09.07.22 -- Meeting Rising Demand For Pediatric Dosage Forms

Challenges for developing pediatric dosage forms relate to the scale of manufacturing, the complexity of development and reformulation work required to support reduced dosing, a range of doses targeted to different age/weight levels, and often more than one formulation type to meet the needs of toddlers through adolescents. Formulation decisions have important implications for drug stability, patient compliance, and accurate dosing.

Understanding both the significant competitive advantages that fixed-dose combination (FDC) products can offer and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Explore considerations for design, formulation, manufacturing, and analysis.

A global biopharmaceutical company with a successful adult anti-infective product franchise was looking to create a pediatric formulation to meet U.S. FDA regulatory requirements, expand patient access to children in an appropriate dosage form and strength, and to extend patent protection of its flagship product line.