Patent ID: 8920835

Claim:
A paliperidone double layered osmotic pump controlled release tablet comprising, based on the total weight of the controlled release tablet, 0.1 to 15% of a moisture-permeable rigid membrane shell having one or more drug release orifices at one end thereof, which is made of the controlled release layer composition comprising a semi-permeable polymer, a porogen and/or a plasticizer; 15 to 60% of a push layer inside the rigid membrane shell and away from the side of the drug release orifice, which is made of a push layer composition comprising, based on the total weight of the push layer composition, 20 to 80% of an expansion material, 10 to 45% of an osmotic agent, 0 to 30% of a binder, and optionally, a colorant and a lubricant; 10 to 80% of a drug layer inside the rigid membrane shell, adjacent to the release orifices and directly contacting with the push layer, which is made of a drug layer composition comprising, based on the total weight of the drug layer composition, 0.1 to 25% of a pharmaceutically active ingredient, 65 to 99% of one or more hydrophilic polymer carriers, and optionally, an osmotic agent, a colorant, a lubricant and an antistatic agent; 0.1 to 30% of an isolation layer located between the inside surfaces of the rigid membrane shell and the tablet core consisting of the drug layer and the push layer, which is made of an isolation layer composition comprising 0 to 30% of a pharmaceutically active ingredient based on the total weight of the isolation layer composition, and one or more hydrophilic polymers; 0 to 20% of an optional aesthetic coating layer coated on the outer surface of the rigid membrane shell, which is made of an aesthetic coating layer composition comprising coating powder for forming the aesthetic coating, and optionally, one or more excipients selected from the group consisting of colorant, a plasticizer, an opacifying agent, and an anti-sticking agent; wherein the hydrophilic polymer carrier in the drug layer is selected from the group consisting of povidone, copolymerized povidone, carbomer, hydroxypropyl cellulose, hypromellose and mixtures thereof; wherein the said paliperidone double layered osmotic pump controlled release tablet shows an gradually increasing release rate at early stage and maintains a constant release rate at later stage, wherein said pharmaceutically active ingredient is selected from the group consisting of paliperidone and pharmaceutically acceptable salts and esters thereof.