Formulation, Evaluation & Development of Extended-Release Tablet of Class I Anti–Depressant Drug

Abstract

This study aimed to develop and assess extended-release tablets of Mirtazapine using various release-retarding polymers to achieve sustained therapeutic effects and enhance patient compliance. A UV-Visible spectrophotometric method was validated for drug quantification in 0.1N HCl and pH 6.8 phosphate buffer, showing excellent linearity over a 2–10 µg/ml range. Pre-compression analysis revealed favorable flow and compressibility characteristics of powder blends. Tablets prepared by direct compression exhibited uniform thickness, suitable hardness, low friability, and consistent drug content within pharmacopeia limits. In vitro dissolution studies demonstrated that drug release was influenced by polymer concentration, with formulation F3 showing the most promising controlled-release profile. FTIR spectroscopy confirmed no significant interactions between Mirtazapine and excipients, ensuring formulation stability. Kinetic modeling indicated that drug release from the optimized formulation followed the Higuchi model, reflecting a diffusion-controlled mechanism, with non-Fickian anomalous transport confirmed by the Peppas model. Carbopol was identified as the most effective release-retarding polymer. The optimized formulation provided sustained Mirtazapine release up to 24 hours, positioning it as a potential once-daily oral dosage form to improve therapeutic outcomes and adherence in depression management.