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首页> 外文期刊>European journal of drug metabolism and pharmacokinetics >Convolution and validation of in vitro-in vivo correlation of water-insoluble sustained-release drug (domperidone) by first-order pharmacokinetic one-compartmental model fitting equation
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Convolution and validation of in vitro-in vivo correlation of water-insoluble sustained-release drug (domperidone) by first-order pharmacokinetic one-compartmental model fitting equation

机译：一阶药代动力学一室模型拟合方程对水不溶性缓释药物（多潘立酮）体内外相关性的卷积和验证

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摘要

The experimental study presents a brief and comprehensive perspective on the methods of developing a Level A in vitro-in vivo correlation (IVIVC) for extended oral dosage forms of water-insoluble drug domperidone. The study also evaluates the validity and predictability of in vitro-in vivo correlation using the convolution technique by one-compartmental first-order kinetic equation. The IVIVC can be substituted as a surrogate for in vivo bioavailability study for the documentation of bioequivalence studies as mandatory from any regulatory authorities. The in vitro drug release studies for different formulations (fast, moderate, slow) were conducted in different dissolution mediums. The f (2) metric (similarity factor) was used to analyze the dissolution data for determination of the most discriminating dissolution method. The in vivo pharmacokinetics parameters of all the formulations were determined by using liquid chromatography mass spectrometry (LC/MS) methods. The absorption rate constant and percentage of absorption of drugs at different time intervals were calculated by using data convolution. In vitro drug release and in vivo absorption correlation were found to be a linear correlation model, which was developed by using percent absorbed drug release versus percent drug dissolved from the three formulations. Internal and external validation was performed to validate the IVIVC. Predicted domperidone concentrations were obtained by convolution technique using first-order one-compartmental fitting equation. Prediction errors estimated for C (max) and AUC (0-infinity) were found to be within the limit.
机译：实验研究对开发用于水不溶性药物多潘立酮的扩展口服剂型的A级体外-体内相关性（IVIVC）的方法提供了简要而全面的观点。该研究还通过一室一阶动力学方程使用卷积技术评估了体内外相关性的有效性和可预测性。 IVIVC可以代替体内生物利用度研究的替代品，以代替任何监管机构强制进行的生物等效性研究的文献记录。在不同的溶出介质中进行了不同制剂（快，中，慢）的体外药物释放研究。 f（2）度量（相似因子）用于分析溶出度数据，以确定最区分的溶出方法。通过使用液相色谱质谱法（LC / MS）确定所有制剂的体内药代动力学参数。通过数据卷积计算出在不同时间间隔的吸收速率常数和药物的吸收百分比。发现体外药物释放和体内吸收相关性是线性相关模型，其是通过使用吸收的药物释放百分率与三种制剂中溶解的药物百分率建立的。执行内部和外部验证以验证IVIVC。通过卷积技术使用一阶单室拟合方程获得了预测的多潘立酮浓度。发现C（max）和AUC（0-infinity）的预测误差在限制范围内。

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