Comparative analysis of mechanical and dissolution properties of single- and multicomponent folic acid supplements

Abstract

Previous reports revealed several concerns related to the quality of marketed folic acid dietary supplements with potential influence on their efficacy, such as underdosages of the folic acid content, complexity of composition and the failure to meet the disintegration and/or dissolution requirements. This study was aimed to compare various marketed folic acid supplements, formulated as single- or multicomponent products, by testing their weight variation, friability, hardness, disintegration and dissolution properties according to the compendial requirements; accompanied with the investigation of influence of composition on the dosage form properties. The obtained results revealed significant differences in mechanical and dissolution properties between the tested supplements, especially between the single- and multicomponent products, where most of the multicomponent products failed to meet the compendial requirements for either dissolution or disintegration. These findings indicate the need for harmonized and strict regulatory requirements for the quality of multicomponent dietary supplements.