JP6360614B2 - 貼付剤 - Google Patents
貼付剤 Download PDFInfo
- Publication number
- JP6360614B2 JP6360614B2 JP2017503422A JP2017503422A JP6360614B2 JP 6360614 B2 JP6360614 B2 JP 6360614B2 JP 2017503422 A JP2017503422 A JP 2017503422A JP 2017503422 A JP2017503422 A JP 2017503422A JP 6360614 B2 JP6360614 B2 JP 6360614B2
- Authority
- JP
- Japan
- Prior art keywords
- adhesive layer
- pressure
- sensitive adhesive
- patch
- release liner
- 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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- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims description 84
- 239000010410 layer Substances 0.000 claims description 60
- 230000001070 adhesive effect Effects 0.000 claims description 54
- 239000000853 adhesive Substances 0.000 claims description 52
- -1 glycerin ester Chemical class 0.000 claims description 45
- 239000012790 adhesive layer Substances 0.000 claims description 41
- 229920002545 silicone oil Polymers 0.000 claims description 41
- 239000003814 drug Substances 0.000 claims description 40
- 229940079593 drug Drugs 0.000 claims description 39
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 claims description 26
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 19
- 239000000194 fatty acid Substances 0.000 claims description 19
- 229930195729 fatty acid Natural products 0.000 claims description 19
- 229920001971 elastomer Polymers 0.000 claims description 16
- 239000005060 rubber Substances 0.000 claims description 16
- 239000007788 liquid Substances 0.000 claims description 14
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical group [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 12
- 229920001577 copolymer Polymers 0.000 claims description 12
- 239000004014 plasticizer Substances 0.000 claims description 12
- XUGNVMKQXJXZCD-UHFFFAOYSA-N isopropyl palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC(C)C XUGNVMKQXJXZCD-UHFFFAOYSA-N 0.000 claims description 10
- 239000004205 dimethyl polysiloxane Substances 0.000 claims description 8
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims description 8
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims description 8
- RSWGJHLUYNHPMX-UHFFFAOYSA-N Abietic-Saeure Natural products C12CCC(C(C)C)=CC2=CCC2C1(C)CCCC2(C)C(O)=O RSWGJHLUYNHPMX-UHFFFAOYSA-N 0.000 claims description 7
- 239000013032 Hydrocarbon resin Substances 0.000 claims description 7
- KHPCPRHQVVSZAH-HUOMCSJISA-N Rosin Natural products O(C/C=C/c1ccccc1)[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 KHPCPRHQVVSZAH-HUOMCSJISA-N 0.000 claims description 7
- 125000002723 alicyclic group Chemical group 0.000 claims description 7
- 150000004665 fatty acids Chemical class 0.000 claims description 7
- 229920006270 hydrocarbon resin Polymers 0.000 claims description 7
- 229930195734 saturated hydrocarbon Natural products 0.000 claims description 7
- 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 claims description 7
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 claims description 6
- 229920002367 Polyisobutene Polymers 0.000 claims description 6
- 229940057995 liquid paraffin Drugs 0.000 claims description 6
- 229920001083 polybutene Polymers 0.000 claims description 6
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- 229920005989 resin Polymers 0.000 claims description 6
- 239000011347 resin Substances 0.000 claims description 6
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerol Natural products OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 5
- CMBYOWLFQAFZCP-UHFFFAOYSA-N Hexyl dodecanoate Chemical compound CCCCCCCCCCCC(=O)OCCCCCC CMBYOWLFQAFZCP-UHFFFAOYSA-N 0.000 claims description 5
- 229940100463 hexyl laurate Drugs 0.000 claims description 5
- 235000011187 glycerol Nutrition 0.000 claims description 4
- 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 claims description 4
- 150000003505 terpenes Chemical class 0.000 claims description 4
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- DNIAPMSPPWPWGF-GSVOUGTGSA-N (R)-(-)-Propylene glycol Chemical compound C[C@@H](O)CO DNIAPMSPPWPWGF-GSVOUGTGSA-N 0.000 claims description 3
- 229920006271 aliphatic hydrocarbon resin Polymers 0.000 claims description 3
- 239000003208 petroleum Substances 0.000 claims description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
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- 238000012360 testing method Methods 0.000 description 21
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- 238000010521 absorption reaction Methods 0.000 description 11
- 238000000034 method Methods 0.000 description 11
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical group OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 10
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- 230000002411 adverse Effects 0.000 description 6
- 230000006872 improvement Effects 0.000 description 6
- OSWPMRLSEDHDFF-UHFFFAOYSA-N methyl salicylate Chemical compound COC(=O)C1=CC=CC=C1O OSWPMRLSEDHDFF-UHFFFAOYSA-N 0.000 description 6
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- WRIDQFICGBMAFQ-UHFFFAOYSA-N (E)-8-Octadecenoic acid Natural products CCCCCCCCCC=CCCCCCCC(O)=O WRIDQFICGBMAFQ-UHFFFAOYSA-N 0.000 description 5
- LVYLCBNXHHHPSB-UHFFFAOYSA-N 2-hydroxyethyl salicylate Chemical compound OCCOC(=O)C1=CC=CC=C1O LVYLCBNXHHHPSB-UHFFFAOYSA-N 0.000 description 5
- LQJBNNIYVWPHFW-UHFFFAOYSA-N 20:1omega9c fatty acid Natural products CCCCCCCCCCC=CCCCCCCCC(O)=O LQJBNNIYVWPHFW-UHFFFAOYSA-N 0.000 description 5
- QSBYPNXLFMSGKH-UHFFFAOYSA-N 9-Heptadecensaeure Natural products CCCCCCCC=CCCCCCCCC(O)=O QSBYPNXLFMSGKH-UHFFFAOYSA-N 0.000 description 5
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- ZQPPMHVWECSIRJ-UHFFFAOYSA-N Oleic acid Natural products CCCCCCCCC=CCCCCCCCC(O)=O ZQPPMHVWECSIRJ-UHFFFAOYSA-N 0.000 description 5
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- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- ASUTZQLVASHGKV-JDFRZJQESA-N galanthamine Chemical compound O1C(=C23)C(OC)=CC=C2CN(C)CC[C@]23[C@@H]1C[C@@H](O)C=C2 ASUTZQLVASHGKV-JDFRZJQESA-N 0.000 description 4
- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
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- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 3
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 description 3
- 239000002253 acid Substances 0.000 description 3
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- 239000000463 material Substances 0.000 description 3
- 229960001047 methyl salicylate Drugs 0.000 description 3
- ARIWANIATODDMH-UHFFFAOYSA-N rac-1-monolauroylglycerol Chemical compound CCCCCCCCCCCC(=O)OCC(O)CO ARIWANIATODDMH-UHFFFAOYSA-N 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- 210000000434 stratum corneum Anatomy 0.000 description 3
- YYGNTYWPHWGJRM-UHFFFAOYSA-N (6E,10E,14E,18E)-2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene Chemical compound CC(C)=CCCC(C)=CCCC(C)=CCCC=C(C)CCC=C(C)CCC=C(C)C YYGNTYWPHWGJRM-UHFFFAOYSA-N 0.000 description 2
- DSSYKIVIOFKYAU-XCBNKYQSSA-N (R)-camphor Chemical compound C1C[C@@]2(C)C(=O)C[C@@H]1C2(C)C DSSYKIVIOFKYAU-XCBNKYQSSA-N 0.000 description 2
- AXTGDCSMTYGJND-UHFFFAOYSA-N 1-dodecylazepan-2-one Chemical compound CCCCCCCCCCCCN1CCCCCC1=O AXTGDCSMTYGJND-UHFFFAOYSA-N 0.000 description 2
- XDOFQFKRPWOURC-UHFFFAOYSA-N 16-methylheptadecanoic acid Chemical compound CC(C)CCCCCCCCCCCCCCC(O)=O XDOFQFKRPWOURC-UHFFFAOYSA-N 0.000 description 2
- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 description 2
- HBKBEZURJSNABK-MWJPAGEPSA-N 2,3-dihydroxypropyl (1r,4ar,4br,10ar)-1,4a-dimethyl-7-propan-2-yl-2,3,4,4b,5,6,10,10a-octahydrophenanthrene-1-carboxylate Chemical compound C([C@@H]12)CC(C(C)C)=CC1=CC[C@@H]1[C@]2(C)CCC[C@@]1(C)C(=O)OCC(O)CO HBKBEZURJSNABK-MWJPAGEPSA-N 0.000 description 2
- YREYLAVBNPACJM-UHFFFAOYSA-N 2-(tert-butylamino)-1-(2-chlorophenyl)ethanol Chemical compound CC(C)(C)NCC(O)C1=CC=CC=C1Cl YREYLAVBNPACJM-UHFFFAOYSA-N 0.000 description 2
- 125000000954 2-hydroxyethyl group Chemical group [H]C([*])([H])C([H])([H])O[H] 0.000 description 2
- LEACJMVNYZDSKR-UHFFFAOYSA-N 2-octyldodecan-1-ol Chemical compound CCCCCCCCCCC(CO)CCCCCCCC LEACJMVNYZDSKR-UHFFFAOYSA-N 0.000 description 2
- 229920002799 BoPET Polymers 0.000 description 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- XIQVNETUBQGFHX-UHFFFAOYSA-N Ditropan Chemical compound C=1C=CC=CC=1C(O)(C(=O)OCC#CCN(CC)CC)C1CCCCC1 XIQVNETUBQGFHX-UHFFFAOYSA-N 0.000 description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 2
- ZCVMWBYGMWKGHF-UHFFFAOYSA-N Ketotifene Chemical compound C1CN(C)CCC1=C1C2=CC=CC=C2CC(=O)C2=C1C=CS2 ZCVMWBYGMWKGHF-UHFFFAOYSA-N 0.000 description 2
- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 description 2
- DUGOZIWVEXMGBE-UHFFFAOYSA-N Methylphenidate Chemical compound C=1C=CC=CC=1C(C(=O)OC)C1CCCCN1 DUGOZIWVEXMGBE-UHFFFAOYSA-N 0.000 description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 2
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- DRHKJLXJIQTDTD-OAHLLOKOSA-N Tamsulosine Chemical compound CCOC1=CC=CC=C1OCCN[C@H](C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 DRHKJLXJIQTDTD-OAHLLOKOSA-N 0.000 description 2
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- 239000004480 active ingredient Substances 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
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- 235000010354 butylated hydroxytoluene Nutrition 0.000 description 2
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- PRAKJMSDJKAYCZ-UHFFFAOYSA-N dodecahydrosqualene Natural products CC(C)CCCC(C)CCCC(C)CCCCC(C)CCCC(C)CCCC(C)C PRAKJMSDJKAYCZ-UHFFFAOYSA-N 0.000 description 2
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- 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 2
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- GHBFNMLVSPCDGN-UHFFFAOYSA-N rac-1-monooctanoylglycerol Chemical compound CCCCCCCC(=O)OCC(O)CO GHBFNMLVSPCDGN-UHFFFAOYSA-N 0.000 description 2
- 229960001534 risperidone Drugs 0.000 description 2
- RAPZEAPATHNIPO-UHFFFAOYSA-N risperidone Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC=3C(=O)N4CCCCC4=NC=3C)=NOC2=C1 RAPZEAPATHNIPO-UHFFFAOYSA-N 0.000 description 2
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- 238000007789 sealing Methods 0.000 description 2
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Classifications
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- 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
- A61K9/7061—Polyacrylates
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- 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
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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- 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
- A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Description
下記の表1及び表2に示す剥離性向上剤(無官能性シリコーンオイル、極性シリコーンオイル、ポリビニルピロリドン、酸化亜鉛、グリシナール、ベントナイト、カオリン、タルク)、粘着基剤(アクリル酸エステル系共重合体)、添加成分(パルミチン酸イソプロピル(可塑剤)、オレイン酸(経皮吸収促進剤))を用いて、下記の表1及び表2に示す組成となるように各成分を秤量し、混合して粘着剤溶液を得た。次いで、得られた粘着剤溶液を、剥離ライナー(表面をシリコーンにより離型処理したPETフィルム)上に塗布し、溶媒を乾燥除去して粘着剤層を形成した(得られた粘着剤層の厚みは100g/m2)。次に、粘着剤層の上に支持体(PETフィルム)を積層し、裁断して貼付剤を得た。その後、得られた貼付剤をアルミラミネートフィルムからなる包装袋に密封して包装した。
前記包装袋に密封する前の各貼付剤(初期)、並びに、前記包装袋に密封した各貼付剤を60℃のチャンバー内に1週間保存した後に包装袋を開封して取り出した各貼付剤(60℃/1W)について、貼付剤から剥離ライナーを除去する際の剥がしやすさ(剥がすために要する力の強さ)について、以下の基準に基づいて評価した。
1:剥離ライナーが粘着剤層からずれている(不合格)
2:軽い力で剥がせるが、剥離ライナーが粘着剤層からずれている場合がある(不合格)
3:剥離ライナーが粘着剤層からずれておらず、適度な力で剥がせる(合格)
4:剥離ライナーが粘着剤層からずれていないが、剥がすのにやや強い力を要する(準合格)
5:剥離ライナーが粘着剤層からずれていないが、剥がすのに非常に強い力を要する(不合格)。
前記包装袋に密封する前の各貼付剤(初期)、並びに、前記包装袋に密封した各貼付剤を60℃のチャンバー内に1週間保存した後に包装袋を開封して取り出した各貼付剤(60℃/1W)について、貼付剤から剥離ライナーを除去した。各貼付剤の表面に液体が染み出しているかについて、以下の基準に基づいて評価した。
A:染み出しは観察されなかった(合格)
B:僅かな染み出しが観察された(準合格)
C:顕著な染み出しが観察された(不合格)。
下記の表5に示す剥離性向上剤(無官能性シリコーンオイル)、粘着基剤(スチレン−イソプレン−スチレンブロック共重合体、ポリイソブチレン)、添加成分(脂環族飽和炭化水素樹脂(粘着付与剤)、流動パラフィン(可塑剤)、パルミチン酸イソプロピル(可塑剤)、オクチルドデカノール(経皮吸収促進剤))を用いて、下記の表5に示す組成となるように各成分を秤量し、溶媒(トルエン)中に溶解して得られた粘着剤溶液を用いるようにしたこと以外は実施例1と同様にして貼付剤を得て包装袋に密封した。なお、表5中の配合量も粘着剤層の全質量を基準とした配合量(質量%)であり、粘着基剤に関しては固形分換算した配合量である。
下記の表7に示す剥離性向上剤(無官能性シリコーンオイル)、粘着基剤(アクリル酸エステル系共重合体)、添加成分(パルミチン酸イソプロピル(可塑剤)、オレイン酸(経皮吸収促進剤))を用いて、下記の表7に示す組成となるように各成分を秤量し、混合して得られた粘着剤溶液を用いるようにしたこと以外は実施例1と同様にして貼付剤を得て包装袋に密封した。なお、表7中の配合量も粘着剤層の全質量を基準とした配合量(質量%)であり、粘着基剤に関しては固形分換算した配合量である。
下記の表9に示す剥離性向上剤(無官能性シリコーンオイル)、粘着基剤(アクリル酸エステル系共重合体)、添加成分(パルミチン酸イソプロピル(可塑剤)、オレイン酸(経皮吸収促進剤))を用いて、下記の表9に示す組成となるように各成分を秤量し、混合して得られた粘着剤溶液を用いるようにしたこと以外は実施例1と同様にして貼付剤を得て包装袋に密封した。なお、表9中の配合量も粘着剤層の全質量を基準とした配合量(質量%)であり、粘着基剤に関しては固形分換算した配合量である。また、表9中の空欄は0(ゼロ)であることを示す。
下記の表11に示す薬物(ガランタミン)、剥離性向上剤(無官能性シリコーンオイル)、粘着基剤(アクリル酸エステル系共重合体)、添加成分(パルミチン酸イソプロピル(可塑剤)、オレイン酸(経皮吸収促進剤))を用いて、下記の表11に示す組成となるように各成分を秤量し、混合して得られた粘着剤溶液を用いるようにしたこと以外は実施例1と同様にして貼付剤を得て包装袋に密封した。なお、表11中の配合量も粘着剤層の全質量を基準とした配合量(質量%)であり、粘着基剤に関しては固形分換算した配合量である。
各貼付剤を剥離ライナーから剥離し、粘着剤層の表面に親指を押し付けてから離した際の貼付剤の凝集力、粘着力について評価した。また、試験用のヒト皮膚(腹部)の角質層側に各貼付剤を貼って32±1℃で3時間保存した後に貼付剤を剥離し、その際の剥離抵抗を評価した。
7〜10週齢のヘアレスマウスより摘出し脂肪を除去した皮膚(体側部)もしくは角質層側から約500μmの厚みに切断(ダーマトーム)した試験用のヒト皮膚(腹部)を用い、角質層側に各貼付剤(3cm2)を貼付し、真皮側をレセプター層側にして、フロースルー型拡散セルに装着した。そして、レセプター層側にはpH7.4のリン酸緩衝生理食塩水を用いて、皮膚表面温度が32±1℃となるように温水を外周部に循環させた。レセプター液の流速は2.5mL/時間の速さとし、サンプリングは4時間毎に行い、各ポイントで得られたレセプター溶液は、流量を正確に測り、高速液体クロマトグラフィーにより薬物濃度を測定し、流量及び薬物濃度の測定値より各貼付剤の1時間あたりの薬物透過速度を算出した。
各貼付剤を6.25cm2の大きさに裁断し、試験に用いるサンプルを得た。温度60℃、湿度75%の恒温恒湿槽中に2週間及び1ヶ月保存した各サンプルの測定により得られた薬物の含有量(Ni)、及び初期サンプルの測定で得られた薬物の含有量(N0)の値を下記式(1):
Ri(%)=(Ni/N0)×100 (1)
に示す関係式に代入して得られた値(Ri)を、各サンプルにおける薬物の各条件における保管後の対初期値(%)とした。
薬物としてインドメタシン(実施例15)、ケトプロフェン(実施例16)、フェルビナク(実施例17)、サリチル酸メチル(実施例18)、サリチル酸グリコール(実施例19)、ビソプロロール(実施例20)、ペルゴリド(実施例21)、ロピニロール(実施例22)、ツロブテロール(実施例23)、ケトチフェン(実施例24)、リドカイン(実施例25)、オキシブチニン(実施例26)、タムスロシン(実施例27)、アセナピン(実施例28)、エストラジオール(実施例29)、リスペリドン(実施例30)、リバスチグミン(実施例31)、メチルフェニデート(実施例32)をそれぞれ用いるようにしたこと以外は実施例13と同様にして得られた各貼付剤を用いて、前述の方法で「剥離ライナーの剥離性試験」及び「ブリード防止性試験」を行った。
Claims (8)
- 支持体の少なくとも一方の面に粘着剤層及び剥離ライナーが積層されてなる貼付剤であって、前記粘着剤層が粘着基剤としてアクリレート系粘着剤及びゴム系粘着剤からなる群から選択される少なくとも一種を含有するものであり、かつ、該粘着剤層に25℃における動粘度が10〜350cStである無官能性シリコーンオイルが0.3〜5質量%配合されている貼付剤。
- 前記粘着剤層に薬物がさらに配合されている請求項1に記載の貼付剤。
- 前記無官能性シリコーンオイルが、ジメチルポリシロキサン及びメチルフェニルポリシロキサンからなる群から選択される少なくとも一種である請求項1又は2に記載の貼付剤。
- 前記粘着剤層に、流動パラフィン、液状ポリブテン、パルミチン酸イソプロピル、ミリスチン酸イソプロピル、セバシン酸ジエチル及びラウリン酸ヘキシルからなる群から選択される少なくとも一種が可塑剤としてさらに配合されている請求項1〜3のうちのいずれか一項に記載の貼付剤。
- 前記粘着剤層に、炭素鎖数6〜20の脂肪酸及び炭素鎖数6〜20の脂肪族アルコールからなる群から選択される少なくとも一種が経皮吸収促進剤としてさらに配合されている請求項1〜4のうちのいずれか一項に記載の貼付剤。
- 前記粘着剤層に、水添ロジンのグリセリンエステル、脂環族飽和炭化水素樹脂、脂肪族系炭化水素樹脂及びテルペン樹脂からなる群から選択される少なくとも一種が粘着付与剤としてさらに配合されている請求項1〜5のうちのいずれか一項に記載の貼付剤。
- 前記粘着基剤がアクリル酸エステル系共重合体であり、前記粘着剤層に液状脂肪酸エステル類及び炭素鎖数6〜20の脂肪酸がさらに配合されている請求項1〜3のうちのいずれか一項に記載の貼付剤。
- 前記粘着基剤がスチレン−イソプレン−スチレンブロック共重合体及びポリイソブチレンであり、前記粘着剤層に脂環族飽和炭化水素樹脂、石油系オイル、液状脂肪酸エステル類及び炭素鎖数6〜20の脂肪族アルコールがさらに配合されている請求項1〜3のうちのいずれか一項に記載の貼付剤。
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