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


Autoria(s): Podilsky G.; Berger-Gryllaki M.; Testa B.; Buclin T.; Roulet M.; Pannatier A.
Data(s)

2009

Resumo

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, AUC(0-infinity), t(1/2), k(e), tmax) were compared statistically, and Cmax, AUC(0-infinity) and t(max) were analyzed for bioequivalence. RESULTS: A statistically significant difference was seen in the AUC(0-infinity) of bromazepam, with nasogastric administration decreasing availability by about 25%: AUC(OR) = 2501 ng mL(-1) h; AUC(NT) = 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: AUC(OR) = 579 ng mL(-1) h; AUC(NT) = 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: AUC(OR) = 37 microg mL(-1) h; AUC(NT) = 41 microg 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.

Identificador

http://serval.unil.ch/?id=serval:BIB_40E54B8E7B5F

isbn:1432-1041[electronic]

pmid:19189088

doi:10.1007/s00228-008-0613-4

isiid:000265440800001

Idioma(s)

en

Fonte

European Journal of Clinical Pharmacology, vol. 65, no. 5, pp. 435-442

Palavras-Chave #Acetaminophen/administration & dosage; Acetaminophen/blood; Administration, Oral; Analgesics, Non-Narcotic/administration & dosage; Analgesics, Non-Narcotic/blood; Anti-Anxiety Agents/administration & dosage; Anti-Anxiety Agents/blood; Anti-Ulcer Agents/administration & dosage; Anti-Ulcer Agents/blood; Area Under Curve; Biological Availability; Bromazepam/administration & dosage; Bromazepam/blood; Cohort Studies; Cross-Over Studies; Female; Half-Life; Humans; Intubation, Gastrointestinal; Male; Metabolic Clearance Rate; Omeprazole/administration & dosage; Omeprazole/blood; Prospective Studies; Reproducibility of Results; Therapeutic Equivalency
Tipo

info:eu-repo/semantics/article

article