Study shows enhanced bioavailability of HY-FOLIC compared to folic acid

Image | adobe.stock/Natallia

A recent study measured the bioavailability of HY-FOLIC, a finished product containing the active form of folic acid (FA), (6S)-5-Methyltetrahydrofolate (5-MTHF), compared with folic acid. The study, “Pharmacokinetic Study of HY-FOLIC and folic acid in healthy volunteers,” was published in the International Journal of Applied Pharmaceutics in 2024. PT Simex Pharmaceutical Indonesia funded the study.

In the randomized, open-label, two-way crossover, single-dose design study, 12 participants were divided into groups of six, the first group receiving 1,100 mcg of HY-FOLIC and the second group receiving 600 mcg of FA. To measure peak concentration (Cmax), the Area Under the Curve at t-time (AUCt), and infinite time (AUCinf), blood samples were taken from participants before administration and at 1, 2, 3, 4, 5, 6, 7, and 8 hours after. Two weeks later, the first group received the FA and the second group received HY-FOLIC.

As highlighted in the abstract, results included:

• Following administration of HY-FOLIC and FA, Cmax of 5-MTHF were 46.91+28.16 vs 22.61+15.73 nmol/l
• AUCt were 214.47+183.46 vs 112.93+112.11 h. mmol/l
• Cmax of Unmetabolized Folic Acid (UMFA) were 9.49+7.89 vs 21.97+14.79 nmol/l; AUCt 33.29+39.34 vs 78.16+58.93 h. nmol/l

The researchers concluded that after a single dose, “HY-FOLIC is much more bioavailable than FA as indicated by much higher Cmax and AUCt of the active form of 5-MTHF.”

The finished product HY-FOLIC is produced by PT Simex Pharmaceutical Indonesia. “Our study findings suggest that HY-FOLIC increases 5-MTHF levels in the body more effectively than folic acid,” states Merrylin Saragih, head of product department at PT. Simex Pharmaceutical Indonesia, in a January 15, 2025, press release. “This is especially important for individuals requiring enhanced folate bioavailability, such as pregnant women or those with genetic polymorphisms affecting folic acid metabolism.”

Gnosis by Lesaffre, a partner of PT Simex Pharmaceutical Indonesia, developed the glucosamine salt of (6S)-5 methyltetrahydrofolate, known as Quatrefolic featured in HY-FOLIC. “We have espoused the need for the standard of care to change,” added Jean Francois Jeanne, substantiation and application manager at Gnosis by Lesaffre. “We contend that clinically validated Quatrefolic offers substantial advantages over folic acid, but also for a wider population. This study provides another strong element to that argument.”

In an earlier retrospective study, Quatrefolic and a vitamin B complex were shown to positively impact pregnancy outcomes in infertile women undergoing Assisted Reproductive Technology.

Reference

1. Nafrialdi, N.; Suyatna, FD. Pharmacokinetic Study of HY-FOLIC® and folic acid in healthy volunteers International Journal of Applied Pharmaceutics. 2024. DOI: 10.22159/ijap.2024v16i6.51874.