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Process Capability Indexes Determination on Tabletting Performance during the Process Validation for Metamizol Tablets

Aline L. Anholeto Vissotto¹, Alberto Wunderler Ramos², Terezinha J. Andreoli Pinto¹, Nádia Araci Bou-Chacra¹

¹ Faculty of Pharmaceutical Sciences, Department of Pharmacy, University of Sao Paulo, Sao Paulo (Brazil)
² Faculty of Pharmaceutical Sciences, Department of Production Engineering, University of Sao Paulo, Sao Paulo (Brazil)

Correspondence: Master Mrs. Aline Vissotto, Faculty of Pharmaceutical Sciences, Department of Pharmacy, Unversity of Sao Paulo, Sao Paulo, SP 05508-90 (Brazil), e-mail address: vissotto@usp.br

The aim of the present study was to provide a numerical measure, through the process capability indexes (PCIs), Cp and Cpk, on whether or not the manufacturing process can be considered capable of producing metamizol (500 mg) tablets. They were also used as statistical tool in order to prove the consistency of the tabletting process, making sure that the tablet weight and the content uniformity of metamizol are able to comply with the preset requirements. Besides that, the ANOVA, the t-test and the test for equal variances were applied to this study, allowing additional knowledge of the tabletting phase. Therefore, the proposed statistical approach intended to assure more safety, precision and accuracy on the process validation analysis.

Key words Process capability indexes • Process validation, tabletting • Statistical tools • Tabletting