Age-appropriate solid oral formulations for pediatric applications with a focus on multiparticulates and minitablets:...

This paper presents the output of a workshop held at the 11th Annual Conference of EuPFI (European Paediatric Formulation Initiative), in September 2019 in Malmo, Sweden, on the development of multiparticulates and minitablets as pediatric formulations. The workshop focused on three specific facets of pediatric drug development, namely selection of the formulation platform, selection of the package or dosing device, and administration of minitablets/multiparticulates with soft food. The workshop discussion indicated significant interest in the use of these dosage forms, filled into stick-packs or capsules, as age-appropriate formulations for younger children, along with a growing consensus that larger sized tablets and capsules designed for adults are often also suitable for adolescents. Among the areas that were identified as technical challenges were: understanding the acceptability of multiparticulates and minitablets relative to alternate formulations; the need for a streamlined approach to compatibility testing with soft foods; the desire to avoid the need to co-administer these products with soft food; and the need for more suitable dosing devices.