Effects of age and gender on the pharmacokinetics of bromfenac in healthy volunteers

OBJECTIVE: To compare the pharmacokinetic parameters of bromfenac, a nonsteroidal antiinflammatory drug under development, in healthy volunteers of various ages and either gender, after single and multiple doses. DESIGN: Open-label, single- and multiple-dose, nonrandomized, parallel study. PARTICIPANTS: Twenty young (18-45 y), 12 young-elderly (65-74 y), and 12 elderly (75-85 y) subjects were studied. Half of the subjects in each group were women. INTERVENTIONS: Bromfenac was given as a single 50-mg dose and then as 50-mg doses every 12 hours for 3 additional days. Twelve blood samples were collected for 12 hours after the first and last doses. MAIN OUTCOME MEASURES: Bromfenac concentrations were measured by using an HPLC procedure with ultraviolet detection. Unbound bromfenac concentrations were measured by equilibrium dialysis. Pharmacokinetic analysis was performed by noncompartmental techniques. RESULTS: No significant differences related to gender were detected. Significant differences were observed in half-life (t1/2), AUC, clearance, and apparent volume of distribution when the elderly group was compared with the young group and in t1/2 when the elderly group was compared with the young-elderly group, although substantial overlap among groups was observed. CONCLUSIONS: Administration of bromfenac to young-elderly or elderly subjects of either gender does not require a dosage adjustment in acute settings. Consideration should be made to titrating dosages in patients over 75 years of age who require repeated doses.