Phytosomal gel of Manjistha extract (MJE) formulated and optimized with central composite design of Quality by Design (QbD)

Abstract

The objective of the current research to investigate the transdermal delivery of phytosomal Manjistha extract gel (MJE gel). The optimized formulation was prepared and evaluated for different parameters. MJE-loaded phytosomes were prepared by solvent evaporation method using rotary evaporator. The formulation was prepared with a variable concentration of lecithin (0.15–0.25% w/v), with stirring speed of the round bottom flask (80–160 rpm). Design expert software was used for the optimization of MJE-loaded phytosomal formulations. Central composite design-based factorial design was applied and evaluated for vesicular size and entrapment efficiency as dependent variables. The optimized formulation was further characterized with vesicle size, zeta potential, in vitro release. The Carbopol 934 was used to convert the phytosomal formulation (F10) into phytosomal gel and evaluated for ex vivo permeation to check the difference in permeation profile in compare to conventional MJE gel. The optimized MJE-loaded phytosomal formulation (F10) showed the vesicular size of 122.15 ± 3.73 nm, entrapment efficiency of 96.25 ± 2.45% with PDI value of 0.98 ± 0.06. Among the drug release kinetic models, the formulation followed the Higuchi model with drug release of 84.2 ± 4.1% in 12 h. Transmission electron micrograph showed the uniform structure and spherical shape. The prepared phytosomal gel shows prolonged release and enhanced permeation compared to conventional MJE gel.