A Statistical Approach to Evaluating the Manufacture of Furosemide Tablets - Pharmaceutical Technology

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A Statistical Approach to Evaluating the Manufacture of Furosemide Tablets
The authors evaluated the manufacturing data of 40-mg tablets of furosemide, a potent diuretic.


Pharmaceutical Technology
Volume 35, Issue 3, pp. 112-121

Conclusion

The statistical approach used in the process evaluation of the blending, tableting, dosage-unit uniformity, weight variation, and dissolution behavior led to better process understanding of the manufacturing process. The results showed that fully nested ANOVA is a powerful tool to identify sources of variability. The process capability indices helped the authors to understand process performance and the potential for process optimization. Although a limited number of batches were investigated, the statistical methods identified possible approaches for process improvement in the manufacturing of furosemide tablets.

Túlia de Souza Botelho is a student, Vanessa Franco Tavares is a student, Cátia Panizzon Dal Curtivo is a student, and Nádia Araci Bou-Chacra* is an assistant professor of pharmaceutics, all at the Faculty of Pharmaceutical Sciences, University of Săo Paulo, 580 Lineu Prestes Ave., Butantan, Săo Paulo, SP – Brazil 05508-900,
. Silvie Rosa Balzan Sarolli is a quality-assurance employee, Márcio Adriano Fernandes is a quality-control employee, and Carmen Maria Donaduzzi is a research pharmacist, all at Prati-Donaduzzi. Raimar Löbenberg is an associate professor of pharmaceutics at the University of Alberta.

*To whom all correspondence should be addressed.

Submitted: Aug. 31, 2010. Accepted: Nov. 29, 2010.

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