Tablet Compression Optimization of Pravastatin Tablets Using Response Surface Methodology with the Box-Behnken Design

This study was done to qualitatively predict the ranges of the tableting attributes required to achieve stable tablet compression with adequate reproducibility. A Box-Behnken design of experiments (DoE) study was used to identify three factors (compression force, and press and feeder speed) in the tableting of pravastatin tablets with reduced weight and size. For a robust compression process, three factors, four responses (hardness, content uniformity, dissolution, and disintegration time), and one center (n = 3) point were listed as critical quality attributes (CQAs) and evaluated by using Design Expert software and analysis of variance. Compression force and feeder speed significantly influenced dissolution and disintegration time (P < 0.05). Press speed was important for content uniformity. These results showed that press (20 rpm) and feeder speed (17-27 rpm), and compression force (4-7.5 kN) produced the optimal reduced weight and size tablet of pravastatin. Thus, the ideal ranges of three factors of tablet compression were successfully identified.