Physicomechanical Behaviour of Novel Directly Compressible Starch-MCC-Povidone Composites and their Application in Ascorbic Acid Tablet Formulation

The goal of this research was to provide critical evaluation of the physicomechanical performance of Starch-MCC-Povidone (SMP) composites engineered via co-processing strategy. Aqueous dispersions of the primary excipients at predetermined combination levels were subjected to physical agglomeration at controlled subgelatinization (55 °C) temperature followed by drying at 60 °C for 48 h. Under scanning electron microscope, the materials appeared as enlarged porous composites of starch-MCC bound by solid bridges of povidone. Powder fluidity indicators suggested acceptable flow properties (Angle of repose 5 gs-1). Compact weight variation studies revealed reproducible volumetric die filling capacity. Analysis of powder compaction indices shows appreciable densification and total volume reduction in both Heckel and Kawakita models. The dilution capacity of the composites was up to 40% using L-ascorbic acid as the model drug. Analysis of post compression tablet properties indicated extensive elastic recovery at low MCC content. All the novel composites were characterised by rapid in-vitro disintegration and efficient in-vitro drug release (t50% <1 min; t80% < 2 min). In comparison to Ludipress® and Prosolv®, moderate to high MCC containing Starch-MCC-Povidone composites (SMP3 and SMP5) could be employed as alternative cost effective direct compression diluents in tablet formulation.