Application of factorial design approach in development and evaluation of self microemulsifying drug delivery system (SMEDDS) of mebendazole

Self microemulsifying drug delivery systems (SMEDDS) are defined as isotropic mixtures of natural or synthetic oils, surfactants and co-solvents/co-surfactants. Upon mild agitation followed by dilution in aqueous media, such as GI fluids, these systems can form fine oil in water o/w microemulsion. The purpose of this study was to formulate SMEDDS containing mebendazole. Labrafil M2125 CS (an oil), Tween 20 (a surfactant), and Maisine 35-1 (a cosurfactant) were used to formulate SMEDDS. Effect of concentrations of oil and surfactant on emulsification process and in vitro drug release (percent cumulative drug release) was studied using 32 factorial design. Multiple regression analysis data and response surfaces obtained showed that viscosity increased significantly with increasing amount of co-surfactant. Whereas, decrease in emulsification time, it may decreases average droplet size of resultant microemulsion and rapid drug release. The drug release from the formulation increased with increasing amount of surfactant concentration increases solubility of drug in system. Prepared SMEDDS produced acceptable properties of immediate-release dosage forms. The L5 formulation was found to be optimized on basis of high percent cumulative drug release. And it is evaluated by globule size and zeta potential indicates globule size is in micrometer range and good stable formulation. It may expect to increase the bioavailability of mebendazole as solubility enhances. © 2016, The Korean Society of Pharmaceutical Sciences and Technology.