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
Abstract

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


Citation:

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.

HTML Full Text

Reference

1. Greg B. Six sigma for managers. New York, NY: McGraw Hill; 2002.

2. Nunnally BK, McConnell JS. Six sigma in the pharmaceutical industry. Boca Raton, FL: CRC Press; 2007. Available from: http://books.google.ie/books?id=5RsQ5rHaruEC&printsec=frontcover&dq=ISBN+9781420054392&hl=&cd=1&source=gbs_api

3. Condé GCP, Martens ML. Six sigma project generation and selection: literature review and feature based method proposition. Prod Plan Control. 2019 Dec 29;;31(16):1303–12. doi: https://doi.org/10.1080/09537287.2019.1706196

4. Miglani A, Saini C, Musyuni P, Aggarwal G. A review and analysis of product recall for pharmaceutical drug product. J Generic Med. 2021 Jul 22;18(2):72–81. doi: https://doi.org/10.1177/17411343211033887

5. Kane VE. Process capability indices. J Qual Technol. 1986 Jan;18(1):41–52.

https://doi.org/10.1080/00224065.1986.11978984

6. Chakravorty SS. Six Sigma programs: an implementation model. Int J Prod Econ. 2009 May;119(1):1–16. doi: http://dx.doi.org/10.1016/j.ijpe.2009.01.003

7. Tjahjono B, Ball P, Vitanov VI, Scorzafave C, Nogueira J, Calleja J, et al. Six sigma: a literature review. Int J Lean Six Sigma. 2010;1(3):216–33. doi: http://doi.org/10.1108/20401461011075017

8. Mikel JH. Six sigma: a breakthrough strategy for profitability. Qual Prog. 1998; 31:35–42.

9. Juran Institute’s Six sigma breakthrough and beyond: quality performance breakthrough methods. [Internet]. Google Books. Available from: lhttps://books.google.co.in/books/about/Juran_Institute_s_Six_Sigma_Breakthrough.html?id=0VHaTb6LJ4QC&redir_esc=y#:~:text=Based%20on%20the%20Juran%20Institute’s,day%20human%2C%20structural%2C%20and%20technologica

10. Klefsjö B, Wiklund H, Edgeman RL. Six sigma seen as a methodology for total quality management. Meas Bus Excell. Emerald; 2001 Mar;5(1):31–35. doi: http://dx.doi.org/10.1108/13683040110385809

11. Steele C. Process capability statistics: Cp and Cpk, working together. Available from: https://blog.minitab.com/blog/statistics-and-quality-improvement/process-capability-statistics-cp-and-cpk-working-together

12. Six sigma-materials: process capability indices. 2020 [cited 2020 Aug 6]. Available from: https://www.six-sigma-material.com/Process-Capability-Indices.html

13. Measuring your process capability [Internet]. Measuring your process capability: Symphony technologies. [cited 2023 Dec 13]. Available from: https://www.symphonytech.com/articles/processcapability.htm

14. Tesfay YY. Process capability analysis. In: Developing structured procedural and methodological engineering designs [Internet]. Cham, Switzerland: Springer International Publishing; 2021. pp 187–209. doi: https://doi.org/10.1007/978-3-030-68402-0_6

15. Neyestani B. Seven basic tools of quality control: the appropriate techniques for solving quality problems in the organizations. SSRN Electron J, 2017. doi: http://dx.doi.org/10.2139/ssrn.2955721

16. George J, Bhaisare AK, Singh A. A study of basic 7 quality control tools & techniques for continuous improvement [Internet]. Bhopal, India: 2nd International Conference on “Emerging Trends in Mechanical Engineering” [ICETME-2018]; 2018 Mar; 5(1). Available from: https://www.researchgate.net/publication/334056570_A_Study_of_Basic_7_Quality_Control_Tools_Techniques_for_Continuous_Improvement

17. Magar VM. Application of 7 quality control (7 QC) tools for continuous improvement of manufacturing processes [Internet]. 2014. Available from: https://www.semanticscholar.org/paper/Application-of-7-Quality-Control-(7-QC)-Tools-for-Magar-Shinde/dd3ec1c0b3a50444d6ff8156b69dc807f9a45d07

18. Gejdoš P. Continuous quality improvement by statistical process control. Procedia Econ Finan. 2015;34:565–72. doi: https://doi.org/10.1016/s2212-5671(15)01669-x

19. Bhaskarabhatla A, Chatterjee C, Anurag P, Pennings E. Mitigating regulatory impact: the case of partial price controls on metformin in India. Health Policy Plan. 2016;czw109.

https://doi.org/10.1093/heapol/czw109

20. Miglani A, Saini C, Musyuni P, Aggarwal G. A review and analysis of product recall for pharmaceutical drug product. J Generic Med. 2021 Jul 22;18(2):72–81. doi: https://doi.org/10.1177/17411343211033887

21. Ebbutt A. Basic statistics and pharmaceutical statistical applications (second edition). Pharm Stat. 2007;7(2):151–2. doi: https://doi.org/10.1002/pst.307

22. Rowe P. Essential statistics for the pharmaceutical sciences. Hoboken, NJ: John Wiley & Sons; 2015. Available from: https://books.google.ie/books?id=nsM1CgAAQBAJ&pg=PA4&dq=ISBN:+978-1-118-91339-0&hl=&cd=1&source=gbs_api.

23. Chikwendu OC, Chima AS, Edith MC. The optimization of overall equipment effectiveness factors in a pharmaceutical company. Heliyon. 2020 Apr 18;6(4):e03796. doi: https://doi.org/10.1016/j.heliyon.2020.e03796

24. Chabukswar AR, Jagdale SC, Kuchekar BS, Kothawade HS, Kuckekar AB, Joshi VD, et al. Six sigma: process of understanding the control and capability of ranitidine hydrochloride tablet. J Young Pharm. 2011 Jan;3(1):15–25. doi: https://doi.org/10.4103/0975-1483.76415

25. Chandarana C, Rai P, Jadhav D. Measurement of process capability of manufacturing process of levetiracetam by applying concept of six sigma. Indian J Pharm Educ Res. 2023 Mar 22;57(2):386–92. doi: https://doi.org/10.5530/ijper.57.2.48

26. Adekeye KS, Ogundele J. Evaluating process capability indices for some quality characteristics of a manufacturing process. Ideas.repec.org. 2013. Available from: https://ideas.repec.org/a/spt/stecon/v2y2013i3f2_3_9.html

27. Nkansah P, Wu S-J, Lukulay P, Taylor G, Hsieh W-Y, Spong B, et al. Using colorimetric techniques and capability analysis to develop standard placebo tablets for clinical studies. J Pharm Innov. 2009 Jun;4(2):71–80. doi: https://doi.org/10.1007/s12247-009-9060-8

28. Vugigi S, Mshila C, Ogaji I. Use of product quality review to evaluate quality and process capability: a case study of Ibuprofen in a model tablet manufacture. ECAJPS. 2021 Nov 14 [cited 2023 Dec 13];24(1):38–47. Available from: https://uonjournals.uonbi.ac.ke/ojs/index.php/ecajps/article/view/842

29. Oo A. A study of some quality characteristics of paracetamol tablet. J Health Med Nurs [Internet]. 2021. Available from: https://iiste.org/Journals/index.php/JHMN/article/view/57699

30. Hassouna ME. Application of lean six sigma methodologies and in-vitro dissolution studies for simultaneous determination of Cefdinir and Sodium Benzoate by RP-HPLC and UPLC methods in their dosage forms. Biomed J Sci Tech Res. 2019 Apr 3;16(5). doi: https://doi.org/10.26717/bjstr.2019.16.002901

31. Chandarana C, Rai P, Jadhav D. Measurement of process capability of manufacturing process of Levetiracetam by applying concept of six sigma. Indian J Pharm Educ Res. 2023 Mar 22;57(2):386–392. doi: https://doi.org/10.5530/ijper.57.2.48

32. Tijare LK, Deshmukh LT, Mohod AA, Bhandakkar VM, Hore S, Padole NN. Process validation of highly potent Antidiabetic tablets of Voglibose 0.2 Mg. Asian J Pharm Res Dev. 2022 Apr 16;10(2):90–110.doi: https://doi.org/10.22270/ajprd.v10i2.1070.

33. Abubakar M. Process capability improvement using define, measure, analyze, improve, and control approach in the manufacturing of fexofenadine hydrochloride tablet. 2020. Available from: https://www.isfcppharmaspire.com/article_html.php?did=13832&issueno=0

Article Metrics
16 Views 0 Downloads 16 Total

Year

Month

Related Search

By author names