Three-Dimensionally Printed Paediatric Medicines: Formulation, Process, and Regulatory Considerations

Paediatric formulations are pharmaceutical dosage forms specifically designed to meet the physiological, developmental, pharmacokinetic, and practical needs of patients from birth to adolescence. Developing safe, effective, and age-appropriate medicines for children remains a significant challenge due to their age-dependent variability in physiological development, pharmacokinetic profiles, and therapeutic needs. These differences, combined with practical barriers such as poor palatability, limited swallowability, inappropriate dosage form size, and instability, often lead to the modification of adult medicines-practices that can cause dosing inaccuracies, contamination risks, and reduced therapeutic efficacy. Three-dimensional printing has emerged as a promising solution to address these limitations by creating personalised paediatric dosage forms with adjustable strengths, multilayer structures for controlled release, and child-friendly shapes that may improve acceptability and adherence. This review offers an overview of the physiological, technological, and regulatory factors involved in developing 3D-printed paediatric medicines. The Critical Quality and Performance Attributes relevant to this field-including dose accuracy and flexibility, release kinetics, palatability, product dimensions, material choice, safety, stability, cost-effectiveness, production time, scalability, and reproducibility-are discussed in the article. Additionally, the review discusses the evolving Good Manufacturing Practice and regulatory landscape necessary to ensure the quality, safety, and consistency of 3D-printed medicinal products. Overall, these insights underline the transformative potential of 3D printing as a pathway towards safer, more effective, and truly personalised pharmacotherapy for paediatric patients.