The role of micronization in the journey to drug product development

May 26, 2026

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Micronization is a key particle engineering step bridging early discovery and drug product formulation. By reducing active pharmaceutical ingredient (API) particles to the micron range, micronization increases surface area, which enhances dissolution rate and bioavailability of poorly soluble compounds—making it critical for oral solid dosage (OSD) performance and consistent tablet properties. It also improves particle size uniformity, aiding blend homogeneity and downstream processing outcomes such as flowability and content uniformity. While micronization strengthens drug delivery potential, it introduces formulation challenges like altered flow and potential solid-state changes that must be managed through careful process design and risk assessment. Effective micronization supports robust formulation design and scalable manufacturing strategy for both clinical and commercial stages of development.