Title: A Pharmacokinetic study showing the increased absorption of palmitoylethanolamide using LipiSperse®.
Background: Palmitoylethanolamide (PEA) is a naturally occurring endogenous fatty acid that benefits human health by exerting a variety of biological functions related to chronic pain and inflammation. The aim of this trial was to determine whether the use of a novel crystalline dispersion technology, LipiSperse®, can be successfully used to improve the absorption of PEA.
Method: A parallel, double-blind, absorption study to measure uptake of PEA over a 4-hour period. The study was conducted with 28 healthy male and female volunteers over 18 years old. Participants were randomised into 2 groups. One group consumed a single 300 mg dose of PEA together with the LipiSperse® delivery technology (commercially referred to as Levagen Plus), while the other group consumed a single 300 mg dose of unprocessed PEA. Blood samples were taken at baseline and 30, 45, 60, 70, 90, 120, 180, 240 minutes post ingestion. The primary outcome measure of the trial was the change in plasma uptake of PEA over a 4 hour period with the resulting Area Under Curve (AUC), concentration max (Cmax) and maximum change from baseline (Delta Cmax) calculated.
Findings: The Levagen Plus formulation significantly increased plasma PEA concentration above baseline concentrations by 1.75 times that of the standard formulation (p<0.05). The maximum concentration of PEA was observed at 45 minutes post ingestion.
Conclusion: These results indicate that by using the LipiSperse® delivery system, PEA absorption is increased above the standard formulation..
David Briskey*, Alistair R Mallard and Amanda Rao