Patch with cover

Abstract

To provide a plaster with cover material which preferably maintains a contact state of a plaster with skin, has excellent adhesive property of a cover material, and suppresses uncomfortable stickiness.SOLUTION: A plaster 1 with cover material comprises: a plaster part 10 having a support body 12 and a drug layer 11 formed on the support body; and a cover part 30 having a cover layer 31 and a cover adhesive layer 32 formed on the cover layer, where the cover adhesive layer is joined to the support body so as to cover the plaster part. The cover layer consists of nonwoven fabric, an elongation rate of the nonwoven fabric in a flow direction and a width direction is 60% or more, and one elongation rate is twice or less the other elongation rate, the cover adhesive layer is constituted by using a rubber-based adhesive agent having a rubber-based adhesive base agent as a main adhesive base agent, and the loss tangent (tanδ) at 32°C and 0.1 Hz is 0.6 to 0.95.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to a patch with a cover material. [Background technology]

[0002] Transdermal and transmucosal absorption preparations have been developed as preparations for administering drugs to the body. Among them, patches have attracted attention because they are easy to handle and can maintain effective blood drug concentrations for a long period of time.

[0003] If the patch becomes partially or completely detached from the skin during administration, the drug concentration in the blood cannot be maintained. To prevent this, a cover material is known that covers the patch and attaches it to the skin to prevent the patch from peeling off and maintain the patch in contact with the skin. For example, Patent Document 1 describes a cover sheet that has both a specific adhesive strength and elasticity to supplement the skin adhesive strength of the patch preparation and ensure its adhesion to the skin surface, and a method for using the cover sheet. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 11-343232 Summary of the Invention [Problem to be solved by the invention]

[0005] Conventional covering materials, including that described in Patent Document 1, have problems such as insufficient adhesion, and unintended external forces such as the user's movements or vibrations while applying the patch can cause the adhesive to gradually protrude beyond the periphery of the formulation, resulting in unpleasant stickiness. The inventors have conducted extensive research focusing on the backing and adhesive of the cover material, and have found that a patch with a cover material that can solve all of the above problems can be provided by combining a specific backing and adhesive, thereby completing the present invention.

[0006] In light of the above-mentioned circumstances, the present invention aims to provide a patch with a cover material, which maintains the patch in good contact with the skin and has a cover material with excellent adhesion and which suppresses unpleasant stickiness. [Means for solving the problem]

[0007] The present invention is a patch with a cover material, which comprises a patch portion having a support and a drug layer formed on the support, and a cover portion having a cover layer and a cover adhesive layer formed on the cover layer, with the cover adhesive layer bonded to the support so as to cover the patch portion. The cover layer is made of a nonwoven fabric, and the extensibility of the nonwoven fabric in both the machine direction and the width direction is 60% or more, with one extensibility being no more than twice the other. The cover adhesive layer is made of a rubber-based adhesive containing a rubber-based adhesive as the main adhesive base, and has a loss tangent (tan δ) at 32° C. and 0.1 Hz of 0.6 to 0.95. Effect of the Invention

[0008] According to the present invention, it is possible to provide a patch with a cover material which maintains a state in which the patch is in good contact with the skin, has excellent adhesion, and at the same time, suppresses unpleasant stickiness. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a plan view showing a patch with a cover material according to one embodiment of the present invention. [Diagram 2] FIG. 2 is a cross-sectional view taken along line II in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] An embodiment of the present invention will be described below. Fig. 1 is a plan view of a patch with cover material 1 according to this embodiment, and Fig. 2 is a cross-sectional view taken along line II in Fig. 1. The patch with cover material 1 comprises a patch portion 10 containing a drug, and a cover portion 30 joined to the patch portion 10.

[0011] 2, patch portion 10 has drug layer 11 and support 12. Drug layer 11 contains a desired drug, and the drug is transdermally absorbed into the body of the user by contact with the skin. Since the patch with cover material 1 maintains contact between drug layer 11 and the skin mainly through the adhesion of cover portion 30, drug layer 11 may or may not be adhesive, but it is preferable for drug layer 11 to be adhesive, as this will ensure that drug layer 11 maintains contact with the skin in an optimal manner and ensure continuous administration of the drug.

[0012] Drug layer 11 contains a base and a drug. Among the bases, examples of adhesive bases for imparting adhesiveness to drug layer 11 include rubber-based adhesive bases, acrylic-based adhesive bases, silicone-based adhesive bases, and the like. The adhesive base is preferably at least one selected from the group consisting of rubber-based adhesive bases, acrylic-based adhesive bases, and silicone-based adhesive bases. The adhesive base may be any one of rubber-based adhesive bases, acrylic-based adhesive bases, and silicone-based adhesive bases, or a combination thereof. The total content of the adhesive base may be 10% by mass to 95% by mass, or may be 20% by mass to 90% by mass, based on the total mass of drug layer 11. It is preferable that drug layer 11 is substantially free of water (non-aqueous). In the present invention, "substantially free of water" means that there is no step in the manufacturing process in which water is intentionally blended into the drug layer, and does not exclude moisture in the air, etc., that is contained during the manufacturing process, or moisture absorbed as sweat, etc. during application of the patch to the skin.

[0013] Examples of rubber-based adhesive bases include, but are not limited to, styrene-isoprene block copolymers, styrene-isoprene-styrene block copolymers, polyisoprene, polyisobutylene, polybutene, styrene-butadiene block copolymers, styrene-butadiene-styrene block copolymers, natural rubber, alkyl vinyl ether (co)polymers, and polybutadiene. From the viewpoints of adhesion, extensibility, and cohesive strength, styrene-butadiene-styrene block copolymers and polyisobutylene are particularly preferred. Among rubber-based adhesive bases, specific examples of styrene-isoprene-styrene block copolymers include Quintac (registered trademark) 3570C (trade name, manufactured by Zeon Corporation), SIS5002, SIS5229, SIS5505, SIS5505P (trade name, manufactured by JSR Corporation), SIBSTAR (registered trademark) T102 (trade name, manufactured by Kaneka Corporation), etc. Polyisobutylene also includes so-called butyl rubber (isobutylene-isoprene rubber). Specific examples of polyisobutylene include Oppanol (registered trademark) N50, N80, N100, N150, B11, B12, B50, B80, B100, B120, B150, B220 (trade names, manufactured by BASF), JSR (registered trademark) Butyl 065, 268, 365 (trade names, manufactured by JSR Corporation), X_Butyl (registered trademark) RB100, 101-3, 301, 402 (trade names, manufactured by ARLANXEO), Exxon (registered trademark) Butyl 065, 065S, 068, 068S, 268, 268S, 365, 365S (trade names, manufactured by Exxon Mobile), and Butyl 065, 268, 365 (trade names, manufactured by Japan Butyl Co., Ltd.). When drug layer 11 contains a rubber-based adhesive base, the content of the rubber-based adhesive base can be 10% by mass to 95% by mass, or may be 20% by mass to 90% by mass, based on the total mass of drug layer 11.

[0014] The acrylic adhesive base is not particularly limited, and may be, for example, a (co)polymer of one or more (meth)acrylic acid alkyl esters. Examples of (meth)acrylic acid alkyl esters include butyl (meth)acrylate, isobutyl (meth)acrylate, hexyl (meth)acrylate, octyl (meth)acrylate, 2-ethylhexyl (meth)acrylate, and decyl (meth)acrylate. In this specification, the term "(meth)acrylic acid" means either or both of acrylic acid and methacrylic acid, and similar expressions are defined in the same manner.

[0015] The acrylic adhesive base is not particularly limited, and may be a copolymer formed from a (meth)acrylic acid alkyl ester (main monomer) and a comonomer. Examples of the main monomer include methyl (meth)acrylate, ethyl (meth)acrylate, butyl (meth)acrylate, hexyl (meth)acrylate, heptyl (meth)acrylate, octyl (meth)acrylate, and 2-ethylhexyl (meth)acrylate. One of these may be used alone, or two or more may be used in combination. The comonomer may be any component that can be copolymerized with the (meth)acrylic acid alkyl ester. Examples of the comonomer include (meth)acrylic acid hydroxyalkyl ester, ethylene, propylene, styrene, vinyl acetate, N-vinylpyrrolidone, (meth)acrylic acid, and (meth)acrylic acid amide. The comonomer may be one of the above, or two or more may be used. Specific examples of such acrylic adhesive bases include the DURO-TAK series (manufactured by Henkel) such as DURO-TAK (registered trademark) 387-2510, DURO-TAK (registered trademark) 87-2510, DURO-TAK (registered trademark) 387-2287, DURO-TAK (registered trademark) 87-2287, DURO-TAK (registered trademark) 87-4287, DURO-TAK (registered trademark) 387-2516, DURO-TAK (registered trademark) 87-2516, DURO-TAK (registered trademark) 87-2074, DURO-TAK (registered trademark) 87-900A, DURO-TAK (registered trademark) 87-901A, DURO-TAK (registered trademark) 87-9301, and DURO-TAK (registered trademark) 87-4098; GELVA (registered trademark) GMS 788, GELVA (registered trademark) GMS Examples of such series include the GELVA series (manufactured by Henkel), such as GELVA 3083 and GELVA (registered trademark) GMS 3253; the MAS series (manufactured by Cosmedi Pharmaceutical Co., Ltd.), such as MAS811 (product name) and MAS683 (product name); the Eudragit (registered trademark) series (manufactured by Evonik), the Nikasol (registered trademark) series (manufactured by Nippon Carbide Industries Co., Ltd.), and the Ultrasol (registered trademark) series (manufactured by Aica Kogyo Co., Ltd.). When drug layer 11 contains an acrylic adhesive base, the content of the acrylic adhesive base can be 10% by mass to 95% by mass, and may be 20% by mass to 90% by mass, based on the total mass of drug layer 11.

[0016] The silicone adhesive base is not particularly limited, but is a compound having an organopolysiloxane skeleton, and examples of the silicone adhesive base include dimethylpolysiloxane, polymethylvinylsiloxane, and polymethylphenylsiloxane. Specific examples of silicone adhesive bases include MD series such as MD7-4502 Silicone Adhesive and MD7-4602 Silicone Adhesive (manufactured by DuPont Toray Specialty Materials Co., Ltd.); BIO-PSA (registered trademark) 7-4301 Silicone Adhesive, BIO-PSA (registered trademark) 7-4302 Silicone Adhesive, BIO-PSA (registered trademark) 7-4201 Silicone Adhesive, BIO-PSA (registered trademark) 7-4202 Silicone Adhesive, BIO-PSA (registered trademark) 7-4101 Silicone Adhesive, BIO-PSA (registered trademark) 7-4102 Silicone Adhesive, BIO-PSA (registered trademark) 7-4601 Silicone Adhesive, BIO-PSA (registered trademark) 7-4602 Silicone Adhesive, and BIO-PSA (registered trademark) 7-4501 Silicone Examples of such adhesives include the BIO-PSA series (manufactured by DuPont-Toray Specialty Materials Co., Ltd.), such as BIO-PSA (registered trademark) 7-4502 Silicone Adhesive, BIO-PSA (registered trademark) 7-4401 Silicone Adhesive, and BIO-PSA (registered trademark) 7-4402 Silicone Adhesive; Dow Corning (registered trademark) 7-9800A, Dow Corning (registered trademark) 7-9800B, Dow Corning (registered trademark) 7-9700A, and Dow Corning (registered trademark) 7-9700B. When drug layer 11 contains a silicone-based adhesive base, the content of the silicone-based adhesive base can be 10% by mass to 95% by mass, or may be 20% by mass to 90% by mass, based on the total mass of drug layer 11.

[0017] There are no particular limitations on the drug, so long as it has a molecular weight that allows it to be absorbed transdermally and can be administered over a long period, for example, for about one week. Drugs to which the present invention can be applied are not particularly limited in terms of efficacy, and examples thereof include hypnotics and sedatives (flurazepam, rilmazafone, phenobarbital, amobarbital, medetomidine, dexmedetocin, etc.), antipyretics, anti-inflammatories, analgesics (butorphanol, perisoxal, acetaminophen, mefenamic acid, diclofenac sodium, aspirin, alclofenac, ketoprofen, flurbiprofen, naproxen, piroxicam, pentazocine, indomethacin, felbinac, glycol salicylate, aminopyrine, loxoprofen, meloxicam, etc.), and the like. cam, lornoxicam, etc.), steroidal anti-inflammatory agents (hydrocortisone, prednisolone, dexamethasone, betamethasone, etc.), stimulants and stimulants (methamphetamine, amphetamine, methylphenidate, etc.), psychotropic agents (imipramine, diazepam, sertraline, fluvoxamine, paroxetine, citalopram, fluoxetine, alprazolam, haloperidol, clomipramine, amitriptyline, desipramine, amoxapine, maprotiline, mianserin, setiptiline, trazolidone, lofepramine, milnacipran, duloxetine , venlafaxine, chlorpromazine, thioridazine, diazepam, meprobamate, etizolam, risperidone, asenapine, etc.), hormones (estradiol, estriol, progesterone, norethisterone, methenolone, testosterone, etc.), local anesthetics (lidocaine, procaine, tetracaine, dibucaine, propitocaine, etc.), urinary organ agents (oxybutynin, tamsulosin, propiverine, imidafenacin, solifenacin, tolterodine, etc.), skeletal muscle relaxants (tizanidine, eperisone, pridinol, suxamethonium, etc.) , reproductive organ agents (ritodrine, meladrine), antiepileptic drugs (sodium valproate, clonazepam, carbamazepine, etc.), autonomic nervous system agents (carpronium, neostigmine, bethanechol, etc.), anti-Parkinson's disease agents (pergolide, bromocriptine, trihexyphenidyl, amantadine, talipexole, cabergoline, droxidopa, biperiden, selegiline, ropinirole, etc.), diuretics (hydroflumethiazide, furosemide, etc.), respiratory stimulants (lobeline, dimorpholamine, naloxone, etc.), antimigraine drugs (dihydroergotamine, sumatriptan,Ergotamine, flunarizine, cyproheptadine, etc.), antihistamines (clemastine, diphenhydramine, chlorpheniramine, diphenylpyraline, promethazine, etc.), bronchodilators (tulobuterol, procaterol, salbutamol, clenbuterol, fenoterol, terbutaline, isoprenaline, formoterol, etc.), cardiac stimulants (isoprenaline, dopamine, etc.), coronary vasodilators (diltiazem, verapamil, isosorbide, nitroglycerin, nicorandil, etc.), peripheral vasodilators (nicametate, tolazoline, etc.), smoking cessation aids (nicotine , varenicline, etc.), circulatory system agents (flunarizine, nicardipine, nitrendipine, nisoldipine, felodipine, amlodipine, nifedipine, nilvadipine, manidipine, benidipine, enalapril, temocapril, alacepril, imidapril, cilazapril, lisinopril, captopril, trandolapril, perindopril erbumine, atenolol, bisoprolol, metoprolol, betaxolol, arotinolol, celiprolol, carvedilol, carteolol, bevantolol, valsartan, candesartan cilexetil, Losartan potassium, clonidine, etc.), antiarrhythmics (propranolol, alprenolol, procainamide, mexiletine, nadolol, disopyramide, etc.), anti-malignant ulcer drugs (cyclophosphamide, fluorouracil, tegafur, procarbazine, ranimustine, irinotecan, fluridin, etc.), antilipidemics (pravastatin, simvastatin, bezafibrate, probucol, etc.), hypoglycemic agents (glibenclamide, chlorpropamide, tolbutamide, glymidine sodium, glybuzole, buformin, etc.), anti-peptic ulcer drugs (proglumide, Cetraxate, spizofurone, cimetidine, glycopyrronium, etc.), cholagogues (ursodeoxycholic acid, osalmid, etc.), gastrointestinal motility improvers (domperidone, cisapride, etc.), liver disease medications (tiopronin, etc.), antiallergic drugs (ketotifen, azelastine, emedastine, etc.), antiviral drugs (acyclovir, etc.), antidote drugs (betahistine, diphenidol, etc.), antibiotics (cephaloridine, cefdinir, cefpodoxime proxetil, cefaclor, clarithromycin, erythromycin, methylerythromycin, kanamycin, cycloserine,Tetracycline, benzylpenicillin potassium, propicillin potassium, cloxacillin sodium, ampicillin sodium, bacampicillin, carbenicillin sodium, chloramphenicol, etc.), habit-forming drugs (cyanamide, etc.), appetite suppressants (mazindol, etc.), chemotherapy drugs (isoniazid, ethionamide, pyrazinamide, etc.), blood coagulation promoters (ticlopidine, warfarin potassium, etc.), anti-Alzheimer's drugs (physostigmine, donepezil, tacrine, arecoline , xanomeline, galantamine, rivastigmine, etc.), serotonin receptor antagonist antiemetics (ondansetron, granisetron, ramosetron, azasetron, etc.), gout treatments (colchicine, probenecid, sulfinpyrazone, etc.), narcotic analgesics (morphine, codeine, cocaine, pethidine, fentanyl, etc.), antifungal drugs (terbinafine, butenafine, amorolfine, neticonazole, miconazole, luliconazole, itraconazole, liranaftate, etc.). The above-mentioned drugs may be used alone or in combination of two or more. The content of the drug can be 0.1% by mass to 30% by mass, and may be 1% by mass to 20% by mass, based on the total mass of drug layer 11.

[0018] Drug layer 11 may contain additives in addition to the base and drug. Examples of additives include tackifier resins, plasticizers, absorption promoters, solubilizers, stabilizers, fillers, adsorbents, desalting agents, pH regulators, and flavors. Only one type of additive may be used, or two or more types may be used.

[0019] The tackifier resin is a component that adjusts the adhesiveness of the drug layer. Examples of the tackifier resin include petroleum-based resins, terpene-based resins, rosin-based resins, phenol-based resins, and xylene-based resins. Examples of the petroleum-based resins include alicyclic petroleum resins (alicyclic saturated hydrocarbon resins, etc.), aliphatic petroleum resins (aliphatic hydrocarbon resins, etc.), and aromatic petroleum resins. More specifically, Arcon P-70, Arcon P-85, Arcon P-90, Arcon P-100, Arcon P-115, Arcon P-125, Arcon M-70, Arcon M-85, Arcon M-90, Arcon M-100, Arcon M-115, and Arcon M-125 (all trade names, manufactured by Arakawa Chemical Industries Co., Ltd.), and Escoretz 8000 (trade name, manufactured by Esso Petrochemical Co., Ltd.). Examples of terpene resins include pinene polymers (α-pinene polymers, β-pinene polymers, etc.), terpene polymers, dipentene polymers, terpene-phenol polymers, aromatic modified terpene polymers, and pinene-phenol copolymers. More specifically, YS resins (YS resin PXN (1150N, 300N), YS resin PX1000, YS resin TO125, YS resin TO105, etc.), Clearon P105, Clearon M115, Clearon K100 (all trade names, manufactured by Yasuhara Chemical Co., Ltd.), and Tamanol 901 (trade name, manufactured by Arakawa Chemical Industries Co., Ltd.) are listed. Examples of rosin resins include hydrogenated rosin glycerin ester, ultra-light-colored rosin, ultra-light-colored rosin ester, and acid-modified ultra-light-colored rosin. More specifically, Pine Crystal (KE-311, PE-590, KE-359, KE-100, etc.) (trade name, manufactured by Arakawa Chemical Industries, Ltd.) and the like can be mentioned. The tackifier resin may be used alone or in combination of two or more of these. When the drug layer contains a tackifier resin, the content of the tackifier resin can be 15% by mass to 80% by mass, and may be 25% by mass to 65% by mass, based on the total mass of the drug layer.

[0020] Examples of the plasticizer include paraffin oil (liquid paraffin, etc.), squalane, squalene, vegetable oils (olive oil, camellia oil, castor oil, tall oil, peanut oil, spearmint oil, eucalyptus oil, jojoba oil, camphor white oil, sunflower oil, orange oil, etc.), fats and oils (dibutyl phthalate, dioctyl phthalate, etc.), and liquid rubber (liquid polybutene, liquid isoprene rubber, etc.). A preferred plasticizer is liquid paraffin. One type of plasticizer may be used alone, or two or more types may be used in combination. When the drug layer contains a plasticizer, the content of the plasticizer is, for example, 3% by mass to 50% by mass, 5% by mass to 30% by mass, or 7% by mass to 20% by mass based on the total mass of the drug layer.

[0021] The percutaneous absorption enhancer may be any compound that has been recognized to have a percutaneous absorption enhancing effect in the skin, such as organic acids, fatty acids having a carbon chain number of 6 to 20, fatty alcohols, fatty acid esters, amides, ethers, aromatic organic acids, aromatic alcohols, aromatic organic acid esters and ethers (which may be saturated or unsaturated, and may be cyclic or linear or branched), lactates, acetates, monoterpene compounds, sesquiterpene compounds, Azone, Azone derivatives, pyrothiodecane, glycerin fatty acid esters, propylene glycol fatty acid esters, sorbitan fatty acid esters (Span type), polysorbates (Tween type), polyethylene glycol fatty acid esters, polyoxyethylene hydrogenated castor oil (HCO type), polyoxyethylene alkyl ethers, sucrose fatty acid esters, and vegetable oils.

[0022] Other percutaneous absorption enhancers include, for example, lauric acid, myristic acid, palmitic acid, stearic acid, isostearic acid, oleic acid, linoleic acid, linolenic acid, lauryl alcohol, myristyl alcohol, oleyl alcohol, isostearyl alcohol, cetyl alcohol, methyl laurate, hexyl laurate, lauric acid diethanolamide, isopropyl myristate, myristyl myristate, octyldodecyl myristate, cetyl palmitate, methyl salicylate, ethylene glycol salicylate, cinnamic acid, methyl cinnamate, cresol, cetyl lactate, lauryl lactate, ethyl acetate, propyl acetate, and geraniol. Examples of the percutaneous absorption enhancer include thymol, eugenol, terpineol, l-menthol, bornealol, d-limonene, isoeugenol, isoborneol, nerol, dl-camphor, glycerin monocaprylate, glycerin monocaprate, glycerin monolaurate, glycerin monooleate, sorbitan monolaurate, sucrose monolaurate, polysorbate 20, propylene glycol, propylene glycol monolaurate, polyethylene glycol monolaurate, polyethylene glycol monostearate, polyoxyethylene lauryl ether, polyoxyethylene hydrogenated castor oil, pyrothiodecane, and olive oil. Two or more of such percutaneous absorption enhancers may be mixed and used. The content of the percutaneous absorption enhancer is, for example, preferably 0.1 to 20% by mass, more preferably 0.5 to 15% by mass, based on the total mass of the drug layer.

[0023] The dissolving agent depends on the type of solute to be dissolved, but examples thereof include fatty acids (e.g., capric acid, oleic acid, linoleic acid, etc.), fatty acid esters (e.g., isopropyl myristate, isopropyl palmitate, etc.), fatty acid derivatives (e.g., propylene glycol monolaurate, diethanolamide laurate, etc.), fatty acid glycerin esters (e.g., glycerin monolaurate, glycerin monooleate, etc.), polyhydric alcohol esters of fatty acids (e.g., sorbitan monolaurate, etc.), fatty alcohols (e.g., octyldodecanol, isostearyl alcohol, oleyl alcohol, etc.), polyhydric alcohols (e.g., propylene glycol, dipropylene glycol, polyethylene glycol, etc.), pyrrolidone derivatives (e.g., N-methyl-2-pyrrolidone, etc.), organic acids (e.g., acetic acid, lactic acid, etc.), and organic acid salts (e.g., sodium acetate, sodium lactate, etc.). As the dissolving agent, one of these may be used alone, or two or more may be used in combination. The content of the solubilizer is, for example, preferably 0 to 20 mass %, and more preferably 0.5 to 15 mass %, based on the total mass of the drug layer.

[0024] Examples of the stabilizer include tocopherol and ester derivatives of tocopherol, ascorbic acid, ascorbic acid stearyl ester, nordihydroguaiaretic acid, dibutylhydroxytoluene, butylhydroxyanisole, etc., and one of these may be used alone or two or more may be used in combination. The content of the stabilizer is preferably, for example, 0.1 to 5% by mass based on the total mass of the drug layer.

[0025] Examples of the filler include inorganic compounds such as silica, aluminum oxide, aluminum hydroxide, zinc oxide, titanium oxide, talc, clay, kaolin, glass, barium sulfate, calcium carbonate, hydroxyapatite, and ceramics; and organic compounds such as cellulose, silk, polyester, polyolefin, polyacrylic acid ester, polymethacrylic acid ester, and polystyrene. As the filler, one of these may be used alone, or two or more may be used in combination. The content of the filler is preferably, for example, 0.1 to 5% by mass based on the total mass of the drug layer.

[0026] Examples of the adsorbent include inorganic and / or organic substances having hygroscopicity, and more specifically, minerals such as talc, kaolin, bentonite, etc.; silicon compounds such as fumed silica (Aerosil (registered trademark), etc.) and hydrated silica; metal compounds such as zinc oxide and dried aluminum hydroxide gel; weak acids such as lactic acid and acetic acid; sugars such as dextrin; and polymers such as polyvinylpyrrolidone, aminoalkyl methacrylate copolymer, crospovidone, carboxyvinyl polymer, and butyl methacrylate methyl methacrylate copolymer. As the adsorbent, one of these may be used alone, or two or more may be used in combination. The content of the adsorbent is, for example, preferably 0.1 to 20% by mass, more preferably 0.5 to 10% by mass, based on the total mass of the drug layer.

[0027] The desalting agent and pH adjusting agent are not particularly limited, but include sodium acetate (including anhydrous sodium acetate), sodium hydroxide, potassium hydroxide, magnesium hydroxide, sodium bicarbonate, potassium bicarbonate, sodium citrate, sodium lactate, etc. As the desalting agent and pH adjusting agent, one of these may be used alone, or two or more may be used in combination. The content of the desalting agent and pH adjusting agent is preferably, for example, 0.1 to 5% by mass based on the total mass of the drug layer.

[0028] The mass of the drug layer is not particularly limited, but is preferably 20 to 500 g / m 2 It is preferable that the thickness is 50 to 300 g / m 2 It is more preferable that:

[0029] There is no particular limitation on the support 12 as long as it can support the drug layer 11, but it is preferable that the support 12 is impermeable to the drug contained in the drug layer 11 or is difficult to permeate. Examples of the material of the support 12 include films made of various synthetic resins. Examples of the material of such a support include synthetic resins such as polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate, and polyethylene naphthalate; polyolefins such as polyethylene and polypropylene; polyurethane; ethylene-vinyl acetate copolymers; metals such as aluminum; and paper. Examples of the form of the support made of such a material include films; sheets such as foam sheets, porous sheets, and microporous sheets; fabrics such as woven fabrics, knitted fabrics, and nonwoven fabrics; foils; and laminates thereof. From the viewpoint of more sufficiently suppressing the migration of the drug from the drug layer to the cover adhesive layer, it is preferable that the support is impermeable to the drug, and among them, polyester films are preferable from the viewpoint of excellent flexibility and drug impermeability.

[0030] The thickness of the support 12 is not particularly limited, but is usually preferably about 2 to 600 μm. From the viewpoint of being able to maintain sufficient strength while being able to be in sufficient close contact with the cover part 30 and being able to be attached to the skin for a longer period of time, the thickness is more preferably 5 to 100 μm.

[0031] The cover section 30 has a cover layer 31 and a cover adhesive layer 32, and is joined to the patch section 10 from the side of the support 12. In a plan view of the patch 1 with a cover material shown in FIG.

[0032] The cover layer 31 according to this embodiment is made of a nonwoven fabric. The material of the fibers constituting the nonwoven fabric is not particularly limited, but examples thereof include polyolefins such as polyethylene, polypropylene, and polybutadiene; polyesters such as ethylene vinyl acetate copolymer, polyvinyl chloride, PET, polyethylene naphthalate, and polybutylene terephthalate; polyamides such as nylon; polyurethanes; and natural fibers such as silk, animal hair (e.g., wool), and cellulose such as cotton, among which synthetic resins such as PET are preferable. The nonwoven fabric may be made of a mixture of multiple types of fibers of different materials, or the cover layer 31 may be made of multiple nonwoven fabrics laminated together. The method for producing the nonwoven fabric is not particularly limited, and any of spunlace nonwoven fabric, thermal bond nonwoven fabric, spunbond nonwoven fabric, needle punch nonwoven fabric, etc. can be applied to the present invention. The weight of the nonwoven fabric is 10 to 200 g / m 2 The preferred thickness is 30 to 150 g / m 2 More preferably, 50 to 100 g / m 2 A degree is even more preferable. The thickness of the nonwoven fabric is preferably about 0.01 to 3 mm, more preferably about 0.1 to 2 mm, further preferably about 0.3 to 1 mm, particularly preferably about 0.33 to 0.86 mm, and most preferably about 0.5 to 0.86 mm. The nonwoven fabric has an elongation percentage in both the machine direction and the width direction of preferably 20 to 500%, more preferably 20 to 300%, even more preferably 50 to 300%, and particularly preferably 68 to 269%. The average elongation percentage in the machine direction and the width direction of the nonwoven fabric is preferably 20 to 500%, more preferably 20 to 300%, even more preferably 50 to 300%, particularly preferably 100 to 250%, and most preferably 102 to 207%. The stretch recovery rate of the nonwoven fabric in both the machine direction and the width direction is preferably 20 to 90%, more preferably 20 to 85%, and further preferably 20 to 70%. The "machine direction" refers to the direction in which the nonwoven fabric is unwound or wound when it is continuously manufactured by a machine, and the "width direction" refers to the direction perpendicular to the machine direction. In the case of a rectangular nonwoven fabric in circulation, one side is usually the machine direction, and the direction perpendicular to this side is the width direction. In the present invention, since the preferred numerical range of the elongation percentage is the same in the machine direction and the width direction, for example, when the cover layer has a non-rectangular shape such as a circle, it is sufficient that the elongation percentage in both a certain direction and a direction perpendicular to the certain direction is within the preferred numerical range.

[0033] The cover adhesive layer 32 according to the present embodiment is configured using a rubber-based adhesive containing a rubber-based adhesive as the main adhesive base. Here, "containing a rubber-based adhesive as the main adhesive base" indicates that the proportion of the rubber-based adhesive base is the largest based on the total mass of the adhesive base of the cover adhesive layer 32. In the present invention, it is preferable that the cover adhesive layer 32 does not contain an adhesive base other than the rubber-based adhesive base, but it may contain one. Examples of adhesive bases other than the rubber-based adhesive base include acrylic adhesive bases and silicone adhesive bases exemplified as the adhesive base of the drug layer 11.

[0034] Examples of materials for the rubber-based adhesive base in the cover adhesive layer 32 include polyisobutylene, polybutene, polyisoprene, polybutadiene, styrene-isoprene copolymer, styrene-isoprene-styrene block copolymer, styrene-butadiene copolymer, styrene-butadiene-styrene block copolymer, alkyl vinyl ether (co)polymer, and natural rubber, and these can be used alone or in combination of two or more types. From the viewpoint of preventing the drug and additives contained in the drug layer 11 from migrating to the cover adhesive layer 32, it is preferable that the main component be polyisobutylene, polybutene, polyisoprene, and polybutadiene, among those mentioned above, and it is more preferable that the main component be polyisobutylene. Among rubber-based adhesive bases, specific examples of styrene-isoprene-styrene block copolymers include Quintac (registered trademark) 3570C (trade name, manufactured by Zeon Corporation), SIS5002, SIS5229, SIS5505 (trade name, manufactured by JSR Corporation), SIBSTAR (registered trademark) T102 (trade name, manufactured by Kaneka Corporation), etc. Polyisobutylene also includes so-called butyl rubber (isobutylene-isoprene rubber). Specific examples of polyisobutylene include Oppanol (registered trademark) N50, N80, N100, N150, B11, B12, B50, B80, B100, B120, B150, B220 (trade names, manufactured by BASF), JSR (registered trademark) Butyl 065, 268, 365 (trade names, manufactured by JSR Corporation), X_Butyl (registered trademark) RB100, 101-3, 301, 402 (trade names, manufactured by ARLANXEO), Exxon (registered trademark) Butyl 065, 065S, 068, 068S, 268, 268S, 365, 365S (trade names, manufactured by Exxon Mobile), and Butyl 065, 268, 365 (trade names, manufactured by Japan Butyl Co., Ltd.). Since the cover adhesive layer 32 is made of a rubber-based adhesive having a rubber-based adhesive base as the main adhesive base, the content of the rubber-based adhesive base is preferably 50 mass% or more, more preferably 70 mass% or more, even more preferably 90 mass% or more, particularly preferably 95 mass% or more, and most preferably 100 mass% based on the total mass of the adhesive base of the cover adhesive layer 32. Furthermore, the content of at least one type of rubber-based adhesive base selected from the group consisting of polyisobutylene, polybutene, polyisoprene, and polybutadiene is preferably 50 mass% or more, more preferably 70 mass% or more, even more preferably 90 mass% or more, particularly preferably 95 mass% or more, and most preferably 100 mass% based on the total mass of the rubber-based adhesive base of the cover adhesive layer 32.

[0035] The cover adhesive layer 32 may contain additives other than the rubber-based adhesive base. Examples of additives include tackifier resins and plasticizers, and one of these may be used alone or two or more may be used in combination.

[0036] The mass of the cover adhesive layer 32 is 5 to 300 g / m 2 The preferred thickness is 30 to 200 g / m 2 The preferred range is 50 to 150 g / m 2 If the mass of the cover adhesive layer is less than the lower limit, the adhesiveness tends to decrease, whereas if it exceeds the upper limit, it tends to become difficult to maintain a sufficient thickness and shape.

[0037] Drug layer 11 and the cover adhesive layer 32 that protrudes around the periphery of patch portion 10 are covered and protected by release liner 2 until use. When using the patch with cover material 1, the release liner 2 is peeled off, and the exposed drug layer 11 and cover adhesive layer 32 are brought into contact with the skin of the user and applied. The material of the release liner 2 is not particularly limited, and various known liners can be used. Examples of the material include paper; polyesters such as PET and polyethylene naphthalate; polyolefins such as polyethylene and polypropylene; polyvinyl chloride, polyvinylidene chloride, nylon, aluminum, etc., and a film made of PET is particularly preferred. The release liner 2 may be made of a plurality of materials, such as a laminate film of fine paper and polyolefin. The surface of the release liner that contacts the drug layer 11 or the cover adhesive layer 32 is preferably release-treated with silicone, fluorinated polyolefin, or the like.

[0038] Those skilled in the art have recognized several problems with patches with cover materials. One is that the drug contained in the drug layer of the patch migrates into the adhesive layer of the cover material. If too much drug migrates into the adhesive layer, the drug may not reach the targeted blood concentration in the user's body or may not be able to maintain that blood concentration for the targeted period of time. The other problem is stickiness caused by the adhesive layer of the cover material protruding out. This is a phenomenon in which the adhesive layer of the cover material adheres to the outside of the area where the patch with cover material was initially applied, and is also called "tongue sticking." The tongue sticking that remains after the patch with cover material is removed after the medication period has ended is called "glue residue." The occurrence of glue residue causes discomfort to the user.

[0039] The inventors have conducted various studies to improve these problems, and as a result, have found that the above problems can be solved by using the following configuration, for example, when the application period is relatively short, or when the patch is applied to a part of the body that is not subjected to much external force due to the user's movements or vibrations while the patch is applied. The cover layer is made of nonwoven fabric, and the elongation percentage in both the machine direction and the width direction is 60% or more, with one elongation percentage being no more than twice the other. The cover adhesive layer is made of a rubber-based adhesive that contains a rubber-based adhesive as the main adhesive base, and the loss tangent at 32°C and 0.1 Hz is 0.6 to 0.95.

[0040] First, with regard to migration of drugs into the adhesive layer of the cover material, it was found that the migration rate was much lower with the rubber-based adhesive, which contains a rubber-based adhesive as the main adhesive base, than with the acrylic-based adhesives that have been widely used in the past. Next, regarding adhesive residue, based on the hypothesis that the difference in conformity between the cover layer and the cover adhesive layer in response to displacement of the application surface due to the body movements of the user of the patch with cover material plays an important role, the optimal configuration of the cover layer was arrived at as a result of various studies described below. Furthermore, it was found that if the loss tangent of the cover adhesive layer is too small, the adhesiveness decreases and the cover tends to peel off during application, whereas if the loss tangent is too large, the cover tends to leave adhesive residue after peeling due to protruding during application. The range of the loss tangent is more preferably 0.7 to 0.95, even more preferably 0.75 to 0.90, and most preferably 0.80 to 0.90. The results of studies that provide the basis for the various configurations of the patch with cover material according to this embodiment are presented below.

[0041] (Experiment 1) In experiment 1, the composition of the cover adhesive layer and the migration of ingredients in the drug layer were examined. The components shown below were thoroughly mixed in an appropriate amount of solvent to prepare a composition for the experimental drug layer. This composition was spread evenly on a release liner (a polyethylene terephthalate film with a release treatment; the same applies below), and the solvent was dried and removed to obtain a plaster mass per unit area of ​​80 g / m2. 2 A support made of a PET film was attached to the side of the obtained experimental drug layer opposite to the release liner, and a thickness of 2.5 cm was formed. 2 The experimental patch was prepared by cutting the sample into pieces of the same size. (Experimental Drug Layer 1) Rubber adhesive base 23.38 parts by weight (Contains styrene-isoprene-styrene block copolymer and polyisobutylene in a mass ratio of 1:1) Silicone adhesive base (DuPont Toray Specialty Materials Co., Ltd. BIO-PSA (registered trademark) AC7-4201 Silicone Adhesive) 7.19 parts by weight Terpene resin 26.97 parts by mass Liquid paraffin 14.38 parts by mass Butorphanol tartrate 6 parts by weight Oleyl alcohol 10 parts by weight Other components (adsorbents and desalting agents) 12.08 parts by mass

[0042] Next, the components of the cover adhesive layer shown in Table 1 were thoroughly mixed in an appropriate amount of solvent to prepare a composition for the cover adhesive layer. This composition was uniformly spread on a release liner, and the solvent was dried and removed to prepare a cover adhesive layer having a mass per unit area of ​​75 g / m. 2 A cover layer made of a PET film was attached to the surface of the resulting cover adhesive layer opposite to the release liner, and then a 5 cm 2 To prepare an experimental cover for each sample, the sheet was cut into pieces of 100 pieces. Details of the materials listed in Table 1 are given below. Rubber-based adhesive 1: Contains styrene-isoprene-styrene block copolymer / polyisobutylene / alicyclic saturated hydrocarbon resin / liquid paraffin in a mass ratio of 16.3:7:51.1:18.6. Note that since the alicyclic saturated hydrocarbon resin and liquid paraffin are additives, Rubber-based Adhesive 1 contains only a rubber-based adhesive base as the adhesive base. Acrylic adhesive 1: MAS811B (manufactured by Cosmedi Pharmaceutical Co., Ltd.) Acrylic adhesive 2: DURO-TAK (registered trademark) 87-2051 (manufactured by Henkel) Acrylic adhesive 3: DURO-TAK (registered trademark) 87-2194 (manufactured by Henkel) Acrylic adhesive 4: DURO-TAK (registered trademark) 87-2516 (manufactured by Henkel)

[0043] The release liner of the experimental cover part was peeled off and the experimental patch part was attached to the support side of the experimental patch part so as to completely cover the experimental patch part in a plan view, thereby obtaining a patch with cover material for each sample.

[0044] [Table 1]

[0045] For each sample, component migration to the cover adhesive layer was evaluated according to the following procedure. The patch with cover material for each sample was sealed in a packaging bag and stored at 60°C for 2 weeks. After that, it was taken out of the packaging bag, the release liner was peeled off, and the experimental patch part was separated from the experimental cover part. The amounts of butorphanol and oleyl alcohol contained in the cover adhesive layer of the experimental cover part were measured, and the migration rate from the experimental drug layer was calculated.

[0046] As shown in Table 1, in samples 1 and 2 in which the cover adhesive layer was formed with a rubber-based adhesive containing a rubber-based adhesive as the main adhesive base, migration of butorphanol to the cover adhesive layer was suppressed compared to samples 3 to 6 in which an acrylic adhesive containing an acrylic adhesive as the main adhesive base was used. In particular, in sample 1 in which the cover adhesive layer was made of polyisobutylene, the migration rate of oleyl alcohol was also suppressed to a low level. From the above, the advantages of using a rubber-based adhesive containing a rubber-based adhesive as the main adhesive base in the cover adhesive layer were confirmed.

[0047] (Experiment 2) In experiment 2, we investigated the adhesive residue that causes stickiness due to the adhesive layer of the cover. The components shown below were thoroughly mixed in an appropriate amount of solvent to prepare a composition for the experimental drug layer. This composition was spread evenly on a release liner, and the solvent was dried and removed to obtain a plaster mass per unit area of ​​60 g / m2. 2 A support made of a PET film was attached to the side of the obtained experimental drug layer opposite to the release liner, and a 30 cm 2 The experimental patch was prepared by cutting the sample into pieces of the same size. (Experimental Drug Layer 2) Rubber adhesive base (containing styrene-isoprene-styrene block copolymer and polyisobutylene in a mass ratio of 1:1) 24.88 parts by mass Silicone adhesive base (BIO-PSA (registered trademark) AC7-4201 Silicone Adhesive) 7.65 parts by weight Terpene resin 28.70 parts by mass Liquid paraffin 15.31 parts by mass Tartaric acid 1.89 parts by mass Oleyl alcohol 10 parts by weight Other components (adsorbent and pH adjuster) 11.57 parts by weight

[0048] Next, the materials were thoroughly mixed in an appropriate amount of solvent according to the composition of the cover adhesive layer shown in Tables 2 to 5 to prepare a composition for the cover adhesive layer. This composition was uniformly spread on a release liner, and the solvent was dried and removed to obtain a composition with a mass per unit area of ​​75 g / m 2 A cover layer having a configuration as described in Tables 2 to 5 was attached to the surface of the resulting cover adhesive layer opposite to the release liner, and then a 47.6 cm 2 The nonwoven fabrics and knitted fabrics shown in each table are the same in terms of the nonwoven fabric or knitted fabric. The release liner of the experimental cover part was peeled off and the experimental patch part was attached to the support side of the experimental patch part so as to completely cover the experimental patch part in a plan view, thereby obtaining a patch with cover material for each sample.

[0049] The following evaluations were performed for each sample. (Calculation of loss tangent) For each sample, the cover adhesive layer was peeled off from the cover layer, and dynamic viscoelasticity measurements were performed under the following measurement conditions using a rheometer "HAAKE MARS" (manufactured by Thermo Fisher Scientific Co., Ltd.) The loss tangent of the cover adhesive layer for each sample was calculated using the measured values ​​of the loss modulus and storage modulus according to the following formula. Loss tangent (tan δ) = loss modulus (G”) / storage modulus (G') [Measurement conditions] Sample: 8mm diameter flat plate Gap Spacing: 1mm Sample size: 0.1-0.5g ·Temperature: 32℃ Frequency: 0.1Hz ·Distortion: 1%

[0050] (Adhesion evaluation) The patch with cover material for each sample was applied to the upper arm of 20 subjects, who then behaved as they normally would for 24 hours. The adhesion of the cover was scored based on the following criteria, and an average score was obtained for each sample. The degree of peeling in the following criteria is the ratio of the area of ​​the cover adhesive layer that is not joined to the patch (i.e., the area in contact with the subject's skin) to 100. No peeling: 100 About 1 / 10 (less than 1 / 8) peeling: 80 About 1 / 5 (1 / 8 to less than 1 / 4) peeling: 60 About 1 / 3 (1 / 4 to less than 1 / 2) peeling: 40 Peeling off 1 / 2 or more: 20 Falling off: 0 Furthermore, the average scores were ranked as follows, with only A being considered a pass. A: Average score of 75 or above B: Average score between 60 and 75 C: Average score below 60

[0051] (Adhesive residue evaluation) After the adhesiveness evaluation, the patch with the cover material was peeled off. The amount of adhesive residue after peeling was scored based on the following criteria, and the average score for each sample was obtained. No adhesive residue: 100 Adhesive residue is found on about 1 / 10 (less than 1 / 8) of the circumference of the cover: 80 Adhesive residue is found on about 1 / 4 of the circumference of the cover (1 / 8 to less than 3 / 8): 60 Adhesive residue is found on about 1 / 2 of the circumference of the cover (3 / 8 to less than 5 / 8): 40 Adhesive residue is found on about 3 / 4 (5 / 8 or more) of the circumference of the cover: 20 Glue residue is found all around the cover: 0 Furthermore, the average scores were ranked as follows, with only A being considered a pass. A: Average score of 75 or above B: Average score between 60 and 75 C: Average score below 60

[0052] [Table 2]

[0053] [Table 3]

[0054] [Table 4]

[0055] [Table 5]

[0056] The sample results shown in Table 2 indicate that nonwoven fabric is suitable for the cover layer. The loss tangent is an index showing the balance between the elasticity and viscosity of a substance. Each sample shown in Table 3 was made using multiple types of polyisobutylene with different loss tangents. The results of the samples shown in Table 3 showed that the loss tangent of the cover adhesive layer is preferably about 0.6 to 0.95.

[0057] From the sample results shown in Table 4, it was confirmed that even if the loss tangent of the cover adhesive layer is within the above-mentioned preferred range, if the cover layer is a knitted fabric (a fabric made of woven fibers), the adhesive transfer suppression effect is insufficient. In other words, it was confirmed that a cover adhesive layer having a loss tangent within the above-mentioned preferred range only exhibits a good adhesive transfer suppression effect when combined with a cover layer made of nonwoven fabric. From the sample results shown in Table 5, it was confirmed that even if the cover adhesive layer contains a mixture of styrene-isoprene-styrene block copolymer as a rubber-based adhesive base other than polyisobutylene, the loss tangent is within the above-mentioned preferred range, and when combined with a cover layer made of nonwoven fabric, it shows a good adhesive transfer suppression effect. Note that the ratio of polyisobutylene to styrene-isoprene-styrene block copolymer in the cover adhesive layers of samples 21 and 22 is 9:1, and polyisobutylene is the main component.

[0058] (Experiment 3) In Experiment 3, considering that a nonwoven fabric is suitable for the cover layer, suitable physical properties of the nonwoven fabric were investigated. Samples 31 to 35 were prepared by changing only the nonwoven fabric of the cover layer compared to Sample 11 used in Experiment 2.

[0059] The nonwoven fabrics used as the cover layers of Samples 11 and 31 to 35 were subjected to the following measurements. (Measurement of elongation rate) The test was performed in accordance with 8.14.1A described in JIS L 1096:2010. The nonwoven fabric used for each sample was cut in the machine direction and the width direction to a width of 25 mm and a length of 110 mm, respectively, to prepare test pieces. The test pieces were gripped with a tensile tester so that the gripping distance in the length direction was 60 mm, and pulled at a pulling speed of 500 mm / min, and the elongation (%) was measured from the length at break (L1) and the original length (L0) according to the following formula. For each nonwoven fabric, measurements were taken three times in each of the machine direction and the width direction, and the average was used as the elongation value. Elongation rate (%) = (L1-L0) x 100 / L0

[0060] (Measurement of elongation recovery rate) The test was performed in accordance with 8.15.1A described in JIS L 1096:2010. For each sample of nonwoven fabric, a test piece similar to that used for the elongation measurement was prepared. The test piece was gripped by a tensile tester so that the gripping distance in the longitudinal direction was 60 mm, and stretched to a length (L1) that was 150% of the original length (L0) at a pulling speed of 500 mm / min, and the load was removed at the same speed. The length at which the stress became 0 was taken as L2, and the elongation recovery rate (%) was calculated from the following formula. Measurements were performed three times for each nonwoven fabric, and the average was used as the elongation recovery rate value. Elongation recovery rate (%)=(L1-L2)×100 / (L1-L0)

[0061] For Samples 31 to 35, the adhesion evaluation and adhesive residue evaluation performed in Experiment 2 were also performed. All the results are shown in Table 6. The nonwoven material of Sample 35 is polyurethane. Incidentally, the nonwoven fabric of Sample 31 broke before being stretched to 150% of its original length, and therefore the elongation recovery rate could not be measured.

[0062] [Table 6]

[0063] The results in Table 6 provide the following insights: When the elongation rate of the nonwoven fabric used as the cover layer in both the machine direction and the width direction is 60% or more, and one elongation rate is no more than twice the other, by combining it with a cover adhesive layer having the above-mentioned loss tangent, adhesive residue can be effectively suppressed. When the nonwoven fabric used as the cover layer has a stretch recovery rate in the machine direction and width direction within the range of 20% to 90%, adhesive transfer can be effectively suppressed by combining it with a cover adhesive layer having the above-mentioned loss tangent.

[0064] In the patch with cover material 1 of this embodiment, in which the specific configuration of each part is set based on the knowledge obtained from the above experiments, the good adhesion of the cover part 30 keeps the drug layer 11 in good contact with the skin, and the unpleasant stickiness during use is suppressed by suppressing adhesive residue of the cover part 30. Furthermore, since the cover adhesive layer is formed using a rubber-based adhesive that has a rubber-based adhesive as the main adhesive base, migration of the drug contained in the drug layer 11 to the cover adhesive layer is suppressed, and it also has the advantage of being easy to design a formulation.

[0065] The above describes one embodiment of the present invention together with experiments using samples. However, the specific configuration is not limited to the specific contents of the embodiment and each sample, and also includes design changes and the like within the scope that does not deviate from the gist of the present invention.

[0066] The present invention includes the following technical ideas. (Section 1) A patch with a cover material, comprising: a patch portion having a support and a drug layer formed on the support; and a cover portion having a cover layer and a cover adhesive layer formed on the cover layer, wherein the cover adhesive layer is bonded to the support so as to cover the patch portion, the cover layer is made of a nonwoven fabric, and the nonwoven fabric has an elongation percentage in both the machine direction and the width direction of 60% or more, and one elongation percentage is not more than twice the other elongation percentage; The cover adhesive layer is formed using a rubber-based adhesive containing a rubber-based adhesive as a main adhesive base, and has a loss tangent (tan δ) of 0.6 to 0.95 at 32°C and 0.1 Hz. A patch with a cover. (Section 2) The rubber-based adhesive base is composed mainly of at least one selected from the group consisting of polyisobutylene, polybutene, polyisoprene, and polybutadiene. Item 1. A patch with a cover material according to item 1. (Section 3) The rubber-based adhesive base is one or more selected from the group consisting of polyisobutylene, polybutene, polyisoprene, and polybutadiene. Item 3. The patch with cover material according to item 1 or 2. (Section 4) The nonwoven fabric has an elongation recovery rate of 90% or less in the machine direction and the width direction. Item 4. The patch with cover material according to any one of items 1 to 3. [Explanation of symbols]

[0067] 1. Patch with cover 10 Patch section 11 Drug Layer 12 Support 30 Cover part 31 Cover Layer 32 Cover adhesive layer

Claims

1. A patch with a cover material, comprising: a patch portion having a support and a drug layer formed on the support; and a cover portion having a cover layer and a cover adhesive layer formed on the cover layer, wherein the cover adhesive layer is bonded to the support so as to cover the patch portion, the cover layer is made of a nonwoven fabric, and the nonwoven fabric has an elongation percentage in both the machine direction and the width direction of 60% or more, and one elongation percentage is not more than twice the other elongation percentage; The cover adhesive layer is formed using a rubber-based adhesive containing a rubber-based adhesive as a main adhesive base, and has a loss tangent (tan δ) at 32° C. and 0.1 Hz of 0.6 to 0.

95. A patch with a cover.

2. The rubber-based adhesive base is composed mainly of at least one selected from the group consisting of polyisobutylene, polybutene, polyisoprene, and polybutadiene. The patch with cover material according to claim 1.

3. The rubber-based adhesive base is at least one selected from the group consisting of polyisobutylene, polybutene, polyisoprene, and polybutadiene. The patch with cover material according to claim 1.

4. The nonwoven fabric has an elongation recovery rate of 90% or less in the machine direction and the width direction. The patch with cover material according to any one of claims 1 to 3.

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