In recent news, the FDA has used key data generated on the Malvern Morphologi G3-ID system to approve the first generic nasal spray drug product containing mometasone furoate. The primary challenge with this approval was proving bioequivalence compared to the innovator product.
In their media release, the FDA indicated that the use of data obtained using Morphology Directed Raman Spectroscopy (MDRS) allowed them to validate the bioequivalence of the two products without the need for costly clinical endpoint bioequivalence studies.
MDRS is an analytical technique which uses a combination of static image analysis and Raman spectroscopy to characterize the size, shape, and chemical identification of particles in a sample. This provides the complete understanding of the characteristics of all components in a drug product including the drug substance, excipients, or any contaminant particles contained in the formulation. It was the unique abilities of this technology which allowed the FDA to justify bioequivalence using in vitro data alone.
If you would like to learn more how the Morphologi G3-ID can assist in the characterization of your drug product, please contact Malvern Instruments to arrange a no obligation product assessment.