Effect of sampling procedures of release testing on drug release and scale-up production feasibility of multiple-unit dextromethorphan resinate tablets: a technical note

释放试验取样程序对右美沙芬树脂多单元片剂药物释放及放大生产可行性的影响:技术说明

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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.

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