SeDeM expert system for directly compressed tablet formulation: A review and new perspectives

The pharmaceutical tablet formulation design is a risky and challenging process since it largely depends on experience. The fundamental reasons lie in the lack of understanding of powder properties and the interactions between the active pharmaceutical ingredients and excipients. To compensate these shortness, the use of expert system (ES) in the formulation development has gradually drawn attentions during the last two decades. The SeDeM expert system is one such intelligent tool aiming at designing direct compression (DC) tablet. It gathers almost all the frequently used physical parameters to fully characterize the compressibility of powdered substances. The mathematical equations for selection of excipients reflect the state of art knowledge of DC tablet formulation. In this paper, the detailed history, principles, applications and derived forms of the SeDeM expert system were reviewed. Contributions of the SeDeM expert system to the manufacturing classification system (MCS) were illustrated. A SeDeM database named iTCM was innovatively proposed. All in all, the functions and application scopes of the originally developed SeDeM expert system have been continuously extended and more improvement could be achieved in the future.

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