Effect of an Al/Mg Hydroxide Antacid and Food on the Pharmacokinetics of Dexibuprofen.

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 (401050), 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.