Acta Pharm. 70 (2020) 443-463

 

full paper

Review

 

Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing

ALEŠA DULAR VOVKO and FRANC VREČER

franc.vrecer@krka.biz

1 Krka, d.d., Novo mesto, 8501 Novo mesto, Slovenia

2 University of Ljubljana, Faculty of Pharmacy, 1000 Ljubljana, Slovenia

Accepted December 3, 2019

Published online December 16, 2019

 

This article presents an overview of using process analytical technology in monitoring the roller compaction process. In the past two decades, near-infrared spectroscopy, near-infrared spectroscopy coupled with chemical imaging, microwave resonance technology, thermal effusivity and various particle imaging techniques have been used for developing at-, off-, on- and in-line models for predicting critical quality attributes of ribbons and subsequent granules and tablets. The common goal of all these methods is improved process understanding and process control, and thus improved production of high-quality products. This article reviews the work of several researchers in this field, comparing and critically evaluating their achievements.

 

Keywords: process analytical technology (PAT), roller compaction, near-infrared (NIR) spectroscopy, near-infrared chemical imaging (NIR-CI), microwave resonance technology, thermal effusivity