Abstract
This study was performed to develop novel core-shell gastroretentive floating pulsatile drug delivery systems using a hot-melt extrusion-paired fused deposition modeling (FDM) 3D printing and direct compression method. Hydroxypropyl cellulose (HPC) and ethyl cellulose (EC)-based filaments were fabricated using hot-melt extrusion technology and were utilized as feedstock material for printing shells in FDM 3D printing. The directly compressed theophylline tablet was used as the core. The tablet shell to form pulsatile floating dosage forms with different geometries (shell thickness: 0.8, 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 designed, printed, and evaluated. All core-shell tablets floated without any lag time and exhibited good floating behavior throughout the dissolution study. The lag time for the pulsatile release of the drug was 30 min to 6 h. The proportion of ethyl cellulose in the filament composition had a significant (p < 0.05) effect on the lag time. The formulation (2 mm shell thickness, 1.6 mm wall thickness, 100% infill density, 0.5% EC) with the desired lag time of 6 h was selected as an optimized formulation. Thus, FDM 3D printing is a potential technique for the development of complex customized drug delivery systems for personalized pharmacotherapy.
Highlights
Maintaining a constant plasma drug concentration is not beneficial in all disease conditions
A significant mass loss of the polymers was observed at temperatures >250 ◦C, implying that the polymers were stable during the Hot-melt extrusion (HME) and 3D printing processes
Different pharmaceutical-grade polymers were recently investigated for fused deposition modeling (FDM) 3D printing of the tablets for various applications
Summary
Maintaining a constant plasma drug concentration is not beneficial in all disease conditions. Some diseases may require pulse delivery of drugs to avoid unwanted adverse effects and drug exposure [1] Certain diseases, such as bronchial asthma, angina pectoris, ulcers, and rheumatoid arthritis, are regulated by the circadian rhythm of the body and require drug administration at specific times of a day, in the early morning hours. Such diseases require pulsatile drug delivery after a lag time to improve patient compliance and drug adherence. The aim of the developed drug delivery system is to achieve both floating characteristics and pulsatile release after the desired lag time to improve therapy and quality of life of patients with asthma
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