Presentation Description: Tablet Formulation and process development for fast track APIs must provide robust formulation and process suitable for the whole clinical development since first-in-human up to commercial manufacturing, without any re-formulation or extensive trials and fine tuning. At the same time, the initial quantities of API or drug product intermediate are typically limited. Material sparing approaches coupled with computational tools for oral drug product are the core of industrial approach to fast track formulation and process development. Here, we present case studies where material sparing and computational methods were successfully applied and enabled direct GMP supply without scale-up trials. Tablet formulation was supported by a formulation database, mixing rules and a platform-based approach. Wherever possible, relevant tablets properties were expressed in size and shape independent measures and were evaluated as a function of tablets porosity and tablet press speed-independent properties. A preliminary design space accounts for acceptable processability, robustness and performance.
Upon completion, participant will be able to list material sparing methods for fast track tablet development
Upon completion, participant will be able to describe how to generate a robust early phase design space
Upon completion, participant will be able to describe how material sparing methods contribute to right first time scale-up and fast track tablet development