3D Printing In Pharmaceutical Dosage Form Development: Recent Advances, Challenges, And Future Perspectives

Three-dimensional printing, also known as additive manufacturing, is emerging as a transformative platform for pharmaceutical dosage form development because it enables precise control over dose, geometry, release behavior, and patient-specific customization. This review summarizes the evolution of 3D printing in pharmaceutics, the principles of digital-to-physical manufacturing, and the main technologies used for drug products, including fused deposition modeling, stereolithography, selective laser sintering, inkjet printing, binder jetting, and semi-solid extrusion. Recent applications in immediate-release, sustained-release, polypill, pediatric, and implantable systems are highlighted, along with the first FDA-approved 3D-printed drug, Spritam (levetiracetam), which marked a major milestone in the field. The review also discusses key barriers such as regulatory uncertainty, quality control, limited printable materials, drug stability, cost, and scalability, while considering emerging directions such as AI-assisted design, 4D printing, bioprinting, and smart drug delivery systems. Overall, 3D printing offers substantial promise for personalized and on-demand medicine, but broader clinical translation will require robust manufacturing standards, harmonized regulations, and stronger process-control strategies.