(368e) Controlling Impurity Incorporation Mechanisms in Pharmaceutical Crystallization Processes

Crystallization is an industrial process that is commonly used for separating and purifying pharmaceutical drug substances, food products, and fine and bulk chemicals. A more scientific understanding of how impurities are retained in a drug substance has implications from both the perspectives of process development and product design. Although the presence of impurities above regulatory thresholds has been responsible for drug recalls, the scientific reasons behind impurity incorporation in pharmaceutical crystallization processes are not well understood. The overall goal of my current PhD research revolves around studying and controlling impurity retention mechanisms occurring in pharmaceutical crystallizations, with the purpose of contributing to expanding both scientific and industrial knowledge for minimizing impurities in drug products that can be harmful to humans and animals.

My work has resulted in the publication of six peer-reviewed papers, two of which I am listed as the first author, three as second author, and an additional one as a co-author. My research includes examining the degree in which impurity incorporation is selective to specific crystal faces, and how facet-specific incorporation affects crystal growth and dissolution. Examining impurity retention at the scale of single crystals and their faces will enable the development of more targeted strategies for manufacturing pharmaceutical drug substances. In addition, controlling the extent of impurity incorporation can aid in the research, development, and design of drugs with favorable pharmacological properties such as solubility and bioavailability. This work will also open the door to more opportunities and possibilities for tuning the solid-state properties of drug substances and aid in the development of drug products that are safe for human consumption.