This white paper details a collaborative effort between Lonza’s Bend, OR site and Pfizer’s Groton, CT team to develop a robust commercial control strategy for a pediatric dosage form for crizotinib (Xalkori) in a material sparing fashion. The multiparticulate formulation was designed to address key challenges in pediatric drug delivery, particularly taste and ease of administration, through taste-masked, coated microspheres with flexible dosing options.
Using Quality by Design (QbD) principles and extensive statistical design of experiments, the melt spray congeal and encapsulation processes were optimized to ensure consistent particle size, potency, and content uniformity across multiple capsule strengths. A single, high drug load intermediate enabled dose flexibility and reduced manufacturing complexity.
This scalable multiparticulate platform helps overcome common technical barriers in pediatric formulation, improving patient experience, supporting treatment compliance, and accelerating access to essential medicines for children.