3D-printed tablets using a single-step hot-melt pneumatic process for poorly soluble drugs.

Main purpose was to evaluate the applicability of a 3D-printer equipped with a hot-melt pneumatic dispenser as a single-step process to prepare tablet dosage forms. Dutasteride, a poorly water-soluble drug, was selected as a model drug. Soluplus®, Kollidon® VA 64, Eudragit® E PO, and hydroxypropyl cellulose (HPC) were premixed as bulking agents prior to printing. Differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), and thermogravimetric analysis (TGA) were utilized to evaluate the physicochemical properties of the 3D-printed tablets. Moreover, different geometries were designed to correlate the surface area/volume (SA/V) of the tablets with respect to their release profiles. As a result, printed dutasteride was confirmed to be in an amorphous state and not recrystallized even after the accelerated storage stability. Out of the four bulking agents, Kollidon® VA 64, enhanced the dissolution of the printed dutasteride, reaching above 80% within 15 min. These results suggest that the hot-melt pneumatic dispenser was efficient in converting the solid state into an amorphous state, which significantly enhanced the dissolution. On the other hand, the tube-shaped 3D-printed tablet exhibited the fastest drug dissolution profile, which had the highest SA/V ratio in comparison to the cube, hemisphere, and pyramid shapes. These results confirm the dependency of the drug dissolution rate not only on its crystallinity but also on the surface area of the 3D-printed tablet. Therefore, a 3D-printer equipped with a hot-melt pneumatic dispenser possesses useful applicability in enhancing drug dissolution, especially for poorly water-soluble drugs, in a single-step process.