RU2003133217A - Чрескожная терапевтическая система для лечения болезни паркинсона, индуцирующая высокие уровни ротиготина в плазме - Google Patents
Чрескожная терапевтическая система для лечения болезни паркинсона, индуцирующая высокие уровни ротиготина в плазме Download PDFInfo
- Publication number
- RU2003133217A RU2003133217A RU2003133217/15A RU2003133217A RU2003133217A RU 2003133217 A RU2003133217 A RU 2003133217A RU 2003133217/15 A RU2003133217/15 A RU 2003133217/15A RU 2003133217 A RU2003133217 A RU 2003133217A RU 2003133217 A RU2003133217 A RU 2003133217A
- Authority
- RU
- Russia
- Prior art keywords
- therapeutic system
- rotigotine
- silicone
- use according
- transdermal therapeutic
- Prior art date
Links
- 230000001225 therapeutic effect Effects 0.000 title claims abstract 13
- KFQYTPMOWPVWEJ-INIZCTEOSA-N rotigotine Chemical compound CCCN([C@@H]1CC2=CC=CC(O)=C2CC1)CCC1=CC=CS1 KFQYTPMOWPVWEJ-INIZCTEOSA-N 0.000 title claims abstract 10
- 229960003179 rotigotine Drugs 0.000 title claims abstract 10
- 208000018737 Parkinson disease Diseases 0.000 title claims 2
- 230000001939 inductive effect Effects 0.000 title 1
- 229920001296 polysiloxane Polymers 0.000 claims abstract 9
- 239000004480 active ingredient Substances 0.000 claims abstract 3
- 239000000853 adhesive Substances 0.000 claims 2
- 230000001070 adhesive effect Effects 0.000 claims 2
- 229910052909 inorganic silicate Inorganic materials 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- 229940035678 anti-parkinson drug Drugs 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000011159 matrix material Substances 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 239000013464 silicone adhesive Substances 0.000 claims 1
- 230000000648 anti-parkinson Effects 0.000 abstract 1
- 239000000939 antiparkinson agent Substances 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 230000036470 plasma concentration Effects 0.000 abstract 1
Classifications
-
- 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
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
- A61K31/381—Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
-
- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hospice & Palliative Care (AREA)
- Psychiatry (AREA)
- Psychology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Optical Elements Other Than Lenses (AREA)
- Radiation-Therapy Devices (AREA)
- Steroid Compounds (AREA)
Claims (11)
1. Применение чрескожной терапевтической системы на основе силикона, имеющей площадь от 10 до 40 см2 и содержащей от 0,1 до 3,15 мг/см2 ротиготина в качестве активного ингредиента, для приготовления противопаркинсонического лекарства, которое индуцирует среднюю концентрацию ротиготина в плазме в интервале от 0,4 до 2 нг/мл в течение 24 ч после наложения.
2. Применение по п.1, где чрескожная терапевтическая система на основе силикона содержит два или более чем два силиконовых адгезива в качестве основных адгезивных компонентов.
3. Применение по п.1 или 2, где чрескожная терапевтическая система на основе силикона дополнительно содержит солюбилизатор.
4. Применение по п.3, где солюбилизатор представляет собой поливинилпирролидон.
5. Применение по п.1, где чрескожная терапевтическая система на основе силикона содержит менее 1 мас.% неорганических силикатов.
6. Применение по п.5, где чрескожная терапевтическая система на основе силикона свободна от неорганических силикатов.
7. Применение по п.1, где чрескожная терапевтическая система на основе силикона имеет площадь от 10 до 30 см2.
8. Применение по п.1, где чрескожная терапевтическая система содержит от 0,1 до 1,5 мг/см2 ротиготина.
9. Применение по п.1, где чрескожная терапевтическая система представляет собой пластырь, имеющий площадь от 10 до 30 см2 и содержание ротиготина от 0,4 до 0,5 мг/см2 в адгезивной матрице на основе силикона.
10. Применение по п.1, где средняя концентрация ротиготина в плазме поддерживается в интервале от 0,4 до 2 нг/мл в течение по меньшей мере 14 суток при непрерывном дальнейшем применении указанной чрескожной терапевтической системы.
11. Способ лечения болезни Паркинсона, при котором к пациенту, страдающему таким заболеванием, прикладывают чрескожную терапевтическую систему на основе силикона, имеющую площадь от 10 до 40 см2 и содержащую от 0,1 до 3,15 мг/см2 ротиготина в качестве активного ингредиента, где указанная чрескожная терапевтическая система индуцирует среднюю концентрацию ротиготина в плазме в интервале от 0,4 до 2 нг/мл в течение 24 ч после наложения.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP01111109A EP1256339B1 (en) | 2001-05-08 | 2001-05-08 | Transdermal therapeutic system for Parkinson's disease inducing high plasma levels of rotigotine |
| EP01111109.3 | 2001-05-08 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2003133217A true RU2003133217A (ru) | 2005-04-20 |
| RU2272625C2 RU2272625C2 (ru) | 2006-03-27 |
Family
ID=8177356
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2003133217/15A RU2272625C2 (ru) | 2001-05-08 | 2002-05-06 | Чрескожная терапевтическая система для лечения болезни паркинсона, индуцирующая высокие уровни ротиготина в плазме |
Country Status (15)
| Country | Link |
|---|---|
| EP (3) | EP1256339B1 (ru) |
| JP (2) | JP5026656B2 (ru) |
| KR (1) | KR100974974B1 (ru) |
| CN (2) | CN1606435A (ru) |
| AT (2) | ATE251901T1 (ru) |
| CY (1) | CY1109861T1 (ru) |
| DE (2) | DE60100994T2 (ru) |
| DK (2) | DK1256339T3 (ru) |
| ES (2) | ES2204780T3 (ru) |
| HK (1) | HK1049444B (ru) |
| HU (1) | HU229350B1 (ru) |
| PT (2) | PT1256339E (ru) |
| RU (1) | RU2272625C2 (ru) |
| WO (1) | WO2002089778A2 (ru) |
| ZA (1) | ZA200209982B (ru) |
Families Citing this family (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10041478A1 (de) | 2000-08-24 | 2002-03-14 | Sanol Arznei Schwarz Gmbh | Neue pharmazeutische Zusammensetzung |
| EP1256340B1 (en) * | 2001-05-08 | 2003-08-13 | Schwarz Pharma Ag | Improved transdermal therapeutic system for the treatment of Parkinson's disease |
| DE10220230A1 (de) * | 2002-05-06 | 2003-11-27 | Sanol Arznei Schwarz Gmbh | Verwendung von Rotigotine zur Behandlung des Restless Leg Syndroms |
| DE10261696A1 (de) * | 2002-12-30 | 2004-07-15 | Schwarz Pharma Ag | Vorrichtung zur transdermalen Verabreichung von Rotigotin-Base |
| DE10334187A1 (de) * | 2003-07-26 | 2005-03-03 | Schwarz Pharma Ag | Substituierte 2-Aminotetraline zur Behandlung von Depressionen |
| DE10334188B4 (de) | 2003-07-26 | 2007-07-05 | Schwarz Pharma Ag | Verwendung von Rotigotin zur Behandlung von Depressionen |
| DE10338174A1 (de) | 2003-08-20 | 2005-03-24 | Lts Lohmann Therapie-Systeme Ag | Transdermale Arzneimittelzubereitungen mit Wirkstoffkombinationen zur Behandlung der Parkinson-Krankheit |
| DE10359528A1 (de) | 2003-12-18 | 2005-07-28 | Schwarz Pharma Ag | (S)-2-N-Propylamino-5-hydroxytetralin als D3-agonistisches Therapeutikum |
| EP1547592A1 (en) | 2003-12-23 | 2005-06-29 | Schwarz Pharma Ag | Intranasal formulation of rotigotine |
| DE10361258A1 (de) * | 2003-12-24 | 2005-07-28 | Schwarz Pharma Ag | Verwendung von substituierten 2-Aminotetralinen zur vorbeugenden Behandlung von Morbus Parkinson |
| DE10361259A1 (de) * | 2003-12-24 | 2005-07-28 | Schwarz Pharma Ag | Verwendung von Rotigotine in einem Frühstadium von Morbus Parkinson zur Prävention des weiteren Neuronenverlustes |
| DE102004014841B4 (de) | 2004-03-24 | 2006-07-06 | Schwarz Pharma Ag | Verwendung von Rotigotin zur Behandlung und Prävention des Parkinson-Plus-Syndroms |
| EP1796610A4 (en) * | 2004-09-29 | 2012-12-05 | Schwarz Pharma Inc | TRANSDERMAL THERAPEUTIC SYSTEM FOR PARKINSON'S DISEASE |
| CN101147739B (zh) | 2007-07-06 | 2010-12-08 | 北京康倍得医药技术开发有限公司 | 含罗替戈汀的组合物及其制药用途以及含该组合物的透皮贴剂 |
| DE102008060203A1 (de) | 2008-12-07 | 2010-06-10 | Dietrich Wilhelm Schacht | Wirkstoffstabilisierende flächenförmige Vorrichtung |
| EP2201941A1 (de) | 2008-12-29 | 2010-06-30 | UCB Pharma GmbH | Pflaster-Herstellungstechnologie |
| WO2011048491A2 (en) * | 2009-10-19 | 2011-04-28 | Actavis Group Ptc Ehf | Amorphous rotigotine co-precipitates |
| JP5815556B2 (ja) | 2009-12-22 | 2015-11-17 | ウーツェーベー ファルマ ゲーエムベーハーＵｃｂ Ｐｈａｒｍａ Ｇｍｂｈ | 非結晶形態のロチゴチンの固体分散体を安定化するためのポリビニルピロリドン |
| 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 |
| EP3016641B1 (de) | 2013-07-03 | 2018-09-05 | LTS Lohmann Therapie-Systeme AG | Transdermales therapeutisches system mit elektronischem bauteil |
| EP3145502B1 (en) | 2014-05-20 | 2022-07-06 | LTS Lohmann Therapie-Systeme AG | Transdermal delivery system containing rotigotine |
| EP3145503A1 (en) | 2014-05-20 | 2017-03-29 | LTS Lohmann Therapie-Systeme AG | Method for adjusting the release of active agent in a transdermal delivery system |
| EP4238580A3 (en) | 2014-05-20 | 2023-10-25 | LTS Lohmann Therapie-Systeme AG | Transdermal delivery system including an interface mediator |
| KR102364378B1 (ko) * | 2014-05-21 | 2022-02-16 | 에스케이케미칼 주식회사 | 안정성을 향상시킨 로티고틴 함유 경피흡수제제 |
| DE102014114282A1 (de) | 2014-10-01 | 2016-04-07 | Neuraxpharm Arzneimittel Gmbh | Transdermales therapeutisches System mit Rotigotin zur Behandlung von Morbus Parkinson |
| CN110121344A (zh) | 2016-12-28 | 2019-08-13 | 久光制药株式会社 | 含布托啡诺的贴附剂 |
| DE102018120506A1 (de) | 2017-10-20 | 2019-04-25 | Amw Gmbh | Stabilisiertes transdermales Darreichungssystem |
| EP3854388B1 (de) | 2020-01-24 | 2023-10-04 | Luye Pharma Switzerland AG | Transdermales therapeutisches system mit dem wirkstoff rotigotin und mindestens einem nicht aminresistenten silikonkleber |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0751515B2 (ja) * | 1986-09-10 | 1995-06-05 | 明治製菓株式会社 | 経皮吸収製剤 |
| US5656286A (en) * | 1988-03-04 | 1997-08-12 | Noven Pharmaceuticals, Inc. | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
| US5474783A (en) * | 1988-03-04 | 1995-12-12 | Noven Pharmaceuticals, Inc. | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
| US5989586A (en) * | 1992-10-05 | 1999-11-23 | Cygnus, Inc. | Two-phase matrix for sustained release drug delivery device |
| FR2732223B1 (fr) * | 1995-03-30 | 1997-06-13 | Sanofi Sa | Composition pharmaceutique pour administration transdermique |
| DE19814084B4 (de) * | 1998-03-30 | 2005-12-22 | Lts Lohmann Therapie-Systeme Ag | D2-Agonist enthaltendes transdermales therapeutisches System zur Behandlung des Parkinson-Syndroms und Verfahren zu seiner Herstellung |
| DE19940238A1 (de) * | 1999-08-25 | 2001-03-01 | Lohmann Therapie Syst Lts | Wirkstoffhaltiges therapeutisches System zur Applikation auf der Haut mit mindestens zwei polymerhaltigen Schichten |
-
2001
- 2001-05-08 DK DK01111109T patent/DK1256339T3/da active
- 2001-05-08 AT AT01111109T patent/ATE251901T1/de active
- 2001-05-08 PT PT01111109T patent/PT1256339E/pt unknown
- 2001-05-08 ES ES01111109T patent/ES2204780T3/es not_active Expired - Lifetime
- 2001-05-08 EP EP01111109A patent/EP1256339B1/en not_active Expired - Lifetime
- 2001-05-08 EP EP03013353A patent/EP1344522A1/en not_active Withdrawn
- 2001-05-08 DE DE60100994T patent/DE60100994T2/de not_active Expired - Lifetime
-
2002
- 2002-05-06 JP JP2002586915A patent/JP5026656B2/ja not_active Expired - Lifetime
- 2002-05-06 PT PT02740569T patent/PT1471892E/pt unknown
- 2002-05-06 WO PCT/EP2002/004976 patent/WO2002089778A2/en not_active Ceased
- 2002-05-06 CN CNA028015401A patent/CN1606435A/zh active Pending
- 2002-05-06 ES ES02740569T patent/ES2331787T3/es not_active Expired - Lifetime
- 2002-05-06 EP EP02740569A patent/EP1471892B1/en not_active Revoked
- 2002-05-06 HU HU0500525A patent/HU229350B1/hu unknown
- 2002-05-06 DK DK02740569T patent/DK1471892T3/da active
- 2002-05-06 KR KR1020037000143A patent/KR100974974B1/ko not_active Expired - Lifetime
- 2002-05-06 AT AT02740569T patent/ATE444061T1/de active
- 2002-05-06 RU RU2003133217/15A patent/RU2272625C2/ru active IP Right Revival
- 2002-05-06 DE DE60233898T patent/DE60233898D1/de not_active Expired - Lifetime
- 2002-05-06 CN CN2011100516651A patent/CN102172351B/zh not_active Expired - Lifetime
- 2002-12-10 ZA ZA200209982A patent/ZA200209982B/xx unknown
-
2003
- 2003-03-04 HK HK03101599.0A patent/HK1049444B/en unknown
-
2009
- 2009-11-05 CY CY20091101150T patent/CY1109861T1/el unknown
-
2010
- 2010-01-07 JP JP2010002209A patent/JP2010106037A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| JP5026656B2 (ja) | 2012-09-12 |
| PT1256339E (pt) | 2004-02-27 |
| CN102172351B (zh) | 2013-07-17 |
| KR20030016373A (ko) | 2003-02-26 |
| HK1049444B (en) | 2004-03-19 |
| CN102172351A (zh) | 2011-09-07 |
| EP1256339B1 (en) | 2003-10-15 |
| JP2004536054A (ja) | 2004-12-02 |
| ATE444061T1 (de) | 2009-10-15 |
| HU229350B1 (en) | 2013-11-28 |
| ES2331787T3 (es) | 2010-01-15 |
| JP2010106037A (ja) | 2010-05-13 |
| DE60233898D1 (de) | 2009-11-12 |
| EP1471892A2 (en) | 2004-11-03 |
| DK1471892T3 (da) | 2009-12-07 |
| ATE251901T1 (de) | 2003-11-15 |
| DK1256339T3 (da) | 2004-02-09 |
| EP1471892B1 (en) | 2009-09-30 |
| RU2272625C2 (ru) | 2006-03-27 |
| EP1256339A1 (en) | 2002-11-13 |
| WO2002089778A2 (en) | 2002-11-14 |
| HUP0500525A2 (hu) | 2005-09-28 |
| PT1471892E (pt) | 2009-12-23 |
| DE60100994T2 (de) | 2004-07-22 |
| CN1606435A (zh) | 2005-04-13 |
| ES2204780T3 (es) | 2004-05-01 |
| EP1344522A1 (en) | 2003-09-17 |
| ZA200209982B (en) | 2003-03-24 |
| KR100974974B1 (ko) | 2010-08-09 |
| HK1049444A1 (en) | 2003-05-16 |
| CY1109861T1 (el) | 2014-09-10 |
| WO2002089778A3 (en) | 2004-08-19 |
| DE60100994D1 (de) | 2003-11-20 |
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