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首页> 外文期刊>journal of pharmaceutical innovation >Multivariate Image and Texture Analysis to Investigate the Erosion Mechanism of Film-coated Tablets: An Industrial Case Study
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Multivariate Image and Texture Analysis to Investigate the Erosion Mechanism of Film-coated Tablets: An Industrial Case Study

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The Quality by Design initiative requires the design space of a process to be based on metrics that are robust and reproducible, and not on qualitative ones that might be easily biased by human perception. Hence, the use of image analysis is attractive for practical industrial applications where the quality assessment is still typically performed by a panel of trained experts. The use of multivariate image and texture analysis is proposed in this study to quantitatively characterize the elegance of film-coated tablets. Four unsupervised metrics are developed to quantify both the color uniformity of tablet faces/bands and the surface erosion. To develop robust statistics, more than 7,000 tablets coated in nine different pilot-scale batches are considered. Latent variable modeling is used to regress the measured elegance against coating operating conditions to investigate the driving forces acting on the system and guide pharmaceutical manufacturing, consistently with the Quality by Design framework. The model allows one to successfully investigate the causes leading to tablet erosion. Additionally, it is shown that the model space can be effectively used as a monitoring chart of the overall batch elegance in terms of color uniformity and surface erosion, since the batches are found to rank according to the surface roughness of the manufactured tablets. Image analysis has been shown to be an effective process analytical technology for the development of the design space of a film-coating process, where quality assessment on the final product is traditionally based on the judgment of panel of trained experts.

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