Solid-state NMR Spectroscopy in Pharmaceutical Sciences from Drug Delivery to Formulation Development

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.

Dr. Su is a Principal Scientist and Head of Biopharmaceutical NMR Laboratory (BNL) in Pharmaceutical Sciences at Merck & Co, Inc. and an Adjunct Faculty in Colleague of Pharmacy at the University of Texas at Austin and Purdue University. He works as an analytical lead of drug product development on small molecules, peptides, oligonucleotides and monoclonal antibodies since joining Merck in 2014. Yongchao has received postdoctoral training at Massachusetts Institute of Technology with Prof. Robert G. Griffin after his Ph.D. at Iowa State University with Prof. Mei Hong in 2011. He is a member in Physical Analysis Expert Committee in United States Pharmacopeia (USP). He currently serves in the Editorial Advisory Board for Molecular Pharmaceuticals, Journal of Pharmaceutical Sciences, and Magnetic Resonance in Chemistry. He has contributed over 80 peer-reviewed journal articles and is a coinventor of patents on drug developments of therapeutic chemicals and proteins.