Patent ID: 6730321
Filing Date: 2004-05-04
Classification: A61K

Abstract:
A press-coated tablet suitable for oral administration, comprising:(a) an immediate-release compartment comprising a compressed blend of an active agent and one or more polymers, wherein said immediate release compartment is characterized by a dissolution profile in which 10-75%  of the active agent is dissolved within one hour and not less than 90% of the active agent is dissolved within 6 hours, based on the total amount of the active agent in the compartment, wherein the dissolution profile is measured in a type 2 dissolution apparatus (paddle) according to U.S. Pharmacopeia XXII at 37Â° C.Â±0.5Â° C. in deionized water at 75 rotations per minute, and (b) an extended-release compartment, wherein said extended-release compartment is characterized by a dissolution profile in which 5-40% of the active agent is dissolved within one hour, 20-75% of the active agent is dissolved within three hours, 40-95% of the active agent is dissolved within 6 hours, and not less than 60% of the active agent is dissolved within 8 hours, based on the total amount of the active agent in the compartment, wherein the dissolution profile is measured in a type 2 dissolution apparatus (paddle) according to U.S. Pharmacopeia XXII at 37Â° C.Â±0.5Â° C. in deionized water at 75 rotations per minute, wherein the extended-release compartment is formed by press-coating to substantially envelop the immediate-release compartment, and comprises a compressed blend of the active agent, a hydrophilic polymer and hydrophobic material, wherein the tablet exhibits a first order release of the active agent interrupted by a pulsed delivery of the active agent.