Minimal food effect for eicosapentaenoic acid and docosahexaenoic acid bioavailability from omega-3-acid ethyl esters with an Advanced Lipid TechnologiesTM (ALT®)-based formulation

Journal of Clinical Lipidology
Miguel A Lopez-ToledanoFrederick D Sancilio

Abstract

The absorption of eicosapentaenoic acid (EPA; 20:5n-3) and docosahexaenoic acid (DHA; 22:6n-3) omega-3-acid ethyl esters (EEs) is influenced by food. There is a need for a formulation of EE that is less impacted by food effect. SC401 is a novel Advanced Lipid Technologies-based formulation of EPA-EE and DHA-EE. In the presence of an aqueous medium, Advanced Lipid Technologies forms stable micelles in situ independent of bile salt secretion. This effect is hypothesized to improve EPA-EE and DHA-EE bioavailability while it helps mitigate the food effect associated with their consumption. The aim of the article was to assess the effect of food on the bioavailability of DHA and EPA after a single oral dose of 1530 mg omega-3 fatty acids EE (SC401) in 24 healthy subjects under fasted and low-fat (9% of total calories from fat) and high-fat (50% of total calories from fat) meal conditions. This was a randomized, open-label, single-dose, 3-period, 3-way crossover study. Blood samples for pharmacokinetic analyses were taken at predose and at 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12 and 24 hours postdose. To assess the safety of the intervention, active monitoring of adverse events, physical examinations, vital signs, cli...Continue Reading

Citations

Dec 15, 2018·Current Opinion in Clinical Nutrition and Metabolic Care·Kevin C Maki, Mary R Dicklin
Jul 31, 2019·Journal of Drug Delivery·Miguel A Lopez-ToledanoFrederick D Sancilio
Mar 18, 2020·Journal of Food Science and Technology·Thiago I B LopesGlaucia B Alcantara
Nov 5, 2019·Clinical Therapeutics·Jean-François LapointePierre Lemieux
Jun 25, 2021·Nanomedicine·Eduardo Burgarelli LagesLucas Antônio Miranda Ferreira

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