Real-time monitoring of the tablet-coating process by near-infrared spectroscopy - Effects of coating polymer concentrations on pharmaceutical properties of tablets

Abstract

In order to establish a pharmaceutical manufacturing process control system based on a Quality-by-Design concept, the pharmaceutical properties of tablets during the tablet-coating process were monitored in real time and predicted using values recorded by in-line near-infrared (NIR) spectroscopy. Coating amount (C%), thickness (L), tablet hardness (HT), and tablet dissolution parameters with elution times (T0, T50, and T80) were measured using individual pharmaceutical tests. Tablet coating was performed by spraying F-A (25 w/w%) or F-B (17.8 w/w%) containing EUDRAGIT® L 30 D-55, and monitored using an in-line NIR spectroscopy instrument. Calibration models to predict tablet properties (C%, L, HT, T0, T50, and T80) were obtained based on NIR spectroscopy using a partial least-squares regression (PLS). Chemometric parameters were found to be sufficiently accurate. Correlations between the predicted and measured values of each tablet property showed satisfactory linear relationships. Therefore, the pharmaceutical properties (C%, L, HT, T0, T50, and T80) of tablets may be monitored in real time during the coating process with an in-line NIR spectroscopy method.