title: Understanding and predicting bed humidity in fluidized bed granulation.
abstract: 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.
authors: Pharmaceutical Development, Johnson and Johnson Pharmaceutical Research and Development, Welsh and McKean roads, Spring House, Pennsylvania 19477, USA. xhu10@prdus.jnj.com
authors: Xinhui
authors: X
authors: Hu
authors: John
authors: J
authors: Cunningham
authors: Denita
authors: D
authors: Winstead
mesh_terms: D006813:Humidity; D008962:Models, Theoretical; D013678:Technology, Pharmaceutical; D013696:Temperature