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Abstract
This study was an investigation of the use of micronized ethylcellulose in extruded and spheronized beads because of its tremendous surface area, water binding ability, and low tack. The beads contained Avicel PH-101, ETHOCEL* FP Premium (fine particle ethylcellulose), and caffeine. Fine particle ethylcellulose replaced an equal mass of Avicel PH-101 to test its potential as a diluent and spheronizing aid. Beads with >45% fine particle ethylcellulose were immediate release products. Statistical analysis assessed the effects of spheronizer speed, amount of water added, and the fine particle ethylcellulose/Avicel ratio on bead size, friability, and yield. Yield was defined as the percentage of beads in the 12/20 mesh fraction. A three-factor, two-level, screening design with center points was initially employed. Since response curvature was suspected, a face-centered cube design was completed to confirm and isolate the curvature. Graphical optimization identified the factor region over which desired results could be obtained.
