Critical factors in manufacturing multi-layer tablets—assessing material attributes, in-process controls, manufacturing process and product performance

Sivakumar R Vaithiyalingam, Vilayat A Sayeed
International Journal of Pharmaceutics 2010 October 15, 398 (1): 9-13
Advancement in the fields of material science, analytical methodologies, instrumentation, automation, continuous monitoring, feed forward/feed back control and comprehensive data collection have led to continual improvement of pharmaceutical tablet manufacturing technology, notably the multi-layer tablets. This review highlights the material attributes, formulation design, process parameters that impact the performance, and manufacturability of the multi-layer tablets. It also highlights on critical-to-quality elements that needs to be addressed in the regulatory submission.

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