DOI: https://doi.org/10.36347/sajp.2025.v14i09.003

Pages: 208-234

The in-vitro bioequivalence study of nasal sprays is useful to understand the efficiency of test product in comparison to reference product so that the equivalency in the in -vivo studies can be assessed. Analytical in vitro release tests were performed to statistically evaluate the performance of the nasal spray suspension formulation containing the corticosteroid active ingredient and compare its performance with the reference drug product. When performing in vitro testing, took into account the EMA Guide on Pharmaceutical Quality of Respiratory and Nasal Products (EMEA/CHMP/QWP/49313/2005 Corr) and the Food and Drug Administration (FDA, Draft Guideline). According to the results of all in vitro bioequivalence studies, it was concluded that Nasal Spray Product containing corticosteroids active ingredient, which contains the corticosteroid active ingredient developed and produced by Abdi İbrahim R&D center, is therapeutically equivalent to the reference product.