Statistical process control of manufacturing tablets for antiretroviral therapy

IF 0.6 4区医学 Q4 PHARMACOLOGY & PHARMACY

Brazilian Journal of Pharmaceutical Sciences Pub Date : 2023-05-22 DOI:10.1590/s2175-97902023e22099

Nataly Paredes da Rocha, Osvaldo Cirilo da Silva, E. J. Barbosa, Gidel Soares, Roberto Oliveira, Lis Marie Monteiro, N. Bou-Chacra

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引用次数: 0

Abstract

In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150 + 300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular “Chopin Tavares de Lima” (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.

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来源期刊

Brazilian Journal of Pharmaceutical Sciences PHARMACOLOGY & PHARMACY-

CiteScore

1.40

自引率

0.00%

发文量

165

审稿时长

7.5 months

期刊介绍： The Brazilian Journal of Pharmaceutical Sciences accepts for publication Original Papers applicable to the fields of Pharmaceutical Sciences; Reviews and Current Comment Articles, which are published under the Scientific Editor and Associate Editors invitation to recognized experts or when they are spontaneously submitted by the authors in the form of abstracts to have their importance evaluated. A critical view of the subject with insertions of results of previous works in the field in relation to the state of art must be included; Short Communications reporting new methods and previews of works on researches of outstanding importance in which originality justify a quick publication. A maximum of 2000 words excluding tables, figures and references is an acceptable limit. One table, one figure and ten references may be added, and Book Reviews of the latest editions of books, prepared by specialists invited by the Scientific Editor and Associate Editors. Thematic Supplements as well as those related to scientific meetings can be published under the Scientific Editor and/or Associate Editors agreement.