Twin-screw melt granulation of Eudragit® FS100

April 07, 2026

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This article reports on a formulation study using twin‑screw melt granulation (TSMG) to create coating‑free, delayed‑release oral matrix tablets by combining the pH‑responsive polymer Eudragit® FS100 with hydroxypropyl methylcellulose (HPMC K4M). By optimizing key variables (drug load, screw speed, and HPMC level), the researchers achieved a robust matrix that minimizes drug release in acidic conditions (≤10 % at pH 1.2) and enables extensive release in intestinal pH (~85 % at pH 7.4). Mechanistic analysis showed controlled swelling and erosion driving near zero‑order release kinetics, while processing remained scalable and solvent‑free. This approach demonstrates an alternative to traditional coatings for delayed‑release tablets, enhancing manufacturability and stability.