In-line cosmetic end-point detection of batch coating processes for colored tablets using multivariate image analysis

Int J Pharm. 2021 Sep 5:606:120953. doi: 10.1016/j.ijpharm.2021.120953. Epub 2021 Jul 27.

Abstract

In this study, an in-line Process Analytical Technology (PAT) for cosmetic (non-functional) coating unit operations is developed using images of the tablet bed acquired in real-time by an inexpensive industrial camera and lighting system. The cosmetic end-point of multiple batches, run under different operating conditions, is automatically computed from these images using a Multivariate Image Analysis (MIA) methodology in conjunction with a stability determination strategy. The end-points detected by the algorithm differed, on average, by 3% in terms of total batch time from those identified visually by a trained operator. Since traditional practice typically relies on a coating overage to ensure full batch aspect homogeneity in the face of disturbances, the current in-line method can be used to reduce coating material and processing time (over 40% for the operating policy adopted in this work). Additionally, monitoring of the color features calculated by the algorithm allowed the identification of abnormal process conditions affecting visible coating uniformity. This work also addresses practical challenges related to image acquisition in the harsh environment of a pan coater, bringing this tool closer to a state of maturity for implementation in production units and opening the path for their optimization, monitoring, and automatic control.

Keywords: End-point detection; Multivariate Image Analysis (MIA); Process Analytical Technology (PAT); Tablet film coating; Visible light imaging; Vision system.

MeSH terms

  • Drug Compounding*
  • Image Processing, Computer-Assisted*
  • Multivariate Analysis
  • Tablets

Substances

  • Tablets