Formulation and Evaluation of Solid-Self Micro Emulsifying Drug Delivery System (S-SMEDDS) of Agomelatine

The aim of this study was to create a solid-self-micro emulsifying drug delivery system (S-SMEDDS) to improve the oral bioavailability of Agomelatine, which is weakly water soluble. Agomelatine, an antidepressant medication, is rapidly absorbed (>75%) after oral administration, but it has a low water solubility and significant first-pass metabolism, resulting in a low absolute bioavailability (4%). Based on solubility of Agomelatine, Capmul MCM (oil), Kolliphor EL (surfactant), PEG 400 (co-surfactant) and Neusilin US2 (solid carrier) were selected to prepare solid SMEDDS. The optimized formulation was stable with zeta potential of –28.0 ± 0.5 mV and globule size 105.2 ± 13.7 nm, PDI 0.32, pH 7.3 ± 0.2, cloud point 65 ± 1°C and assay 98.0 ± 0.6% which corresponds to L-SMEDDS. It was robust to dilution. TEM image showed uniformly distributed globules. The result of in-vitro drug release study suggested that there was greater drug release from Agomelatine S-SMEDDS as compared to plain drug suspension. S-SMEDDS drug release followed zero order kinetics, indicating that it is unaffected by drug concentration.

Priyanka Tomar, Saji, J.M., Patel, D. et al. Formulation and Evaluation of Solid-Self Micro Emulsifying Drug Delivery System (S-SMEDDS) of Agomelatine. Colloid J (2023). https://doi.org/10.1134/S1061933X22600014

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