The SeDeM expert system is used to reveal direct compression (DC) suitability of the active ingredients and excipients in preformulation. In this study, the system was used to predict compressibility of rhodiola extract (RhE) and its mixture with excipients. The parameter index (IP), parameter profile index (IPP), and good compressibility index (IGC) of RhE mixtures with different fillers were investigated. The results showed that RhE and mixture with lactose or starch were not suitable for DC according to the values of IP, IPP, and IGC, which can be corrected by pregelatinized starch (P-STA). The quality of tablets corrected by P-STA all satisfied the USP monograph limit. The findings from this study showed that the system is a useful tool to predict DC suitability on the mixture of RhE and an excipient.
The SeDeM Expert System was first known as a galenic pre-formulation system, which was based on the experimental research and quantitative determination of powdered substances. And the mathematical formula provided by the SeDeM Expert System has plays an important role in the study of powder properties. The system can be used not only to evaluate the powder direct compression (DC) of excipients and active pharmaceutical ingredients (API's), but also to predict the possible formulations, so it can reduce unnecessary research and trials, and shorten the time of development. In this paper, the research development and application of SeDeM Expert System in DC was summarized, and the results showed that with a few exceptions, the system was skilled in predicting acceptable tablet formulations. Finally, the new application prospect of the system is presented, including the application of the Internet traffic and content management (iTCM) database and the new co-processed excipients.
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