JPH11501323A - 17−デアセチルノルゲスチマートを単独でまたはエストロゲンと組み合わせて投与するための経皮パッチおよび方法 - Google Patents
17−デアセチルノルゲスチマートを単独でまたはエストロゲンと組み合わせて投与するための経皮パッチおよび方法Info
- Publication number
- JPH11501323A JPH11501323A JP9501723A JP50172397A JPH11501323A JP H11501323 A JPH11501323 A JP H11501323A JP 9501723 A JP9501723 A JP 9501723A JP 50172397 A JP50172397 A JP 50172397A JP H11501323 A JPH11501323 A JP H11501323A
- Authority
- JP
- Japan
- Prior art keywords
- patch
- deacetylnorgestimate
- estradiol
- day
- matrix
- 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.)
- Granted
Links
- 229940011871 estrogen Drugs 0.000 title claims abstract description 37
- 239000000262 estrogen Substances 0.000 title claims abstract description 37
- ISHXLNHNDMZNMC-VTKCIJPMSA-N (3e,8r,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-3-hydroxyimino-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-ol Chemical compound O/N=C/1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C\1 ISHXLNHNDMZNMC-VTKCIJPMSA-N 0.000 title claims abstract description 35
- 229960002667 norelgestromin Drugs 0.000 title claims abstract description 31
- 238000000034 method Methods 0.000 title claims abstract description 23
- 239000000203 mixture Substances 0.000 claims abstract description 38
- BFPYWIDHMRZLRN-UHFFFAOYSA-N 17alpha-ethynyl estradiol Natural products OC1=CC=C2C3CCC(C)(C(CC4)(O)C#C)C4C3CCC2=C1 BFPYWIDHMRZLRN-UHFFFAOYSA-N 0.000 claims abstract description 35
- BFPYWIDHMRZLRN-SLHNCBLASA-N Ethinyl estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 BFPYWIDHMRZLRN-SLHNCBLASA-N 0.000 claims abstract description 35
- 229960002568 ethinylestradiol Drugs 0.000 claims abstract description 35
- 230000016087 ovulation Effects 0.000 claims abstract description 24
- 230000002401 inhibitory effect Effects 0.000 claims abstract description 16
- 238000002657 hormone replacement therapy Methods 0.000 claims abstract description 10
- 239000011159 matrix material Substances 0.000 claims description 47
- 229920002367 Polyisobutene Polymers 0.000 claims description 27
- 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 claims description 18
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims description 18
- 229960005309 estradiol Drugs 0.000 claims description 17
- -1 aliphatic alcohols Chemical class 0.000 claims description 14
- 229920001296 polysiloxane Polymers 0.000 claims description 12
- 239000003961 penetration enhancing agent Substances 0.000 claims description 11
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 9
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 9
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 9
- WRIDQFICGBMAFQ-UHFFFAOYSA-N (E)-8-Octadecenoic acid Natural products CCCCCCCCCC=CCCCCCCC(O)=O WRIDQFICGBMAFQ-UHFFFAOYSA-N 0.000 claims description 4
- LQJBNNIYVWPHFW-UHFFFAOYSA-N 20:1omega9c fatty acid Natural products CCCCCCCCCCC=CCCCCCCCC(O)=O LQJBNNIYVWPHFW-UHFFFAOYSA-N 0.000 claims description 4
- QSBYPNXLFMSGKH-UHFFFAOYSA-N 9-Heptadecensaeure Natural products CCCCCCCC=CCCCCCCCC(O)=O QSBYPNXLFMSGKH-UHFFFAOYSA-N 0.000 claims description 4
- ZQPPMHVWECSIRJ-UHFFFAOYSA-N Oleic acid Natural products CCCCCCCCC=CCCCCCCCC(O)=O ZQPPMHVWECSIRJ-UHFFFAOYSA-N 0.000 claims description 4
- 239000005642 Oleic acid Substances 0.000 claims description 4
- QQQMUBLXDAFBRH-UHFFFAOYSA-N dodecyl 2-hydroxypropanoate Chemical group CCCCCCCCCCCCOC(=O)C(C)O QQQMUBLXDAFBRH-UHFFFAOYSA-N 0.000 claims description 4
- 150000002148 esters Chemical class 0.000 claims description 4
- QXJSBBXBKPUZAA-UHFFFAOYSA-N isooleic acid Natural products CCCCCCCC=CCCCCCCCCC(O)=O QXJSBBXBKPUZAA-UHFFFAOYSA-N 0.000 claims description 4
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 claims description 4
- 230000005540 biological transmission Effects 0.000 claims description 3
- 238000002560 therapeutic procedure Methods 0.000 claims description 3
- 229960000417 norgestimate Drugs 0.000 claims description 2
- 229930182833 estradiol Natural products 0.000 claims 8
- 238000009792 diffusion process Methods 0.000 claims 2
- 239000010410 layer Substances 0.000 description 22
- 239000000853 adhesive Substances 0.000 description 15
- 230000001070 adhesive effect Effects 0.000 description 15
- 230000004907 flux Effects 0.000 description 13
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 12
- 239000000178 monomer Substances 0.000 description 11
- 229940079593 drug Drugs 0.000 description 9
- 239000003814 drug Substances 0.000 description 9
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 description 9
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 8
- 239000003623 enhancer Substances 0.000 description 7
- 229920000728 polyester Polymers 0.000 description 7
- 229920000642 polymer Polymers 0.000 description 6
- 229920000058 polyacrylate Polymers 0.000 description 5
- 229940070721 polyacrylate Drugs 0.000 description 5
- 238000009472 formulation Methods 0.000 description 4
- UQDUPQYQJKYHQI-UHFFFAOYSA-N methyl laurate Chemical compound CCCCCCCCCCCC(=O)OC UQDUPQYQJKYHQI-UHFFFAOYSA-N 0.000 description 4
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 3
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 3
- 229920003081 Povidone K 30 Polymers 0.000 description 3
- 239000000654 additive Substances 0.000 description 3
- 239000003431 cross linking reagent Substances 0.000 description 3
- 125000000524 functional group Chemical group 0.000 description 3
- 230000027758 ovulation cycle Effects 0.000 description 3
- 229920001083 polybutene Polymers 0.000 description 3
- 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 2
- GOXQRTZXKQZDDN-UHFFFAOYSA-N 2-Ethylhexyl acrylate Chemical compound CCCCC(CC)COC(=O)C=C GOXQRTZXKQZDDN-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
- 102000012673 Follicle Stimulating Hormone Human genes 0.000 description 2
- 108010079345 Follicle Stimulating Hormone Proteins 0.000 description 2
- 102000015779 HDL Lipoproteins Human genes 0.000 description 2
- 108010010234 HDL Lipoproteins Proteins 0.000 description 2
- 102000009151 Luteinizing Hormone Human genes 0.000 description 2
- 108010073521 Luteinizing Hormone Proteins 0.000 description 2
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 description 2
- 230000000712 assembly Effects 0.000 description 2
- 238000000429 assembly Methods 0.000 description 2
- 235000013870 dimethyl polysiloxane Nutrition 0.000 description 2
- 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 2
- 230000000694 effects Effects 0.000 description 2
- 229940028334 follicle stimulating hormone Drugs 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 2
- 229940040129 luteinizing hormone Drugs 0.000 description 2
- 239000002207 metabolite Substances 0.000 description 2
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 2
- 239000000583 progesterone congener Substances 0.000 description 2
- 239000013464 silicone adhesive Substances 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- BORJONZPSTVSFP-UHFFFAOYSA-N tetradecyl 2-hydroxypropanoate Chemical compound CCCCCCCCCCCCCCOC(=O)C(C)O BORJONZPSTVSFP-UHFFFAOYSA-N 0.000 description 2
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
- DXPPIEDUBFUSEZ-UHFFFAOYSA-N 6-methylheptyl prop-2-enoate Chemical compound CC(C)CCCCCOC(=O)C=C DXPPIEDUBFUSEZ-UHFFFAOYSA-N 0.000 description 1
- UYIFTLBWAOGQBI-BZDYCCQFSA-N Benzhormovarine Chemical compound C([C@@H]1[C@@H](C2=CC=3)CC[C@]4([C@H]1CC[C@@H]4O)C)CC2=CC=3OC(=O)C1=CC=CC=C1 UYIFTLBWAOGQBI-BZDYCCQFSA-N 0.000 description 1
- 239000004971 Cross linker Substances 0.000 description 1
- UOACKFBJUYNSLK-XRKIENNPSA-N Estradiol Cypionate Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H](C4=CC=C(O)C=C4CC3)CC[C@@]21C)C(=O)CCC1CCCC1 UOACKFBJUYNSLK-XRKIENNPSA-N 0.000 description 1
- RSEPBGGWRJCQGY-RBRWEJTLSA-N Estradiol valerate Chemical compound C1CC2=CC(O)=CC=C2[C@@H]2[C@@H]1[C@@H]1CC[C@H](OC(=O)CCCC)[C@@]1(C)CC2 RSEPBGGWRJCQGY-RBRWEJTLSA-N 0.000 description 1
- JIGUQPWFLRLWPJ-UHFFFAOYSA-N Ethyl acrylate Chemical compound CCOC(=O)C=C JIGUQPWFLRLWPJ-UHFFFAOYSA-N 0.000 description 1
- 102000007330 LDL Lipoproteins Human genes 0.000 description 1
- 108010007622 LDL Lipoproteins Proteins 0.000 description 1
- CERQOIWHTDAKMF-UHFFFAOYSA-M Methacrylate Chemical compound CC(=C)C([O-])=O CERQOIWHTDAKMF-UHFFFAOYSA-M 0.000 description 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 229920001328 Polyvinylidene chloride Polymers 0.000 description 1
- RJKFOVLPORLFTN-LEKSSAKUSA-N Progesterone Chemical class 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 description 1
- 229920002472 Starch Polymers 0.000 description 1
- YDQDJLTYVZAOQX-GOMYTPFNSA-N [(8r,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(OC(C)=O)C#C)[C@@H]4[C@@H]3CCC2=C1 YDQDJLTYVZAOQX-GOMYTPFNSA-N 0.000 description 1
- 238000005299 abrasion Methods 0.000 description 1
- 150000001252 acrylic acid derivatives Chemical class 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 125000001931 aliphatic group Chemical group 0.000 description 1
- 125000005250 alkyl acrylate group Chemical group 0.000 description 1
- CQEYYJKEWSMYFG-UHFFFAOYSA-N butyl acrylate Chemical compound CCCCOC(=O)C=C CQEYYJKEWSMYFG-UHFFFAOYSA-N 0.000 description 1
- 125000004432 carbon atom Chemical group C* 0.000 description 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000003433 contraceptive agent Substances 0.000 description 1
- 230000002254 contraceptive effect Effects 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000004205 dimethyl polysiloxane Substances 0.000 description 1
- 229960003575 estradiol acetate Drugs 0.000 description 1
- FHXBMXJMKMWVRG-SLHNCBLASA-N estradiol acetate Chemical compound C1C[C@]2(C)[C@@H](O)CC[C@H]2[C@@H]2CCC3=CC(OC(=O)C)=CC=C3[C@H]21 FHXBMXJMKMWVRG-SLHNCBLASA-N 0.000 description 1
- 229950002007 estradiol benzoate Drugs 0.000 description 1
- 229960005416 estradiol cypionate Drugs 0.000 description 1
- 229960004766 estradiol valerate Drugs 0.000 description 1
- 239000005038 ethylene vinyl acetate Substances 0.000 description 1
- 230000003325 follicular Effects 0.000 description 1
- VOZRXNHHFUQHIL-UHFFFAOYSA-N glycidyl methacrylate Chemical compound CC(=C)C(=O)OCC1CO1 VOZRXNHHFUQHIL-UHFFFAOYSA-N 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 150000003903 lactic acid esters Chemical class 0.000 description 1
- 229960004400 levonorgestrel Drugs 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 150000002734 metacrylic acid derivatives Chemical class 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- KIQQMECNKUGGKA-NMYWJIRASA-N norgestimate Chemical compound O/N=C/1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(OC(C)=O)C#C)[C@@H]4[C@@H]3CCC2=C\1 KIQQMECNKUGGKA-NMYWJIRASA-N 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229940068196 placebo Drugs 0.000 description 1
- 239000000902 placebo Substances 0.000 description 1
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920000139 polyethylene terephthalate Polymers 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
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- 229920002635 polyurethane Polymers 0.000 description 1
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- 150000003431 steroids Chemical class 0.000 description 1
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
-
- 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
- A61K31/568—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 positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K31/569—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 positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
-
- 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
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
-
- 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
- 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
-
- 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
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- 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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Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.女性の***を抑制するための経皮パッチであって、次のaおよびbを有す る経皮パッチ: a)バッキング層;および b)該バッキング層の下に存在するマトリックス層であって、17−デア セチルノルゲスチマート、および少なくともシリコーンおよびポリイソブチレン のうちの1種を含む感圧性粘着剤の混合物を含有し、女性の皮膚に拡散による伝 達がなされるように、そして***を阻止する量の17−デアセチルノルゲスチマー トを投与するように適用される、マトリックス層。 2.前記量が175−300μg/日である、請求項1に記載のパッチ。 3.前記感圧性粘着剤がポリイソブチレンである、請求項1に記載のパッチ。 4.前記マトリックス層が皮膚透過増強剤を含有する、請求項1に記載のパッ チ。 5.前記皮膚透過増強剤が、C12−C18の脂肪族アルコールの乳酸エステル、 オレイン酸、およびPGMLで実質的になる群から選択される、請求項4に記載 のパッチ。 6.前記皮膚透過増強剤が乳酸ラウリルである、請求項5に記載のパッチ。 7.女性の***を抑制するための経皮パッチであって、次のaおよびbを有す る経皮パッチ: a)バッキング層;および b)該バッキング層の下に存在するマトリックス層であって、17−デア セチルノルゲスチマート、エストロゲン、および少なくともシリコーンおよびポ リイソブチレンのうちの1種を含む感圧性粘着剤の混合物を含有し、女性の皮膚 に拡散による伝達がなされるように、そして***を阻止する量の17−デアセチル ノルゲスチマートおよびエストロゲンを共投与するように適用される、マトリッ クス層。 8.前記感圧性粘着剤がポリイソブチレンである、請求項7に記載のパッチ。 9.前記マトリックス層が皮膚透過増強剤を含有する、請求項8に記載のパッ チ。 10.前記エストロゲンがエストラジオールである、請求項9に記載のパッチ 。 11.前記エストラジオールがエチニルエストラジオールまたは17−β−エス トラジオールである、請求項10に記載のパッチ。 12.前記エストラジオールがエチニルエストラジオールである、請求項11 に記載のパッチ。 13.前記量が175−300μg/日の17−デアセチルノルゲスチマートおよび10 −35μg/日のエチニルエストラジオールである、請求項12に記載のパッチ。 14.前記エストラジオールが17−β−エストラジオールである、請求項11 に記載のパッチ。 15.前記量が175−300μg/日の17−デアセチルノルゲスチマートおよび30 −150μg/日の17−β−エストラジオールである、請求項14に記載のパッチ 。 16.前記皮膚透過増強剤が、C12−C18の脂肪族アルコールの乳酸エステル 、オレイン酸、およびPGMLで実質的になる群から選択される、請求項11に 記載のパッチ。 17.前記皮膚透過増強剤が乳酸ラウリルである、請求項16に記載のパッチ 。 18.女性の***を抑制するための方法であって、***を阻止する量の17−デ アセチルノルゲスチマートをマトリックスから経皮的に該女性に投与することを 包含し、該マトリックスが、17−デアセチルノルゲスチマート、および少なくと もシリコーンおよびポリイソブチレンのうちの1種を含む感圧性粘着剤の混合物 を含有する、方法。 19.前記量が175−300μg/日である、請求項18に記載の方法。 20.女性の***を抑制するための方法であって、***を阻止する量の17−デ アセチルノルゲスチマートおよびエストロゲンをマトリックスから経皮的に該女 性に共投与することを包含し、該マトリックスが、17−デアセチルノルゲスチマ ート、エストロゲン、および少なくともシリコーンおよびポリイソブチレンのう ちの1種を含む感圧性粘着剤の混合物を含有する、方法。 21.前記エストロゲンがエチニルエストラジオールである、請求項20に記 載の方法。 22.前記量が175−300μg/日の17−デアセチルノルゲスチマートおよび10 −35μg/日のエチニルエストラジオールである、請求項21に記載の方法。 23.女性においてホルモン置換療法を提供するための経皮パッチであって、 次のaおよびbを有する経皮パッチ: a)バッキング層;および b)該バッキング層の下に存在するマトリックス層であって、17−デア セチルノルゲスチマート、エストロゲン、および少なくともシリコーンおよびポ リイソブチレンのうちの1種を含む感圧性粘着剤の混合物を含有し、女性の皮膚 に拡散による伝達がなされるように、そして療法に用いられる量の17−デアセチ ルノルゲスチマートおよびエストロゲンを該皮膚に共投与するように適用される 、マトリックス層。 24.前記感圧性粘着剤がポリイソブチレンである、請求項23に記載のパッ チ。 25.前記マトリックス層が皮膚透過増強剤を含有する、請求項24に記載の パッチ。 26.前記エストロゲンがエストラジオールである、請求項25に記載のパッ チ。 27.前記エストラジオールがエチニルエストラジオールまたは17−β−エス トラジオールである、請求項26に記載のパッチ。 28.前記エストラジオールがエチニルエストラジオールである、請求項27 に記載のパッチ。 29.前記17−デアセチルノルゲスチマートの量が175−300μg/日であり、 そしてエチニルエストラジオールの量が10−35μg/日である、請求項28に記 載のパッチ。 30.前記エストラジオールが17−β−エストラジオールである、請求項27 に記載のパッチ。 31.前記17−デアセチルノルゲスチマートの量が175−300μg/日であり、 そして17−β−エストラジオールの量が30−150μg/日である、請求項30に 記載のパッチ。 32.前記皮膚透過増強剤が、C12−C18の脂肪族アルコールの乳酸エステル 、オレイン酸、およびPGMLで実質的になる群から選択される、請求項27に 記載のパッチ。 33.前記皮膚透過増強剤が乳酸ラウリルである、請求項32に記載のパッチ 。 34.女性において、ホルモン置換療法を提供する方法であって、療法に用い られる量の17−デアセチルノルゲスチマートをマトリックスから経皮的に女性に 投与し、該マトリックスが、17−デアセチルノルゲスチマート、および少なくと もシリコーンおよびポリイソブチレンのうちの1種を含む感圧性粘着剤の混合物 を含有する、方法。 35.前記17−デアセチルノルゲスチマートの量が約175−300μg/日である 、請求項34に記載の方法。 36.女性において、ホルモン置換療法を提供する方法であって、療法に用い られる量の17−デアセチルノルゲスチマートおよびエストロゲンをマトリックス から経皮的に女性に共投与することを包含し、該マトリックスが、17−デアセチ ルノルゲスチマート、エストロゲン、および少なくともシリコーンおよびポリイ ソブチレンのうちの1種を含む感圧性粘着剤の混合物を含有する、方法。 37.前記エストロゲンがエチニルエストラジオールである、請求項34に記 載の方法。 38.前記17−デアセチルノルゲスチマートの量が約175−300μg/日であり 、そしてエチニルエストラジオールの量が約10−35μg/日である、請求項34 に記載の方法。 39.女性の***を抑制するための経皮パッチであって、次のaおよびbを有 する経皮パッチ: a)バッキング層;および b)該バッキング層の下に存在するマトリックス層であって、17−デア セチルノルゲスチマート、ポリイソブチレン感圧性粘着剤、およびポリビニルピ ロリドンの混合物を含有し、女性の皮膚に拡散による伝達がなされるように、そ して***を阻止する量の17−デアセチルノルゲスチマートを投与するように適用 される、マトリックス層。
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
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US47353195A | 1995-06-07 | 1995-06-07 | |
US08/473,531 | 1995-06-07 | ||
US51726395A | 1995-08-21 | 1995-08-21 | |
US08/517.263 | 1995-08-21 | ||
US08/517,263 | 1995-08-21 | ||
PCT/US1996/009396 WO1996040355A1 (en) | 1995-06-07 | 1996-06-06 | Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen |
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JP2003376231A Division JP2004043510A (ja) | 1995-06-07 | 2003-11-05 | 17−デアセチルノルゲスチマートを単独でまたはエストロゲンと組み合わせて投与するための経皮パッチおよび方法 |
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JPH11501323A true JPH11501323A (ja) | 1999-02-02 |
JP3534775B2 JP3534775B2 (ja) | 2004-06-07 |
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JP50172397A Expired - Lifetime JP3534775B2 (ja) | 1995-06-07 | 1996-06-06 | 17−デアセチルノルゲスチマートを単独でまたはエストロゲンと組み合わせて投与するための経皮パッチおよび方法 |
JP2003376231A Pending JP2004043510A (ja) | 1995-06-07 | 2003-11-05 | 17−デアセチルノルゲスチマートを単独でまたはエストロゲンと組み合わせて投与するための経皮パッチおよび方法 |
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JP2003376231A Pending JP2004043510A (ja) | 1995-06-07 | 2003-11-05 | 17−デアセチルノルゲスチマートを単独でまたはエストロゲンと組み合わせて投与するための経皮パッチおよび方法 |
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US5783208A (en) * | 1996-07-19 | 1998-07-21 | Theratech, Inc. | Transdermal drug delivery matrix for coadministering estradiol and another steroid |
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1996
- 1996-06-06 CN CNB96195390XA patent/CN1188189C/zh not_active Expired - Lifetime
- 1996-06-06 US US08/660,024 patent/US5876746A/en not_active Expired - Lifetime
- 1996-06-06 EP EP96921353A patent/EP0836506B2/en not_active Expired - Lifetime
- 1996-06-06 PL PL96323729A patent/PL181582B1/pl unknown
- 1996-06-06 PT PT96921353T patent/PT836506E/pt unknown
- 1996-06-06 DK DK96921353.7T patent/DK0836506T4/da active
- 1996-06-06 HU HU9802326A patent/HU228434B1/hu unknown
- 1996-06-06 CZ CZ19973932A patent/CZ292151B6/cs not_active IP Right Cessation
- 1996-06-06 JP JP50172397A patent/JP3534775B2/ja not_active Expired - Lifetime
- 1996-06-06 WO PCT/US1996/009396 patent/WO1996040355A1/en active IP Right Grant
- 1996-06-06 AU AU62597/96A patent/AU703593B2/en not_active Expired
- 1996-06-06 DE DE69625483T patent/DE69625483T3/de not_active Expired - Lifetime
- 1996-06-06 RU RU98100451/14A patent/RU2177311C2/ru active
- 1996-06-06 CA CA002222133A patent/CA2222133C/en not_active Expired - Lifetime
- 1996-06-06 ES ES96921353T patent/ES2190472T5/es not_active Expired - Lifetime
- 1996-06-06 NZ NZ311304A patent/NZ311304A/xx not_active IP Right Cessation
- 1996-06-06 KR KR1019970709164A patent/KR100301226B1/ko not_active IP Right Cessation
- 1996-06-06 IL IL12243296A patent/IL122432A/xx not_active IP Right Cessation
- 1996-06-06 AT AT96921353T patent/ATE229828T1/de active
- 1996-06-06 UA UA98010009A patent/UA48973C2/uk unknown
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1997
- 1997-12-03 NO NO19975586A patent/NO316308B1/no not_active IP Right Cessation
- 1997-12-05 MX MX9709666A patent/MX9709666A/es unknown
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1998
- 1998-10-02 US US09/165,526 patent/US5972377A/en not_active Expired - Lifetime
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1999
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2003
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JP2005519961A (ja) * | 2002-03-11 | 2005-07-07 | ジヤンセン・フアーマシユーチカ・ナームローゼ・フエンノートシヤツプ | 継続的スルファターゼ阻害プロゲストゲンホルモン補充療法 |
JP2005519962A (ja) * | 2002-03-11 | 2005-07-07 | ジヤンセン・フアーマシユーチカ・ナームローゼ・フエンノートシヤツプ | スルファターゼを阻害する継続的プロゲストゲン避妊レジメン |
JP2005519964A (ja) * | 2002-03-11 | 2005-07-07 | ジヤンセン・フアーマシユーチカ・ナームローゼ・フエンノートシヤツプ | スルファターゼ阻害プロゲストゲンのみの避妊レジメン |
WO2006093066A1 (ja) * | 2005-02-28 | 2006-09-08 | Hisamitsu Pharmaceutical Co., Inc. | 粘着基材及び該粘着基材を含む医療用貼付製剤 |
JP2010507601A (ja) * | 2006-10-26 | 2010-03-11 | エルテーエス ローマン テラピー−ジステーメ アーゲー | 避妊及びホルモン補充のためのノルエルゲストロミンを含む経皮治療システム |
JP2014051507A (ja) * | 2006-10-26 | 2014-03-20 | Lts Lohmann Therapie-Systeme Ag | 避妊及びホルモン補充のためのノルエルゲストロミンを含む経皮治療システム |
JP2016532642A (ja) * | 2013-10-07 | 2016-10-20 | テイコク ファーマ ユーエスエー インコーポレーテッド | デクスメデトミジン経皮送達デバイス及びその使用法 |
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