Stability studies of mefenamic acid Self-Nanoemulsifying Drug Delivery System (SNEEDS) preparation with oleic acid as the oil phase

Abstract

Background: Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) with low solubility in water. Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) play a role to improve the solubility and bioavailability of mefenamic acid. Objective: This study aimed to determine the stability of mefenamic acid in SNEDDS formulation through various stability studies. Methods: The stability studies conducted consisted of centrifugation test, heating-cooling cycle test, freezethaw cycle test, robustness to dilution, accelerated storage test, and determination of drug content. Results: The centrifugation test, heating-cooling cycle test, and freeze-thaw cycle test showed no phase separation in the samples. The robustness to dilution and accelerated storage test resulted in 2 formulas of mefenamic acid loaded SNEDDS having good stability with 10% oleic acid, 80% tween 80, 10% PEG 400 and 10% oleic acid, 70% tween 80, 20% PEG 400. The determination of drug content in both of these formulations showed 98.20 ± 0.04% and 90.98 ± 0.06%. Conclusion: The SNEDDS formulation of mefenamic acid in this study had good stability. Keywords: SNEDDS, mefenamic acid, stability study, oleic acid