The aim of the study was to assess the pharmacokinetic and bioavailability of 2 formulations of 5-mg prednisolone tablets, reference product (Teva UK Limited) and Pred (Eskayef Bangladesh Ltd) as test product. The open-label, randomized, 2-way crossover studies were conducted on 14 healthy subjects. Participants were assigned to receive both products as a single dose (20 mg formulations, 4 × 5 mg tablets) followed by a 2 weeks’ washout period. Following oral administration, samples were obtained at various time intervals and analyzed for prednisolone concentrations using a validated high-performance liquid chromatography assay method with ultraviolet detection. The obtained values for test and reference products were 683.00 ± 94.54 ng/mL and 635.16 ± 125.57 ng/mL for Cmax; 2716.54 ± 196.28 ng·h/mL and 2780.5 ± 119.73 ng·h/mL for AUC0-12; 3284.36 ± 138.12 ng·h/mL and 3317.96 ± 133.95 ng·h/mL for AUC0-∞, respectively. From the paired Student t test, no significant differences between 2 formulations were observed (P > .05). The 90% confidence intervals of Cmax, AUC0-12, and AUC0-∞ were found to be 99.0% to 100.9%, 99.4% to 100.5%, and 99.9% to 101.3%, respectively. Finally, it can be concluded that Pred (Test) of Eskayef Bangladesh Ltd and prednisolone (Reference) of Teva UK Limited are bioequivalent and interchangeable.
A diabetic individual gradually becomes more prone to infections and can be prescribed Metformin concurrently with a broad spectrum antibiotic like Cefepime. Our research examines the possibility of drug-drug interaction between Metformin and Cefepime in a number of in vitro and in vivo parameters. The in vitro tests including Differential Scanning Calorimeter, Scanning Electron Microscope and Fourier Transform Infra Red analysis were found to reveal visible changes in melting points, morphological structures and rearrangement of functional groups due to the interaction. The disc diffusion method was used to compare the antimicrobial properties of all the test samples and the antimicrobial potential of Cefepime was found to be suppressed moderately after in vitro interaction with Metformin. The alteration of the in vivo antidiabetic activity of Metformin was evaluated in streptozotocin-induced Long-Evans Rats, and the anti-hyperglycemic effect of Metformin was detected to decrease significantly in the resulting product of this interaction.
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