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ORALLY-DISINTEGRATING SOLID PREPARATION
专利权人:
ТАКЕДА ФАРМАСЬЮТІКАЛ КОМПАНІ ЛІМІТЕД
发明人:
Курасава Такаші,Ватанабе Ясуко,Омачі Йошіхіро
申请号:
UA201011967
公开号:
UA105628C2
申请日:
2009.03.10
申请国别(地区):
UA
年份:
2014
代理人:
摘要:
The present invention provides an orally-disintegrating solid preparation comprising fine granules showing controlled release of a pharmaceutically active ingredient, which has a coating layer comprising methacrylic acid - methyl acrylate - methyl methacrylate copolymer which has a casting film having an elongation at break of about 100 percent - about 700 percent, wherein the pharmaceutically active ingredient dissolved from the fine granules showing controlled release of the pharmaceutically active ingredient is not more than 10 percent in 2 hours as expressed by the dissolution rate in a pH 1.2 solution, and not more than 5 percent in 1 hour as expressed by the dissolution rate in a pH 6.8 solution, and wherein the fine granules have an average particle size of about 500 im (micometers or microns) or below. Also disclosed is a solid preparation comprising two different fine granules with different release rates which have a coating layer of methacrylic acid - methyl acrylate - methyl methacrylate copolymer. Further disclosed is a method for supressing breakages of fine granules showing controlled release of a pharmaceutically active ingredient which are comprised in an orally-disintegrating tablet obtained by tableting the fine granules and an additive, which method comprises, during production of the tablet, coating the fine granules with a coating layer comprising a methacrylic acid - methyl acrylate - methyl methacrylate copolymer, which has a casting film having an elongation at break of about 100 - about 700 percent.Изобретение касается орально дезинтегрируемой твердой лекарственной формы, содержащей мелкие гранулы, которые имеют средний размер частиц приблизительно 500 мкм или ниже, с контролируемым высвобождением фармацевтически активного ингредиента, который является ингибитором протонной помпы, где мелкие гранулы имеют пленку с контролируемым высвобождением, где пленка с контролируемым высвобождением сформирована на промежуточном слое гранул ядра, которы
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