JP4528296B2 - Uv安定性経皮膏薬 - Google Patents
Uv安定性経皮膏薬 Download PDFInfo
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- JP4528296B2 JP4528296B2 JP2006501740A JP2006501740A JP4528296B2 JP 4528296 B2 JP4528296 B2 JP 4528296B2 JP 2006501740 A JP2006501740 A JP 2006501740A JP 2006501740 A JP2006501740 A JP 2006501740A JP 4528296 B2 JP4528296 B2 JP 4528296B2
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- 239000002674 ointment Substances 0.000 title 1
- 239000004480 active ingredient Substances 0.000 claims description 53
- 239000010410 layer Substances 0.000 claims description 46
- 239000006096 absorbing agent Substances 0.000 claims description 32
- 239000012790 adhesive layer Substances 0.000 claims description 29
- 230000001225 therapeutic effect Effects 0.000 claims description 28
- 239000000758 substrate Substances 0.000 claims description 27
- 239000000203 mixture Substances 0.000 claims description 25
- -1 polydimethylsiloxane Polymers 0.000 claims description 18
- 239000000853 adhesive Substances 0.000 claims description 11
- 229920000642 polymer Polymers 0.000 claims description 9
- 229920002367 Polyisobutene Polymers 0.000 claims description 8
- 238000000926 separation method Methods 0.000 claims description 7
- ALYNCZNDIQEVRV-UHFFFAOYSA-N 4-aminobenzoic acid Chemical group NC1=CC=C(C(O)=O)C=C1 ALYNCZNDIQEVRV-UHFFFAOYSA-N 0.000 claims description 6
- RRHGJUQNOFWUDK-UHFFFAOYSA-N Isoprene Chemical compound CC(=C)C=C RRHGJUQNOFWUDK-UHFFFAOYSA-N 0.000 claims description 6
- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 claims description 6
- 229920000058 polyacrylate Polymers 0.000 claims description 6
- 239000000126 substance Substances 0.000 claims description 6
- 239000004698 Polyethylene Substances 0.000 claims description 5
- 230000004888 barrier function Effects 0.000 claims description 5
- 229920000573 polyethylene Polymers 0.000 claims description 5
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 5
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 5
- 239000004743 Polypropylene Substances 0.000 claims description 4
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims description 4
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims description 4
- 229920001577 copolymer Polymers 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 4
- 229920001155 polypropylene Polymers 0.000 claims description 4
- 229920002635 polyurethane Polymers 0.000 claims description 4
- 239000004814 polyurethane Substances 0.000 claims description 4
- 150000008366 benzophenones Chemical class 0.000 claims description 3
- 229920001400 block copolymer Polymers 0.000 claims description 3
- 239000004205 dimethyl polysiloxane Substances 0.000 claims description 3
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims description 3
- 229920001083 polybutene Polymers 0.000 claims description 3
- 229920001195 polyisoprene Polymers 0.000 claims description 3
- OIQXFRANQVWXJF-ACCUITESSA-N (2e)-2-benzylidene-4,7,7-trimethylbicyclo[2.2.1]heptan-3-one Chemical compound CC1(C)C2CCC1(C)C(=O)\C2=C\C1=CC=CC=C1 OIQXFRANQVWXJF-ACCUITESSA-N 0.000 claims description 2
- WBYWAXJHAXSJNI-VOTSOKGWSA-M .beta-Phenylacrylic acid Natural products [O-]C(=O)\C=C\C1=CC=CC=C1 WBYWAXJHAXSJNI-VOTSOKGWSA-M 0.000 claims description 2
- OIQXFRANQVWXJF-UHFFFAOYSA-N 2-benzylidene-4,7,7-trimethylbicyclo[2.2.1]heptan-3-one Chemical class CC1(C)C2CCC1(C)C(=O)C2=CC1=CC=CC=C1 OIQXFRANQVWXJF-UHFFFAOYSA-N 0.000 claims description 2
- TYYHDKOVFSVWON-UHFFFAOYSA-N 2-butyl-2-methoxy-1,3-diphenylpropane-1,3-dione Chemical compound C=1C=CC=CC=1C(=O)C(OC)(CCCC)C(=O)C1=CC=CC=C1 TYYHDKOVFSVWON-UHFFFAOYSA-N 0.000 claims description 2
- VSXIZXFGQGKZQG-UHFFFAOYSA-N 2-cyano-3,3-diphenylprop-2-enoic acid Chemical compound C=1C=CC=CC=1C(=C(C#N)C(=O)O)C1=CC=CC=C1 VSXIZXFGQGKZQG-UHFFFAOYSA-N 0.000 claims description 2
- WSSJONWNBBTCMG-UHFFFAOYSA-N 2-hydroxybenzoic acid (3,3,5-trimethylcyclohexyl) ester Chemical compound C1C(C)(C)CC(C)CC1OC(=O)C1=CC=CC=C1O WSSJONWNBBTCMG-UHFFFAOYSA-N 0.000 claims description 2
- LUKNZSDCSDDKNC-UHFFFAOYSA-N 3-benzylidene-1,7,7-trimethylbicyclo[2.2.1]heptan-2-one methyl hydrogen sulfate Chemical compound COS(O)(=O)=O.CC1(C)C2CCC1(C)C(=O)C2=CC1=CC=CC=C1 LUKNZSDCSDDKNC-UHFFFAOYSA-N 0.000 claims description 2
- RJCHCFQTUKAYAA-UHFFFAOYSA-N 5-[[2-amino-5-[(4-methoxyphenyl)methyl]-3-methylimidazol-4-yl]methyl]-2-methoxybenzene-1,3-diol Chemical compound C1=CC(OC)=CC=C1CC1=C(CC=2C=C(O)C(OC)=C(O)C=2)N(C)C(=N)N1 RJCHCFQTUKAYAA-UHFFFAOYSA-N 0.000 claims description 2
- WBYWAXJHAXSJNI-SREVYHEPSA-N Cinnamic acid Chemical compound OC(=O)\C=C/C1=CC=CC=C1 WBYWAXJHAXSJNI-SREVYHEPSA-N 0.000 claims description 2
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 claims description 2
- 239000005977 Ethylene Substances 0.000 claims description 2
- YBGZDTIWKVFICR-JLHYYAGUSA-N Octyl 4-methoxycinnamic acid Chemical compound CCCCC(CC)COC(=O)\C=C\C1=CC=C(OC)C=C1 YBGZDTIWKVFICR-JLHYYAGUSA-N 0.000 claims description 2
- WYWZRNAHINYAEF-UHFFFAOYSA-N Padimate O Chemical compound CCCCC(CC)COC(=O)C1=CC=C(N(C)C)C=C1 WYWZRNAHINYAEF-UHFFFAOYSA-N 0.000 claims description 2
- 229920001328 Polyvinylidene chloride Polymers 0.000 claims description 2
- 229940064734 aminobenzoate Drugs 0.000 claims description 2
- 229960004050 aminobenzoic acid Drugs 0.000 claims description 2
- 150000005417 aminobenzoic acid derivatives Chemical class 0.000 claims description 2
- 229960005193 avobenzone Drugs 0.000 claims description 2
- QRUDEWIWKLJBPS-UHFFFAOYSA-N benzotriazole Chemical compound C1=CC=C2N[N][N]C2=C1 QRUDEWIWKLJBPS-UHFFFAOYSA-N 0.000 claims description 2
- 239000012964 benzotriazole Substances 0.000 claims description 2
- OCWYEMOEOGEQAN-UHFFFAOYSA-N bumetrizole Chemical compound CC(C)(C)C1=CC(C)=CC(N2N=C3C=C(Cl)C=CC3=N2)=C1O OCWYEMOEOGEQAN-UHFFFAOYSA-N 0.000 claims description 2
- YKPUWZUDDOIDPM-SOFGYWHQSA-N capsaicin Chemical compound COC1=CC(CNC(=O)CCCC\C=C\C(C)C)=CC=C1O YKPUWZUDDOIDPM-SOFGYWHQSA-N 0.000 claims description 2
- 229930016911 cinnamic acid Natural products 0.000 claims description 2
- 235000013985 cinnamic acid Nutrition 0.000 claims description 2
- 150000001851 cinnamic acid derivatives Chemical class 0.000 claims description 2
- 239000005556 hormone Substances 0.000 claims description 2
- 229940088597 hormone Drugs 0.000 claims description 2
- WBYWAXJHAXSJNI-UHFFFAOYSA-N methyl p-hydroxycinnamate Natural products OC(=O)C=CC1=CC=CC=C1 WBYWAXJHAXSJNI-UHFFFAOYSA-N 0.000 claims description 2
- DXGLGDHPHMLXJC-UHFFFAOYSA-N oxybenzone Chemical compound OC1=CC(OC)=CC=C1C(=O)C1=CC=CC=C1 DXGLGDHPHMLXJC-UHFFFAOYSA-N 0.000 claims description 2
- 229960001173 oxybenzone Drugs 0.000 claims description 2
- 229920002239 polyacrylonitrile Polymers 0.000 claims description 2
- 229920000915 polyvinyl chloride Polymers 0.000 claims description 2
- 239000004800 polyvinyl chloride Substances 0.000 claims description 2
- 239000005033 polyvinylidene chloride Substances 0.000 claims description 2
- 230000001681 protective effect Effects 0.000 claims description 2
- 150000003872 salicylic acid derivatives Chemical class 0.000 claims description 2
- CXVGEDCSTKKODG-UHFFFAOYSA-N sulisobenzone Chemical compound C1=C(S(O)(=O)=O)C(OC)=CC(O)=C1C(=O)C1=CC=CC=C1 CXVGEDCSTKKODG-UHFFFAOYSA-N 0.000 claims description 2
- 229960000368 sulisobenzone Drugs 0.000 claims description 2
- RJKFOVLPORLFTN-LEKSSAKUSA-N Progesterone Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 RJKFOVLPORLFTN-LEKSSAKUSA-N 0.000 claims 2
- AALXZHPCKJILAZ-UHFFFAOYSA-N (4-propan-2-ylphenyl)methyl 2-hydroxybenzoate Chemical compound C1=CC(C(C)C)=CC=C1COC(=O)C1=CC=CC=C1O AALXZHPCKJILAZ-UHFFFAOYSA-N 0.000 claims 1
- LSNNMFCWUKXFEE-UHFFFAOYSA-M Bisulfite Chemical compound OS([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-M 0.000 claims 1
- 239000011185 multilayer composite material Substances 0.000 claims 1
- 239000000186 progesterone Substances 0.000 claims 1
- 229960003387 progesterone Drugs 0.000 claims 1
- LOIYMIARKYCTBW-OWOJBTEDSA-N trans-urocanic acid Chemical compound OC(=O)\C=C\C1=CNC=N1 LOIYMIARKYCTBW-OWOJBTEDSA-N 0.000 claims 1
- 238000009472 formulation Methods 0.000 description 16
- 239000000583 progesterone congener Substances 0.000 description 8
- 230000001070 adhesive effect Effects 0.000 description 6
- 229940095055 progestogen systemic hormonal contraceptives Drugs 0.000 description 6
- FMRHJJZUHUTGKE-UHFFFAOYSA-N Ethylhexyl salicylate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1O FMRHJJZUHUTGKE-UHFFFAOYSA-N 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 4
- 229920000307 polymer substrate Polymers 0.000 description 4
- 230000006750 UV protection Effects 0.000 description 3
- 238000009792 diffusion process Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000011159 matrix material Substances 0.000 description 3
- 230000003711 photoprotective effect Effects 0.000 description 3
- 239000002985 plastic film Substances 0.000 description 3
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- 238000002360 preparation method Methods 0.000 description 3
- 230000004224 protection Effects 0.000 description 3
- 206010040880 Skin irritation Diseases 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 230000036556 skin irritation Effects 0.000 description 2
- 231100000475 skin irritation Toxicity 0.000 description 2
- WWYNJERNGUHSAO-XUDSTZEESA-N (+)-Norgestrel Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 WWYNJERNGUHSAO-XUDSTZEESA-N 0.000 description 1
- YNGDWRXWKFWCJY-UHFFFAOYSA-N 1,4-Dihydropyridine Chemical compound C1C=CNC=C1 YNGDWRXWKFWCJY-UHFFFAOYSA-N 0.000 description 1
- CNXZMGRWEYQCOQ-UHFFFAOYSA-N 2-methoxy-3-phenylprop-2-enoic acid Chemical class COC(C(O)=O)=CC1=CC=CC=C1 CNXZMGRWEYQCOQ-UHFFFAOYSA-N 0.000 description 1
- VEJWWWARNJEPPG-UHFFFAOYSA-N 2-methylhexyl 2-hydroxybenzoate Chemical compound C(C=1C(O)=CC=CC1)(=O)OCC(CCCC)C VEJWWWARNJEPPG-UHFFFAOYSA-N 0.000 description 1
- ZCILGMFPJBRCNO-UHFFFAOYSA-N 4-phenyl-2H-benzotriazol-5-ol Chemical class OC1=CC=C2NN=NC2=C1C1=CC=CC=C1 ZCILGMFPJBRCNO-UHFFFAOYSA-N 0.000 description 1
- 230000002745 absorbent Effects 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
- 239000011358 absorbing material Substances 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- RWCCWEUUXYIKHB-UHFFFAOYSA-N benzophenone Chemical compound C=1C=CC=CC=1C(=O)C1=CC=CC=C1 RWCCWEUUXYIKHB-UHFFFAOYSA-N 0.000 description 1
- 239000012965 benzophenone Substances 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- OKBVVJOGVLARMR-QSWIMTSFSA-N cefixime Chemical compound S1C(N)=NC(C(=N\OCC(O)=O)\C(=O)N[C@@H]2C(N3C(=C(C=C)CS[C@@H]32)C(O)=O)=O)=C1 OKBVVJOGVLARMR-QSWIMTSFSA-N 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000006071 cream Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229920002457 flexible plastic Polymers 0.000 description 1
- SIGSPDASOTUPFS-XUDSTZEESA-N gestodene Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](C=C4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 SIGSPDASOTUPFS-XUDSTZEESA-N 0.000 description 1
- 229960005352 gestodene Drugs 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- GKQPCPXONLDCMU-CCEZHUSRSA-N lacidipine Chemical compound CCOC(=O)C1=C(C)NC(C)=C(C(=O)OCC)C1C1=CC=CC=C1\C=C\C(=O)OC(C)(C)C GKQPCPXONLDCMU-CCEZHUSRSA-N 0.000 description 1
- 229960004340 lacidipine Drugs 0.000 description 1
- 229960004400 levonorgestrel Drugs 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 230000004526 pharmaceutical effect Effects 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 230000000475 sunscreen effect Effects 0.000 description 1
- 239000000516 sunscreening agent Substances 0.000 description 1
- 229940072226 suprax Drugs 0.000 description 1
- 238000002211 ultraviolet spectrum Methods 0.000 description 1
- LOIYMIARKYCTBW-UHFFFAOYSA-N urocanic acid Chemical compound OC(=O)C=CC1=CNC=N1 LOIYMIARKYCTBW-UHFFFAOYSA-N 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 229910052724 xenon Inorganic materials 0.000 description 1
- FHNFHKCVQCLJFQ-UHFFFAOYSA-N xenon atom Chemical compound [Xe] FHNFHKCVQCLJFQ-UHFFFAOYSA-N 0.000 description 1
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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
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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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
- A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/34—Gestagens
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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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
- A61K47/08—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
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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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- General Chemical & Material Sciences (AREA)
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- Organic Chemistry (AREA)
- Diabetes (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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- Biomedical Technology (AREA)
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
−UV領域に吸収を有する無色基材とポリマー基質内の活性成分との相互作用により、上記TTSの安定に関して望まない影響を引き起こす場合がある;
−ポリマー基質と活性成分を通す裏層との間の堅い結合により、主に裏層がポリプロピレン、ポリエチレンまたはポリウレタンからなる場合、ポリマー基質から裏層への活性成分の受け入れ難い広範囲にわたる拡散を引き起こす可能性があり、最終的には、裏層/カバーシートの表面に出現または結晶化する可能性がある;
−裏層/カバーシート中に存在するUV吸収材と皮膚との直接的な接触により皮膚の炎症が生じる可能性がある;
点で不利である。
−上記UV吸収材を含む層の厚さまたは層中のUV吸収材の濃度を変えることにより、所望のUV保護に正確に調節することができる。これは、UV保護機能を有する従来のTTSの使用と比較したときの重要な利点である。
−上記UV吸収材と上記活性成分含有基質中の上記活性成分またはその集合物との接触が防止されるので、上記UV吸収材および光の作用で分解されたUV吸収材の分解物のどちらも上記活性成分と反応することがない。
−活性成分を通すことができるカバーシートを用いたと仮定した場合、上記システムが有する活性成分の拡散は、受け入れられない高いレベルに達する可能性がある。そして、活性成分が上記カバーシートの表面に現れたり、結晶化する可能性がある。この結果は、例えば、ポリプロピレン、ポリエチレンまたはポリウレタンからなるカバーシートを用いたときに見ることができる。本発明によれば、上記UV吸収材を含む層と上記活性成分を含む層との間に提供される上記分離層は、ここでは上記カバーシートを通る拡散による活性成分の損失に対する防壁(barrier)に相当する。
本発明およびその有利な特性は、下記の実施例により詳細に説明される。
プロゲストゲンの群から感光性の活性成分の2つの製剤(formulation)を製造した。製剤Iは、粘着層と分離層を含み、粘着層は3質量%のUV吸収物質を含有する。
製剤IIは、粘着層と分離層を含まず、比較のための製剤として用いられる。
1.活性成分含有基質:
−1.9%プロゲストゲン
−98.1%ポリイソブチレンを主成分とする接着剤
2.粘着層:
−3%Tinuvin(登録商標)326
−97%ポリイソブチレンを主成分とする接着剤
各例において、プロゲストゲンの群から選択される感光性の活性成分と、粘着層と、ポリエチレンテレフタレート(三菱ポリエステル社製Hostaphan(登録商標)、Wiesbaden)からなる分離層とを有する製剤。
上記製剤は、下記の組成を有する。
1.活性成分含有基質:
−1.9%プロゲストゲン
−98.1%ポリイソブチレンを主成分とする接着剤
2.粘着層1および2
−3%Uvinul(登録商標)MC80
−97%ポリアクリレートを主成分とする接着剤
各例において、プロゲストゲンの群から選択される感光性の活性成分と、2つの粘着層と、ポリエチレンテレフタレート(三菱ポリエステル社製Hostaphan(登録商標)、Wiesbaden)からなる分離層とを有する製剤。
製剤Iは、下記の組成を有する。
3.活性成分含有基質:
−1.9%プロゲストゲン
−98.1%ポリイソブチレンを主成分とする接着剤
4.粘着層1および2
−3%Uvinul(登録商標)M40
−97%ポリアクリレートを主成分とする接着剤
各例において、プロゲストゲンの群から選択される感光性の活性成分と、少なくとも1つの粘着層と、分離層とを有する製剤。ここで、上記活性成分含有基質は例1〜3と同様に設計され、上記粘着層は、ポリイソブチレンを主成分とする接着剤からなり、下記の組成を有する。
各例において、プロゲストゲンの群から選択される感光性の活性成分と、少なくとも1つの粘着層と、分離層とを有する製剤。ここで、上記活性成分含有基質は例1〜3と同様に設計され、上記粘着層は、ポリアクリレートを主成分とする接着剤からなり、下記の組成を有する。
各例において、プロゲストゲンの群から選択される感光性の活性成分と、少なくとも1つの粘着層と、分離層とを有する製剤。ここで、上記活性成分含有基質は例1〜3と同様に設計され、上記粘着層は下記の組成を有する。
Claims (10)
- 裏層と、少なくとも1層の活性成分含有基質と、任意の構成要素である取り外し可能なシートとからなり、UV吸収材を含む経皮治療システムであって、
前記裏層と、前記活性成分含有基質の皮膚の表面から最も離れているものとの間に、少なくとも1層のUV吸収材を含有する粘着層が設けられていること、および
前記UV吸収材含有粘着層と、前記活性成分含有基質の皮膚の表面から最も離れているものとの間に、活性成分および前記UV吸収材を通さない少なくとも1つの分離層が設けられている経皮治療システムで、
前記分離層がバリアーポリマーからなり4〜10μmの厚さであり、
前記粘着層の単位面積当たりの質量が、5〜50g/m 2 であり、
前記基質および/または粘着層が自己粘着性で、
ポリイソブチレン、ポリブテン、ポリアクリレート、ポリジメチルシロキサン、スチレン/イソプレンブロック共重合体およびポリイソプレンの群から選択されるポリマーからなり、
前記UV吸収材が、0.5〜10%(m/m)の濃度で、前記粘着層中に溶解された状態で存在することを特徴とする経皮治療システム。 - 皮膚とは反対側から始まる、前記経皮治療システムにおける各層の順序が、裏層、UV吸収材を含有する粘着層、分離層、そして、最後に1層または2層の活性成分含有基質であり、前記活性成分含有基質が、取り外し可能な保護シートにより覆われている感圧性の粘着表面を有することを特徴とする請求項1に記載の経皮治療システム。
- 前記バリアーポリマーが、ポリエチレンテレフタレート、ポリアクリロニトリル、ポリ塩化ビニル、ポリ塩化ビニリデンまたはその共重合体もしくは積層したもの(colaminates)からなるからなることを特徴とする請求項1または2に記載の経皮治療システム。
- 前記基質の単位面積あたりの質量が、30〜150g/m2である請求項1〜3のいずれかに記載の経皮治療システム。
- 前記裏層が、ポリプロピレン、ポリエチレン、ポリウレタン、エチレン/ビニルアセテート共重合体、またはこれらの材料と1種または2種以上の他の材料との多層複合材料からなることを特徴とする請求項1〜4のいずれかに記載の経皮治療システム。
- 前記粘着層のみが、前記UV吸収材を有することを特徴とする請求項1〜5のいずれかに記載の経皮治療システム。
- 前記UV吸収材が、p−アミノ安息香酸、アミノ安息香酸誘導体、2−エチルヘキシル4−ジメチルアミノベンゾエートおよび/またはポリエトキシエチル4−ビス(ポリエトキシル)アミノベンゾエート、桂皮酸、桂皮酸誘導体、好ましくは、イソアミル4−メトキシシナメートおよび/または2−エチルヘキシル4−メトキシシナメート、3−ベンジリデンボルナン−2−オン、ベンジリデンボルナン−2−オン誘導体、好ましくは3−(4′)−メチルベンジリデンボルナン−2−オン、3−(4−スルホン)−ベンジリデンボルナン−2−オン、および/または3−(4′−トリメチルアンモニウム)ベンジリデンボルナン−2−オンメチルサルフェート、サリチル酸誘導体、4−イソプロピルベンジルサリチラート、2−メチルヘキシルサリチラート、および/または3,3,5−トリメチルシクロヘキシルサリチラート、ベンゾトリアゾール、2−(5−クロロ−2H−ベンゾトリアゾール−2−イル)−6−(1,1−ジメチルエチル)−4−メチルフェノール、2,4,6′−トリアニリン−p−(カルボ−2′−エチルヘキシル−1′−オキシ)−1,3,5−トリアジン、3−イミダゾール−4−イルアクリル酸、3−イミダゾール−4−イル−3−イミダゾール−4−イルアクリル酸エステル、2−フェニレンベンズイミダゾール−5−スルホン酸および/またはそのK、Naおよびトリエタノールアミン(=TEA)塩、2−シアノ−3,3−ジフェニルアクリル酸、テレフタロイリデンジカンファースルホン酸、ブチルメトキシジベンゾイルメタン、ベンゾフェノンおよび/またはベンゾフェノン誘導体、ベンゾフェノン−3および/またはベンゾフェノン−4の群から選択される少なくとも1種の物質または前記群から選択される物質の混合物であることを特徴とする請求項1〜6のいずれかに記載の経皮治療システム。
- 少なくとも1つのホルモンが、活性成分として作用することを特徴とする請求項1〜7のいずれかに記載の経皮治療システム。
- 前記活性成分が、プロゲステロンであることを特徴とする請求項1〜8のいずれかに記載の経皮治療システム。
- 前記経皮治療システムが、前記活性成分の放出を制御する膜を有していないことを特徴とする請求項1〜9のいずれかに記載の経皮治療システム。
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US20050129756A1 (en) | 2003-12-10 | 2005-06-16 | Hans-Peter Podhaisky | UV-stable, liquid or semisolid transdermal pharmaceutical preparation with light sensitive active ingredient |
US8668925B2 (en) * | 2003-12-12 | 2014-03-11 | Bayer Intellectual Property Gmbh | Transdermal delivery of hormones without the need of penetration enhancers |
JP4965263B2 (ja) | 2003-12-12 | 2012-07-04 | バイエル ファーマ アクチエンゲゼルシャフト | 浸透増強剤を必要としないホルモンの経皮送達 |
UA89766C2 (en) | 2003-12-12 | 2010-03-10 | Байер Шеринг Фарма Акциенгезельшафт | Transdermal delivery system of gestodene |
JP4504109B2 (ja) | 2004-06-15 | 2010-07-14 | 株式会社新陽社 | 画像表示装置及び画素構成体 |
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EP1719504A1 (de) | 2005-05-02 | 2006-11-08 | Schering AG | Festes transdermales therapeutisches System mit UV-Absorber |
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