Neutron and synchrotron X-ray scattering in pharmaceutical R&D : aqueous sugar systems, tablets, freeze-dried powders, and other stories

Orateur : Dr. Evgenyi SHALAEV (Allergan Inc, RD2-2D, 2525 Dupont Drive, Irvine, CA 92612, USA)

Pharmaceutical and biotech products represent systems of variable complexity, ranging from relatively simple molecules (e.g., aspirin) to biopolymers (e.g., proteins and olygonucleotides), viruses, and cell (e.g., parasite vaccines). Use of synchrotron X-ray in characterization of pharmaceutically-relevant materials is on the rise, covering both simple aqueous solutions, amorphous solids, and multi-component and multiphase systems such as tablets. Whereas neutron scattering, which is recognized as a powerful tool in studies of structure and dynamics of both proteins and small molecules, is still an exotic method for pharmaceutical R&D community. The presentation provides examples of use of synchrotron X-ray scattering to solve issues encountered during development process, such as investigating physical stability of freeze-dried powders, evaluating crystalline mesophases in active ingredient and formulations, and monitoring amorphous and crystalline forms of an API in tablets. Use of small-angle and wide-angle neutron scattering to probe heterogeneities in model aqueous solutions and glasses is discussed in some detail. Potential future applications of neutron scattering, such as investigation of protein aggregation and predicting physical stability of pharmaceutical glasses, are highlighted.

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