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ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ МЕМАНТИНА
专利权人:
ТЕВА ФАРМАСЬЮТИКАЛ ИНДАСТРИЕС ЛТД. (IL)
发明人:
КАГАН Элена (IL),ШАГАР Нитцан (IL),ХАРОНСКИ Элина (IL),ДЕРОЗА Грегг Р. (US)
申请号:
RU2015107517
公开号:
RU2015107517A
申请日:
2013.08.16
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. Solid finished dosage form for modified release oral administration comprising a therapeutically effective amount of memantine or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient for controlling the release rate which is adapted for receiving a patient in need thereof, an interval between doses 5 days or more, 5 days, (c) is characterized by in vivo plasma profile at steady state at a concentration Spriblizitelno 160 ng / ml or less than approx Cbolee itelno 30 ng / ml and AUCbolee than about 14000 ng hr / ml, and / or (d) having a dissolution profile of not more than 45% for 24 hours, no more than 70% for 48 hours, and no more than 80% of 55 chasov.2. The solid formulation according to claim. 1, adapted to receive a patient in need thereof once a nedelyu.3. The solid formulation according to claim. 1, comprising memantine or a pharmaceutically acceptable salt thereof in an amount of at least about 112 mg, at least about 140 mg, at least about 160 mg, at least about 170 mg, or at least about 190 mg.4. The solid formulation according to claim. 1, comprising memantine or a pharmaceutically acceptable salt thereof in an amount of from about 140 to about 190 mg, from about 160 to about 190 mg, from about 170 mg to about 190 mg, or from about 140 to about 200 mg, from about 160 to about 200 mg, from about 170 to about 200 mg or from about 190 to about 200 mg.5. Solid finished dosage form for modified release oral administration, comprising at least
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