Pediatric patients are considered a special category of patients in pharmacotherapy who are still facing challenges in terms of dose accuracy, palatability, and formulation availability. The traditional approach of preparing tablets based on fixed-dose theories has failed to address the individual needs of paediatric patients at different developmental stages. Three-dimensional printing has been considered a game-changer in the pharmaceutical industry by providing the opportunity for the development of accurate-dose tablets with improved palatability and child-friendly formulations. This review critically discusses the major 3D printing technologies that are being used for the development of tablets for paediatric patients, such as fused deposition modeling, semi-solid extrusion, selective laser sintering, stereolithography, and binder jetting/inkjet printing. The review will cover the pharmacokinetic rationale for the development of personalized paediatric formulations, approaches to improve acceptability and compliance in the paediatric population, materials and excipients, QA issues, and the current regulatory situation with input from the FDA and the EMA. The review will also cover the major clinical feasibility trials, including the development of the first-ever personal formulations for epilepsy, adrenal insufficiency, hypothyroidism, and metabolic disorders. Finally, the challenges facing the field will be discussed in the context of the future of the field.
Soni et al. (Thu,) studied this question.