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.

HERE’S HOW

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.

Micro Case Study FBRM characterization allows for rapid optimization of formulation compositions so we can study the impact of processing conditions on product performance in a couple of days instead multiple weeks.

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