Pharmacokinetic comparisons between liposome formulation and non-liposome formulation of omega-3 fatty acids: a randomized clinical study

Liposomal delivery systems may enhance the systemic exposure of lipophilic nutrients. This study evaluated the effect of a liposomal omega-3 formulation (Liposomal ABMax Omega-3) on the extent of absorption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) compared with conventional ethyl ester (EE) and re-esterified triglyceride (rTG) formulations. In a randomized, double-blinded, parallel, active-controlled clinical study, 45 healthy adults received a single oral dose of (1,800 mg total) liposomal omega-3 (Liposomal ABMax Omega-3), EE omega-3, or rTG omega-3. Baseline-corrected serum concentrations of EPA and DHA were measured up to 24 h post-dose. Pharmacokinetic parameters were derived using noncompartmental methods, with incremental AUC (iAUC) as the primary endpoint. Liposomal omega-3 (Liposomal ABMax Omega-3) resulted in significantly higher baseline-corrected iAUC for DHA and EPA+DHA than the conventional EE and rTG formulations. No clinically significant safety concerns were identified. Liposomal formulation significantly enhanced systemic exposure of EPA and DHA compared with conventional formulations, supporting its potential to improve systemic exposure. These findings support that liposomal omega-3 (Liposomal ABMax Omega-3) enhances the systemic exposure of EPA and DHA and shows good tolerability within body.Trial Registration This study was registered with the Clinical Research Information Service (KCT 0011550).