Comparative Pharmacokinetic Study of Single Oral Doses of Ibuprofen in Healthy Volunteers for Palestinian, British and American Pharmaceutical Equivalents in The Local Market

Year: 
2003
Discussion Committee: 
Dr. Ansam Sawalha- Supervisor
Dr. Nidal Za'atar-Internal Examiner
Dr. Omar Abuzaitoun- External Examiner
Supervisors: 
Dr. Ansam Sawalha
Authors: 
Abed-Al-Rahaman Mohammad Jarrar
Abstract: 
This study is conducted so as to test for the existence of actual or potential bioequivalence problems belonging to pharmaceutical equivalents of ibuprofen drug specifically the Palestinian local quality, British (Nurofen ) and American (Advil ) formulations available in the local market.To carry out this study three samples each of 24 healthy volunteers of both genders (12 males and 12 females) with the following average characteristics: age, weight, height and body mass index 20.667(year), 65.292(kg), 1.6929(m) and 22.750(kg/m²) respectively were admitted to the central laboratory of An-Najah National university and a single oral dose of 400 mg of each of the formulations was administered. Three blood samples were withdrawn to measure the drugs concentrations at three periods of time- (0.5hr, 1 hr and 1.5hr following administration). The analysis of blood plasma samples after cleaning them was carried out by utilizing the HPLC/UV. The concentration of ibuprofen in each sample was calculated and upon analyzing the results statistically, it was verified with a high degree of validation that there is a significant bio equivalence problem regarding the local brand relative to the other pharmaceutical equivalents and the difference between Nurofen and Advil was of no significant value.
Pages Count: 
137
Status: 
Published