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.
Highlights
From the time of World War–II, anesthesiology got its importance for induction in combating casualties
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
Summary
From the time of World War–II, anesthesiology got its importance for induction in combating casualties. Were kinetically stable with reduced aqueous phase drug concentration.[15,16,17] No significant differences in pharmacokinetics and sedation properties were observed on comparison to a commercial soy-based propofol emulsion.[18] To decrease the amount of free propofol in the aqueous phase propofol emulsions were fabricated with medium and long-chain triglycerides (MCT/LCT).[19,20,21,22] Heat generated during processing of a propofol product can swiftly induce microbial growth.[20] It was evident from a randomized double-blind clinical trial that pain on injection was reduced with small particle size lipid emulsion of propofol.[23] Soybean oil, glycerol, egg lecithin, and disodium edetate are present in the propofol innovator product (Diprivan, Astra Zeneca), and the combination of triglycerides and phospholipids in the formulation reduces the chance of free propofol concentration.[24,25,26]. Process duration and homogenization pressure have been optimized for obtaining stable nano-emulsion of reduced particle size
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