Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, Graz, Austria.
Int J Pharm. 2013 Dec 5;457(2):407-22. doi: 10.1016/j.ijpharm.2013.08.022. Epub 2013 Aug 26.
Coating of tablets is a common unit operation in the pharmaceutical industry. In most cases, the final product must meet strict quality requirements; to meet them, a detailed understanding of the coating process is required. To this end, numerous experiment studies have been performed. However, to acquire a mechanistic understanding, experimental data must be interpreted in the light of mathematical models. In recent years, a combination of analytical modeling and computational simulations enabled deeper insights into the nature of the coating process. This paper presents an overview of modeling and simulation approaches of the coating process, covering various relevant aspects from scale-up considerations to coating mass uniformity investigations and models for drop atomization. The most important analytical and computational concepts are presented and the findings are compared.
片剂包衣是制药行业中常见的单元操作。在大多数情况下,最终产品必须满足严格的质量要求;为了满足这些要求,需要对包衣过程有详细的了解。为此,已经进行了大量的实验研究。然而,为了获得机械理解,必须根据数学模型来解释实验数据。近年来,分析建模和计算模拟的结合使人们能够更深入地了解包衣过程的本质。本文综述了包衣过程的建模和模拟方法,涵盖了从放大考虑到涂层质量均匀性研究以及液滴雾化模型等各个相关方面。介绍了最重要的分析和计算概念,并对研究结果进行了比较。