Nanoemulsions in Pediatric Drug Delivery: Formulation Strategies, Therapeutic Applications, Safety, and Future Perspectives

Abstract

Pediatric patients have distinctive pharmacokinetic, physiological, developmental, and acceptability requirements that make conventional adult formulations difficult to use safely and effectively. Nanoemulsions are submicron dispersions of oil and aqueous phases stabilized by surfactants and, when appropriate, cosurfactants. Their large interfacial area, capacity to solubilize lipophilic compounds, and flexibility across oral, topical, nasal, pulmonary, ocular, and parenteral routes make them attractive for pediatric drug delivery. This review summarizes the rationale for nanoemulsions in children, formulation and characterization considerations, representative pediatric applications, and major safety and translational barriers. Particular attention is given to dose flexibility, palatability, excipient selection, bioavailability enhancement, and age-related physiological differences. Available evidence includes promising preclinical studies and a limited number of pediatric-focused formulation investigations, including nanoemulsions or self-nanoemulsifying systems of vitamin D3, stiripentol, amphotericin B, and bedaquiline. However, most evidence remains formulation- or animal-based rather than derived from pediatric clinical trials. Successful translation will require child-appropriate excipients, robust stability and manufacturing controls, age-specific pharmacokinetic evaluation, and systematic safety assessment. Nanoemulsions therefore represent a promising but still emerging platform for pediatric medicines rather than a universally applicable solution.