Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing

The objective of this study was to enhance tabletability of a poorly compactible drug, acetaminophen, by wet granulation using twin screw extruder at high temperature. It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and fall within a size range suitable for tableting without any further processing. Mixtures of acetaminophen (95%) with binders (5% povidone or partially pregelatinized starch) were wet granulated through twin screw extruder at 70°C by adding 7% w/w water. The process had a short granulation time (90% granules in the size range of 125 to 1000 μm (