Module232025

Excipients in Pediatric CMC Development

Role of Excipients : o Enhance stability, bioavailability, taste, and patient compliance. o Include binders, preservatives, sweeteners, surfactants, coloring agents, and more. Diversity & Safety Considerations : o Average tablet/capsule contains ~8.8 inactive ingredients. o Differences in excipient combinations impact tolerability and safety, especially in pediatric populations. o Concerns with specific excipients like ethanol and PEG due to immature pediatric organ metabolism. Adverse Reactions : o Allergic or intolerant reactions reported, particularly for benzalkonium chloride, benzoates, PEG, and ethanol. o PEG allergic reactions may occur (e.g., seen in PEG-ASNase for leukemia or mRNA COVID-19 vaccines). Initiatives to Address Safety : o EuPFI’s STEP database compiles pharmacologic and safety data on excipients to improve pediatric formulations.

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs