Stability of Dexlansoprazole MR Granules in Soft Foods and Liquids Appropriate for Alternative Methods of Administration
Abstract
Purpose: The proton pump inhibitor dexlansoprazole (DEX) is a pH-dependent modified release (MR) formulation consisting of 2 types of granules within a single capsule. DEX MR is approved for use in adults for treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease (GERD), healing of erosive esophagitis (EE), maintenance of healed EE and relief of heartburn. The option to administer DEX MR granules mixed with liquids or soft foods is desirable for patients unable to take capsules. The objectives were to assess the in vitro stability of DEX MR granules when mixed with liquids or soft foods and assess the bioavailability (BA) of DEX MR granules mixed with applesauce or water. Methods: The stability of DEX MR granules in soft foods and liquids was determined by an in use stability study. DEX MR capsules were opened and granules were sprinkled on foods or mixed with liquids. After exposing the granules to foods or liquids under ambient conditions, the granules were analyzed for assay and dissolution to determine the DEX potency and the granule enteric coating integrity. Two phase 1, randomized, single-dose, crossover studies were conducted in healthy subjects 18-55 years old. In Study 1, subjects received a single oral dose of DEX MR 90 mg as a capsule or as granules sprinkled on applesauce. In Study 2, subjects received a single oral dose of DEX MR 60 mg as a capsule or an aqueous mixture of granules administered via oral syringe or NG tube.…
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