Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; Department of Pharmacology, Martin Luther University Halle-Wittenberg, Halle, Germany.
Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
Eur J Pharm Sci. 2014 Jun 2;56:87-91. doi: 10.1016/j.ejps.2014.02.013. Epub 2014 Mar 5.
A sum of two inverse Gaussian functions is proposed as a highly flexible empirical model for fitting of in vitro dissolution profiles. The model was applied to quantitatively describe theophylline release from effervescent multi-layer coated floating tablets containing different amounts of the anti-tacking agents talc or glyceryl monostearate. Model parameters were estimated by nonlinear regression (mixed-effects modeling). The estimated parameters were used to determine the mean dissolution time, as well as to reconstruct the time course of release rate for each formulation, whereby the fractional release rate can serve as a diagnostic tool for classification of dissolution processes. The approach allows quantification of dissolution behavior and could provide additional insights into the underlying processes.
提出了一个双逆高斯函数的和作为一个非常灵活的经验模型，用于拟合体外溶出曲线。该模型被应用于定量描述茶碱从含有不同量抗粘剂滑石或甘油单硬脂酸酯的泡腾多层包衣漂浮片中的释放。通过非线性回归（混合效应模型）来估计模型参数。利用估计的参数来确定平均溶出时间，以及重建每个配方的释放速率的时间过程，其中分数释放速率可以作为溶解过程分类的诊断工具。该方法可以定量描述溶解行为，并为深入了解潜在过程提供更多信息。
