treatment.
  • the technical result is achieved by the fact that in an external therapy for patients with atopic dermatitis, including zinc pyrithione in an amount of 0.2%, the active substance, emulsifiers, emollients, moisturizer and water, urea is used as the active substance, glyceryl stearate is used as an emulsifier, emulsion wax and triethanolamine, as emollients - cocoa butter, corn oil, mineral oil, triglycerides of caprylic and capric acids and cyclomethicone, as a moisturizer - glycerin.
  • carbopol and peach flavor are further added. The components are taken in the following ratio, wt.%:
  • the invention consists in a combination of these components.
  • urea as an active substance (along with zinc pyrithione) provides kerotolytic and penetrating effects, affecting keratin, improves the penetration of zinc pyrithione into the deeper layers of the skin, and since urea is part of the skin's NMF (Natural Moisturizing Factor), its small amounts help to retain its own moisture in the upper layers of the epidermis.
  • NMF Natural Moisturizing Factor
  • glyceryl stearate, emulsion wax and triethanolamine as emulsifiers contributes to the activation of zinc pyrithione, since these emulsifiers are cationic.
  • cocoa butter, corn oil, mineral oil, triglycerides of caprylic and capric acid and cyclomethicone as emollients not only creates a protective film on the skin, but also gives the skin a feeling of softness and silkiness.
  • glycerin serves to moisturize the skin, does not cause complications from the liver and kidneys, and also does not cause allergies.
  • carbopol which is a gelling agent, is necessary for the formation of the optimal consistency.
  • Peach flavoring is necessary to create a gentle light fruity aroma to improve the organoleptic properties of the cream.
  • the qualitative and quantitative composition of the components of the drug are selected experimentally and provides a moisturizing, anti-inflammatory and softening effect on the skin of patients with atopic dermatitis and psoriasis in the inter-relapse period without side effects.
  • the invention is as follows.
  • Triethanoamine 0.6 g (0.5 wt.%) Is placed in a third glass.
  • the first and second glasses (with the aqueous and fat phase, respectively) are heated to a temperature of 80 ° C, then the fat phase is added to the water (in the first glass) and mixed.
  • the resulting mass is homogenized and then cooled.
  • triethnolamine is added and constantly stirred until thickened.
  • After cooling the resulting mass add 0.3 g (0.1 wt.%) Of peach flavor and 0.417 g of a 48% suspension of pyrithione zinc (which corresponds to 0.2 wt% in terms of pure zinc pyrithione) and mix.
  • SCORAD index from 6.9 to 7.5 points
  • the last typical exacerbation of blood pressure (SCORAD index 6.7 points) developed after contact with washing powder.
  • the patient was prescribed a new external agent 2 times a day on the skin in the face and hands.
  • the use of a new external agent was carried out for 20 days, after which all symptoms regressed (for a list of symptoms, see the Table).
  • the patient noted the excellent tolerability of the drug, was satisfied with the properties of the skin after treatment, since dryness and tightness of the skin were completely absent; the use of the drug was continued in a maintenance mode (2 times a week), clinical remission of blood pressure remains.
  • the comparison group (according to the prototype) was composed of patients with mild atopic dermatitis, before the start of therapy, the average group index SCORAD was 8.3 ⁇ 0.9 points, that is, it did not statistically differ from the index of the main group.
  • Zinocap cream was used as an external agent. After a 4-week course of therapy in both groups, the residual symptoms of atopic dermatitis (BP) were evaluated by the attending physician and the subjective attitude of the patients to the external treatment was studied (therapy compliance factors).
  • the new external agent was characterized by excellent and good tolerance (93.3%), high satisfaction with the use of the drug and overall satisfaction of the patient with skin properties after treatment (100% and 93.3%, respectively).

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne la médecine et notamment la dermatologie et peut s'utiliser pour le traitement des malades souffrant de dermatite atopique. Le produit de traitement externe des malades souffrant de dermatite atopique comprend les composants suivants, en % en masse : pyrithione de zinc - 0,20, urée - 1,50, stéarate de glycérol - 3,00, cire d'émulsion - 3,00, triéthanolamine - 0,50, beurre de cacao - 3,00, huile de maïs - 1,00, huile minérale - 5,00, triglycérides d'acides caprylique et caprique - 3,00, Cyclométhicone - 2,00, glycérine - 2,00, Carbopol - 0,25, parfum de pêche 0,10, eau potable pour le reste. Ce produit à usage externe est caractérisé par une acceptabilité bonne ou supérieure (93,3%), une satisfaction élevée à l'usage de la préparation et une satisfaction générale de la cliente vis-à-vis des propriétés de la peau après traitemetn (100 et 93,3%, respectivement).
PCT/RU2013/000670 2012-08-10 2013-08-02 Produit de traitement externe des malades souffrant de dermatite atopique WO2014025290A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2012134483/15A RU2496476C1 (ru) 2012-08-10 2012-08-10 Средство наружной терапии для больных атопическим дерматитом
RU2012134483 2012-08-10

Publications (1)

Publication Number Publication Date
WO2014025290A1 true WO2014025290A1 (fr) 2014-02-13

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PCT/RU2013/000670 WO2014025290A1 (fr) 2012-08-10 2013-08-02 Produit de traitement externe des malades souffrant de dermatite atopique

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RU (1) RU2496476C1 (fr)
WO (1) WO2014025290A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018049557A1 (fr) * 2016-09-13 2018-03-22 The Procter & Gamble Company Méthodes de modification de la composition de la peau
US11906507B2 (en) 2020-03-24 2024-02-20 The Procter & Gamble Company Methods for testing skin samples

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11447506B2 (en) 2016-05-09 2022-09-20 Anacor Pharmaceuticals, Inc. Crystal forms of crisaborole in free form and preparation method and use thereof
US20190151214A1 (en) * 2017-11-21 2019-05-23 Topix Pharmaceuticals, Inc. Methods and compositions for treatment of skin

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0544391A1 (fr) * 1991-09-02 1993-06-02 Teva Pharmaceutical Industries, Ltd. Compositions pour le traitement local du psoriasis et du dermatite atopique
RU2208430C1 (ru) * 2002-07-29 2003-07-20 Георгиева Елена Константиновна Крем-бальзам "апи-флора"
RU2233152C1 (ru) * 2002-12-30 2004-07-27 Небольсин Владимир Евгеньевич Крем противовоспалительного и противозудного действия для лечения дерматологических заболеваний
RU2448713C2 (ru) * 2006-11-30 2012-04-27 Галдерма С.А. Композиция в форме мази, содержащая производное витамина d

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2006300478B2 (en) * 2005-10-05 2010-06-17 Mitsubishi Tanabe Pharma Corporation Dermatitis treating agent
CN101460060A (zh) * 2006-03-01 2009-06-17 特莱斯特拉塔公司 局部治疗焦油响应性皮肤病用的组合物和方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0544391A1 (fr) * 1991-09-02 1993-06-02 Teva Pharmaceutical Industries, Ltd. Compositions pour le traitement local du psoriasis et du dermatite atopique
RU2208430C1 (ru) * 2002-07-29 2003-07-20 Георгиева Елена Константиновна Крем-бальзам "апи-флора"
RU2233152C1 (ru) * 2002-12-30 2004-07-27 Небольсин Владимир Евгеньевич Крем противовоспалительного и противозудного действия для лечения дерматологических заболеваний
RU2448713C2 (ru) * 2006-11-30 2012-04-27 Галдерма С.А. Композиция в форме мази, содержащая производное витамина d

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BARBINOV V. V. ET AL.: "Novye vozmozhnosti kombinirovannoi naruzhnoi terapii pri atopicheskom dermatite.", ROSSIISKII ZHURNAL KOZHNYKH I VENERICHESKIKH BOLEZNEI, no. 6, 2009, pages 30 - 32 *
TSINOKAP. SPRAVOCHNIK VIDAL., LEKARSTVENNYE PREPARATY V ROSSY, 2010, pages B-1408 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018049557A1 (fr) * 2016-09-13 2018-03-22 The Procter & Gamble Company Méthodes de modification de la composition de la peau
US11906507B2 (en) 2020-03-24 2024-02-20 The Procter & Gamble Company Methods for testing skin samples

Also Published As

Publication number Publication date
RU2496476C1 (ru) 2013-10-27

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