GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543, Singapore.
Int J Pharm. 2013 Feb 14;442(1-2):65-73. doi: 10.1016/j.ijpharm.2012.09.003. Epub 2012 Sep 7.
The aim of this study was to develop a responsive disintegration test apparatus that is particularly suitable for rapidly disintegrating tablets (RDTs). The designed RDT disintegration apparatus consisted of disintegration compartment, stereomicroscope and high speed video camera. Computational fluid dynamics (CFD) was used to simulate 3 different designs of the compartment and to predict velocity and pressure patterns inside the compartment. The CFD preprocessor established the compartment models and the CFD solver determined the numerical solutions of the governing equations that described disintegration medium flow. Simulation was validated by good agreement between CFD and experimental results. Based on the results, the most suitable disintegration compartment was selected. Six types of commercial RDTs were used and disintegration times of these tablets were determined using the designed RDT disintegration apparatus and the USP disintegration apparatus. The results obtained using the designed apparatus correlated well to those obtained by the USP apparatus. Thus, the applied CFD approach had the potential to predict the fluid hydrodynamics for the design of optimal disintegration apparatus. The designed visiometric liquid jet-mediated disintegration apparatus for RDT provided efficient and precise determination of very short disintegration times of rapidly disintegrating dosage forms.
本研究旨在开发一种特别适用于快速崩解片剂（RDT）的响应式崩解测试仪器。设计的 RDT 崩解仪由崩解室、立体显微镜和高速摄像机组成。计算流体动力学（CFD）用于模拟隔间的 3 种不同设计，并预测隔间内的速度和压力模式。CFD 预处理程序建立了隔间模型，CFD 求解器确定了描述崩解介质流动的控制方程的数值解。通过 CFD 与实验结果的良好一致性验证了模拟的准确性。基于结果，选择了最合适的崩解室。使用了 6 种市售的 RDT，并使用设计的 RDT 崩解仪和 USP 崩解仪测定这些片剂的崩解时间。设计仪器获得的结果与 USP 仪器获得的结果相关性良好。因此，所应用的 CFD 方法有可能预测用于优化崩解仪器设计的流体动力学。用于 RDT 的可视液体射流介导的崩解仪提供了快速崩解剂型非常短崩解时间的高效和精确测定。
