Opportunities for enteral drug delivery for neonates, infants, and toddlers: a critical exploration.

INTRODUCTION: The field of neonatal, infant and toddler pharmaceutical development is constantly improving, however a lag still remains in comparison to older children and adults. Their rapid anatomical, physiological and behavioral developmental rates pose extra challenges in diagnosing, treating, or preventing their disease. In turn, this brings complexity in formulating truly age-appropriate medicinal products that suit this heterogeneous pediatric subset. Progress in the availability of such products has ensued following the introduction of the 2007 European Union Pediatric Regulation, and in recent years, oral multiparticulate and dispersible solid formulations have gained interest alongside liquid formulations. However, the need is still great for dosage forms that do not compromise on pharmaceutical efficacy, safety and global accessibility in those aged under 2. AREAS COVERED: This article highlights some of the formulation challenges correlated with this age group and critically explores recent solid age-appropriate formulations and their administration devices for enteral drug delivery. EXPERT OPINION: There are many formulation requirements to consider when formulating drug products for children aged under 2. Efforts are required into understanding acceptability in this age group and of their carers, and whether innovation or optimization is required, to help guide formulators toward optimal approaches without impacting access.