Work

A commercial-scale high-throughput near-infrared transmission spectroscopy system for full inspection of active pharmaceutical ingredient content in all tablets

Year: 2025

Type: article

Abstract: • Developed a high-speed, high-intensity NIR time-stretch spectroscopy system. • Achieved 100% API content measurement at a throughput of 186,000 tablets per hour using a belt-conveyor system. • Demonstrated real-time rejection of tablets with out-of-specification API content. Near-infrared (NIR) spectroscopy is a nondestructive analytical technique that is increasingly considered for inclusion in Process Analytical Technology (PAT) frameworks and for 100% inspection, with the potential to raise pharmaceutical product quality. While reflectance-based NIR systems already deliver throughputs suitable for commercial manufacturing, transmission-based NIR systems, although offering superior predictive accuracy for active pharmaceutical ingredient (API) content in tablets, have been throughput-limited. Recently, a newly developed transmission NIR spectrometer has been shown to acquire precise tablet spectra within a few milliseconds. In this study, a spectrometer was integrated into a belt-conveyor transport apparatus to create a high-throughput analytical system for pharmaceutical tablets. A throughput of 186,000 tablets per hour was achieved, demonstrating 100% API content measurement and real-time rejection of out-of-specification tablets.

Source: International Journal of Pharmaceutics

DOI: 10.1016/j.ijpharm.2025.126516