SI20060A - Uporaba pramipeksola v zdravljenju sindroma nemirnih nog - Google Patents
Uporaba pramipeksola v zdravljenju sindroma nemirnih nog Download PDFInfo
- Publication number
- SI20060A SI20060A SI9820013A SI9820013A SI20060A SI 20060 A SI20060 A SI 20060A SI 9820013 A SI9820013 A SI 9820013A SI 9820013 A SI9820013 A SI 9820013A SI 20060 A SI20060 A SI 20060A
- Authority
- SI
- Slovenia
- Prior art keywords
- pramipexole
- treatment
- restless legs
- amino
- pharmacologically acceptable
- Prior art date
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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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/428—Thiazoles condensed with carbocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular 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
-
- 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
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- 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
- A61P25/20—Hypnotics; Sedatives
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Epidemiology (AREA)
- Anesthesiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Psychology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Thiazole And Isothizaole Compounds (AREA)
- Medicinal Preparation (AREA)
- Semiconductor Memories (AREA)
- Liquid Crystal Substances (AREA)
Abstract
Predloženi izum zagotavlja uporabo pramipeksola v zdravljenju sindroma nemirnih nog.ŕ
Description
Področje izuma
Predloženi izum se nanaša na uporabo pramipeksola ali 2-amino-6-n-propilamino4,5,6,7-tetrahidrobenzo-tiazola ali njegovih (-)-enantiomerov in njegovih farmakološko sprejemljivih soli v zdravljenu sindroma nemirnih nog.
Ozadje izuma
Sindrom nemirnih nog (RLS - restless leg syndrome) je nevrosenzorimotoma motnja z parestetezijami, motnjami spanja in, v večini primerov, periodičnimi gibi uda v spanju (PLMS - periodic limb movements of sleep).
Pramipeksol je dopaminski-D3/D2 agonist, sinteza katerega je opisana v evropskem patentu 186 087 in njegovem paralelnem US patentu 4,886,812. Predvsem je znan za zdravljenje shizofrenije in Parkinsonove bolezni. Iz nemške patentne prijave DE 38 43 227 je znano, da pramipeksol znižuje plazemski nivo prolaktina. Ta evropska patentna prijava opisuje tudi uporabo pramipeksola v zdravljenju odvisnosti od mamil. Nadalje je iz nemške patentne prijave DE 39 33 738 znano, da se lahko pramipeksol uporablja za znižanje abnormalno visokih nivojev ščitnico stimulirajoČega hormona (TSH - thyroid stimulating hormone). US patent 5,112,842 opisuje transdermalno dajanje spojin in transdermalne sisteme, ki vsebujejo te aktivne spojine. WO patentna prijava PCT/EP 93/03389 opisuje pramipeksol kot antidepresivno sredstvo, medtem ko PCT prijava PCT/US 95/15618 opisuje nevroprotektivne učinke pramipeksola.
Presenetljivo in nepričakovano smo ugotovili, da lahko pramipeksol in njegove farmakološko sprejemljive soli uporabimo v zdravljenju sindroma nemirnih nog.
Povzetek izuma
Predloženi izum še zlasti zagotavlja postopek za zdravljenje sindroma nemirnih nog pri pacientu, ki trpi zaradi takšnega stanja ali je zanj občutljiv, ki obsega dajanje učinkovite količine pramipeksola. S pramipeksolom mislimo 2-amino-6-npropilamino-4,5,6,7-tetrahidrobenzotiazol, njegov (-)-enantiomer in njegove farmakološko sprejemljive soli, še zlasti (-)-2-amino-6-n-propilamino-4,5,6,7tetrahidrobenzotiazol dihidroklorid (H2O).
2-Amino-6-n-propilamino-4,5,6,7-tetrahidrobenzotiazol, še zlasti njegov (-)-enantiomer in njegove farmakološko sprejemljive kislinske adicijske soli lahko dajemo za zdravljenje RSL. Oblika konvencionalnih galenskih pripravkov v bistvu sestoji iz inertnega farmacevtskega nosilca in učinkovite doze aktivne substance; npr. navadne in obložene tablete, kapsule, pastile, praški, raztopine, suspenzije, emulzije, sirupi, svečke itd.
Prednostne so tablete, ki obsegajo 0,88 (0,125), 0,18 (0,25), 0,7 (1,0), 0,88 (1,25) oziroma 1,1 (1,5) mg pramipeksolne baze (mg pramipeksola 2HC1) in ki nadalje kot ekscipiente obsegajo manitol, koruzni škrob, koloidni silicijev dioksid, polividon in magnezijev stearat.
Učinkovito dozirno območje je 0,001 do 10,0 mg/dan in pacienta, prednostno med 0,001 in 6, bolj prednostno med 0,01 do 6 in še zlasti prednostno med 0,75 in
4,5 mg/dan in pacienta p.o.. Poleg tega, da pramipeksol dajemo po oralni ali intravenski poti, ga lahko dajemo tudi transdermalno ali z inhalacijo.
Doze moramo poviševati postopoma od začetne doze okoli 0,264 mg baze na dan. katero nato povišujemo vsakih 5-7 dni. Pod pogojem, da pacienti nimajo nesprejemljivih stranskih učinkov, moramo za doseganje maksimalnega terapevtskega učinka dozo titrirati.
Opis prednostnih izvedb
Predloženi izum je bolj popolno ponazorjen s spodaj podanimi primeri:
V pilotski študiji sindroma nemirnih nog smo v navzkrižnem dizajnu 10 pacientov obdelali s pramipeksolom. Pacienti so prejeli do 1,5 mg pramipeksola na dan v obdobju 4 tednov. Prvemu obdobju zdravljenja je sledilo dvotedensko obdobje spiranja in dodatno 4-tedensko obdobje zdravljenja.
Ker so simptomi RLS dokaj očitni, je bilo njihovo izboljšanje vsled zdravljenja raziskovalcu očitno.
Claims (3)
- Patentni zahtevki1. Uporaba 2-amino-6-n-propilamino-4,5,6,7-tetrahidrobenzotiazola, njegovega (-)-enantiomera ali njegove farmakološko sprejemljive soli za pripravo zdravila za zdravljenje sindroma nemirnih nog pri pacientu, ki trpi zaradi takšega stanja ali je zanj občutljiv.
- 2. Uporaba po zahtevku 1, kjer je spojina pramipeksol, njegov dihidroklorid ali njegov dihidroklorid-(H2O).
- 3. Uporaba po zahtevku 2, kjer je doza pramipeksola okoli 0,01 - 10,0 mg/dan.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19701619A DE19701619B4 (de) | 1997-01-17 | 1997-01-17 | Verwendung von Pramipexol zur Behandlung des restless legs syndroms |
| PCT/US1998/000216 WO1998031362A1 (en) | 1997-01-17 | 1998-01-16 | Use of pramipexole in the treatment of restless legs syndrome |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI20060A true SI20060A (sl) | 2000-04-30 |
Family
ID=7817708
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI9820013A SI20060A (sl) | 1997-01-17 | 1998-01-16 | Uporaba pramipeksola v zdravljenju sindroma nemirnih nog |
Country Status (23)
| Country | Link |
|---|---|
| EP (1) | EP0989850B1 (sl) |
| JP (2) | JP4406685B2 (sl) |
| KR (2) | KR100761774B1 (sl) |
| CN (1) | CN1117564C (sl) |
| AT (1) | ATE281165T1 (sl) |
| AU (1) | AU723119B2 (sl) |
| BG (1) | BG64614B1 (sl) |
| CA (1) | CA2275379C (sl) |
| CZ (1) | CZ289863B6 (sl) |
| DE (2) | DE19701619B4 (sl) |
| ES (1) | ES2231959T3 (sl) |
| FI (1) | FI120135B (sl) |
| HU (1) | HU226564B1 (sl) |
| NO (1) | NO321151B1 (sl) |
| NZ (2) | NZ510007A (sl) |
| PL (1) | PL190898B1 (sl) |
| PT (1) | PT989850E (sl) |
| RO (1) | RO120757B1 (sl) |
| RU (1) | RU2192252C2 (sl) |
| SI (1) | SI20060A (sl) |
| SK (1) | SK284264B6 (sl) |
| WO (1) | WO1998031362A1 (sl) |
| ZA (1) | ZA98420B (sl) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19701619B4 (de) * | 1997-01-17 | 2007-10-11 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verwendung von Pramipexol zur Behandlung des restless legs syndroms |
| US6001861A (en) * | 1998-01-16 | 1999-12-14 | Pharmacia & Upjohn Company | Use of pramipexole in the treatment of restless legs syndrome |
| SE9803760D0 (sv) * | 1998-11-04 | 1998-11-04 | Jan Hedner | Sätt att behandla och diagnostisera syndromet restless legs och motsvarande medel |
| DE19938825A1 (de) * | 1999-08-19 | 2001-04-26 | Boehringer Ingelheim Pharma | Wirkstoffkombination mit Clonidin |
| DE10220230A1 (de) * | 2002-05-06 | 2003-11-27 | Sanol Arznei Schwarz Gmbh | Verwendung von Rotigotine zur Behandlung des Restless Leg Syndroms |
| EP1588704A1 (en) * | 2004-04-22 | 2005-10-26 | Newron Pharmaceuticals S.p.A. | Alpha-aminoamide derivatives useful in the treatment of restless legs syndrome and addictive disorders |
| JP2009511618A (ja) * | 2005-10-18 | 2009-03-19 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 中度から重度のむずむず脚症候群（ｒｌｓ）を治療するためのプラミペキソールの使用 |
| WO2007117431A2 (en) * | 2006-04-03 | 2007-10-18 | Teva Pharmaceutical Industries, Ltd. | Use of rasagiline for the treatment of restless legs syndrome |
| TR200906997A1 (tr) | 2009-09-11 | 2011-03-21 | Sanovel �La� San. Ve T�C. A. �. | Pramipeksol farmasötik bileşimleri. |
| TR200907554A1 (tr) | 2009-10-06 | 2011-04-21 | Sanovel İlaç San.Ve Ti̇c.A.Ş. | Oral yolla dağılan pramıpexole bileşimleri. |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3572485D1 (en) * | 1984-12-22 | 1989-09-28 | Thomae Gmbh Dr K | Tetrahydro-benzothiazoles, their production and their use as intermediates or drugs |
| DE3843227A1 (de) * | 1988-12-22 | 1990-07-05 | Boehringer Ingelheim Kg | Neue verwendung von 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzthiazol |
| DE3933738A1 (de) * | 1989-10-10 | 1991-04-11 | Boehringer Ingelheim Kg | Neue verwendung von 2-aminothiazol-derivaten (tsh) |
| DE3937271A1 (de) * | 1989-11-09 | 1991-05-16 | Boehringer Ingelheim Kg | Transdermale applikation von 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazol |
| DE4125446A1 (de) * | 1991-08-01 | 1993-02-04 | Uwe Dipl Ing Behmann | Verfahren und einrichtung zur elektrischen kurzschlusspruefung und -ortung fuer leitungen, insbesondere fuer fahrleitungen elektrischer bahnen |
| US5598352A (en) * | 1994-09-30 | 1997-01-28 | Cirrus Logic, Inc. | Method and apparatus for audio and video synchronizing in MPEG playback systems |
| US5650420A (en) * | 1994-12-15 | 1997-07-22 | Pharmacia & Upjohn Company | Pramipexole as a neuroprotective agent |
| DE19701619B4 (de) * | 1997-01-17 | 2007-10-11 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verwendung von Pramipexol zur Behandlung des restless legs syndroms |
-
1997
- 1997-01-17 DE DE19701619A patent/DE19701619B4/de not_active Expired - Lifetime
-
1998
- 1998-01-16 DE DE69827387T patent/DE69827387T2/de not_active Expired - Lifetime
- 1998-01-16 PT PT98903378T patent/PT989850E/pt unknown
- 1998-01-16 SK SK920-99A patent/SK284264B6/sk not_active IP Right Cessation
- 1998-01-16 SI SI9820013A patent/SI20060A/sl active Search and Examination
- 1998-01-16 CA CA002275379A patent/CA2275379C/en not_active Expired - Lifetime
- 1998-01-16 CN CN98801721A patent/CN1117564C/zh not_active Expired - Lifetime
- 1998-01-16 EP EP98903378A patent/EP0989850B1/en not_active Expired - Lifetime
- 1998-01-16 AT AT98903378T patent/ATE281165T1/de active
- 1998-01-16 NZ NZ510007A patent/NZ510007A/en not_active IP Right Cessation
- 1998-01-16 ES ES98903378T patent/ES2231959T3/es not_active Expired - Lifetime
- 1998-01-16 KR KR1020057012562A patent/KR100761774B1/ko not_active Expired - Lifetime
- 1998-01-16 WO PCT/US1998/000216 patent/WO1998031362A1/en not_active Ceased
- 1998-01-16 CZ CZ19992478A patent/CZ289863B6/cs not_active IP Right Cessation
- 1998-01-16 HU HU0001913A patent/HU226564B1/hu unknown
- 1998-01-16 JP JP53336998A patent/JP4406685B2/ja not_active Expired - Lifetime
- 1998-01-16 NZ NZ336804A patent/NZ336804A/xx not_active IP Right Cessation
- 1998-01-16 RU RU99118211/14A patent/RU2192252C2/ru active
- 1998-01-16 KR KR1019997006461A patent/KR20000070234A/ko not_active Ceased
- 1998-01-16 RO RO99-00818A patent/RO120757B1/ro unknown
- 1998-01-16 PL PL334498A patent/PL190898B1/pl unknown
- 1998-01-16 AU AU60168/98A patent/AU723119B2/en not_active Expired
- 1998-01-19 ZA ZA9800420A patent/ZA98420B/xx unknown
-
1999
- 1999-07-01 BG BG103543A patent/BG64614B1/bg unknown
- 1999-07-07 NO NO19993360A patent/NO321151B1/no not_active IP Right Cessation
- 1999-07-16 FI FI991616A patent/FI120135B/fi not_active IP Right Cessation
-
2008
- 2008-10-22 JP JP2008272286A patent/JP2009062388A/ja active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| IF | Valid on the event date | ||
| OU01 | Decison according to article 73(1) ipa 1992, publication of decision on fulfilment of conditions on patentability |
Effective date: 20061218 |
|
| SP73 | Change of data on owner |
Owner name: PHARMACIA & UPJOHN COMPANY LLC; DE Effective date: 20071025 |
|
| SP73 | Change of data on owner |
Owner name: BOEHRINGER INGELHEIM PHARMA GMBH & CO KG; DE Effective date: 20090820 |