Paediatric formulation challenges for enteral feeding tube administration – Current understanding and future directions

Enteral administration of oral dosage forms is a highly desirable treatment approach for children having impaired swallowing ability or limited gastro-intestinal access. However, the complex interplay between drug formulation and enteral feeding tube risk factors, along with the inherent anatomical and physiological differences, puts the paediatric population at a higher risk of medication administration errors via enteral feeding tubes (EFTs). Pharmaceutical companies developing drug products for the paediatric patient population are required to devise an appropriate formulation strategy and provide data to demonstrate the feasibility of administration through an EFT, yet there are limited guidelines available on evaluation of the administration of new oral paediatric drug products via EFTs. Healthcare professionals also face challenges in preparing and administering medicines through EFTs as few medications are licensed for this route of administration, and additionally, there are no harmonised guidelines on this practice. By thoroughly examining these aspects, the industry can identify specific challenges and requirements, leading to more effective and tailored drug formulations that not only meet the unique needs of paediatric patients but also ensure optimal delivery and efficacy when administered through EFTs. Moreover, a comprehensive understanding of these factors can guide regulatory evaluations and quality assurance processes. However, current literature reveals significant gaps in knowledge regarding some of these factors. There are several neglected areas that require further exploration and deeper understanding. This systematic review provides an overview of the current understanding of these factors and highlights the areas in which more targeted research is required to address the gaps, optimize formulation strategies, and the evaluations needed to demonstrate the feasibility of administration of medication via EFTs to the paediatric population. Furthermore, the understanding of these factors affecting administration of drug products through EFTs could support development of evidence-based recommendations or guidance for pharmaceutical companies to assess administration of new oral paediatric drug products via EFTs and for healthcare professionals to harmonise clinical practice.