Design and Characterization of a Self-Micro Emulsifying Drug Delivery System (SMEDDS) for the Delivery of Omega Fatty Acids

Abstract

Introduction: The global market for nutraceuticals is expanding due to increased health awareness, yet the bioavailability of bioactive components, such as polyunsaturated fatty acids, is often compromised by low aqueous solubility and stability in the gastrointestinal tract. To overcome these limitations, Self-Micro Emulsifying Drug Delivery Systems (SMEDDS) have emerged as a vital strategy to enhance solubility and oral bioavailability. Aim: This study focuses on the design and characterization of a SMEDDS formulation specifically aimed at improving the delivery of omega fatty acids. Methodology: Surfactants and co-surfactants were screened via miscibility studies to determine optimal solubility. Pseudo-ternary phase diagrams were constructed using the aqueous titration method to identify the optimal ratios of oil, surfactant (Tween 80), and co-surfactant (PEG 400). The formulation was prepared using a high-shear homogenizer and characterized for self-emulsification time, viscosity, droplet size, zeta potential, in-vitro dissolution, and stability under accelerated conditions. Results: The miscibility study identified Tween 80 and PEG 400 as the ideal surfactant and co-surfactant, with a 2:1 ratio yielding the largest monophasic region on the phase diagram. The optimized SMEDDS exhibited a rapid self-emulsification time of less than one minute, a mean globule size of 645.2 nm, and a stable zeta potential of -34.9 mV. In-vitro dissolution studies demonstrated a drug release of over 63% in the first 15 minutes, significantly higher than that of pure oil. Conclusion: The developed SMEDDS formulation successfully improved the solubility and dissolution profile of omega fatty acids. The formulation remained physically stable for a month under various storage conditions, suggesting this approach is a viable strategy for delivering poorly water-soluble nutraceuticals.