Implementation of Quality by Design approach for Development of Optimized Drug Delivery System of Antidepressant Drug

Abstract

The work presented aimed to implement of “Quality by Design” (QbD) approach to develop optimized fast dissolving tablet (FDT) of Fluoxentine. A face centered Central composite design was employed to develop optimized dosage form. FDTs were prepared by direct compression followed using sublimation technique with additive effect of super disintegrants. Impact of independent variables such as concentration of super-disintegrant and sublimating agent was determined on dependent variables i.e. wetting time, disintegration time and drug release. Data optimization was done by developing validation check batches as well as overlay plot developed by statistical software. Optimized formulation shows 18.08 s wetting time (WT), 19.84 s disintegration time (DT) and the drug release was found to be 85.82 % in 5 m. The accelerated stability studies for optimized FDTs shows no significant changes during one month stability studies. In conclusion, the optimized fast dissolving tablets for Fluoxentine was successfully developed employing by QbD approach with least utilization of man, money and efforts.