Preparation and Evaluation of Emulsomes as a Drug Delivery System for Bifonazole

Abstract:

Purpose: The main objective of present study is to evaluate the effect of various factors which have direct influence on the characteristic parameters of emulsomes formulation, so that optimized combination of factors can be find out which meet the high level of set desirability criteria. The present work is focused on the optimization of emulsomes formulation by applying Box-Behnken design (BBD) of experiment. Emulsomes are the modified form of emulsomes which consists of solid lipid core surrounded by phospholipid bilayer. Methods: Emulsomes were prepared by lipid film hydration method using Phosphatidylcholine (PHL), Tristearin (TRI), Stearylamine (STR), Cholesterol (CHOL) and Bifonazole as drug candidate. Formulations were optimized by using three factor three levels Box-Behnken (BBD) design of experiment. BBD was applied considering 3 factors as independent variables viz. Phospholipid ratio to Drug (A), Phospholipid to Tristearin ratio (B) and Phospholipid ratio to Stearylamine (C) at 3 levels (-1, 0, +1) to study their effect on dependent variables viz. Particle size (Y1), Zeta Potential (Y2) and Entrapment efficiency (Y3). Results of independent variables (A, B, C) were analysed to construct quadratic equation and 3-D response surface curves for each dependent variable (Y1, Y2, Y3). Results: The optimized formulation was selected on the basis of desirability criteria of minimum particle size, maximum zeta potential and maximum entrapment efficiency. The final optimized formulation has predicted particle size (390.394 nm), zeta potential (45.0mV) and entrapment efficiency (81.642%). Conclusion: BBD is remarkable design of experiment for studying the effect of 3-factors at 3-levels on the responses in optimizing the emulsomes formulation.

Key words: Box-Behnken Design (BBD), Emulsomes, Bifonazole, Phospholipid, Stearylamine, Tristearin.