Formulation and evaluation of multidose propofol nanoemulsion using statistically designed experiments

Abstract

Despite of the clinical, scientific, and commercial development, many patients complain about pain on the intravenous injection of propofol. Present work was undertaken to develop a stable multi-dose propofol nano-emulsion using 32 full factorial design which is supposed to be associated with less anticipated pain during intravenous administration. Propofol was incorporated in the mixture of disodium edetate, sodium oleate, thioglycerol, glycerol, egg lecithin, soyabean oil and medium chain triglyceride oil, and homogenization was continued at controlled temperature of 20 °C. The product did not show any significant change in visible extraneous particulate matter, pH, osmolality, bacterial endo-toxin, sterility, high performance liquid chromatography (HPLC) their stability and impurities after exposing at 40 °C for 3 and 6 months. Homogenization at 850 bar pressure of 30 min duration produced 174 nm particles with -53.6 mV zeta potential indicating its stability.