Summary
In May 2023, the FDA updated the fluticasone propionate, mometasone furoate and fluticasone furoate nasal suspensions FDA bioequivalence guidelines to include dissolution testing as an in-vitro Bioequivalence (IVBE) requirement. This update has given generic companies the opportunity to better understand the product being formulated by detecting meaningful differences between the candidate Test and Reference product formulations. The differences between the products may be minor, however the knowledge gained from the dissolution testing can be further expanded on by using other orthogonal techniques, such as Morphology Directed Raman Spectroscopy (MDRS) and Particle Size Distribution (PSD) by Laser Diffraction. These additional tests can give insights into the reasons for differences seen in the dissolution data by assessing the particle size within the bulk product formulation, whilst also giving API specific size and shape information. These are critical variables that will affect dissolution (and as a result for these products, the pharmacokinetic profile observed). This design of experiment approach is not limited to nasal sprays and can also be used to aid in de-formulation, early screening and assessment of other OINDP delivery platforms.
In this study, the dissolution profiles of two commercially available mometasone furoate nasal sprays which have already been proven to be bioequivalent, were appraised and differences between these two products were further assessed using MDRS and laser diffraction. Although deemed bioequivalent; subtle differences were seen in the dissolution profiles which were evaluated using the supporting orthogonal analysis which confirmed a slight difference in API particle size within one of the device manufacturers.