Data/hora: 13/06/2024 07:18:39

Provedor de dados: | 42
País: | Brazil
Título: | Physicochemical quality profiles of commercial oral tablets and capsules containing lutein – impact of insufficient specific sanitary regulations
Autores: | ANSELMO,CARINA DE S.; MENDES,THAMARA C.; CABRAL,LUCIO M.; SOUSA,VALÉRIA P. DE.
Data: | 2018-09-01
Ano: | 2018
Palavras-chave: | Dietary supplements; Lutein; Quality control; Age-related macular degeneration.
Resumo: | Abstract Dietary supplements in many countries such as the USA do not require registration prior to commercialization. The Agência Nacional de Vigilância Sanitária (ANVISA) registers substances with functional properties as foods. Lutein is a carotenoid with antioxidant activity available on the market. However, no regulatory mandates exist to govern the design of quality control tests, which are necessary to ensure formulation effectiveness. Therefore, in the present study, tablet and dosage formulations from different manufacturers were tested following general methods outlined in the Brazilian and American Pharmacopeias. The averageweight, disintegration, content and dose uniformity assays were performed for all tablets and capsules, whereas hardness assays were only performed on tablets. None of the 10 formulations studied were found to be of satisfactory quality. Of all tablets tested, two had no-significant available lutein content, which may indicate adulteration. The capsules displayed adequate amounts of lutein, however had alarmingly negative disintegration and dissolution test results, which may contribute to non-bioavailability of lutein. All formulations analyzed are currently being marketed in the Brazilian and American markets. The low physicochemical performance in these formulations can be explained by the lack of specific regulations, which are necessary to ensure the quality of lutein-containing products on the market.
Tipo: | Info:eu-repo/semantics/article
Idioma: | Inglês
Identificador: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0001-37652018000603063
Editor: | Academia Brasileira de Ciências
Relação: | 10.1590/0001-3765201820170972
Formato: | text/html
Fonte: | Anais da Academia Brasileira de Ciências  v.90 n.3 2018
Fonte: | info:eu-repo/semantics/openAccess