Physicochemical quality profiles of commercial oral tablets and capsules containing lutein - impact of insufficient specific sanitary regulations.

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 Cienc

authors

Anselmo CS,Mendes TC,Cabral LM,Sousa VP

doi

10.1590/0001-3765201820170972

subject

Has Abstract

pub_date

2018-07-01 00:00:00

pages

3063-3073

issue

3

eissn

0001-3765

issn

1678-2690

pii

S0001-37652018005012109

journal_volume

90

pub_type

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