Three-dimensional printing as a transformative platform for patient-centric pediatric drug delivery: technologies, formulation strategies and clinical translation.

BACKGROUND

Pediatric patients require age-appropriate dosage forms because developmental differences in physiology, pharmacokinetics and swallowing ability can significantly affect therapeutic outcomes. Conventional dosage forms are often unsuitable for children and practices such as tablet splitting, crushing or extemporaneous preparation may lead to dose inaccuracy, altered stability, poor palatability and reduced adherence. These limitations highlight the need for innovative formulation strategies that provide precise dosing while improving acceptability and therapeutic effectiveness. In this context, three-dimensional (3D) printing has emerged as a promising platform for personalized pediatric drug delivery.

OBJECTIVE

This review critically examines recent advances in 3D printing technologies for pediatric drug delivery and provides a formulation-focused and translational perspective by integrating pediatric therapeutic needs with technology selection, polymer considerations and dosage form design flexibility.

METHODS

A comprehensive literature review was conducted to evaluate recent developments in pediatric pharmaceutical applications of 3D printing. Major technologies including fused deposition modeling, semi-solid extrusion, binder jet printing and inkjet printing were assessed with respect to formulation design, polymer selection, drug-polymer compatibility and pediatric suitability. Particular emphasis was placed on taste-masking approaches, personalized dosing capability and dosage adaptability for different pediatric age groups.

RESULTS

Three-dimensional printing enables fabrication of diverse pediatric-friendly dosage forms including chewable gummies, mini-tablets, orodispersible films and confectionery-like formulations. Published studies demonstrated improved dose precision, effective taste masking, customizable drug release profiles and enhanced patient acceptability. Regulatory approval of Spritam further supports the clinical feasibility of this technology. However, challenges remain regarding printer calibration, reproducibility, limited pharmaceutical-grade printable materials, long-term stability and regulatory harmonization.

CONCLUSION

Three-dimensional printing represents an important advancement in patient-centric pediatric pharmacotherapy by enabling precise control over dose, geometry, release kinetics and sensory attributes. This review highlights its practical potential and translational readiness for pediatric healthcare.