Framework for Rational Amorphous API Development

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In this project the amorphous generation landscape will be explored by determining the impact of molecular structure, process history and impurities on the local structure, stability, and performance of relevant API compounds.To understand how different processing routes can favour desirable outcomes, the influence of processing and isolation routes on the ease of amorphous solid formation and stability will be investigated.The project will focus on key objectives including:1. Selection of initial API candidates to study.2. Take each API through a selected processing chain to include crystallisation, spray drying, melt quenching, ASD formulation.3. Explore the isolation and drying stages following amorphous solids generation to determine their impact on the final API stability and develop new strategies for optimising them (focus on understanding the impact of dynamic drying profiles with respect to Tg and on solvent plasticisation).4. Samples will be characterised using relevant techniques including optical, thermal, spectroscopic, diffraction/scattering and/or mechanical tests to identify consistency or variability in amorphous sample structure as a function of the processing route. Samples will also be subjected to stress//accelerated stability conditions to assess physical stability and changes/re-crystallisation as a function of key stress conditions (such as T, %RH, aqueous environments and mechanical).