QbD Based Development of Novel Self Emulsifying Drug Delivery System of Rosuvastatin

Abstract

Objectives: The present study aims to systematically develop a Self-Emulsifying Drug Delivery System (SMEDDS) of Rosuvastatin using a (QbD) framework. Materials and Methods: The formulation development was initiated by defining the CQAs and QTPP with suitable justification. A statistical mixture design was employed, where Maisine CC, propylene glycol and labrasol, were chosen as independent variables. Emulsification time, transmittance, drug release at 15 min and drug content were found as important CQAs. Eight rosuvastatin self-emulsifying systems were prepared and assessed. The global desirability approach was used for simultaneous optimization. Results: The experimental data showed good fit to the regression models, with high correlation coefficient “R² values ranging from 0.95 to 0.98’’. Among the evaluated responses, transmittance was statistically significant (p<0.05), while other CQAs are not statistically significant (p>0.05). The zeta potential and particle size for optimized formulation were evaluated, which were found to be -38.5 mV and 112.3 nm, respectively. According to in vitro drug release studies, the formulation’s best fit to the korsmeyer-peppas (R²=0.933; n=0.117) suggested Fiskian diffusion. The global Desirability value of 0.7363 indicated good correlation between dependent and independent variables. Conclusion: The QbD-based development of Rosuvastatin SMEDDS successfully identified critical material attributes influencing formulation performance, demonstrating the effectiveness of QbD in building quality into oral drug delivery systems.