RU2014113663A - COMPOSITIONS OF SKIN FILLER FOR TREATMENT OF SMALL WRINKLES - Google Patents

COMPOSITIONS OF SKIN FILLER FOR TREATMENT OF SMALL WRINKLES Download PDF

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RU2014113663A
RU2014113663A RU2014113663/15A RU2014113663A RU2014113663A RU 2014113663 A RU2014113663 A RU 2014113663A RU 2014113663/15 A RU2014113663/15 A RU 2014113663/15A RU 2014113663 A RU2014113663 A RU 2014113663A RU 2014113663 A RU2014113663 A RU 2014113663A
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hyaluronic acid
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specified
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RU2626513C2 (en
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Самит ПЭЛИУАЛ
Гэбриел Н. НЦЗИКАН
СяоЦзе ЮЙ
Футянь ЛЮ
Николас Джей. МАНЕЗИС
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Аллерган, Инк.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
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    • A61L27/54—Biologically active materials, e.g. therapeutic substances
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    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
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    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/006—Heteroglycans, i.e. polysaccharides having more than one sugar residue in the main chain in either alternating or less regular sequence; Gellans; Succinoglycans; Arabinogalactans; Tragacanth or gum tragacanth or traganth from Astragalus; Gum Karaya from Sterculia urens; Gum Ghatti from Anogeissus latifolia; Derivatives thereof
    • C08B37/0063—Glycosaminoglycans or mucopolysaccharides, e.g. keratan sulfate; Derivatives thereof, e.g. fucoidan
    • C08B37/0072—Hyaluronic acid, i.e. HA or hyaluronan; Derivatives thereof, e.g. crosslinked hyaluronic acid (hylan) or hyaluronates
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    • C08J3/24—Crosslinking, e.g. vulcanising, of macromolecules
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    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • C08L5/08—Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/91—Injection
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/402—Anaestetics, analgesics, e.g. lidocaine
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/428—Vitamins, e.g. tocopherol, riboflavin
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    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions
    • A—HUMAN NECESSITIES
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    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction
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    • C08J2305/00—Characterised by the use of polysaccharides or of their derivatives not provided for in groups C08J2301/00 or C08J2303/00
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    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/02—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
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Abstract

1. Композиция кожного наполнителя, содержащая:компонент гиалуроновой кислоты, сшитый сшивающим компонентом;добавку, отличную от указанного сшивающего компонента;причем указанная композиция является, по существу, оптически прозрачной; иуказанная композиция характеризуется сниженным эффектом Тиндаля при введении в область дермы пациента по сравнению с, по существу, идентичной композицией, не содержащей добавки.2. Композиция по п. 1, отличающаяся тем, что указанная добавка представляет собой производное витамина C.3. Композиция по п. 1, отличающаяся тем, что указанная добавка представляет собой AA2G.4. Композиция по п. 1, отличающаяся тем, что указанная добавка представляет собой Vitagen.5. Композиция по п. 1, отличающаяся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой.6. Композиция по п. 1, отличающаяся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой при степени конъюгирования от приблизительно 3 мол.% до приблизительно 40 мол.%.7. Композиция по п. 1, отличающаяся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой при степени конъюгирования от приблизительно 3 мол.% до приблизительно 10 мол.%.8. Композиция по п. 1, отличающаяся тем, что указанный сшивающий компонент представляет собой BDDE.9. Композиция по п. 1, дополнительно содержащая анестетик.10. Композиция по п. 1, дополнительно содержащая лидокаин.11. Композиция по п. 1, характеризующаяся значением G′ от приблизительно 40 Па до приблизительно 100 Па.12. Композиция по п. 1, характеризующаяся значением G′ не более чем приблизительно 100 Па.13. Композиция по1. A dermal filler composition comprising: a hyaluronic acid component crosslinked with a crosslinking component, an additive other than said crosslinking component, said composition being substantially optically transparent; and said composition is characterized by a reduced Tyndall effect when administered to the dermis of a patient as compared to a substantially identical composition containing no additive. The composition according to claim 1, characterized in that said additive is a vitamin C derivative. The composition according to claim 1, wherein said additive is AA2G. 4. A composition according to claim 1, wherein said additive is Vitagen. A composition according to claim 1, characterized in that said component of hyaluronic acid is chemically conjugated to said additive. The composition of claim 1, wherein said hyaluronic acid component is chemically conjugated to said additive at a degree of conjugation from about 3 mol% to about 40 mol%. The composition of claim 1, wherein said hyaluronic acid component is chemically conjugated to said additive at a degree of conjugation from about 3 mol% to about 10 mol%. The composition of claim 1, wherein said crosslinking component is BDDE. The composition according to claim 1, further comprising an anesthetic. 10. The composition of claim 1, further comprising lidocaine. 11. The composition of claim 1, having a G 'value from about 40 Pa to about 100 Pa. The composition of claim 1 having a G 'value of no more than about 100 Pa. 13. Composition by

Claims (42)

1. Композиция кожного наполнителя, содержащая:1. A dermal filler composition comprising: компонент гиалуроновой кислоты, сшитый сшивающим компонентом;a hyaluronic acid component crosslinked with a crosslinking component; добавку, отличную от указанного сшивающего компонента;an additive other than the specified crosslinking component; причем указанная композиция является, по существу, оптически прозрачной; иwherein said composition is substantially optically transparent; and указанная композиция характеризуется сниженным эффектом Тиндаля при введении в область дермы пациента по сравнению с, по существу, идентичной композицией, не содержащей добавки.said composition is characterized by a reduced Tyndall effect when introduced into the patient’s dermal region as compared to a substantially identical composition containing no additives. 2. Композиция по п. 1, отличающаяся тем, что указанная добавка представляет собой производное витамина C.2. The composition according to p. 1, characterized in that said additive is a derivative of vitamin C. 3. Композиция по п. 1, отличающаяся тем, что указанная добавка представляет собой AA2G.3. The composition according to p. 1, characterized in that said additive is AA2G. 4. Композиция по п. 1, отличающаяся тем, что указанная добавка представляет собой Vitagen.4. The composition according to p. 1, characterized in that said additive is Vitagen. 5. Композиция по п. 1, отличающаяся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой.5. The composition according to p. 1, characterized in that the specified component of hyaluronic acid is chemically conjugated with the specified additive. 6. Композиция по п. 1, отличающаяся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой при степени конъюгирования от приблизительно 3 мол.% до приблизительно 40 мол.%.6. The composition according to p. 1, characterized in that the specified component of hyaluronic acid is chemically conjugated with the specified additive at a degree of conjugation from about 3 mol.% To about 40 mol.%. 7. Композиция по п. 1, отличающаяся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой при степени конъюгирования от приблизительно 3 мол.% до приблизительно 10 мол.%.7. The composition according to p. 1, characterized in that the specified component of hyaluronic acid is chemically conjugated with the specified additive with a degree of conjugation from about 3 mol.% To about 10 mol.%. 8. Композиция по п. 1, отличающаяся тем, что указанный сшивающий компонент представляет собой BDDE.8. The composition according to p. 1, characterized in that the crosslinking component is a BDDE. 9. Композиция по п. 1, дополнительно содержащая анестетик.9. The composition of claim 1, further comprising an anesthetic. 10. Композиция по п. 1, дополнительно содержащая лидокаин.10. The composition of claim 1, further comprising lidocaine. 11. Композиция по п. 1, характеризующаяся значением G′ от приблизительно 40 Па до приблизительно 100 Па.11. The composition according to p. 1, characterized by a value of G ′ from approximately 40 PA to approximately 100 PA. 12. Композиция по п. 1, характеризующаяся значением G′ не более чем приблизительно 100 Па.12. The composition according to p. 1, characterized by a value of G ′ not more than approximately 100 PA. 13. Композиция по п. 1, характеризующаяся значением G′ не менее чем приблизительно 40 Па.13. The composition according to p. 1, characterized by a value of G ′ not less than approximately 40 PA. 14. Способ лечения мелких морщин на коже пациента, включающий:14. A method for treating fine wrinkles on a patient’s skin, comprising: введение в кожу пациента композиции, содержащей смесь компонента гиалуроновой кислоты, сшивающего компонента, сшивающего гиалуроновую кислоту, и добавки, отличной от указанного сшивающего компонента;introducing into the patient’s skin a composition containing a mixture of a component of hyaluronic acid, a crosslinking component, a crosslinking hyaluronic acid, and an additive other than said crosslinking component; причем указанная композиция является, по существу, оптически прозрачной; иwherein said composition is substantially optically transparent; and при этом указанная композиция кожного наполнителя характеризуется сниженным эффектом Тиндаля по сравнению с, по существу, идентичной композицией, не содержащей добавки.however, the specified composition of the skin filler is characterized by a reduced Tyndall effect compared to a substantially identical composition containing no additives. 15. Способ по п. 14, отличающийся тем, что указанная добавка представляет собой производное витамина C.15. The method according to p. 14, characterized in that said additive is a derivative of vitamin C. 16. Способ по п. 14, отличающийся тем, что указанная добавка представляет собой AA2G.16. The method according to p. 14, characterized in that the additive is AA2G. 17. Способ по п. 14, отличающийся тем, что указанная добавка представляет собой Vitagen.17. The method according to p. 14, characterized in that said additive is Vitagen. 18. Способ по п. 14, отличающийся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой.18. The method according to p. 14, characterized in that the specified component of hyaluronic acid is chemically conjugated with the specified additive. 19. Способ по п. 14, отличающийся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой при степени конъюгирования от приблизительно 3 мол.% до приблизительно 10 мол.%.19. The method according to p. 14, characterized in that the specified component of hyaluronic acid is chemically conjugated with the specified additive with a degree of conjugation from about 3 mol.% To about 10 mol.%. 20. Способ по п. 14, отличающийся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой при степени конъюгирования от приблизительно 3 мол.% до приблизительно 40 мол.%.20. The method according to p. 14, characterized in that the specified component of hyaluronic acid is chemically conjugated with the specified additive with a degree of conjugation from about 3 mol.% To about 40 mol.%. 21. Способ улучшения эстетического вида лица, включающий этапы:21. A method for improving the aesthetic appearance of a face, comprising the steps of: введения в область дермы пациента по существу оптически прозрачной композиции кожного наполнителя, характеризующейся отсутствующим или незначительным эффектом Тиндаля, полученной путем осуществления следующих этапов:introducing into the patient's dermal region a substantially optically transparent skin filler composition characterized by an absent or insignificant Tyndall effect obtained by performing the following steps: обеспечения гиалуроновой кислоты;providing hyaluronic acid; взаимодействия сшивающего агента с производным витамина C;the interaction of a crosslinking agent with a derivative of vitamin C; добавления прореагировавших сшивающего агента и производного витамина C к гиалуроновой кислоте с получением композиции сшитой гиалуроновой кислоты, содержащей ковалентно конъюгированный витамин C; иadding a reacted crosslinking agent and a vitamin C derivative to hyaluronic acid to obtain a crosslinked hyaluronic acid composition containing covalently conjugated vitamin C; and гомогенизации и нейтрализации композиции сшитой гиалуроновой кислоты с получением инъецируемой композиции кожного наполнителя.homogenizing and neutralizing the crosslinked hyaluronic acid composition to form an injectable dermal filler composition. 22. Способ по п. 21, отличающийся тем, что указанная добавка представляет собой производное витамина C.22. The method according to p. 21, characterized in that the additive is a derivative of vitamin C. 23. Способ по п. 21, отличающийся тем, что указанная добавка представляет собой AA2G.23. The method according to p. 21, characterized in that the additive is AA2G. 24. Композиция по п. 21, отличающаяся тем, что указанная добавка представляет собой Vitagen.24. The composition according to p. 21, characterized in that the additive is Vitagen. 25. Способ по п. 21, отличающийся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой.25. The method according to p. 21, characterized in that the specified component of hyaluronic acid is chemically conjugated with the specified additive. 26. Способ по п. 21, отличающийся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой при степени конъюгирования от приблизительно 3 мол.% до приблизительно 40 мол.%.26. The method according to p. 21, characterized in that the specified component of hyaluronic acid is chemically conjugated with the specified additive with a degree of conjugation from about 3 mol.% To about 40 mol.%. 27. Способ по п. 21, отличающийся тем, что указанный компонент гиалуроновой кислоты химически конъюгирован с указанной добавкой при степени конъюгирования от приблизительно 3 мол.% до приблизительно 10 мол.%.27. The method according to p. 21, characterized in that the specified component of hyaluronic acid is chemically conjugated with the specified additive with a degree of conjugation from about 3 mol.% To about 10 mol.%. 28. Способ снижения внешних проявлений мелких морщин в областях кожи пациента, включающий: введение пациенту композиции кожного наполнителя на глубину не более приблизительно 1 мм, причем указанная композиция является, по существу, оптически прозрачной композицией кожного наполнителя на основе гиалуроновой кислоты, содержащей витамин C или производное витамина C.28. A method of reducing external manifestations of fine wrinkles in areas of the patient’s skin, comprising: administering to the patient a skin filler composition to a depth of not more than about 1 mm, said composition being an essentially optically transparent hyaluronic acid based skin filler composition containing vitamin C or vitamin C derivative 29. Способ по п. 28, отличающийся тем, что указанную композицию вводят на глубину не более приблизительно 0,8 мм.29. The method according to p. 28, characterized in that the composition is administered to a depth of not more than approximately 0.8 mm 30. Способ по п. 28, отличающийся тем, что указанную композицию вводят на глубину не более приблизительно 0,6 мм.30. The method according to p. 28, characterized in that the composition is administered to a depth of not more than approximately 0.6 mm 31. Способ по п. 28, отличающийся тем, что указанную композицию вводят на глубину не более приблизительно 0,4 мм.31. The method according to p. 28, characterized in that the composition is introduced to a depth of not more than approximately 0.4 mm 32. Композиция кожного наполнителя, содержащая:32. A dermal filler composition comprising: компонент гиалуроновой кислоты, сшитый сшивающим компонентом; иa hyaluronic acid component crosslinked with a crosslinking component; and витамин C или производное витамина C, ковалентно конъюгированное с компонентом гиалуроновой кислоты при степени конъюгирования по меньшей мере приблизительно 3 мол.%;vitamin C or a vitamin C derivative covalently conjugated to a component of hyaluronic acid with a degree of conjugation of at least about 3 mol%; причем указанная композиция является по существу оптически прозрачной и характеризуется значением G' от приблизительно 40 Па до приблизительно 100 Па.wherein said composition is substantially optically transparent and has a G ′ value of from about 40 Pa to about 100 Pa. 33. Композиция по п. 32, содержащая концентрацию гиалуроновой кислоты от приблизительно 18 мг/г до приблизительно 30 мг/г.33. The composition according to p. 32, containing a concentration of hyaluronic acid from about 18 mg / g to about 30 mg / g 34. Композиция по п. 32, содержащая концентрацию гиалуроновой кислоты от приблизительно 12 мг/г до приблизительно 30 мг/г.34. The composition according to p. 32, containing a concentration of hyaluronic acid from about 12 mg / g to about 30 mg / g 35. Композиция по п. 32, отличающаяся тем, что степень конъюгирования составляет приблизительно 10 мол.%.35. The composition according to p. 32, characterized in that the degree of conjugation is approximately 10 mol.%. 36. Композиция по п. 32, отличающаяся тем, что указанная гиалуроновая кислота по меньшей мере на 90% представляет собой ГК с низкой молекулярной массой.36. The composition of claim 32, wherein said hyaluronic acid is at least 90% low molecular weight HA. 37. Композиция по п. 32, отличающаяся тем, что указанный компонент гиалуроновой кислоты, по существу, полностью представляет собой ГК с низкой молекулярной массой.37. The composition according to p. 32, characterized in that the specified component of hyaluronic acid, essentially completely represents a HA with low molecular weight. 38. Инъецируемая композиция для снижения внешних проявлений мелких морщин на лице, содержащая:38. Injectable composition to reduce the external manifestations of small wrinkles on the face, containing: гиалуроновую кислоту (ГК) с низкой молекулярной массой, сшитую диглицидиловым эфиром 1,4-бутандиола (BDDE), причем ГК имеет среднюю молекулярную массу от приблизительно 300 кДа до приблизительно 900 кДа; иlow molecular weight hyaluronic acid (HA) crosslinked with 1,4-butanediol diglycidyl ether (BDDE), the HA having an average molecular weight of from about 300 kDa to about 900 kDa; and производное витамина C, ковалентно конъюгированное с гиалуроновой кислотой при степени конъюгирования приблизительно 10 мол.%;a vitamin C derivative covalently conjugated to hyaluronic acid with a conjugation degree of about 10 mol%; причем указанная композиция характеризуется значением G' от приблизительно 60 Па до приблизительно 80 Па.wherein said composition is characterized by a G ′ value of from about 60 Pa to about 80 Pa. 39. Композиция по п. 38, отличающаяся тем, что средняя молекулярная масса ГК составляет от приблизительно 300 кДа до приблизительно 500 кДа.39. The composition according to p. 38, characterized in that the average molecular weight of the HA is from about 300 kDa to about 500 kDa. 40. Композиция по п. 39, отличающаяся тем, что значение G' композиции составляет приблизительно 80 Па.40. The composition of claim 39, wherein the G ′ value of the composition is approximately 80 Pa. 41. Композиция по п. 38, являющаяся оптически прозрачной.41. The composition according to p. 38, which is optically transparent. 42. Композиция по п. 38, содержащая концентрацию ГК приблизительно 25 мг/г. 42. The composition according to p. 38, containing a concentration of HA of approximately 25 mg / g
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