Abstract

This study evaluated the effects of certain process variables on the properties of tablets prepared from granulations composed of essentially spherical, free-flowing pellets. A complete factorial experimental design was used to indicate the significant main effects and interactions related to water content, extruder speed, extruder screen size, spheronizer speed, and spheronizer residence time on tablet hardness and dissolution rate. This series of experiments demonstrated that changes in process variables, particularly water content, can result in significant differences in the dissolution rate and hardness of tablets composed of 80% drug and 20% binder. The factorial experimental design proved useful in predicting the effects of such changes between the limits producing usable pelletized granulations.

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