Navigating regulations and methods for Morphologically Directed Raman Spectroscopy in nasal sprays

Morphologically-Directed Raman Spectroscopy (MDRS) is a unique technique combining automated image analysis with Raman spectroscopy which has found key applications within bioequivalence testing of complex generics. Complex generics often contain a combination of active and excipients in the final form. The ability of MDRS to produce component specific particle size and shape data means that you can compare physicochemical attributes between generic and reference material in place of a clinical end point study.

In this webinar we will focus on nasal sprays. The FDA draft guidance for Nasal sprays include characterisation of the drug particle size distribution by microscopy. And while you can estimate which particles are active from the image alone, this can be confirmed by adding Raman spectroscopy. Hence, an increasing number of ANDA submissions for nasal suspensions have contained MDRS data. We will introduce how MDRS works, discuss how you might develop and validate methods for Nasal Sprays as well as reviewing recent publications.