The importance of particle size analysis
Particle size reduction is a fast and cost-effective answer to increasing the exposure of poorly soluble oral drugs by increasing surface area and thereby improving dissolution rate. This approach will only work for DCS IIa1 drugs where dissolution rate is the rate-limiting factor for absorption. This may be applicable to around one-sixth of drugs currently in development.2
PARTICLE size is an important attribute in APIs, solid oral drug products (tablets and capsules – impacting on homogeneity, flow and processing), and as a critical quality attribute in semi-solids (suspensions) and sterile liquid products (injectables). Particle size analysis has become a proxy for routine surface area measurement. However, context is important. Therefore, representative sampling, sample homogeneity and particle morphology are important because of the small sample sizes, potential settling of the sample, etc.