Particle Engineering As Applied to Pharmaceutical Formulations

This session seeks papers within the scope of particle engineering of active pharmaceutical ingredients (APIs) and excipients to enable pharmaceutical formulation design and development. The manufacturability and performance of a formulation can be greatly affected by the nature of the excipients and APIs (physical properties, physical and chemical stability), as well as the interactions of these components. The efficient development of pharmaceutical drug product formulations requires the design of fit for purpose APIs and excipients in such a way to achieve robust and reproducible manufacturability, as well as the critical quality attributes (CQAs) of safety, quality and efficacy of the drug product. Particle engineering offers tools and methodologies, both experimental and numerical, to design particles e.g. via different crystallization, co-processing and formulation approaches. Both novel manufacturing processes and formulations that yield engineered particles are of interest to this session. Also, scientific approaches that relate particle formation, structure and functional performance are welcome. Experimental as well as fundamental, theoretical or modeling works (e.g. based on DEM, FEM or CFD) that provide insight into the formation and behavior of the particles in the dosage form are also encouraged.