BACKGROUND: SeDeM (Sediment Delivery Model) expert system is a preformulation tool employed for evaluating direct compression suitability of various excipients. SeDeM is a 12 parameters derived diagram and SeDeM-ODT (Sediment Delivery Model-Orodispersible tablets) is a 15 parameters derived diagram that can be used as a research tool for reducing the product development time. The best possible excipients for a specified pharmaceutical active ingredient could be screened for direct compression suitability.
OBJECTIVE: SeDeM expert system has been successfully used and implemented for characterizing galenic properties of pharmaceutical excipients, direct compression suitability of excipients, development of ODT formulations, development of sustained-release formulations, and development of tablets of taste-masked drugs.
CONCLUSIONS: In the present review paper, the development and applications of SeDeM and SeDeMODT systems have been discussed in detail.

The ICH quality vision introduced the concept of quality by design (QbD), which requires a greater understanding of the raw material attributes, of process parameters, of their variability and their interactions. Microcrystalline cellulose (MCC) is one of the most important tableting excipients thanks to its outstanding dry binding properties, enabling the manufacture of tablets by direct compression (DC). DC remains the most economical technique to produce large batches of tablets, however its efficacy is directly impacted by the raw material attributes. Therefore excipients\' variability and their impact on drug product performance need to be thoroughly understood. To help with this process, this review article gathers prior knowledge on MCC, focuses on its use in DC and lists some of its potential critical material attributes (CMAs).