THE OPTIMIZATION OF THE FORMULATION AND PRODUCTION BY EXTRUSION-SPHERONIZATION OF INERT PELLETS BASED ON MICROCRYSTALINE CELULOSE AND LACTOSE

The "design of experiment" approach to the manufacture of a product allows thesimultaneous study of formulation and process variables that significantly influence the quality of a finished product, by performing only a limited number of experiments. The aim of this study was to use design of experiment in order to optimize the laboratoryscale production by extrusion-spheronization of inert pellet cores consisting of a completely biodegradable, binary mixture of microcrystalline cellulose (MCC) and lactose (L). We have established the exact proportion of MCC, L and binder solution (a 2.5 % solution of polyvinylpyrrolidone, Kollidon K29/32 in water) and process variables (spheronization time and speed) required for the production of pellets with desired, known, preset characteristics, such as size distribution, circularity and flow behavior