Paediatric medicinal products are more complex than their adult alternatives due to the need to cater for differences in physiology and anatomy, whilst providing flexible dosing and taste-masking without impeding in vivo efficacy.  Identification of effective formulations is complex and slow as currently no standardised techniques exist to assess product quality; this results in excessive iteration in formulation development studies, with associated cost and high risk of producing a sub-optimal product.

Industrial and academic expertise has recently led to increased fundamental understanding in this field and so the potential to develop new tools  to predict the quality and performance of  complex formulated products is now possible.

This project will  develop these new analytical tools through an open innovation consortium to provide a novel process to guide the design and selection of complex paediatric formulations enabling assessment of their acceptability quickly and ensuring regulatory compliance. This will create a “right first time” process rather than iterative formulation product design (radical formulated product design). The tools will determine which compounds can be delivered by a range of technologies in order to better select the most appropriate delivery strategy for a given chemical entity.  A range of dosage forms suitable for children across the paediatric age range will be assessed with concomitant evaluation of downstream processing performance.