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Statistical modeling methods to analyze the impacts of multiunit process variability on critical quality attributes of Chinese herbal medicine tablets. Sun Fei,Xu Bing,Zhang Yi,Dai Shengyun,Yang Chan,Cui Xianglong,Shi Xinyuan,Qiao Yanjiang Drug design, development and therapy The quality of Chinese herbal medicine tablets suffers from batch-to-batch variability due to a lack of manufacturing process understanding. In this paper, the Panax notoginseng saponins (PNS) immediate release tablet was taken as the research subject. By defining the dissolution of five active pharmaceutical ingredients and the tablet tensile strength as critical quality attributes (CQAs), influences of both the manipulated process parameters introduced by an orthogonal experiment design and the intermediate granules' properties on the CQAs were fully investigated by different chemometric methods, such as the partial least squares, the orthogonal projection to latent structures, and the multiblock partial least squares (MBPLS). By analyzing the loadings plots and variable importance in the projection indexes, the granule particle sizes and the minimal punch tip separation distance in tableting were identified as critical process parameters. Additionally, the MBPLS model suggested that the lubrication time in the final blending was also important in predicting tablet quality attributes. From the calculated block importance in the projection indexes, the tableting unit was confirmed to be the critical process unit of the manufacturing line. The results demonstrated that the combinatorial use of different multivariate modeling methods could help in understanding the complex process relationships as a whole. The output of this study can then be used to define a control strategy to improve the quality of the PNS immediate release tablet. 10.2147/DDDT.S119122
Research progress on the application of spectral imaging technology in pharmaceutical tablet analysis. International journal of pharmaceutics Tablet as a traditional dosage form in pharmacy has the advantages of accurate dosage, ideal dissolution and bioavailability, convenient to carry and transport. The most concerned tablet quality attributes include active pharmaceutical ingredient (API) contents and polymorphic forms, components distribution, hardness, density, coating state, dissolution behavior, etc., which greatly affect the bioavailability and consistency of tablet final products. In the pharmaceutical industry, there are usually industry standard methods to analyze the tablet quality attributes. However, these methods are generally time-consuming and laborious, and lack a comprehensive understanding of the properties of tablets, such as spatial information. In recent years, spectral imaging technology makes up for the shortcomings of traditional tablet analysis methods because it provides non-contact and rich information in time and space. As a promising technology to replace the traditional tablet analysis methods, it has attracted more and more attention. The present paper briefly describes a series of spectral imaging techniques and their applications in tablet analysis. Finally, the possible application prospect of this technology and the deficiencies that need to be improved were also prospected. 10.1016/j.ijpharm.2022.122100