Abstract:

The concept of self-emulsifying drug delivery system (SEDDS) has emerged as one of the most extensively studied lipid-based systems aimed at addressing problems related to low aqueous solubility and unpredictable oral bioavailability of Biopharmaceutics Classification System (BCS) Class II and IV drugs. This systematic review aims to collate recent advances in terms of classification, formulation, mode of action, and evaluation of self-emulsifying drug delivery systems with a special focus on findings achieved over the past decade. This review discusses the impact of spontaneous emulsification, formation of nano-sized droplets, and manipulation of intestinal lymphatic transport on drug solubility and permeability. New trends, including solid-state SEDDS, supersaturated systems, as well as applications of artificial intelligence and machine learning to formulation optimisation, together with current issues like gastrointestinal precipitation, problems with capsule compatibility, and regulatory issues are critically discussed. The review concludes that despite the fact that SEDDS technology has been advanced to an appropriate stage of development and commercialisation, its further clinical implementation requires in vitro-in vivo correlation, lipolysis testing, and data-based formulation optimisation.

Keywords:

self-emulsifying drug delivery systems, oral bioavailability, lipid-based formulations, poorly water-soluble drugs, solid SEDDS.

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Methods