Volume-2 ,Issue-6, June- 2026

The present study aimed to formulate and evaluate prolonged-release tablets of Rufinamide to achieve sustained antiepileptic therapy and improve patient compliance by reducing dosing frequency. Rufinamide, used in Lennox–Gastaut syndrome, was selected due to its short half-life and need for controlled plasma levels. Matrix tablets were prepared using Hydroxypropyl Methylcellulose (HPMC K100M) along with microcrystalline cellulose, magnesium stearate, and talc by direct compression across ten formulations (F1–F10). Preformulation studies confirmed its crystalline nature, melting point of 201 ± 1°C, poor aqueous solubility, and moderate lipophilicity (partition coefficient 1.5 ± 0.05). Powder blends showed good flow and compressibility suitable for direct compression. Post-compression evaluation revealed acceptable hardness, low friability, uniform weight variation, and drug content within pharmacopeial limits (98.5 ± 0.8% to 100.2 ± 0.4%). In vitro studies demonstrated sustained drug release over 12 hours, with formulation F7 identified as optimized, showing 80 ± 0.9% release compared to marketed product (78 ± 0.9%). Stability studies as per ICH guidelines confirmed no significant changes under accelerated and long-term conditions. Overall, the developed HPMC K100M-based matrix tablets successfully provided sustained release of Rufinamide with potential to enhance therapeutic efficacy and patient compliance.

Keyword: Rufinamide, prolonged-release tablets, sustained release, HPMC K100M, matrix tablets, direct compression