Date of Publication: 14-Jun-2022
Process capability improvement using define, measure, analyze, improve, and control approach in the manufacturing of fexofenadine hydrochloride tablet
Author: Md Abubakar, Sukhbir Kaur
Aim: Process capability improvement using define, measure, analyze, improve, and control (DMAIC) approach in the manufacturing of fexofenadine hydrochloride (FEX HCL) tablet. Materials and Methods: The FEX HCL tablet was formulated by wet granulation method containing the equivalent to 120 mg FEX HCL. Process capability assessment was done by calculating process capability (Cp) and control chart was prepared using quality control parameter of tablets. Results: FEX HCL granules were evaluated for angle of repose 25.84 ---PlusMinusSymbol--- 0.50, bulk density 0.42 ---PlusMinusSymbol--- 0.01, tapped density 0.38 ---PlusMinusSymbol--- 0.01, Hausner’s ratio 1.04 ---PlusMinusSymbol--- 0.01, and Carr’s index 6.25 ---PlusMinusSymbol--- 0.32. Obtained result possessed good flow property. The post-compression evaluation results were found to be: Hardness 3.79 ---PlusMinusSymbol--- 0.12, friability 0.507%, thickness 4.4 ---PlusMinusSymbol--- 0.0.5, drug content 95.99–98.38%, disintegration 129.09 ---PlusMinusSymbol--- 1.65, and in vitro release 95.47–99.30% in 30 min. The process capability of the applied procedure was tested by calculating the “Cp” value for drug content, which was found to be 1.15, which means certain modifications are required in the process. Hence, we apply failure, mode, and effect analysis for low drug content process capability and the value of Cp was raised to 6.05. Conclusion: After successful implementation of DMAIC approach with the help of process capability analysis, process of FEX HCL tablets manufacturing was improved for Cp = 6.05 compared to previous, i.e., 1.15.
Keywords: Define, measure, analyze, improve, and control, fexofenadine hydrochloride tablets, process capability index, process capability
1. Greg B. Six Sigma for Manager. New York: McGrew Hill; 2002. p. 10-25.
2. Nunnally BK, McConnell JS. Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics. Boca Raton, FL: CRC Press; 2007.
3. Kane VE. Process capability indices. J Qual Technol 1986;18:41-52.
4. Chakravorty SS. Six sigma programs: An implementation model. Int J Prod Econ 2009;119:1-16.
5. Portnoy JM, Dinakar C. Review of cetirizine hydrochloride for the treatment of allergic disorders. Expert Opin Pharmacother 2004;5:125-35.