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Folic acid preparations dissolution requirements

29 March 2004

In 2001, the Therapeutic Goods Administration (TGA) was advised of reports from the United States that some folic acid-containing tablets failed to release folic acid when analysed by conventional dissolution tests.

In view of the United States findings, the TGA tested the dissolution of 51 folic acid tablets available in Australia against the Australian standard for disintegration and also against the United States Pharmacopoeia (USP) dissolution test. The products tested represented a range of sponsors and manufacturers and various concentrations of folic acid. Ten of the products tested did not comply with the USP dissolution test, however compliance with this test was not a legal requirement in Australia at that time.

The TGA requested advice from the Complementary Medicines Evaluation Committee (CMEC) as to whether dissolution testing for products containing folic acid should be introduced in Australia. The CMEC recommended that a dissolution standard should be a legal requirement for folic acid supplement preparations, in tablet form, of a strength of 100 micrograms or more per dosage unit. The CMEC also recommended that products containing a higher dose of folic acid (ie. 400 micrograms or over) should be required to comply with the dissolution standard earlier than the lower dose products.

The TGA accepted CMEC's recommendation, and in December 2001 put industry on notice of its intention to introduce the stricter USP dissolution test as the standard for products containing folic acid, and indicated that it would allow time to reformulate products where necessary. In July 2002, the therapeutic goods legislation was amended to make it a requirement that tablets containing folic acid comply with the USP dissolution test. Tablets containing 400 micrograms or more of folic acid were required to comply with the stricter standard by November 2002, and tablets containing 100 micrograms or more of folic acid were required to comply by November 2003.

Strengthening the quality requirements for folic acid has helped ensure that Australia continues to use world best practice standards for regulating these products and plays an important part in maintaining consumer confidence in complementary medicines available in Australia.