Assessment of the Formulation Quality of Folic Acid-Containing Supplements

Abstract

Folic acid supplementation is essential during pregnancy to mitigate the risk of neural tube defects in the fetus. Moreover, folic acid supplements are often necessary to meet the recommended Folic Acid dosage during pregnancy. Although these supplements are classified as food products, information on their quality is lacking. Therefore, this study assessed the quality of folic acid supplements. According to the Japanese Pharmacopoeia guidelines, seven over-the-counter folic acid supplements were subjected to various tests, such as mass variation, dissolution, content measurement, and disintegration tests, and compared with available medical folic acid tablets. Content measurement tests revealed that the folic acid content of the three folic acid supplements were below the lower limit of the acceptable range for Nutritional Ingredient Labeling Standards, which is stipulated by Consumer Affairs Agency. Furthermore, one and four supplements during the disintegration and dissolution tests failed to meet the Japanese Pharmacopoeia standards, suggesting that some folic acid supplements did not properly dissolve and disintegrate, even under conditions similar to those in the digestive tract, which is typically targeted by medical folic acid tablets. In the present scenario, in which folic acid intake during pregnancy is dependent on dietary supplements, providing information that allows consumers to select products of assured quality is necessary.