Hu Xinhui, Cunningham John, Winstead Denita
Pharmaceutical Development, Johnson and Johnson Pharmaceutical Research and Development, Welsh and McKean roads, Spring House, Pennsylvania 19477, USA.
J Pharm Sci. 2008 Apr;97(4):1564-77. doi: 10.1002/jps.21133.
Bed humidity is a critical parameter that needs to be controlled in a fluidized bed granulation to ensure reliability. To predict and control the bed humidity during the fluidized bed granulation process, a simple model based on the mass conservation of moisture was developed. The moisture mass balance model quantitatively simulates the effects of spray rate, binder solution concentration, airflow rate, inlet air temperature, and dew point on the bed humidity. The model was validated by a series of granulations performed in different scale granulators including Glatt GPCG-1, GPCG-15, and GPCG-60. Good agreement was observed between the theoretical prediction and the measured loss on drying (LOD). The model developed in the current work enables us to choose the appropriate parameters for the fluidized bed granulation and can be used as a valuable tool in process scaling-up.
床层湿度是流化床制粒过程中需要控制的关键参数，以确保可靠性。为了预测和控制流化床制粒过程中的床层湿度，基于水分质量守恒建立了一个简单模型。水分质量平衡模型定量模拟了喷雾速率、黏合剂溶液浓度、气流速率、进气温度和露点对床层湿度的影响。该模型通过在不同规模制粒机（包括Glatt GPCG - 1、GPCG - 15和GPCG - 60）中进行的一系列制粒实验进行了验证。理论预测值与干燥失重（LOD）测量值之间观察到良好的一致性。当前工作中开发的模型使我们能够为流化床制粒选择合适的参数，并且可作为工艺放大中的宝贵工具。
