Bioavailability of a crushed pantoprazole tablet after buffering with sodium hydrogencarbonate or magaldrate relative to the intact enteric coated pantoprazole tablet

The aim of this study was to determine the bioavailability of orally admini stered, crashed pantoprazole tablets after buffering with either 1.4% sodiu m hydrogencarbonate or 1600mg magaldrate relative to the intact enteric coa ted pantoprazole tablet. A single dose, three-period crossover study was pe rformed with 18 healthy male volunteers. The crushed pantoprazole suspensio n, together with either sodium hydrogencarbonate or magaldrate, was adminis tered via a nasogastral tube. T-max of crushed pantoprazole was earlier as compared to the intact tabley (0.5h vs, 3h) and C-max was 93% when using so dium hydrogencarbonate as the buffering agent, and 88% when using magaldrat e. Based on the internationally approved confidence intervals for AUC (0.80 -1.20) and C-max (0.70-1.43), the crushed tablet buffered with sodium hydro gencarbonate was shown to be bioequivalent with the intact tablet (point es timates for AUC or C-max ; 0.93 or 1.10). For the crushed tablet buffered w ith magaldrate (point estimates for AUC or C-max; 0.88 or 1.12) bioequivale nt with the intact tablet could not be formally demonstrated, although the lower confidence limit for AUC of 0.78 was only slightly below the lower li mit of the equivalence range of 0.80. (C) 2001 Prous Science. All rights re served.