Towards the development of a standard toolbox for compatibility testing of pediatric drug products with common dosing vehicles − Fruit juice, apple sauce, yogurt, and pudding

Co-administration of oral drug products with dosing vehicles is common practice in pediatric drug administration. The present work focused on the development of a set of standard vehicles that reflects the key characteristics of four different vehicle types commonly used in the administration of pediatric drug formulations. The aim was to rationalize and standardize the compatibility assessment of pediatric dosage forms with individual vehicle types and thereby contribute to a better risk assessment regarding this route of administration. In order to develop the standard vehicles, a comprehensive number of fruit juices, apple sauces, yogurts, and puddings were characterized with regard to their physicochemical properties. The characterization results served as target values for a set of standard vehicles which was successfully developed and followed a design of experiments approach. These standard vehicles represent the first and central components of a standardized vehicle toolbox designed for global use. Their use will enable pharmaceutical developers and regulatory authorities to gain insight into the compatibility of pediatric medicines with these dosing vehicles. Pending validation through comparative studies with the original vehicles, for which data are forthcoming, the toolbox is expected to serve as a valuable resource for assessing the safety and feasibility of combining pediatric formulations with liquid or semi-solid vehicles, thereby supporting more informed decision-making in drug development.