Pharmacokinetics of bromfenac in healthy subjects after single oral administration of three different doses.

The pharmacokinetic profile of bromfenac (2-amino-3-(4-bromobenzoyl) benzeneacetic acid, CAS91714-93-1) has been investigated in 12 healthy subjects (6 male and 6 female) after single oral doses of 25, 50 and 75 mg. Plasma concentrations were determined by a sensitive HPLC method with spectrophotometric detection. Sampling was performed up to 300 min after drug ingestion. Linear pharmacokinetics could be verified for this dose-range; there was a clear, positive dose-plasma concentration relationship. Bromfenac exhibits a cmax of 3.49 +/- 1.65-8.81 +/- 3.45 micrograms/ml at tmax 52 +/- 27-42 +/- 15 min. The elimination half-life was 39.8 +/- 7.3-34.2 +/- 8.0 min with a clearance (Cl/f) of 120.6 +/- 51.6-135.3 +/- 34.6 ml/min and a volume of distribution (Vd/f) 6.82 +/- 2.88-6.64 +/- 2.29 l. The results obtained show a fast absorption and rapid elimination of bromfenac when administered orally. The short plasma half-life of bromfenac apparently presents no direct relationship to its clinical effectiveness.