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The aim of the current study was to screen theophylline (125 mg) tablets manufactured via twin screw granulation in order to improve process understanding and knowledge of process variables which determine granule and tablet quality. A premix of theophylline anhydrate, α-lactose monohydrate and PVP (ratio: 30/67.5/2.5, w/w) was granulated with demineralized water. Experiments were done using the high shear wet granulation module (based on twin screw granulation) of the ConsiGma TM -25 unit (a continuous tablet manufacturing system) for particle size enlargement. After drying, granules were compressed using a MODUL TM P tablet press (compression force: 10 kN, tablet diameter: 12 mm). Using a D-optimal experimental design, the effect of several process variables (throughput (10 -25 kg/h), screw speed (600 -950 rpm), screw configuration (number (2, 4, 6 and 12) and angle (30, 60 and 90 degrees) of kneading elements), barrel temperature (25 -40°C) and method of binder addition (dry vs wet)) on the granulation process (torque and temperature increase of barrel wall), granule (particle size distribution, friability and flowability) and tablet (tensile strength, porosity, friability, disintegration time and dissolution) quality was evaluated. The results showed that the quality of granules and tablets can be optimized by adjusting specific process variables (number of kneading elements, barrel temperature and binder addition method) during a granulation process using a continuous twin screw granulator.

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