Quality by design applied to pediatric-friendly formulations

August 28, 2025

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The article explores how Quality by Design (QbD) frameworks can be systematically applied to the development of solid pediatric formulations, with a focus on enhancing safety, efficacy, palatability, and process robustness. Recognizing the stringent limitations on excipient use in pediatric products, the study emphasizes identifying critical quality attributes (CQAs) and critical material/process parameters early in development. This approach often necessitates minimizing or substituting excipients to reduce pediatric exposure while leveraging risk assessment, Design of Experiments (DoE), and taste-masking strategies to deliver practical, child-friendly dosage forms. By mapping these critical variables from the outset, QbD enables more reliable, efficient workflow and ensures pediatric drug products meet quality and regulatory expectations.