RU2009123368A - Трансдермальная терапевтическая система для введения активного вещества бупренорфина - Google Patents
Трансдермальная терапевтическая система для введения активного вещества бупренорфина Download PDFInfo
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- RU2009123368A RU2009123368A RU2009123368/15A RU2009123368A RU2009123368A RU 2009123368 A RU2009123368 A RU 2009123368A RU 2009123368/15 A RU2009123368/15 A RU 2009123368/15A RU 2009123368 A RU2009123368 A RU 2009123368A RU 2009123368 A RU2009123368 A RU 2009123368A
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- therapeutic system
- transdermal therapeutic
- buprenorphine
- carboxylic acid
- active substance
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- 230000001225 therapeutic effect Effects 0.000 title claims abstract 19
- RMRJXGBAOAMLHD-IHFGGWKQSA-N buprenorphine Chemical compound C([C@]12[C@H]3OC=4C(O)=CC=C(C2=4)C[C@@H]2[C@]11CC[C@]3([C@H](C1)[C@](C)(O)C(C)(C)C)OC)CN2CC1CC1 RMRJXGBAOAMLHD-IHFGGWKQSA-N 0.000 title claims abstract 10
- 229960001736 buprenorphine Drugs 0.000 title claims abstract 10
- 239000013543 active substance Substances 0.000 title claims abstract 8
- 150000001735 carboxylic acids Chemical class 0.000 claims abstract 10
- 239000010410 layer Substances 0.000 claims abstract 10
- 239000011159 matrix material Substances 0.000 claims abstract 8
- JOOXCMJARBKPKM-UHFFFAOYSA-N 4-oxopentanoic acid Chemical compound CC(=O)CCC(O)=O JOOXCMJARBKPKM-UHFFFAOYSA-N 0.000 claims abstract 6
- 229920001296 polysiloxane Polymers 0.000 claims abstract 6
- -1 polysiloxanes Polymers 0.000 claims abstract 6
- 150000001412 amines Chemical group 0.000 claims abstract 4
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims abstract 4
- 239000004205 dimethyl polysiloxane Substances 0.000 claims abstract 4
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims abstract 4
- 239000000853 adhesive Substances 0.000 claims abstract 3
- 229940040102 levulinic acid Drugs 0.000 claims abstract 3
- 229920000058 polyacrylate Polymers 0.000 claims abstract 3
- 229920002367 Polyisobutene Polymers 0.000 claims abstract 2
- 239000002253 acid Substances 0.000 claims abstract 2
- 150000007513 acids Chemical class 0.000 claims abstract 2
- 239000012790 adhesive layer Substances 0.000 claims abstract 2
- 238000009792 diffusion process Methods 0.000 claims abstract 2
- 230000003993 interaction Effects 0.000 claims abstract 2
- 239000007788 liquid Substances 0.000 claims abstract 2
- 239000000203 mixture Substances 0.000 claims abstract 2
- 239000011241 protective layer Substances 0.000 claims abstract 2
- 238000010521 absorption reaction Methods 0.000 claims 1
- 230000001070 adhesive effect Effects 0.000 claims 1
- 230000003444 anaesthetic effect Effects 0.000 claims 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 claims 1
- 238000001727 in vivo Methods 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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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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- 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
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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
- 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
- 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
- A61K9/7092—Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs
-
- 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
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/32—Alcohol-abuse
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- Hematology (AREA)
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Abstract
1. Трансдермальная терапевтическая система для введения бупренорфина в кожу, включающая внешний слой, непроницаемый для активного вещества, по меньшей мере, один самоклеящийся матричный слой, содержащий активное вещество бупренорфин и, по меньшей мере, одну карбоновую кислоту, и удаляемый перед употреблением защитный слой, отличающаяся тем, что матричный слой создан на основе полисилоксанов или полиизобутилена, бупренорфин растворен в карбоновой кислоте или кислотах, и этот раствор в виде капель диспергирован в матричном слое, и матричный слой находится в диффузионном взаимодействии с самоклеящимся слоем на основе полиакрилатов, контактирующим с кожей. ! 2. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что полисилоксаном является устойчивый к аминам диметилполисилоксан. ! 3. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что полисилоксан представляет собой смесь устойчивого и неустойчивого к аминам диметилполисилоксана, причем содержание последнего составляет до 40 мас.%. ! 4. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что карбоновая кислота диффундирует в кожу быстрее, чем активное вещество бупренорфин. ! 5. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что количество диспергированного раствора составляет до 40 мас.%, предпочтительно до 20 мас.%. ! 6. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что карбоновая кислота при температуре кожи представляет собой жидкость. ! 7. Трансдермальная терапевтическая система по п.6, отличающаяся тем, что карбоновой кислотой является левулиновая кислота. ! 8. Трансдермальная
Claims (11)
1. Трансдермальная терапевтическая система для введения бупренорфина в кожу, включающая внешний слой, непроницаемый для активного вещества, по меньшей мере, один самоклеящийся матричный слой, содержащий активное вещество бупренорфин и, по меньшей мере, одну карбоновую кислоту, и удаляемый перед употреблением защитный слой, отличающаяся тем, что матричный слой создан на основе полисилоксанов или полиизобутилена, бупренорфин растворен в карбоновой кислоте или кислотах, и этот раствор в виде капель диспергирован в матричном слое, и матричный слой находится в диффузионном взаимодействии с самоклеящимся слоем на основе полиакрилатов, контактирующим с кожей.
2. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что полисилоксаном является устойчивый к аминам диметилполисилоксан.
3. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что полисилоксан представляет собой смесь устойчивого и неустойчивого к аминам диметилполисилоксана, причем содержание последнего составляет до 40 мас.%.
4. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что карбоновая кислота диффундирует в кожу быстрее, чем активное вещество бупренорфин.
5. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что количество диспергированного раствора составляет до 40 мас.%, предпочтительно до 20 мас.%.
6. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что карбоновая кислота при температуре кожи представляет собой жидкость.
7. Трансдермальная терапевтическая система по п.6, отличающаяся тем, что карбоновой кислотой является левулиновая кислота.
8. Трансдермальная терапевтическая система по п.7, отличающаяся тем, что бупренорфин и левулиновая кислота присутствуют в равном весовом соотношении.
9. Трансдермальная терапевтическая система по п.1, отличающаяся тем, что полиакрилатный клеящий материал не содержит свободных карбоксильных групп.
10. Трансдермальная терапевтическая система по одному из пп.1-9, отличающаяся тем, что усвоение активного вещества в условиях in vivo достигает, по меньшей мере, 30%, предпочтительно, по меньшей мере, 40%, особенно предпочтительно, по меньшей мере, 50%.
11. Применение трансдермальной терапевтической системы по одному из пп.1-10 в обезболивающем лечении.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102006054731.4 | 2006-11-21 | ||
| DE102006054731A DE102006054731B4 (de) | 2006-11-21 | 2006-11-21 | Transdermales therapeutisches System zur Verabreichung des Wirkstoffs Buprenorphin und Verwendung desselben in der Schmerztherapie |
| PCT/EP2007/009622 WO2008061625A2 (de) | 2006-11-21 | 2007-11-07 | Transdermales therapeutisches system zur verabreichung des wirkstoffs buprenorphin |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2009123368A true RU2009123368A (ru) | 2010-12-27 |
| RU2484822C2 RU2484822C2 (ru) | 2013-06-20 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2009123368/15A RU2484822C2 (ru) | 2006-11-21 | 2007-11-07 | Трансдермальная терапевтическая система для введения активного вещества бупренорфина |
Country Status (25)
| Country | Link |
|---|---|
| US (5) | US9308202B2 (ru) |
| EP (2) | EP2769714B1 (ru) |
| JP (2) | JP5763296B2 (ru) |
| KR (1) | KR101444967B1 (ru) |
| CN (1) | CN101528207B (ru) |
| AR (1) | AR064268A1 (ru) |
| AU (1) | AU2007323387B2 (ru) |
| BR (1) | BRPI0719115B8 (ru) |
| CA (1) | CA2670290C (ru) |
| CY (2) | CY1118154T1 (ru) |
| DE (1) | DE102006054731B4 (ru) |
| DK (2) | DK2769714T3 (ru) |
| ES (2) | ES2543977T3 (ru) |
| HU (2) | HUE028971T2 (ru) |
| IL (2) | IL198743A (ru) |
| IN (1) | IN2009CN02662A (ru) |
| MX (2) | MX344241B (ru) |
| NZ (1) | NZ575500A (ru) |
| PL (2) | PL2769714T3 (ru) |
| PT (1) | PT2769714E (ru) |
| RU (1) | RU2484822C2 (ru) |
| SI (2) | SI2769714T1 (ru) |
| TW (1) | TWI411452B (ru) |
| WO (1) | WO2008061625A2 (ru) |
| ZA (1) | ZA200901695B (ru) |
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| TWI630208B (zh) | 2008-12-08 | 2018-07-21 | 歐陸斯迪公司 | 二氫羥戊甲嗎啡 |
| PL2468274T3 (pl) * | 2010-12-14 | 2015-11-30 | Luye Pharma Ag | Przezskórny układ terapeutyczny do podawania substancji czynnej |
| DE102011076653A1 (de) * | 2011-05-27 | 2012-11-29 | Acino Ag | Transdermales therapeutisches System enthaltend Buprenorphin und eine alpha-Hydroxysäure |
| EP2729148A4 (en) | 2011-07-06 | 2015-04-22 | Parkinson S Inst | COMPOSITIONS AND METHOD FOR THE TREATMENT OF SYMPTOMS IN PATIENTS WITH MORBUS PARKINSON |
| US9301920B2 (en) | 2012-06-18 | 2016-04-05 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| CA2856520C (en) | 2011-11-23 | 2021-04-06 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
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| WO2014031958A1 (en) * | 2012-08-24 | 2014-02-27 | Integurx Therapeutics, Llc | Chemical compositions and methods for enhancing transdermal delivery of therapeutic agents |
| TW201431570A (zh) | 2012-11-22 | 2014-08-16 | Ucb Pharma Gmbh | 用於經皮投服羅替戈汀（Ｒｏｔｉｇｏｔｉｎｅ）之多天式貼片 |
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| US10568891B2 (en) | 2012-12-21 | 2020-02-25 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US11266661B2 (en) | 2012-12-21 | 2022-03-08 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
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| US11246875B2 (en) | 2012-12-21 | 2022-02-15 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10537581B2 (en) | 2012-12-21 | 2020-01-21 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| WO2014100599A1 (en) * | 2012-12-21 | 2014-06-26 | Teikoku Pharma Usa, Inc. | Compositions and methods for transdermal delivery of hormones and other medicinal agents |
| CN103893154A (zh) * | 2012-12-26 | 2014-07-02 | 江苏康倍得药业有限公司 | 包含丁丙诺啡的透皮给药系统 |
| US11547676B2 (en) | 2012-12-28 | 2023-01-10 | Teikoku Seiyaku Co., Ltd. | Extended buprenorphine transdermal delivery compositions and methods for using the same |
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