Formulation and Evaluation of Self-Emulsifying Drug-Delivery System Tablets for Enhanced Oral Bioavailability of Simvastatin

Oral absorption of poorly water-soluble drugs like simvastatin is often limited. Self-emulsifying drug-delivery systems (SEDDSs) offer a strategy to enhance solubility and bioavailability. This study aimed to develop and evaluate SEDDS-based tablets of simvastatin using castor and olive oils as the lipid phase and Tween 60 as the surfactant.Liquid SEDDS formulations were adsorbed onto microcrystalline cellulose and compressed into tablets using 10.5 mm shallow concave punches. The tablets were then assessed for key quality attributes, including drug content, mechanical strength, disintegration, and dissolution.Simvastatin showed high solubility in a 10:1 mixture of oils and Tween 60. The tablets exhibited rapid self-emulsification (<200 seconds) and high thermal stability (cloud point >60°C). All formulations met content uniformity requirements (98.5–101%) and passed mechanical tests, including crushing strength (58–96 N) and friability (≤1%). Tablets disintegrated within 15 minutes and released the drug completely within 30 minutes.Direct compression of SEDDS formulations using common excipients produced simvastatin tablets with improved dissolution and potential bioavailability. These SEDDS-based tablets represent a promising alternative to conventional simvastatin tablets.