Optimizing Metformin HCl manufacturing: A Six Sigma approach to assess process capability

Raagul Seenivasan Jey Kumar Pachiyappan Vivek Reddy Murthannagari Gonna Nandhi Krishnan Ganesh   

Open Access   

Published:  Jun 07, 2024

DOI: 10.7324/JAPS.2024.177701

A process capability analysis uses indices such as process capability, process capability index, process performance index, and process performance to evaluate the output of an in-control process in relation to stated restrictions. In the instance of Metformin HCl tablets, the goal of a Six Sigma study is to enhance the method for creating perfect pills while ensuring maximum customer satisfaction. Process capability is critical for meeting industry standards, reducing variation, and ensuring product quality before commercialization, consequently streamlining and cost-effectively streamlining the inspection process. The control and capacities of antidiabetic pills are described in this study, with a focus on data collection and process capability analysis utilizing statistical tools such as MINITAB 21.2. The results show that the process capabilities for several tests-hardness, thickness, disintegration, dissolution, and friability exceed the 3.64 threshold. Finally, based on this analysis, the current process capability is rated appropriate, showing its capability to fulfill industry standards effectively.

Keyword:     Metformin HCl process performance index MINITAB Statistical tool process capability analyses Six Sigma


Seenivasan R, Ganesh GNK, Murthannagari VR. Optimizing Metformin HCl manufacturing: A Six Sigma approach to assess process capability. J Appl Pharm Sci, 2024. Online First. http://dx.doi.org/10.7324/JAPS.2024.177701

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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