Scientific papers
"Monitoring critical quality attributes (CQAs) in-line during the tableting process is crucial for implementing a real-time release strategy. CQAs such as tablet mass, API content, dissolution, hardness, and tensile strength are commonly assessed. Since dissolution testing is labor-intensive, time-consuming, and unsuitable for in-line application, predictive models based on other CQAs, like tablet porosity and hardness, are preferred to estimate dissolution characteristics. Traditionally, porosity is measured offline using gas adsorption methods or techniques like Terahertz spectroscopy or gas in scattering media absorption spectroscopy, while tablet hardness is assessed with a hardness tester. These destructive tests, though feasible at-line, have limited use for in-line, high-percentage inspections. Optical coherence tomography (OCT) has recently emerged as a potential tool for assessing quality attributes. This study presents the first application of OCT for predicting tablet porosity and hardness. Tablets produced using a ConsiGma 25™ tableting line and a Stylcam 200R compaction simulator under various compaction forces were measured with OCT and correlated with porosity and hardness. The results demonstrated that OCT can be easily integrated in-line, providing real-time data on critical material attributes. These findings confirm the viability of OCT as a real-time quality control method and its potential to replace traditional, time-consuming, and destructive offline measurements."
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