Bioavailability and Bioequivalence of Two Oral Single Dose of Ibuprofen 400 mg to Healthy Volunteers.

Abstract

Objective: The objective of the two pharmacokinetic studies reported here was to compare the relative bio availability and bio equivalence of an ibuprofen 400 mg tablet from National Company (SDI) as a test with a reference formulation. Study Design: Evaluation of two open, randomized, cross-over studies, one single dose in healthy male volunteers. Methods: 20 healthy volunteers were randomized in a cross-over design to single dose of Profedin 400 mg produced from National Company, ibuprofen formulation, as a test and a reference formulation produced from Pharmacia & Upjohn, Ibuprofen 400 mg. Ibuprofen and standard of ibuprofen were analyzed by utilizing HPLC, the sample extracted from 0.5ml of plasma with an organic solution of isooctane and 2-propanol. The mobile phase consisted of 44% acetonitrile and 0.1% phosphoric acid. The flow rate was 1 ml/min. The analytical column was a C-18, 5um packing size. Detection of Ibuprofen and the internal standard occurred by UV absorbance at wavelength of 220 nm. Results: A single-dose study demonstrated that the bio availability of ibuprofen for both formulations was not significantly different. In addition, mean plasma levels of ibuprofen predictive of clinical efficacy were achieved within 1.5- 2.0 hours and the elimination of ibuprofen tablets is virtually complete in 12 hours after the single dose. The serum half-life is 1.8 to 2.0 hours. The Cmax, Tmax, Kelemin.0.5 were calculated for the test and reference. They were not significantly different. Conclusions: Blood levels predicted that the present slow-release formulation of ibuprofen should offer reliable day and night control of pain and fever and is associated with a favorable safety profile.