溶出法研究进展综述

Ashok B. Patel, Avadhi R. Bundheliya, Rushali V. Zala, Amit J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth
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引用次数: 1

摘要

溶出度测试是一种关键的方法;广泛应用于新药品的开发。该试验以其最简单的形式包括将制剂置于含有合适溶解介质的溶解装置中。BCS已成为评估制剂对人、药物口服生物利用度的前瞻性影响的预测工具。当与体外溶出度试验结合使用时,BCS可以保持对体内产品性能和发展的预测。过滤在药物溶出度测试中是至关重要的,因为过滤停止了溶出过程,并允许通过分离溶解和未溶解成分进行准确定量。本研究的目的是确定其他下沉物的形状是否会影响溶解的速率、程度或变异性。通过溶出度试验来研究药物在剂型中的释放和体内性能。溶出度试验用于评定药品批间质量。开发和验证溶出程序,并提供确定方法的特异性,线性,范围,准确度,精密度,LOD, LOQ和鲁棒性的实用方法。
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A Brief Review on Dissolution Method Development
Dissolution testing is a critical methodology; widely utilized in the development of a new pharmaceutical product. The test, in its simplest form, consists of placing the formulation in a dissolution apparatus containing suitable dissolution medium. The BCS has been a predictive tool for assess the prospective effects of formulation on the human, drug oral bioavailability. When used in combination with in vitro dissolution tests, the BCS can maintain the prediction of in vivo product performance and the development. Filtration is critical in drug dissolution testing as filtration stops the dissolution process and allows for accurate quantitation through separation of dissolved and un-dissolved components. The objective of this investigation was to determine if other sinker shapes will influence the rate, extent, or variability of dissolution. Dissolution test is required to study the drug release from the dosage form and its in vivo performance. Dissolution test is used to asses the lot-to-lot quality of drug product. development and validation of dissolution procedure(s) and to provide practical approaches for determining specificity, linearity, range, accuracy, precision, LOD, LOQ and robustness of methods.
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