Department of Life Science Engineering, Faculty of New Science and Technology, University of Tehran, Iran.
School of Chemical Engineering, College of Engineering, University of Tehran, Tehran, Iran.
Eur J Pharm Biopharm. 2017 Dec;121:61-72. doi: 10.1016/j.ejpb.2017.09.007. Epub 2017 Sep 22.
A comprehensive model with all effective phenomena in drug release such as diffusion, swelling and erosion was considered. In this work, a mathematical model was developed to describe drug release from controlled release HPMC matrices as a favorable system in pharmaceutical industries. As a novel study, the impact of the MCC presence as a filler in tablet preparation process was considered in the mathematical model. In addition, we found that the volume expansion of these polymeric matrices did not follow the ideal mixing rule and we derived an equation for estimating the volume of hydrated matrix. Furthermore, some equations were derived to estimate the parameters of model (K, D) as well as the change in matrix volume based on the amount of polymer and filler in formulation. This investigation gave deeper insight into underlying drug release mechanisms. According to the results, K increases linearly and D increases exponentially with the increase in the amount of MCC in formulation. Application of this comprehensive mathematical model enables us to predict the behavior of HPMC-MCC based matrices. Furthermore, this model is able to represent the formulation for the desired drug release profile which is useful to design new controlled release matrix as well as improving the system geometry and dimensions of tablets. The presented model was validated by two independent tests: (a) predicting the behavior of matrix with certain MCC/HPMC ratio upon exposure to the release medium; (b) designing formulation of Bupropion hydrochloride extended release tablet.
考虑了一种包含扩散、溶胀和侵蚀等所有有效现象的综合模型。在这项工作中，开发了一个数学模型来描述作为制药工业中有利系统的 HPMC 控释基质中的药物释放。作为一项新颖的研究，考虑了 MCC 作为填充剂存在于片剂制备过程中对数学模型的影响。此外，我们发现这些聚合基质的体积膨胀不符合理想混合规则，我们推导出了一个用于估计水合基质体积的方程。此外，还推导出了一些方程来估计模型（K、D）的参数以及基于配方中聚合物和填充剂的量的基质体积的变化。这项研究深入了解了潜在的药物释放机制。根据结果，K 随配方中 MCC 量的增加呈线性增加，D 随配方中 MCC 量的增加呈指数增加。这种综合数学模型的应用使我们能够预测 HPMC-MCC 基基质的行为。此外，该模型能够代表所需药物释放曲线的配方，这对于设计新的控释基质以及改进片剂的系统几何形状和尺寸非常有用。通过两个独立的测试验证了所提出的模型：（a）预测在释放介质中暴露于特定 MCC/HPMC 比例的基质的行为；（b）设计盐酸安非他酮缓释片的配方。
