Cambridge, United Kingdom – Intertek, a leading global Total Quality Assurance provider to industries worldwide, today announced an expansion in technology that offers clients a new tool in the development of Orally Inhaled and Nasal Drug Products (OINDPs), in particular for generic nasal suspensions, providing generics developers with a more efficient route to market.
This new technology, Malvern Instruments’ Morphologi G3-ID, which is now offered by Intertek Melbourn, uses morphologically-directed Raman spectroscopy (MDRS), allowing direct measurement of active pharmaceutical ingredient (API) particle size in the nasal suspension. This was previously difficult to achieve without the Raman function as excipient particles are often a similar size and shape to the API particles. MDRS allows Raman spectra to be produced for selected particles, with this additional chemical information providing robust identification of both drug and excipient.
Companies bringing generic, off-patent nasal medicines to market are required to conduct potentially costly bioequivalence studies to ensure the safety and efficacy of their products which includes conducting clinical pharmacokinetics (PK) studies to support in-vitro work, depending on the intended market and the previously available analytical techniques.
For locally-acting drugs, such as nasal sprays, bioequivalence is extremely challenging, as it is often impossible to accurately measure drug concentrations in the systemic blood circulation, adding to both the analytical complexity and time and cost of development.
The U.S. Food & Drug Administration (FDA) Centre for Drug Evaluation and Research recently released a white paper*, citing Apotex’s successful abbreviated new drug application (ANDA) for a generic mometasone furoate nasal spray. The white paper describes how the approval hinged on Apotex’s use of MDRS data as part of a weight-of-evidence approach in lieu of a traditional clinical endpoint study.
Meeting regulatory requirements through cost-effective and efficient approaches, such as the inclusion of MDRS data, is of huge interest to generics developers and should support the development and approval of more generic nasal products in the future.
Chris Vernall, Intertek Melbourn said: “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.”
Intertek’s integrated formulation and analytical team for inhalation medicines have over 20 year of experience in conducting early stage pre-formulation support, formulation development, excipient compatibility, method development and validation, solubility screening, drug-excipient compatibility, stability testing and device selection support. These specialist capabilities are focused on helping clients to overcome the challenges in both formulation and testing of these products.
Notes to editors
*US FDA White paper; ‘FDA Embraces Emerging Technology for Bioequivalence Evaluation of Locally Acting Nasal Sprays’; Li Bing; June 2016
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 40,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains.
Bringing quality and safety to life
For media information, please contact
UK PR Manager
Tel: 07786 525390