The poor water solubility and hence bioavailability of most newly developed active pharmaceutical ingredients (APIs) challenges formulators in industry in the development of a suitable formulation. Different enabling techniques for the bioavailability enhancement are available and need to be evaluated based on a limited available data, restricted amount of material and within short time lines. The here presented approach allows taking scientifically based decisions at stages from early drug development (e.g. finding the best stabilizing excipient class for a given API based on predicted intermolecular interactions) via formulation development (e.g. identifying optimal API loads, cosolvents or excipients, predicting the influence of different storage conditions) to the selection of a rational manufacturing process (e.g. designing a robust manufacturing process and defining critical quality attributed for that). By combination of thermodynamic and molecular mobility models, it is even possible to predict the shelf life (API crystallization) in metastable formulations.
This computer-aided approach is universally applicable to different formulation types during all stages of formulation development and thus a powerful tool for scientists in formulation development.
This session is not available to view on demand.
Gabriele Sadowski, Professor Laboratory for Thermodynamics, TU Dortmund University