Montserrat Miñarro Carmona

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.

New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression

Abstract: SeDeM-ODT expert system is an innovative tool for predicting whether or not an excipient or mixture of powders containing API and excipients is suitable to obtain a buccal dispersible tablet by direct compression. This preformulation tool identifies the index of good compressibility and orodispersibility (IGCB index), unique to each powder or mixture of powders and based on the SeDeM expert system. The IGCB index indicates if a mixture of powder can be compressed by direct compression and, at the same time, indicates if the resulting tablets would be suitable for use as orodispersible tablets. SeDeM ODT and SeDeM expert systems are excellent tools to optimize tablet fabrication. These tools allow a reduction in the number of unnecessary experiments in the laboratory because they provide information on rheology, compactibility properties, etc. In addition, these tools also provide information that can be used for a better understanding of the formulation design.