DK2515887T3 - Polyvinylpyrrolidon til stabilisering af en faststofdispersion af den ikke-krystallinske form af rotigotin - Google Patents
Polyvinylpyrrolidon til stabilisering af en faststofdispersion af den ikke-krystallinske form af rotigotin Download PDFInfo
- Publication number
- DK2515887T3 DK2515887T3 DK10796399.3T DK10796399T DK2515887T3 DK 2515887 T3 DK2515887 T3 DK 2515887T3 DK 10796399 T DK10796399 T DK 10796399T DK 2515887 T3 DK2515887 T3 DK 2515887T3
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- DK
- Denmark
- Prior art keywords
- rotigotine
- polyvinylpyrrolidone
- solid dispersion
- weight ratio
- tts
- Prior art date
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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
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- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- 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
-
- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Dermatology (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Psychology (AREA)
- Pain & Pain Management (AREA)
- Inorganic Chemistry (AREA)
- Hospice & Palliative Care (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (13)
1. Fremgangsmåde til stabilisering af rotigotin, hvilken fremgangsmåde omfatter at tilvejebringe en faststofdispersion omfattende et dispergeringsmiddel og en dispergeret fase, hvilket dispergeringsmiddel omfatter mindst ét trykfølsomt silikoneklæbemiddel, og den dispergerede fase omfatter polyvinylpyrrolidon og en ikke-krystallinsk form af rotigotin, hvor vægtforholdet mellem rotigotin og polyvinylpyrrolidon er i området fra 9:4 til 9:6, hvor rotigotin er den frie rotigotinbase, og opløseligheden af rotigotin i dispergeringsmidlet er under 1 % efter vægt.
2. Fremgangsmåde ifølge krav 1, hvor vægtforholdet mellem rotigotin og polyvinylpyrrolidon i den dispergerede fase er i området 9:4 til 9:4,5.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor molekylvægten af polyvinylpyrrolidon er i området 1.000.000 til 1.500.000 Dalton.
4. Faststofdispersion omfattende et dispergeringsmiddel og en dispergeret fase, hvilket dispergeringsmiddel omfatter mindst ét trykfølsomt silikoneklæbemiddel, og den dispergerede fase omfatter rotigotin og polyvinylpyrrolidon, hvor vægtforholdet mellem rotigotin og polyvinylpyrrolidon er i området fra 9:4 til 9:6, hvor rotigotin er den frie rotigotinbase, og opløseligheden af rotigotin i dispergeringsmidlet er under 1 % efter vægt.
5. Faststofdispersion ifølge krav 4, hvor dispergeringsmidlet omfatter en blanding af et første trykfølsomt silikoneklæbemiddel og et andet trykfølsomt silikoneklæbemiddel, og hvor faststofdispersionen har en kompleks viskositet mellem 5 og 15 MP.
6. Faststofdispersion ifølge krav 4 eller 5, hvor molekylvægten af polyvinylpyrrolidon er i området fra 1.000.000 til 1.500.000 Dalton.
7. Farmaceutisk sammensætning omfattende faststofdispersionen ifølge krav 4, 5 eller 6.
8. Transdermalt terapeutisk system omfattende faststofdispersionen ifølge krav 4 eller 5.
9. Transdermalt terapeutisk system ifølge krav 8, omfattende 0,1 til cirka 3,15 mg/cm2 rotigotin på fri baseform, og hvor vægtforholdet mellem rotigotin og polyvinylpyrrolidon er 9:4.
10. Transdermalt terapeutisk system ifølge krav 9, omfattende 0,2 til cirka 1 mg/cm2 rotigotin på fri baseform.
11. Transdermalt terapeutisk system ifølge krav 8, 9 eller 10 med et vandindhold på under 2 % efter vægt.
12. Transdermalt terapeutisk system ifølge krav 8, 9, 10 eller 11, hvor molekylvægten af polyvinylpyrrolidon er i området fra 1.000.000 til 1.500.000 Dalton.
13. Fremgangsmåde til fremstilling af det transdermale terapeutiske system ifølge krav 8, 9, 10, 11 eller 12.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US28930209P | 2009-12-22 | 2009-12-22 | |
| PCT/EP2010/070563 WO2011076879A1 (en) | 2009-12-22 | 2010-12-22 | Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2515887T3 true DK2515887T3 (da) | 2018-09-17 |
Family
ID=43568293
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10796399.3T DK2515887T3 (da) | 2009-12-22 | 2010-12-22 | Polyvinylpyrrolidon til stabilisering af en faststofdispersion af den ikke-krystallinske form af rotigotin |
| DK17185284.1T DK3257504T3 (da) | 2009-12-22 | 2010-12-22 | Polyvinylpyrrolidon til stabillisering af en fast dispersion af den ikke-krystallinske form af rotigotin |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17185284.1T DK3257504T3 (da) | 2009-12-22 | 2010-12-22 | Polyvinylpyrrolidon til stabillisering af en fast dispersion af den ikke-krystallinske form af rotigotin |
Country Status (26)
| Country | Link |
|---|---|
| US (4) | US9925150B2 (da) |
| EP (3) | EP4403172A2 (da) |
| JP (1) | JP5815556B2 (da) |
| KR (3) | KR20170023772A (da) |
| CN (3) | CN102665699A (da) |
| AU (1) | AU2010334805B2 (da) |
| BR (1) | BR112012017737A8 (da) |
| CA (1) | CA2767068C (da) |
| CY (1) | CY1120621T1 (da) |
| DK (2) | DK2515887T3 (da) |
| EA (1) | EA025584B1 (da) |
| ES (1) | ES2679800T3 (da) |
| FI (1) | FI3257504T3 (da) |
| HK (1) | HK1200335A1 (da) |
| HR (1) | HRP20181173T1 (da) |
| HU (1) | HUE039447T2 (da) |
| IL (1) | IL219091A (da) |
| LT (2) | LT3257504T (da) |
| ME (1) | ME03053B (da) |
| MX (1) | MX2012007326A (da) |
| PL (1) | PL2515887T3 (da) |
| PT (1) | PT2515887T (da) |
| RS (1) | RS57457B1 (da) |
| SI (1) | SI2515887T1 (da) |
| TR (1) | TR201810322T4 (da) |
| WO (1) | WO2011076879A1 (da) |
Families Citing this family (36)
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| 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 |
| DE10234673B4 (de) | 2002-07-30 | 2007-08-16 | Schwarz Pharma Ag | Heißschmelz-TTS zur Verabreichung von Rotigotin und Verfahren zu seiner Herstellung sowie Verwendung von Rotigotin bei der Herstellung eines TTS im Heißschmelzverfahren |
| DE10334187A1 (de) * | 2003-07-26 | 2005-03-03 | Schwarz Pharma Ag | Substituierte 2-Aminotetraline zur Behandlung von Depressionen |
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| DE10359528A1 (de) * | 2003-12-18 | 2005-07-28 | Schwarz Pharma Ag | (S)-2-N-Propylamino-5-hydroxytetralin als D3-agonistisches Therapeutikum |
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| EP2281559A1 (en) | 2009-06-26 | 2011-02-09 | UCB Pharma GmbH | Pharmaceutical composition comprising rotigotine salts (acid or Na), especially for iontophoresis |
| AU2010334805B2 (en) | 2009-12-22 | 2015-01-22 | Lts Lohmann Therapie-Systeme Ag | Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine |
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| US10046151B2 (en) | 2013-07-03 | 2018-08-14 | Lts Lohmann Therapie-Systeme, Ag | Transdermal therapeutic system with electronic component |
| ES2954087T3 (es) | 2014-05-20 | 2023-11-20 | Lts Lohmann Therapie Systeme Ag | Sistema de administración transdérmica que incluye un mediador de interfase |
| CN106456567A (zh) | 2014-05-20 | 2017-02-22 | Lts勒曼治疗系统股份公司 | 在经皮递送系统中调节活性剂释放的方法 |
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