CELEBRATING OUR STUDENT SUCCESS - The Role of Crystallization Science in Pharmaceutical Solid-Form Development

ABSTRACT

Solid-state form selection remains a critical aspect of pharmaceutical development, as crystallinity, polymorphism, hydration state, and particle properties can significantly influence a drug candidate's stability, manufacturability, and bioavailability. Despite advances in computational prediction and process design, identifying and controlling the optimal solid form remains a largely experimental challenge that requires a detailed understanding of crystallization behavior and phase transformations. My work focuses on developing this understanding through the integration of crystallization process development, solid-form screening, and advanced analytical characterization.

In this seminar, I will discuss approaches used to investigate and control the solid-state properties of small-molecule pharmaceutical compounds. By combining polymorph, salt, and cocrystal screening strategies with characterization techniques such as X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), dynamic vapor sorption (DVS), microscopy, and spectroscopic methods, it is possible to establish relationships between molecular structure, crystallization conditions, and material properties. These studies provide insight into phase stability, hydrate and solvate formation, thermal behavior, and particle attributes that are critical for successful pharmaceutical development.

BIOGRAPHY

Maria Fadelici is a Scientist III in Material and Analytical Sciences at Boehringer Ingelheim, where she focuses on pharmaceutical solid-state chemistry, crystallization process development, and material characterization. Her research centers on understanding and controlling the solid-state properties of drug candidates through polymorph, salt, and cocrystal screening, crystallization process development, and advanced analytical characterization. She has supported the development of numerous novel pharmaceutical compounds and routinely applies techniques such as X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), dynamic vapor sorption (DVS), spectroscopy, chromatography, and microscopy to investigate relationships between crystallization conditions, solid-form outcomes, and material performance.

Prior to joining Boehringer Ingelheim, Maria earned her M.S. in Chemistry from Stevens Institute of Technology, where she conducted medicinal chemistry research under the supervision of Dr. Sunil Paliwal. Her graduate research focused on the design and synthesis of novel small-molecule derivatives for antiviral drug discovery and combined synthetic organic chemistry with computational approaches to molecular design. Earlier in her career, Maria worked as a Clinical Research Associate at Memorial Sloan Kettering Cancer Center, where she supported clinical trials investigating novel therapies for patients with advanced sarcomas. She received her B.S. in Chemistry from the University of Scranton, where she performed undergraduate research in organic synthesis, developing synthetic methodologies and investigating the mechanistic pathways underlying organic transformations.