Abstract

In planetary centrifugal wet granulation, the binder is often mixed into the formulation as a powder, followed by the addition of a wetting liquid, in a single step. Therefore, the amount and dispersion of the wetting liquid are important factors that determining granulation success and granules characteristics. In this study, granulation experiments, according to the Box-Behnken design, were performed. Further, the effects of equipment parameters, namely, processing speed, processing time, and vessel size, on the minimum amount of wetting liquid required to enable granulation and dispersion state in the vessel were statistically analyzed. Placebo granules were formulated with lactose hydrate and corn starch (7 : 3), using sodium carmellose as a binder. Results showed that the amount of wetting liquid decreased with increase in processing speed, processing time, and vessel size; however, the dispersion state of the wetting liquid was not significantly affected. Analysis of the effects of the equipment parameters on granule characteristics showed that a larger vessel size was proportional to a larger median diameter and smaller particle-size distribution width (span), and a faster processing speed was proportional to a smaller span. Furthermore, granules with the target properties could be prepared according to the parameters estimated from the model. In conclusion, the equipment parameters for controlling the amount of wetting liquid, which affected the granule properties, were clarified.

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