(571q) Preparation of Sodium Starch Glycolate Using Reactive Extrusion: Effect of the Reactive Extrusion Process On Its Molecular Structure and Comparison of Its Physical, Chemical and Functional Properties with VivaStarP

In a previous study, we previously prepared cross-linked carboxymethyl starch (CMS) using reactive extrusion. Cross-linked carboxymethyl starch, used for pharmaceutical applications is called sodium starch glycolate (SSG). During extrusion, the starch granule is gelatinized whereas when CMS is prepared using a conventional batch process, the integrity of the starch granule is maintained. In this study, we determined the molecular structure of SSG using scanning electron microscopy, and compared it with the molecular structure of commercial SSG, VivaStarP®. The effect of the molecular structure on the functional properties of SSG was determined by studying the liquid uptake of loose SSG powder, the simultaneous disintegration force and liquid uptake in pure SSG compacts and the disintegration and dissolution properties of solid dosages prepared using soluble and insoluble fillers. Other physical and chemical properties, including Na (bound as starch glycolate) assay, particle size distribution, loose bulk density, tapped bulk density, flow properties, viscosity, settling volume and the carbohydrate soluble fraction, were compared.