The success of modern medications for the purpose of benefiting patients is a product of the best practice of interdisciplinary sciences and technologies. Structural details often provide the molecular mechanism to construct the interplay among biology, chemistry and engineering. Solid-state NMR spectroscopy (ssNMR) analyzes a wide range of insoluble pharmaceutical materials from small molecule medicines to biological products in a non-invasive and quantitative manner. The obtained structural information at macroscopic and microscopic scales offer critical knowledge for understanding and optimizing drug delivery, chemical and physical stability, bioavailability, formulation composition, and manufacturing process. This presentation will overview the versatile roles of ssNMR in pharmaceutical development for providing the structural basis for the design of drug substances and products. Advanced techniques including proton detection under ultrafast magic angle spinning (UF-MAS) and dynamic nuclear polarization (DNP) for overcoming low sensitivity challenges of natural abundance crystalline compounds, amorphous drug substance and solid dosages will be discussed. A variety of studies from small molecules to biopharmaceutics will be included as examples to introduce the molecular structure mediated questions in pharmaceutical sciences and elaborate how ssNMR techniques are employed to tackle these analytical challenges.
Yongchao Su, Ph.D
Principal Scientist and Head of Biopharmaceutical NMR Laboratory (BNL) in Pharmaceutical Sciences at Merck & Co, Inc.