Pasty composition for skin application

Abstract

To provide a pasty composition for skin application having superior adhesive force with reduced skin irritation.SOLUTION: A pasty composition for skin application comprises the following components (a), (b), (c), and (d), wherein the mass ratio (b):(c):(d) of the components (b), (c), and (d) is 1:(1.4-3):(0.8-1.6): (a) pharmacologically active ingredient: 0.01-20 mass%, (b) SIS: 15-25 mass%, (c) liquid paraffin: 22-60 mass%, (d) tackifier: 5-38 mass%.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a skin patch composition and a tape preparation. [Background technology]

[0002] A patch is a skin patch applied between a support and a release liner. The patch, primarily composed of a lipophilic polymer, has strong adhesive properties to the skin. This allows for the administration of medicinal ingredients by applying the patch once or twice a day or once every few days. It is also resistant to peeling and suitable for application to mobile areas, making it widely used. However, while strong adhesive properties enhance the penetration and absorption of medicinal ingredients and reduce the risk of peeling, they can also cause skin irritation, such as rashes. Furthermore, strong adhesive properties tend to exfoliate keratin cells upon removal, potentially increasing skin irritation. Furthermore, since patches are often used over long periods of time, repeated exfoliation can lead to discontinuation of treatment with the patch. Therefore, a need exists for a patch that uses a skin patch with excellent adhesive properties and minimal skin irritation.

[0003] Various methods have been proposed to reduce skin irritation, including a tape preparation with low skin irritation that uses a support with a large pore volume (Patent Document 1), a preparation with adjusted moisture evaporation (Patent Document 2), a method in which isostearic acid and a fatty acid having 10 to 18 carbon atoms that is liquid at room temperature are blended into an adhesive base (Patent Document 3), a method in which a sucrose fatty acid ester is included in an adhesive base (Patent Document 4), and a patch that reduces the adhesive strength of the paste to reduce damage to the stratum corneum when removed (Non-Patent Document 1). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 06-142178 [Patent Document 2] Japanese Patent Application Publication No. 06-271461 [Patent Document 3] Japanese Patent Application Publication No. 11-35458 [Patent Document 4] Japanese Patent Application Laid-Open No. 2005-097132 [Non-patent literature]

[0005] [Non-Patent Document 1] Kobayashi, I. et al. (1992), Effects of TY-0161P on rabbit skin, Basic and Clinical Studies 26, 5277-5299 Summary of the Invention [Problem to be solved by the invention]

[0006] However, these methods have not been completely satisfactory in their effectiveness. Furthermore, problems have arisen, such as a decrease in adhesiveness, which can cause the tape to peel off, or a decrease in adhesion to the skin, which can prevent the medicinal ingredients from fully exerting their effects. Therefore, while skin irritation has been addressed by changing the application site for medicinal ingredients that act systemically, the use of tape preparations has sometimes been abandoned for medicinal ingredients that act locally. Therefore, there has been a need for the development of a skin patch that has excellent adhesive strength, minimal skin irritation, and is safe, stable, and has excellent transdermal absorption.

[0007] Therefore, an object of the present invention is to provide a skin patch composition that has excellent adhesive strength and little skin irritation, and further to provide a tape preparation using the skin patch composition. [Means for solving the problem]

[0008] As a result of intensive research, the present inventors have discovered that a skin patch composition containing a specific ratio of a medicinal ingredient, styrene-isoprene-styrene block copolymer (hereinafter abbreviated as SIS), liquid paraffin, and a tackifier not only achieves extremely high adhesion to the skin, but also has excellent adhesive strength, extremely little stratum corneum peeling, and little skin irritation. Having confirmed that a tape using this skin patch composition is excellent in safety, efficacy, and stability, the present invention has been completed.

[0009] That is, the present invention provides the following inventions [1] to [8]. [1] A plaster composition for application to the skin, comprising the following components (a), (b), (c), and (d), wherein the mass ratio of the components (b):(c):(d) is 1:(1.4-3):(0.8-1.6): (a) 0.01 to 20% by mass of a medicinal ingredient; (b) SIS 15~25% by mass, (c) liquid paraffin 22 to 60 mass %; (d) Tackifier: 5 to 38% by mass [2] The adhesive composition for application to the skin according to [1], wherein the medicinal ingredient is a medicinal ingredient that acts locally or systemically. [3] The adhesive composition for skin application according to [1] or [2], wherein the styrene / isoprene ratio of the SIS is in the range of 14 / 86 to 25 / 75. [4] The adhesive base composition for skin application according to any one of [1] to [3], wherein the SIS is in the ranges of specific gravity 0.90 to 0.95, hardness (ISO 7619) 20 to 45, tensile strength (ISO37) 2 to 35 MPa, 300% modulus (ISO37) 0.1 to 3 MPa, and elongation at break (ISO37) 1000 to 1800%. [5] The adhesive composition for skin application according to any one of [1] to [4], wherein the specific gravity of the liquid paraffin is 0.83 to 0.89. [6] The adhesive base composition for application to skin according to any one of [1] to [5], wherein the tackifier is one or two selected from alicyclic saturated hydrocarbon resins and polyterpene resins. [7] The adhesive composition for skin application according to any one of [1] to [6], further comprising one or more selected from essential oil components, absorption enhancers, adhesive base materials and anti-aging agents. [8] A tape preparation having the adhesive base composition for skin application according to any one of [1] to [7] on a support in a thickness of 10 to 500 μm. [Effects of the Invention]

[0010] The composition of the present invention makes it possible to provide a skin patch that has high skin adhesion and strong adhesive strength, yet causes minimal keratin peeling and is less irritating to the skin.Furthermore, it makes it possible to provide a tape that has excellent adhesive strength, safely maximizes the pharmacological effects of the medicinal ingredients, is easy to use, and has an excellent feel when used. DETAILED DESCRIPTION OF THE INVENTION

[0011] The adhesive composition for application to the skin of the present invention contains (a) a medicinal ingredient, (b) SIS, (c) liquid paraffin, and (d) a tackifier. The tape preparation of the present invention contains the adhesive composition for application to the skin on a support. One aspect of the present invention is a skin patch composition containing the following components (a), (b), (c), and (d), wherein the mass ratio of components (b):(c):(d) is 1:(1.4-3):(0.8-1.6): (a) 0.01 to 20% by mass of a medicinal ingredient; (b) SIS 15~25% by mass, (c) liquid paraffin 22 to 60 mass %; (d) tackifier: 5 to 38 mass %.

[0012] (a) The medicinal ingredient is not particularly limited, but is preferably a percutaneously absorbable ingredient typically administered externally. Examples of such medicinal ingredients include medicinal ingredients that act locally and medicinal ingredients that act systemically. As the locally acting medicinal ingredient, topical analgesics and anti-inflammatory agents are preferred, and specific examples include diclofenac sodium, loxoprofen sodium, indomethacin, felbinac, ketoprofen, flurbiprofen, glycol salicylate, methyl salicylate, glycyrrhetinic acid, belladonna extract, nonanoic acid vanillylamide, capsicum extract, d-camphor, dl-camphor, peppermint oil, l-menthol, d-borneol, tocopherol acetate, benzyl nicotinate, diphenhydramine, zinc oxide, etc. Examples of systemically acting medicinal ingredients include antianginal drugs such as nitroglycerin and isosorbide dinitrate, menopausal disorder treatment drugs such as estradiol and norethisterone acetate, bronchial asthma treatment drugs such as tulobuterol, smoking cessation aids such as nicotine, cancer pain treatment drugs or chronic pain treatment drugs such as fentanyl, fentanyl citrate, buprenorphine and diclofenac sodium, Alzheimer's disease treatment drugs such as rivastigmine, Parkinson's disease or restless legs syndrome treatment drugs such as rotigotine and ropinirole hydrochloride, overactive bladder treatment drugs such as oxybutynin hydrochloride, essential hypertension and tachycardiac atrial fibrillation treatment drugs such as bisoprolol, allergic rhinitis treatment drugs such as emedastine fumarate, and schizophrenia treatment drugs such as blonanserin. The preferred content of the (a) medicinal ingredient in the adhesive composition for skin application varies depending on the pharmacodynamic properties of the medicinal ingredient, the target disease, and the chemical or physicochemical properties of the medicinal ingredient itself, but is preferably in the range of 0.01 to 20% by mass, more preferably 0.1 to 10% by mass. For example, for nonsteroidal anti-inflammatory drugs (NSAIDs) such as diclofenac sodium and loxoprofen sodium, the content is preferably 0.5 to 10% by mass, and particularly for topical anti-inflammatory analgesics and topical analgesics, 1 to 5% by mass is preferred, and for systemic pain medications, 2.5 to 10% by mass is preferred.

[0013] The adhesive composition for skin application of the present invention uses (b) SIS as the adhesive base. SIS is a copolymer consisting of three blocks of polystyrene-polyisoprene-polystyrene, in which styrene polymers are polymerized on both ends of a chain of isoprene polymers, and has an average molecular weight of 100,000 to 200,000. In order to obtain a paste that has high skin adhesion and strong adhesive strength, yet causes very little keratin peeling and is less irritating to the skin, the SIS used in the present invention preferably has a styrene / isoprene ratio in the range of 14 / 86 to 25 / 75, more preferably in the range of 14 / 86 to 20 / 80, and even more preferably in the range of 14 / 86 to 17 / 83. Furthermore, from the viewpoint of obtaining a paste that exhibits high skin adhesion and strong adhesive strength, yet causes minimal keratin peeling and is minimally irritating to the skin, it is more preferable that the SIS have a specific gravity of 0.90 to 0.95, a hardness (ISO 7619) of 20 to 45, a tensile strength (ISO 37) of 2 to 35 MPa, a 300% modulus (ISO 37) of 0.1 to 3 MPa, and an elongation at break (ISO 37) of 1000 to 1800%.More preferably, the SIS has a specific gravity of 0.91 to 0.94, a hardness (ISO 7619) of 23 to 38, a tensile strength (ISO 37) of 4 to 32 MPa, a 300% modulus (ISO 37) of 0.3 to 2 MPa, and an elongation at break (ISO 37) of 1200 to 1500%. Such SIS is commercially available under the trade names of, for example, D1114P, D1117P, D1161JSP, and D1163J (manufactured by KRATON CORPORATION), SIS 5002, SIS 5229, SIS 5229P, SIS 5403P, and SIS 5505P (manufactured by ENEOS Kraton Elastomers), and Quintac 3421, Quintac 3433N, and Quintac 3450 (manufactured by Zeon Corporation). The content of SIS in the adhesive composition for skin application is preferably 15 to 25% by mass, more preferably 16 to 24% by mass, and particularly preferably 18 to 23% by mass, from the viewpoint of obtaining an adhesive that causes very little keratin peeling and is less irritating to the skin.

[0014] (c) As for liquid paraffin, from the viewpoint of obtaining a paste with extremely little exfoliation of keratin and little skin irritation, any liquid paraffin that complies with the Japanese Pharmacopoeia and has a specific gravity (20 / 20°C) of 0.83 to 0.89 (test method: Japanese Pharmacopoeia 18th revision) can be used. Furthermore, liquid paraffin with a specific gravity (20 / 20°C) of 0.83 to 0.89 and a viscosity (37.8°C) of 37 to 100 mm (test method: Japanese Pharmacopoeia 18th revision) can be used. 2 / s, in particular, specific gravity (20 / 20°C) 0.86 to 0.89 and viscosity (37.8°C) 50 to 90 mm (Test method: Japanese Pharmacopoeia 18th revision) 2 / s is more preferable. Such liquid paraffin is available, for example, as Liquid Paraffin No. 350S (manufactured by Sanko Chemical Industry Co., Ltd.), Liquid Paraffin No. 380SP (manufactured by Sanko Chemical Industry Co., Ltd.), and Moresco White P-350P (manufactured by MORESCO). The content of (c) liquid paraffin in the adhesive composition for skin application is preferably 22 to 60% by mass, more preferably 30 to 55% by mass, and even more preferably 32 to 51% by mass, from the viewpoint of obtaining an adhesive composition that causes minimal keratin peeling and minimal skin irritation.

[0015] (d) Examples of tackifiers that can be used include alicyclic saturated hydrocarbon resins, rosin ester resins, polyterpene resins, terpene phenol resins, petroleum resins, etc. Among these, from the viewpoint of obtaining a paste that causes minimal keratin peeling and is less irritating to the skin, it is preferable to use one or two types selected from alicyclic saturated hydrocarbon resins and polyterpene resins. These tackifiers are available, for example, as Alcon P90, Alcon P100, and Alcon P115 (manufactured by Arakawa Chemical Industries), YS Resin PX1150, and YS Resin PX1150N (manufactured by Yasuhara Chemical). The content of (d) tackifier in the adhesive composition for skin application is preferably in the range of 5 to 38% by mass, more preferably 10 to 35% by mass, and even more preferably 22 to 30% by mass, from the viewpoint of obtaining an adhesive composition that causes minimal keratin peeling and minimal skin irritation.

[0016] In the adhesive base composition for skin application of the present invention, the mass ratio of SIS to liquid paraffin and tackifier is preferably (b) SIS:(c) liquid paraffin:(d) tackifier=1:(1.4-3):(0.8-1.6), more preferably 1:(1.5-2.8):(0.9-1.5), and even more preferably 1:(1.5-2.7):(1.0-1.5), from the viewpoints of making the adhesive base flexible and easily deformable, increasing adhesion to the skin when applied to strengthen adhesive strength, and minimizing keratin peeling and reducing irritation when removed.

[0017] The adhesive composition for skin application of the present invention may contain, in addition to the medicinal ingredient, SIS, liquid paraffin, and tackifier, one or more selected from essential oil components, absorption enhancers, adhesive base materials, and anti-aging agents, as necessary.

[0018] The essential oil component is not particularly limited as long as it can generally be used in topical preparations, but specific examples include l-menthol, dl-menthol, dl-camphor, peppermint oil, etc. When the active ingredient is an NSAID such as diclofenac sodium, it is particularly preferable to use l-menthol. The amount of the essential oil component added is preferably 0 to 5% by mass, more preferably 0 to 2% by mass, of the total mass of the adhesive base composition for skin application. In particular, when the active ingredient is an NSAID such as diclofenac sodium, it is preferably 0 to 1% by mass.

[0019] The absorption enhancer is not particularly limited as long as it can be generally used in external preparations, but an optimal absorption enhancer can be used depending on the type of active ingredient. When the active ingredient is an NSAID such as diclofenac sodium, suitable absorption enhancers include pyrrolidone or its derivatives, fatty acid esters, aliphatic ethers, and organic acids. These can be used alone or in combination of two or more. Examples of pyrrolidone or a derivative thereof include 2-pyrrolidone and N-methyl-2-pyrrolidone, with N-methyl-2-pyrrolidone being preferred. The content of pyrrolidone or a derivative thereof is preferably 0.2 to 5% by mass, more preferably 1 to 4% by mass, and even more preferably 2 to 4% by mass, based on the total mass of the adhesive base composition for skin application. Examples of fatty acid esters or aliphatic ethers include diisopropyl adipate, diethyl sebacate, isopropyl myristate, hexyl laurate, oleyl oleate, decyl oleate, lauromacrogol, etc., of which diisopropyl adipate, diethyl sebacate, and isopropyl myristate are preferred. The content of the fatty acid ester or aliphatic ether is preferably 0.2 to 7.5% by mass, more preferably 0.5 to 5% by mass, and even more preferably 1 to 4% by mass, based on the total mass of the adhesive base composition for skin application. Examples of organic acids include citric acid, tartaric acid, succinic acid, and lactic acid, with citric acid being particularly preferred. The content of the organic acid is preferably 0.01 to 2% by mass, more preferably 0.1 to 1% by mass, and even more preferably 0.2 to 0.5% by mass, based on the total mass of the adhesive base composition for skin application.

[0020] Plaster base materials other than SIS include synthetic rubber resins such as polyisobutylene, polystyrene-butadiene copolymer, and silicone rubber, acrylic acid-based resins such as alkyl acrylate and alkyl methacrylate, and natural rubber. When the active ingredient is an NSAID such as diclofenac sodium, suitable base materials to be added include synthetic rubber resins such as polybutene and polyisobutylene, with polyisobutylene being particularly preferred. The content is preferably 0 to 5% by mass, more preferably 0 to 4% by mass, and even more preferably 0 to 2% by mass, based on the total mass of the adhesive composition for skin application.

[0021] Examples of antioxidants include dibutylhydroxytoluene, dibutylhydroxyanisole, and mercaptobenzimidazole, and when the active ingredient is an NSAID such as diclofenac sodium, dibutylhydroxytoluene is more preferred. The content of the antioxidant is preferably 0.1 to 2% by mass, more preferably 0.25 to 1% by mass, based on the total mass of the adhesive base composition for skin application.

[0022] The adhesive composition for skin application of the present invention can be produced by kneading the above-mentioned components, for example, with a heated kneader, etc. After preparing the adhesive composition for skin application, the adhesive is spread onto one side of a flexible backing or release liner by a conventional method such as the hot melt method, and then the release liner or backing is attached to produce a tape (hereinafter sometimes referred to as a patch).

[0023] The adhesive strength of the adhesive base for skin application (hereinafter also referred to as adhesive base) of the present invention obtained as described above is preferably between 1 N / cm and 3 N / cm, more preferably between 1 N / cm and 2.8 N / cm, and even more preferably between 1 N / cm and 2.5 N / cm, as measured by the 180° peel test method. The adhesive strength of the adhesive layer is measured in accordance with the 180° peel test of the Japanese Pharmacopoeia. The tape, which had been left at room temperature (near 25°C) for at least one hour, is cut to a width of 50 mm and a length of approximately 100 mm. A 50mm wide, 20mm long plastic plate is attached to one end of the testing machine's jig to serve as a grip. A 50mm wide, 80mm long tape is applied to a carbon test plate measuring at least 70mm wide and 150mm long, with one end aligned. A 2kg pressure roller is immediately moved back and forth over the tape at a speed of approximately 10mm per second. Immediately after application, the tape is placed in a constant temperature bath heated to 32°C for one hour. Using a tensile tester, the free end of the product with the attached plastic plate is clamped between the upper jig and the test end between the lower jig, and the two are peeled off at a speed of 300mm per minute. The first 25% of the measured length was ignored, and the adhesive strength of the next 50% of the length peeled from the test plate was averaged. The results are shown in Table 3 (Reference: Japanese Pharmacopoeia, 18th Edition).

[0024] The viscosity (complex modulus) of the adhesive base for skin application of the present invention is preferably 1500 Pa·s to 4000 Pa·s, more preferably 1600 Pa·s to 3800 Pa·s, and even more preferably 1700 Pa·s to 3500 Pa·s. The viscosity of the adhesive base is measured using a rheometer by melting the base on the lower plate, sandwiching it between the upper cone-plate plates, and cooling it to 32°C. Strain-dependent measurements are performed to determine the strain rate in the linear region. Frequency-dependent measurements are performed at this strain rate to measure the complex modulus [Pa·s] at a frequency of 1 Hz. The results are shown in Table 4.

[0025] In a 30% elongation test, the tape preparation of the present invention is preferably 3 N / 5 cm or less in the long side direction and 6 N / 5 cm or less in the short side direction, more preferably 2.8 N / 5 cm or less in the long side direction and 5.6 N / 5 cm or less in the short side direction, and even more preferably 2.6 N / 5 cm or less in the long side direction and 5.4 N / 5 cm or less in the short side direction. Here, the test method for the 30% elongation test of the tape preparation is as follows: First, the tape preparation is cut into a specimen piece in the long direction, 50 mm wide and 100 mm long, and a specimen piece in the short direction, 50 mm wide and 70 mm long. Plastic plates, 50 mm wide and 20 mm long, are attached to both ends of the long side to serve as jig grips. Plastic plates, 50 mm wide and 5 mm long, are attached to the short side to serve as jig grips. Using a tensile tester, both ends are clamped in the jig. The distance between the grips is set to 60 mm in both the long and short side directions, and the specimen is pulled at a rate of 200 mm per minute. The stress per unit width [N / 5 cm] is measured when the elongation rate relative to the distance between the grips of the specimen is 30% (the distance between the grips of the specimen is 78 mm). The results are shown in Table 5.

[0026] The fluidity of the adhesive base for skin application of the present invention is preferably 40 to 400 μm, more preferably 60 to 400 μm. The fluidity of the adhesive was measured by first digging a groove of about 400 μm in an acrylic plate at room temperature and then applying a tape on the groove. 2With a weight of 100g placed on top, the sample was left in a thermostatic chamber at 40°C. After leaving it for 3 hours, it was observed under a microscope and the distance that the paste had penetrated into the groove was measured. The results are shown in Table 6.

[0027] The amount of stratum corneum peeled from the adhesive base for skin application of the present invention is preferably 40% or less, more preferably 38% or less. The amount of stratum corneum peeling was measured by applying the tape to the lower backs of 30 healthy adult males for 6 hours. After removing the tape from the lower back, approximately 2 mL of a 0.5% Brilliant Green / 1% Gentian Violet mixed solution was applied to the adhesive surface of the tape and allowed to stand for 1 hour. After rinsing with water 10 times and air-drying, the stained stratum corneum on the surface of the tape was observed under a microscope, and images were taken of three random locations. Image processing software (ImageJ) was used to determine the area of the stained area per field of view of the obtained images (stratum corneum peeling area), and the percentage of the peeled area was calculated as the amount of stratum corneum peeling. The results are shown in Table 7.

[0028] In the present invention, the thickness of the paste varies depending on the type and concentration of the active ingredient, the area of the tape, etc., but is preferably in the range of 10 to 500 μm, more preferably 20 to 400 μm, and even more preferably 35 to 250 μm.

[0029] Any type of flexible sheet-like support can be used as long as the adhesive layer does not penetrate to the backside. Specific examples of sheet-like supports that can be used in the present invention include woven fabrics, nonwoven fabrics, and plastic films such as polyolefin films, polyvinyl alcohol films, vinyl chloride films, urethane alloy and urethane-vinyl chloride copolymer films, and ethylene-vinyl acetate films; foam films made from blends of acrylic or polystyrene-polybutadiene and polyisoprene; films obtained by vapor-depositing metal onto the above films; and sheets obtained by laminating two or more of these films. The thickness of the support is typically about 1000 μm or less, preferably in the range of 30 to 700 μm. Release liners include those having a release layer formed on their surface that has release properties, such as plastic films treated with silicone resin. The tape preparation applied as described above is produced by cutting it to an optimum size depending on the dosage of the medicinal ingredient and packaging it as necessary.

[0030] The tape preparation using the adhesive composition for skin application of the present invention thus obtained is used by applying it to the skin.

[0031] In addition to the above-mentioned formulation additives, the skin patch composition of the present invention may also contain one or more pharmaceutical additives typically used in topical pharmaceuticals, such as stabilizers, preservatives, buffers, suspending agents, emulsifiers, flavoring agents, solubilizers, antiseptics, solubilizers, and surfactants. Specific examples of these additives are listed in the Pharmaceutical Additives Encyclopedia 2021 (edited by the Japan Pharmaceutical Additives Association, Yakuji Nipposha), Yakushoku-hatsu No. 1204-1 (Pharmaceutical Affairs Administration Law), and the Japan Pharmaceutical Additives Association website (http: / / www.jpec.gr.jp / ).

[0032] Preferred embodiments of the present invention are described below. <1> A skin patch composition containing the following components (a), (b), (c), and (d), wherein the mass ratio of the components (b):(c):(d) is 1:(1.4-3):(0.8-1.6): (a) 0.01 to 20% by mass of a medicinal ingredient; (b) SIS 15~25% by mass, (c) liquid paraffin 22 to 60 mass %; (d) Tackifier: 5 to 38% by mass

[0033] <2> The medicinal ingredient is a locally acting medicinal ingredient or a systemically acting medicinal ingredient; <1> The adhesive composition for application to skin described above. <3> The styrene / isoprene ratio of SIS is in the range of 14 / 86 to 25 / 75. <1> or <2> The adhesive composition for application to skin described above. <4> SIS has a specific gravity of 0.90 to 0.95, a hardness (ISO 7619) of 20 to 45, a tensile strength (ISO37) of 2 to 35 MPa, a 300% modulus (ISO37) of 0.1 to 3 MPa, and an elongation at break (ISO37) of 1000 to 1800%. <1> ~ <3> 10. The adhesive composition for application to skin according to claim 1, wherein <5> The specific gravity of liquid paraffin is 0.83 to 0.89. <1> ~ <4> 10. The adhesive composition for application to skin according to any one of the preceding claims. <6> The tackifier is one or two selected from an alicyclic saturated hydrocarbon resin and a polyterpene resin. <1> ~ <5> 10. The adhesive composition for application to skin according to any one of the preceding claims. <7> Furthermore, it contains one or more selected from essential oil components, absorption enhancers, plaster base materials, and anti-aging agents. <1> ~ <6> 10. The adhesive composition for application to skin according to any one of the preceding claims. <8> The adhesive strength of the paste when applied to a carbon test plate is 1N / cm to 3N / cm. <1> ~ <7> 10. The adhesive composition for application to skin according to any one of the preceding claims. <9> The complex modulus of elasticity of the paste at 32°C is 1500 Pa·s to 4000 Pa·s. <1> ~ <8> 10. The adhesive composition for application to skin according to any one of the preceding claims. <10> When stretched at 300 mm / min, the 30% elongation test of the tape is 3 N / 5 cm or less in the long side direction and 6 N / 5 cm or less in the short side direction. <1> ~ <9> 1. The adhesive composition for skin application according to claim 1, <11> The fluidity at 40°C is 40 μm to 400 μm. <1> ~ <10> 1. The adhesive composition for skin application according to claim 1, <12> The amount of stratum corneum peeled from the plaster is 40% or less. <1> ~ <11> 1. The adhesive composition for skin application according to claim 1, <13> <1> ~ <12> 1. A tape preparation having the adhesive composition for skin application according to any one of the above on a support at a thickness of 10 to 500 μm. [Example]

[0034] The present invention will now be described in more detail with reference to examples, but the present invention is not limited to these examples.

[0035] Examples 1 to 8 (Production of the Plaster Composition for Skin Application of the Present Invention) The compositions shown in Table 1 were kneaded in a heated kneader by a conventional method to obtain a skin patch composition of the present invention, which was then applied and spread on a release liner to form a paste layer, followed by laminating a backing and cutting to the desired size to obtain a tape preparation.

[0036] [Table 1]

[0037] Comparative Examples 1 to 6 (Production of a comparative skin patch composition) The compositions shown in Table 2 were kneaded in a heated kneader by conventional methods to obtain comparative skin patch compositions, which were then applied and spread onto a release liner to form a plaster layer, followed by laminating a backing and cutting to the desired size to obtain tapes.

[0038] [Table 2]

[0039] Test Example 1: Adhesion test The adhesive strength of the tapes of Examples 1 to 8 and Comparative Examples 1 to 6 was measured. The results are shown in Table 3.

[0040] [Table 3]

[0041] It is clear that the adhesive composition for skin application of the present invention is superior to the comparative preparation and has sufficient adhesive strength.

[0042] Test Example 2: Viscosity measurement test The adhesive strength was measured for Examples 1 to 8 and Comparative Examples 1 to 6. The results are shown in Table 4.

[0043] [Table 4]

[0044] It can be seen that the adhesive composition for skin application of the present invention has a higher complex modulus of elasticity than Comparative Preparations 1, 2 and 5, and has a certain degree of hardness as an adhesive, and has a lower complex modulus of elasticity than Comparative Preparations 3, 4 and 6, and has good deformability.

[0045] Test example 3: 30% elongation test The load at 30% elongation was measured for Examples 1, 4, 5, and 7 and Comparative Examples 3, 4, and 6. The results are shown in Table 5.

[0046] [Table 5]

[0047] The adhesive composition for skin application of the present invention has a better load at 30% elongation than the comparative preparation, and is therefore excellent in deformability.

[0048] Test Example 4: Fluidity test The fluidity was measured for Examples 1, 2, 3, 4, 6, and 8 and Comparative Examples 4 and 6. The results are shown in Table 6.

[0049] [Table 6]

[0050] It can be seen that the adhesive base composition for skin application of the present invention has better fluidity and is more deformable than the comparative preparation.

[0051] Test Example 5: Exfoliation test The keratin peeling was measured for Examples 1, 2, 3, 4, 6, and 8 and Comparative Examples 1, 2, 3, 4, 5, and 6. The results are shown in Table 7.

[0052] [Table 7]

[0053] It can be seen that the adhesive composition for skin application of the present invention causes much less keratin peeling than the comparative preparation.

Claims

1. A plaster composition for application to the skin, comprising the following components (a), (b), (c), and (d), wherein the mass ratio of the components (b), (c), and (d), (b):(c):(d), is 1:(1.4-3):(0.8-1.6). (a) 0.01 to 20% by mass of a medicinal ingredient; (b) SIS 15 to 25% by mass, (c) liquid paraffin 22 to 60% by mass, (d) Tackifier: 5 to 38% by mass

2. 2. The adhesive composition for application to skin according to claim 1, wherein the medicinal ingredient is a medicinal ingredient that acts locally or systemically.

3. 2. The adhesive base composition for skin application according to claim 1, wherein the styrene / isoprene ratio of the SIS is in the range of 14 / 86 to 25 / 75.

4. 2. The adhesive base composition for skin application according to claim 1, wherein the SIS has a specific gravity of 0.90 to 0.95, a hardness (ISO 7619) of 20 to 45, a tensile strength (ISO 37) of 2 to 35 MPa, a 300% modulus (ISO 37) of 0.1 to 3 MPa, and an elongation at break (ISO 37) of 1000 to 1800%.

5. 2. The adhesive composition for skin application according to claim 1, wherein the specific gravity of the liquid paraffin is 0.83 to 0.

89.

6. 2. The adhesive base composition for skin application according to claim 1, wherein the tackifier is one or two selected from the group consisting of alicyclic saturated hydrocarbon resins and polyterpene resins.

7. 2. The adhesive composition for skin application according to claim 1, further comprising one or more selected from the group consisting of essential oil components, absorption enhancers, adhesive base materials and anti-aging agents.

8. A tape preparation comprising the adhesive composition for skin application according to any one of claims 1 to 7 on a support at a thickness of 10 to 500 µm.

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