Relative bioavailability of diclofenac potassium from softgel capsule versus powder for oral solution and immediate-release tablet formulation.

摘要: The oral bioavailability of diclofenac potassium 50 mg administered as a soft gelatin capsule (softgel capsule), powder for solution (oral solution), and tablet was evaluated in randomized, open-label, 3-period, 6-sequence crossover study healthy adults. Plasma concentrations were measured using validated liquid chromatography-mass spectrometry/mass spectrometry method, pharmacokinetic analysis performed by noncompartmental methods. median time to achieve peak plasma 0.5, 0.25, 0.75 hours with the softgel capsule, solution, formulations, respectively. geometric mean ratio associated 90%CI AUCinf, Cmax formulation relative 0.97 (0.95-1.00) 0.85 (0.76-0.95), AUCinf 1.04 (1.00-1.08) 1.67 (1.43-1.96), In conclusion, exposure (AUC) new comparable that existing formulations. concentration from 67% higher than formulation, whereas it 15% lower comparison formulation.