Three-Dimensional Printing of Personalised Oral Dosage Forms: Technologies, Point-of-Care Applications and Regulatory Perspectives

Conventional oral dosage forms are mass-produced in fixed strengths, which limits dose adjustment for children, older adults and patients with rare metabolic disorders. Three-dimensional (3D) printing builds dosage forms layer by layer from a digital design and can therefore produce small batches of personalised medicines on demand. This narrative review describes the main printing technologies used for oral solid dosage forms (fused deposition modelling, semi-solid extrusion, direct powder extrusion, selective laser sintering, stereolithography and powder-bed printing), the excipients and process constraints that govern their use, and the design of personalised printlets and multi-drug polypills. It then examines point-of-care evidence from paediatric and geriatric settings, including a prospective crossover study in children with maple syrup urine disease, and the quality-control and regulatory questions raised by printing medicines in hospitals and pharmacies. Twenty-two key articles identified by a structured literature search were appraised. The evidence shows that 3D printing is technically feasible and acceptable to patients, and that one printed product has reached the market, but clinical studies remain small, quality-control methods designed for batch manufacture do not fit small printed batches, and rules for prefilled feedstock cartridges are unsettled. Larger controlled studies, validated in-process monitoring and harmonised regulatory guidance are the main needs before routine point-of-care use.