Based on the thermodynamic and kinetic properties of the complex systems, the ESR will identify and validate the attainable size ranges and limitations of the different processing routes and predictive in silico approaches for the relevant phenomena e.g. time constants for nucleation/growth kinetics and effective surface poisoning/affinity of the selected excipients resulting in nanosuspensions possessing different physical and chemical qualities and stabilities. ESR 5 will also explore more generic applicability of modelling and excipient selection tools across bottom-up and top-down manufacturing methods for nanosuspensions.
A generalized experimental workflow and decision tree for technology platform and excipient selection for the development of aqueous suspensions will be developed. The derived methodology will be the result of the investigation of proprietary Janssen compounds in addition to the insights gained on model APIs by ESR 1-4.