Page Susanne, Baumann Karl-Heinrich, Kleinebudde Peter
Martin-Luther-University Halle-Wittenberg, Institute of Pharmaceutics and Biopharmaceutics,Wolfgang-Langenbeck-Str 4, D-06120 Halle, Germany.
AAPS PharmSciTech. 2006 May 5;7(2):E43. doi: 10.1208/pt070243.
For the prediction of the air and product temperatures, the product moisture, and the air humidity during a coating process in a Bohle Lab-Coater, a model was developed. The purpose of this work was to determine the limit moisture, the critical moisture, and the constant for the exchange rate between both zones and to use these values for other sets of experiments to test the model. The adaptation of the 3 parameters (limit moisture, critical moisture, and exchange rate constant) was done by calculation of the product temperature in both zones for several sets of parameters in order to minimize the sum of square deviation between the calculated and the measured product temperatures. This set of parameters was used to test the validity of the model. By applying the model, the product temperature could be predicted based on the product, process, and equipment-related parameters. Hence, the model can be used to theoretically investigate the influence of different process parameters. The mean difference between the predicted and measured product temperatures in the steady state is approximately 2 up to 3 K using the determined parameter set for the limit moisture, the critical moisture, and the exchange rate constant. The model is useful for the prediction of the air and product temperatures, the product moisture, and air humidity during a coating process in the Bohle Lab-Coater using round, biconvex tablets.
为了预测Bohle实验室包衣机包衣过程中的空气温度、产品温度、产品水分和空气湿度，开发了一个模型。这项工作的目的是确定极限水分、临界水分以及两个区域之间的交换速率常数，并将这些值用于其他实验集以测试该模型。通过计算几组参数下两个区域的产品温度来调整这三个参数（极限水分、临界水分和交换速率常数），以使计算得到的产品温度与实测产品温度之间的平方偏差之和最小。这组参数用于测试模型的有效性。通过应用该模型，可以根据产品、工艺和设备相关参数预测产品温度。因此，该模型可用于从理论上研究不同工艺参数的影响。使用确定的极限水分、临界水分和交换速率常数参数集，稳态下预测的产品温度与实测产品温度之间的平均差值约为2至3K。该模型对于使用圆形双凸片在Bohle实验室包衣机包衣过程中预测空气温度、产品温度、产品水分和空气湿度很有用。
