Process optimization for continuous extrusion wet granulation

Abstract

Three granulating binders in high drug-load acetaminophen blends were evaluated using high shear granulation and extrusion granulation. A polymethacrylate binder enhanced tablet tensile strength with rapid disintegration in simulated gastric fluid, whereas polyvinylpyrrolidone and hydroxypropyl cellulose binders produced less desirable tablets. Using the polymethacrylate binder, the extrusion granulation process was studied regarding the effects of granulating liquid, injection rate and screw speed on granule properties. A full factorial experimental design was conducted to allow the statistical analysis of interactions between extrusion process parameters. Response variables considered in the study included extruder power consumption (screw loading), granule bulk/tapped density, particle size distribution, tablet hardness, friability, disintegration time and dissolution.

Keywords::

• Extrusion
• wet granulation
• continuous processing
• binder
• high shear
• high loading

Acknowledgements

The authors would like to thank the journal referees for their constructive comments.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.