Abstract
The interaction of materials within the context of a formulation and its manufacturing process can have a defining impact on a parenteral drug product performance. Therefore, establishment of methodologies to investigate the interactions of drug substance with itself and other components can be a critical aspect of developing a product and understanding its potential failure modes. This paper will discuss some of the methodologies used to investigate assembly properties of different delivery systems, including separation techniques combined with on-line multiple detectors, and nanoscale imaging. Examples where the data are combined with modelling the morphology demonstrate the strength of combining multiple experiments with calculations to provide deeper insight into functionality for e.g. polymeric nanoparticles and drug dendrimer conjugates.
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