**2. SeDeM-ODT expert system**

SeDeM-ODT expert system is novel pre-formulation technique applied for development of a solid dosage form (tablets) by direct compression technology [11]. The system characterizes powder substance on the basis of various parameters related to flow, compressibility, and disintegration behavior. Physical profile of powder substance is developed, suggesting its suitability for direct compression and bucco-dispersibility [12, 13]. SeDeM expert system can be segmented into the following:

**SeDeM expert system:** It determines suitability of the powder substance for direct compression only [11, 13]. That is, the system characterizes powder substance with respect to its rheological characteristics and compressibility.

**SeDeM-ODT expert system:** It is the newest version of SeDeM expert system and characterizes the powder substances with respect to rheological characteristics, compressibility, and disintegration behavior, simultaneously [14]. Three extra parameters related to characterization of disintegration behavior are included in the SeDeM-ODT expert system.

The SeDeM-ODT expert system has been introduced with the aim of designing oro-dispersible tablets (ODTs) by direct compression [14]. This system is unique as it provides an oro-dispersible tablet formulation by direct compression, i.e., it links prediction of suitability of powder for direct compression and rapid disintegration of the tablets. SeDeM-ODT expert system is used for evaluation of critical quality attributes of powder substance, having an impact on the final product. Quality by Design guidelines ICH-Q8 [15] provides the basis for SeDeM-ODT expert system.

SeDeM-ODT expert system also calculates the amount of excipients with certain characteristic required for the correction of a particular property in order to make a final blend suitable for direct compression [14]. Several parameters have been selected that must be fulfilled by the formulation (excipients) to ensure successful and robust processing by direct compression technology.

*SeDeM-ODT Expert System: A Solution to Challenges in Characterization of Pharmaceutical… DOI: http://dx.doi.org/10.5772/intechopen.92444*
