Tablets Capsules

TC0121

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34 January/February 2021 Tablets & Capsules A Federica Giatti, Caterina Funaro, Fabrizio Consoli, and Fabiano Ferrini IMA Active Application of NIR spectroscopy for tablet manufacturing control process analytical technology In a typical tableting process, raw-material variations or deviations in granulation or handling can affect the final blend quality and generate problems such as seg- regation, inhomogeneity, capping, lamination, or poor tablet quality. Manufacturers commonly monitor tablet weight, thickness, hardness, friability, and API content during production and try to minimize variation in each of these characteristics to ensure high quality. When using a quality-by-design (QbD) and process analytical technology (PAT) approach, specialized sen- sors such as near-infrared (NIR) spectrometers are placed in critical areas of the process to deliver real-time data This article describes a case study evaluating the potential for using NIR spectroscopy to identify blend variations in a tablet- ing process and the impact of sensor location on data acquisition. chieving high productivity without sacrificing quality is an important target for every pharmaceutical company. Free-flowing formulations, characterized by uniform par- ticles within a narrow particle-size range that are cohe- sive enough to interlock and hold together but not so much that they adhere to metal equipment surfaces, rep- resent the ideal for a tableting process.

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