(645d) Agglomerate Characterization in Pharmaceutical Systems

Particle agglomerates (large particles comprised of small primary particles) can be formed in various unit operations in the pharmaceutical industry.  Physical properties (i.e., size, shape, and strength) and amount of these agglomerates can affect the critical quality attributes of drug substance and drug product. This presentation will focus on various approaches that can be used to detect and characterize agglomerates when present in a bulk power, including the benefits and limitations of each analytical technique.  Additionally, information will be presented on small scale studies that were designed to provide a thermodynamic understanding of agglomerate formation.   Results from these small scale studies were used to design an optimized packing strategy for the powder to avoid the formation of detrimental agglomerates.