JPH07157423A - Percutaneously absorbable cataplasm - Google Patents

Abstract

PURPOSE:To obtain a percutaneously absorfable cataplasm having low stimula tion on a skin even when stuck to a person with a hypersensitive skin and easily getting a rash. CONSTITUTION:This cataplasm has a formed adhesive layer containing a medicine at least on one surface of a supporting body, where an adhesive forming the adhesive layer is either one of an acrylic based one, a rubber based one or a silicone based one, and the adhesive strength of the adhesive layer is 5-100g/10mm and a moisture permeability of the whole adhesive for 30-60mum adhesive layer thickness is 1000-10000g/m<2>/day. The supporting body of the adhesive is preferably flexible and has >=1000g/m<2>/day moisture permeability and its thickness is preferably <=500mum, especially 5-150mum in view of use feeling and the thickness of the adhesive layer is suitably 30-60mum.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a transdermal patch.

[0002]

2. Description of the Related Art In recent years, as a percutaneous absorption preparation for administering a drug into a living body through the skin, an external preparation for sticking to the skin such as a patch or tape using a plaster or an adhesive has been developed. There is. This percutaneous absorption preparation is often applied to the same site on the skin for a long time or repeatedly, and the skin irritation caused by this is a problem.

As a measure to eliminate this skin irritation, a gel preparation that does not irritate the skin surface at the time of peeling is obtained by using a gel-like pressure-sensitive adhesive layer having a skin adhesive force so that the corneocytes on the skin surface do not peel off. It is disclosed (Japanese Patent Laid-Open No. 5-65224). However, in the case of humans whose skin is sensitive to the above-mentioned gel preparation, the skin at the application site may become red before peeling off the gel preparation, or skin irritation such as itching may appear, and it is only necessary to reduce the exfoliation of the skin. There was a problem that the stimulus could not be suppressed.

[0004]

SUMMARY OF THE INVENTION The present invention has been made in view of the above-mentioned drawbacks, and it is an object of the present invention that the skin irritation is low even when it is applied to a person whose skin is sensitive and easily rashes. It is to provide a transdermal patch.

[0005]

[Means for Solving the Problems]

The transdermal patch of the present invention comprises a support having a pressure-sensitive adhesive layer provided on at least one surface thereof, and the pressure-sensitive adhesive layer is formed from a pressure-sensitive adhesive composition comprising a pressure-sensitive adhesive and a drug. .

The support is preferably flexible and has a moisture permeability of 1,000 g / m ² / day or more.

Examples of such a support include polyurethane,
Resin films such as porous polyethylene; woven or non-woven fabrics such as cotton, polyester, rayon, polypropylene and the like can be mentioned, and these are used as a single layer or a laminate.

The thickness of the above-mentioned support is determined in consideration of the feeling of use.
It is preferably 500 μm or less, more preferably 5 to 150.
μm.

The pressure-sensitive adhesive is any one selected from acrylic pressure-sensitive adhesives, rubber-based pressure-sensitive adhesives, and silicon-based pressure-sensitive adhesives that have pressure sensitivity at room temperature.

As the acrylic pressure-sensitive adhesive, one having a (meth) acrylic acid alkyl ester (co) polymer as a main component is preferable, and the (meth) acrylic acid alkyl ester (co) polymer has 1 to 1 carbon atoms. 18) A (co) polymer of an aliphatic alcohol and a (meth) acrylic acid alkyl ester monomer obtained from (meth) acrylic acid, or a copolymerization of the (meth) acrylic acid alkyl ester monomer and another functional monomer Coalescence is preferably used.

Examples of the (meth) acrylic acid alkyl ester monomer include methyl (meth) acrylate, ethyl (meth) acrylate, butyl (meth) acrylate, isobutyl (meth) acrylate, and (meth) acrylic acid. Hexyl, octyl (meth) acrylate, (meth)
2-ethylhexyl acrylate, isooctyl (meth) acrylate, decyl (meth) acrylate, isodecyl (meth) acrylate, lauryl (meth) acrylate,
Stearyl (meth) acrylate and the like can be mentioned, and one or more of these are used.

Examples of the functional monomer include a monomer having a hydroxyl group, a monomer having a carboxyl group, a monomer having an amide group, a monomer having an amino group, and the like.

Examples of the above-mentioned monomer having a hydroxyl group include 2-hydroxyethyl (meth) acrylate,
Hydroxyalkyl (meth) acrylate such as hydroxypropyl (meth) acrylate is preferably used.

Examples of the monomer having a carboxyl group include α, β such as (meth) acrylic acid.
-Unsaturated carboxylic acid; maleic acid monoalkyl ester such as butyl maleate; (anhydrous) maleic acid, fumaric acid, crotonic acid, etc. are preferably used.

Examples of the monomer having an amide group include alkyl (meth) acrylamides such as acrylamide, dimethylacrylamide and diethylacrylamide; alkyl ether methylol (meth) acrylamides such as butoxymethylacrylamide and ethoxymethylacrylamide; diacetone acrylamide and N. −
Vinylpyrrolidone and the like are preferably used.

As the monomer having an amino group, for example, dimethylaminoethyl acrylate is preferably used.

Functional monomers other than those mentioned above include vinyl acetate, styrene, α-methylstyrene, vinyl chloride,
Acrylonitrile, ethylene, propylene, butadiene, etc. can also be used.

If necessary, a polyfunctional monomer copolymerizable with other monomers may be added to the acrylic pressure-sensitive adhesive as long as it does not adversely affect the drug release and the mildness. Good. This polyfunctional monomer causes only slight cross-linking between the resulting copolymers, increasing the internal cohesive strength of the adhesive. This internal cohesive force almost eliminates the so-called adhesive residue phenomenon that occurs when the transdermal patch is peeled off, regardless of the properties of the applied skin and the amount of perspiration.

Examples of the polyfunctional monomer include, for example,
Di (meth) acrylate, tri (meth) acrylate,
Tetra (meth) acrylate is mentioned, and specifically,
Di (meth) acrylate obtained by reacting polymethylene glycols such as hexamethylene glycol and octamethylene glycol with (meth) acrylic acid; polyalkylene glycols such as polymethylene glycol and polypropylene glycol and (meth) acrylic acid Di (meth) acrylate obtained by the reaction; tri (meth) acrylates such as trimethylolpropane tri (meth) acrylate and glycerin (meth) acrylate, and tetra (meth) acrylates such as pentaerythritol tetra (meth) acrylate. . Two or more kinds of these polyfunctional monomers may be used in combination.

If the amount of the polyfunctional monomer used is small, the effect of improving the internal cohesive force due to the crosslinking of the pressure-sensitive adhesive will not be obtained, and if it is large, the pressure-sensitive adhesive will easily gel and adversely affect the diffusion and release of the drug. 0.005-0.5% by weight is preferable in all the monomers used for the pressure-sensitive adhesive.

The above-mentioned acrylic pressure-sensitive adhesive is prepared, for example, by mixing the above-mentioned monomers in the presence of a polymerization initiator and carrying out solution polymerization.

Examples of the rubber-based adhesive include natural rubber, styrene-isoprene-styrene block copolymer (SIS), polyisoprene (IR), polybutene,
Those using a rubber elastic material such as polyisobutylene or ethylene-vinyl acetate copolymer as a base polymer are preferably used.

As the above-mentioned silicone-based pressure-sensitive adhesive, those containing polydimethylsiloxane as a main component are preferably used.

If desired, tackifiers, plasticizers, fillers, anti-aging agents and the like may be added to the acrylic, rubber and silicone adhesives. Examples of the tackifier include rosin-based resins, terpene-based resins, petroleum resins, coumarone-indene resins, terpene-phenol resins and the like. As the plasticizer,
Examples thereof include softening agents such as liquid polybutene, mineral oil, lanolin, liquid polyisoprene, and liquid polyacrylate.

When a tackifier is added to the rubber-based pressure-sensitive adhesive, 20 to 200 parts by weight of the tackifier is preferably added to 100 parts by weight of the base polymer.

The above-mentioned drug is not particularly limited as long as it can permeate the biological membrane transdermally, and the followings are specifically mentioned.

Acetaminophenone, phenacetin, mefenamic acid, diclofenac sodium, flufenamic acid, aspirin, sodium salicylate, aminopyrine, alclofenac, ibuprofen, naproxen, flurpiprofen, ketoprofen, amphenac sodium, mepyrizole, indomethacin, pentazocine. , Antipyretic and analgesic anti-inflammatory agents such as piroxicam; steroidal anti-inflammatory agents such as hydrocortisone, triamcinolone, dexamethasone and prednisolone.

Vasodilators such as diltiazem hydrochloride, pentaerythritol tetranitrate, isosorbide dinitrate, trazipyr, nicorandil, nitroglycerin, prenylamine lactate, molsidomine, amyl nitrite, tolazoline hydrochloride, nifedipine; procainamide hydrochloride, lidocaine hydrochloride,
Antiarrhythmic agents such as propranolol hydrochloride, alprenolol hydrochloride, atenolol, nadolol, metoprolol tartrate, azimarin, disopyramide, mexiletine hydrochloride;
Antihypertensive agents such as ecarazine hydrochloride, indapamide, clonidine hydrochloride, bunitrolol hydrochloride, labetalol hydrochloride, captopril, guanabenz acetate, mebutamate, betanidine sulfate.

Carbetapentane citrate, cloperastine, oxerazine tannate, cloptinol hydrochloride, clofedanol hydrochloride, noscapine hydrochloride, ephedrine hydrochloride, isoproterenol hydrochloride, chlorprenaline hydrochloride,
Antitussive and expectorant such as methoxyphenamine hydrochloride, procaterol hydrochloride, tulopterol hydrochloride, clenpterol hydrochloride and ketotifen fumarate.

Anti-neoplastic agents such as cyclophosphamide, fluorouracil, degafur, mitomycin C, procarbazine hydrochloride, doxyfluridine, lanimustine; ethyl aminobenzoate, tetracaine hydrochloride, brocaine hydrochloride, dibucaine hydrochloride, oxybuprocaine hydrochloride,
Local anesthetic such as propitocaine hydrochloride.

Hormonal agents such as propylthiouracil, thiamazole, metelonone acetate, estradiol, estriol, progesterone; antihistamines such as diphenhydramine hydrochloride, chlorpheniramine maleate, promethazine, cyproheptadine hydrochloride, diphenylpyraline hydrochloride.

Anticoagulants such as warfarin potassium and ticlopidine hydrochloride; antispasmodics such as methylatropine bromide and scopolamine; general anesthetics such as thiopental sodium and pentobarbital sodium; hypnotic and analgesic such as bromvalenylurea, amobarbital and phenobarbital. Agents: antiepileptic agents such as phenytoin sodium.

Stimulants / stimulants such as methamphetamine hydrochloride; sedatives such as difendol hydrochloride and betahistine mesylate; psychotropic agents such as chlorpromazine hydrochloride, thioridazine, meprobamate, imipramine hydrochloride, chlordiazepoxide, diazepam; suskimethonium hydrochloride, eperisone hydrochloride, etc. Skeletal muscle relaxant; neostigmine bromide,
Agents for autonomic nerves such as bethanechol chloride; anti-Parkinson agents such as amantadine hydrochloride.

Diuretics such as hydroflumethiazide, isosorbide and furosemide; vasoconstrictors such as phenylephrine hydrochloride; respirators such as lobeline hydrochloride, dimorphoramine and naloxone hydrochloride; glycopyrronium bromide, proglumide,
Remedies for peptic ulcer such as cetraxate hydrochloride, cimetidine, and spizofron; choleretic agents such as ursodesoxycholic acid and osalmid; agents for genitourinary and anus such as hexamine, spartine, dinoprost, and ritodrine hydrochloride.

Agents for parasitic skin diseases such as salicylic acid, ciclopirox olamine and croconazole hydrochloride; emollients such as urea; calcitriol, thiamine hydrochloride, riboflapine sodium phosphate, pyridoxine hydrochloride, nicotinic acid amide, bread Vitamin preparations such as tenol and ascorbic acid; mineral preparations such as calcium chloride, potassium iodide and sodium iodide.

Hemostatic agents such as ethanesylate; agents for liver diseases such as thiopronin; agents for addictive addiction such as cyanamide; agents for respiring colchicine, probenecid, sulfinpyrazone etc .; tolbutamide, chlorpropamide, sodium glymidine, glypzole. , Pformin hydrochloride, insulin and other antidiabetic agents.

Benzylpenicillin potassium, propicillin potassium, cloxacillin sodium, ampicillin sodium, bacampyricin hydrochloride, carbenicillin sodium, cephaloridine, cefoxitin sodium,
Antibiotics such as erythromycin, chloramphenicol, tetracycline, kanamycin sulfate and cycloserine; chemotherapeutic agents such as isocyanide, pyrazinamide and ethionamide; narcotics such as morphine hydrochloride, codeine phosphate, cocaine hydrochloride and pethidine hydrochloride.

The amount of the above-mentioned drug added varies depending on the kind of the drug and the purpose of use of the transdermal patch, but it is usually preferably 0.01 to 50% by weight in the pressure-sensitive adhesive composition. The amount of the drug added is appropriately determined depending on the composition of the pressure-sensitive adhesive within the above range, but by dissolving it in the pressure-sensitive adhesive at a concentration as close as possible to the saturated solubility so that crystal precipitation does not occur, a high release property is obtained. Is obtained.

The composition of the transdermal patch of the present invention is as described above, and its production can be carried out by a conventionally known method for producing an adhesive tape. A typical example thereof is a solvent coating method, and other examples include a hot melt coating method and an emulsion coating method.

When carrying out solvent coating, for example, a predetermined amount of an adhesive, a drug and a percutaneous absorption enhancer are dissolved or dispersed in a solvent such as ethyl acetate, and the obtained liquid is applied onto a support,
A method of drying, a method of coating on a release paper, drying and then transferring to a support, and the like are preferably used. This release paper may be used to protect the adhesive layer of the patch until use.

The thickness of the above-mentioned pressure-sensitive adhesive layer is preferably 30 to 60 μm, because when it becomes thin, the drug concentration cannot be obtained, and when it becomes thick, the required moisture permeability cannot be obtained.

When the adhesive strength of the above-mentioned pressure-sensitive adhesive layer becomes small, it becomes difficult to apply it to the skin, and when it becomes large, it adversely affects the skin when the transdermal absorption patch is peeled off.
Limited to g / 10 mm. This adhesive strength is JIS Z
It is a value measured according to the 180 degree peeling method of 0237.

When the moisture permeability of the percutaneous absorption patch of the present invention is small, skin irritation may occur in hypersensitive humans, and when it is large, the drug release property is deteriorated. Therefore, the thickness of the adhesive layer is 30 to 60 μm. At 1,000 to 10,
Limited to 000 g / m ² / day. This moisture permeability is JI
It is a value measured according to S Z0237.

The above-mentioned percutaneous absorption patch is cut into a predetermined shape and housed and stored in a packaging material. As the packaging material, a material that does not permeate oxygen or does not easily permeate oxygen is preferable. Examples thereof include an aluminum foil coated with polyethylene terephthalate or polyethylene, and a laminated film of polyvinylidene chloride and polyvinyl chloride.

[0045]

EXAMPLES Next, examples of the present invention will be described. (Example 1) 2-ethylhexyl acrylate (hereinafter referred to as E
348.5 g (75 mol%) of HA), 70.0 g (25 mol%) of vinylpyrrolidone (hereinafter referred to as VP) and 40.0 mg (0.02 wt%) of 1,6-hexamethylene glycol dimethacrylate are stirred. Then, the mixture was placed in a separable flask equipped with a cooling device, and 418.5 g of ethyl acetate was further added to adjust the monomer concentration to 50% by weight. The temperature of this solution was raised to 60 ° C. under a nitrogen atmosphere, and a solution of 2 g of lauroyl peroxide dissolved in 100 g of cyclohexane was divided into 10 parts, 1 of which was added to the separable flask within 5 hours of the initial reaction, and then the remaining No. 9 was added at 1 hour intervals. Separately prepare 250 g of ethyl acetate,
While observing the temperature rise and viscosity of the reaction system, the reaction system was added so that the reaction system would not run away and that stirring could be sufficiently performed.
Polymerization was carried out for a period of time to obtain an acrylic pressure-sensitive adhesive (hereinafter referred to as acrylic pressure-sensitive adhesive A) solution.

Ethyl acetate was added to the acrylic adhesive A solution to adjust the solid content concentration to 28% by weight, and 90 g (solid content) of the adhesive was mixed with 10 g of ketoprofen,
A pressure-sensitive adhesive composition was obtained by uniformly mixing with a dissolver. The obtained composition was applied onto a polyethylene-treated polyethylene terephthalate film (thickness: 48 μm) and dried in a gear oven at 60 ° C. for 30 minutes to form a pressure-sensitive adhesive layer having a thickness of 50 μm. Nylon non-woven fabric as a body (“Eltus N01020” manufactured by Asahi Kasei)
The pressure-sensitive adhesive layer was transferred and laminated onto the above to obtain the transdermal patch of the present invention.

Example 2 A transdermal patch was obtained in the same manner as in Example 1 except that 85 parts by weight (solid content) of the acrylic adhesive A was mixed with 15 parts by weight of nifedipine.

Example 3 A transdermal patch was obtained in the same manner as in Example 1 except that 80 parts by weight (solid content) of acrylic adhesive A was mixed with 20 parts by weight of isosorbide dinitrate.

Example 4 A transdermal patch was obtained in the same manner as in Example 1 except that 90 parts by weight (solid content) of acrylic adhesive A was mixed with 10 parts by weight of clonidine hydrochloride.

Example 5 A transdermal patch was obtained in the same manner as in Example 1 except that 90 parts by weight (solid content) of acrylic adhesive A was mixed with 10 parts by weight of estradiol.

(Example 6) 25 parts by weight of a styrene-isoprene-styrene block copolymer ("Califlex TR1107" manufactured by Shell Chemical Co.) as a base polymer,
42 parts by weight of alicyclic hydrogenated petroleum resin (“Arcon-P90” manufactured by Arakawa Chemical Co., Ltd.) as a tackifier, 3 parts by weight of polybutene (“HV-300” manufactured by Nisseki Chemical Co., Ltd.) as a softening agent, and liquid paraffin 30 Parts by weight of cyclohexane 18
It was dissolved in 6 parts by weight to obtain a rubber pressure-sensitive adhesive C solution having a solid content of 35% by weight. An adhesive composition prepared by mixing 90 parts by weight (solid content) of the above rubber-based adhesive C solution with 10 parts by weight of ketoprofen was coated on a release paper treated with a silicone terephthalate film so that the thickness after drying was 30 μm. After working, it was dried at 60 ° C. for 30 minutes to form a pressure-sensitive adhesive layer. Then, a pressure-sensitive adhesive layer was transferred and laminated on a nylon nonwoven fabric (“ELTAS N01020” manufactured by Asahi Kasei Corp.) as a support to obtain a transdermal patch of the present invention.

Example 7 55 parts by weight of Silascon 355 (manufactured by Dow Corning Co., Ltd.) as a silicone adhesive and 45 parts by weight of a terpene resin were dissolved in tetrahydrofuran to adjust the solid content concentration to 15% by weight, and then the solid content was 85%. 5 parts by weight of isopropyl myristate, 10 parts by weight of ketoprofen and 10 parts by weight of tetrahydrofuran were placed in a container and uniformly mixed using a dissolver to prepare an adhesive composition. After coating the above-mentioned pressure-sensitive adhesive composition on a release paper treated with a silicone terephthalate film so as to have a thickness after drying of 50 μm, 6
It dried at 0 degreeC for 30 minutes, and formed the adhesive layer. Then
Nylon non-woven fabric as a support (“Eltas N” manufactured by Asahi Kasei Corporation)
[01020]), and the pressure-sensitive adhesive layer was transferred and laminated on the above to obtain the transdermal patch of the present invention.

Comparative Example 1 A transdermal patch was obtained in the same manner as in Example 1 except that a polyethylene film having a thickness of 30 μm was used as a support.

Comparative Example 2 A transdermal patch was obtained in the same manner as in Example 2, except that a polyethylene film having a thickness of 30 μm was used as a support.

Comparative Example 3 A transdermal patch was obtained in the same manner as in Example 3 except that a polyethylene film having a thickness of 30 μm was used as a support.

Comparative Example 4 A transdermal patch was obtained in the same manner as in Example 4 except that a polyurethane film having a thickness of 50 μm was used as a support.

Comparative Example 5 A transdermal patch was obtained in the same manner as in Example 5, except that a polyurethane film having a thickness of 50 μm was used as a support.

Comparative Example 6 A transdermal patch was obtained in the same manner as in Example 6 except that a polyethylene film having a thickness of 50 μm was used as a support.

Comparative Example 7 A transdermal patch was obtained in the same manner as in Example 7 except that a polyethylene film having a thickness of 50 μm was used as a support.

Example 8 EHA 302 g (65 mol%), VP 98 g (35 mol%) and 1,6-hexamethylene glycol dimethacrylate 40 mg (0.02)
(Wt%) was charged into a separable flask equipped with a stirrer and a cooling device, and 418.5 g of ethyl acetate was further added to adjust the monomer concentration to 50 wt%. The temperature of this solution was raised to 60 ° C. under a nitrogen atmosphere, and a solution of 2 g of lauroyl peroxide dissolved in 100 g of cyclohexane was divided into 10 parts.
Was added to the separable flask within 5 hours of the initial reaction, and then the remaining 9 was added at 1-hour intervals. Separately, prepare 250 g of ethyl acetate and add it so that the reaction system does not run away while observing the temperature rise and viscosity of the reaction system and allow sufficient stirring, and polymerize for a total of 32 hours to obtain an acrylic adhesive (hereinafter acrylic Adhesive B) solution was obtained.

Ethyl acetate was added to the acrylic pressure-sensitive adhesive B solution to prepare a solid content concentration of 28% by weight, and then 90% by weight of the acrylic pressure-sensitive adhesive B solid content was mixed with 10 parts by weight of ketoprone. The agent composition was applied onto a release paper treated with a polyethylene terephthalate film to give a thickness of 50 μm after drying.
It dried at 30 degreeC for 30 minutes, and formed the adhesive layer. Then, as a support, a non-woven nylon fabric (“ELTAS N0 manufactured by Asahi Kasei Corporation
1020 ") and the adhesive layer was transferred onto it to obtain the transdermal patch of the present invention.

Comparative Example 9 Transdermal absorption patch was carried out in the same manner as Comparative Example 8 except that 15 parts by weight of nifedipine was added to 85 parts by weight of acrylic adhesive B (solid content) to prepare an adhesive composition solution. I got an agent.

Comparative Example 10 Transdermal absorption was performed in the same manner as in Comparative Example 8 except that 20 parts by weight of isosorbide dinitrate was added to 80 parts by weight of acrylic adhesive B (solid content) to prepare an adhesive composition solution. A patch was obtained.

(Comparative Example 11) Transdermal absorption was performed in the same manner as in Comparative Example 8 except that 10 parts by weight of clonidine hydrochloride was added to 90 parts by weight of acrylic adhesive B (solid content) to prepare an adhesive composition solution. A patch was obtained.

Comparative Example 12 Transdermal absorption patch was carried out in the same manner as Comparative Example 8 except that 10 parts by weight of estradiol was added to 90 parts by weight of acrylic adhesive B (solid content) to prepare an adhesive composition solution. I got an agent.

(Comparative Example 13) 35 parts by weight of a styrene-isoprene-styrene block copolymer ("Califlex TR1101" manufactured by Shell Chemical Co.) as a base polymer, and an alicyclic hydrogenated petroleum resin (Arakawa Chemical Co., Ltd.) as a tackifier. 55 parts by weight of "Arcon-P90" manufactured by the company, and polybutene as a softening agent ("HV-300" manufactured by Nisseki Chemical Co., Ltd.)
10 parts by weight was dissolved in 186 parts by weight of cyclohexane to obtain a rubber adhesive D solution having a solid content of 35% by weight. An adhesive composition prepared by mixing 90 parts by weight (solid content) of the above rubber-based adhesive D with 10 parts by weight of ketoprofen was applied onto a release paper treated with a polyethylene terephthalate film so that the thickness after drying would be 30 μm. After 6
It dried at 0 degreeC for 30 minutes, and formed the adhesive layer. Then
Nylon non-woven fabric as a support (“Eltas N” manufactured by Asahi Kasei Corporation)
01020 ") to transfer the pressure-sensitive adhesive layer thereon to obtain the transdermal patch of the present invention.

Performance Evaluation of Percutaneous Absorption Patches The following performance evaluations were conducted on the transdermal absorption patches obtained in the above Examples and Comparative Examples, and the results are shown in Table 1. (1) Adhesiveness In accordance with JIS Z0237, a strip-shaped transdermal absorption patch is applied to a stainless steel plate, and is reciprocated once with a roller having a weight of 2 kg to bring it into close contact.
Peeling was performed at a speed of mm / min, and 180 degree peeling was performed to measure the adhesive force.

(2) Water vapor transmission rate In accordance with JIS Z0237, a cup containing 15 g of a moisture absorbent.
Was put, and the adhesive layer of the transdermal patch was attached to the cup with the adhesive layer facing inward, the periphery was sealed with paraffin, and the weight change after 24 hours was measured to determine the moisture vapor transmission rate.

(3) Guinea pig skin irritation test A transdermal patch was applied to the shaved abdomen of a Hartley type 5 week old guinea pig for 48 hours after occluding and peeling, and 30 minutes after peeling, skin irritation The determination was performed using the Draize criterion, and the average value was calculated.

(4) Human skin irritation test: 20 adults, 2 cm in diameter (3.1 cm) inside the upper arm
A percutaneous absorption patch punched out in a circular shape of 4 cm ² ) was occluded for 48 hours, and after peeling, the total evaluation was divided by the number of subjects for the skin irritation by the Japanese patch test research group's judgment method, and multiplied by 100. The skin irritation index was calculated.

[0071]

[Table 1]

[0072]

The composition of the transdermal patch of the present invention is as described above, and the adhesive force of the adhesive layer is weakened and the moisture permeability is increased to reduce the skin irritation during application. It can be applied to human skin sensitive to skin irritation with a sense of security.

Claims (1)

[Claims] 1. A percutaneous absorption patch having a pressure-sensitive adhesive layer containing a drug formed on at least one surface of a support, wherein the pressure-sensitive adhesive forming the pressure-sensitive adhesive layer is an acrylic pressure-sensitive adhesive or a rubber-based pressure-sensitive adhesive. And any one selected from silicone-based adhesives, wherein the adhesive force of the adhesive layer is 5 to 100 g / 10 mm, and the thickness of the adhesive layer is 30 to 60 μm. Water vapor transmission rate is 1,000 to 10,000
A transdermal patch, which is 0 g / m ² / day.