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

Abstract

Keywordsbiaxial kneading extruder; fused deposition modelling type three-dimensional printer; geometrical structure of three-dimensional tablet; hypromellose phthalate; rebamipide Correspondence AbstractObjectives 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 computeraided 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.

Injection-Molded Coamorphous Tablets: Analysis of Intermolecular Interaction and Crystallization Propensity

“…21,22 Various mold designs can produce a variety of dosage forms for personalized or "tailor-made" medicine, similar to recent advances in 3D printing in the pharmaceutical field. 23,24 The IM process has been used to directly produce pharmaceutical dosage forms as well as ASD-based tablets including fenofibrate and polyvinyl caprolactamÀpolyvinyl acetateÀpolyethylene glycol graft copolymers (Soluplus). 25 An integrated hot-melt extrusion and IM for the continuous tablet manufacturing was successfully developed using griseofulvin (API), maltodextrin (carrier), xylitol (plasticizer), and lactose (reinforcing agent).…”