Commercially available folic acid supplements and their compliance with the British Pharmacopoeia test for dissolution

Abstract

A recent report suggested that some folic acid preparations available in the United States failed to meet the specifications for dissolution specified by the US Pharmacopoeia (USP), of 70 percent drug release in the first hour of testing. The Teratology Society recommends that women of child-bearing age should take a daily supplement of 400 μg folic acid when they are trying to conceive, to reduce the risk of foetal neural tube defects. The consequence of this failure to meet the USP requirements may be that an inadequate dose of folate may be absorbed and thus the expected level of protection against neural tube defects not afforded. The purpose of the present study was to examine a number of brands of folic acid (400 μg), available commercially in the United Kingdom, for compliance with the British Pharmacopoeia (BP) test for dissolution. Ten tablets (or capsules) from each of 11 brands were tested using dissolution apparatus compliant with BP requirements, using 0.1 M sodium hydroxide as the dissolution medium. The results indicated that four of the brands failed to release 70 per cent of the nominal drug content in the first hour of test and thus did not comply with the test. Two of the seven brands that passed the test went on to release more than 150 per cent of the nominal 400 μg drug content. These results highlight the problems of dose uniformity and the potential health risks of slow dissolution and under-dosing in commercially available folic acid dosage forms.