Scale-up feasibility in high-shear mixers: Determination through statistical procedures

The wet granulation scale-tip of a formulation exhibiting plastic deformati on behavior under compression was examined. Through experimental factorial design, the effect of solution level, mixing time, and mixer speed on granu lation properties was investigated. Measurements of mean particle size, tap ped density, bulk density, Carr's index, coarse-to-fine ratio, cumulative p ercentage, and flow rate were taken and compared among granulations. In add ition, comparisons were done on the hardness of tablets made from the formu lations. It was shown that the characteristics of the granulations made tin der different conditions were highly reproducible. The excipient system of microcrystalline cellulose and pregel starch was shown to be a very robust formulation that is resistant to changes in the scaling-tip process in high -shear mixers.