JP6528154B2 - ビソプロロール含有貼付製剤 - Google Patents
ビソプロロール含有貼付製剤 Download PDFInfo
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- JP6528154B2 JP6528154B2 JP2014177675A JP2014177675A JP6528154B2 JP 6528154 B2 JP6528154 B2 JP 6528154B2 JP 2014177675 A JP2014177675 A JP 2014177675A JP 2014177675 A JP2014177675 A JP 2014177675A JP 6528154 B2 JP6528154 B2 JP 6528154B2
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- Prior art keywords
- pressure
- sensitive adhesive
- adhesive layer
- styrene
- weight
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 229920005549 butyl rubber Polymers 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 239000006229 carbon black Substances 0.000 description 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 1
- 150000001732 carboxylic acid derivatives Chemical class 0.000 description 1
- 229960001777 castor oil Drugs 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 239000012461 cellulose resin Substances 0.000 description 1
- 229960000541 cetyl alcohol Drugs 0.000 description 1
- 239000013522 chelant Substances 0.000 description 1
- 238000010382 chemical cross-linking Methods 0.000 description 1
- 229920006147 copolyamide elastomer Polymers 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 125000002704 decyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 238000000151 deposition Methods 0.000 description 1
- 125000004386 diacrylate group Chemical group 0.000 description 1
- 229940031578 diisopropyl adipate Drugs 0.000 description 1
- VNGOYPQMJFJDLV-UHFFFAOYSA-N dimethyl benzene-1,3-dicarboxylate Chemical compound COC(=O)C1=CC=CC(C(=O)OC)=C1 VNGOYPQMJFJDLV-UHFFFAOYSA-N 0.000 description 1
- 125000000118 dimethyl group Chemical group [H]C([H])([H])* 0.000 description 1
- FBSAITBEAPNWJG-UHFFFAOYSA-N dimethyl phthalate Natural products CC(=O)OC1=CC=CC=C1OC(C)=O FBSAITBEAPNWJG-UHFFFAOYSA-N 0.000 description 1
- 229960001826 dimethylphthalate Drugs 0.000 description 1
- 125000003438 dodecyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 230000036267 drug metabolism Effects 0.000 description 1
- 238000010894 electron beam technology Methods 0.000 description 1
- HDERJYVLTPVNRI-UHFFFAOYSA-N ethene;ethenyl acetate Chemical group C=C.CC(=O)OC=C HDERJYVLTPVNRI-UHFFFAOYSA-N 0.000 description 1
- UIWXSTHGICQLQT-UHFFFAOYSA-N ethenyl propanoate Chemical compound CCC(=O)OC=C UIWXSTHGICQLQT-UHFFFAOYSA-N 0.000 description 1
- 125000005448 ethoxyethyl group Chemical group [H]C([H])([H])C([H])([H])OC([H])([H])C([H])([H])* 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- LVGKNOAMLMIIKO-QXMHVHEDSA-N ethyl oleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC LVGKNOAMLMIIKO-QXMHVHEDSA-N 0.000 description 1
- 229940093471 ethyl oleate Drugs 0.000 description 1
- 229920001038 ethylene copolymer Polymers 0.000 description 1
- 239000005038 ethylene vinyl acetate Substances 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000002657 fibrous material Substances 0.000 description 1
- 239000010419 fine particle Substances 0.000 description 1
- 239000012458 free base Substances 0.000 description 1
- 125000002541 furyl group Chemical group 0.000 description 1
- 239000011086 glassine Substances 0.000 description 1
- 150000002334 glycols Chemical class 0.000 description 1
- 125000003187 heptyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 125000004051 hexyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 229920001519 homopolymer Polymers 0.000 description 1
- 229930195733 hydrocarbon Natural products 0.000 description 1
- 150000002430 hydrocarbons Chemical class 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- NYMPGSQKHIOWIO-UHFFFAOYSA-N hydroxy(diphenyl)silicon Chemical compound C=1C=CC=CC=1[Si](O)C1=CC=CC=C1 NYMPGSQKHIOWIO-UHFFFAOYSA-N 0.000 description 1
- 239000010954 inorganic particle Substances 0.000 description 1
- QXJSBBXBKPUZAA-UHFFFAOYSA-N isooleic acid Natural products CCCCCCCC=CCCCCCCCCC(O)=O QXJSBBXBKPUZAA-UHFFFAOYSA-N 0.000 description 1
- XUGNVMKQXJXZCD-UHFFFAOYSA-N isopropyl palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC(C)C XUGNVMKQXJXZCD-UHFFFAOYSA-N 0.000 description 1
- 229940075495 isopropyl palmitate Drugs 0.000 description 1
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 description 1
- 239000002655 kraft paper Substances 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 238000010030 laminating Methods 0.000 description 1
- 229940039717 lanolin Drugs 0.000 description 1
- 235000019388 lanolin Nutrition 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 239000000395 magnesium oxide Substances 0.000 description 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 1
- 239000011976 maleic acid Substances 0.000 description 1
- FPYJFEHAWHCUMM-UHFFFAOYSA-N maleic anhydride Chemical compound O=C1OC(=O)C=C1 FPYJFEHAWHCUMM-UHFFFAOYSA-N 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000000691 measurement method Methods 0.000 description 1
- 238000001465 metallisation Methods 0.000 description 1
- 125000005397 methacrylic acid ester group Chemical group 0.000 description 1
- LVHBHZANLOWSRM-UHFFFAOYSA-N methylenebutanedioic acid Natural products OC(=O)CC(=C)C(O)=O LVHBHZANLOWSRM-UHFFFAOYSA-N 0.000 description 1
- RZRNAYUHWVFMIP-UHFFFAOYSA-N monoelaidin Natural products CCCCCCCCC=CCCCCCCCC(=O)OCC(O)CO RZRNAYUHWVFMIP-UHFFFAOYSA-N 0.000 description 1
- JXTPJDDICSTXJX-UHFFFAOYSA-N n-Triacontane Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCC JXTPJDDICSTXJX-UHFFFAOYSA-N 0.000 description 1
- 125000001400 nonyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical class CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 1
- KSCKTBJJRVPGKM-UHFFFAOYSA-N octan-1-olate;titanium(4+) Chemical compound [Ti+4].CCCCCCCC[O-].CCCCCCCC[O-].CCCCCCCC[O-].CCCCCCCC[O-] KSCKTBJJRVPGKM-UHFFFAOYSA-N 0.000 description 1
- 229960002446 octanoic acid Drugs 0.000 description 1
- 125000002347 octyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 235000014593 oils and fats Nutrition 0.000 description 1
- JRZJOMJEPLMPRA-UHFFFAOYSA-N olefin Natural products CCCCCCCC=C JRZJOMJEPLMPRA-UHFFFAOYSA-N 0.000 description 1
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 1
- 239000004006 olive oil Substances 0.000 description 1
- 235000008390 olive oil Nutrition 0.000 description 1
- 150000001451 organic peroxides Chemical class 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 125000001147 pentyl group Chemical group C(CCCC)* 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 239000005011 phenolic resin Substances 0.000 description 1
- 229920003229 poly(methyl methacrylate) Polymers 0.000 description 1
- 229920002432 poly(vinyl methyl ether) polymer Polymers 0.000 description 1
- 229920002857 polybutadiene Polymers 0.000 description 1
- 229920006289 polycarbonate film Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001721 polyimide Polymers 0.000 description 1
- 239000004926 polymethyl methacrylate Substances 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920005606 polypropylene copolymer Polymers 0.000 description 1
- 150000003097 polyterpenes Chemical class 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- UIIIBRHUICCMAI-UHFFFAOYSA-N prop-2-ene-1-sulfonic acid Chemical compound OS(=O)(=O)CC=C UIIIBRHUICCMAI-UHFFFAOYSA-N 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 229940032094 squalane Drugs 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 229920006132 styrene block copolymer Polymers 0.000 description 1
- 150000005846 sugar alcohols Polymers 0.000 description 1
- 125000000020 sulfo group Chemical group O=S(=O)([*])O[H] 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 210000004243 sweat Anatomy 0.000 description 1
- 230000002889 sympathetic effect Effects 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 125000000999 tert-butyl group Chemical group [H]C([H])([H])C(*)(C([H])([H])[H])C([H])([H])[H] 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- KHPCPRHQVVSZAH-UHFFFAOYSA-N trans-cinnamyl beta-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OCC=CC1=CC=CC=C1 KHPCPRHQVVSZAH-UHFFFAOYSA-N 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- ZIBGPFATKBEMQZ-UHFFFAOYSA-N triethylene glycol Chemical compound OCCOCCOCCO ZIBGPFATKBEMQZ-UHFFFAOYSA-N 0.000 description 1
- VLPFTAMPNXLGLX-UHFFFAOYSA-N trioctanoin Chemical compound CCCCCCCC(=O)OCC(OC(=O)CCCCCCC)COC(=O)CCCCCCC VLPFTAMPNXLGLX-UHFFFAOYSA-N 0.000 description 1
- 125000002948 undecyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 229940117958 vinyl acetate Drugs 0.000 description 1
- 229920001567 vinyl ester resin Polymers 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 239000008096 xylene Substances 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Vascular Medicine (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Adhesives Or Adhesive Processes (AREA)
Description
[1] 支持体の片面に、遊離型ビソプロロールと粘着剤とを含有する粘着剤層が積層された貼付製剤であって、粘着剤層の応力緩和率が20〜90%であり、且つ、粘着剤層のズレ応力が1.0〜6.5N/30mm幅であるビソプロロール含有貼付製剤。
[2] 粘着剤層の応力緩和率が40〜90%であり、且つ、粘着剤層のズレ応力が1.0〜4.0N/30mm幅である、上記[1]に記載のビソプロロール含有貼付製剤。
[3] 粘着剤は、ゴム系粘着剤を含む上記[1]又は[2]に記載のビソプロロール含有貼付製剤。
[4] ゴム系粘着剤は、ポリイソブチレン及び/又はスチレン−イソプレン−スチレンブロック共重合体である上記[3]に記載のビソプロロール含有貼付製剤。
[5] ポリイソブチレンは、粘度平均分子量40,000〜5,500,000のポリイソブチレンである、上記[4]に記載のビソプロロール含有貼付製剤。
[6] ポリイソブチレンは、粘度平均分子量1,800,000〜5,500,000の第1のポリイソブチレン(a)と、粘度平均分子量40,000〜85,000の第2のポリイソブチレン(b)とを含み、第1のポリイソブチレン(a)と、第2のポリイソブチレン(b)の配合割合(a:b)が重量比で1:0.1〜1:3である、上記[4]に記載のビソプロロール含有貼付製剤。
[7] スチレン−イソプレン−スチレンブロック共重合体は、スチレン比率が30重量%未満である、上記[4]に記載のビソプロロール含有貼付製剤。
[8] スチレン−イソプレン−スチレンブロック共重合体の粘着剤層中の含有量が5〜50重量%である、上記[4]または[7]に記載のビソプロロール含有貼付製剤。
1種単独でポリイソブチレンを含有する場合、粘着剤層中のポリイソブチレンの含有量は、好ましくは15〜60重量%、より好ましくは15〜55重量%である。ポリイソブチレンの含有量が15重量%未満であると、粘着剤層に必要な内部凝集力を付与し難くなる虞があり、他方、60重量%を超えると、粘着剤層の皮膚接着性やタックが低下する虞がある。
また、1種単独でポリイソブチレンを含有する場合、ポリイソブチレンの分子量は特に限定されず、粘度平均分子量は、好ましくは40,000〜5,500,000、より好ましくは45,000〜5,000,000である。粘度平均分子量が40,000未満であると、粘着剤層に必要な内部凝集力を付与し難くなる虞があり、他方、5,500,000を超えると、粘着剤層の皮膚接着性やタックが低下する虞がある。
1)
ηSP=t/to−1
t :溶液のフロータイム (Hagenbach-Couette補正式による)
t0:溶媒のフロータイム (Hagenbach-Couette補正式による)
c :溶液の濃度(g/cm3)
J0=3.06×10−2Mv0.65 (2)
Mv:粘度平均分子量
ゴム系粘着剤として分子量の異なる2種のポリイソブチレンを使用する場合、第1のポリイソブチレン(a)と第2のポリイソブチレン(b)を使用する態様では、第1のポリイソブチレン(a)と、第2のポリイソブチレン(b)の配合割合(a:b)は、重量比で好ましくは1:0.1〜1:3、より好ましくは1:0.5〜1:2、更に好ましくは1:0.65〜1:0.97、最も好ましくは1:0.77〜1:0.97である。これら2種のポリイソブチレンのうち、第2のポリイソブチレン(b)の配合割合が上記上限を超えると、粘着剤層の内部凝集力の低下が大きくなる虞があり、他方、下限未満であると、粘着剤層の皮膚接着力の低下が大きくなる虞がある。
例えば、ゴム系粘着剤として、スチレン−イソプレン−スチレンブロック共重合体を単独で使用する場合、スチレン比率が10〜24重量%のものが好ましく、スチレン比率が15〜24重量%のものがより好ましい。また、スチレン−イソプレン−スチレンブロック共重合体のスチレン比率が10重量%以上、15重量%未満の場合、粘着剤層中のスチレン−イソプレン−スチレンブロック共重合体の含有量は10〜30重量%が好ましく、スチレン−イソプレン−スチレンブロック共重合体のスチレン比率が15〜24重量%の場合、スチレン−イソプレン−スチレンブロック共重合体の粘着剤層中の含有量は17.5〜22.5重量%が好ましい。
工業製品としての種類が多く、貼付製剤に用いるのに適切な厚さのものが数多く市販されており、求める品質のものを選択しやすいため、剥離ライナーとして、プラスチックフィルムが好ましく、ポリエステルフィルムがより好ましく、PETフィルムがさらに好ましい。剥離ライナーの厚みは特に限定されず、例えば10〜200μm、好ましくは25〜150μmである。
PIB1:ポリイソブチレン 粘度平均分子量4,000,000
PIB2:ポリイソブチレン 粘度平均分子量400,000
PIB3:ポリイソブチレン 粘度平均分子量55,000
SIS1:スチレン−イソプレン−スチレンブロック共重合体(スチレン比率25重量%、ジブロック比率17重量%)
SIS2:スチレン−イソプレン−スチレンブロック共重合体(スチレン比率25重量%、ジブロック比率42重量%)
SIS3:スチレン−イソプレン−スチレンブロック共重合体(スチレン比率22重量%、ジブロック比率15重量%)
SIS4:スチレン−イソプレン−スチレンブロック共重合体(スチレン比率14重量%、ジブロック比率26重量%)
TF1:粘着付与剤 脂環族飽和炭化水素樹脂 軟化点100℃
TF2:粘着付与剤 脂環族飽和炭化水素樹脂 軟化点140℃
流パラ:流動パラフィン
IPM:ミリスチン酸イソプロピル
ODO:2−オクチル−1−ドデカノール
表1に記載の配合割合にしたがって粘着剤組成物の粘稠トルエン溶液を調製し、得られた溶液を、シリコーン剥離処理を施したポリエチレンテレフタレート(PET)製ライナー(厚さ75μm)上に、乾燥厚さが表2に記載の厚さとなるように塗布し、これを熱風循環式乾燥機中で100℃、5分間乾燥して粘着剤層を形成した。この粘着剤層を厚さ2μmのPET製フィルムと目付量12g/m2のPET製不織布との積層フィルムの不織布側に貼り合わせ、シート状の貼付製剤を得た。得られた貼付製剤の応力緩和率とズレ応力を上記の方法にて測定した結果を表2に示す。なお、表1に記載の各成分の配合割合は、粘着剤組成物全体に対する割合(重量%)である。
実施例1〜8及び比較例1〜8で得られた貼付製剤の粘着力を、以下の方法で測定した。ステンレス板(JIS G4305に規定されるSUS304鋼板)の表面を、まず360番の耐水研磨紙にて均一に研磨し、次いで酢酸エチルを染み込ませた布で洗浄した。ビソプロロール含有貼付製剤を切断して、幅24mmおよび長さ50mmの試験片を調製した。ライナーを剥離した試験片の粘着面を、質量2kgのゴムローラーを用いてステンレス板の研磨および洗浄した表面に貼り合せた(ゴムローラー通過速度300mm/分、通過回数2回)。試験片を貼り合せたステンレス板を23±2℃、65±10%R.H.の雰囲気下に30分間静置した。ステンレス板から試験片の一端を約5mm剥がして180°角に折り返し、補助紙(幅30mm)を貼り付けた。引張り試験機を用い、補助紙の一端を上部の留金にはさみ、ステンレス板を下部の留金にはさみ、23±2℃、65±10%R.H.の雰囲気下で、300mm/分の速度で180°方向に試験片を連続して引き剥がし、粘着力を測定した。結果を表3に示す。
上記粘着力から、下記の基準により貼付性を判定した。
粘着力が0.1N/24mm幅以下だと粘着力が弱く、貼付時に剥がれるおそれがあるため、貼付性不可(×)と判定した。
粘着力が0.1N/24mm幅超、2.0N/24mm幅未満だと、適度な粘着力を有し、剥離時の皮膚刺激が生じるおそれがないため、貼付性は良好(○)と判定した。
粘着力が2.0N/24mm幅以上、3.0N/24mm幅未満だと、優れた皮膚接着性を有し、かつ剥離時の皮膚刺激が生じるおそれもないため、貼付性は優秀(◎)と判定した。
粘着力が3.0N/24mm幅以上、3.9N/24mm幅未満だと、剥離時の皮膚刺激が生じるおそれがあるため、貼付性可(△)と判定した。
粘着力が3.9N/24mm幅以上だと粘着力が強く、剥離時に皮膚刺激が生じるため、貼付性不可(×)と判定した。
結果を表3に示す。
応力緩和率から、下記の基準により粘着剤層の伸縮性を判定した。
応力緩和率が20%未満だと皮膚面に対する追従性が十分ではなく、貼付時にツッパリ感や剥がれるおそれがあるため、伸縮性不可(×)と判定した。
応力緩和率が20%以上、90%以下だと、適度な追従性を有し、貼付時の違和感や周辺端部のめくれが生じないため、伸縮性は良好(○)と判定した。
応力緩和率が90%超だと、粘着剤層が柔らかくなり過ぎ、剥離時に糊残りが生じるおそれがあるため、伸縮性不可(×)と判定した。
結果を表3に示す。
上記(1)粘着力の項にて、粘着力を測定した後のステンレス板の表面を目視で観察し、ステンレス板の表面への転写物の有無を下記の基準により評価した。結果を表3に示す。
○:転写物は存在しなかった。
△:一部転写物が存在した。
×:貼付箇所の全面に転写物が存在した。
一方、表2においてズレ応力が好適範囲の下限値未満にあることが示された比較例1〜3は粘着力が著しく低く、貼付性に劣るものであった。また、粘着剤層中に粘着剤層成分を保持できず、表面に滲み出しが見られたため、剥離後の被着体に転写物が存在した。
応力緩和の試験中に製剤が被着体から剥離した比較例4〜8は、応力緩和率が10%以下であると推察され、被着面が伸び縮みするような皮膚面に対しては、十分な追従性を示さず、貼付中に剥がれてしまうことが推察された。
以上のことから、応力緩和率を20〜90%、且つ、ズレ応力を1.0〜6.5N/30mm幅とすることで、皮膚面へ貼付、剥離する際の応力の緩和・分散ができ、優れた皮膚接着性を発揮するとともに、剥離時における刺激性の低減が可能となった。
2 粘着剤層
3 剥離ライナー
10 貼付製剤(試験片)
21 ベークライト板
31 チャック部
Claims (6)
- 支持体の片面に、遊離型ビソプロロールと粘着剤とを含有する粘着剤層が積層された貼付製剤であって、
前記粘着剤は、スチレン−イソプレン−スチレンブロック共重合体を含むゴム系粘着剤を含み、
前記スチレン−イソプレン−スチレンブロック共重合体は、ジブロック比率が17〜26重量%であり、
粘着剤層の応力緩和率が32〜66%であり、且つ
粘着剤層のズレ応力が1.0〜6.5N/30mm幅である
ビソプロロール含有貼付製剤。 - 粘着剤層のズレ応力が1.0〜4.0N/30mm幅である、
請求項1に記載のビソプロロール含有貼付製剤。 - 前記スチレン−イソプレン−スチレンブロック共重合体は、スチレン比率が30重量%未満である、請求項1または2に記載のビソプロロール含有貼付製剤。
- 前記スチレン−イソプレン−スチレンブロック共重合体の粘着剤層中の含有量が5〜50重量%である、請求項1〜3のいずれか一項に記載のビソプロロール含有貼付製剤。
- 前記粘着剤層は、液状またはペースト状の有機成分を含む請求項1〜4のいずれか一項に記載のビソプロロール含有貼付製剤。
- 前記液状またはペースト状の有機成分は、流動パラフィンを含む請求項5に記載のビソプロロール含有貼付製剤。
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