Yeom Su Bin, Ha Eun-Sol, Kim Min-Soo, Jeong Seong Hoon, Hwang Sung-Joo, Choi Du Hyung
Department of Pharmaceutical Engineering, Inje University, Gyeongnam 621-749, Korea.
College of Pharmacy, Pusan National University, Busandaehak-ro 63 beon-gil, Geumjeong-gu, Busan 46241, Korea.
Pharmaceutics. 2019 Aug 15;11(8):414. doi: 10.3390/pharmaceutics11080414.
Process simulation using mathematical modeling tools is becoming more common in the pharmaceutical industry. A mechanistic model is a mathematical modeling tool that can enhance process understanding, reduce experimentation cost and improve product quality. A commonly used mechanistic modeling approach for powder is the discrete element method (DEM). Most pharmaceutical materials have powder or granular material. Therefore, DEM might be widely applied in the pharmaceutical industry. This review focused on the basic elements of DEM and its implementations in pharmaceutical manufacturing simulation. Contact models and input parameters are essential elements in DEM simulation. Contact models computed contact forces acting on the particle-particle and particle-geometry interactions. Input parameters were divided into two types-material properties and interaction parameters. Various calibration methods were presented to define the interaction parameters of pharmaceutical materials. Several applications of DEM simulation in pharmaceutical manufacturing processes, such as milling, blending, granulation and coating, were categorized and summarized. Based on this review, DEM simulation might provide a systematic process understanding and process control to ensure the quality of a drug product.
使用数学建模工具进行过程模拟在制药行业正变得越来越普遍。机理模型是一种数学建模工具，它可以增强对过程的理解、降低实验成本并提高产品质量。一种常用的用于粉末的机理建模方法是离散元法（DEM）。大多数药物材料都有粉末或颗粒状物质。因此，离散元法可能会在制药行业中得到广泛应用。本综述聚焦于离散元法的基本要素及其在制药制造模拟中的应用。接触模型和输入参数是离散元法模拟中的关键要素。接触模型计算作用于颗粒 - 颗粒和颗粒 - 几何相互作用的接触力。输入参数分为两类——材料属性和相互作用参数。介绍了各种校准方法来定义药物材料的相互作用参数。对离散元法模拟在制药制造过程中的几种应用，如研磨、混合、制粒和包衣进行了分类和总结。基于此综述，离散元法模拟可能会提供系统的过程理解和过程控制，以确保药品质量。
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