Pharmaceutical evaluation of matrix tablets prepared using a fused deposition modelling type three‐dimensional printer – Effect of geometrical internal microstructural factors on drug release from enteric‐polymer tablets containing rebamipide

摘要

Abstract Objectives Three‐dimensional (3‐D) printers are widely expected to provide a novel manufacturing method in the future to make personalized medicines in hospitals. Methods Functional filament containing 5–20% drug was prepared with rebamipide (REB; a poorly water‐soluble model drug) and hypromellose phthalate (HPMCP; enteric base) at 130–170°C using a biaxial kneading extruder. Several tablet models with various internal structures were designed using computer‐aided design. REB‐containing 3‐D tablets were prepared based on these designs from filament using a fused deposition modelling type 3‐D printer. Key findings Physicochemical characteristics of the filament and 3‐D tablets were measured by powder X‐ray diffraction and differential scanning calorimetry. The results suggested that a part of the crystalline REB dispersed into the HPMCP and transformed into an amorphous form, because crystalline REB was kneaded with melted HPMCP at 130–170°C during the preparation processes of filament and 3‐D tablets. The drug‐release properties of 3‐D tablets were tested in both pH 1.2 and 6.8 buffers. REB was not released from the 3‐D tablets at pH 1.2, but HPMCP dissolved at pH 6.8, and then REB was rapidly released from the tablet. Conclusions The dissolution of 3‐D tablets in the small intestine could be controlled by the tablet geometrical structure.