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

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Abstract

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.

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ACKNOWLEDGMENTS

Authors would like to thank Intas Pharmaceutical Limited, Ahmedabad for gift sample of Agomelatine and Abitec Corporation, USA for gift sample of Capmul MCM.

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Authors and Affiliations

  1. Centre for Relevance and Excellence in Novel drug delivery systems, Shri G. H. Patel Building, Donor’s Plaza, Pharmacy Department, Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara-390002, Gujarat, India

    Priyanka Tomar, Jiya Mary Saji, Darshana Patel & Hetal Thakkar

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  1. Priyanka Tomar
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  2. Jiya Mary Saji
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Correspondence to Hetal Thakkar.

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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 85, 276–286 (2023). https://doi.org/10.1134/S1061933X22600014

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