RU2005124166A - Устройство для трансдермального введения в организм ротиготина в виде основания - Google Patents
Устройство для трансдермального введения в организм ротиготина в виде основания Download PDFInfo
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- RU2005124166A RU2005124166A RU2005124166/15A RU2005124166A RU2005124166A RU 2005124166 A RU2005124166 A RU 2005124166A RU 2005124166/15 A RU2005124166/15 A RU 2005124166/15A RU 2005124166 A RU2005124166 A RU 2005124166A RU 2005124166 A RU2005124166 A RU 2005124166A
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- Prior art keywords
- matrix
- rotigotine
- polymer
- amino
- forming
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Classifications
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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
- 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
- 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
- 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
-
- 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
- A61P25/24—Antidepressants
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Psychology (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (14)
1. Матрица для трансдермального введения в организм ротиготина [(-)-5,6,7,8-тетрагидро-6-[пропил[2-(2-тиенил)этил]амино]-1-нафтола], содержащая образующий ее полимер, который пересыщен ротиготином в виде основания, отличающаяся тем, что не растворенная в образующем матрицу полимере часть ротиготина диспергирована в нем в виде аморфных частиц со средним диаметром максимум 30 мкм, а в самой матрице отсутствуют гидротропные солюбилизаторы, ингибиторы кристаллизации и диспергаторы.
2. Матрица для трансдермального введения в организм ротиготина [(-)-5,6,7,8-тетрагидро-6-[пропил[2-(2-тиенил)этил]амино]-1-нафтола], состоящая из
а) образующего ее полимера,
б) ротиготина в виде основания в концентрации, превышающей предел его растворимости в образующем матрицу полимере, не растворенная в котором часть ротиготина диспергирована в нем в виде аморфных частиц со средним диаметром максимум 30 мкм, и
в) необязательно одного или нескольких антиоксидантов.
3. Матрица по одному из предыдущих пунктов, в которой образующий ее полимер представляет собой аминостойкий силикон или смесь аминостойких силиконов.
4. Матрица по одному из п.1 или 2, отличающаяся тем, что она является самоклеящейся.
5. Матрица по одному из п.1 или 2, отличающаяся тем, что она состоит
а) на 60-95 мас.% из по меньшей мере одного аминостойкого силикона или смеси аминостойких силиконов,
б) на 5-40 мас.% из диспергированного в силиконе ротиготина в виде основания и
в) на 0-2 мас.% из антиоксиданта.
6. Устройство плоской формы для трансдермального введения в организм ротиготина, содержащее матрицу по одному из п.1 или 2 и не проницаемый для ротиготина тыльный слой.
7. Устройство по п.6, отличающееся тем, что степень наполнения матрицы ротиготином составляет от 0,3 до 6 мг/см2.
8. Применение устройства или матрицы по одному из п.1 или 2 для получения лекарственного средства, предназначенного для лечения болезни Паркинсона или синдрома Экбома.
9. Применение устройства или матрицы по одному из п.1 или 2 для получения лекарственного средства, предназначенного для лечения депрессий.
10. Способ получения фармацевтической матрицы для трансдермального введения в организм ротиготина, отличающийся тем, что
а) образующий матрицу полимер растворяют в растворителе,
б) к полученному раствору добавляют ротиготин в виде основания в кристаллической форме в количестве, превышающем предел его растворимости в используемом на стадии (а) образующем матрицу полимере,
в) удаляют растворитель и полученную образующую полимерную матрицу массу нагревают до температуры по меньшей мере 74°С с выдержкой при этой температуре до расплавления ротиготина и
г) образующую полимерную матрицу массу охлаждают.
11. Способ по п.10, в котором образовавшуюся на стадии (б) пересыщенную ротиготином полимерную массу наносят на не проницаемую для ротиготина пленку и затем выполняют дальнейшие стадии (в) и (г), указанные в п.10.
12. Способ по п.10, отличающийся тем, что растворимость ротиготина в образующем матрицу полимере составляет менее 3 мас.%.
13. Способ по п.10, отличающийся тем, что в качестве образующего матрицу полимера используют аминостойкий силикон.
14. Способ по п.10, отличающийся тем, что в качестве образующего матрицу полимера используют аминостойкий контактный силиконовый клей или смесь нескольких аминостойких контактных силиконовых клеев.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10261696.5 | 2002-12-30 | ||
DE2002161696 DE10261696A1 (de) | 2002-12-30 | 2002-12-30 | Vorrichtung zur transdermalen Verabreichung von Rotigotin-Base |
Publications (2)
Publication Number | Publication Date |
---|---|
RU2005124166A true RU2005124166A (ru) | 2007-02-10 |
RU2340339C2 RU2340339C2 (ru) | 2008-12-10 |
Family
ID=32519524
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
RU2005124166/15A RU2340339C2 (ru) | 2002-12-30 | 2003-12-24 | Устройство для трансдермального введения в организм ротиготина в виде основания |
Country Status (22)
Country | Link |
---|---|
US (2) | US20050175678A1 (ru) |
EP (1) | EP1490052B1 (ru) |
JP (1) | JP5134187B2 (ru) |
KR (1) | KR100875532B1 (ru) |
CN (1) | CN1731995B (ru) |
AT (1) | ATE363274T1 (ru) |
AU (1) | AU2003294007B2 (ru) |
BR (1) | BR0311637A (ru) |
CA (1) | CA2485656C (ru) |
CY (1) | CY1108084T1 (ru) |
DE (2) | DE10261696A1 (ru) |
DK (1) | DK1490052T3 (ru) |
ES (1) | ES2285234T3 (ru) |
HK (1) | HK1088227A1 (ru) |
IL (1) | IL165131A (ru) |
MX (1) | MXPA04012151A (ru) |
NO (1) | NO335200B1 (ru) |
PL (1) | PL215307B1 (ru) |
PT (1) | PT1490052E (ru) |
RU (1) | RU2340339C2 (ru) |
WO (1) | WO2004058247A1 (ru) |
ZA (1) | ZA200408523B (ru) |
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