HRP20150956T1 - Polimorfni oblik rotigotina - Google Patents
Polimorfni oblik rotigotina Download PDFInfo
- Publication number
- HRP20150956T1 HRP20150956T1 HRP20150956TT HRP20150956T HRP20150956T1 HR P20150956 T1 HRP20150956 T1 HR P20150956T1 HR P20150956T T HRP20150956T T HR P20150956TT HR P20150956 T HRP20150956 T HR P20150956T HR P20150956 T1 HRP20150956 T1 HR P20150956T1
- Authority
- HR
- Croatia
- Prior art keywords
- rotigotine
- polymorphic form
- medicinal substance
- parkinson
- pharmaceutical composition
- Prior art date
Links
- KFQYTPMOWPVWEJ-INIZCTEOSA-N rotigotine Chemical compound CCCN([C@@H]1CC2=CC=CC(O)=C2CC1)CCC1=CC=CS1 KFQYTPMOWPVWEJ-INIZCTEOSA-N 0.000 title claims 20
- 229960003179 rotigotine Drugs 0.000 title claims 20
- 239000012907 medicinal substance Substances 0.000 claims 9
- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 claims 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- 208000035475 disorder Diseases 0.000 claims 4
- 239000008194 pharmaceutical composition Substances 0.000 claims 4
- 229960003638 dopamine Drugs 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 208000001640 Fibromyalgia Diseases 0.000 claims 2
- 208000018737 Parkinson disease Diseases 0.000 claims 2
- 208000005793 Restless legs syndrome Diseases 0.000 claims 2
- 239000013543 active substance Substances 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 230000005855 radiation Effects 0.000 claims 2
- 230000001225 therapeutic effect Effects 0.000 claims 2
- KFQYTPMOWPVWEJ-UHFFFAOYSA-N 6-{propyl[2-(thiophen-2-yl)ethyl]amino}-5,6,7,8-tetrahydronaphthalen-1-ol Chemical compound C1CC2=C(O)C=CC=C2CC1N(CCC)CCC1=CC=CS1 KFQYTPMOWPVWEJ-UHFFFAOYSA-N 0.000 claims 1
- 206010034010 Parkinsonism Diseases 0.000 claims 1
- 238000001237 Raman spectrum Methods 0.000 claims 1
- 238000002083 X-ray spectrum Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 238000000634 powder X-ray diffraction Methods 0.000 claims 1
- 238000001228 spectrum Methods 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D333/00—Heterocyclic compounds containing five-membered rings having one sulfur atom as the only ring hetero atom
- C07D333/02—Heterocyclic compounds containing five-membered rings having one sulfur atom as the only ring hetero atom not condensed with other rings
- C07D333/04—Heterocyclic compounds containing five-membered rings having one sulfur atom as the only ring hetero atom not condensed with other rings not substituted on the ring sulphur atom
- C07D333/06—Heterocyclic compounds containing five-membered rings having one sulfur atom as the only ring hetero atom not condensed with other rings not substituted on the ring sulphur atom with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to the ring carbon atoms
- C07D333/14—Radicals substituted by singly bound hetero atoms other than halogen
- C07D333/20—Radicals substituted by singly bound hetero atoms other than halogen by nitrogen atoms
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Animal Behavior & Ethology (AREA)
- Neurology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Psychology (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Epidemiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Heterocyclic Compounds Containing Sulfur Atoms (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (14)
1. Polimorfni oblik (II) Rotigotina ((-)-5,6,7,8-tetrahidro-6-[propil[2-(2-tienil)etil]-amino]-1-nafthalenol) koji ima najmanje jedno od:
Rendgenski spektar praha koji sadrži pikove pri slijedećim ° 2θ uglovima (± 0.2): 12.04, 13.68, 17.72 i 19.01, mjereno Cu-Kα zračenjem (1.54060 Å);
Raman spektar koji sadrži pikove pri sljedećim valnim brojevima (± 3 cm-1) odabranim od: 226.2, 297.0, 363.9, 710.0, 737.3, 743.3, 750.8, 847.3, 878.3, 1018.7, 1075.6, 1086.2, 1214.3, 1255.1, 1278.2, 1330.7, 1354.3 i 1448.7;
DSC pik sa Tonset na 97°C ± 2°C mjereno pri brzini zagrijavanja od 10 °/min;
točku taljenja na 97°C ± 2°C.
2. Polimorfni oblik Rotigotina koji ima rendgenski spektar difrakcije praha mjeren Cu-Kα zračenjem (1.54060 Å) supstancijalno kao prikazano na Slici 1.
3. Rotigotin ljekovita supstanca koja sadrži najmanje 5% polimorfnog oblika Rotigotina kako je definirano u bilo kojem od patentnih zahtjeva 1-2.
4. Rotigotin ljekovita supstanca koja sadrži najmanje 50% polimorfnog oblika Rotigotina kako je definirano u bilo kojem od patentnih zahtjeva 1-2.
5. Rotigotin ljekovita supstanca koja sadrži najmanje 90% polimorfnog oblika Rotigotina kako je definirano u bilo kojem od patentnih zahtjeva 1-2.
6. Rotigotin ljekovita supstanca koja sadrži najmanje 95% polimorfnog oblika Rotigotina kako je definirano u bilo kojem od patentnih zahtjeva 1-2.
7. Rotigotin ljekovita supstanca prema bilo kojem od patentnih zahtjeva 3-6 za upotrebu kao terapeutski aktivna supstanca.
8. Kristalni polimorf prema bilo kojem od patentnih zahtjeva 1 do 2 za upotrebu kao terapeutski aktivna supstanca.
9. Upotreba polimorfnog oblika Rotigotina kako je definirano u bilo kojem od patentnih zahtjeva 1-2 ili Rotigotin ljekovite supstance prema patentnim zahtjevima 3-6 i najmanje jednog farmaceutski prihvatljivog ekscipijensa u postupku proizvodnje farmaceutskog sastava.
10. Upotreba prema patentnom zahtjevu 9, naznačena time što je farmaceutski sastav u obliku transdermalnog terapeutskog sustava.
11. Metoda za proizvodnju farmaceutskog sastava korištenjem polimorfnog oblika Rotigotina kako je definirano u bilo kojem od patentnih zahtjeva 1-2 ili Rotigotin ljekovite supstance prema zahtjevima 3-6 i najmanje jednog farmaceutski prihvatljivog ekscipijensa.
12. Metoda prema zahtjevu 11, naznačena time da je farmaceutski sastav u obliku transdermalnog terapeutskog sustava.
13. Polimorfni oblik Rotigotina kako je definirano u bilo kojem od patentnih zahtjeva 1-2 ili Rotigotin ljekovita supstanca prema zahtjevima 3-6 za upotrebu u postupku liječenja pacijenta koji pati od poremećaja povezanih sa dopaminom, gdje je spomenuti poremećaj odabran od Parkinsonove Bolesti Parkinsonovog plus sindroma, depresije, fibromijalgije i/ili sindroma nemirnih nogu.
14. Upotreba polimorfnog oblika Rotigotina kako je definirano u bilo kojem od patentnih zahtjeva 1-2 ili Rotigotin ljekovite supstance prema patentnim zahtjevima 3-6 za proizvodnju lijeka za liječenje pacijenta koji pati od poremećaja povezanih sa dopaminom, gdje je sa dopaminom povezani poremećaj odabran od Parkinsonove bolesti, Parkinsonovog plus sindroma, depresije, fibromijalgije i/ili sindroma nemirnih nogu.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US99072107P | 2007-11-28 | 2007-11-28 | |
| EP07121795 | 2007-11-28 | ||
| EP08166576 | 2008-10-14 | ||
| PCT/EP2008/066137 WO2009068520A2 (en) | 2007-11-28 | 2008-11-25 | Polymorphic form of rotigotine |
| EP08853236.1A EP2215072B1 (en) | 2007-11-28 | 2008-11-25 | Polymorphic form of rotigotine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20150956T1 true HRP20150956T1 (hr) | 2016-01-15 |
Family
ID=40676399
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20150956TT HRP20150956T1 (hr) | 2007-11-28 | 2015-09-10 | Polimorfni oblik rotigotina |
Country Status (28)
| Country | Link |
|---|---|
| US (2) | US8592477B2 (hr) |
| EP (1) | EP2215072B1 (hr) |
| JP (1) | JP5391204B2 (hr) |
| KR (1) | KR101694551B1 (hr) |
| CN (1) | CN101970422B (hr) |
| AR (1) | AR070036A1 (hr) |
| AU (1) | AU2008328920B2 (hr) |
| CA (1) | CA2703561C (hr) |
| DK (1) | DK2215072T3 (hr) |
| EA (1) | EA017836B1 (hr) |
| ES (1) | ES2547231T3 (hr) |
| HK (1) | HK1143162A1 (hr) |
| HR (1) | HRP20150956T1 (hr) |
| HU (1) | HUE027647T2 (hr) |
| IL (1) | IL204991A (hr) |
| ME (1) | ME02275B (hr) |
| MX (1) | MX2010005925A (hr) |
| MY (1) | MY165575A (hr) |
| NZ (1) | NZ584363A (hr) |
| PH (1) | PH12013501503A1 (hr) |
| PL (1) | PL2215072T3 (hr) |
| PT (1) | PT2215072E (hr) |
| RS (1) | RS54235B1 (hr) |
| SG (1) | SG10201610626PA (hr) |
| SI (1) | SI2215072T1 (hr) |
| TW (1) | TWI418349B (hr) |
| WO (1) | WO2009068520A2 (hr) |
| ZA (1) | ZA201002192B (hr) |
Families Citing this family (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| DE10041479A1 (de) * | 2000-08-24 | 2002-03-14 | Sanol Arznei Schwarz Gmbh | Neue pharmazeutische Zusammensetzung zur Verabreichung von N-0923 |
| US20030026830A1 (en) * | 2001-05-08 | 2003-02-06 | Thomas Lauterback | Transdermal therapeutic system for parkinson's disease inducing high plasma levels of rotigotine |
| US20030027793A1 (en) * | 2001-05-08 | 2003-02-06 | Thomas Lauterback | Transdermal treatment of parkinson's disease |
| US20040048779A1 (en) * | 2002-05-06 | 2004-03-11 | Erwin Schollmayer | Use of rotigotine for treating the restless leg syndrome |
| US8246979B2 (en) * | 2002-07-30 | 2012-08-21 | Ucb Pharma Gmbh | Transdermal delivery system for the administration of rotigotine |
| 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 |
| US8246980B2 (en) * | 2002-07-30 | 2012-08-21 | Ucb Pharma Gmbh | Transdermal delivery system |
| US8211462B2 (en) * | 2002-07-30 | 2012-07-03 | Ucb Pharma Gmbh | Hot-melt TTS for administering rotigotine |
| DE10261696A1 (de) | 2002-12-30 | 2004-07-15 | Schwarz Pharma Ag | Vorrichtung zur transdermalen Verabreichung von Rotigotin-Base |
| DE10334188B4 (de) * | 2003-07-26 | 2007-07-05 | Schwarz Pharma Ag | Verwendung von Rotigotin zur Behandlung von Depressionen |
| DE10334187A1 (de) * | 2003-07-26 | 2005-03-03 | Schwarz Pharma Ag | Substituierte 2-Aminotetraline zur Behandlung von Depressionen |
| DE10359528A1 (de) * | 2003-12-18 | 2005-07-28 | Schwarz Pharma Ag | (S)-2-N-Propylamino-5-hydroxytetralin als D3-agonistisches Therapeutikum |
| DE10361258A1 (de) * | 2003-12-24 | 2005-07-28 | Schwarz Pharma Ag | Verwendung von substituierten 2-Aminotetralinen zur vorbeugenden Behandlung von Morbus Parkinson |
| US20050197385A1 (en) * | 2004-02-20 | 2005-09-08 | Schwarz Pharma Ag | Use of rotigotine for treatment or prevention of dopaminergic neuron loss |
| DE102004014841B4 (de) * | 2004-03-24 | 2006-07-06 | Schwarz Pharma Ag | Verwendung von Rotigotin zur Behandlung und Prävention des Parkinson-Plus-Syndroms |
| PL1750766T3 (pl) | 2004-05-11 | 2013-12-31 | Eb Ip Lybrido B V | Preparaty farmaceutyczne i ich zastosowania do leczenia zaburzeń seksualnych u kobiet |
| EP1790343A1 (en) | 2005-11-11 | 2007-05-30 | Emotional Brain B.V. | Pharmaceuticals formulations and uses thereof in the treatment of female sexual dysfunction |
| TWI392670B (zh) * | 2006-06-22 | 2013-04-11 | Ucb Pharma Gmbh | 經取代的２-胺基萘滿之於製造用於預防、減緩及／或治療各種類型疼痛之藥物上的用途 |
| EP1925307A1 (en) | 2006-11-03 | 2008-05-28 | Emotional Brain B.V. | Use of 3-alpha-androstanediol in the treatment of sexual dysfunction |
| EP1987815A1 (en) * | 2007-05-04 | 2008-11-05 | Schwarz Pharma Ag | Oronasopharyngeally deliverable pharmaceutical compositions of dopamine agonists for the prevention and/or treatment of restless limb disorders |
| US8344165B2 (en) | 2007-05-30 | 2013-01-01 | Chemagis Ltd. | Crystalline rotigotine base and preparation process therefor |
| NZ584363A (en) | 2007-11-28 | 2012-11-30 | Ucb Pharma Gmbh | Drug formulations of Rotigotine which comprise the thermodynamically stable polymorphic form 2 |
| EP2281559A1 (en) | 2009-06-26 | 2011-02-09 | UCB Pharma GmbH | Pharmaceutical composition comprising rotigotine salts (acid or Na), especially for iontophoresis |
| DE102009052972A1 (de) | 2009-11-12 | 2011-09-15 | Lts Lohmann Therapie-Systeme Ag | Verfahren zur Verhinderung der Kristallisation von Arzneistoffen in einem Polymerfilm |
| EP3257504B1 (en) | 2009-12-22 | 2024-06-19 | UCB Biopharma SRL | Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine |
| WO2012084969A1 (en) | 2010-12-22 | 2012-06-28 | Hexal Ag | Adhesive composition containing rotigotine and transdermal therapeutic system comprising the adhesive composition |
| EP2559435A1 (en) | 2011-08-19 | 2013-02-20 | UCB Pharma GmbH | Rotigotine in the treatment of hemispatial neglect, stroke and deficits following stroke |
| DE102012013439A1 (de) | 2012-07-03 | 2014-01-23 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Transdermales therapeutisches System umfassend Rotigotin und Kristallisationsinhibitor |
| DE102012013421A1 (de) | 2012-07-03 | 2014-01-09 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Transdermales therapeutisches System (TTS) mit Rotigotin |
| WO2013075823A1 (en) | 2011-11-22 | 2013-05-30 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Transdermal therapeutic system comprising rotigotine and crystallization inhibitor |
| 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 |
| WO2014136122A1 (en) * | 2013-03-04 | 2014-09-12 | Mylan Laboratories Limited | Process for the preparation of rotigotine polymorphic form-i |
| BR112015032929B1 (pt) | 2013-07-03 | 2022-08-23 | Lts Lohmann Therapie-Systeme Ag | Sistema terapêutico transdérmico com componente eletrônico e métodos de produção de um sistema terapêutico transdérmico |
| ES2924899T3 (es) | 2014-05-20 | 2022-10-11 | Lts Lohmann Therapie Systeme Ag | Sistema de administración transdérmica que contiene rotigotina |
| 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 |
| WO2015186138A1 (en) * | 2014-06-03 | 2015-12-10 | Davaluri Ramamohan Rao | Improved process for the preparation of crystalline form ii of rotigotine |
| WO2016014242A1 (en) * | 2014-07-21 | 2016-01-28 | Spriaso Llc | Compositions comprising bioreversible derivatives of hydroxy n-substituted-2-aminotetralins, dosage forms, and related methods |
| EP3730129A4 (en) | 2017-12-19 | 2020-12-09 | Hisamitsu Pharmaceutical Co., Inc. | ROTIGOTINE PLASTER |
| KR20210104101A (ko) | 2019-02-15 | 2021-08-24 | 히사미쓰 세이야꾸 가부시키가이샤 | 로티고틴 안정화 방법 |
| PL3854388T3 (pl) | 2020-01-24 | 2024-02-26 | Luye Pharma Switzerland Ag | Transdermalny system terapeutyczny z substancją czynną rotygotyną i co najmniej jednym klejem silikonowym nieodpornym na działanie amin |
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