Designing drug products suitable for the youngest patient. Enabling access to medicines for the most vulnerable and complex patient population.

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Developing oral formulations for children under 2 years of age pose many different multifaceted challenges to those associated with the development of oral formulations for children over 2 years of age e.g. excipient burden, dose volume, dosing device requirements, impact on feeding etc. In fact, this subset of the paediatric population remain somehow therapeutic orphans not only due to unmet clinical needs but also due to a lack of proven dosage forms or technology, to enable oral dosing. This pharmaceutical technology focused research at the interface of chemistry, data gathering, engineering and materials sciences provides a fantastic opportunity to greatly improve patient outcomes by i) understanding the needs/research capabilities of this unique patient population ii) evaluating the current available oral dosage form types against these requirements andiii) developing a platform that is appropriate for this age group. Such drug delivery platforms need to also consider other factors such as market considerations e.g. cost; need for personalised dosing e.g. oncology, chronic or acute dosing and cultural considerations. Examples of creative and transformational approaches to investigate include the feasibility of a 'gelling dispersible tablet' that forms a gel on a spoon to aid dosing to neonates which may meet the requirements of low cost territories; feasibility of dispersible mini tablets or granules; orodispersible films; or foam based delivery systems that might be more applicable to niche therapies where dose flexibility is critical and/or cost constraints are not a key driver. This high priority healthcare challenge is a critical area of paediatric drug delivery of which little is known and where availability of proven platforms is limited. It truly encourages translational research and opens up pathways to impact.