. Optimal process conditions and excipients will be selected to obtain a specific crystal size distribution using a high throughput screening approach. The objectives of this project are for the ESR to gain skills and generate data on the nucleation and crystal growth of the selected class of APIs during antisolvent precipitation. Molecular dynamics simulations on each active pharmaceutical ingredient (API) model system, excipient and solvent/antisolvent system will be conducted. In situ monitoring will support the proposed mechanisms by which the crystallization process is proceeding with control over the resultant polymorphic form demonstrated. API suspensions will also be produced with the same crystal size distributions using industrially accepted top down approaches. Controlled release kinetics, stability and bioactivity of the resulting suspensions in biorelevant media suitable for the target application of the relevant API will be compared.
