Intertek has announced the addition of morphologically-directed Raman spectroscopy (MDRS) capabilities to its OINDP analytical and development services with the acquisition of a Malvern Instruments Morphologi G3-ID.
MDRS has the ability to distinguish API particle from excipient particles in nasal suspensions, allowing for direct measurement of API particle size distribution, making it easier for generics developers to demonstrate bioequivalence.
The company cites recent statements by the FDA’s Bing Li suggesting that the FDA’s acceptance of an ANDA from Apotex for its mometasone furoate nasal spray based on MDRS data in lieu of a clinical endpoint BE study “opened the possibility for in vitro appraisals of BE to be used in the review of future ANDAs submitted to the FDA.”
Intertek Melbourn Business Development Manager Chris Vernall commented, “This recent development in technology, coupled with an example of successful approval means that well-formulated generic nasal products now have a far greater chance of in-vitro only bioequivalence approval, meaning a potentially quicker and less expensive route to market.”
Read the Intertek press release.
