The Process Development Blog

Particle sizing is hugely important, with FDA mandating control of particle size for New Drug Applications. However, it is laden with complexities and there is a general misunderstanding of the techniques used.

Subtle changes in particle size, shape, and distribution can have a major impact on pharmaceutical solubility and stability. Moreover, low bulk densities can cause flow and formulation challenges during processing.

Traditional solvent screening takes too long to fix crystallization problems for fast-moving clinical candidates. However molecular modeling and smart experimentation to screen can help speed things up.