Module232025

Challenges of Excipients in CMC for Pediatric Drugs (1) 1.Safety Concerns : Limited data on pediatric excipient safety; risks

from metabolic immaturity (e.g., ethanol, propylene glycol). 2.Regulatory Barriers : Strict safety studies required, even for excipients common in adult drugs. 3.Age-Specific Tolerance : Differing tolerances across pediatric subgroups need tailored excipients. 4.Taste Masking : Safe excipients are needed to improve taste and adherence. 5.Excipient Compatibility : Must ensure stability and bioavailability with APIs in pediatric formulations. 6.Innovation Needs : Few excipients are designed for children, requiring new development and testing.

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs