Assessment of the Quality of the Simvastatin Commercialized by Pharmacies of Manipulation from the City of Belo Horizonte/Brazil

• Main Author: Leal, Alexandre Soares
• Publication Date: 2014
• Other Authors: Melo, Fernanda Peixoto Sepe, Gomes, Tatiana Cristina Bomfim, Santana, Amália Soares, Cunha, Luzia Helena da, Saiki, Mitiko
• Format: Article
• Language: por
• Source: Vigilância Sanitária em Debate
• Download full: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/113
• topic: Quality Control; Simvastatin; Good Practice of Manipulation; Health Surveillance; Controle de Qualidade; Sinvastatina; Boas Práticas de Manipulação; Vigilância Sanitária

The growing expansion of the magistral sector associated with reports of deviations from quality of compounded drugs, with serious cases, has generated a series of efforts by the Health Surveillance in the search for an efficient monitoring of pharmacies and products offered to the population. Thus, the aim of this study was to evaluate the quality of preparations containing simvastatin, manipulated in some pharmacies of Belo Horizonte/MG, after reviewing the health legislation occurred in 2007, through the realization of pharmacopoeic physicochemical analyzes of determination weight, identity and content of active ingredient and uniformity of dosage units. Further, research by neutron activation analysis, the presence and concentration of inorganic impurities in the samples of simvastatin manipulated. The results expressed an index of satisfactoriness of only 30%. This fact confirms the need for fast and efficient acts by public health authorities, and improving processes used in the manipulation within the establishments, to ensure the quality of compounded drugs.