Development and validation of a dissolution test for lutein tablets and evaluation of intestinal permeability. (1st November 2016)

• Record Type: Journal Article
• Authors: Anselmo, Carina de Souza; Mendes, Thamara de Carvalho; Honorio, Thiago da Silva; do Carmo, Flávia Almada; Cabral, Lucio Mendes; de Sousa, Valeria Pereira
• Is Part Of: Food chemistry. Volume 210(2016)
• Page Start: 63
• Page End: 69
• Publication Date: 2016-11-01
• Subjects: Dissolution test -- Carotenoid -- Non-everted rat intestinal sac model -- Intestinal permeation -- Food regulation -- Drug release -- USP apparatus II; Food -- Analysis -- Periodicals; Food -- Composition -- Periodicals; 664
• DOI: 10.1016/j.foodchem.2016.04.081
• Languages: English
• ISSNs: 0308-8146

Abstract

Highlights: Lutein presents instability in sodium lauryl sulfate aqueous medium. Dissolution tests are an essential quality control tool for formulations containing lutein. Lutein's apparent permeability coefficient of is similar to highly permeable substances. Lutein belongs in the class II of the biopharmaceutical classification system. Abstract: Lutein is a carotenoid with antioxidant activity that is present in various dosage forms. The bioavailability of carotenoid from oral dosage formulations depends on their release, dissolution and its permeability through the gastrointestinal tract. Here, a dissolution test was developed for evaluating formulations and the bioavailability was assessed. The test utilized a USP-apparatus II with rotations of 50, 75 and 100 rpm in water with P80 at 1, 2 and 5% (w/v). A non-everted rat intestinal sac model was used in conjunction to assess the intestinal permeability. The most discriminative conditions were 100 rpm in water with 2% polysorbate 80, which showed profile differences between two formulations. The intestinal permeation studies showed a lag-time and apparent permeability coefficient that were characteristic of highly permeable drugs. We suggest that a dissolution test can be an essential quality control tool for formulations containing compounds as lutein, although not mandatory by the regulation agencies.