Exploring Impact of Excipient Properties on Development of Directly Compressible Tablet Using SeDeM Expert System

Abstract

A preformulation tool used to assess the acceptability of different excipients for direct compression is the SeDeM (Sediment Delivery Model) expert system. A research tool for shortening the time it takes to produce a new product is SeDeM, a diagram developed from 12 parameters, and SeDeM-ODT (Sediment Delivery Model Orodispersible tablets), a diagram derived from 15 parameters. The SeDeM calculates the parameters mathematically for easily obtaining the final tablet formulation for DC process, which requires the minimum excipients and minimum tests. Dimension, compressibility, flowability/powder flow, lubricity/stability, and lubricity/dosage are the categories in which the information is categorized. This information can be shown graphically using the SeDeM Diagram. Direct compression appropriateness could be used to screen the best potential excipients for a certain pharmaceutical active component. The SeDeM expert system has proven to be effective in assessing the galenic properties of pharmaceutical excipients, determining whether an excipient is suitable for direct compression, creating ODT formulations, creating sustained-release formulations, and creating tablets containing taste-masked medications. This research work include introduction of direct compression then detail information about SeDeM expert system which includes all the formulas required for the evaluation of the powder blend.Different grade of excipients have been taken for the study that is Pearlitol 25C, Pearlitol 200SD, Flowlac 100, Tablettose 70, Avicel PH-102, Avicel PH-200.Drug-x belong to class-1 calcium channel blocker is used as the model API.12 batches were formulated with the combination of 2 diluents. The entire blends were evaluated using SeDeM formulas and converted into radar charts. Evaluation of tablet is also taken into consideration. In conclusion resulted data of the SeDeM diagram is compiled and discussed the flow properties and good compressibility index of the blend and tablet.