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Pseudoephedrine -containing formulations particles .

机译:含伪麻黄碱的制剂颗粒。

摘要

PROBLEM TO BE SOLVED: To provide preparation particles composing a pseudoephedrine-mixed sustained release preparation which is dosed as a granule agent or a dispersing agent as it is, is provided as a capsule by encapsulating it in a gelatin hard capsule, has a suitable size without enlarging these preparations when mixed with other excipients, subjected to compression molding and made into a tablet, does not require considerable time in the production thereof, causes elution of pseudoephedrine or a salt thereof to be delayed when applied with film coating, and retains the drug effect of pseudoephedrine over a long period of time directly after dosing by combining with immediately release pseudoephedrine-containing preparation particles, for example preparation particles without being applied with film coating.;SOLUTION: The preparation particle does not include nuclear particles made of only an excipient, includes pseudoephedrine or a salt thereof and the excipient, has a mean particle diameter of 500 to 1,500 μm, has a geometric standard deviation of particle size distribution of 1.4 or less, and has spheroidicity of 0.7 or higher.;COPYRIGHT: (C)2011,JPO&INPIT
机译:解决的问题:提供由伪麻黄碱混合的缓释制剂组成的制剂颗粒,其以颗粒剂或分散剂的形式原样给药,通过将其封装在明胶硬胶囊中而作为胶囊提供,具有合适的尺寸当与其他赋形剂混合,经过压缩成型并制成片剂时,无需扩大这些制剂的制备时间,并不需要花费大量时间,而在涂膜衣剂中延迟伪麻黄碱或其盐的洗脱,并保留了通过与立即释放的含伪麻黄碱的制剂颗粒(例如未涂有膜衣的制剂颗粒)组合使用,可在给药后的很长一段时间内立即对伪麻黄碱产生药物作用;解决方案:制剂颗粒不包括仅由赋形剂,包括伪麻黄碱或其盐,并且该赋形剂具有平均粒径直径为500至1,500μm,颗粒尺寸分布的几何标准偏差为1.4或更小,球度为0.7或更高。版权所有:(C)2011,JPO&INPIT

著录项

  • 公开/公告号JP5668317B2

    专利类型

  • 公开/公告日2015-02-12

    原文格式PDF

  • 申请/专利权人 大正製薬株式会社;

    申请/专利号JP20100095206

  • 发明设计人 浜下 智宏;

    申请日2010-04-16

  • 分类号A61K31/137;A61K47/36;A61K47/26;A61K47/04;A61K47/38;A61K47/32;A61K9/14;A61P11/02;

  • 国家 JP

  • 入库时间 2022-08-21 15:30:18

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