EFFECTIVE GASTRIC-ACID SUPPRESSION AFTER ORAL-ADMINISTRATION OF ENTERIC-COATED OMEPRAZOLE GRANULES

Omeprazole is inactivated by exposure to gastric acid and is formulate d as a gelatin capsule containing enteric-coated granules that release the drug in alkaline medium. In clinical situations where patients ar e unable to take the capsule orally, the optimum means of administrati on is uncertain. Eleven normal volunteers were given omeprazole 20 mg every day for one week before breakfast in random order as either a 20 -mg capsule with water or free enteric-coated granules with either 8 o z of orange juice, 8 oz of water with 2 Alka-Seltzer antacid tablets ( aspirin free), or 1 teaspoon of apple sauce. On day 7 of each regimen, an 8-hr intragastric pH study was performed following omeprazole 20 m g and standard breakfast. The median percentage of time of gastric aci d pH > 4 after an omeprazole capsule was 68.5 (25-100); after granules with orange juice 59 (43-100); after granules in Alka-Seltzer solutio n 63 (31-100), and after granules in apple sauce 65 (30-99), with no s ignificant differences (ANOVA). The time for the gastric pH to reach < 4' after having been above was also similar for all four regimens (ANO VA). Omeprazole granules administered orally in a variety of ways achi eve gastric acid suppression as effectively as the intact capsule.