Evaluation of coating uniformity for the digestion-aid tablets by portable near-infrared spectroscopy

Process analysis can effectively stabilize pharmaceutical quality and optimize the control of production process. For the sustained-release digestion-aid tablets, the coating film thickness is an important indicator to measure the quality of products. Traditional method mainly spot-checks tablets and measures with visual microscopy, which is time-consuming and laborious. This study attempted to use a portable near-infrared spectroscopy for rapid detection of a Chinese medicine tablets from production line. First, PLS regression models were established for coating film at twelve different locations of the tablet section, and the results showed that the correlation coefficients of training and validation sets were all over 0.80. Subsequently, the twelve locations were divided into six groups to further establish regressions. After chemometrics optimization, the optimal of six group models were generally better than single location models, with R_c² and R_v² all above 0.85, and RMSEV values all below 2.0. The mean relative error of prediction of the optimal model was 9.49%. The pharmaceutical process detection based on the portable NIR spectroscopy met the demand of managing digestion-aid tablet coating data conveniently. The proposed approach can successfully realize on-site and online pharmaceutical monitoring and has a promising practical value.