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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.

DOI:10.1208/pt0804117
PMID:18181538
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2750703/
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

1
Effect of polysulfonate resins and direct compression fillers on multiple-unit sustained-release dextromethorphan resinate tablets.聚磺酸盐树脂和直接压片填充剂对多单元缓释右美沙芬树脂酸盐片的影响。
AAPS PharmSciTech. 2005 Sep 30;6(2):E190-7. doi: 10.1208/pt060228.
2
Dual ambroxal and chlorpheniramine resinate as an alternative carrier in concurrent resinate administration.氨溴索和氯苯那敏树脂酸盐双重制剂作为同时使用树脂酸盐时的替代载体。
Pharmazie. 2003 Mar;58(3):195-9.
3
Use of ion-exchange resins to prepare 100 microm-sized microcapsules with prolonged drug-release by the Wurster process.使用离子交换树脂通过Wurster法制备具有延长药物释放功能的100微米大小的微胶囊。
Int J Pharm. 2001 Mar 23;216(1-2):67-76. doi: 10.1016/s0378-5173(01)00573-7.
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Controlled-release liquid suspensions based on ion-exchange particles entrapped within acrylic microcapsules.基于包裹在丙烯酸微胶囊内的离子交换颗粒的控释液体悬浮液。
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Effect of ion exchange resins on the drug release from matrix tablets.离子交换树脂对基质片剂药物释放的影响。
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Sustained-release drug delivery system I: Coated ion-exchange resin system for phenylpropanolamine and other drugs.缓释药物递送系统I：用于苯丙醇胺及其他药物的包衣离子交换树脂系统。
J Pharm Sci. 1981 Apr;70(4):379-84. doi: 10.1002/jps.2600700409.
8
Polycarboxylic acid ion-exchange resin adsorbates for taste coverage in chewable tablets.用于咀嚼片中味道覆盖的多元羧酸离子交换树脂吸附物
J Pharm Sci. 1971 Oct;60(10):1523-7. doi: 10.1002/jps.2600601018.