ABSTRACT
OBJECTIVE: To investigate the relationship between the process parameters and granulation behavior during high shear granulation process. METHODS: Andrographis extract was utilized as a model drug and mixed with microcryslalline cellulose (MCC) or soluble starch at the ratio of 1:1 by weigh, respectively. The process parameters were selected according to fractional factorial experiment. The granules were prepared by using high shear granulation. The aggregation behavior was evaluated by granule yield and ratio of lumps and fine powder. The effect of process parameters on granulation behavior was analyzed through stepwise regression. Standard least squares regression analysis was used to establish the mathematical model of granule yield. RESULTS: The process parameters had different effects on the granulation behaviors of MCC and starch mixtures. The granule yield predicted by the fitting model was (66.66 ± 3.7)%, and the measured values for MCC and starch mixture were 68.9% and 66.1%, respectively. CONCULSION: The established mathematical model is useful in predicting the performance of materials duing high shear granulation process. Understanding the impact of process parameters on granulation behavior provides the basis of modulating granulation parameters in order to optimize product performance and improve the yield.