Monday 18 January 2016
Read “Process Analytical Technology for High Shear Wet Granulation: Wet Mass Consistency Reported by In-Line Drag Flow Force Sensor Is Consistent With Powder Rheology Measured by At-Line FT4 Powder Rheometer®” by Ajit S. Narang1, Valery Sheverev2, Tim Freeman3, Douglas Both1, Vadim Stepaniuk2, Doug Millington-Smith3, Kevin Macias3, Ganeshkumar Subramanian1 in the Journal of Pharmaceutical Sciences today.
1 Bristol-Myers Squibb, New Brunswick, New Jersey, USA
2 Lenterra Inc., Newark, New Jersey, USA
3 Freeman Technology, Tewkesbury, Gloucestershire, UK
The paper published earlier this month concludes that the drag flow force (DFF) sensor that measures the force exerted by wet mass in a granulator on a thin cylindrical probe was shown to be a promising process analytical technology for real-time in-line high-resolution monitoring of wet mass consistency during high shear wet granulation. Previous studies had indicated that this process analytical technology tool could be correlated to granulation end point established independently through drug product critical quality attributes.
In this study, the measurements of flow force by a DFF sensor, taken during wet granulation of 3 placebo formulations with different binder content, are compared with concurrent at line FT4 Powder Rheometer® characterisation of wet granules collected at different time points of the processing. The wet mass consistency measured by the DFF sensor correlated well with the granulation's resistance to flow and interparticulate interactions as measured by FT4 Powder Rheometer®. This indicated that the force pulse magnitude measured by the DFF sensor was indicative of fundamental material properties (e.g., shear viscosity and granule size/density), as they were changing during the granulation process.
These studies therefore indicate that DFF sensor can be a valuable tool for wet granulation formulation and process development and scale up, as well as for routine monitoring and control during manufacturing.