Formulation Design and Optimization of Hydrophilic Matrix Based Sustained Release Tablet of Clarithromycin Using a Design of Experiment (DoE)

A well-defined and strictly controlled dissolution rate plays vital role in optimization of sustained release dosage form. For this purpose, a computer optimized technique, based on response surface methodology (RSM) utilizing quadratic equation factorial design has been widely used for designing different pharmaceutical formulations, which requires smaller number experimental runs is less time consuming than conventional formulation methods. The aim the present study was to evaluate once daily clarithromycin tablet, using two molecular weight grades hydrophilic polymers, i.e. Methocel® K15M CR K100M as retarding materials, Design Experiment (DoE) approach. tablets were manufactured by 32 full polynomial where both polymers independent variables, along with other requisite excipients. cumulative percentages drug released at 2, 12 24 hr selected dependent variables restricted 0-20%, 45-70%, 80-100%, respectively. Regression analyses performed ExpertÒ software found that pattern from matrix followed non-linear model 2 12hrs but 24hrs, linear. From overlay plot, one among proposed prepared practically further investigation then evaluated physical biopharmaceutical properties. predicted error observed vitro studies be -0.57, -1.78 0.49% 24hr, Finally, modelling data suggested that, Higuchi anomalous/non-Fickian type mechanism.