Background: The present study deals with the formulation and optimization of piroxicam
fast dissolving tablets and analyzes the impact of an independent variable while selecting the
optimized formulation utilizing Quality by Design (QbD) and Box-Behnken Design (BBD).
Method: Seventeen formulations were prepared by direct compression technique by altering the
proportion of cross carmellose sodium, spray dried lactose and hydro propyl methyl cellulose
(HPMC K4M). The BBD statistical technique was used to optimize formulations and correlate the
relationship among all the variables. Also, the powder mixture characteristics and tablet physiochemical
properties such as hardness, friability, drug content, Disintegration Time (DT) and dissolution
test were determined using 900 ml of 0.1N HCl (pH-1.2) at 37 ± 0.5°C.
Result: Significant quadratic model and second order polynomial equations were established using
BBD. To find out the relationship between variables and responses, 3D response surface and 2D
contour plot was plotted. A perturbation graph was also plotted to identify the deviation of the variables
from the mean point. An optimized formula was prepared based on the predicted response and
the resulting responses were observed to be close with the predicted value.
Conclusion: The optimized formulation with the desired parameter and formulation with variables
and responses can be obtained by BBD and could be used in the large experiment with the involvement
of a large number of variables and responses.