QUALITY BY DESIGN (QBD) FORMULATION, DEVELOPMENT AND OPTIMIZATION OF POLYMERIC NANOSPONGES GEL CONTAINING BETA SITOSTEROL FOR TOPICALLY DELIVERY BOX-BEHNKEN DESIGN APPROACH
Bhumika Kshetrapal, Kaushelendra Mishra, Kajal Sharma, Mehta Parulben D.
ABSTRACT
The aim of this study was to develop and optimize a polymeric nanosponges gel formulation containing Beta-sitosterol for topical delivery using the Box-Behnken design. Beta-sitosterol was characterized for its organoleptic properties, solubility, pH, and melting point. The nanosponges were prepared by the inclusion complexation method using Beta-cyclodextrin (?-CD) as a polymer and diphenyl carbonate (DPC) as a crosslinker. Various formulation parameters such as polymer concentration, crosslinker concentration, stirring time, and drug loading were optimized. The particle size and entrapment efficiency were analyzed, and the optimized formulation exhibited a particle size of 321.5 nm and an entrapment efficiency of 94.6%. The release kinetics study revealed a zero-order release pattern, ensuring sustained drug release. The formulation was further evaluated for its physical properties, including viscosity, pH, and spreadability. Stability studies showed that the formulation remained stable over a period of 90 days under both controlled and accelerated conditions. These findings suggest that the developed Beta-sitosterol nanosponges gel formulation is a promising candidate for efficient topical drug delivery, with sustained release and good stability.
[Full Text Article]