Esomeprazole administered through a nasogastric tube provides bioavailability similar to oral dosing.
OBJECTIVE
To determine if nasogastric tube administration of the enteric-coated pellets from an opened esomeprazole capsule provides bioavailability similar to oral dosing with the intact capsule.


METHODS
A randomized, single-centre, open-label, two-period crossover pharmacokinetic study consisting of two 5-day dosing periods separated by a 7- to 14-day washout period was conducted. Healthy subjects between the ages of 18 and 50 years received esomeprazole 40 mg once daily either orally as an intact capsule, or as a suspension of the enteric-coated pellets from an opened capsule in water through a nasogastric tube.


RESULTS
In 47 evaluable subjects, the 90% confidence intervals were 0.87-1.08 and 0.93-1.25 for the geometric mean of the ratio of nasogastric tube administration relative to administration of the intact capsule for the area under the plasma concentration-time curve and for maximum plasma concentration, respectively, on day 1, demonstrating bioequivalence. Oral and nasogastric administration also demonstrated similar bioavailabilities on day 5. Esomeprazole was well tolerated regardless of the mode of administration.


CONCLUSIONS
Nasogastric tube administration of the enteric-coated pellets from an opened esomeprazole 40 mg capsule provides bioavailability similar to oral dosing. Administration of the contents of an opened esomeprazole 40 mg capsule in water through a nasogastric tube is a practical alternative for patients with feeding tubes who require effective gastric acid suppression, but cannot swallow an oral preparation.
Sostek
M B
MB
Clinical Research, Biostatistics and Experimental Medicine, AstraZeneca LP, Wilmington, DE 19850-5437, USA. Mark.Sostek@astrazeneca.com
Chen
Y
Y
Skammer
W
W
Winter
H
H
Zhao
J
J
Andersson
T
T
D000281:Administration, Intranasal; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D064098:Esomeprazole / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D007440:Intubation; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors
D054328:Proton Pump Inhibitors; D064098:Esomeprazole