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Twin-screw melt granulation of Eudragit® FS100: optimization of coating-free delayed-release matrix tablets with HPMC K4M modulation

Abstract This study aimed to develop a scalable, coating-free delayed-release matrix tablet via twin-screw melt granulation (TSMG) using Eudragit® FS100 and extra-granular hydroxypropyl methylcellulose K4M (HPMC). A Central Composite Design was employed to optimize three critical variables (drug load (10–30 %), screw speed (20–50 rpm), and HPMC concentration (5.6–13.1 % w/w)) to achieve 85 % in intestinal conditions (pH 7.4). The optimized formu…
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Pharma Excipients broke the news in on Wednesday, November 12, 2025.
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