Near‐Infrared Spectroscopy Application to the Pharmaceutical Industry

Abstract Near‐infrared spectroscopy (NIR) is widely used in pharmaceutical manufacturing because it can rapidly measure the critical material attributes (CMAs) of a product in real time, nondestructively, and noncontact during manufacturing processes as a process analysis technology. NIR has shown practical applicability in various processes in pharmaceutical manufacturing, including the following examples: Spectroscopic analysis of crystalline quality of a bulk drug in pharmaceutical formulations. Evaluation of the pharmaceutical properties of tablets by in‐line NIR monitoring during granulation processes. Evaluation of the pharmaceutical properties of tablets, in which the drug substance undergoes crystal polymorphic transformation, during the granulation process by in‐line NIR monitoring. Prediction of the dissolution properties of tablets based on the NIR spectra of the compressed tablets. Tablet quality evaluation during tablet manufacturing processes based on physical and chemical information in NIR spectra of the compressed tablets. NIR spectral imaging of pharmaceutical products. Evaluation of the polymorphic content of bilayer tablets using NIR on compressed tablets. In‐line NIR monitoring of tablet ‐ coating (TC) processes for controlled drug release preparations. The effectiveness of hand‐held NIR spectrometers in the pharmaceutical industry.