The thermodynamic pharma challenge: A cross-cutting perspective

The development of pharmaceutical products and processes is associated with inherent challenges related to the stability, safety and purity of products for therapeutic applications. Low solubility and bioavailability of newly developed active pharmaceutical ingredients are among the biggest challenges in pharmaceutical development today, as this affects >90 % of newly developed drug molecules. Therefore, thermodynamic research could and should play a crucial role in the modelling and measurement of thermodynamic and kinetic data required for the understanding and design of safe and stable pharmaceutical products as well as their efficient and reliable production. The sixth edition of the IUT Symposium at the ECCE/ECAB 2023 meeting therefore focused on this “Thermodynamic Pharma Challenge”. The aim was to initiate an open discussion between stakeholders from industry and academia to share knowledge and identify bottlenecks that need to be addressed by the thermodynamic community. This manuscript addresses the topics discussed and presented in two sessions of the symposium: the panel discussion and the contributed talks. The symposium emphasized the need for advanced thermodynamic modeling to reduce the experimental effort required to estimate the solubility, stability and dissolution behavior of APIs. This is the most important prerequisite for the development of stable formulations and for increasing the efficiency of pharmaceutical production processes.