Optimization of On-Line Automated Dissolution System for Solid Dose Control Release Tablets

Abstract

Abstract ⎯ An optimization of an automated dissolution system for control release tablets has been accomplished by the implementation of several variables using Six Sigma tools. Variables under evaluation includes: filter retention, baselines verification and addition of system suitability parameters. The implementation of the analyzed variables were compare before and after the optimization within 95% confidence interval generating statistically difference between them for three (3) out of four (4) sampling points. Additionally, after the statistical evaluation of the changes the dissolution profiles were evaluated by dissolution similarity factor (f2) test, where the improvements shows an increase of fifteen (15) units against the same test before the implementation of the optimization. Key Terms ⎯ Control Release Tablets, Dissolution profile, UV/VIS Spectroscopy.