Pharmacokinetics of a Newly Formulated Ibuprofen Tablet in Arabic Healthy Individuals

Objective: To evaluate the pharmacokinetics (PKs) of a newly formulated immediate-release ibuprofen (IBU) 400 mg tablet administered to healthy Arabic volunteers. Methods: This was a single-dose study conducted on healthy Arabic subjects under overnight fasting. Each subject received one 400 mg tablet of the newly formulated IBU. Blood samples were collected at pre-determined intervals for up to 12 h post-dose. Pharmacokinetic parameters including maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), area under the curve from time zero to last measurable concentration (AUC₀₋ₜ), area under the curve from time zero to infinity (AUC₀₋∞), elimination rate constant (Kₑ), elimination half-life (T 0.5), mean residence time (MRT), clearance/bioavailability (Cl/F), and volume of distribution/bioavailability (Vd/F) were calculated using non-compartmental analysis. Results: The mean±SD pharmacokinetic parameters of IBU after a single 400 mg dose were as follows: Cmax = 26.1±4.7 µg/ml, Tmax = 1.98±0.56 h, AUC₀₋ₜ = 103.4±23.5 µg·h/ml, AUC₀₋∞ = 107.8±28.6 µg·h/ml, %AUCextra= 3.5±2.6, Kₑ = 0.310±0.047 h⁻¹, T 0.5 = 2.29±0.42 h, MRT = 4.17±0.84 h, Cl/F = 3.9±0.71 l/h, Vd/F = 12.6±2.3 l. The newly formulated IBU tablet was well tolerated by all participants with no significant adverse effects observed. Conclusion: The present investigation introduced the PK parameters of a newly formulated IBU tablet administered to Arabic healthy individuals which were found to be comparable to the data presented in literature for other IBU tablets. Consequently, the new IBU formula can be introduced to the market as a safe and effective product.