ENDUR-ACIN® exhibits a dissolution profile similar to prescription niacin, study shows

Summary

This study was designed to compare the dissolution profiles of ENDUR-ACIN®, other non-prescription extended-release (ER) niacin supplements and inositol niacinate supplements. A prescription ER niacin drug (Niaspan) was chosen as the reference due to its extensive pre-market safety and efficacy review by the FDA.

A total of 19 commercially available supplements were evaluated, including 7 extended-release nicotinic acid supplements and 12 inositol niacinate supplements. (Inositol niacinate is the so-called “flush free” form of niacin introduced to the market with the intent of improving the tolerability of niacin, even though these products are not recommended for the treatment of dyslipidemia.) The free niacin content of powder (equivalent to 500 mg niacin) was measured according to the official U.S. Pharmacopeia monograph.

Results indicate significant variations in dissolution profiles among the 19 supplements. Of the 12 inositol niacinate products, a high variation in niacin release was found, ranging from 6% to 34% at 240 minutes. Of the seven ER supplements, one failed to demonstrate extended release, and five had dissolution profiles that were significantly (P<.05) higher than that of the prescription drug (mean 98 to 369 mg/hr vs. 90 mg/hr, respectively). Only ENDUR-ACIN® had a dissolution profile similar to that of the prescription drug (mean 93 mg/hr vs. 90 mg/hr, respectively).

These findings indicate that wide variability exists in dissolution profiles among extended-release niacin dietary supplements. Only ENDUR-ACIN® was found to have a dissolution profile similar to that of prescription ER niacin.