Original Article PHARMACOKINETICS OF A NEWLY FORMULATED IBUPROFEN TABLET IN ARABIC HEALTHY INDIVIDUALS DUAA JAAFAR JABER AL-TAMIMI 1* , SABA ABDULHADI JABER 2 , HALAH TALAL SULAIMAN 3 1 College of Pharmacy, Al-Nisour University, Ministry of Higher Education and Scientific Research, Baghdad, Iraq. 2,3 Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad, Iraq * Corresponding author: Duaa Jaafar Jaber Al-tamimi; * Email: duaa.altamimi1@gmail.com Received: 18 Jun 2025, Revised and Accepted: 28 Jul 2025. Publication: 20 Aug 2025 ABSTRACT 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. Keywords: Ibuprofen tablet, Pharmacokinetics, Arabic men © 2025 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/) DOI: https://dx.doi.org/10.22159/ijap.2025v17i5.55640 Journal homepage: https://innovareacademics.in/journals/index.php/ijap INTRODUCTION Ibuprofen (IBU) was the first available over-the-counter (OTC) drug used and prescribed widely as a potent antipyretic, analgesic, and non-steroidal anti-inflammatory. It is available on the market in different doses, dosage forms and routes of administration, including injection, suspension, capsule, chewable tablet, and sustained- release tablet, in addition to a wide dose range of 100, 200, 400, 600, and 800 mg of immediate-release tablets. As OTC, IBU is usually given every 4-6 h orally in doses of 200-400 mg (not more than 1200 mg daily). It is prescribed orally for inflammatory disease every 6-8 h in a dose range of 400-800 mg (not exceed 3200 mg daily), for osteoarthritis and rheumatoid arthritis in 300, 400, 600, or 800 mg doses every 6-8 h (not more than 3200 mg daily) [1]. Ibuprofen (IBU) is rapidly and very well absorbed orally attaining its peak plasma levels within 1 to 2 h after extravascular intake. The terminal plasma elimination plasma half-life (t 0.5) of IBU is about 2 h [2- 5]. Administration of IBU tablet directly after food causes a reduction in the rate but not the extent of the absorption from GIT [6-8]. In addition, other factors may also affect the absorption of IBU [9-13]. Due to differences in the PKs of drugs because of many reasons such as administration of drugs in different doses, dosage forms like solid and ophthalmic dosage forms, routes of administration, food intake, concomitant therapy, and among various populations; therefore, there are ongoing recent researches for studying drugs PKs, bioavailability, particularly for drugs which possess difficulties in measuring in plasma and clearly identifying it clinical outcomes [14- 22]. Concerning IBU, it was found that the rate and extent of IBU absorption in the GIT from different formulations demonstrate significant differences in the onset, intensity and duration of pain reduction [23]. Hence, the current study was conducted to evaluate IBU PKs following the administration of a newly formulated IBU tablet in Arabic healthy men. This is the first study conducted in an Arabic population to calculate pharmacokinetics (PKs) by applying a newly developed formula, which is intended to be officially registered. MATERIALS AND METHODS Study design The study protocol was prepared according to the trial’s objectives and ICH guidelines for good clinical practice [24, 25] and the recent version of the Declaration of Helsinki [26]. As per the above-mentioned guidelines [24-26], the study protocol was ethically approved by the research ethics committee at the University of Baghdad under the approval number 442024G. The protocol described all details, including clinical, bioanalytical, and PKs. All the screened subjects were fully informed about all details of this clinical trial involving the objectives and any potential risks associated with their participation, in addition to their rights to withdraw at any time during the trial. All screened subjects were financially compensated. At the screening stage, the clinical investigator and the participant and two witnesses signed two original copies of the consent forms. Each participant was delivered his original copy of the informed consent, and the other copy of the informed consent was archived in the study source documents. Inclusion criteria Arabic healthy adult men who were willing to comply with all requirements of the protocol involving pre and post-study clinical examinations were chosen to be enrolled in this trial according to the following inclusion criteria: 1) ages between 18-50 y, 2) body mass index (BMI) range from18-30 kg/m 2 , 3) non-smoker or light smoker (<10 cigarettes per day), 4) no history of alcohol and drug abuse, 5) no involvements in any clinical trials such as PKs, bioavailability, 6) no recent surgical operation and/or blood donation for at least eight weeks prior this trial, and, 7) absence of acute infection within at least two weeks prior the study. International Journal of Applied Pharmaceutics ISSN- 0975-7058 Vol 17, Issue 5, 2025