WO2021201266A1 - 短時間溶解マイクロニードル - Google Patents
短時間溶解マイクロニードル Download PDFInfo
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- WO2021201266A1 WO2021201266A1 PCT/JP2021/014279 JP2021014279W WO2021201266A1 WO 2021201266 A1 WO2021201266 A1 WO 2021201266A1 JP 2021014279 W JP2021014279 W JP 2021014279W WO 2021201266 A1 WO2021201266 A1 WO 2021201266A1
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Definitions
- the present invention relates to the technical field of rapid skin administration of skin valuables.
- Lotions and creams are generally used for skin administration as cosmetics and quasi-drugs of skin valuables, and microneedle administration has also been recently reported.
- it is composed of a sugar that dissolves and disappears in a living body such as maltose, has a square or circular cross-sectional shape having a side or diameter of 0.1 to 100 ⁇ m, and a square column or columnar shape having a length of 0.5 to 500 ⁇ m.
- a functional micropile in which a pile is provided on a substrate
- a skin needle Patent Document 2 in which a plurality of needles containing biodegradable materials such as polylactic acid and maltose are provided around a central member.
- microneedles Regarding the administration of skin valuables by microneedles, administration for 1 hour to 1 night (about 8 hours) was common, and administration in a shorter time was an issue.
- the present inventors have developed a microneedle that can be dissolved within 30 minutes by containing a specific monosaccharide and / or disaccharide in an intradermally soluble microneedle based on a water-soluble polymer (patented). Document 3).
- An object to be solved by the present invention is the rapid skin administration of skin valuables by a microneedle array.
- the microneedle When used for cosmetic purposes, the microneedle is inserted into the epidermis including the stratum corneum of the skin and the needle tip dissolves rapidly, so that administration can be performed in a short time.
- the thickness of the stratum corneum of human skin is usually 10 to 20 ⁇ m.
- a specific object of the present invention is to provide a microneedle array in which 10 ⁇ m or more of the needle tip is dissolved within 15 minutes.
- the low molecular weight component of the water-soluble polymer has a molecular weight of 100,000 or less and 2000 or more, or the viscosity (20 ° C.) of the aqueous solution of the low molecular weight component of 5% by mass is 6 dPa ⁇ S or less.
- the microneedle array according to [2], wherein the low molecular weight component of the water-soluble polymer has a molecular weight of 10,000 or less and 2000 or more.
- the high molecular weight component is a water-soluble polymer having a molecular weight of more than 100,000 or a water-soluble or water-swelling solution having a viscosity (20 ° C.) of a 5% by mass aqueous solution exceeding 6 dPa ⁇ S. It is a sex polymer component, and the low molecular weight component of the water-soluble polymer has a molecular weight of 10,000 or less and 2000 or more, and the amount of the high molecular weight component added is 10 parts by mass or more with respect to 100 parts by mass of the microneedle array.
- the microneedle array according to [1].
- the microneedle array is characterized by containing 20 parts by mass or more of a low molecular weight component of the water-soluble polymer and 0.1 to 60 parts by mass of valuable skin resources with respect to 100 parts by mass of the microneedle array [1] to [5].
- the microneedle array according to any. [7] A support having a thickness of the substrate portion of the microneedle array of 60 ⁇ m or less and a hardness of 3 N or less in the flexibility test is provided on the back surface of the microneedle array [1] to [6].
- the microneedle array according to any one of.
- valuable skin resources can be administered to the skin in a short time, and the application of the microneedle patch for a long time is released.
- the microneedle array of the present invention contains low molecular weight components of a water-soluble polymer and skin valuables. This will be described in detail below.
- the composition means a microneedle array as a finished product. 100 parts by mass of the composition is equivalent to 100 parts by mass of the microneedle array. More specifically, a component having a molecular weight of 100,000 or less and 2000 or more, or a 5% by mass aqueous solution having a viscosity (20 ° C.) of 6 dPa ⁇ S or less is used in an amount of 20 parts by mass or more with respect to 100 parts by mass of the composition. It was brought about by making it the main component of the agent.
- a component having a molecular weight of more than 100,000 of a water-soluble polymer has sufficient mechanical strength, but the molecules are highly entangled, and it takes a long time to dissolve due to moisture in the skin. Further, a water-soluble component having a molecular weight of less than 2000 has good solubility but poor mechanical strength, which makes the microneedle array brittle, which is inconvenient in manufacturing, storage, or use.
- a low molecular weight water-soluble polymer having a molecular weight of 2000 or more and 100,000 or less has both advantageous properties in microneedle molding such as tenacity inherent in the polymer and properties of a low molecular weight water-soluble substance that dissolves in a short time. Is.
- microneedles that are soluble in a short time and have excellent mechanical strength have become possible.
- a lower molecular weight water-soluble polymer can be used as long as the mechanical strength of the microneedle is not impaired.
- a water-soluble polymer having a molecular weight of 50,000 or less and 2,000 or more or a molecular weight of 10,000 or less and 2,000 or more can sufficiently achieve the object of the present invention.
- Examples of the low molecular weight component of the water-soluble polymer or the component having a viscosity (20 ° C.) of a 5% by mass aqueous solution having a viscosity (20 ° C.) of 6 dPa ⁇ S or less include hydrolyzed natrim hyaluronate, natrim microhyaluronate (molecular weight 10,000 or less), and hyaluronic acid oligomer.
- sodium chondroitin sulfate (molecular weight 100,000 or less), hydroxypropyl cellulose (HPC, molecular weight 150,000 or less), proteoglycan (molecular weight 100,000 or less), gelatin (molecular weight 100,000 or less), polyvinylpyrrolidone (molecular weight 100,000 or less) , Hydrolyzed collagen, carboxymethyl cellulose (molecular weight 100,000 or less), polyethylene glycol (molecular weight 100,000 or less), polyvinyl alcohol (molecular weight 100,000 or less, saponification degree 90% or less 50% or more), dextran (molecular weight 100,000 or less), Dextrin (molecular weight 100,000 or less), polyacrylic acid polymer (molecular weight 100,000 or less), polyacrylamide (molecular weight 100,000 or less), polyethylene oxide (molecular weight 100,000 or less), fucoidan (molecular weight 200,000 or less) are applicable.
- a polyvinyl alcohol having a saponification degree of 90% or less and 50% or more is a polyvinyl alcohol having a low saponification degree. Further, the saponification degree is preferably 80% or less and 60% or more.
- the high molecular weight component of the water-soluble polymer or the component having a viscosity (20 ° C.) of a 5% by mass aqueous solution exceeding 6 dPa ⁇ S include sodium hyaluronate (molecular weight 200,000 or more), chondroitin sodium sulfate (molecular weight 200,000 or more). Carboxymethyl cellulose (molecular weight of 200,000 or more), hydroxypropyl cellulose (HPC, molecular weight of 200,000 or more), etc. are applicable.
- the viscosity (20 ° C.) of a high molecular weight (water-soluble polymer exceeding 100,000) or 5% by mass aqueous solution is water-soluble or water-swellable exceeding 6 dPa ⁇ S.
- a polymer component may be added. In that case, the amount added is preferably 30 parts by mass or less with respect to 100 parts by mass of the composition.
- the low molecular weight component of the water-soluble polymer is 10,000 or less and 2000 or more
- the viscosity (20 ° C.) of the high molecular weight (water-soluble polymer exceeding 100,000) or 5% by mass aqueous solution exceeds 6 dPa ⁇ S.
- Addition of sex or water swelling polymer components is essential. In that case, the addition amount is required to be 10 parts by mass to 30 parts by mass with respect to 100 parts by mass of the composition.
- Skin valuables are not particularly limited as long as they are valuables absorbed through the skin.
- pigmentation inhibitor moisturizer, metabolism activator, antioxidant, active oxygen scavenger / radical scavenger, fat metabolism promoter, anti-inflammatory agent, blood flow promoter, testosterone 5 ⁇ reductase activity inhibitor, hair
- examples include a papillary activator, a hair growth promoter, and the like.
- the content of valuable skin substances is preferably 0.1 part by mass to 60 parts by mass with respect to 100 parts by mass of the composition.
- Anti-pigmentation agent An anti-pigmentation agent can be added to the present invention.
- the pigmentation inhibitor include p-aminobenzoic acid derivative, sartylic acid derivative, benzenesulfonamide derivative, imidazole derivative, naphthalene derivative, hydroxyanthranic acid or a salt thereof, and their derivatives, anthranic acid derivative, coumarin derivative, and allantin.
- nicotinic acid derivatives ascorbic acid or salts thereof and derivatives thereof, tocopherols or salts thereof and derivatives thereof, tocotrienol or salts thereof and derivatives thereof, kodiic acid or derivatives thereof, oxybenzone, benzophenone, guaiazulene, ciconin, bicarin or Its salts and their derivatives, baikarain or its salts and their derivatives, velverin or its salts and their derivatives, apigenin or its salts and their derivatives, luteolin or its salts and their derivatives, kenferol or its salts and theirs.
- moisturizers can be added to the present invention.
- moisturizers include chitosan seeds, agar or derivatives thereof, casein, glucose, galactose, mannose, xylose, fructose, maltose, isomaltose, cellobiose, gentiobiose, trehalose, pyrarose, 1,3-butylene glycol, glycerin, propylene.
- Glycol polyethylene glycol, dipropylene glycol, 1,2-pentanediol, 1,5-pentanediol, 1,2-hexanediol, 1,6-hexanediol, mannitol and sorbitol, 1,2-propanediol, 1, 3-Propanediol, Polypropylene Glycol, 1,2-Butanediol, 1,3-Butanediol, 1,4-Butanediol, Pentylene Glycol, Hexylene Glycol, 1,3-Pentanediol, 1,4-Pentanediol , Erythritol, pentaerythritol, dipentaerythritol, xylitol, martitol, inositol, pantenol or derivatives thereof, dextrin, gelatin, pectin, starch, carrageenan, carboxymethyl
- Metabolism activator A metabolism activator can be added to the present invention.
- Specific examples of the metabolic activator include vitamin A group: retinol or a salt thereof and a derivative thereof, retinal or a salt thereof and a derivative thereof, dehydroretinal or a salt thereof and a derivative thereof, retinoic acid or a salt thereof and a derivative thereof.
- Vitamin C group ascorbic acid or salts thereof and their derivatives
- Vitamin D group ergocalciferol or its salt and its derivatives
- choleciferol and its salts and their derivatives Vitamin E group, etc .: tocopherol or a salt thereof and a derivative thereof, tocotrienol or a salt thereof and a derivative thereof, ubiquinone or a salt thereof and a derivative thereof, linoleic acid or a salt thereof and a derivative thereof, linolenic acid or a salt thereof and a salt thereof.
- Amino acids such as amino acid derivatives such as acids, ⁇ -hydroxy acids such as glycolic acid, citric acid, malic acid, tartaric acid, lactic acid, succinic acid, 2-hydroxycarboxylic acids, polyhydroxycarboxylic acids or hydroxypolycarboxylic acids, lactobionic acid , Photosensitizer No. 301, hinokithiol, pantothenic acid or a derivative thereof, allantin, trimethylglycine, proteoglycan, and the like.
- amino acid derivatives such as acids, ⁇ -hydroxy acids such as glycolic acid, citric acid, malic acid, tartaric acid, lactic acid, succinic acid, 2-hydroxycarboxylic acids, polyhydroxycarboxylic acids or hydroxypolycarboxylic acids, lactobionic acid , Photosensitizer No. 301, hinokithiol, pantothenic acid or a derivative thereof, allantin, trimethylglycine, proteoglycan, and the like.
- Antioxidants can be added to the present invention.
- Specific examples of antioxidants include ascorbic acid or a salt thereof and a derivative thereof, tocopherol or a salt thereof and a derivative thereof, tocotrienol or a salt thereof and a derivative thereof, butylhydroxytoluene (BHT), butylhydroxyanisole (BHA), and the like.
- BHT butylhydroxytoluene
- BHA butylhydroxyanisole
- Active oxygen scavenger / radical scavenger can be added to the present invention.
- active oxygen scavengers and radical scavengers include superoxide dismutase, catalase, glutathione peroxidase, bilirubin, quercetin, quercitrin, catechin, catechin derivatives, rutin or derivatives thereof, gallic acid or salts thereof, and derivatives thereof, curcumin.
- Lipid metabolism promoter An lipid metabolism promoter can be added to the present invention.
- Specific examples of fat metabolism promoters include xanthine derivatives (caffeine, theophylline, theobromine, xanthine, aminophylline, cholineteophylline, diprophylline, proxiphyllin, oxtriphyllin, etc.), cocculus orbicula extract, cocculus extract, and cocculus orbicula.
- Examples include (self-defense) extract, gajutsu ( ⁇ ) extract, Karakusakeman extract, kikyo (kikyo, kikyo root) extract, kizuta extract, pepper (kosho) extract, and the like.
- Anti-inflammatory agent can be added to the present invention.
- anti-inflammatory agents include quinolinone derivatives, dibenzooxepine derivatives, thiotroposine, phthalimide derivatives, flurubiprofen, fervinac, bufexamac, sprofene, 1,4-diphenylpropylpiperazin derivatives, carxin compounds, chromanol glycosides ( 2- ( ⁇ -D-glucopyranosyl) methyl-2,5,7,8-tetramethylchroman-6-ol), ictamol, indomethacin, kaolin, diphenhydramine hydrochloride, d-camfur, DL-camfur, salicylic acid, sodium salicylate, Methyl salicylate, acetylsalicylic acid, hydrocortisone, guaiazulene, camazulene, chlorpheniramine maleate, diphenhydramine hydrochloride, cremastine fumarate
- Derivatives glycylic acid or salts thereof and derivatives thereof, mephenumic acid, phenylbutazone, ibprofen, ketoprofen, allantin, calcium pantothenate, pantenols such as ethyl ether ether and salts thereof, and derivatives thereof, ⁇ -aminocaproic acid, Examples thereof include sodium diclofenac, salicylic acid or a derivative thereof, sulfatide, chlorpheniramine maleate, diphenhydramine hydrochloride, and the like.
- Blood flow promoter A blood flow promoter can be added to the present invention.
- blood flow enhancers include tocopherol or a salt thereof and a derivative thereof, tocotrienol or a salt thereof and a derivative thereof, cepharanthin, carpronium chloride, eugenol derivative, minoxidil, tincture tincture, vanylamide nonylate, cantalis tincture, ginger.
- Tincture L-menthol, camphor, benzyl nicotinate, ictamol, ⁇ -borneol, valenylamide nonylate, capsaicin, senburi extract, garlic extract, carrot extract, gentian extract, touki extract, ginger extract, semburi (this drug) Extracts, etc. can be mentioned.
- Testosterone 5 ⁇ -reductase activity inhibitor / hair papilla activator / hair growth promoter can be added.
- Specific examples of testosterone 5 ⁇ reductase activity inhibitor, hair papilla activator, and hair growth promoter include ⁇ -amino- ⁇ -hydroxybutyric acid esters, amine oxides, alkyl betaines, pyrimidine-N-oxide derivatives, and acetylcarnitine.
- a salt thereof, geranylgeranyl acetone, a hydroxamic acid derivative or a salt thereof, proanthocyanidins, and the like can be mentioned.
- ingredients usually used for external preparations for skin such as cosmetics and pharmaceuticals may be added. It consists of one or more components consisting of aqueous components, oily components, plant extracts, animal extracts, powders, surfactants, oils, alcohols, pH regulators, preservatives, thickeners, pigments, fragrances, etc. It is a part of the base and may also act as a valuable resource due to its effect on the skin.
- the microneedle array of the present invention is a forest of conide-shaped, pyramid-shaped, or needle-shaped microneedles having a height of 100 to 350 ⁇ m on a substrate having a thickness of 10 to 200 ⁇ m.
- the skin valuables of the microneedles are dissolved or dispersed in the base.
- the method for producing the microneedle array of the present invention is not particularly limited, and it may be produced by any conventionally known method. Examples thereof include a method in which a raw material solution in which an aqueous solution or suspension composed of an agent is added with other components as necessary is cast, dried, and then peeled off. After peeling, it is cut into a patch shape and lined with an adhesive support for use.
- the size of the patch (microneedle patch) consisting of the microneedle array is 1 to 100 square cm. If it is less than 1 square cm, the effect is limited and the effectiveness is difficult to be exhibited. If it exceeds 100 square cm, there is a tendency for problems in adhesion to cover the body surface.
- a plurality of microneedle patches of 100 square cm or less may be used to cover a wide body surface.
- the adhesive support is a support film having an adhesive layer on one side.
- an adhesive sheet made of a commercially available adhesive can be used.
- a rubber-based pressure-sensitive adhesive, a silicone-based pressure-sensitive adhesive, or the like can be used, but an acrylic-based pressure-sensitive adhesive is preferable in consideration of adhesion to the skin and adhesion to the support film.
- it is a copolymer of an acrylic acid alkyl ester and a copolymer of acrylic acid, acrylamide, vinyl acetate, etc. mainly containing an acrylic acid alkyl ester.
- a plasticizer such as isopropyl myristate or isopropyl palmitate may be added to these adhesives to improve skin adhesion.
- the thickness of the adhesive layer is preferably 10 ⁇ m or more and 300 ⁇ m or less.
- HiPAS adhesive acrylic ester, manufactured by Cosmed Pharmaceutical Co., Ltd.
- MASCOS10 adhesive acrylic ester, manufactured by Cosmed Pharmaceutical Co., Ltd.
- an acrylic resin having a hardness of 3 or less is preferable as the acrylic pressure-sensitive adhesive in the present invention.
- Vinizol 1087FT (Acrylate Copolymer Ammonium, manufactured by Daido Kasei Kogyo Co., Ltd.)
- Yodosol GH800 F Ammonium Alkyl Acrylate Copolymer, manufactured by Akzo Nobel Co., Ltd.
- the like can be preferably used.
- the support film a film made of a synthetic polymer is preferable, and it is necessary that it has excellent adhesiveness to an acrylic pressure-sensitive adhesive, can maintain strength, and can be easily molded into a thin film.
- it is selected from polyethylene, PET (polyethylene terephthalate), polyvinylpyrrolidone, polyvinyl alcohol, and an acrylic resin.
- the hardness of the acrylic resin is preferably 3N or more.
- the hardness value is more preferably 4 or more and 50 or less. If the hardness is less than 3, the support film may become sticky, which is inconvenient to use.
- Nonwoven fabrics, knitted fabrics and the like can also be preferred supports.
- FIG. 1 is a cross-sectional view showing an example of a method for manufacturing a microneedle array of the present invention.
- 1 is a concave portion for forming a conide type microneedle in which a conide type microneedle pattern is transferred by electroforming after forming a conide type microneedle pattern by a lithography method of irradiating a photosensitive resin with light.
- 11 is the formed mold.
- Reference numeral 2 denotes a microneedle raw material liquid that has flowed into the microneedle forming recess 11.
- the microneedle forming recesses 11 are conide-shaped with a root diameter of 0.6 mm, a tip diameter of 0.02 mm, and a depth of 0.15 mm, and are arranged in a grid pattern at 0.8 mm intervals.
- 100 parts by mass of water contains 75 parts by mass of hydroxypropyl cellulose (manufactured by Nippon Soda, trade name NISSO HPC SSL), hyaluronic acid (manufactured by Kikkoman Biochemifa, trade name "FCH-SU", molecular weight 100,000, 5% by mass aqueous solution).
- the viscosity indicated by is 4.3 dPa ⁇ S (20 ° C.)) 20 parts by mass and 5 parts by mass of 3-o-ethylascorbic acid (Nippon Seika Co., Ltd.) dissolved in an aqueous solution (microneedle raw material solution) as a template. After casting on No. 1 and heating to evaporate the water content of the aqueous solution layer, it was peeled off from the mold 1 and punched into an elliptical shape (10 x 50 mm, minor axis x major axis).
- Example 2-12 An aqueous solution (microneedle raw material solution) having the composition shown in Table 1 was prepared, and a microneedle array was prepared according to the production method of Example 1.
- Comparative Example 1-3 An aqueous solution (microneedle raw material solution) having the composition shown in Table 1 was prepared, and a microneedle array was prepared according to the production method of Example 1.
- the present invention is performed by setting an elliptical microneedle array (10 x 50 mm, minor axis x major axis) in the center of a rectangular (16 x 60 mm) adhesive tape with a support with rounded corners. Obtained a microneedle array with protective adhesive tape.
- microneedle arrays of the examples 10 micrometers or more from the tip was dissolved within 15 minutes. Since the microneedle array of the comparative example did not contain the low molecular weight component of the water-soluble polymer, the solubility of the tip portion was lower than that of the example product.
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Abstract
Description
本発明は、以下に示す通りである。
〔1〕 水溶性ポリマーの低分子量成分と皮膚有価物とを必須構成成分とすることを特徴とするマイクロニードルアレイ。
〔2〕 水溶性ポリマーの低分子量成分が分子量10万以下2000以上であるか、又は5質量%の該低分子量成分の水溶液の粘度(20℃)が6dPa・S以下であることを特徴とする〔1〕に記載のマイクロニードルアレイ。
〔3〕 水溶性ポリマーの低分子量成分が分子量5万以下2000以上であることを特徴とする〔2〕に記載のマイクロニードルアレイ。
〔4〕 水溶性ポリマーの低分子量成分が分子量1万以下2000以上であることを特徴とする〔2〕に記載のマイクロニードルアレイ。
〔5〕 さらに水溶性ポリマーの高分子量成分を含み、該高分子量成分は分子量10万を超える水溶性ポリマー又は5質量%の水溶液の粘度(20℃)が6dPa・Sを超える水溶性又は水膨潤性高分子成分であり、水溶性ポリマーの低分子量成分が分子量1万以下2000以上であり、該高分子量成分の添加量がマイクロニードルアレイ100質量部に対し10質量部以上であることを特徴とする〔1〕に記載のマイクロニードルアレイ。
〔6〕 マイクロニードルアレイ100質量部に対し、水溶性ポリマーの低分子量成分を20質量部以上、皮膚有価物を0.1~60質量部含むことを特徴とする〔1〕~〔5〕のいずれかに記載のマイクロニードルアレイ。
〔7〕 マイクロニードルアレイの基板部の厚みが60μm以下であり、柔軟性試験において硬さが3N以下である支持体をマイクロニードルアレイの背面に有することを特徴とする〔1〕~〔6〕のいずれかに記載のマイクロニードルアレイ。
〔8〕 皮膚投与後15分以内に針部の先端部から10μm以上が溶解することを特徴とする〔1〕~〔7〕のいずれか記載のマイクロニードルアレイ。
〔9〕 マイクロニードルアレイの背面が粘着層上に固定されていることを特徴とする〔1〕~〔8〕のいずれかに記載のマイクロニードルアレイ。
〔10〕 水溶性高分子の低分子量成分が、低ケン化度ポリビニルアルコールであることを特徴とする〔1〕~〔9〕のいずれかに記載のマイクロニードルアレイ。
〔11〕 水溶性高分子の低分子量成分が、ヒドロキシプロピルセルロースであることを特徴とする〔1〕~〔9〕のいずれかに記載のマイクロニードルアレイ。
〔12〕 水溶性高分子の低分子量成分が、ヒアルロン酸であることを特徴とする〔1〕~〔9〕のいずれかに記載のマイクロニードルアレイ。
本発明による組成物および方法に有用な具体的方策は、低分子量水溶性ポリマーを主基剤とする。ここで、組成物とは完成品としてのマイクロニードルアレイを意味する。組成物100質量部は、マイクロニードルアレイ100質量部と等価である。さらに詳細には、分子量10万以下2000以上、あるいは5質量%の水溶液の粘度(20℃)が6dPa・S以下である成分を、組成物100質量部に対して20質量部以上用いて、基剤の主成分とすることによりもたらされた。水溶性ポリマーの分子量10万を超える成分は、力学的強度は十分であるが分子の絡み合いが大きく、皮膚中水分により溶解するのに長時間を要する。また、分子量2000未満の水溶性成分は、溶解性がよいが力学的強度に乏しくマイクロニードルアレイがもろくなり、製造上、保管上、あるいは使用上において不便である。分子量2000以上10万以下の低分子量水溶性ポリマーは、高分子本来が有する粘り強さなどのマイクロニードル成型のおける有利な性質と短時間で溶解するという低分子水溶性物質の性質とを兼ね備えたものである。このような低分子量水溶性ポリマーを基剤の主成分とすることにより、短時間溶解性の力学的強度に優れたマイクロニードルが可能となった。分子量の上限に関してはマイクロニードルの力学的強度を損なわない範囲でより低分子量水溶性ポリマーを使用できる。分子量5万以下2000以上あるいは分子量1万以下2000以上の水溶性ポリマーも、十分に本発明の目的を達成できる。
水溶性ポリマーの低分子量成分又は5質量%の水溶液の粘度(20℃)が6dPa・S以下である成分としては、加水分解ヒアルロン酸ナトリム、マイクロヒアルロン酸ナトリム(分子量1万以下)、ヒアルロン酸オリゴマー及びその誘導体、コンドロイチン硫酸ナトリウム(分子量10万以下)、ヒドロキシプロピルセルロース(HPC、分子量15万以下)、プロテオグリカン(分子量10万以下)、ゼラチン(分子量10万以下)、ポリビニルピロリドン(分子量10万以下)、加水分解コラーゲン、カルボキシメチルセルロース(分子量10万以下)、ポリエチレングリコール(分子量10万以下)、ポリビニルアルコール(分子量10万以下、ケン化度90%以下50%以上)、デキストラン(分子量10万以下)、デキストリン(分子量10万以下)、ポリアクリル酸系ポリマー(分子量10万以下)、ポリアクリルアミド(分子量10万以下)、ポリエチレンオキシド(分子量10万以下)、フコイダン(分子量20万以下)、が該当する。ケン化度90%以下50%以上のポリビニルアルコールは、低ケン化度ポリビニルアルコールである。さらに、ケン化度が80%以下60%以上が好ましい。
水溶性ポリマーの高分子量成分又は5質量%の水溶液の粘度(20℃)が6dPa・Sを超える成分としては、ヒアルロン酸ナトリウム、(分子量20万以上)、コンドロイチン硫酸ナトリウム(分子量20万以上)、カルボキシメチルセルロース(分子量20万以上)ヒドロキシプロピルセルロース(HPC、分子量20万以上)、等が該当する。
皮膚有価物としては、皮膚から吸収される有価物であれば特に限定されるものではない。例えば、色素沈着抑制剤、保湿剤、代謝活性化剤、抗酸化剤、活性酸素消去剤・ラジカル消去剤、脂肪代謝促進剤、抗炎症剤、血流促進剤、テストステロン5αレダクターゼ活性阻害剤、毛乳頭活性化剤、発毛促進剤、等が挙げられる。
組成物100質量部に対して、皮膚有価物の含有量は0.1質量部~60質量部であることが好ましい。
本発明には色素沈着抑制剤を添加することができる。色素沈着抑制剤の具体例として、p-アミノ安息香酸誘導体、サルチル酸誘導体、ベンゼンスルホンアミド誘導体、イミダゾール誘導体、ナフタレン誘導体、ヒドロキシアントラニル酸又はその塩並びにそれらの誘導体、アントラニル酸誘導体、クマリン誘導体、アラントイン誘導体、ニコチン酸誘導体、アスコルビン酸又はその塩並びにそれらの誘導体、トコフェロール又はその塩並びにそれらの誘導体、トコトリエノール又はその塩並びにそれらの誘導体、コウジ酸又はその誘導体、オキシベンゾン、ベンゾフェノン、グアイアズレン、シコニン、バイカリン又はその塩並びにそれらの誘導体、バイカレイン又はその塩並びにそれらの誘導体、ベルベリン又はその塩並びにそれらの誘導体、アピゲニン又はその塩並びにそれらの誘導体、ルテオリン又はその塩並びにそれらの誘導体、ケンフェロール又はその塩並びにそれらの誘導体、クエルセチン又はその塩並びにそれらの誘導体、クエルシトリン又はその塩並びにそれらの誘導体、イソクエルシトリン又はその塩並びにそれらの誘導体、ルチン又はその塩並びにそれらの誘導体、ミリセチン又はその塩並びにそれらの誘導体、ナリンゲニン又はその塩並びにそれらの誘導体、ヘスペリジン又はその塩並びにそれらの誘導体、グルタチオン又はその塩並びにそれらの誘導体、エラグ酸又はその塩並びにそれらの誘導体、等が挙げられる。
本発明には保湿剤を添加することができる。保湿剤の具体例として、クインスシード、寒天またはその誘導体、カゼイン、グルコース、ガラクトース、マンノース、キシロース、フルクトース、マルトース、イソマルトース、セロビオース、ゲンチオビオース、トレハロース、ピラロース、1,3-ブチレングリコール、グリセリン、プロピレングリコール、ポリエチレングリコール、ジプロピレングリコール、1,2-ペンタンジオール、1,5-ペンタンジオール、1,2-ヘキサンジオール、1,6-ヘキサンジオール、マンニトール及びソルビトール、1,2-プロパンジオール、1,3-プロパンジオール、ポリプロピレングリコール、1,2-ブタンジオール、1,3-ブタンジオール、1,4-ブタンジオール、ペンチレングリコール、ヘキシレングリコール、1,3-ペンタンジオール、1,4-ペンタンジオール、エリスリトール、ペンタエリスリトール、ジペンタエリスリトール、キシリトール、マルチトール、イノシトール、パンテノール又はその誘導体、デキストリン、ゼラチン、ペクチン、デンプン、カラギーナン、カルボキシメチルキチン又はキトサン、キトサン塩、硫酸化キチン又はキトサン、リン酸化キチン又はキトサン、アルギン酸又はその塩、ヒアルロン酸又はその塩、コンドロイチン硫酸又はその塩、β-1,3-グルカン、β-1,4-グルカン、β-1,6-グルカン、グルコサミン、ヘパリン、エチルセルロース、メチルセルロース、カルボキシメチルセルロース、カルボキシエチルセルロース、カルボキシエチルセルロースナトリウム、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ニトロセルロース、結晶セルロース、ヒドロキシプロピルメチルセルロース、ポリビニルアルコール、ポリビニルメチルエーテル、ポリビニルピロリドン、ポリアクリル酸塩、カルボキシビニルポリマー、デルマタン硫酸、ケラタン硫酸等の水溶性高分子類、ピロリドンカルボン酸又はその塩、ポリグルタミン酸又はその塩、天然保湿因子に含有されるピロリドンカルボン酸、尿素、ウロカニン酸、ベタイン、乳酸ナトリウム、アスパラギン酸、グルタミン酸、イソロイシン、ヒスチジン、フェニルアラニン、トレオニン、セリン、バリン、プロリン、グリシン、アラニン、リシン、アルギニン、セラミド1、セラミド2、セラミド3、セラミド4、セラミド5、セラミド6II、セラミド9などのセラミド類、等が挙げられる。
本発明には代謝活性化剤を添加することができる。代謝活性化剤の具体例として、ビタミンA群:レチノール又はその塩並びにそれらの誘導体、レチナール又はその塩並びにそれらの誘導体、デヒドロレチナール又はその塩並びにそれらの誘導体、レチノイン酸又はその塩並びにそれらの誘導体、カロチン又はその塩並びにそれらの誘導体、リコピン又はその塩並びにそれらの誘導体、
ビタミンB群:チアミン又はその塩並びにそれらの誘導体、リボフラビン又はその塩並びにそれらの誘導体、ピリドキシン又はその塩並びにそれらの誘導体、ピリドキサール又はその塩並びにそれらの誘導体、シアノコバラミン又はその塩並びにそれらの誘導体、葉酸又はその塩並びにそれらの誘導体、ニコチン酸又はその塩並びにそれらの誘導体、パントテン酸又はその塩並びにそれらの誘導体、ビオチン又はその塩並びにそれらの誘導体、コリン又はその塩並びにそれらの誘導体、イノシトール又はその塩並びにそれらの誘導体、
ビタミンC群:アスコルビン酸又はその塩並びにそれらの誘導体、
ビタミンD群:エルゴカルシフェロール又はその塩並びにそれらの誘導体、コレカルシフェロール及びその塩並びにそれらの誘導体、
ビタミンE群等:トコフェロール又はその塩並びにそれらの誘導体、トコトリエノール又はその塩並びにそれらの誘導体、ユビキノン又はその塩並びにそれらの誘導体、リノール酸又はその塩並びにそれらの誘導体、リノレン酸又はその塩並びにそれらの誘導体、アラキドン酸又はその塩並びにそれらの誘導体等、カルニチン又はその塩並びにそれらの誘導体、フェルラ酸又はその塩並びにそれらの誘導体、γ-オリザノール又はその塩並びにそれらの誘導体、
ビタミンP群:ルチン又はその塩並びにそれらの誘導体、ヘスペリジン又はその塩並びにそれらの誘導体、アミノ酸類その他:バリン、ロイシン、イソロイシン、トレオニン、メチオニン、フェニルアラニン、トリプトファン、リジン、グリシン、アラニン、アスパラギン、グルタミン、セリン、システイン、シスチン、チロシン、プロリン、ヒドロキシプロリン、アスパラギン酸、グルタミン酸、ヒドロキシリジン、アルギニン、オルニチン、ヒスチジン又はその誘導体等や、それらの硫酸塩、リン酸塩、硝酸塩、クエン酸塩、あるいはピロリドンカルボン酸等のアミノ酸誘導体等のアミノ酸類、グリコール酸、クエン酸、リンゴ酸、酒石酸、乳酸、コハク酸等のα-ヒドロキシ酸類、2-ヒドロキシカルボン酸類、ポリヒドロキシカルボン酸又はヒドロキシポリカルボン酸類、ラクトビオン酸、感光素301号、ヒノキチオール、パントテン酸又はその誘導体、アラントイン、トリメチルグリシン、プロテオグリカン、等が挙げられる。
本発明には抗酸化剤を添加することができる。抗酸化剤の具体例として、アスコルビン酸又はその塩並びにそれらの誘導体、トコフェロール又はその塩並びにそれらの誘導体、トコトリエノール又はその塩並びにそれらの誘導体、ブチルヒドロキシトルエン(BHT)、ブチルヒドロキシアニソール(BHA)、コエンザイムQn(n=7~10)、ピロロキノリンキノン、没食子酸プロピル、セサモール、カロテノイド類等が挙げられる。
本発明には活性酸素消去剤・ラジカル消去剤を添加することができる。活性酸素消去剤・ラジカル消去剤の具体例として、スーパーオキシドディスムターゼ、カタラーゼ、グルタチオンペルオキシダーゼ、ビリルビン、クエルセチン、クエルシトリン、カテキン、カテキン誘導体、ルチン又はその誘導体、没食子酸又はその塩並びにそれらの誘導体、クルクミン又はその塩並びにそれらの誘導体、トランスフェリン、セルロプラスミン、コエンザイムQn(n=7~10)、尿酸、ビリルビン、メタロチオネイン、等が挙げられる。
本発明には脂肪代謝促進剤を添加することができる。脂肪代謝促進剤の具体例として、キサンチン誘導体(カフェイン、テオフィリン、テオブロミン、キサンチン、アミノフィリン、コリンテオフィリン、ジプロフィリン、プロキシフィリン及びオクストリフィリン等)、アオツヅラフジ(木防巳)エキス、アザミエキス、オオツヅラフジ(防己)エキス、ガジュツ(莪朮)エキス、カラクサケマンエキス、キキョウ(桔梗、桔梗根)エキス、キヅタエキス、コショウ(胡椒)エキス、等が挙げられる。
本発明には抗炎症剤を添加することができる。抗炎症剤の具体例として、キノリノン誘導体、ジベンゾオキセピン誘導体、チオトロポシン、フタルイミド誘導体、フルルビプロフェン、フェルビナク、ブフェキサマク、スプロフェン、1,4-ジフェニルプロピルピペラジン誘導体、カルキシン化合物、クロマノール配糖体(2-(α-D-グルコピラノシル)メチル-2,5,7,8-テトラメチルクロマン-6-オール)、イクタモール、インドメタシン、カオリン、塩酸ジフェンヒドラミン、d-カンフル、DL-カンフル、サリチル酸、サリチル酸ナトリウム、サリチル酸メチル、アセチルサリチル酸、ヒドロコルチゾン、グアイアズレン、カマズレン、マレイン酸クロルフェニラミン、塩酸ジフェンヒドラミン、フマル酸クレマスチン、塩酸シプロヘプタジン、塩酸プロメタジン、ピペラジン誘導体、α-D-フェニルグリコシド誘導体、グリチルリチン酸又はその塩並びにそれらの誘導体、グリチルレチン酸又はその塩並びにそれらの誘導体、メフェナム酸、フェニルブタゾン、イブプロフェン、ケトプロフェン、アラントイン、パントテン酸カルシウム、パントテニルエチルエーテル等のパンテノール又はその塩並びにそれらの誘導体、ε-アミノカプロン酸、ジクロフェナクナトリウム、トラネキサム酸又はその誘導体、スルファチド、マレイン酸クロルフェニラミン、塩酸ジフェンヒドラミン、等が挙げられる。
本発明には血流促進剤を添加することができる。血流促進剤の具体例として、トコフェロール又はその塩並びにそれらの誘導体、トコトリエノール又はその塩並びにそれらの誘導体、セファランチン、塩化カルプロニウム、オイゲノール誘導体、ミノキシジル、トウガラシチンキ、ノニル酸バニルアミド、カンタリスチンキ、ショウキョウチンキ、L-メントール、カンフル、ニコチン酸ベンジル、イクタモール、α-ボルネオール、ノニル酸ワレニルアミド、カプサイシン、センブリエキス、ニンニクエキス、ニンジンエキス、ゲンチアナエキス、トウキエキス、ショウガ(生姜)エキス、センブリ(当薬)エキス、等が挙げられる。
本発明にはテストステロン5αレダクターゼ活性阻害剤・毛乳頭活性化剤・発毛促進剤を添加することができる。テストステロン5αレダクターゼ活性阻害剤・毛乳頭活性化剤・発毛促進剤の具体例として、γ-アミノ-β-ヒドロキシ酪酸エステル類、アミンオキシド類、アルキルベタイン類、ピリミジン-N-オキシド誘導体、アセチルカルニチン又はその塩、ゲラニルゲラニルアセトン、ヒドロキサム酸誘導体またはその塩、プロアントシアニジン類、等が挙げられる。
本発明のマイクロニードルアレイは厚さ10~200μmの基板上に高さ100~350μmのコニーデ状、ピラミッド状、あるいは針状のマイクロニードルが林立したものである。マイクロニードルの皮膚有価物は、基剤中に溶解もしくは分散している。
「硬さ測定法」
数種のアクリル系樹脂から厚さ3mmのシートを作製し、小型卓上試験機EZ Test EZSX(島津製作所製)を用いて直径1.5mmのステンレス円柱をシート上面から圧縮する(圧縮速度0.5mm/min)。得られた圧縮応力~圧縮深さ曲線において安定した圧縮応力が得られる圧縮深さが0.1から0.2mmに至る0.1mmの深さ圧縮における圧縮応力(単位N)を得る。本方法によって得られる値をもって本発明における「硬さ」と定義する。
マイクロニードルアレイの作製
図1は本発明のマイクロニードルアレイの製造方法の一例を示す断面図である。図中、1は、感光性樹脂に光照射するリソグラフィ法によりコニーデ型のマイクロニードルパターンを形成した後、電鋳加工することによりコニーデ型のマイクロニードルパターンを転写したコニーデ型のマイクロニードル形成用凹部11が形成された鋳型である。2は、マイクロニードル形成用凹部11に流延したマイクロニードル原料液である。
マイクロニードル形成用凹部11は根元の直径が0.6mm、先端直径が0.02mm、深さ0.15mmのコニーデ型であり、0.8mm間隔に格子状に配列されている。
室温で水100質量部にヒドロキシプロピルセルロース(日本曹達製、商品名NISSO HPC SSL)75質量部、ヒアルロン酸(キッコーマンバイオケミファ製、商品名「FCH-SU」、分子量100,000、5質量%水溶液で示す粘度は4.3dPa・S(20℃)である)20質量部及び3-o-エチルアスコルビン酸(日本精化(株))5質量部を溶解した水溶液(マイクロニードル原料液)を鋳型1上に流延し、加熱して水溶液層の水分を蒸発させた後、鋳型1から剥離して楕円形(10x50mm、短径x長径)に打ち抜いた。
表1に記載の組成の水溶液(マイクロニードル原料液)を調製し、実施例1の製造方法に従って、マイクロニードルアレイを作製した。
表1に記載の組成の水溶液(マイクロニードル原料液)を調製し、実施例1の製造方法に従って、マイクロニードルアレイを作製した。
楕円形のマイクロニードルアレイ(10x50mm、短径x長径)を、角を丸めた長方形(16x60mm)の支持体付き粘着テープの中央部にセットすることにより、本発明の保護粘着テープ付きマイクロニードルアレイを得た。
2 マイクロニードル原料液
11 マイクロニードル形成用凹部
Claims (12)
- 水溶性ポリマーの低分子量成分と皮膚有価物とを必須構成成分とすることを特徴とするマイクロニードルアレイ。
- 水溶性ポリマーの低分子量成分が分子量10万以下2000以上であるか、又は5質量%の該低分子量成分の水溶液の粘度(20℃)が6dPa・S以下であることを特徴とする請求項1に記載のマイクロニードルアレイ。
- 水溶性ポリマーの低分子量成分が分子量5万以下2000以上であることを特徴とする請求項2に記載のマイクロニードルアレイ。
- 水溶性ポリマーの低分子量成分が分子量1万以下2000以上であることを特徴とする請求項2に記載のマイクロニードルアレイ。
- さらに水溶性ポリマーの高分子量成分を含み、該高分子量成分は分子量10万を超える水溶性ポリマー又は5質量%の水溶液の粘度(20℃)が6dPa・Sを超える水溶性又は水膨潤性高分子成分であり、水溶性ポリマーの低分子量成分が分子量1万以下2000以上であり、該高分子量成分の添加量がマイクロニードルアレイ100質量部に対し10質量部以上であることを特徴とする請求項1に記載のマイクロニードルアレイ。
- マイクロニードルアレイ100質量部に対し、水溶性ポリマーの低分子量成分を20質量部以上、皮膚有価物を0.1~60質量部含むことを特徴とする請求項1~5のいずれか1項に記載のマイクロニードルアレイ。
- マイクロニードルアレイの基板部の厚みが60μm以下であり、柔軟性試験において硬さが3N以下である支持体をマイクロニードルアレイの背面に有することを特徴とする請求項1~6のいずれか1項に記載のマイクロニードルアレイ。
- 皮膚投与後15分以内に針部の先端部から10μm以上が溶解することを特徴とする請求項1~7のいずれか1項に記載のマイクロニードルアレイ。
- マイクロニードルアレイの背面が粘着層上に固定されていることを特徴とする請求項1~8のいずれか1項に記載のマイクロニードルアレイ。
- 水溶性高分子の低分子量成分が、低ケン化度ポリビニルアルコールであることを特徴とする請求項1~9のいずれか1項に記載のマイクロニードルアレイ。
- 水溶性高分子の低分子量成分が、ヒドロキシプロピルセルロースであることを特徴とする請求項1~9のいずれか1項に記載のマイクロニードルアレイ。
- 水溶性高分子の低分子量成分が、ヒアルロン酸であることを特徴とする請求項1~9のいずれか1項に記載のマイクロニードルアレイ。
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- 2021-04-02 AU AU2021249948A patent/AU2021249948B2/en active Active
- 2021-04-02 KR KR1020217037374A patent/KR20220002969A/ko unknown
- 2021-04-02 CA CA3142201A patent/CA3142201A1/en active Pending
- 2021-04-02 EP EP21780968.0A patent/EP4129392A4/en active Pending
- 2021-04-02 US US17/613,741 patent/US20220233833A1/en active Pending
- 2021-04-02 CN CN202180003012.8A patent/CN113766913A/zh active Pending
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Also Published As
Publication number | Publication date |
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US20220233833A1 (en) | 2022-07-28 |
JP2021164635A (ja) | 2021-10-14 |
KR20220002969A (ko) | 2022-01-07 |
CN113766913A (zh) | 2021-12-07 |
CA3142201A1 (en) | 2021-10-07 |
AU2021249948A1 (en) | 2021-12-09 |
AU2021249948B2 (en) | 2023-07-20 |
EP4129392A1 (en) | 2023-02-08 |
EP4129392A4 (en) | 2024-04-24 |
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