Formulation Design and Optimization of Aceclofenac Tablets (100 mg) Using Central Composite Design with Response Surface Methodology

The aim of study is to develop and optimize aceclofenac tablets using central composite design with response surface methodology (RSM). Immediate-release aceclofenac tablets were prepared through direct compression and were optimized by central composite rotatable design (CCRD) using three variables (Avicel, magnesium stearate, and Acdisol) and five levels (+/- alpha, 0, and +/- 1). Overall, fifteen formulations were generated by Design Expert (R) placing eight formulations on factorial, six on axial and one on centre point rotation. On the basis of powder blend properties, eight formulations (F1, F2, F3, F5, F7, F12, F14, F15) were subjected to compression using single punch machine. Quality attributes of compressed tablets were evaluated using various compendial and non-compendial testings. RSM was used to observe the response variables of weight variation, friability, disintegration and dissolution. F2, F12, and F15 were chosen as optimized formulations due to higher dissolution and assay. Observation of RSM showed that proposed model for all response variables is significant, holding good correlation between predicted and actual values. Aceclofenac tablets are satisfactorily prepared by direct compression using CCRD and RSM is a useful experimental strategy to explore the effect of all test variables on responses.