Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems

摘要

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT? In tube-fed patients with severe neurodevelopmental problems, omeprazole for the treatment of gastro-oesophageal reflux disease often needs to be administered through the feeding tube.? In daily practice, various procedures are used to administer the commercially available, enteric-coated omeprazole formulations through a feeding tube.? No bioavailability data are available to support a rational choice between the available administration procedures.WHAT THIS STUDY ADDS? This study demonstrates a substantial interindividual variability in omeprazole pharmacokinetics after administration through the gastrostomy tube in patients with severe neurodevelopmental problems.? In most patients, plasma concentration–time profiles seem more favourable with a suspension formulation than with a MUPS? formulation.? Consequently, there is no apparent advantage in choosing a MUPS? formulation over the more easily administered suspension formulation.AIMS Omeprazole is often administered through a gastrostomy tube as either (i) a Multiple Unit Pellet System (MUPS?) tablet disintegrated in water (MUPS? formulation), or (ii) a suspension in 8.4% sodium bicarbonate (suspension formulation). This bioavailability study evaluates this practice in tube-fed patients with severe neurodevelopmental problems.METHODS Nonblinded, two-phase cross-over trial.RESULTS In seven of 10 patients, bioavailability was higher for the suspension formulation than for the MUPS? formulation. Median (90% confidence interval) area under the plasma concentration–time curve ratio (MUPS? over suspension) was 0.5 (0.06–2.37).CONCLUSIONS In this population, omeprazole MUPS? formulation has no apparent advantage over the more easily administered suspension formulation.