NEAR-INFRARED SPECTROSCOPIC MONITORING OF THE FILM COATING PROCESS

Purpose. The purpose of this study was to investigate the potential of near-infrared (near-IR) spectroscopy for non-destructive at-line dete rmination of the amount of polymer coat applied to tablet cores in a W urster column. Methods. The effects of coating composition on the near -IR spectroscopic determination of ethylcellulose (Aquacoat ECD-30) or hydroxypropylmethylcellulose (HPMC)-based (Spectrablend) coating were evaluated, as were the performance of several chemometric techniques. Results. Tablets were coated with up to 30% ethylcellulose or 22% HPM C, and samples were pulled at regular intervals during each coating ru n. Near-IR reflectance spectra of the intact tablets were then collect ed. The spectra were preprocessed by multiplicative scatter correction (MSG) or second derivative (D2) calculations, and calibrations develo ped using either principal components (PCs) or multiple spectral wavel engths. The near-IR method provided predictions of film applied with s tandard errors of 1.07% w/w or less. Conclusions. Near-IR spectroscopy can be profitably employed in a rapid and non-destructive determinati on of the amount of polymer film applied to tablets, and offers a simp le means to monitor the film coating process.