Optimized double emulsion-solvent evaporation process for production of solid lipid nanoparticles containing baclofene as a lipid insoluble drug

Intrathecal injection of baclofen is the reference treatment for severe spasticity of cerebral-spinal origin. Solid lipid nanoparticles (SLNs) could be considered as a beneficial delivery system for enhancing penetration of drug through the blood brain barrier (BBB). In this study, baclofen- loaded SLNs were prepared using double emulsification-solvent evaporation method and a Box-Behnken design, based on three independent variables, was used to reduce the number of required experiments. Variable parameters were drug/lipid ratio, w/o phase ratio and the amount of surfactant. It was deduced that SLNs with small particle size, lipophilic feature, high entrapment efficiency and good loading capacity could be produced by this method and experimental design method could be useful for predicting optimum baclofen loaded SLNs with minimum numbers of experiments. Characterization of optimum formulation, provided by evaluation of experimental data, showed no significant difference between calculated and measured data.