Our client wanted to explore the possibility to make an adjustment in their formulation. A seemingly simple change from one isomer to another did in this case not only give rise to a different phase behavior; the manufacturing process needed to be altered and a non-trivial combinations of interactions came into play.
We identified the potential risk and ran a set of fundamental experimental studies to assess the associative behavior between the molecule and the other ingredients of the product. Today, the company can take a mature decision on which isomer to use based on clinical data but also on the different product- and process robustness the two isomers give rise to, respectively.
