Statistical comparison of high-shear versus low-shear granulation using a common formulation.

Experimental combinations from the ranges assigned to the independent factors were studied using both a low-shear (planetary) mixer and a high-shear mixer for granulation. The independent factors studied were X1 calcium phosphate/mannitol ratio, X2 pregelatinized starch, X3 magnesium stearate, X4 mixer type, and X5 compression pressure. To optimize the tablet properties fully, the experimental range was varied from -2 to +2 experimental units, with the exception of X4, which was assigned -1 for the planetary mixer and +1 for the high-shear mixer. Drug dissolution did not seem to be affected by mixer type, but tablet hardness was affected by mixer type.