Simulation Aided Pharmaceutical Hot Melt Extrusion Process Understanding, Setup and Scale-up

Abstract

During the pharmaceutical product development it is important, especially in the early phases, on get a good idea on the processability of the candidate formulations. Especially for hot melt extrusion (HME) based formulations choosing the appropriate equipment and process setup that will result in the desired product quality is not trivial. Especially significant in the early phases of the product development cycle, where typically only small amounts of active pharmaceutical ingredients (API) are available (often in the rage of couple of grams only), it is crucial to still be able to give educated guesses on the processability of the formulation, the expected product quality and, ideally, being able to propose candidate process setups. In order to fulfil the goals mentioned above, development of formulation and process specific knowledge is required, as well as development of potent in silico methodologies capable of mirroring the actual process itself. This work focuses on the development of suitable in silico tools for the accurate HME process capturing, extended experimental investigations and product quality correlation and prediction.