Using Raman for the characterization of nasal drug suspension products

Demonstrating bioequivalence (BE) in locally acting nasal suspension drug products is a significant challenge, though essential for the commercialization of generics.

This paper presents studies of the utility of morphologically directed Raman spectroscopy (MDRS) within this context, based on measurement of the particle size distribution of mometasone furoate monohydrate (MFM) in different suspension formulations. FDA product specific guidance for nasal drug suspension products highlight the potential to use MDRS in place of comparative clinical endpoint studies, a strategy with potential to accelerate generics to market. Drug substance particle size distribution data were measured using MDRS for a reference listed drug (Nasonex) and four test formulations. Other characteristics such as dissolution profile were also assessed. The data highlight the potential of dissolution testing as an orthogonal, critical analytical tool in BE studies.