Evaluation of a Conical Mill for Screening of Direct Compression Formulations

Abstract

Suitability of a Quadro Comil™ for screening of direct compression tablet masses was evaluated with respect to alteration of particle size distribution and blending efficiency. Air jet sieving was qualijied for determination of a particle size of spraydried lactose and microcrystalline cellulose. Using a full 3¹ × 2³ factorial design not only effects of single processing parameters (output screen size, impeller shape, velocity of the mill, and type of powder), but also their respective combinations were investigated in terms of impact on particle size and flow properties (angle of repose, bulk and tapped densities). Particle sizes before and after passing the Comil were found to be normally distributed. The results indicate that the process does not allow any of the powder characteristics studied beyond normal batch-to batch variability. This refers in particular to the proportion of fines. For evaluation of the deagglomeration effectiveness, a 2³ design was implemented with iron oxide as a model drug. Homogeneity of the blends was determined optically, and after screening twice it was found to be acceptable even with this substance, which has a particularly high agglomeration tendency, high density, and small particle size. The Quadro Comil is therefore regarded as fully suitable for deagglomeration of powders in a gentle and effective manner