Abstract
The aim of the study was to investigate core–shell pulsatile tablets by combining the advantages of FDM 3D printing and traditional pharmaceutical technology, which are suitable for a patient’s individual medication and chronopathology. The tablets were designed and prepared with the commercial verapamil hydrochloride tablets as core inside and the fused deposition modelling (FDM) 3D-printed shell outside. Filaments composed of hydroxypropylmethyl cellulose (HPMC) and polyethylenglycol (PEG) 400 were prepared by hot melt extrusion (HME) and used for fabrication of the shell. Seven types of printed shells were designed for the tablets by adjusting the filament composition, geometric structure and thickness of the shell. A series of evaluations were then performed on the 3D-printed core–shell tablets, including the morphology, weight, hardness, thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), X-ray powder diffraction (XRD), in vitro drug release and CT imaging. The results showed that the tablets prepared by FDM 3D printing appeared intact without any defects. All the excipients of the tablet shells were thermally stable during the extruding and printing process. The weight, hardness and in vitro drug release of the tablets were affected by the filament composition, geometric structure and thickness of the shell. The pulsatile tablets achieved personalized lag time ranging from 4 h to 8 h in the drug release test in phosphate-buffered solution (pH 6.8). Therefore, the 3D-printed core–shell pulsatile tablets in this study presented good potential in personalized administration, thereby improving the therapeutic effects of the drug for circadian rhythm disease.
Highlights
Three-dimensional printing is defined as the “fabrication of objects through the deposition of a material using a print head, nozzle, or another printer technology” by the International Standard Organization (ISO) [1]
fused deposition modelling (FDM) 3D-printed core–shell pulsatile tablets were fabricated successfully in this study, which were designed with a commercial immediate-release tablet inside and a 3D-printed shell outside
Three factors were considered for the printed shell of the pulsatile tablets, including filament compositions, geometric structures and thicknesses of shell
Summary
Three-dimensional printing is defined as the “fabrication of objects through the deposition of a material using a print head, nozzle, or another printer technology” by the International Standard Organization (ISO) [1]. Since it was introduced in the 1980s, 3D printing has been widely used as a fast and economical technology in a variety of fields, such as aerospace, automobiles, architecture and jewelry. 3D printing is still in its infancy [3] but has the potential to change the design and manufacture of medicines [4]. Three-dimensional printing has the characteristics of low cost, high efficiency and flexibility [5], and can support the design of medicines that have complex structures, can be produced on-demand and are tailored to the individual needs of each patient [6,7,8].
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