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A sinvastatina, pertencente à classe das estatinas, é um importante fármaco redutor do colesterol e é encontrada comercialmente como medicamentos referência, genéricos e similares em diferentes dosagens, sendo a de 10 mg a mais comum. Este trabalho tem como objetivo avaliar a qualidade e a equivalência entre comprimidos de sinvastatina 10 mg comercializados no mercado brasileiro. Foram selecionados dois medicamentos similares, um genérico e referência. Os ensaios de controle de qualidade aplicados foram: determinação do peso médio, dureza, friabilidade, desintegração, teor de princípio ativo, uniformidade de conteúdo e dissolução in vitro. Para tanto, foi necessário desenvolvimento e validação de metodologia por espectrofotometria na região do ultravioleta (UV). As formulações apresentaram-se dentro dos limites preconizados para todas as análises. No entanto, quando analisou-se estatisticamente os perfis de dissolução, verificou-se a não equivalência entre os medicamentos similares e o de referência. Porém, através dos resultados obtidos, podemos evidenciar a equivalência entre o genérico e o de referência, sugerindo sua intercambialidade.

Simvastatin, a well-known medicine of the statin class, is used therapeutically for the reduction of cholesterol and is commercially available in reference, similar and generic forms, in various doses, the tablet of 10 mg being the commonest in prescriptions. The purpose of this study was to test the quality and the pharmaceutical equivalence of tablets containing 10 mg of simvastatin available on the Brazilian market. One generic, one reference and two similar dosage forms were selected. The quality-control variables used were: weight variation, hardness, friability, disintegration, content of the active principle, content uniformity and dissolution in vitro. A UV-spectrophotometric method was developed and validated. All formulations were approved in the quality analysis. By using mathematical and statistical models, it was observed that the dissolution profiles of the similar dosage forms were not equivalent to that of the reference. On the other hand, when the generic medicine was compared with the reference, their interchangeability was confirmed. [ABSTRACT FROM AUTHOR]

The aim of this work was to assess pharmaceutical equivalence among medicinal products containing cisplatin, doxorubicin hydrochloride and paclitaxel that are marketed in Brazil by various manufacturers. We analyzed 14 lots of cisplatin injectable solution from 4 manufacturers (Labs B, C, H and I), 15 lots of doxorubicin hydrochloride injectable lyophilized powder from 5 manufacturers (Labs C, F, G, H and J) and 38 lots of paclitaxel injectable solution from 8 manufacturers (Labs A, B, C, D, E, F, G and H). All products complied with the criteria established in the Brazilian and American pharmacopoeias. The assay results for contents of cisplatin, doxorubicin hydrochloride and paclitaxel were 94.3-105.9%, 97.1- 106.6% and 90.2-109.4%, respectively. Statistical analysis showed that the same products from the various manufacturers were equivalent. [ABSTRACT FROM AUTHOR]