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KR100761774B1 - 프라미펙솔의 하지 불안 증후군 치료 용도 - Google Patents

프라미펙솔의 하지 불안 증후군 치료 용도 Download PDF

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KR100761774B1
KR100761774B1 KR1020057012562A KR20057012562A KR100761774B1 KR 100761774 B1 KR100761774 B1 KR 100761774B1 KR 1020057012562 A KR1020057012562 A KR 1020057012562A KR 20057012562 A KR20057012562 A KR 20057012562A KR 100761774 B1 KR100761774 B1 KR 100761774B1
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pramipexole
treatment
syndrome
restless legs
legs syndrome
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볼프강 하. 외르텔
디이터 마이어
발타짜르 고메쯔-만실라
자끄 몽플라시
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파마시아 앤드 업존 캄파니 엘엘씨
베링거 잉겔하임 파르마 게엠베하 운트 코 카게
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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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A—HUMAN NECESSITIES
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Abstract

본 발명은 프라미펙솔의 하지 불안 증후군의 치료에 있어서의 용도를 제공한다.
프라미펙솔, 하지 불안 증후군 치료

Description

프라미펙솔의 하지 불안 증후군 치료 용도 {Use of Pramipexole in the Treatment of Restless Legs Syndrome}
본 발명은 프라미펙솔, 또는 2-아미노-6-n-프로필아미노-4,5,6,7-테트라히드로벤조-티아졸, 또는 그의 (-)-에난티오머, 및 제약학적으로 허용되는 그의 염의 하지 불안 증후군의 치료에 있어서의 용도에 관한 것이다.
하지 불안 증후군 (RLS)은 감각 이상, 수면 장해 및 대부분의 경우, 수면중 주기적 사지 운동 (PLMS)이 있는 감각운동신경 장애이다.
프라미펙솔은 도파민-D3/D2 효능제이며, 그의 합성은 유럽 특허 제186 087호 및 그의 대응 미국 특허 제4,886,812호에 기재되어 있다. 프라미펙솔은 주로 정신분열증과 파킨슨 질환 치료용으로 공지되었다. 독일 특허 출원 제DE 38 43 227호에서는 프라미펙솔이 프로락틴의 혈장 농도를 저하시키는 것으로 알려졌다. 또한, 이 유럽 특허 출원에서는 프라미펙솔의 약물 의존증의 치료에 있어서의 용도를 개시하였다. 또한, 독일 특허 출원 제DE 39 33 738호에서는 프라미펙솔이 비정상적으로 높은 수준의 갑상선 자극 호르몬(TSH)을 감소시키기 위해 사용할 수 있는 것 으로 알려져 있다. 미국 특허 제5,112,842호에서는 화합물의 경피 투여 및 이들 활성 화합물을 함유하는 경피계를 개시하였다. 국제 특허 출원 제PCT/EP93/03389호에서는 항우울증약으로서 프라미펙솔을 기재하였고, 한편, 국제 특허 출원 제PCT/US95/15618호에서는 프라미펙솔의 신경 보호 효과를 기술하였다.
놀랍고도 기대치 않게, 본 발명에 이르러 프라미펙솔 및 제약학적으로 허용되는 그의 염이 하지 불안 증후군의 치료에 사용될 수 있음을 발견하기에 이르렀다.
본 발명은 특히 유효량의 프라미펙솔을 투여하는 것을 포함하는 (comprising), 하지 불안 증후군 환자 또는 그러한 질환에 걸리기 쉬운 환자의 하지 불안 증후군 치료 방법을 제공한다. 프라미펙솔은 2-아미노-6-n-프로필아미노-4,5,6,7-테트라히드로벤조티아졸, 그의 (-)-에난티오머, 및 제약학적으로 허용되는 그의 염, 특히, (-)-2-아미노-6-n-프로필아미노-4,5,6,7-테트라히드로벤조티아졸 이염산염(H2O)을 의미한다.
2-아미노-6-n-프로필아미노-4,5,6,7-테트라히드로벤조티아졸, 특히 그의 (-)-에난티오머, 및 제약학적으로 허용되는 그의 산 부가염은 RSL을 치료하기 위해 투여할 수 있다. 종래의 갈레노스(galenic) 제제 형태; 예를 들면, 나정 또는 피복정, 캡슐제, 로젠지제, 분말제, 용액제, 현탁제, 유제, 시럽제, 좌제 등은 본질 적으로 불활성 제약학적 담체 및 유효량의 활성 물질로 이루어진다.
각각 0.088 (0.125), 0.18 (0.25), 0.7 (1.0), 0.88 (1.25) 및 1.1 (1.5) ㎎의 프라미펙솔 베이스(㎎ 프라미펙솔 2HCl)를 함유하고, 부형제로서 만니톨, 옥수수 전분, 콜로리드성 실리카, 폴리비돈 및 스테아르산마그네슘을 추가로 함유하는 정제가 바람직하다.
유효량 범위는 0.001 내지 10.0 ㎎/일이고, 바람직하게는 0.001 내지 6 ㎎/일, 더 바람직하게는 0.01 내지 6 ㎎/일, 특히 바람직하게는 0.75 내지 4.5 ㎎/일이다 (환자 경구). 경구 또는 정맥내 경로로 투여하는 것 외에, 프라미펙솔은 또한 경피 또는 흡입 투여할 수 있다.
투여량은 1일 약 0.264 ㎎ 베이스의 출발 투여량으로 시작한 다음 5 내지 7일 마다 증가시켜 점차 증가시켜야 한다. 환자가 견디기 힘든 부작용을 겪지 않는다면, 투여량은 최대 치료 효과를 얻도록 적정해야 한다.
본 발명은 다음 실시예에 의해 보다 완전히 이해된다.
<실시예>
하지 불안 증후군에 대한 파일럿(pilot) 연구에서, 10명의 환자를 프라미펙솔로 교차 디자인으로 치료하였다. 환자들에게 4주에 걸쳐 1일 1.5 ㎎ 이하의 프라미펙솔을 투여하였다. 첫 번째 치료기 이후, 2주간의 휴지기를 갖고, 추가로 4주간의 치료기를 가졌다.
RLS의 증상은 매우 명백하므로, 치료에 의한 환자의 개선은 관찰자에게 명백하였다.
프라미펙솔 및 제약학적으로 허용되는 그의 염을 사용하여 하지 불안 증후군을 치료할 수 있다.

Claims (3)

  1. 화합물 2-아미노-6-n-프로필아미노-4,5,6,7-테트라히드로벤조티아졸 이염산염 또는 이염산염-수화물 유효량을 포함하는, 하지 불안 증후군 치료용 제약 조성물.
  2. 제1항에 있어서, 화합물의 투여량이 약 0.01 내지 10.0 ㎎/일인 제약 조성물.
  3. 화합물 2-아미노-6-n-프로필아미노-4,5,6,7-테트라히드로벤조티아졸, 그의 (-)-에난티오머, 또는 제약학적으로 허용되는 그의 염 유효량을 포함하는, 하지 불안 증후군 치료용 제약 조성물.
KR1020057012562A 1997-01-17 1998-01-16 프라미펙솔의 하지 불안 증후군 치료 용도 Expired - Lifetime KR100761774B1 (ko)

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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
DE19701619.7 1997-01-17
KR1019997006461A KR20000070234A (ko) 1997-01-17 1998-01-16 프라미펙솔의 하지 불안 증후군 치료 용도

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KR100761774B1 true KR100761774B1 (ko) 2007-10-04

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KR1019997006461A Ceased KR20000070234A (ko) 1997-01-17 1998-01-16 프라미펙솔의 하지 불안 증후군 치료 용도

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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
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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
WO2007045620A1 (de) * 2005-10-18 2007-04-26 Boehringer Ingelheim International Gmbh Verwendung von pramipexol zur behandlung des moderaten bis schweren restless legs syndroms (rls)
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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.

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WO1996018395A1 (en) * 1994-12-15 1996-06-20 Pharmacia & Upjohn Company Use of pramipexole as a neuroprotective agent

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