| Disintegrants are the main excipients applied in tablet formulations to accelerate their disintegration in the gastrointestinal environment, consequently increasing the release of active ingredients. However the number of superdisintegrants available is still limited, hence the need for more efficient ones. In the present study, we aimed to develop a novel superdisintegrant suitable for the formulation of rapidly disintegrating tablets. In this regard, the decoration of leucine, a hydrophilic amino acid, on the starch may improve its disintegration capability. Accordingly, leucine-grafted starch was synthesized, fully characterized, and applied as a disintegrant in the formulation of rapidly disintegrating tablets of domperidone, a vomiting medicine. The tablet formulated with leucine-grafted starch was evaluated for friability, hardness, disintegration time, and drug dissolution. The results were compared with the tablets formulated with starch and sodium starch glycolate as negative and positive controls, respectively. Disintegration time and dissolution study outcomes revealed that both the onset of disintegration and quantities of the released drug were faster and higher in leucine-grafted starch compared with sodium starch glycolate. It was concluded that the novel developed superdisintegrant has a proper potential for application in the formulation of rapidly disintegrating tablets. |