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GASTRIC RESISTANT PHARMACEUTICAL OR NUTRICEUTIC COMPOSITION WITH RESISTANCE TO ETHANOL
专利权人:
Эвоник Рем ГмбХ (DE)
发明人:
ШАТТКА Ян Хендрик (DE),МАЙЕР Кристиан (DE),ЮНГ Херберт (DE),КРАХТУС Хеди (DE),ДЕЛЬ РОЗАРИО ФЕРРАНД Джессика (DE)
申请号:
RU2014101230/15
公开号:
RU2014101230A
申请日:
2012.06.12
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A gastro-resistant pharmaceutical or nutraceutical composition that comprises a core containing a pharmaceutical or nutraceutical active ingredient and a gastro-resistant coating layer on the core, the gastro-resistant coating layer containing at least 30 wt.% (Meth) acrylate copolymer containing polymerized units, from 10 to 40% by weight of acrylic or methacrylic acid, from 10 to 80% by weight of C-CI alkyl ester of acrylic or methacrylic acid, and optionally from 0 to 60% by weight of another vinyl monomer whereby the release of the pharmaceutical or nutraceutical ingredient is not more than 10% in vitro at pH 1.2 after 2 hours in USP medium with or without 20% (v / v) ethanol. 2 . The gastric-resistant pharmaceutical or nutraceutical composition according to claim 1, wherein the gastro-resistant coating layer comprises a (meth) acrylate copolymer containing polymerized units from 10 to 40 wt.% Acrylic or methacrylic acid, from 10 to 50 wt.% Ethyl acrylate, 10 to 80% by weight of C-C1-6 alkyl ester of acrylic or methacrylic acid and optionally from 0 to 20% by weight of methyl methacrylate. 3. The gastro-resistant pharmaceutical or nutraceutical composition according to claim 1, wherein the release of the pharmaceutical or nutraceutical active ingredient is at least 50% in vitro at a pH of 6.8 after 45 minutes in a buffer medium according to USP.4. The gastro-resistant pharmaceutical or nutraceutical composition according to claim 1, wherein the (meth) acrylate copolymer has an average glass transition temperature of from 25 to 80 ° C. Gastro-Resist1. Желудочно-резистентная фармацевтическая или нутрицевтическая композиция, которая содержит ядро, содержащее фармацевтический или нутрицевтический активный ингредиент, и на ядре желудочно-резистентный покрывающий слой, причем желудочно-резистентный покрывающий слой содержитпо меньшей мере 30 мас.% (мет)акрилатного сополимера, содержащего полимеризованные звенья,от 10 до 40 мас.% акриловой или метакриловой кислоты,о
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