Strategies For The Development Of Safe And Effective Pediatric Formulations

Medicines developed for infants and children present unique formulation challenges compared to those intended for adults. In deciding on the appropriateness of the pharmaceutical design, the relevant developmental physiology and the age specifics should be considered. In addition, selecting a child-friendly dosage form and optimizing a set of characteristics related to palatability and ease of administration are essential. The ability to precisely administer a dose is also essential as children exhibit significant variability in drug absorption, distribution, metabolism, and excretion as compared to adults, and as the required dosage typically varies by age and/or weight. Especially for therapies targeting neonates, the small volumes needed for parenteral formulations can be challenging. Formulators must also account for potential dosage form modification by the caregiver, such as crushing tablets and mixing with food, done with the aim to aid in administration, potentially impacting formulation performance.

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