Patch

Abstract

A patch comprising a support layer, an adhesive layer laminated on the support layer, and a release liner provided on a surface of the adhesive layer opposite to the support layer, wherein the adhesive layer contains a drug, water, gelatin, l-menthol, a methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion, and magnesium aluminometasilicate, and based on the total mass of the adhesive layer, the content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion is 1.5% by mass to 20% by mass, the content of magnesium aluminometasilicate is 0.25% by mass to 0.45% by mass, and the content of gelatin is 1% by mass to 3% by mass.

Description

Technical Field

[0001] The present invention relates to a poultice.

Background Art

[0002] A poultice is a type of patch produced by spreading an adhesive layer containing a drug on a support layer such as cloth. Generally, the water content of the adhesive layer is high. In order to achieve a high water content in the adhesive layer and ensure excellent shape retention and cohesiveness, the adhesive layer contains water-soluble polymers such as gelatin, polyacrylic acid, neutralized polyacrylic acid, and polyvinyl alcohol. In addition, a poultice containing a cooling agent such as l-menthol can give a cooling sensation during use and exhibit a pain-relieving effect and a cooling effect (for example, Patent Document 1 and Patent Document 2).

[0003] In a poultice containing l-menthol, there is a known problem that crystals of l-menthol may precipitate in the adhesive layer. To solve this problem, for example, in Patent Document 3, the content of menthol in the hydrogel composition is set to a specific amount, and one or more selected from silica and talc are blended in the hydrogel composition to suppress the precipitation of menthol.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0005] In the process of developing a patch in which the crystallization of l-menthol is suppressed, in addition to the crystallization of l-menthol, uneven spreading may occur during spreading, components of the adhesive layer may ooze out from the support layer after spreading, the adhesiveness and liner peelability may be insufficient, and pain may occur when peeling off the patch after sticking it to the skin. The inventors have found that such problems may occur.

[0006] The present invention has been made in view of the problems of the above prior art, and an object thereof is to provide a patch in which the crystallization of l-menthol is suppressed, there is no uneven spreading, the adhesiveness and liner peelability are excellent, oozing is suppressed, and pain during peeling is suppressed.

Means for Solving the Problems

[0007] As a result of intensive studies to achieve the above object, the inventors have found that in an adhesive layer containing water, gelatin, l-menthol, a methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion, and magnesium aluminometasilicate, by setting the content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion within a predetermined range, a patch in which the crystallization of l-menthol is suppressed can be obtained.

[0008] However, even though the content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion was within a predetermined range, new problems occurred, such as unevenness during spreading of the adhesive layer, oozing of the components of the adhesive layer into the support layer after spreading, insufficient adhesiveness and liner peelability, and pain when peeling off the patch.

[0009] As a result of intensive studies by the inventors on the above problems, it has been found that by setting the blending amounts of magnesium aluminometasilicate and gelatin among the components contained in the patch of the present invention within a predetermined range, the above problems can be solved, and the present invention has been completed.

[0010] That is, the present invention includes the following [1] to [2]. [1] A poultice comprising a support layer, an adhesive layer laminated on the support layer, and a release liner provided on a surface of the adhesive layer opposite to the support layer, wherein the adhesive layer contains a drug, water, gelatin, l-menthol, a methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion, and magnesium aluminometasilicate, and based on the total mass of the adhesive layer, the content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion is 1.5% by mass to 20% by mass, the content of magnesium aluminometasilicate is 0.25% by mass to 0.45% by mass, and the content of gelatin is 1% by mass to 3% by mass. [2] The poultice according to [1], wherein the adhesive layer further contains at least one selected from the group consisting of polyacrylic acid and a neutralized product of polyacrylic acid.

Effects of the Invention

[0011] According to the present invention, it is possible to provide a poultice in which the crystallization of l-menthol is suppressed, there is no uneven spreading, the adhesiveness and liner peelability are excellent, seepage is suppressed, and the pain during peeling is suppressed.

Modes for Carrying Out the Invention

[0012] Hereinafter, preferred embodiments of the present invention will be described in detail.

[0013] The poultice according to the first embodiment of the present invention includes a support layer, an adhesive layer laminated on the support layer, and a release liner provided on a surface of the adhesive layer opposite to the support layer, wherein the adhesive layer contains a drug, water, gelatin, l-menthol, a methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion, and magnesium aluminometasilicate, and based on the total mass of the adhesive layer, the content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion is 1.5% by mass to 20% by mass, the content of magnesium aluminometasilicate is 0.25% by mass to 0.45% by mass, and the content of gelatin is 1% by mass to 3% by mass.

[0014] The support layer only needs to be capable of supporting the pressure-sensitive adhesive layer containing water, and those well-known to those skilled in the art can be used. Examples of the support layer include woven fabrics (including knitted fabrics), non-woven fabrics, resin films, foamed sheets, and paper. When using a woven fabric, non-woven fabric, or resin film as the support layer, the material thereof includes, for example, polyolefins such as polyethylene, polypropylene, and polybutylene, polyesters such as polyethylene terephthalate, rayon, polyurethane, and cotton. These may be used alone or in combination of two or more, and may be single-layer or laminated. The material of the support layer is more preferably polyester.

[0015] The support layer is preferably a non-woven fabric or a woven fabric, and particularly preferably a non-woven fabric or a woven fabric having a predetermined elongation recovery rate (elongation elastic modulus). In this specification, the "elongation recovery rate" is a value measured according to the description in JIS L1096:2010, and means the "elongation elastic modulus at constant load" or the "elongation elastic modulus at constant rate elongation". For example, the "50% elongation recovery rate" is the elongation elastic modulus when elongated (constant rate elongation) so that the elongation rate becomes 50%, and the "load at 50% elongation" is the load (constant load) required to elongate so that the elongation rate becomes 50%. By using a non-woven fabric or a woven fabric having a predetermined elongation recovery rate, when attached to a movable part such as a joint, the support layer expands and contracts according to the movement of the attachment site, which is preferable.

[0016] When the support layer is a non-woven fabric, for example, the 50% elongation recovery rate of the non-woven fabric is 60 to 99%, preferably 65 to 95%, and more preferably 70 to 90%. Also, the load at 50% elongation of the non-woven fabric is, for example, 1 to 6 N / 50 mm in the longitudinal direction (major axis direction) and preferably 0.1 to 3 N / 50 mm in the transverse direction (minor axis direction). The basis weight of a suitable support layer is, for example, 80 to 150 g / m 2 and preferably 90 to 120 g / m 2It is preferably so. The thickness of the suitable support layer is, for example, 0.5 to 2 mm. The basis weight and thickness of the support layer are measured according to the standards of JIS L1906:2000. Also, the stiffness and flexibility of the support layer (the method for measuring stiffness and flexibility is by Method A (45° cantilever method) of JIS L1096:2010.) can be, for example, 20 to 40 mm in the longitudinal direction (major axis direction) and 10 to 35 mm in the transverse direction (minor axis direction), preferably 25 to 35 mm in the longitudinal direction (major axis direction) and 15 to 30 mm in the transverse direction (minor axis direction).

[0017] The knitted fabrics used as the support layer include, for example, knitted fabrics in which stitches are gathered by circular knitting, warp knitting, weft knitting, etc. and processed into a cloth shape. Knitted fabrics made by combining one or more materials such as polyester-based, nylon-based, polypropylene-based, and rayon-based materials are preferable, and among them, knitted fabrics made of polyethylene terephthalate with less interaction with drugs are more preferable.

[0018] In particular, when the support layer is a woven fabric, the 50% elongation recovery rate of the woven fabric is, for example, 60 to 99%, preferably 65 to 95%, and more preferably 70 to 90%. Also, the load at 50% elongation is, for example, 1 to 5 N / 25 mm in the longitudinal direction (major axis direction) and preferably 0.1 to 3 N / 25 mm in the transverse direction (minor axis direction). The stiffness and flexibility of the support layer can be, for example, 10 to 30 mm in the longitudinal direction (major axis direction) and 10 to 30 mm in the transverse direction (minor axis direction), preferably 15 to 25 mm in the longitudinal direction (major axis direction) and 15 to 25 mm in the transverse direction (minor axis direction).

[0019] The thickness of the woven fabric as the support layer is preferably 0.5 to 2 mm.

[0020] In particular, for a polyethylene terephthalate woven fabric with a basis weight of 80 to 150 g / m 2 When it is, during spreading, the water contained in the adhesive is less likely to ooze out through the meshes of the woven fabric, and the anchoring property between the woven fabric and the adhesive is more excellent.

[0021] In addition, the polyethylene terephthalate woven fabric preferably has a longitudinal (major axis direction) modulus of 2 to 12 N / 50 mm and a transverse (minor axis direction) modulus of 2 to 8 N / 50 mm (the modulus is measured according to JIS L1018:1999). If the modulus is lower than 2 N / 50 mm, the woven fabric may stretch when spreading the adhesive, and the adhesive may penetrate into the mesh, resulting in a decrease in the function as a poultice. On the other hand, if the modulus is higher than 12 N / 50 mm (longitudinal direction) or 8 N / 50 mm (transverse direction), the stretchability is poor, and it may be difficult to follow the skin stretching when attaching the poultice to a movable part.

[0022] The material of the release liner is not particularly limited, and a liner made of a material generally known to those skilled in the art can be used. When using a woven fabric, non-woven fabric, knitted fabric or resin film as the support layer, the material of the release liner may be, for example, polyethylene, polypropylene, polybutylene, polyethylene terephthalate, rayon, polyurethane, paper, etc. These materials may be used alone or in combination of two or more. The material of the release liner is preferably a polypropylene film.

[0023] The adhesive layer contains a drug, water, gelatin, l-menthol, a methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion, and magnesium aluminometasilicate.

[0024] The drug is not particularly limited as long as it has percutaneous absorbability. Examples of the drug include non-steroidal anti-inflammatory agents such as indomethacin, felbinac, flurbiprofen, diclofenac, diclofenac sodium, methyl salicylate, glycol salicylate, ketoprofen or esters thereof, antihistamines such as diphenhydramine, analgesics such as aspirin, acetaminophen, ibuprofen, loxoprofen sodium, local anesthetics such as lidocaine, muscle relaxants such as succinylcholine chloride, antifungal agents such as clotrimazole, antihypertensive agents such as clonidine, vasodilators such as nitroglycerin, isosorbide nitrate, vitamins such as vitamin A, vitamin E (tocopherol), tocopherol acetate, vitamin K, octothiamine, riboflavin butyrate, prostaglandins, scopolamine, fentanyl, capsicum extract, nonyl vanillylamide and the like. Some drugs have two kinds of optical isomers, namely R-form and S-form. The drug used in the present embodiment may be any one of the optical isomers or a mixture of the two kinds of optical isomers at an arbitrary ratio. The drug may be in the form of a pharmaceutically acceptable salt, and pharmaceutically acceptable salts include inorganic base salts such as sodium salt, potassium salt, calcium salt; organic base salts such as amine salts of monoethanolamine, diethanolamine; inorganic acid salts such as hydrochloride, nitrate, phosphate; organic acid salts such as acetate, lactate, benzenesulfonate, citrate and the like.

[0025] The content of the drug in the adhesive layer may be an amount that allows the drug to exert its medicinal effect, and it varies depending on the type of the drug. For example, indomethacin can be 0.5% to 1.5% by mass, diclofenac sodium can be 0.5% to 1.5% by mass, ketoprofen can be 0.1% to 1% by mass, felbinac can be 0.5% to 1.5% by mass, and flurbiprofen can be 0.1% to 1% by mass.

[0026] The water content in the adhesive layer can be 30% to 70% by mass based on the total mass of the adhesive layer, and may also be 30% to 60% by mass, or 35% to 52% by mass.

[0027] The content of gelatin in the adhesive layer is 1% by mass to 3% by mass, preferably 1.25% by mass to 3% by mass, more preferably 1.5% by mass to 3% by mass, based on the total mass of the adhesive layer.

[0028] The content of l-menthol in the adhesive layer can be 0.5% by mass to 3% by mass, preferably 1% by mass to 2% by mass, more preferably 1% by mass to 1.5% by mass, based on the total mass of the adhesive layer.

[0029] The methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion is an emulsion (aqueous emulsion) in which the methyl acrylate / 2-ethylhexyl acrylate copolymer resin is dispersed in water. The content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin in the emulsion can be 55% to 65% by mass based on the total mass of the emulsion. The emulsion may contain an emulsifier, and examples of the emulsifier include polyoxyethylene nonylphenyl ether. The content of the emulsifier can be 1% to 5% by mass based on the total mass of the emulsion. The content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion in the adhesive layer is 1.5% to 20% by mass (corresponding to 0.825% to 13% by mass as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin) based on the total mass of the adhesive layer, preferably 2% to 19% by mass (corresponding to 1.1% to 12.35% by mass as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin) or 3% to 20% by mass (corresponding to 1.65% to 13% by mass as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin), more preferably 3% to 18% by mass (corresponding to 1.65% to 11.7% by mass as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin). Commercially available methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsions include, for example, Nikazol TS-620 (trade name, manufactured by Nippon Carbide Industries Co., Ltd.) and BPW HW-2 (trade name, manufactured by Toyochem Co., Ltd.).

[0030] The content of magnesium aluminometasilicate in the adhesive layer is 0.25% to 0.45% by mass, preferably 0.25% to 0.43% by mass, more preferably 0.28% to 0.4% by mass, based on the total mass of the adhesive layer.

[0031] The ratio of the content of methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion to the content of magnesium aluminometasilicate in the adhesive layer is preferably 3.3:1 to 80:1 (corresponding to 1.815:1 to 52:1 as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin), more preferably 5.4:1 to 76:1 (corresponding to 2.97:1 to 49.4:1 as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin) or 6.6:1 to 80:1 (corresponding to 3.63:1 to 52:1 as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin), and even more preferably 7.5:1 to 72:1 (corresponding to 4.125:1 to 46.8:1 as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin). The ratio of the content of methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion to the content of gelatin in the adhesive layer is preferably 0.5:1 to 20:1 (corresponding to 0.275:1 to 13:1 as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin), more preferably 0.75:1 to 16:1 (corresponding to 0.4125:1 to 10.4:1 as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin) or 1:1 to 20:1 (corresponding to 0.55:1 to 13:1 as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin), and even more preferably 1:1 to 12:1 (corresponding to 0.55:1 to 7.8:1 as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin).

[0032] The adhesive layer may contain, as other components, water-soluble polymers (excluding gelatin; the same applies hereinafter), cooling agents (excluding l-menthol; the same applies hereinafter), tackifiers (excluding methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion; the same applies hereinafter), solubilizers, crosslinking agents (excluding magnesium aluminometasilicate; the same applies hereinafter), fillers, moisturizers, stabilizers, preservatives, chelating agents, colorants, flavoring agents, pH adjusters, etc. In one embodiment of the present invention, it is preferable that the adhesive layer does not contain propylene glycol.

[0033] Examples of the tackifier include acrylic ester copolymers such as aminoalkyl methacrylate copolymer E. When the pressure-sensitive adhesive layer contains a tackifier, its content is preferably 0.1% by mass to 1.0% by mass based on the total mass of the pressure-sensitive adhesive layer. The pressure-sensitive adhesive layer preferably does not contain a tackifier other than the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion.

[0034] The water-soluble polymer is not particularly limited as long as it can retain moisture in the adhesive layer, and those generally known to those skilled in the art can be used. Examples of the water-soluble polymer include polyacrylic acid, neutralized polyacrylic acid, polyvinyl alcohol, polyvinyl pyrrolidone, sodium alginate, hydroxypropyl cellulose, sodium carboxymethyl cellulose (sodium carmellose), methyl cellulose, and carrageenan. The water-soluble polymer may be used alone or in combination of two or more. The neutralized polyacrylic acid may be a completely neutralized polyacrylic acid, a partially neutralized polyacrylic acid, or a mixture thereof. Examples of the neutralized polyacrylic acid include polyacrylates, and for example, sodium salts, potassium salts, calcium salts, ammonium salts, etc. can be used. The partially neutralized polyacrylic acid is one in which structural units derived from acrylic acid and structural units derived from acrylate are present in an arbitrary ratio in one polymer chain. It is preferable to use a partially neutralized polyacrylic acid in which 50 mol% of the carboxy groups in one polymer chain are neutralized. It is preferable that the water-soluble polymer contains at least one selected from the group consisting of polyacrylic acid and neutralized polyacrylic acid, and more preferably contains polyacrylic acid and neutralized polyacrylic acid. When the adhesive layer contains a water-soluble polymer, its content is preferably 3% by mass to 15% by mass, more preferably 5% by mass to 13% by mass, and even more preferably 7% by mass to 11% by mass based on the total mass of the adhesive layer. When the adhesive layer contains polyacrylic acid, its content is preferably 1% by mass to 5% by mass, more preferably 2% by mass to 5% by mass, and even more preferably 2.5% by mass to 4.5% by mass based on the total mass of the adhesive layer. When the adhesive layer contains a neutralized polyacrylic acid, its content is preferably 1% by mass to 5% by mass, more preferably 1.5% by mass to 4.5% by mass, and even more preferably 2% by mass to 4% by mass based on the total mass of the adhesive layer.When the adhesive layer contains polyvinyl alcohol, its content is preferably 1% by mass to 5% by mass, more preferably 1% by mass to 4% by mass, and still more preferably 1.5% by mass to 3.5% by mass based on the total mass of the adhesive layer.

[0035] Examples of the cooling agent include thymol, l-isopulegol, peppermint oil, etc. The cooling agent may be used alone or in combination of two or more. When the adhesive layer contains a cooling agent, its content is preferably 1% by mass to 1.5% by mass based on the total mass of the adhesive layer.

[0036] The solubilizing agent is not particularly limited as long as it can dissolve the drug. Examples include crothamide; N-methylpyrrolidone; polyalkylene glycols such as polyethylene glycol (PEG) and polybutylene glycol; oxyalkylene fatty acid esters such as polyethylene glycol monostearate; polyoxyalkylene sorbitan fatty acid esters such as polysorbate 80; sorbitan fatty acid esters such as sorbitan monooleate; and surfactants such as polyoxyethylene hydrogenated castor oil. These solubilizing agents may be used alone or in combination of two or more. When the adhesive layer contains a solubilizing agent, its content is preferably 0.1% by mass to 3% by mass, more preferably 0.2% by mass to 1% by mass, and still more preferably 0.3% by mass to 0.7% by mass based on the total mass of the adhesive layer.

[0037] The crosslinking agent is a component for adjusting the progress of the crosslinking reaction between polyacrylic acid neutralized products and the crosslinking reaction between the polyacrylic acid neutralized product and polyacrylic acid optionally added, and a crosslinking agent generally used in poultices can be used. Examples of the crosslinking agent include aluminum compounds. When the pressure-sensitive adhesive layer contains a crosslinking agent, its content is preferably 0.05% by mass to 1% by mass, more preferably 0.1% by mass to 0.7% by mass, and still more preferably 0.2% by mass to 0.5% by mass based on the total mass of the pressure-sensitive adhesive layer. When the content of the crosslinking agent is within this range, a poultice with better followability to the skin can be obtained. The pressure-sensitive adhesive layer preferably does not contain a crosslinking agent other than magnesium aluminum metasilicate.

[0038] Examples of the filler include inorganic fillers such as silicic anhydride, titanium oxide, synthetic aluminum silicate, kaolin, talc, bentonite, and magnesium aluminum metasilicate, and it may be one of these or a combination of two or more. When the pressure-sensitive adhesive layer contains a filler, its content is preferably 0.1% by mass to 1.5% by mass, more preferably 0.2% by mass to 1% by mass, and still more preferably 0.3% by mass to 0.7% by mass based on the total mass of the pressure-sensitive adhesive layer.

[0039] The humectant is not particularly limited as long as it can suppress the evaporation of moisture from the pressure-sensitive adhesive layer over time. Examples of the humectant include polyhydric alcohols such as glycerin, sorbitol, ethylene glycol, 1,4-butanediol, polyethylene glycol, and liquid paraffin. These humectants may be used alone or in combination of two or more. It is preferable to contain at least one selected from the group consisting of glycerin and sorbitol as the humectant, and it is more preferable to contain glycerin and sorbitol. When the pressure-sensitive adhesive layer contains a humectant, its content is preferably 15% by mass to 45% by mass, more preferably 20% by mass to 40% by mass, and still more preferably 25% by mass to 35% by mass based on the total mass of the pressure-sensitive adhesive layer.

[0040] Stabilizers include, for example, oxybenzone, dibutylhydroxytoluene (BHT), sodium edetate, UV absorbers (e.g., dibenzoylmethane derivatives), and the like. When the pressure-sensitive adhesive layer contains a stabilizer, its content is preferably 0.05% by mass to 1% by mass, more preferably 0.1% by mass to 0.6% by mass, and even more preferably 0.2% by mass to 0.6% by mass based on the total mass of the pressure-sensitive adhesive layer.

[0041] Preservatives include, for example, methyl paraoxybenzoate, ethyl paraoxybenzoate, propyl paraoxybenzoate, butyl paraoxybenzoate, 1,2-pentanediol, benzoic acid and its salts, salicylic acid and its salts, sorbic acid and its salts, dehydroacetic acid and its salts, 4-isopropyl-3-methylphenol, 2-isopropyl-5-methylphenol, phenol, hinokitiol, cresol, 2,4,4'-trichloro-2'-hydroxydiphenyl ether, 3,4,4'-trichlorocarbanilide, chlorobutanol, benzalkonium chloride, and benzethonium chloride. These preservatives may be used alone or in combination of two or more. When the pressure-sensitive adhesive layer contains a preservative, its content is preferably 0.01% by mass to 1% by mass, more preferably 0.05% by mass to 0.5% by mass, and even more preferably 0.1% by mass to 0.2% by mass based on the total mass of the pressure-sensitive adhesive layer.

[0042] Chelating agents include, for example, edetic acid (also known as ethylenediaminetetraacetic acid, EDTA) or its salts, ascorbic acid, pyrophosphates, hexametaphosphates, gluconates, and the like. These chelating agents may be used alone or in combination of two or more. More specifically, sodium edetate is an example of an edetate salt. When the pressure-sensitive adhesive layer contains a chelating agent, its content is preferably 0.05% by mass to 1% by mass, more preferably 0.1% by mass to 0.6% by mass, and even more preferably 0.2% by mass to 0.6% by mass based on the total mass of the pressure-sensitive adhesive layer.

[0043] The total mass of the adhesive layer is 200 g / m 2 ~1000 g / m 2 and can be 400 g / m 2 ~1000 g / m 2 or can be 400 g / m 2 ~650 g / m 2 or can be. Preferably, 400 g / m 2 ~650 g / m 2 By setting it in this range, the fit feeling can be improved, and the adhesion for a longer period can be enhanced. If the total mass of the adhesive layer is within the above range, the thickness of the entire poultice can be reduced, making it easier to follow the skin. Furthermore, when applied, the step difference with the peripheral part becomes smaller, making it tend to be difficult to peel off.

[0044] The pH of the adhesive layer is preferably 4 to 8, and more preferably 4.5 to 6. By setting the pH to 4 or more, the irritation to the skin is reduced, and by setting the pH to 8 or less, the moldability and shape retention of the poultice can be improved. In particular, when the support layer is a woven fabric, especially a knitted fabric, bleeding may occur when forming the adhesive layer, but when the pH is 5 to 6.5, bleeding tends to be suppressed. The pH can be measured, for example, in accordance with the pH measurement method of the General Test Methods of the Japanese Pharmacopoeia, using a glass composite electrode and diluting the sample 20-fold with purified water.

[0045] The poultice can be manufactured, for example, by mixing a drug, water, gelatin, l-menthol, a methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion, magnesium aluminometasilicate, and, if necessary, any of the above-mentioned optional components to obtain an adhesive composition, uniformly spreading this adhesive composition on a release liner, and laminating a support layer thereon. Also, the poultice may be manufactured by uniformly spreading the adhesive composition on the support layer and laminating a release liner thereon.

Example

[0046] The components of the compositions shown in Examples and Comparative Examples of Tables 1 to 4 (the numerical values of each component in the table represent mass %) were mixed to prepare an adhesive composition. Next, the obtained adhesive composition was uniformly spread on a release liner (a polypropylene film) so that the mass of the adhesive layer per unit area was 500 g / m 2 and a support layer (a nonwoven fabric made of polyethylene terephthalate, basis weight: 100 g / m 2 ) was laminated thereon, and then cut into a size of 140 cm 2 (10 cm × 14 cm) to obtain a poultice. As the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion, Nikazol TS-620 (trade name, manufactured by Nippon Carbide Industries Co., Ltd.) was used. Also, as the concentrated glycerin and D-sorbitol solution, those listed in the Japanese Pharmacopoeia (The Eighteenth Revised Japanese Pharmacopoeia) were used. The l-menthol precipitation, unevenness during spreading, bleeding, liners peel, liner peelability, initial adhesiveness, adhesiveness over time, pain during peeling, and remaining adhesive layer of each poultice were evaluated by the following methods, respectively.

[0047] <Unevenness during spreading> The adhesive layer during spreading was observed and evaluated according to the following evaluation scores. A score of 2 or more was judged as acceptable. 2. The surface and thickness are uniform and there is no spreading unevenness over the entire surface of the adhesive layer (area: 90% or more) 1. The surface and / or thickness is not uniform in a part of the adhesive layer (area: exceeding 10%), and spreading unevenness is confirmed.

[0048] All of the following evaluations were performed on the poultices that were sealed in aluminum packaging bags, allowed to stand at 25°C for 10 days or more, up to 15 days at most, and then taken out from the packaging bags.

[0049] <l-menthol precipitation> The surface of the adhesive layer of the poultice was visually observed, and the presence or absence of crystal precipitation of l-menthol was evaluated according to the following criteria. Ten poultices were evaluated, and the average value of the scores was taken as the evaluation result. A score (average value) of 2.0 or more was judged as acceptable. 2. No precipitation 1. With exudation

[0050] <Bleeding out> The area of the part where the components of the adhesive layer bled out onto the support layer was measured and evaluated according to the following evaluation scores. Five to twenty patches were evaluated, and the average value of the scores was taken as the evaluation result. A score (average value) of 5.0 or more was determined to be acceptable. 5. No bleeding out 4. Slight bleeding out (area: less than 10%) 3. Some bleeding out (area: 10% or more and less than 20%) 2. Considerable bleeding out (area: 20% or more and less than 30%) 1. Substantial bleeding out (area: 30% or more)

[0051] <Liners' le The degree of deviation between the adhesive layer of the patch and the release liner was scored according to the following criteria. Five to twenty patches were evaluated, and the average value of the scores was taken as the evaluation result. A score (average value) of 4.0 or more was determined to be acceptable. 4. No liners' le (deviation less than 0.5 mm) 3. Almost no liners' le (deviation 0.5 mm or more and less than 1.5 mm) 2. Obvious liners' le (deviation 1.5 mm or more) 1. Unmeasurable (the liner layer during the test fell off)

[0052] <Liner peelability> The ease of peeling the release liner from the patch was scored according to the following criteria. Five to twenty patches were evaluated, and the average value of the scores was taken as the evaluation result. A score (average value) of 3.0 or more was determined to be acceptable. 5. Very easy to peel 4. Slightly easy to peel 3. Acceptable peelability 2. Slightly difficult to peel 1. Very difficult to peel

[0053] <Initial adhesiveness> The release liner was peeled off from the patch and applied to the elbows of 5 to 20 subjects. After the elbows were bent 40 times, the adhesiveness of the adhesive layer to the skin was scored according to the following criteria. The average value of the scores of 5 to 20 subjects was used as the evaluation result, and a score (average value) of 5.0 or more was determined to be acceptable. 6. No peeling 5. Peeling at the edge (less than 1 / 4) 4. Peeling of 1 / 4 or more and less than 1 / 3 3. Peeling of 1 / 3 or more and less than 1 / 2 2. Peeling of 1 / 2 or more 1. Detachment

[0054] <Adhesiveness over time> The release liner was peeled off from the patch and applied to the elbows of 5 to 20 subjects. After 4 hours and 6 hours had passed, the adhesiveness of the adhesive layer to the skin was scored respectively according to the following criteria. The average value of the scores of 5 to 20 subjects was used as the evaluation result, and a score (average value) of 5.0 or more was determined to be acceptable. 6. No peeling 5. Peeling at the edge (less than 1 / 4) 4. Peeling of 1 / 4 or more and less than 1 / 3 3. Peeling of 1 / 3 or more and less than 1 / 2 2. Peeling of 1 / 2 or more 1. Detachment

[0055] <Pain during peeling> In the above adhesiveness over time test, after 6 hours of application, the patch was peeled off from the elbow of the subject, and the pain when peeling the patch was scored according to the following criteria. The average value of the scores of 5 to 20 subjects was used as the evaluation result, and a score (average value) of 3.0 or more was determined to be acceptable. 4. None 3. Slight (not noticeable) 2. Somewhat 1. Considerable

[0056] <Remaining adhesive layer> In the above-mentioned peeling pain test, the residual ratio (area basis) of the adhesive layer on the skin after peeling of the patch was scored according to the following criteria. The average value of the scores of 5 to 20 subjects was used as the evaluation result, and a score (average value) of 3.0 or more was determined to be acceptable. 4. None 3. Slightly remaining (less than 1 / 10) 2. Remaining slightly (more than 1 / 10 and less than 1 / 5) 1. Remaining considerably (more than 1 / 5)

[0057] The results were summarized in Tables 1 to 4. In the tables, A indicates that the acceptable conditions in the above evaluation are satisfied, and B indicates that the acceptable conditions are not satisfied.

Table 1

[0058] As is clear from the results shown in Table 1, in the patch (Comparative Example 1) in which the content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion is less than 1.5% by mass, crystallization of l-menthol occurs, and it was confirmed that the liner peelability is insufficient. On the other hand, in the patches (Comparative Examples 2 to 6) in which the content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion is 3.0% to 25% by mass, although crystallization of l-menthol was suppressed, it was confirmed that another problem occurs in that at least one of liner peelability, adhesiveness, bleeding, and peeling pain becomes insufficient.

[0059]

Table 2

[0060] As is clear from the results shown in Table 2, in the cataplasms where the content of magnesium aluminometasilicate is less than 0.25% by mass or exceeds 0.45% by mass (Comparative Examples 7, 8, 11, 12, and 15) and in the cataplasms where the content of gelatin is less than 1% by mass or exceeds 3% by mass (Comparative Examples 7 to 15), it was confirmed that they were insufficient in at least one of the unevenness during spreading, adhesiveness, bleeding, and liner peelability.

[0061] [Table 3]

[0062] [Table 4]

[0063] As is clear from the results shown in Tables 3 to 4, it was confirmed that the cataplasms of the present invention (Examples 1 to 8 and 14 to 18) were excellent in all evaluation items.

[0064] In addition, except that diclofenac sodium (1.0% by mass), ketoprofen (0.3% by mass), felbinac (0.7% by mass), or flurbiprofen (0.33% by mass) was used instead of indomethacin, cataplasms (Examples 9 to 12) were produced in the same manner as in Example 4, and the cataplasms were evaluated. All of the cataplasms of Examples 9 to 12 showed good results in all evaluation items.

[0065] In addition, except that BPW HW-2 (trade name, manufactured by Toyochem Co., Ltd.) was used instead of Nikazole TS-620 (trade name, manufactured by Nippon Carbide Industries Co., Ltd.) as the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion, a cataplasm (Example 13) was produced in the same manner as in Example 4, and the cataplasm was evaluated. The cataplasm of Example 13 showed good results in all evaluation items.

Claims

1. a backing layer, an adhesive layer laminated on the backing layer, a release liner provided on a surface of the adhesive layer opposite to the backing layer, comprising, wherein the adhesive layer contains a drug, water, gelatin, l-menthol, a methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion, and magnesium aluminometasilicate, wherein, based on the total mass of the adhesive layer, the content of the methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion is 1.5% by mass to 20% by mass, the content of magnesium aluminometasilicate is 0.25% by mass to 0.45% by mass, and the content of gelatin is 1% by mass to 3% by mass, a cataplasm.

2. The cataplasm according to claim 1, wherein the adhesive layer further contains at least one selected from the group consisting of polyacrylic acid and a neutralized product of polyacrylic acid.

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