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

Podilsky, Gregory ; Berger-Gryllaki, Markoulina ; Testa, Bernard ; Buclin, Thierry ; Roulet, Michel ; Pannatier, Andre

In: European Journal of Clinical Pharmacology, 2009, vol. 65, no. 5, p. 435-442

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    Title
    • The bioavailability of bromazepam, omeprazole and paracetamol given by nasogastric feeding tube
    Author
    • Podilsky, Gregory. Department of Pharmacy, University Hospital Centre, Rue du Bugnon 46, 1011, Lausanne, Switzerland
    • Berger-Gryllaki, Markoulina. Department of Pharmacy, University Hospital Centre, Rue du Bugnon 46, 1011, Lausanne, Switzerland
    • Testa, Bernard. Department of Pharmacy, University Hospital Centre, Rue du Bugnon 46, 1011, Lausanne, Switzerland
    • Buclin, Thierry. Division of Clinical Pharmacology, University Hospital Lausanne, Lausanne, Switzerland
    • Roulet, Michel. Clinical Nutrition Unit, University Hospital Lausanne, Lausanne, Switzerland
    • Pannatier, Andre. Department of Pharmacy, University Hospital Centre, Rue du Bugnon 46, 1011, Lausanne, Switzerland
    Document Type
    • Postprint
    Language
    • English
    Published in
    • European Journal of Clinical Pharmacology, 2009, vol. 65, no. 5, p. 435-442. Springer-Verlag
    Other Version
    OAI-PMH Identifier
    • oai:doc.rero.ch:310351
    Summary
    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) = 0.74 [90% confidence interval (CI) 0.64-0.87]. However, this does not appear to be clinically relevant given the usual dosage range and the drug's half-life (approx. 30h). A large interindividual variability in omeprazole parameters prevented any statistical conclusion from being drawn in terms of both modes of administration despite their similar average profile: AUCOR = 579ng mL−1 h; AUCNT = 587ng 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 drugs