发明名称 アリピプラゾールを含む経口固形製剤、及びアリピプラゾールを含む経口固形製剤の製造方法
摘要 An object of the present invention is to provide an oral solid preparation that can be produced in a simpler manner than conventional methods, that exhibits high bioavailability and high dissolubility even in persons having low stomach acid, and that can also ensure dissolubility after being allowed to stand for a certain period of time. Another object is to provide a simple method for producing the oral solid preparation. The present invention relates to an oral solid preparation comprising, as an active ingredient, a finely milled crystal obtained by milling an aripiprazole hydrate crystal, and a pharmaceutically acceptable carrier, the finely milled crystal having a mean particle size of 15 μm or less; an oral solid preparation comprising, as an active ingredient, a finely milled powder obtained by milling a highly hygroscopic aripiprazole anhydrous crystal, and a pharmaceutically acceptable carrier, the finely milled crystal having a mean particle size of 10 μm or less; a method for producing an oral solid preparation comprising the steps of (1) milling an aripiprazole hydrate crystal into a finely milled crystal having a mean particle size of 15 μm or less, and (2) mixing the obtained finely milled crystal with a pharmaceutically acceptable carrier; and a method for producing an oral solid preparation comprising the steps of: (1') milling a highly hygroscopic aripiprazole anhydrous crystal into a finely milled powder having a mean particle size of 10 μm or less; and (2') mixing the obtained finely milled powder with a pharmaceutically acceptable carrier.
申请公布号 JP5931219(B2) 申请公布日期 2016.06.08
申请号 JP20140553001 申请日期 2014.04.18
申请人 大塚製薬株式会社 发明人 吉田 晴加;谷口 俊亮;向井 正志
分类号 A61K31/496;A61K9/16;A61K9/20;A61K9/48;A61P25/28 主分类号 A61K31/496
代理机构 代理人
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