WO2005072675A1 - 貼付剤入り包装袋及び薬物移行抑制方法 - Google Patents
貼付剤入り包装袋及び薬物移行抑制方法 Download PDFInfo
- Publication number
- WO2005072675A1 WO2005072675A1 PCT/JP2005/001348 JP2005001348W WO2005072675A1 WO 2005072675 A1 WO2005072675 A1 WO 2005072675A1 JP 2005001348 W JP2005001348 W JP 2005001348W WO 2005072675 A1 WO2005072675 A1 WO 2005072675A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- patch
- packaging bag
- drug
- layer
- sensitive adhesive
- Prior art date
Links
- 229940079593 drug Drugs 0.000 title claims abstract description 90
- 239000003814 drug Substances 0.000 title claims abstract description 90
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- 239000000853 adhesive Substances 0.000 title claims abstract description 21
- 238000000034 method Methods 0.000 title claims description 12
- 230000002401 inhibitory effect Effects 0.000 title claims 2
- 238000013508 migration Methods 0.000 title description 7
- 230000005012 migration Effects 0.000 title description 7
- 239000010410 layer Substances 0.000 claims abstract description 67
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims abstract description 35
- -1 2-isopropoxyethoxymethyl Chemical group 0.000 claims abstract description 29
- 229920002239 polyacrylonitrile Polymers 0.000 claims abstract description 18
- 150000003839 salts Chemical class 0.000 claims abstract description 8
- 238000004806 packaging method and process Methods 0.000 claims description 79
- 239000012790 adhesive layer Substances 0.000 claims description 19
- 238000012546 transfer Methods 0.000 claims description 17
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 13
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 13
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 10
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- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 claims description 6
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 4
- 239000000178 monomer Substances 0.000 claims description 3
- 229920000642 polymer Polymers 0.000 claims description 3
- 239000012528 membrane Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 125000004200 2-methoxyethyl group Chemical group [H]C([H])([H])OC([H])([H])C([H])([H])* 0.000 abstract description 2
- 239000002274 desiccant Substances 0.000 description 9
- 229920001577 copolymer Polymers 0.000 description 8
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- 229920000346 polystyrene-polyisoprene block-polystyrene Polymers 0.000 description 5
- 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 5
- 229920002126 Acrylic acid copolymer Polymers 0.000 description 4
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 3
- 229920000298 Cellophane Polymers 0.000 description 3
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
- 239000013032 Hydrocarbon resin Substances 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 3
- 239000004743 Polypropylene Substances 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
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- 230000007774 longterm Effects 0.000 description 3
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 description 3
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- 229920000573 polyethylene Polymers 0.000 description 3
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- 239000000741 silica gel Substances 0.000 description 3
- 229910002027 silica gel Inorganic materials 0.000 description 3
- 239000002904 solvent Substances 0.000 description 3
- PRAKJMSDJKAYCZ-UHFFFAOYSA-N squalane Chemical compound CC(C)CCCC(C)CCCC(C)CCCCC(C)CCCC(C)CCCC(C)C PRAKJMSDJKAYCZ-UHFFFAOYSA-N 0.000 description 3
- 229920006132 styrene block copolymer Polymers 0.000 description 3
- 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
- WDQMWEYDKDCEHT-UHFFFAOYSA-N 2-ethylhexyl 2-methylprop-2-enoate Chemical compound CCCCC(CC)COC(=O)C(C)=C WDQMWEYDKDCEHT-UHFFFAOYSA-N 0.000 description 2
- OMIGHNLMNHATMP-UHFFFAOYSA-N 2-hydroxyethyl prop-2-enoate Chemical compound OCCOC(=O)C=C OMIGHNLMNHATMP-UHFFFAOYSA-N 0.000 description 2
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- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 2
- 239000005977 Ethylene Substances 0.000 description 2
- BAPJBEWLBFYGME-UHFFFAOYSA-N Methyl acrylate Chemical compound COC(=O)C=C BAPJBEWLBFYGME-UHFFFAOYSA-N 0.000 description 2
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- 230000032798 delamination Effects 0.000 description 2
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
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- 239000011888 foil Substances 0.000 description 2
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- FUZZWVXGSFPDMH-UHFFFAOYSA-N hexanoic acid Chemical compound CCCCCC(O)=O FUZZWVXGSFPDMH-UHFFFAOYSA-N 0.000 description 2
- AOGQPLXWSUTHQB-UHFFFAOYSA-N hexyl acetate Chemical compound CCCCCCOC(C)=O AOGQPLXWSUTHQB-UHFFFAOYSA-N 0.000 description 2
- 229940057995 liquid paraffin Drugs 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
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- 208000007530 Essential hypertension Diseases 0.000 description 1
- CMBYOWLFQAFZCP-UHFFFAOYSA-N Hexyl dodecanoate Chemical compound CCCCCCCCCCCC(=O)OCCCCCC CMBYOWLFQAFZCP-UHFFFAOYSA-N 0.000 description 1
- 108010029541 Laccase Proteins 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 239000005642 Oleic acid Substances 0.000 description 1
- ZQPPMHVWECSIRJ-UHFFFAOYSA-N Oleic acid Natural products CCCCCCCCC=CCCCCCCCC(O)=O ZQPPMHVWECSIRJ-UHFFFAOYSA-N 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
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- 239000004902 Softening Agent Substances 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- BHEOSNUKNHRBNM-UHFFFAOYSA-N Tetramethylsqualene Natural products CC(=C)C(C)CCC(=C)C(C)CCC(C)=CCCC=C(C)CCC(C)C(=C)CCC(C)C(C)=C BHEOSNUKNHRBNM-UHFFFAOYSA-N 0.000 description 1
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 1
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical class ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 1
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- 239000002253 acid Substances 0.000 description 1
- 239000003522 acrylic cement Substances 0.000 description 1
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- IEQUNHXCJVILJQ-UHFFFAOYSA-N aluminum palladium Chemical compound [Al].[Pd] IEQUNHXCJVILJQ-UHFFFAOYSA-N 0.000 description 1
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- 125000003118 aryl group Chemical group 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 1
- CQEYYJKEWSMYFG-UHFFFAOYSA-N butyl acrylate Chemical compound CCCCOC(=O)C=C CQEYYJKEWSMYFG-UHFFFAOYSA-N 0.000 description 1
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- HNPSIPDUKPIQMN-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane Chemical compound O=[Si]=O.O=[Al]O[Al]=O HNPSIPDUKPIQMN-UHFFFAOYSA-N 0.000 description 1
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- 150000002314 glycerols Chemical class 0.000 description 1
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- 235000013773 glyceryl triacetate Nutrition 0.000 description 1
- 229960002389 glycol salicylate Drugs 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
- 229940100463 hexyl laurate Drugs 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 239000011229 interlayer Substances 0.000 description 1
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- 229920003049 isoprene rubber Polymers 0.000 description 1
- 125000001449 isopropyl group Chemical group [H]C([H])([H])C([H])(*)C([H])([H])[H] 0.000 description 1
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- 229920001778 nylon Polymers 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
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 1
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- 230000000144 pharmacologic effect Effects 0.000 description 1
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 description 1
- 229920001083 polybutene Polymers 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 239000005033 polyvinylidene chloride Substances 0.000 description 1
- 229960004063 propylene glycol Drugs 0.000 description 1
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- 239000005060 rubber Substances 0.000 description 1
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- 239000002356 single layer Substances 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 229940032094 squalane Drugs 0.000 description 1
- 229940031439 squalene Drugs 0.000 description 1
- TUHBEKDERLKLEC-UHFFFAOYSA-N squalene Natural products CC(=CCCC(=CCCC(=CCCC=C(/C)CCC=C(/C)CC=C(C)C)C)C)C TUHBEKDERLKLEC-UHFFFAOYSA-N 0.000 description 1
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- 201000004059 subependymal giant cell astrocytoma Diseases 0.000 description 1
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- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- 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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/58—Adhesives
Definitions
- the present invention relates to a patch-containing packaging bag and a method for suppressing drug transfer.
- Patent Document 1 As a method for preventing the organic liquid component in a patch from being adsorbed and transferred to the inner surface of a packaging material, a method of using a plastic material having a solubility parameter of 9 or more on the inner surface of the packaging material is known (Patent Document 1). ). Drugs such as pisoprolol are used as the medicinal component of the patch. In this case, a mouth opening bag made of cellophane is used.
- Patent Document 1 Japanese Patent Application Laid-Open No. 5-305108
- the present inventors have found that even when a plastic material has a solubility parameter of 9 or more, migration occurs remarkably depending on the components contained in the patch.
- a film having a solubility parameter of 9 or more such as an ethylene Z-vinyl alcohol copolymer or an acrylonitrile z-methyl atalylate copolymer, is used.
- adhesion cannot be prevented by using.
- the present invention provides a packaging bag containing a patch containing pisoprolol and a compound having a skeleton similar to that of pisoprolol, in which the drug is unlikely to adhere to the inner surface of the packaging bag, and It is intended to provide.
- the patch-containing packaging bag of the present invention includes a patch in which an adhesive layer is laminated on at least one surface of a support and a release film is adhered to the adhesive layer.
- the pressure-sensitive adhesive layer contains a drug represented by the following general formula (1) or a pharmaceutically acceptable salt thereof, and the adhesive bag is in contact with the patch. At least a partial force of the inner surface is characterized by polyacrylonitrile force.
- R represents a 2-isopropoxyethoxymethyl group, a rubamoylmethyl group or a 2-methoxethyl group.
- the transfer of the drug represented by the general formula (1) (hereinafter referred to as "drug (1)”) can be suppressed.
- the drug (1) has the property of migrating on the support or release film, which has a high migration property, reaching the inner layer of the packaging bag and then spreading over the entire inner layer of the packaging bag.
- the adhesion of the drug can be prevented. Therefore, drug migration can be minimized.
- Examples of the drug include a drug in which R in the general formula (1) is a 2-isopropoxyethoxymethyl group, a rubamoylmethyl group, or a 2-methoxyethyl group.
- R in the general formula (1) is a 2-isopropoxyethoxymethyl group, a rubamoylmethyl group, or a 2-methoxyethyl group.
- the pressure-sensitive adhesive layer of the patch comprises an acrylic pressure-sensitive adhesive containing a polymer containing a (meth) acrylic acid ester as a monomer unit, a block copolymer-based pressure-sensitive adhesive containing a styrene-based block copolymer, and the above-mentioned adhesive layer. It is preferable to include at least one type of pressure-sensitive adhesive selected from the group consisting of pressure-sensitive adhesives containing an acrylic pressure-sensitive adhesive and the block copolymer-based pressure-sensitive adhesive. Such an adhesive is useful as a base because it can contain the above-mentioned drug and can also enhance the transdermal absorbability of the drug.
- the packaging bag is constituted by a multilayer film, and the inner surface of the multilayer film is It is preferred that the layer also has a polyacrylonitrile force. If the film on the inner surface has high drug permeability and material strength, delamination of the multilayer film may occur during storage of the patch. However, by setting the inner layer to polyacrylonitrile, the drug (1 ) Is prevented, so that the problem of delamination does not occur. In particular, when the inner layer is entirely made of polyatary-tolyl, the adhesion of the drug can be suppressed efficiently. That is, even after the patch containing the drug is accommodated inside the packaging bag and the patch moves inside the packaging bag, the adhesion of the drug can be prevented.
- the layer of the multilayer film which is the outer surface of the packaging bag, be made of polyethylene terephthalate.
- the inner layer can be physically protected and the outer surface of the packaging bag can be prevented from being modified such as by corrosion.
- the patch-containing packaging bag is provided with a layer which also has an aluminum force between the inner layer of the multilayer film and the outer layer of the multilayer film.
- the packaging bag containing the patch has an aluminum layer, the migration of the drug contained in the patch can be suppressed, and the volatile components in the formulation volatilize outside the packaging bag, and moisture etc. enter the packaging bag. It is possible to prevent intrusion and the like, and to improve gas nobility.
- the present invention is a drug transfer suppressing method for suppressing transfer of the drug to the inner surface of a packaging bag containing a patch provided with an adhesive layer containing the drug, wherein the drug is A drug represented by the general formula (1) or a pharmaceutically acceptable salt thereof, wherein at least a part of the inner surface has a surface having polyacrylonitrile power.
- the packaging bag with a patch of the present invention migration of a drug such as pisoprolol contained in the patch can be suppressed.
- the drug content contained in the patch can be maintained by storing the patch in a packaging bag. It can be transferred to the skin and the like.
- FIG. 1 is a cross-sectional view showing a patch-containing packaging bag according to a first embodiment.
- FIG. 2 is a cross-sectional view showing a patch-containing packaging bag according to a second embodiment.
- FIG. 3 is a cross-sectional view of the patch according to the first embodiment.
- FIG. 4 is a cross-sectional view of the patch according to the second embodiment.
- FIG. 5 is a cross-sectional view of the patch according to the third embodiment.
- FIG. 1 is a cross-sectional view of the patch-containing packaging bag according to the first embodiment.
- the patch-containing packaging bag 100 shown in FIG. 1 contains the patch 2 inside the packaging bag 1.
- the packaging bag 1 is composed of a multilayer film 10a in which an inner layer lla, an intermediate layer 12a and an outer layer 13a are laminated in this order, and a multilayer film 10b in which an inner layer llb, an intermediate layer 12b and an outer layer 13b are laminated in this order.
- a multilayer film 10a in which an inner layer lla, an intermediate layer 12a and an outer layer 13a are laminated in this order
- a multilayer film 10b in which an inner layer llb, an intermediate layer 12b and an outer layer 13b are laminated in this order.
- opposed inner layers 11a ⁇ lib are bonded.
- the patch 2 is formed by laminating a support 21, an adhesive layer 22, and a release film 23 in this order, and the adhesive layer 22 contains the drug (1).
- the patch 2 is in contact with the inner surfaces 31a and 31b of the packaging bag 1, that is, the surfaces of the inner layer 11a and the inner layer lib, and the inner layers 11a and lib to which the patch 2 is in contact are made of polyacrylonitrile.
- the intermediate layers 12a and 12b also have an aluminum force, and the outer layers 13a and 13b are made of polyethylene terephthalate.
- the drug (1) contained in the adhesive layer 22 of the patch 2 migrates along the support 21 and the release film 23 over time. If the drug (1) migrates to the surface of the inner layer 11a and lib, the migration may occur one after another, and the entire inner surfaces 31a and 31b may be covered with the drug (1). Also, the amount of the drug (1) in the adhesive layer 22 decreases over time. At the same time, the surface and inner surfaces 31a and 31b of patch 2 are contaminated with drug (1). Therefore, even if the patch 2 is sealed and the patch 2 is stored, a large amount of the drug (1) is released from the patch 2 inside the package 1, and the patch 2 after storage is ready for use. It will not be obtained.
- the inner layers l la and l ib also have a polyacrylonitrile force, so that the inner layers l la and l ib of the drug (1) are formed.
- the drug (1) released from the pressure-sensitive adhesive layer 22 is reduced. Therefore, even after long-term storage, the drug (1) in the patch 2 does not decrease and can be suitably used.
- the intermediate layers 12a and 12b are made of aluminum-palladium, volatilization can be achieved only by suppressing the transfer of the drug contained in the patch. It is possible to prevent volatile components from volatilizing out of the packaging bag and prevent water and the like from entering the packaging bag, etc., and to improve gas nobility. Further, since the outer layers 13a and 13b are made of polyethylene terephthalate, the intermediate layers 12a and 12b can be protected, wear can be prevented, and the thickness of the intermediate layers 12a and 12b can be made extremely thin.
- the packaging bag 1 may be made of a single-layer film of polyacrylonitrile.
- the polyethylene terephthalate of the outer layers 13a and 13b may be another resin.
- Other resins used for the outer layers 13a and 13b include polyethylene, polypropylene, nylon, cellophane, polyvinylidene chloride, ethylene-butyl alcohol copolymer and the like.
- the inner layer lla and lib are both made of polyacrylonitrile, and only one of the inner layers lla and lib is made of polyacrylo-tril. You may make it become. Furthermore, a part of the inner layer 11a or the rib, at least a part in contact with the patch 2, may be made of polyacrylonitrile.
- the thickness of the multilayer film 10a or 10b depends on gas permeability and ease of handling as a packaging bag. From the viewpoint of, 20-100 / zm is preferable. If it is less than 20 / zm, the film may be easily broken due to insufficient strength, and the airtightness may be deteriorated. If it exceeds 100 / zm, the flexibility of the film may be lost and the film may be difficult to handle.
- the multilayer films 10a and 10b of the packaging bag 1 can be manufactured by laminating the inner layers lla and lib, the intermediate layers 12a and 12b, and the outer layers 13a and 13b by a known heat lamination method or an adhesive. Monkey
- FIG. 2 is a cross-sectional view of the patch-containing packaging bag according to the second embodiment.
- the patch-containing packaging bag 110 has the same configuration as that of the first embodiment except that the desiccant 4 is accommodated in the void inside the packaging bag 1.
- the drug content of the patch 2 can be maintained at a high ratio. It is known that the drug (1) used in the present invention is liable to be hydrolyzed in addition to being easily transferred. Therefore, by containing the desiccant 4, the drug content of the patch 2 can be maintained even after long-term storage.
- the drying agent 4 is not particularly limited, but examples thereof include silica gel, synthetic or natural zeolite, and viscous minerals such as montmorillonite.
- FIG. 3-5 is a cross-sectional view showing the first to third embodiments of the patch contained in the packaging bag 1.
- the patch 2 according to the first embodiment shown in FIG. 3 corresponds to the patch 2 shown in FIGS. 1 and 2, and has a larger area between the support 21 and the release film 23 than the release film 23.
- the pressure-sensitive adhesive layer 22 is sandwiched in the same area as the support 21 having a smaller size.
- the patch 2a according to the second embodiment shown in FIG. 4 is obtained by laminating a support 21, an adhesive layer 22, and a release film 23 having the same area in this order.
- the patch 2b according to the third embodiment shown in FIG. 5 has a structure in which the adhesive layer 22 and the support 21 are laminated in this order on the surface of the release film 23 on which the adhesive layer 22 is formed in FIG. Things.
- the release film 23 is releasably laminated on the pressure-sensitive adhesive layer 22.
- the adhesive layer 22 is exposed at the end portion, and the adhesive 2a that is more easily transferred to the inner layers lla and 11b surfaces is packaged. Even when stored in the bag 1, the transfer of the drug (1) can be suppressed without any problem.
- the drug contained in the adhesive layer 22 is a drug represented by the general formula (1) or a pharmaceutically acceptable salt thereof.
- the drug represented by the general formula (1) generally selects the j8 receptor of the sympathetic nervous system.
- R in the general formula (1) is a 2-isopropoxhetoxymethyl group, it can be suitably used, particularly, for ameliorating essential hypertension, angina, and arrhythmia.
- this pharmaceutically acceptable salt refers to a salt of the drug of the general formula (1), which exhibits the same pharmacological activity as described above.
- the content of the drug in the pressure-sensitive adhesive layer 22 is more preferably 5 to 20% by mass, preferably 1 to 50% by mass, based on the total mass of the pressure-sensitive adhesive layer 22. If the content of the drug is less than 1% by mass, the drug is released from the pressure-sensitive adhesive layer 22, which tends to make it difficult to administer an appropriate amount of the drug at the time of use. On the other hand, if it exceeds 50% by mass, the drug cannot be retained in the pressure-sensitive adhesive layer 22, and the pressure-sensitive adhesive properties deteriorate.
- the pressure-sensitive adhesive layer 22 is made of a pressure-sensitive adhesive composition containing the drug (1), and may contain a pressure-sensitive adhesive, a softener, and the like, if necessary.
- a pressure-sensitive adhesive contained in the pressure-sensitive adhesive composition an acrylic pressure-sensitive adhesive containing a polymer containing a (meth) acrylic acid ester as a monomer unit, and a styrene-based pressure-sensitive adhesive because of its excellent adhesiveness and excellent drug release property.
- Examples include a block copolymer-based pressure-sensitive adhesive containing a block copolymer or a pressure-sensitive adhesive containing the acrylic pressure-sensitive adhesive and the block copolymer-based pressure-sensitive adhesive.
- Acrylic adhesives include (meth) acrylic acid represented by acrylic acid, 2-ethylhexyl acrylate, methyl acrylate, butyl acrylate, hydroxyethyl acrylate or 2-ethylhexyl methacrylate, etc. There is no particular limitation as long as it is copolymerized by containing at least one (ester), for example, 2-ethylhexyl acrylate′-butyl acetate copolymer, 2-ethylhexyl acrylate.
- acrylic acid - 2 - Echiru hexyl 'vinyl acetate copolymer, hexyl acetate Bulle-acrylic acid copolymer to acrylic acid 2 Echiru is preferably /,.
- styrene block copolymer As the styrene block copolymer, styrene isoprene styrene block copolymer (SI S), styrene butadiene styrene block copolymer (SBS), styrene ethylene butylene styrene block copolymer (SEBS), styrene ethylene propylene-styrene block copolymer (SEPS), and the like, with styrene isoprene styrene block copolymer (SIS) being particularly preferred. . Still more preferably, it is an adhesive obtained by mixing SIS and 2-ethylhexyl acrylate / vinyl acetate / acrylic acid copolymer.
- the softening agent examples include petroleum-based oils (eg, paraffin-based process oil, naphthenic-based process oil and aromatic-based process oil), squalane, squalene, and vegetable-based oils (eg, almond oil, olive oil, camellia oil, Castor oil, tall oil or laccase oil, etc., oleic acid, silicone oil, dibasic acid ester (eg, dibutyl phthalate or dioctyl phthalate), liquid rubber (eg, polybutene or liquid isoprene rubber), liquid fatty acid ester (myristine) Isopropyl, hexyl laurate, diethyl sebacate or isopropyl sebacate), diethylene glycol, polyethylene glycol, glycol salicylate, propylene glycol, dipropylene glycol, triacetin, triethyl citrate Or crotamiton and the like.
- tackifier examples include alicyclic saturated hydrocarbon resin, rosin derivative (eg, rosin, glycerin ester of rosin, hydrogenated rosin, glycerin ester of hydrogenated rosin, pentaerythritol ester of rosin, etc.), terpene Resin, petroleum resin or maleic resin.
- rosin derivative eg, rosin, glycerin ester of rosin, hydrogenated rosin, glycerin ester of hydrogenated rosin, pentaerythritol ester of rosin, etc.
- terpene Resin terpene Resin
- petroleum resin or maleic resin terpene Resin
- alicyclic saturated hydrocarbon resins and glycerin esters of hydrogenated rosin are particularly preferred.
- These tackifiers may be used alone or in combination of two or more.
- a material which is excellent in flexibility while maintaining good drug transferability is desired.
- Polyethylene terephthalate, polyethylene, polypropylene, polychlorinated vinyl chloride, ethylene / vinyl acetate copolymer or polyurethane is desirable. Examples include films, nonwoven fabrics, woven fabrics and knitted fabrics having the same strength. Among them, polyethylene terephthalate or ethylene-vinyl acetate copolymer is preferred.
- a resin film such as polyethylene terephthalate or polypropylene, a release-treated paper, or the like can be used. In particular, a silicon-treated polyethylene terephthalate film is preferably used.
- the method for producing the patch 2 is not particularly limited. For example, after a drug, an adhesive and a softener are heat-melted, applied to the release film 23 or the support 21, and the adhesive layer 22 is formed. Then, the patch 2 can be obtained by laminating with the support 21 or the release film 23. Further, the drug, adhesive and softener are dissolved in a solvent such as toluene, hexane, heptane or ethyl acetate, and the resultant is spread on the release film 23 or the support 21 and the solvent is removed by drying. After the formation, the patch 2 can be obtained by laminating with the support 21 or the release film 23.
- a solvent such as toluene, hexane, heptane or ethyl acetate
- the packaging bags with patches 100 and 110 are manufactured by storing the patch 2 or the patch 2 and the desiccant 4 in the packaging bag 1 and bonding the peripheral portions of the multilayer films 10a and 10b. . Therefore, the stability of the content of the drug contained in the patch 2 also depends on the environment of the space inside the packaging bag 1. It is preferable to maintain the relative humidity of the space below 25%. These conditions may be adjusted during the manufacturing process, or may be adjusted so as to be included in the above conditions by containing the desiccant 4 or the like.
- the present invention is a method for suppressing drug transfer that can suppress drug transfer from patch 2 to packaging bag 1.
- the packaging bag 1 whose inner surface is made of polyacrylonitrile, the transfer of the drug of the general formula (1) contained in the patch 2 from the patch 2 to the packaging bag 1 can be suppressed.
- this method it is possible to prevent the drug from adhering to the inner surface of the packaging bag 1, and it is possible to maintain the drug content of the patch until the time of use, even when manufacturing the patch.
- Multi-layer film A in which a polyacrylonitrile film (PAN, thickness 20 ⁇ m), aluminum foil (Al, thickness 7 m) and polyester film (PET, thickness 12 m) are laminated in this order (Height: 85 mm, width: 79 mm, thickness: 40 ⁇ m).
- PAN polyacrylonitrile film
- Al aluminum foil
- PET polyester film
- the polyacrylonitrile layers of the multilayer film A were arranged so as to face each other, three sides of the peripheral portion were bonded by heat fusion, and after air cooling, one side was opened to accommodate the patch.
- Packaging bag A was obtained.
- the obtained coating liquid is applied on a silicon-treated polyethylene terephthalate release film, the solvent is removed by drying to form an adhesive layer, and the resultant is adhered to a polyethylene terephthalate support to adhere to the target adhesive.
- Got. The obtained patch was cut into 10 cm 2 (square).
- the adhesive layer of the patch had a thickness of 100 m.
- the adhesive patch A was accommodated in the packaging bag A, and the opened peripheral portion was bonded by heat fusion to obtain a sealed packaging bag A with the adhesive.
- a packaging bag A and a patch A were prepared according to Example 1.
- a commercially available mouth-wrap packaging material (a packaging material consisting of four layers, the inner three layers consisting of a cellophane film, a polyethylene film, and aluminum foil
- the outer layer used was a polyester film (made by Toppan Printing Co., Ltd.).
- the adhesive patch A was accommodated in the cellonium packaging material, and the peripheral edge was adhered by heat fusion to obtain a sealed adhesive-containing packaging bag C.
- the above-mentioned patch A and a desiccant are contained in the celloium wrapping material, and the peripheral edge is adhered by heat fusion to obtain a sealed packaging bag D containing the patch.
- a desiccant silicone gel (manufactured by Sudo Chemical Co., Ltd.)
- Example 2 Immediately after the preparation in Example 2 and Comparative Examples 1 and 2, the drug content ( ⁇ ) of each of the patch-containing packaging bags A to D was measured. Then, it was stored in a thermo-hygrostat at 60 ° C, and the content (nl) of the drug one month later was measured. Then, the content (R) of the drug was calculated from the relationship shown in the following equation (2).
- Comparative Example 2 As is clear from Table 2, the patch-containing packaging bags according to the present invention of Examples 1 and 2 have a high drug content even after being stored in a 60 ° C constant temperature and humidity chamber for one month. Example 2, which contained a desiccant, was able to maintain a high drug content. On the other hand, in Comparative Examples 1 and 2, which did not contain the polyatali-tolyl on the inner surface, 0) the drug content after storage was significantly reduced. As a result, the packaging bag with the patch of the present invention ⁇
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Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
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US10/587,660 US20070128262A1 (en) | 2004-01-30 | 2005-01-31 | Package containing adhesive patch and method of inhibiting drug migration |
JP2005517551A JPWO2005072675A1 (ja) | 2004-01-30 | 2005-01-31 | 貼付剤入り包装袋及び薬物移行抑制方法 |
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JP2004-024470 | 2004-01-30 | ||
JP2004024470 | 2004-01-30 |
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PCT/JP2005/001348 WO2005072675A1 (ja) | 2004-01-30 | 2005-01-31 | 貼付剤入り包装袋及び薬物移行抑制方法 |
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Cited By (7)
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JP2008061862A (ja) * | 2006-09-08 | 2008-03-21 | Hisamitsu Pharmaceut Co Inc | 貼付剤製品 |
JP2009160389A (ja) * | 2007-12-14 | 2009-07-23 | Nitto Denko Corp | 貼付剤包装構造 |
JP2009160388A (ja) * | 2007-12-14 | 2009-07-23 | Nitto Denko Corp | 貼付剤包装構造 |
WO2010123103A1 (ja) | 2009-04-24 | 2010-10-28 | 久光製薬株式会社 | 貼付剤入り包装袋、及び貼付剤の保存方法 |
JP2010285415A (ja) * | 2009-06-15 | 2010-12-24 | Hisamitsu Pharmaceut Co Inc | バレニクリン又は薬学的に許容されるバレニクリン酸付加塩を含有する経皮薬物送達システムの包装体 |
JP5208209B2 (ja) * | 2008-05-30 | 2013-06-12 | 日東電工株式会社 | ドネペジル含有貼付製剤およびその包装体 |
KR20180089394A (ko) | 2015-11-30 | 2018-08-08 | 디아이씨 가부시끼가이샤 | 첩부제의 포장 구조 |
Families Citing this family (5)
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EP2090310B1 (en) * | 2006-12-01 | 2013-07-10 | Nitto Denko Corporation | Method for prevention of coloration in donepezil-containing skin adhesive preparation, and method for reducing the production of donepezil analogue in donepezil-containing skin adhesive preparation |
RU2435570C2 (ru) * | 2006-12-01 | 2011-12-10 | Нитто Денко Корпорейшн | Композиция для чрескожного всасывания |
KR20110020788A (ko) * | 2008-05-30 | 2011-03-03 | 에자이 알앤드디 매니지먼트 가부시키가이샤 | 경피 흡수 제제 |
JP6041097B2 (ja) * | 2012-09-21 | 2016-12-07 | 東洋製罐株式会社 | 包装材およびそれを用いてなる包装構造 |
JP6150240B2 (ja) * | 2012-09-21 | 2017-06-21 | 東洋製罐株式会社 | 包装材およびそれを用いてなる包装構造 |
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- 2005-01-31 US US10/587,660 patent/US20070128262A1/en not_active Abandoned
- 2005-01-31 WO PCT/JP2005/001348 patent/WO2005072675A1/ja active Application Filing
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Publication number | Priority date | Publication date | Assignee | Title |
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JP2008061862A (ja) * | 2006-09-08 | 2008-03-21 | Hisamitsu Pharmaceut Co Inc | 貼付剤製品 |
JP2009160389A (ja) * | 2007-12-14 | 2009-07-23 | Nitto Denko Corp | 貼付剤包装構造 |
JP2009160388A (ja) * | 2007-12-14 | 2009-07-23 | Nitto Denko Corp | 貼付剤包装構造 |
KR101539771B1 (ko) * | 2007-12-14 | 2015-07-27 | 닛토덴코 가부시키가이샤 | 패치 포장 구조체 |
KR101552723B1 (ko) | 2007-12-14 | 2015-09-11 | 닛토덴코 가부시키가이샤 | 패치 포장 구조체 |
JP5208209B2 (ja) * | 2008-05-30 | 2013-06-12 | 日東電工株式会社 | ドネペジル含有貼付製剤およびその包装体 |
WO2010123103A1 (ja) | 2009-04-24 | 2010-10-28 | 久光製薬株式会社 | 貼付剤入り包装袋、及び貼付剤の保存方法 |
CN102361639A (zh) * | 2009-04-24 | 2012-02-22 | 久光制药株式会社 | 内包贴附剂的包装袋、及贴附剂的保存方法 |
JP5933974B2 (ja) * | 2009-04-24 | 2016-06-15 | 久光製薬株式会社 | 貼付剤入り包装袋、及び貼付剤の保存方法 |
JP2010285415A (ja) * | 2009-06-15 | 2010-12-24 | Hisamitsu Pharmaceut Co Inc | バレニクリン又は薬学的に許容されるバレニクリン酸付加塩を含有する経皮薬物送達システムの包装体 |
KR20180089394A (ko) | 2015-11-30 | 2018-08-08 | 디아이씨 가부시끼가이샤 | 첩부제의 포장 구조 |
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US20070128262A1 (en) | 2007-06-07 |
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