3D-Printed Oral Solid Dosage forms: Current Status, Regulatory Challenges, and Future Prospects

Abstract

Three-dimensional (3D) printing, or additive manufacturing, is an emerging pharmaceutical manufacturing approach in which oral solid dosage forms are fabricated layer by layer from a digital design. Unlike conventional tablet compression, 3D printing can modify dose, geometry, internal architecture and drug-release characteristics with comparatively little change to physical tooling. These features make the technology attractive for personalized medicine, pediatric and geriatric therapy, polypills and small-batch or on-demand manufacturing. The regulatory relevance of pharmaceutical 3D printing was established in 2015 with FDA approval of SPRITAM® (levetiracetam), manufactured using Aprecia Pharmaceuticals' ZipDose® technology. Recent literature shows continued development of fused deposition modelling, semi-solid extrusion, selective laser sintering, stereolithography, inkjet printing and powder-bed/binder-jet approaches. However, translation from laboratory research to routine pharmaceutical manufacturing remains limited by material variability, thermal or photochemical drug degradation, printer-to-printer variability, content uniformity, process validation, stability, cleaning, digital-file integrity and regulatory uncertainty. Recent EMA guidance activity in 2026 specifically addresses implementation of 3D printing for solid oral dosage forms. This review summarizes the current status of 3D-printed oral solid dosage forms, major technologies, formulation and quality considerations, regulatory challenges and future opportunities.

Keywords: 3D printing; additive manufacturing; oral solid dosage forms; printlets