ГОРДОН Роберт Д. (US),ХОЛЬМ Пер (DK),ЛЕЙДМАНН Анне-Марие (DK)
申请号：
RU2011104205/15
公开号：
RU2011104205A
申请日:
2009.07.07
申请国别(地区):
RU
年份:
2012
代理人:
摘要：
1. An extended release oral dosage form containing tacrolimus or a pharmaceutically active analogue thereof as an active substance for immunosuppressive treatment once a day for a patient in need thereof, where this dosage form releases the active substance over a prolonged period of time determined by the release of greater than 63.5% of the active substance at time 12 hours and a release of at least 8% at time 4 hours as determined by in vitro dissolution and when tested by the dissolution test method USP II (paddle) or the dissolution test USP I (basket) in a medium having a pH of 4.5 and containing 0.005% hydroxypropyl cellulose, and with rotation of 50 rpm. ! 2. An extended release oral dosage form containing tacrolimus or a pharmaceutically active analogue thereof as an active substance for immunosuppressive treatment once a day for a patient in need thereof, where this dosage form releases an active substance with a substantially zero order release profile over a period of a prolonged period of time, determined by the release from a time point of 8 hours to a time point of 15 hours when tested using a dissolution test USP II (blade) sludge dissolution test USP I (basket) in a medium having a pH of 4.5 and containing 0.005% hydroxypropylcellulose, and during rotation of 50 rev / min, the release profile essentially zero order is determined as a linear release profile with a deviation less than ± 15%. ! 3. Sustained-release oral dosage form containing as active1. Пероральная лекарственная форма с пролонгированным высвобождением, содержащая в качестве активного вещества такролимус или его фармацевтически активный аналог, для иммуносупрессивного лечения один раз в сутки пациента, нуждающегося в этом, где эта лекарственная форма высвобождает активное вещество в течение пролонгированного периода времени, определяемого высвобождением самое большее 63,5% от содержания активного вещества в момент времени 12 ч и высвобождением по меньшей мере 8% в момент времени 4 ч пр
