EFFECTS OF AGE AND GENDER ON THE PHARMACOKINETICS OF BROMFENAC IN HEALTHY-VOLUNTEERS

OBJECTIVE: To compare the pharmacokinetic parameters of bromfenac, a n onsteroidal antiinflammatory drug under development, in healthy volunt eers of various ages and either gender, after single and multiple dose s. DESIGN: Open-label, single- and multiple-dose, nonrandomized, paral lel 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 sub jects 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 addit ional 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 technique s. RESULTS: NO significant differences related to gender were detected . Significant differences were observed in half-life (t(1/2)), AUC, cl earance, and apparent volume of distribution when the elderly group wa s compared with the young group and in t(1/2) when the elderly group w as compared with the young-elderly group, although substantial overlap among groups was observed. CONCLUSIONS: Administration of bromfenac t o 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 repeat ed doses.