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

Experimental combinations from the ranges assigned to the independent facto rs were studied using both a low-shear (planetary) mixer and a high-shear m ixer for granulation. The independent factors studied were X-1 calcium phos phate/mannitol ratio, X-2 pregelatinized starch, X-3 magnesium stearate, X- 4 mixer type, and X-5 compression pressure. To optimize the tablet properti es fully, the experimental range was varied from -2 to +2 experimental unit s, with the exception of X-4, which was assigned -1 for the planetary mixer and +1 for the high-shear mixer Drug dissolution did not seem to be affect ed by mixer type, but tablet hardness was affected by mixer type.