Development and Evaluation of Self-Emulsifying Drug-Delivery System–Based Tablets for Simvastatin, a BCS Class II Drug

Abstract

Background Self-emulsifying drug-delivery systems (SEDDSs) are designed to improve the oral bioavailability of poorly water-soluble drugs. This study aimed at formulating and characterization of SEDDS-based tablets for simvastatin using castor and olive oils as solvents and Tween 60 as surfactant. Methods The liquids were adsorbed on microcrystalline cellulose, and all developed formulations were compressed using 10.5 mm shallow concave round punches. Results The resulting tablets were evaluated for different quality-control parameters at pre- and postcompression levels. Simvastatin showed better solubility in a mixture of oils and Tween 60 (10:1). All the developed formulations showed lower self-emulsification time (˂200 seconds) and higher cloud point (˃60°C). They were free of physical defects and had drug content within the acceptable range (98.5%–101%). The crushing strength of all formulations was in the range of 58–96 N, and the results of the friability test were within the range of USP (≤1). Disintegration time was within the official limits (NMT 15 min), and complete drug release was achieved within 30 min. Conclusion Using commonly available excipients and machinery, SEDDS-based tablets with better dissolution profile and bioavailability can be prepared by direct compression. These S-SEDDSs could be a better alternative to conventional tablets of simvastatin.

African Breadfruit Seed Oil as Lipid Phase of Self-Emulsifying Drug Delivery System for Improved Gastrointestinal Fluid Solubility of Ibuprofen: Design and Evaluation

“…Data for the construction of the PTPD was generated using the water titration technique. [19] while the plotting was performed with the aid of Sigma Plot 14 software. To generate data for the plot, five sets of surfactant and co-surfactant mixtures (Tween 80 and PEG) in different weight ratios of 1:1, 1:2, 1:3, 3:1, 2:1 were prepared.…”