WO2006070673A1

WO2006070673A1 - Indometacin-containing adhesive patch

Info

Publication number: WO2006070673A1
Application number: PCT/JP2005/023535
Authority: WO
Inventors: Tatsuya Nakai; Kenichi Suzuki
Original assignee: Kowa Co., Ltd.
Priority date: 2004-12-28
Filing date: 2005-12-21
Publication date: 2006-07-06
Also published as: CN101094669A; KR20070089692A; JPWO2006070673A1; CN101094669B; TW200635583A

Abstract

An indometacin-containing adhesive patch which comprises a moisture-permeable polyethylene film and, superposed thereon through an adhesive, a (non)woven fabric and an indometacin-containing plaster, characterized in that the indometacin-containing plaster comprises 0.1-10 mass% indometacin, 0.01-10 mass% arginine or salt thereof, 0.1-20 mass% partially neutralized polyacrylics acid, and 10-70 mass% water. The indometacin-containing adhesive path is highly convenient and has satisfactory long-term stability of indometacin content.

Description

Specification

Patch containing indomethacin

Technical field

[0001] The present invention relates to an indomethacin-containing patch with improved convenience and good content stability over time.

Background art

[0002] Indomethacin-containing patches are marketed for the purpose of improving tendonitis and myalgia. Moisture in the plaster is volatilized over time, resulting in a decrease in adhesive strength and indomethacin absorbability. Since it decreased after several hours, the method needed to be applied to the affected area several times a day, which was inconvenient. For this reason, there has been a demand for a patch with improved absorbability that lasts for a long time and has the convenience of being applied once a day, that is, a patch with improved compliance.

[0003] As a method of maintaining the drug absorbability for a long time in a hydrous patch, a method of weakening the bridging property of the plaster and increasing the adhesiveness, a method of combining a moisture permeable film with a nonwoven fabric, and the like are known. However, if the crosslinkability of the plaster is weakened, the plaster remains on the skin and the feeling of use deteriorates, and the plaster softens and dissolves when sweating. In addition, as a method of combining the moisture permeable film with the nonwoven fabric, a polyurethane or PET moisture permeable film is used as the moisture permeable film. And moisture permeability changes, which is not preferable. Furthermore, PET-based moisture-permeable films are not preferred because the film has poor flexibility and is uncomfortable to use, and it is difficult to control moisture permeability. On the other hand, since the moisture permeability film of polyethylene has a small change in moisture permeability over time, continuous drug release can be expected. Moreover, since it is flexible and has a tactile feel, it has a high commercial value.

[0004] Indomethacin-containing external preparations containing basic amino acids are known (Patent Document 1), but basic amino acids are formulated as elution aids and percutaneous absorption enhancers. Nothing is described about the time stability of indomethacin in the preparation. Patent Document 1: JP-A-57-81409

Patent Document 2: Japanese Patent Laid-Open No. 9-12450

Patent Document 3: Japanese Patent Laid-Open No. 10-158165

Disclosure of the invention

Problems to be solved by the invention

[0005] Therefore, the present inventors have made various studies to find an indomethacin-containing patch with improved convenience. As a result, it has been clarified that when a polyethylene moisture-permeable film that is conventionally good in terms of sustained drug release, flexibility, and touch is used for an indomethacin-containing patch, the indomethacin content decreases. It was speculated that the cause was an alkaline earth metal salt (calcium carbonate, etc.) in a polyethylene moisture-permeable film that was formulated for the purpose of controlling moisture permeability. A decrease in the content of indomethacin is not preferable because the absorbed amount of indomethacin may decrease and a sufficient medicinal effect may not be obtained. Accordingly, an object of the present invention is to provide an indomethacin-containing adhesive that has improved convenience and content stability over time.

[0006] In addition, regarding the stability of indomethacin, for example, a patch (Patent Document 2), sodium edetate, in which crotamiton and a dihydric alcohol having 4 to 6 carbon atoms are mixed to improve the stability of indomethacin, A patch (Patent Document 3) or the like in which the stability of indomethacin is improved by blending dibutylhydroxytoluene and tartaric acid and adjusting the pH of the plaster to 4-6 is known. However, crotamiton and dihydric alcohols having 4 to 6 carbon atoms cause irritation and odor, and dibutylhydroxytoluene is carcinogenic and is preferable from the viewpoint of safety. Although there is a method of improving the stability of indomethacin by adding a buffer or stabilizer, a sufficient effect cannot be obtained by adding glycine or the like generally used as a buffer.

Means for solving the problem

[0007] Therefore, as a result of further investigations, the present inventors have found that a non-woven fabric or a woven fabric laminated with a polyethylene moisture permeable film and an adhesive and an indomethacin-containing plaster of a patch composed of an indomethacin-containing plaster. If a specific amount of polyacrylic acid partially neutralized product and water are further added to the mixture, and arginine or a salt thereof is further added, sufficient effects can be obtained by applying once a day. The present invention was completed by finding that an indomethacin-containing patch with improved stability and content stability over time could be obtained.

[0008] That is, the present invention is a patch comprising a nonwoven fabric or a woven fabric laminated with a polyethylene moisture-permeable film and an adhesive and an indomethacin-containing paste, wherein the indomethacin-containing paste is indomethacin 0.1 to 10 weight ^_0/0, arginine or a salt thereof 0.01 to 10 wt%, partially neutralized polyacrylic acid 0.1 to 20% by weight and that you containing 10 to 70% by weight of water A featured indomethacin-containing patch is provided.

The invention's effect

[0009] The indomethacin-containing patch of the present invention can be sustained for a long time, and if applied once a day, is a preparation with enhanced convenience that is effective in improving tendonitis and myalgia. It is a formulation with improved compliance. In addition, the adhesiveness to the skin over time, the stability of indomethacin content, and the absorbability are good, and the quality is excellent. Also, when applied, the surface of the preparation is free and the feeling of use is good.

BEST MODE FOR CARRYING OUT THE INVENTION

[0010] The polyethylene moisture-permeable film used in the present invention can be produced by a usual method. For example, after polyethylene film blended with an alkaline earth metal salt is melt-formed, a polyethylene moisture-permeable film with pores formed can be obtained by stretching the film. Examples of the alkaline earth metal salt to be used include calcium carbonate, barium sulfate, calcium nitrite, magnesium sulfate, calcium phosphate, basic magnesium carbonate, barium carbonate, and the like. The thickness of the polyethylene moisture permeable film is not particularly limited, but if it is too thin, it may be difficult to control the moisture permeability. If it is too thick, it may cause an uncomfortable feeling when applied, which may impair the feeling of use. Therefore, 5 to 100 μm, particularly 10 to 50 μm is preferable. In addition, when the moisture permeability is insufficient, the polyethylene moisture permeable film can be obtained by further imparting moisture permeability by performing perforation treatment.

[0011] Examples of the adhesive for laminating the polyethylene moisture permeable film and the nonwoven fabric or the woven fabric used in the present invention include poly (butyl acetate), poly (butyl alcohol), and poly (bullaceta). Thermoplastics of polyurethane, polysalt, vinyl, acrylic, polyamide, and cellulose thermoplastics, urea, melamine, phenol, epoxy, polyester, polyurethane, and polyamatic In particular, a polyurethane-based adhesive is preferable because of its adhesive surface strength between the nonwoven fabric and the polyethylene moisture-permeable film.

[0012] Examples of the material of the nonwoven fabric or woven fabric used in the present invention include cotton, polyester, rayon, nylon, polyolefin, polyethylene, vinylon, acetate, polypropylene, polyurethane and the like, particularly polyester, rayon and polyolefin. preferable. Examples of the method for producing the nonwoven fabric include a needle punch method, a spun lace method, a spun bond method, a stitch bond method, a melt blown method, and the like. In particular, a one-dollar punch method and a spun race method are preferable. The basis weight of the nonwoven fabric or woven fabric is not particularly limited, but if it is too small, the amount of moisture transpiration will increase and the plaster may harden, resulting in failure to obtain a sustained medicinal effect. The power of 20 to 200 g / m ² , especially 40 to 150 g / m ^{2, is} preferred because it can cause a sense of incongruity when it is applied and the feeling of use may deteriorate.

[0013] The moisture permeability of a nonwoven fabric or a woven fabric (hereinafter sometimes referred to as a support) laminated with a polyethylene moisture permeable film via an adhesive is not particularly limited. 200 to 3000 (gZm ² Z24h) is preferred from the viewpoint of drug absorption and drug efficacy, 200 to 2500 (g / m ² / 24h) force S is more preferable, 200 to 2000 (g / m ² / 24h) Force S More preferred 200-1000 (gZm ² Z24h) is particularly preferred. If the moisture permeability is within the above range, the amount of water transpiration from the plaster can be moderately suppressed. As a result, the curing of the plaster can be suppressed, and a sustained medicinal effect can be expected. Moreover, air permeability is maintained moderately and there is no irritation to the skin.

[0014] The content of indomethacin, 0.1 1 against indomethacin-containing paste mass:. Is a LO wt%, further from 0.1 to 5 mass ^_0/0, especially 0.3 to 1 5 weight ⁰ / ₀ is preferred. If the content of indomethacin exceeds 10% by mass, irritation to the skin of the drug itself may become a problem, and if it is less than 0.1% by mass, it is difficult to obtain the expected medicinal effect.

[0015] Examples of arginine salts include arginine hydrochloride and the like. As arginine or a salt thereof, L-arginine and L-arginine hydrochloride are preferred, and L-arginine is particularly preferred. The content of arginine or a salt thereof is 0.01 to 10% by mass with respect to the mass of indomethacin-containing plaster. % By weight, more preferably 0.01 to 1% by weight, especially 0.01 to 0.5% by weight.

[0016] The partially neutralized polyacrylic acid is a polymer obtained by partially neutralizing and polymerizing acrylic acid, and is contained to increase the adhesiveness of the plaster. The degree of neutralization is preferably 70 mol% or less, more preferably 60 mol% or less, and particularly preferably 50 mol% or less. Further, the degree of neutralization is preferably 10 mol% or more from the viewpoint of productivity. The content of the partially neutralized polyacrylic acid is preferably a force of 0.1 to 20% by mass, particularly 0.5 to 10% by mass, with respect to the mass of the indomethacin-containing plaster. If the content of the partially neutralized polyacrylic acid exceeds 20% by mass, the paste may aggregate and the adhesive strength may be reduced. On the other hand, when the content is less than 0.1% by mass, there are problems that the shape retention of the plaster is lowered and the adhesion to the skin is deteriorated. Examples of commercially available products of partially neutralized polyacrylic acid include Piscomate NP-600, Piscomate NP-700, Viscomate NP-800 (manufactured by Showa Denko).

[0017] The water content is preferably 10 to 70% by mass, more preferably 10 to 60% by mass, and particularly preferably 20 to 50% by mass with respect to the indomethacin-containing plaster mass. If the water content exceeds 70% by mass, the shape retention and adhesiveness of the plaster may be significantly reduced. If it is less than 10% by mass, it is difficult to cause a crosslinking reaction. This is not preferable because a paste remains when it is peeled off.

[0018] If the indomethacin-containing plaster of the present invention further contains a cross-linking agent, a mineral powder, and a curing modifier, the cohesiveness of the plaster is appropriately adjusted, which is preferable.

[0019] Examples of the cross-linking agent include magnesium aluminate silicate, magnesium aluminum hydroxide, magnesium aluminate metasilicate, synthetic hydrotalcite, dihydroxyaluminum aminoacetate, and dry aluminum hydroxide aluminum gel. The content of the cross-linking agent is not particularly limited. However, if the amount is too large, there may be a problem that the cross-linking is excessive and the plaster aggregates. Since a body residue may be generated, 0.001 to 1% by mass, particularly 0.001 to 0.3% by mass is preferable with respect to the mass of the indomethacin-containing plaster.

[0020] Examples of the mineral powder include kaolin, bentonite, montmorillonite, zinc oxide, titanic oxide, and caustic anhydride. The content of the mineral powder is not particularly limited, but if it is too large, it may be difficult to prepare the formulation and a uniform formulation may not be obtained. Since the paste may agglomerate and adhesive strength may decrease, the content is preferably 0.5 to 15% by mass, particularly 1 to 10% by mass based on the mass of the indomethacin-containing plaster.

[0021] Examples of the curing regulator include citrate, malic acid, tartaric acid, disodium edetate, darconic acid, and lactic acid. The content of the curing modifier is not particularly limited, but if it is too large, the crosslinking may be excessive and the agglomerate may be agglomerated and the adhesive strength may be reduced. On the other hand, if it is too small, the crosslinking will be insufficient. Since the remainder may be generated, 0.001 to 3% by mass, particularly 0.01 to 2% by mass is preferable with respect to the mass of the indomethacin-containing paste.

[0022] In addition to these components, additives used for ordinary plaster can be appropriately blended in the indomethacin-containing plaster depending on the purpose. Additives include adhesion enhancers, solvents, oil components, absorption promoters, stabilizers, surfactants, and the like. These supplements can be used alone or in combination of two or more.

[0023] Examples of the adhesion enhancer include ester gum, xanthan gum, carmellose sodium, alicyclic saturated hydrocarbon resin, polybutene rosin and the like. The content of the adhesion enhancer is not particularly limited, but is 0.1 to 50% by mass, more preferably 0.5 to 40% by mass, particularly 1 to 30% with respect to the mass of the indomethacin-containing plaster from the viewpoint of the adhesion enhancing effect. Mass% is preferred.

[0024] Solvents include (concentrated) glycerin, D-sorbitol solution, propylene glycol, dipropylene glycolol, ethylene glycolol, macrogonol, diethylene glycolol, 1,3-butylene glycol, dipropylene glycolol polyethylene glycol, 2- Ethanolates 1, 3 Polyhydric alcohols such as monohexanediol and polypropylene glycol 2000; monohydric alcohols such as ethanol, isopropanol, benzyl alcohol, stearyl alcohol and oleyl alcohol; diisopropyl adipate, isopropyl myristate, triacetin, Examples include esters such as medium chain fatty acid triglycerides such as diisopropyl sebacate, decyl sebacate, triisooctanoic acid, etc .; ketones such as crotamiton, etc. . These solvents can be used alone or in combination of two or more. Although there is no restriction | limiting in particular in content of a solvent, 10-60 mass% with respect to the mass of indomethacin containing plaster body, Especially 20-50 mass% is preferable.

[0025] Examples of the oil component include olive oil, camellia oil, castor oil, safflower oil, castor oil, southern power oil, soybean oil, cottonseed oil, sesame oil, coconut oil, palm oil, and chiioji oil. [0026] Examples of the absorption promoter include L-menthol, oleic acid, isopropyl myristate, and the like.

[0027] Stabilizers include phenolic substances such as methyl parabenzoate and propyl parabenzoate; neutral substances such as chlorobutanol and phenolethyl alcohol; and reverse substances such as benzalkonium chloride and benzethonium chloride. Antioxidants such as vitamin E, butylhydroxyl-sol, tocopherol acetate, propyl gallate, 2-mercaptobensimidazole; reducing agents such as ascorbic acid, sodium bisulfite, sodium thiosulfate, sodium edetate And the like. The content of the stabilizer is not particularly limited, but is preferably 0 to 0.5 mass%, particularly preferably 0.001 to 0.1 mass%, based on the mass of the indomethacin-containing paste.

[0028] Surfactants include anionic surfactants such as calcium stearate, magnesium stearate and sodium lauryl sulfate, and cationic surfactants such as salt cetyl pyridinium; glyceryl monostearate, Nonionic surfactants such as sugar fatty acid esters, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene fatty acid esters, polyoxyethylene alkyl ethers and the like can be mentioned. The content of the surfactant is not particularly limited, but is 0 to 3% by mass, particularly preferably 0.01 to 1% by mass with respect to the mass of the indomethacin-containing plaster.

[0029] In addition, the adhesive strength of the indomethacin-containing plaster is not particularly limited, but the ball-tack adhesive strength of the hydrous drug-containing plaster is No. 4 or higher from the viewpoint of preventing peeling off during application. In particular, No. 5 or higher is preferable.

[0030] The surface of the indomethacin-containing patch of the present invention may be covered with a liner! Examples of the liner include, for example, a plastic liner such as polyethylene and polypropylene, a cellulose liner, and the liner coated on the surface with a silicone release agent, a paper sheet, and the like. This is the preferred liner.

[0031] As a method for producing the patch of the present invention, an ordinary formulation method can be used. For example, a non-woven fabric or a woven fabric surface of a support in which a moisture-permeable film is laminated on a non-woven fabric via an adhesive and a liner In the meantime, the indomethacin-containing plaster is spread to prepare a patch. Example

[0032] The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples.

[0033] <Moisture permeability test>

Measured by the salty calcium method according to JIS L 1099—1993 “Method of testing moisture permeability of textile products” (A—1 method, 40 ° C, 90% RH) o

Put about 33 g of a moisture absorbent (calcium chloride) evenly in a moisture-permeable cup warmed to about 40 ° C in advance. A test piece was placed on a moisture permeable cup, a knockin and a ring were mounted in order, fixed with a butterfly nut, and the mounting side was sealed with bull adhesive tape to obtain a test specimen.

The specimen was placed in a constant temperature and humidity device at a temperature of 40 ± 2 ° C and a humidity of 90 ± 5% RH. Remove the specimen after 1 hour and immediately measure the mass (a) to lmg. After measurement, place the specimen again in a constant temperature and humidity chamber, remove the specimen one hour later, and immediately reduce the mass (a) to lmg.

2 measured. The moisture permeability was calculated by the following formula.

[0034] (Formula)

Moisture permeability (gZm ² Z24h) = (aa) Z (SX 24 X 10000)

twenty one

S: Breathable area (cm ² )

[0035] Example 1

To 30 parts by mass of purified water, 0.8 part by mass of polyvinyl alcohol was added, heated to 60 ° C for dissolution, and then cooled to room temperature. To this, 1.3 parts by weight of tartaric acid, 0.1 part by weight of sodium edetate and 0.1 part by weight of L-arginine (manufactured by Kyowa Hakko Kogyo), 25 parts by weight of D sorbitol solution (70%), 3 parts by weight of kaolin The aqueous phase was prepared by uniformly suspending the part. Separately, 0.5 parts by mass of indomethacin and 0.5 parts by weight of L-menthol were dissolved in 2 parts by weight of Macrogol 400 at 40 ° C, cooled to room temperature, and then 20 parts by weight of concentrated glycerin was dissolved. Thereafter, 3.5 parts by mass of rumellose sodium, 6 parts by mass of a partially neutralized polyacrylic acid and 0.1 part by mass of dihydroxyaluminum acetate were uniformly dispersed to prepare an oil phase.

Add the aqueous phase to the prepared oil phase and make the mass 100 parts by weight with purified water, then knead with a kneader (Dalton: revolution 40 rpm, rotation: 80 rpm) for 15 minutes. Got. The ball-tack adhesive strength of the patch aged at 25 ° C for 2 weeks is No. 13. there were.

[0036] A non-woven fabric of a support, in which a polyester non-woven fabric (weight per unit: lOOgZm ² ) is laminated on a polyethylene moisture-permeable film (thickness: 20 μm) with pores formed of calcium carbonate via a polyurethane adhesive. Using a spreader (made by Ikeda Machine Industry), spread the water-containing drug-containing plaster between the surface and the polypropylene liner so that the thickness of the plaster is lmm, and make it 10 x 14 cm in size. The preparation was prepared by cutting. The moisture permeability of the support was 310 (g / m ² Z24h).

[0037] Comparative Examples 1 to 4

Arginine is borax (Comparative Example 1: Kosuge Pharmaceutical), Benzoic acid (Comparative Example 2: Wako Pure Chemical Industries), Glycine (Comparative Example 3: Kyowa Hakko Kogyo) or L Isoleucine (Comparative Example 4: Kyowa Hakko Kogyo) In the same manner as in Example 1, a patch was prepared.

[0038] Comparative Example 5

To 14.5 parts by mass of purified water, 0.8 part by mass of polyvinyl alcohol was added, heated to 60 ° C for dissolution, and then cooled to room temperature. Here, 0.1 part by mass of sodium edetate and 0.1 part by mass of L-arginine (manufactured by Kyowa Hakko Kogyo), 25 parts by mass of D-sorbitol solution (70% by mass), 20 parts by mass of concentrated glycerin, macro Goal 400 2 parts by mass were sequentially added, and 3 parts by mass of kaolin were uniformly suspended. Next, 0.5 parts by mass of indomethacin, 0.5 parts by mass of L-menthol, and 3.5 parts by mass of carmellose sodium were added and mixed well. Next, 4 parts by mass of a 10% by mass dialdehyde starch aqueous solution and 25 parts by mass of a 40% by mass gelatin aqueous solution were added and mixed.

After making the mass 100 parts by mass with purified water, the mixture was mixed for 15 minutes with a propeller mixer (manufactured by HEIDON: 500 rpm) to obtain a hydrous drug-containing paste. During the non-woven surface and the polypropylene liner same support as in Example 1 (moisture permeability ^{31 0 (g / m 2 /} 24h)), hydrated drug containing plaster spreadability machine (manufactured by Ikeda Machinery Industry) It was spread so that the thickness of the plaster was 1 mm and cut into a size of 1 OX 14 cm to prepare a preparation.

[0039] Test Example 1

The patches obtained in Example 1 and Comparative Examples 1 to 5 were put in an aluminum bag one by one, sealed and aged at 25 ° C. for 2 weeks. Start after aging, 60 ° C — Indian metamorphosis after 1 week storage The residual content of indomethacin when the starting content was taken as 100% was calculated. The formulation and the results are shown in Table 1.

[0040] [Table 1]

* 1: PVA 2 1 7 S (Kuraray)

* 2: Piscomate N P—700 (neutralization degree 50 mol%, Showa Denko)

* 3: Gelatin E 1 (made by Futsubishi)

* 4: 60 ° C: After 1 week

[0041] The indomethacin-containing patch of the present invention (Example 1) was excellent in the stability of the indomethacin content over time. On the other hand, an indomethacin-containing patch containing borax (Comparative Example 1), benzoic acid (Comparative Example 2), glycine (Comparative Example 3) or isoleucine (Comparative Example 4) instead of arginine is the indomethacin of the present invention. The content stability over time was inferior to that of the containing patch. In addition, the indomethacin-containing patch (Comparative Example 5) containing gelatin instead of the partially neutralized polyacrylic acid is inferior in content stability over time compared to the indomethacin-containing patch of the present invention! / It was.

[0042] Example 2 In 30 parts by mass of purified water, 0.8 part by mass of polybulal alcohol was heated to 60 ° C and dissolved, and then cooled to room temperature. After dissolving 1.3 parts by weight of tartaric acid, 0.1 parts by weight of sodium edetate and 0.5 parts by weight of L-arginine, 25 parts by weight of D-sorbitol solution (70%) and 3 parts by weight of kaolin were added. A water phase was prepared by suspending uniformly. Separately, 0.5 parts by mass of indomethacin and 0.5 parts by mass of L menthol were dissolved in 2 parts by mass of Macrogol 400 at 40 ° C, and then cooled to room temperature. After dissolving 20 parts by mass of concentrated glycerin, 3.5 parts by mass of carmellose sodium, 6 parts by mass of partially neutralized polyacrylic acid and 0.1 part by mass of dihydroxyaluminum acetate were prepared to prepare an oil phase. did.

An indomethacin-containing patch was prepared in the same manner as in Example 1.

[0043] Example 3

One part by weight of gelatin was dissolved in 27 parts by weight of purified water at 60 ° C. Lactic acid 1.25 parts by mass, L-arginine (manufactured by Kyowa Hakko Kogyo Co., Ltd.) 0.1 part by mass, D-sorbitol solution (70%) 22 parts by mass and kaolin 3 parts by mass An aqueous phase was prepared by dispersing. Separately, 2.5 parts by mass of light liquid paraffin was dissolved in 10 parts by mass of ester gum at 120 ° C. to prepare an adhesive phase. Separately, 1 part by mass of indomethacin and 1 part by mass of L-menthol were dissolved at 40 ° C and cooled to room temperature. To this, 22 parts by mass of concentrated glycerin, 3 parts by mass of carmellose sodium, 3.5 parts by mass of partially neutralized polyacrylic acid and 0.2 parts by mass of dried aluminum hydroxide gel were added and dispersed uniformly to prepare an oil phase. did.

After heating the aqueous phase to 120 ° C, the pressure-sensitive adhesive phase was added and dispersed uniformly. After cooling to room temperature, an oil phase was added, and a paste containing indomethacin was prepared with purified water at a total mass of 100 parts by mass.

In the same manner as in Example 1, the patch was spread so that the thickness of the plaster was 0.2 mm to prepare an indomethacin-containing patch.

[0044] The stability of indomethacin content over time of the indomethacin-containing patches prepared in Examples 2 and 3 was good. In addition, the surface was dry when applied, and the feeling of use was good.

Claims

The scope of the claims

[1] A patch comprising a nonwoven fabric or a woven fabric laminated with a polyethylene moisture-permeable film and an adhesive and an indomethacin-containing plaster strength, comprising indomethacin-containing plaster strength 0.1-10 mass ⁰ / _0, arginine or a salt thereof 0.01 to 10 mass ^_0/0, indomethacin-containing patch which is characterized in that it contains polyacrylic acid unit content neutralized product 0.1 to 20% by weight and 10 to 70% by weight of water Agent.

[2] The indomethacin-containing patch according to claim 1, which has a moisture permeability S200 to 3000 (g / m ² / 24h) of a nonwoven fabric or a woven fabric laminated with a polyethylene moisture permeable film via an adhesive.

[3] The patch containing indomethacin according to claim 1 or 2, further comprising 0.001 to 1% by mass of a crosslinking agent in the paste containing indomethacin.

[4] Further, the indomethasin-containing plaster contains 0.5 to 15% by mass of a mineral powder.

The indomethacin-containing patch according to any one of 1 to 3.

[5] The patch containing indomethacin according to any one of claims 1 to 4, further comprising 0.001 to 3% by mass of a curing regulator in the indomethacin-containing plaster.