Analytical development can make or break a drug, and at Nucleo, analytical chemistry and formulation development work hand-in-hand to help make sure yours succeeds. We first characterize the drug and then use an iterative process to further refine the formulation development.
We test the chemical and physical stability of lead prototypes according to ICH guidelines to assess their shelf life under stressed conditions. We then transfer our analytical methods to CMOs so they’re ready for method validation. In fact, we developed the use of the focused beam reflectance measurement (FBRM) to monitor particle kinetics of solid dosage formulations.