The bioavailability of bromazepam, omeprazole and paracetamol given by nasogastric feeding tube

Abstract

Aims: To characterize and compare the pharmacokinetic profiles of bromazepam, omeprazole and paracetamol when administered by the oral and nasogastric routes to the same healthy cohort of volunteers. Methods: In a prospective, monocentric, randomized crossover study, eight healthy volunteers received the three drugs by the oral (OR) and nasogastric routes (NT). Sequential plasma samples were analyzed by high-performance liquid chromatography-UV, pharmacokinetic parameters (Cmax, $${\text{AUC}}_{0 - \infty }$$ , t½, ke, tmax) were compared statistically, and Cmax, $${\text{AUC}}_{0 - \infty }$$ and tmax were analyzed for bioequivalence. Results: A statistically significant difference was seen in the $${\text{AUC}}_{0 - \infty }$$ of bromazepam, with nasogastric administration decreasing availability by about 25%: AUCOR = 2501 ng mL−1 h; AUCNT = 1855ng mL−1 h (p  0.05); ratio (geometric mean) = 1.01 (90% CI 0.64-1.61). An extended study with a larger number of subjects may possibly provide clearer answers. The narrow 90% confidence limits of paracetamol indicate bioequivalence: AUCOR = 37μg mL−1 h; AUCNT = 41μg mL−1 h(p > 0.05); ratio (geometric mean) = 1.12 (90% CI 0.98-1.28). Conclusion: The results of this study show that the nasogastric route of administration does not appear to cause marked, clinically unsuitable alterations in the bioavailability of the tested drug