Formulation and In-Vitro Evaluation of Mirtazapine Oral Disintegrating Tablets Using Natural and Synthetic Super disintegrants by Direct Compression

Abstract

Objective: To formulate and evaluate oral disintegrating tablets (ODTs) of the antidepressant mirtazapine using direct compression. This study comparatively assesses the efficacy of various natural (Plantago ovata, dehydrated banana powder) and synthetic (crospovidone, sodium starch glycolate, Ly coat) super disintegrants to develop a rapidly dissolving formulation suitable for patients with dysphagia.

Methods: Fifteen formulations (F1-F15) were prepared by direct compression, varying the type and concentration (2%, 4%, 6% w/w) of super disintegrants. Pre-compression (micromeritics) and post-compression (hardness, friability, weight variation, drug content, disintegration time) parameters were evaluated. Drug-excipient compatibility was assessed via FTIR. In-vitro dissolution studies were performed in 6.8 pH phosphate buffer, and release kinetics of the optimized formulation were analysed.

Results: All formulations exhibited good powder flow and produced tablets with acceptable mechanical strength and content uniformity. Formulation F15, containing 6% w/w Ly coat, demonstrated the most rapid drug release, achieving 98.06% dissolution within 15 minutes, with a disintegration time of 40 seconds. The rank order of super disintegrant efficacy was Ly coat > Sodium Starch Glycolate > Crospovidone > Dehydrated Banana Powder > Plantago ovata. Kinetic analysis of F15 indicated the best fit for the Higuchi model (R2=0.988), suggesting a diffusion-based release mechanism.

Conclusion: The study successfully demonstrates that direct compression is a viable method for producing robust Mirtazapine ODTs. Ly coat, a hydroxypropyl pea starch, at a 6% w/w concentration, was identified as the most effective super disintegrant, yielding a formulation with superior in-vitro dissolution performance.