Challenges, opportunities and recent advances in near infrared spectroscopy applications for monitoring blend uniformity in the continuous manufacturing of solid oral dosage forms

Abstract

Near infrared (NIR) spectroscopy has been widely recognized as a powerful PAT tool for monitoring blend uniformity in continuous manufacturing (CM) processes. However, the dynamic nature of the powder stream and the fast rate at which it moves, compared to batch processes, introduces challenges to NIR quantitative methods for monitoring blend uniformity. For instance, defining the effective sample size interrogated by NIR, selecting the best sampling location for blend monitoring, and ensuring NIR model robustness against influential sources of variability are challenges commonly reported for NIR applications in CM. This article reviews the NIR applications for powder blend monitoring in the continuous manufacturing of solid oral dosage forms, with a particular focus on the challenges, opportunities for method optimization and recent advances with respect three main aspects: effective sample size measured by NIR, probe location and method robustness.

Keywords: Continuous manufacturing; Effective sample size; Method robustness; Near infrared spectroscopy; Probe location; Process analytical technology.