Comparison of Granules Properties Obtained in Two Different Twin-Screw Equipment at the Same Shear Rate

CESCHAN, NAZARETH ELIANA; BALBI, MARÍA CECILIA; RAVAZZOLI, PABLO; MUZZIO FERNANDO J.; DRAZER, GERMAN; CALLEGARI, GERARDO

Orlando

Congreso; 2023 AIChE Annual Meeting; 2023

AIChe

Introduction: In recent years, the pharmaceutical industry has considered moving from the historical production method in batch to continuous manufacturing. The latter is a faster and more efficient production process and FDA has encouraged the pharmaceutical industry to implement it in order to improve product quality and reduce hold times. Among different technologies for producing oral solid dosage forms, wet granulation is a well-known technique for processing materials with poor flow properties and/or with limited tabletability properties. Wet granulation (WG) is a commonly used size enlargement process to obtain granules by starting from particulate drugs and excipients and using a liquid as ligand. Granules obtained possess improved flow properties compared to raw materials. Usually, twin-screw extruders are used for continuous wet granulation. As different extruders, with varied dimensions and process capabilities are available, direct comparison among granulators cannot be made without considering further adjustments in process conditions. Thus, in this work, two continuous twin-screw extruders (QBcon1 from Bohle and Pharma 11 from ThermoScientific) were used to obtain granules and screw speed was varied in order to obtain the same shear rate in each equipment. Granules critical characteristics were studied and compared in order to optimize the process.