News & Insights

Addition of the Malvern G3-ID at Nanopharm for the characterisation of nasal spray suspensions for regulatory and scientific purposes

Demonstrating bioequivalence (BE) for complex generics such as nasal spray suspension drug products is a challenging task. Sponsors not only have to consider device requirements but also understand the properties of the API in the presence of functional excipients. The process of achieving equivalence to the reference listed drug product is therefore complex. One of the key challenges for nasal suspensions is the measurement of the API particle size in the formulation suspension. To help accurately determine the API particle size in the formulated nasal spray, we at Nanopharm have further developed the Morphology-Directed Raman Spectroscopy (MDRS) approach using Malvern’s G3-ID to measure the particle size of the API in the suspension.

We have taken a systematic approach for measuring and assessing the API particle size changes within the formulation using the MDRS method, and have related these measurements with the dissolution behaviour of the API in the formulation. We have presented this research with Malvern Instruments in a recent webinar, where we explore how these analytical methods facilitate the determination of critical material and process attributes that may affect drug product quality. As part of the presentation we have shown research carried out during the development of a generic mometasone furoate product.

To view the recording of the webinar, please follow the link below: