Assessment of formulation factors on the release behaviour of BCS Class II drug from tablet dosage form using DoE.

A model immunosuppressant BCS Class II drug was selected for the work to assess the formulation variables on the release rate using design of experiment (DoE) - Stat-Ease software. Surface solid dispersion was prepared with dichloromethane (DCM) and ethanol mixture (4:1), and converted to tablet by adsorption on a neutral carrier. Different batches were prepared with DoE full factorial design. The concentrations of Polaxamer 188, Kollidon CL and magnesium stearate were found to be the critical factors affecting the performance of the tablets. These parameters were selected as the independent variables in DoE and the formulated batches were evaluated for their percentage release at 120 minutes. The actual and predicted plots fall close to the line. ANOVA (partial sum squares-type-III) reveals the model with F-value of 1417.12 which implies significant. The optimized batch with dissolution profile of 99.6% falls close to the innovator product 98.8%.