New Jersey Center for Engineered Particulates and Department of Chemical and Materials Engineering, New Jersey Institute of Technology, 138 Warren St, Newark, New Jersey, 07102, USA.
AAPS PharmSciTech. 2019 Jan 4;20(2):40. doi: 10.1208/s12249-018-1241-7.
Polymer strip film is a promising dosage form for oral delivery of poorly water-soluble drugs. Drying is an important step in the production of polymer strip films with significant effects on critical quality attributes (CQAs). In this study, a custom-made batch drying setup was used to study convective drying kinetics of wet polymer strip films loaded with dry-coated micronized griseofulvin (GF) at various drying conditions. A rate-based semi-empirical model was formulated and parameters were estimated by integral method of analysis using a coupled optimizer-ordinary differential equation solver. Despite its simplicity with three parameters, the model could fit the experimental data very well for all drying conditions, which enabled us to examine the effects of air velocity, temperature, and initial wet film thickness on drying kinetics quantitatively. The modeling results clearly delineate a drying mechanism with constant-rate and falling-rate periods. One set of kinetic parameter estimates reasonably predicted the drying kinetics for two different wet film thicknesses in the selected process conditions, which demonstrates the predictive capability of the model. After reporting the limitations of the semi-empirical model, upon future modification and refinement, its potential use in drying process development and process control was highlighted.
聚合物条带薄膜是一种很有前途的口服传递剂型，可用于传递水中溶解度差的药物。干燥是聚合物条带薄膜生产中的一个重要步骤，对关键质量属性（CQAs）有重大影响。在这项研究中，使用定制的批处理干燥装置，在各种干燥条件下研究了负载有干涂入微粉灰黄霉素（GF）的湿聚合物条带薄膜的对流干燥动力学。制定了基于速率的半经验模型，并通过使用耦合优化器-常微分方程求解器的分析积分方法来估计参数。尽管该模型只有三个参数，但其非常简单，但却可以很好地拟合所有干燥条件下的实验数据，这使我们能够定量地研究空气速度、温度和初始湿膜厚度对干燥动力学的影响。建模结果清楚地描绘了具有恒速和降速期的干燥机理。一组动力学参数估计值合理地预测了所选工艺条件下两种不同湿膜厚度的干燥动力学，这证明了该模型的预测能力。在报告了半经验模型的局限性之后，强调了在未来的修改和完善之后，该模型在干燥工艺开发和过程控制中的潜在用途。
