A Review on Application of Quality by Design (QbD) Principles to the Development of Age-Appropriate Pediatric Ondansetron Formulations

Ondansetron, a foundational 5-HT3 receptor antagonist, plays a crucial role in managing chemotherapy-induced, post-operative, and acute gastroenteritis-related vomiting in children. Despite its widespread use, significant challenges persist, notably the absence of established safety and efficacy data for children younger than four years. Furthermore, marked age-dependent pharmacokinetic (PK) variability, characterized by reduced drug clearance in neonates, mandates flexible, weight-based dosing to prevent overexposure. This review applies the Quality by Design (QbD) framework (ICH Q8(R2)) to develop age-appropriate ondansetron formulations (ODF or oral solution), establishing the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), and Control Strategy (ICH Q10). Through proactive Quality Risk Management (QRM) and Failure Mode and Effects Analysis (FMEA), it ensures the product’s safety, efficacy, and lifecycle quality control.