Objective: The present work was designed to formulate and optimize Orodispersible tablets of Piroxicam using QbD approach. The central composite design tool was used to evaluate the scientific understanding of input and output variables to construct design space for regulatory flexibility. Methodology: The concentrations of super disintegrants were selected as independent variables. The dependent variables selected were in vitro dispersion time and percentage drug release. The quantitative effect of independent variables at different levels on response variables was predicted using polynomial equations. The model was found to be nonlinear and the curvature effect was significant. Therefore study resorted to composite design for optimization. Results and Discussion: DSC studies indicated drug and excipients were compatible. Precompression parameters indicated fairly good flow properties. Tablets were prepared by direct compression method and all the tablets prepared in the above studies were evaluated for pharmacotechnical properties and were found to be within specified limits. Increase in the concentration of Sodium starch glycolate (SSG), Crospovidone (CP) decreased the in vitro dispersion time and increased percentage drug release. Kinetic studies revealed that drug release from all formulations followed first order release. The relationship between independent variables and dependent variables was further elucidated using contour plots. Based on these plots most economical batch was decided which were in desired range. The statistical model is mathematically valid as the experimental values and predicted values suggested by the full model were relatively close to each other. Conclusion: The results demonstrated the effectiveness of the proposed design for development of Piroxicam orodispersible tablets with optimized properties.
Key words: Piroxicam, Croscarmellose sodium (CCS), Sodium starch glycolate (SSG), Crospovidone (CP), Central composite design.
