Abstract
Continuous pharmaceutical manufacturing together with PAT (Process Analytical Technology) provides a suitable platform for automatic control of the end product quality as desired by QbD (quality by design)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires corrective actions in the process/raw material variability before product quality can be influenced. In this manuscript, a combined feed-forward/feed-back control system has been developed for a direct compaction continuous tablet manufacturing process. The feed-forward controller takes into account the effect of process disturbances proactively while the feed-back control system ensures the end product quality consistently. The coupled feed-forward/feed-back control system ensures the minimum variability in the final product quality irrespective of process and raw material variations. The performance of the combined control strategy has been evaluated through process simulation and is found to be more effective in comparison with a feed-back only control strategy and, therefore, demonstrates potential to further improve pharmaceutical tablet manufacturing operations.
Highlights
Pharmaceutical companies are one of the most strictly regulated companies where precise control of the end product quality is highly desired to satisfy the high standard set by regulatory authorities to ensure the efficiency and efficacy of the drug products [1,2]
A feed-forward only control strategy does not take into account the feed-back signal of the control variables and, as a result of other unmeasured process disturbances, the control variables or end product quality can deviate from the desired values
A well-designed control system incorporating the feed-forward and feed-back control algorithm is developed in this work to obtain a precise pre-defined end-product quality for a pharmaceutical product as mandated by regulatory authorities
Summary
Pharmaceutical companies are one of the most strictly regulated companies where precise control of the end product quality is highly desired to satisfy the high standard set by regulatory authorities to ensure the efficiency and efficacy of the drug products [1,2]. Some physical properties (e.g., blend bulk density, shear) have significant effects on the end product quality (e.g., weight, hardness, dissolution) of the pharmaceutical tablets. The inline real time monitoring of the physical properties of the blend (e.g., bulk density) and its incorporation into the control system so that it does not affect the end product quality is highly desired [8]. Singh et al (2014) have implemented a MPC based feed-back control system into the direct compaction tablet manufacturing process with focus on drug concentration control at blending unit operation [3]. For the first time, a combined feed-forward/feed-back control system has been developed for an integrated continuous direct compaction pharmaceutical tablet manufacturing process. The systematic application of the feed-forward/feed-back control can take proactive action on a process disturbance and will enable the industrial practitioners to achieve a predefined end product quality more consistently
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