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Morphologically-Directed Raman Spectroscopy (MDRS)

31 August 2017 No Comment

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GEN covers the role of MDRS in reducing the need for clinical bioequivalence endpoint studies

 

MDRS-300x270-NewMorphologically-Directed Raman Spectroscopy (MDRS) combines the capabilities of automated imaging with Raman spectroscopy in a single platform, creating a powerful analytical tool that spans multiple industries. It exhibits particular value in both innovator and generic pharmaceutical development, as detailed particle characterization enables a thorough understanding of individual materials and how they impact the final product – as demonstrated by a recent Malvern Panalytical article, featured on the GEN website.

 

Raman spectroscopy and MDRS enable determination of the size and shape of specific components within a multi-component blend.

This article followed the recent approval of an abbreviated new drug application (ANDA) for a locally-acting mometasone furoate nasal spray, which provided the opportunity for the US Food and Drug Administration (FDA) to highlight the pivotal and pioneering role MDRS played.

MDRS enables determination of the size and shape of specific components within a multi-component blend. For the purposes of the ANDA, this capability was used to compare the size of the active pharmaceutical ingredient (API) in the reference and test nasal sprays and confirm their close similarity. The resulting data were accepted in lieu of a clinical bioequivalence (BE) endpoint study, setting a precedent for future ANDAs – this could help reduce the cost and complexity of tests associated with a submission and accelerate new products to market.

At Malvern Panalytical, we understand the challenges faced by our customers and are constantly pushing the boundaries of instrument design and software control, and are always seeking to improve usability and increase measurement speed and range.

We’re proud to be unveiling the ultimate solution for every scientist who seeks absolute analysis and understanding of their samples to create confidence and control in optimized development and manufacture processes.

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