This study was performed to develop novel core-shell gastroretentive floating pulsatile drug\ndelivery systems using a hot-melt extrusion-paired fused deposition modeling (FDM) 3D printing\nand direct compression method. Hydroxypropyl cellulose (HPC) and ethyl cellulose (EC)-based\nfilaments were fabricated using hot-melt extrusion technology and were utilized as feedstock material\nfor printing shells in FDM 3D printing. The directly compressed theophylline tablet was used as the\ncore. The tablet shell to form pulsatile floating dosage forms with different geometries (shell thickness:\n0.8, 1.2, 1.6, and 2.0 mm; wall thickness: 0, 0.8, and 1.6 mm; and % infill density: 50, 75, and 100) were\ndesigned, printed, and evaluated. All core-shell tablets floated without any lag time and exhibited\ngood floating behavior throughout the dissolution study. The lag time for the pulsatile release of the\ndrug was 30 min to 6 h. The proportion of ethyl cellulose in the filament composition had a significant\n(p < 0.05) effect on the lag time. The formulation (2 mm shell thickness, 1.6 mm wall thickness, 100%\ninfill density, 0.5% EC) with the desired lag time of 6 h was selected as an optimized formulation.\nThus, FDM 3D printing is a potential technique for the development of complex customized drug\ndelivery systems for personalized pharmacotherapy.
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