From Particles to Drug Product Performance and Stability

How a pharmaceutical tablet disintegrates and dissolves when it comes in contact with a physiological fluid is crucial for the performance of the medicine. Critical performance characteristics are controlled by the chemical and physical properties of the drug substance and excipients paired with the manufacturing processes used to transform the powder into a compact. The microstructure created during manufacturing in combination with the wetting, swelling and dissolution properties of the raw materials are decisive for reliable drug release. Recently it has also become increasingly clearer that physical characteristics of pharmaceutical tablets change during storage, which in turn affect the performance when the medicine reaches the patient.

In this webinar, we will discuss the interplay between particle properties, formulation, microstructure and stability-related performance changes. We will demonstrate the integrated use of advanced measurement techniques with multi-scale modelling approaches to gain insights into the relationship between particle characteristics, compact microstructure, storage conditions and the disintegration and dissolution performance of tablets. The new insights gained about the relationship between the raw material attributes, manufacturing process and drug product performance will allow us to move away from a laborious and lengthy empirical, trial and error, development to a digitally driven design process, where the tablet disintegrates and releases the drug substance in a reproducible and predictable manner.