Precision In Miniature: Optimizing Multiparticulate Formulations For Pediatric Oncology

By: Hannah Sullivan, Principal Investigator, Manager CMC, Lonza; Brett Waybrant, Principal Engineer, MSAT, Lonza; and Logan Howell, Program Manager, Lonza

When an oral liquid formulation of crizotinib had to be discontinued in a pediatric trial because patients experienced burning and irritation, the development team faced a formulation problem without an obvious solution. Taste-masking through excipients had already failed. The answer was a wax-based multiparticulate: coated microspheres that minimize API contact with oral taste receptors while enabling flexible, weight-based dosing across three capsule strengths.

This white paper, authored by Hannah Sullivan, Brett Waybrant, and Logan Howell, details the full technical path from melt spray congealing through encapsulation process validation. It examines the specific process parameters that governed particle size and potency uniformity, the DoE strategies used to optimize both manufacturing steps while conserving limited clinical material, and the content uniformity challenges posed by a 47mg fill weight at the lowest dose strength. The process performance qualification results offer a concrete look at what it takes to bring a pediatric oncology multiparticulate from development to commercial readiness. Read the white paper to explore the science in full.