Abstract
Objectives In this communication we report an important findings, the
effect of Al/Mg hydroxide antacid and food on the pharmacokinetics
of dexibuprofen when administered concomitantly.
Methods Subjects were divided into four groups, each containing 6
subjects, to evaluate the effect of antacid and food on pharmacokinetic of
dexibuprofen. A new HPLC method was developed and validated for plasma
sample analysis. Mobile phase was comprised of Acetonitrile: Methanol: 0.05M
Phosphate buffer (40:10:50), pH was adjusted to 6.85±0.01 with NaOH.
Mobile phase was eluted through C18-ODS column and drug was detected at
223 nm. Plasma was obtained and stored at
− 70°C until analysis. Drug was extracted from each
plasma sample of volunteer and quantified by using HPLC technique.
Results A decrease in dexibuprofen absorption was observed in Test
Group-1 when administered with Antacid as compared to Controlled Group-1.
Mean Cmax values showed a significant (p value 0.035) decrease
from 44.14±2.3 to 33.1±0.8 μg/mL.
Tmax, Area under curve, t1/2, Cl,
Vd and Ke were not affected significantly. AUC
increased from 195.7±8.9 μg.hr/mL to
222.8±14.7 μg.hr/mL. In contrast, test
Group-2 showed an increase in dexibuprofen absorption.
t1/2 increased significantly from 4.505±0.19
hrs to 6.216±0.36 hrs whereas Ke reduced from
0.159±0.00 to 0.116±0.006 hrs-1. Cmax
increased from 44.877±2.263 to
51.721±0.096 μg/mL.
Conclusion It is concluded that concomitant intake of Al/Mg
hydroxide antacid or food with dexibuprofen has an impact to significantly
alter its pharmacokinetic parameters.
Key words
dexibuprofen - pharmacokinetic - drug-Interaction - HPLC