Statistical Comparison of High-Shear Versus Low-Shear Granulation Using a Common Formulation

Abstract

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.

Key Words:

• Granulation mixer
• Optimization