RCT suggests promise for Akay’s Fenumat technology

Published: 31-Mar-2021

The formulation is designed to enable co-delivery of lipophilic phytonutrients with enhanced bioavailability at low dose

A recent RCT published in the Journal of Functional Foods, reported Akay’s Fenumat formulation, characterisation and pharmacokinetic properties of two poorly bioavailable lipophilic phytonutrients, namely curcuminoids, and 3-Acetyl-11-keto-β-boswellic acid (AKBA), following their co-delivery at a single dose of 250 mg. Curcuminoids and boswellic acids are known to act synergistically for joint health and musculoskeletal pain. But the poor oral bioavailability contributed by the lipophilicity, water insolubility and rapid biotransformation and elimination have always posed inherent problems, Akay says.

Simultaneous delivery through the Fenumat platform reportedly caused enhanced absorption of the free forms of both curcuminoids and AKBA with 24.8-fold and 6.9-fold higher bioavailability than their unformulated counterparts. The observed bioavailability of curcuminoids from the formulation was 5.6-fold higher than that of those formulated with turmerones or turmeric oil, the classical bioavailable form of curcumin, the researchers said.

The study was a single-dose, double-blinded, 4-way crossover, 4-sequence pharmacokinetics study. The primary objective was to assess the relative absorption of curcuminoids and AKBA following the oral administration of a 250 mg dose of the Fenumat formulation in comparison to the absorption of its unformulated counterparts; unformulated curcuminoids, unformulated Boswellia extract standardized to AKBA, and unformulated curcumin with 3% turmerones in healthy subjects. UPLC-ESI-QQQ-MS/MS analyses was employed to detect, confirm and quantify free curcuminoids and AKBA in plasma samples.

“The formulation consists of 35% curcuminoids, 10% AKBA and 6% turmeric oil in the form of free flowing beadlets and used fenugreek soluble dietary fibre (Galactomannans) as a hydrogel matrix for the delivery. It was confirmed by Scanning electron and tunnelling electron microscopy (SEM and TEM) studies that the hydrophobic molecules such as the unformulated curcuminoids and boswellia extracts can well encapsulate within the conformationally constrained hydrophobic pockets of the hydrogel matrix. The Fenumat beadlets are amphiphilic and swells extensively in the gastrointestinal tract to affect the sustained-erosion of self-emulsified colloidal particles (150 – 200 nm) of phytonutrients for better absorption,” added the Chief Research Officer at Akay Natural Ingredients and corresponding author of the article, Dr Krishnakumar.

“The technology has already used in the delivery of free curcuminoids as curcumagalactomannosides (CGM or CurQfen) and has been shown to possess improved blood-brain-barrier permeability. We have now extended the technology to various hydrophobic molecules and their combinations such as Boswellic acids, Resveratrol, Fisetin etc and their combinations as a disruptive ‘Green technology’ for the delivery of phytonutrients. Being food grade, 100% natural without any synthetic excipients and clean label, the formulations are suitable for both pharma (capsules, tablets, soft gels) and food/beverage (sachet, stick packs, gummies, instant soups, chocolates, liquid shots, etc), with Natural claim. Go green, Go natural”, added Mr. Emmanuel Nambusseril.

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