Principal Scientist Lonza Pharma and Biotech Bend, Oregon
Presentation Description: Low organic solubility compounds in need of bioavailability enhancement by spray drying are increasingly prevalent in many development pipelines. Using mixed aqueous/organic solvents is one way to improve organic solubility, thereby increasing process throughput, though this approach may impart phase separation risks by solvent enrichment during drying. Practical tools for predicting the impacts of mixed solvents on the properties and performance of spray-dried dispersions is an important gap in process and formulation development. This work presents a model for droplet drying and phase behavior in a four-component system incorporating two different solvents. The model is intended to assist spray solvent selection by assessing phase boundaries encountered as a result of the starting solvent composition. The Ritonavir/PVP-VA/Methanol/Water system is discussed as an model system in which the API is soluble in the starting and ending states of the droplet, but encounters a miscibility gap at intermediate compositions.
Optimize process spray drying process throughput by choosing optimized solvent compositions.
Minimize phase separation risks by identifying high risk solvent compositions.
Apply modeling tools to a representative quaternary spray solution system.