Effect of spheronizer plate design on the spheronization of ketoprofen

Abstract

Spheronization is a rapid process for production of microspheres. The process involves the dry mixing ofdrug with microcrystalline cellulose (MCC), which on subsequent wetting with water forms a plasticmass suitable for extrusion and spheronization. As in any pharmaceutical operation, large number offactors may affect the production of pellets, which can be related to formulation or processing ma-chinery. Among the factors related to spheronizers is the spheronization plate design. This work is aimedat evaluation of the effect of using the radial design and the cross-hatch design on product qualitythrough a factorial experiment using ketoprofen as a model drug. The factors studied were MCC level,spheronizer speed and spheronization time. The evaluation methods included sieving analysis, densityand porosity measurements, shape analysis, and dissolution testing. Preliminary experiments revealedthat MCC level is of great significance on pellets yield. Also, all the produced pellets were of acceptablesphericity score. The factorial experiments showed that an increase of pellets yield of desired size can beobtained when using the radial design of friction plate, while no significant changes were foundregarding density, porosity and dissolution rate