USE OF NEAR-INFRARED SPECTROSCOPY TO EVALUATE AN ACTIVE IN A FILM-COATED TABLET

Purpose. To provide a method to rapidly screen tablets in the developm ent of new coating technology. Methods. Near-Infrared (NIR) reflectanc e spectroscopy was used to quantitatively analyze tablets which were c omposed of a drug active encasing an active drug core. Diffuse reflect ance NIR scans of 240 individual tablets over the range of 1100-2500 n m were obtained. High Performance Liquid Chromatography (HPLC) was use d as the reference method. Results, Both qualitative, Principal Compon ent Analysis, and quantitative results showed a strong agreement betwe en the NIR and HPLC methods. The NIR analysis was non-invasive and all owed subsequent testing of the tablets. The contents of the drug activ e contained in a drug coating was determined to +/-4% of the target va lue using NIR analysis. Over 400 samples were analyzed in less than a month utilizing this technique which allowed the optimization of a new coating technology. Conclusions. NIR analysis allowed the evaluation of the efficiency of a new drug film coating manufacturing process mor e quickly and inexpensively. Because the Near-Infrared method was non- invasive the tablets were available for further analysis unlike the ch romatography method.