释放度检测取样程序对多单元树脂酸右美沙芬片药物释放及放大生产可行性的影响：技术说明
Effect of sampling procedures of release testing on drug release and scale-up production feasibility of multiple-unit dextromethorphan resinate tablets: a technical note.
作者信息
Pongjanyakul Thaned
机构信息
Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand.
出版信息
AAPS PharmSciTech. 2007 Dec 28;8(4):E117. doi: 10.1208/pt0804117.
Abstract
In conclusion, multiple-unit DMP resinate tablets showed a good feasibility for scale-up production for industrial manufacturing. Good physical properties and continuous drug release of the resinate tablets in simulated GI conditions were obtained. Moreover, the variation of drug release from the resinate tablets can be accepted. This study also suggests that a high level of sampling volume and frequency should be conducted in the sampling procedure when using a fixed-volume dissolution apparatus in order to obtain the complete drug release of the resinates.
摘要
总之，多单元的树脂酸酯DMP片剂在工业生产放大规模方面显示出良好的可行性。在模拟胃肠道条件下，树脂酸酯片剂具有良好的物理性质和持续释药性能。此外，树脂酸酯片剂的药物释放差异是可以接受的。本研究还表明，在使用定容溶出装置时，取样过程中应采用较高的取样量和频率，以获得树脂酸盐药物的完全释放。
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本文引用的文献
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