Summary

Demonstrating bioequivalence of nasal suspension sprays is a challenging task. The application of analytical tools are required to determine particle size of the active pharmaceutical ingredient (API) and formulation structure. This study investigated, the utility of the Morpologi-M4-ID to investigate the particle size distribution (PSD) of API formulated nasal sprays. Rotational rheometry was used to investigate formulation structure. A systematic approach was utilised to develop a robust method for the analysis of the PSD of Mometasone fuorate in five test formulations containing different concentrations of Avicel. Rheometric measurements were sensitive to variations in the Avicel content and at lower concentration than Nasonex exhibited different gel-like and shear thinning properties.  Together, these analytical methods may facilitate the determination of critical material and process attributes that may affect drug product quality.

Key Message

Four nasal suspensions with different concentrations of Avicel were formulated. The concentration of Avicel has a major impact on the rheology properties and particle morphology of the formulations and, consequently, on the droplet size distribution. No effect was observed for API particle size distribution and dissolution profile.