Continuous High Shear Wet Granulation: Impact of Process and Design Parameters on Granule Properties

摘要

Wet granulation (WG) is used broadly in the pharmaceutical industry. This technology has many advantages such as enhancing compression and powder handling, decreasing ingredient segregation and ensuring the content uniformity through size enlargement. A high level of interest exists at the present time in the continuous technology, both by the US FDA, and by large pharmaceutical manufacturers because continuous manufacturing methods can provide significant technical and business advantages relative to batch methods. As has been demonstrated in other process industries, continuous manufacturing methods are more robust and controllable. They achieve the same production rates as batch processes in much smaller and thus less capital-intensive equipment. However, despite these advantages, the pharmaceutical industry still relies almost exclusively on traditional batch methods to produce tablets and capsules. In recent years different continuous WG techniques have been investigated, such as fluid bed agglomeration and twin screw extrusion. However, integration of these unit operations into a complete continuous tablet manufacturing line is still a bottleneck due to high production cost and poor understanding of impact of granule properties.