SeDeM Diagram: an expert system for preformation, characterization and optimization of tablets obtained by direct compression

Abstract

SeDeM expert system is an innovative tool which allows characterization of a powdered substance. This information is used to identify strengths and weaknesses for development of tablets by direct compression. The tool allows successful design of tablets, avoiding unnecessary studies and trials, and reducing the lead time of development. In addition, SeDeM expert system provides a mathematical formula to obtain the final formulation of tablets by direct compression in an easy way containing the minimum excipient (one) with a minimum test. The information provided is categorised as dimension, compressibility, flowability/powder flow, lubricity/ stability, and lubricity/dosage—this can be provided in graphical form, the SeDeM Diagram. The methodology information can be used in further studies using Quality by Design. In this chapter, the methodology is described along with some examples. It has been widely demonstrated in pharmaceutical labs that this is a robust tool. This tool was developed at the University of Barcelona.