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MESALAZINE TABLET WITH IMPROVED SOLUBILITY
专利权人:
ДИСФАР ИНТЕРНЕШНЛ Б.В. (NL)
发明人:
ДЕ ФЛУИТЕР Хендрик Корнелис (NL)
申请号:
RU2013106945/15
公开号:
RU2013106945A
申请日:
2011.09.01
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A method of manufacturing an enteric-coated mesalazine tablet comprising: (i) granulating a composition containing masalazine, a pharmaceutically acceptable salt or ester thereof, into mesalazine granules; (ii) tabletting a basic composition containing mesalazine granules obtained in step (i), obtaining a tablet core; (iii) coating the tablet core obtained in step (ii) with at least one intermediate layer and an enteric coating; where the tablet core hardness is between 80 and 105N, and the intermediate layer is less than 2% of the total tablet weight. 2. The method according to claim 1, wherein the tablet core hardness is between about 83 and 103N, preferably between 88 and 98N, more preferably between about 90 and about 96N, especially about 92-94N. The method according to claim 1 or 2, wherein the intermediate layer is present in an amount of about 0.1% or more of the total weight of the tablet, preferably about 0.5% or more, and about 2% or less, preferably about 0.5 to about 1.5% and more preferably from about 0.5 to about 0.9%. 4. The method of claim 1 or 2, wherein the intermediate layer does not or substantially does not contain methyl acrylic acid / methyl methacrylate copolymer and / or contains a cellulose derivative and / or polyvinyl pyrrolidone, optionally with a polyol. The method according to claim 1 or 2, in which the tablet releases at least about 80% mesalazine after 40 minutes when measured using a solubility apparatus USP II (paddle method), 100 rpm, pH 7.2 in phosphate buffer, 37 ° C. 6. The method according to claim 1 or 2, in which the tablet releases not less than about 10% mesalazine after 15 minutes when measured using an apparatus for evaluation1. Способ изготовления таблетки месалазина с энтеросолюбильным покрытием, включающий:(i) гранулирование композиции, содержащей масалазин, фармацевтически приемлемую соль или ее эфир, в месалазиновые гранулы;(ii) таблетирование основной композиции, содержащей гранулы месалазина, полученные на ста
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中国工程科技知识中心
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