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Comparative in vitro and in vivo bioavailability of naproxen from tablet and caplet formulations
Author(s) -
Charles B. G.,
Mogg G. A. G.
Publication year - 1994
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.2510150204
Subject(s) - naproxen , bioavailability , crossover study , chemistry , pharmacokinetics , chromatography , high performance liquid chromatography , washout , in vivo , dosage form , pharmacology , bioequivalence , plasma concentration , medicine , alternative medicine , microbiology and biotechnology , pathology , biology , placebo
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 T max 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 C max (77·9 mg 1 −1 versus 71·4 mg 1 −1 ), and average area AUC 0–∞ under the plasma concentration—time curve (1210·2 mg 1 −1 h versus 1211·0 mg 1 −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 T 70 (6·67 min versus 20·2 min), differed significantly.