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

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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 = 1855 ng 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. 30 h). 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 = 579 ng mL−1 h; AUCNT = 587 ng 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 = 37 μg mL−1 h; AUCNT = 41 μg 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.

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Acknowledgements

The authors express their gratitude to Ms. Monique Appenzeller for her help during the trials, the nutrition nurse Ms. Isabelle Bordier, the technicians in the bioanalytical laboratory and the volunteers in this trial.

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Authors and Affiliations

  1. Department of Pharmacy, University Hospital Centre, Rue du Bugnon 46, 1011, Lausanne, Switzerland

    Gregory Podilsky, Markoulina Berger-Gryllaki, Bernard Testa & Andre Pannatier

  2. Division of Clinical Pharmacology, University Hospital Lausanne, Lausanne, Switzerland

    Thierry Buclin

  3. Clinical Nutrition Unit, University Hospital Lausanne, Lausanne, Switzerland

    Michel Roulet

  4. School of Pharmaceutical Sciences, EPGL, University of Geneva, University of Lausanne, Geneva, Switzerland

    Andre Pannatier

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  1. Gregory Podilsky
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  2. Markoulina Berger-Gryllaki
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  3. Bernard Testa
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  4. Thierry Buclin
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  5. Michel Roulet
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  6. Andre Pannatier
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Correspondence to Andre Pannatier.

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Podilsky, G., Berger-Gryllaki, M., Testa, B. et al. The bioavailability of bromazepam, omeprazole and paracetamol given by nasogastric feeding tube. Eur J Clin Pharmacol 65, 435–442 (2009). https://doi.org/10.1007/s00228-008-0613-4

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  • DOI: https://doi.org/10.1007/s00228-008-0613-4

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