OPTIMIZATION OF GRANULATES IN A HIGH-SHEAR MIXER BY MIXTURE DESIGN

Optimization of wet granulation in a 10 litre high shear mixer was exa mined by mixture design. Lactose, com starch and cellulose microcrysta lline were used as eccipients of the granules. Mixing ratios of these eccipients were selected as formulation factors. In addition, the impe ller speed and granulation time was employed as independent process va riables. A two-phase experimental strategy was drawn up: one phase for the percentages of the three eccipients and the other phase for the d etermination of the influence of process variable on geometric mean di ameter. The percentages were studied using a Scheffe simplex-centroid design, and the other phase was examined using a Doehlert experimental matrix.