#$%^&*AU2013273835A120140116.pdf#####TIMED, PULSATILE RELEASE SYSTEMS Abstract The invention relates to 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 optional 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 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. IN HCl and thereafter in 900 mL at pH 6.8).
