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Nonencapsulated, intact omeprazole granules effectively suppress intragastric acidity when administered via a
V K Sharma1, E J Heinzelmann, E N Steinberg
1Department of Internal Medicine, and W. J. B. Dorn Veterans' Affairs Medical Center, University of South Carolina School of Medicine, Columbia 29203-6808, USA.
Unlabelled:
Because of its acid-labile nature, omeprazole is usually administered as encapsulated enteric-coated granules. The gelatin capsule and acid-resistant coating are essential for effective drug absorption and optimal bioavailability.
Objective:
This study tested the effectiveness of nonencapsulated, intact omeprazole granules in suppressing intragastric acidity when administered through a gastrostomy.
Methods:
Fourteen male patients with established gastrostomies underwent a baseline 24-h intragastric pH monitoring study while off any acid-suppressing medication. Via the gastrostomy, they then received 7 days of dosing with 20 mg omeprazole as intact granules in orange juice. Twenty-four-hour intragastric pH monitoring was repeated on the seventh day.
Results:
Mean intragastric pH during the baseline study was 1.8 (+/- SD 0.7). This pH increased to 4.9 +/- 0.8 with omeprazole granules (p < 0.0001). Median intragastric pH rose from 1.3 to 5.3 (p < 0.0001). During the baseline study, intragastric pH was above 3 for 21.2 +/- 14.1%, above 4 for 14.9 +/- 11.0%, and above 5 for 9.5 +/- 8.4% of the 24-h recording period. Corresponding values after 7 days of omeprazole were 80 +/- 15.1%, 72.5 +/- 16.3%, and 59.1 +/- 16.6% (p < 0.0001 for each comparison with pretreatment values).
Conclusion:
Omeprazole effectively suppresses intragastric acidity when given through a gastrostomy tube as nonencapsulated, intact granules.