Oral tablet compositions of dexlansoprazole

摘要

Oral tablet compositions of dexlansoprazole or pharmaceutically acceptable salts or hydrated forms thereof having a gradual release and processes for the manufacture of the tablet composition and its use in the treatment of gastrointestinal disorders.

主权项

1. A dual release oral tablet of at least one of dexlansoprazole, pharmaceutically acceptable salts and hydrates thereof and having a gradual release, wherein said tablet comprises:
a) 5.0 to 40.0% by weight of the dexlansoprazole in powder form; b) 60.0 to 95.0% by weight of the dexlansoprazole in granule form comprising the dexlansoprazole, lactose, and microcrystalline cellulose; and c) a single enteric coating that dissolves at between pH 5.5 and 6.4, wherein upon oral administration, the tablet achieves dual release of the dexlansoprazole in that the dexlansoprazole is released in the small intestine at pH 5.5, and then at pH 6.0 to 6.5, with prevention of dose dumping of the dexlansoprazole.