Effect of water temperature on a simple suspension method for lansoprazole orally disintegrating tablets

Abstract

In this study, we examined the physical properties, including disintegration, passage through a nasogastric administration tube, and acidoresistance, of one branded and five generic formulations of lansoprazole orally disintegrating (OD) tablets containing enteric-coated granules to examine the feasibility of a simple suspension method. The generic tablets immediately disintegrated in warm (55°C) and lukewarm water (35°C) and released the enteric-coated granules, which passed through an administration tube. Moreover, the released enteric-coated granules were stable under a simulated gastric acid environment. However, although the branded tablet disintegrated in warm water, the released enteric-coated granules formed aggregates that did not pass through the administration tube. Meanwhile, the granules released from the branded tablet in lukewarm water did not form aggregates. The present study demonstrated the applicability of a simple suspension method using warm or lukewarm water for generic lansoprazole OD tablets. Additionally, the method is applicable to branded lansoprazole OD tablets using lukewarm water.