Meeting The Challenges Of Pediatric Adherence With Patient-Centric Formulations

By Srinivasan Shanmugam, PhD

Pediatric drug development presents a distinct set of challenges—from taste and swallowability issues to regulatory complexities and physiological variability across age groups. Successfully addressing these requires a patient-centric approach that prioritizes formulation design and delivery methods tailored to children’s needs.

Key barriers to adherence include bitter taste and difficulty swallowing, both of which can be mitigated through advanced taste-masking technologies and mini-tablet formats. Regulatory frameworks also play a critical role, balancing mandates with incentives while ensuring ethical and scientifically sound clinical practices. Emerging sensing technologies offer promising tools for bitterness detection, though they remain supplementary to human expertise.

Formulators must also consider excipient safety, especially in injectable and oral pediatric products. Ingredients like lactose and alcohol require careful justification and age-appropriate alternatives. Real-world evidence is gaining traction as a complementary tool for regulatory submissions, though its use must be balanced with data quality and ethical considerations.

For teams navigating pediatric formulation and compliance, this resource offers practical insights and expert guidance. Explore the full asset to learn how to design therapies that meet the real-world needs of pediatric patients.