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ORAL PHARMACEUTICAL TABLET WITH REGULATED MESALAZINE RELEASE AND METHOD FOR ITS PRODUCTION
专利权人:
ЛАБОРАТОРИОС ЛИКОНСА; С.А. (ES)
发明人:
ЛЁХЕС БЛАС Давид (ES),БАРАС ФЕРНАНДЕС-МОЛИНА Роберто (ES),МАРТИНЕС ПЕРЕС Мерседес (ES)
申请号:
RU2013125148/15
公开号:
RU2013125148A
申请日:
2011.12.23
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. An oral pharmaceutical tablet with controlled release of mesalazine or a pharmaceutically acceptable salt thereof as an active ingredient, comprising a core and a gastric juice-resistant outer coating, characterized in that said core contains: i) mesalazine in an amount of from 40 to 90% based on on the total weight of the tablet; and ii) a hydrophilic matrix consisting of hydroxypropyl methyl cellulose (HPMC) having a viscosity of less than 200 mPa · s in a 2% aqueous solution, and hydroxypropyl methyl cellulose (HPMC) having a viscosity of more than 200 mPa · s in a 2% aqueous solution, in a weight ratio of 10: 1 to 1:10, said hydrophilic matrix comprising from 1 to 20% of the total tablet weight; and the fact that said gastric juice resistant outer coating contains: iii) a pH-dependent release polymer, wherein said layer the outer coating is present in quantity from 5 to 25% based on the total weight of the tablet. 2. An oral pharmaceutical tablet according to claim 1, characterized in that mesalazine is present in an amount of from 50 to 90%, preferably from 60 to 80%, based on the total weight of the tablet. An oral pharmaceutical tablet according to claim 1, characterized in that the hydrophilic matrix is present in an amount of from 1 to 15%, preferably from 2 to 10%, and more preferably from 3 to 5%, based on the total weight of the tablet. An oral pharmaceutical tablet according to claim 1, characterized in that the outer coating layer is present in an amount of 10 to 20% based on the total weight of the tablet. Oral pharmaceutical tablet according to claim 1, characterized in that the hydrophilic matrix consists of hydroxypropyl1. Пероральная фармацевтическая таблетка с контролируемым высвобождением месалазина или его фармацевтически приемлемой соли в качестве активного ингредиента, содержащая ядро и устойчивое к действию желудочного сока наружное покрытие, характеризующаяся тем, что указанное ядро содержит:i) месалазин в количестве от 40 до 90% из расч
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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