Patent ID: 8741345

Claim:
A modified release oral pharmaceutical composition of dexlansoprazole or pharmaceutically acceptable salts or hydrated forms thereof in the form of a bilayer tablet, comprising (a) a first layer comprising: i) a film-coated core comprising dexlansoprazole or pharmaceutically acceptable salts or hydrated forms thereof with one or more pharmaceutically acceptable excipients; ii) an enteric coating that dissolves at pH 5.5 or higher comprising at least one polymer selected from cellulose acetate phthalate, cellulose acetate succinate, hydroxpropyl cellulose phthalate, hydroxpropyl ethylcellulose phthalate, hydroxyl propyl methyl cellulose phthalate, hydroxyl propyl methyl cellulose acetate succinate, hydroxyethyl cellulose phthalate, methylcellulose phthalate, polyvinyl acetate phthalate, polyvinylacetate hydrogen phthalate, amylase acetate phthalate, cellulose ester phthalates, cellulose ether phthalates, sodium cellulose acetate phthalate, starch acid phthalate, cellulose acetate butyrate, cellulose acetate maleate, cellulose acetate trimellitate, cellulose acetate propionate, styrene maleic acid dibutyl phthalate copolymer, styrene maleic acid polyvinyl acetate phthalate copolymer propionate, shellac or mixtures thereof; and iii) a rate controlling agent that dissolves independently from pH; and (b) a film-coated second layer comprising dexlansoprazole or pharmaceutically acceptable salts or hydrated forms thereof with one or more pharmaceutically acceptable excipients, wherein the rate controlling agent is in only the first layer and not in the second layer or in a tablet coating, wherein a weight ratio of the at least one polymer in the enteric coating to the rate controlling agent in the first layer is 10:1 to 1:10, and wherein the bilayer tablet is formed with a compression force between 2 to 30 kN.