Bead Manufacture by Extrusion/spheronization – a Statistical Design for Process Optimization

Abstract

AbstractOur recent experience in developing bead formulations for a hydrophilic drug using an extrusion/spheronization technique highlighted several critical processing factors. It was observed that the yield of beads of desired size fraction was significantly affected by water level, water temperature, extrusion speed, spheronization speed, and spheronization time. To further elucidate the roles of these factors, a split-plot factorial design was used to evaluate their effects on the yield of desired size beads, and to determine the optimal levels to maximize the yield. Several 18 kg batches of beads were manufactured using a predetermined level of each factor. The finished beads were sieved using #14 and #20 mesh screens and the yields of beads between #14–20 mesh screen were determined. It was observed that the temperature of water used at the granulation stage significantly affected the bead formation. Using room temperature water for granulation, the significant factors were water level, extruder spe...