Orodispersible Tablets for Paediatric Use: A Systematic Review and Outlook for Future Research

Background: Children are often underserved by oral medicines designed for adults, leading to off-label use and workarounds that risk dosing inaccuracy. Objective: To synthesise recent advances in paediatric orodispersible tablets (ODTs), covering manufacturing technologies, disintegrant choices, taste-masking strategies and in-vitro disintegration methods. Methods: Following PRISMA, we searched PubMed, EMBASE, MEDLINE, Scopus and Google Scholar for experimental studies formulating ODTs relevant to paediatric use. Two reviewers screened records and extracted data on technology, excipients, disintegration/dissolution testing and key outcomes; risk of bias was evaluated using a six-domain framework. Results: Sixty-four studies met inclusion criteria. Direct compression was the predominant approach, with additional use of freeze-drying, sublimation, spray-drying, nanoparticle-in-tablet systems, and semi-solid extrusion/3D printing for personalised dosing. Crospovidone, croscarmellose sodium and sodium starch glycolate were the most frequent superdisintegrants; natural and co-processed systems showed promise as cost-effective alternatives. Disintegration time was commonly assessed with pharmacopoeial methods, but multiple modified set-ups were reported to better simulate oral conditions. Conclusions: Paediatric ODT development has accelerated, with direct compression remaining first-line and 3D-printing emerging for dose individualisation. Though paediatric ODTs are now a practical platform, translation hinges on three priorities: (i) harmonised, physiologically relevant disintegration tests aligned with Ph. Eur./USP; (ii) routine, age-stratified acceptability reporting alongside in-vitro data; and (iii) GMP-ready workflows. Head-to-head benchmarking of co-processed and natural/synthetic superdisintegrants using common endpoints, plus attention to dose flexibility, heat-stable packaging, and affordability, will accelerate equitable uptake.