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.
journal_name
An Acad Bras Ciencjournal_title
Anais da Academia Brasileira de Cienciasauthors
Anselmo CS,Mendes TC,Cabral LM,Sousa VPdoi
10.1590/0001-3765201820170972subject
Has Abstractpub_date
2018-07-01 00:00:00pages
3063-3073issue
3eissn
0001-3765issn
1678-2690pii
S0001-37652018005012109journal_volume
90pub_type
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