Formulation studies for mirtazapine orally disintegrating tablets.

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems

Background:

• Orally disintegrating tablets (ODTs) are crucial for patients with dysphagia, including pediatric, geriatric, and psychiatric populations.
• Mirtazapine, an antidepressant, presents taste-masking challenges due to its inherent bitterness.

Purpose of the Study:

• To develop novel orally disintegrating tablet (ODT) formulations of mirtazapine.
• To evaluate simple and cost-effective preparation methods like coacervation and direct compression.
• To compare the developed ODTs with the reference product (Remereon SolTab).

Main Methods:

• Taste masking of mirtazapine was achieved using the coacervation method.
• In vitro characterization included diameter, thickness, weight variation, hardness, friability, and disintegration time.
• Dissolution testing was conducted in various media (0.1 N HCl, pH 6.8 phosphate buffer, pH 4.5 acetate buffer) at 37°C.

Main Results:

• A Eudragit® E-100 concentration of 6% (w/w) yielded a dissolution profile closest to the reference product.
• Formulations D, E, and F exhibited superior disintegration times.
• Groups E and F formulations demonstrated optimal dissolution properties across all tested media.

Conclusions:

• Specific formulations (D1, D4, D5, E3, E4, F1, F5) were identified as suitable ODTs based on favorable disintegration and dissolution profiles.
• The developed mirtazapine ODTs show promise for exhibiting characteristics similar to the original formulation.