Comparative in vitro and in vivo bioavailability of naproxen from tablet and caplet formulations.
A 500 mg dose of naproxen in a caplet formulation (product A) or a tablet (Naprosyn 500, product B) was administered to 14 fasting healthy subjects on two separate occasions, separated by a 1-2 week washout period in an open, randomized crossover. Blood samples were drawn periodically and plasma naproxen concentrations measured by HPLC. The median time Tmax to reach peak concentration for product A was shorter than that for product B (1.025 h versus 1.5 h) but A and B were similar with respect to median peak plasma concentration Cmax (77.9 mg l-1 versus 71.4 mg l-1), and average area AUC0-infinity under the plasma concentration-time curve (1210.2 mg l-1 h versus 1211.0 mg l-1 h). In vitro parameters (A versus B) of mean dissolution time MDT (5.03 min versus 15.0 min), and time for 70% dissolution T70 (6.67 min versus 20.2 min), differed significantly.
Charles
B G
BG
Department of Pharmacy, University of Queensland, Australia.
Mogg
G A
GA
D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D002214:Capsules; D005260:Female; D006801:Humans; D066298:In Vitro Techniques; D008297:Male; D008954:Models, Biological; D009288:Naproxen / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013607:Tablets
D002214:Capsules; D013607:Tablets; D009288:Naproxen