A Single-dose, Comparative Bioavailability Study of a Formulation containing OM3 as Phospholipid and Free Fatty Acid to an Ethyl Ester Formulation in the Fasting and Fed States

Clinical Therapeutics
Jean-François LapointePierre Lemieux

Abstract

Formulations of ω (OM)-3 with adequate bioavailability in the low-fat fed state are advantageous in patients with severe hypertriglyceridemia (HTG), as these patients are advised to adhere to a low-fat diet. The OM3-containing prescription drugs approved by the US Food and Drug administration (FDA) provide OM3 in either ethyl ester (EE) or free fatty acid (FFA) forms. The OM3 FFA form and formulations with micelle-forming ability have shown improved bioavailability versus the EE form. OM3 phospholipid (PL)/FFA, a krill oil-derived OM3 mixture containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) present as PL esters and FFA, is being developed for the treatment of severe HTG. Both forms of OM3 in OM3-PL/FFA are believed to be digested and absorbed more efficiently as compared to OM3 in EE. This hypothesis was tested by comparing the relative bioavailabilities of EPA and DHA from a single 4-g dose administration of OM3-PL/FFA to those the FDA-approved HTG drug OM3-EE in the fed (high-fat meal) and fasted states. The effects of food on the bioavailability of both drugs were also tested. This open-label, randomized, 4-way crossover bioavailability study was conducted in 56 healthy adults who were randomly assigned ...Continue Reading

Citations

Apr 10, 2020·Food & Function·Ronan LordanIoannis Zabetakis
Dec 16, 2020·Comprehensive Reviews in Food Science and Food Safety·Mirja Kaizer AhmmedAlaa El-Din Bekhit
Aug 1, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Armond DaciGokce Topal
Nov 5, 2019·Clinical Therapeutics·Jean-François LapointePierre Lemieux
Jan 7, 2022·JAMA Network Open·Dariush MozaffarianUNKNOWN TRILOGY (Study of CaPre in Lowering Very High Triglycerides) investigators

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