Biowaiver Study on Prednisolone Tablets 5 mg in Three Different Brands Marketed in Sudan

[摘要] Prednisolone is widely used synthetic corticosteroids in inflammatory conditions. In the present study, the bioequivalence was studied in three different brands of prednisolone 5 mg tablets [Histacortine (Brand A, Innovtor), Crotrope Brand (B) and Cimapresone Brand (C) marketed in local Sudanese market using biowaiver. Firstly, the pharmaceutical equivalence was evaluated for the three brands, and then the biowaiver study was done using three different buffer solutions: pH 1.2, 4.5 and 6.8. The three brands complied with requirements of pharmaceutical equivalence. Brand (B) was bioequivalent to the innovator (release ≥85% in 15 min), for brand (C) less than 85% was released in 15 min so the similarity factor (f2) was calculated to evaluate the bioequivalence and it was less than 50, which mean brand (C) was failed to qualify biowaiver, therefore in vivo bioequivalence studies are required to ascertain bioequivalence.

[学科分类] 药理学

[关键词] Safaa Mohamed;Tilal Elsaman;Biowaiver;prednisolone;dissolution;bioequivalence