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FDA highlights Malvern’s innovative MDRS technology for Complex Generic drug product development

14 June 2016 No Comment

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MDRS Technology

Finally!  After what has felt like one of the wettest and longest winters in memory here in the UK, we’re now heading into the long, mellow days of midsummer.

But casting its miserable shadow over the barbecues, school holidays and paddling pools is the dreaded allergy season.  As one of the downsides of life in our “green and pleasant land”, during June we are hit hard by the combined impact of pollen from trees, grasses and weeds.

Many of us are now taking a daily antihistamine of some sort, and others reaching for corticosteroid nasal sprays to stop the inevitable itching, running, sneezing and wheezing.  The sun may be shining bright, but lots of us are hiding behind our shades, closing the windows, and settling into air-conditioned bliss!

All of which makes this blog, and some exciting news we have to share, extremely timely. On May 19th, the FDA’s Centre for Drug Evaluation and Research (CDER) published a story within the FDA/CDER SBIA (Small Business and Industry Assistance) Chronicles on its approval of the first generic nasal spray containing mometasone furoate.  This product is indicated for the treatment of both seasonal and year-round allergies, great news for hayfever sufferers like myself!

Any ANDA (abbreviated new drug application) approval is noteworthy, but the 8 year-long authorization process for Apotex’s generic allergy treatment is particularly significant.  The application of a traditional pharmacokinetic (PK) approach to establish bioequivalence for a locally-acting drug, rather than a systemic product, is extremely difficult.  This is further complicated by the unique drug-device interactions that are inherent in nasal sprays.  Requirements for the demonstration of bioequivalence for such products are substantial and complex, often resulting in lengthy and expensive studies, which rather defies the primary objective of generics development!

Nasal SprayThe team at Malvern is proud to have been able to support Apotex in their in vitro demonstration of bioequivalence for their generic mometasone furoate nasal spray, accepted by the FDA in lieu of a clinical endpoint study.

This is a historical first which may now pave the way for simpler, faster and less expensive development and subsequent FDA approval of some complex generics such as nasal spray drug suspensions.

Specifically, Apotex used the Malvern Morphologi G3-ID, which applies the technique of Morphologically-Directed Raman Spectroscopy (MDRS) to simultaneously analyze the size, shape and chemical ID of individual particles within their nasal spray suspensions. This  unique capability enabled Apotex to confirm the form of the drug and its particle size,  and enabled the FDA to bypass their requirement for a clinical-endpoint bioequivalence study. This revelation has also encouraged the FDA’s Office of Generic Drugs (OGD) to consider future in vitro studies of bioequivalence for inclusion in the approval of new ANDAs.

Do take a look at the FDA/CDER SBIA article, and to hear more OINDP industry perspectives, watch our webinar, Characterizing Nasal Suspensions for Regulatory and Scientific Purposes, by Dr. Jag Shur of Nanopharm. In this presentation, Jag discusses some of the analytical challenges in demonstrating bioequivalence which are faced by developers of complex generics.  He also describes Nanopharm’s use of the Morphologi G3-ID to provide robust particle size data specifically for the active ingredient (again mometasone furoate) in their generic nasal spray suspension, together with rotational rheometry via a Malvern Instruments Kinexus, to measure the rheological properties of this thixotropic formulation.

Morphologi G3-ID Request-a-demo
Kinexus Request-a-demo

Our whitepaper, “Laser Diffraction and automated imaging: complementary techniques for nasal spray development” is also not to be sneezed at!

Wishing you a happy, healthy, allergy-free summer, from all at Malvern Instruments.