Dissolution Release Mechanisms for Amorphous Solid Dispersions

Over 70% of drug candidates in early development suffer from poor aqueous solubility, a critical challenge in pharmaceutical innovation that increases time, cost, and risk. Addressing this issue often requires labour-intensive and time-consuming approaches in materials science, formulation, or processing to overcome solubility limitations. Amorphous solids present a promising solution, offering significantly higher solubility and dissolution rates compared to their crystalline counterparts.

Furthermore, they can be produced using existing pharmaceutical processes. However, their development is limited by thermodynamic instability, a high risk of recrystallisation, analytical complexities, and unpredictable structures and properties, all of which add substantial cost and risk.

To tackle these challenges, this project develops new experimental cyberphysical system to study phase transformations during dissolution. A novel high-throughput system integrating optical coherence tomography (OCT) and UV-vis spectroscopy within a flow cell will be developed. This setup enables simultaneous quantification of microstructural changes, swelling, and liquid diffusion, as well as identification of phase transformations on the dosage form surface.

These advancements will provide valuable insights into the effects of formulation, processing, and dissolution media on drug release mechanisms and performance, paving the way for more efficient and effective pharmaceutical development.