Quality by Design Based Optimization and Development of Cyclodextrin Inclusion Complexes of Quercetin for Solubility Enhancement

The purpose of the current work was to enhance the solubility of Quercetin (QUE) by developing inclusion complexes. The current research focused on preparing ternary cyclodextrin inclusion complexes of Quercetin (ICQs) with tween-80 as surfactant employing quality by the design tool. The concentration of hydroxypropyl-β-cyclodextrin, tween-80, and preparation method was taken as critical process parameters and evaluated to get the final product with desired solubility and dissolution rate as the responses. The central composite design was used for the systemic development of ICQs. The % yield and drug content of the prepared ICQs were found to be greater than 90% & 98%, respectively. X-ray diffraction and differential scanning calorimetry results showed the QUE was converted into an amorphous form after the formulation of ICQs. Improved solubility and dissolution rate was observed for the prepared ICQs than pure drug. The design method was optimized, and design validation studies were also performed. All the factors significantly influenced both solubility and dissolution at p < 0.05. Based on the suggested combinations by overlay plot of graphical optimization, a new formulation was developed and evaluated for solubility and dissolution, which were impressively increased from pure QUE.