Patent ID: 9161918
Filing Date: 2015-10-20
Classification: A61K,A61P

Abstract:
1. A pharmaceutical composition comprising one or more populations of timed, pulsatile release beads, wherein at least one population of timed, pulsatile release beads comprises: a) a core particle comprising an acidic active pharmaceutical ingredient or a pharmaceutically acceptable salt thereof; b) an inner barrier coating comprising a water insoluble polymer in combination with a water-soluble/pore-forming polymer; and c) an outer lag-time coating comprising a water-insoluble polymer in combination with an enteric polymer wherein the at least one population of timed, pulsatile release beads provides a lag time greater than 6 hours before onset of drug release when tested using USP Apparatus 1 or 2 and a two-stage dissolution medium (first two hours in 700 mL of 0.1N HCl and thereafter in 900 mL at pH 6.8).