Ajit Narang, Ph.D. <br>VP, Chemistry Manufacturing and Controls, ORIC Pharmaceutical

fsrzgdzn
Recognition

Ajit Narang, Ph.D.
VP, Chemistry Manufacturing and Controls, ORIC Pharmaceutical

In comparison with off-line rheometer, Lenterra Inline Rheometer demonstrated superior sensitivity to changes in the wet mass during granulation process.

I was involved in the application of Lenterra’s technology to monitor high shear wet granulation of small molecule drugs, including brivanib alaninate, placebo, and several formulations. Lenterra’s sensor, a millimeter-sized pin inserted into the powder, enabled observation of various stages of the granulation process on the computer screen that allowed us to predict granulation endpoints and develop scaling factors. The technology allows for concurring real-time measurements of three independent metrics that characterize granule densification, powder consistency, and temperature, respectively. In comparison with a conventional off-line rheometer, Lenterra Inline Rheometer demonstrated superior sensitivity to changes in the wet mass during granulation and greater repeatability. LIR appears to be a very promising tool for formulation development and pharmaceutical process monitoring. It is featured in our recent Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm.

Ajit Narang, Ph.D.   VP, Chemistry Manufacturing and Controls ORIC Pharmaceuticals, Inc.