Study on the Optimization of Fluidized Bed Granulation Processes by Quality Engineering

Abstract

This study aims to understand granulation processes by fluidized bed numerically with Quality Engineering. The author defined a variety of drugs as a noise factor, designed experiment with L9 orthogonal array and conducted a model test.Firstly, the author investigated distribution of drug content, spray liquid ingredient, constituent adherent to the inside of chamber. Secondly the author analyzed the distribution's result with Quality Engineering, and then calculated both sensitivities and signal-to-noise ratios. Finally the author confirmed its repeatability.The results of analyses are as follows ; air volumes of fluidization and sprays are critical factors, which affect varieties of drug content significantly. Quantity of drug collected to filters is not related to drug content, but to control factors and types of drugs. It is necessary to control progress of granulation at the primary particle level in order to adjust contents distribution. In conclusion, numerical understandings of the above mentioned relation allows the author to optimize the distribution of drug contents.