**5. Conclusions**

determination of reproducibility of various batches of pharmaceutical ingredients (APIs and excipients). Various batches were characterized according to the SeDeM expert system, and reproducibility was estimated on the basis of consistency of the results [13].

Josep et al. [33] applied SeDeM expert system for the optimization of Hausner ratio and relative humidity. The proposed optimization did not involve any conceptual change in the parameters considered or did a significant change in the results obtained compared with the previous calculation methodology initially established, meaning that the conclusion obtained by applying this method is

SeDeM expert system can be applied for the determination of reproducibility of manufacturing process of pharmaceutical powder substance (API and excipients). By establishing specifications for different parameters as per SeDeM-ODT expert system, variation among different batches of a product produced by the same manufacturing process can be determined [34]. **Figure 7** shows the SeDeM diagram of different batches of glucosamine sulfate, prepared by the same manufacturing

SeDeM-ODT expert system has been applied for the differentiation of excipients

**4.6 Quality control of batches of pharmaceutical powders (APIs and**

**excipients) prepared by the same procedure**

**4.7 Differentiation of excipients with same functionality**

having the same chemical nature and function on the basis of physical

**4.5 Optimization of powder characteristics**

*Correction of "compressibility" and "flowability" of APIs with excipient [12].*

equivalent [33].

**Figure 6.**

*Advanced Functional Materials*

procedure.

**182**

SeDeM-ODT expert system is a novel tool for the characterization of powder substances on the basis of their physical parameters. The system has been successfully applied for the determination of rheological characteristics, mechanical strength, and disintegration behavior of pharmaceutical powders (APIs and excipients) and determination of suitability for direct compression and buccodispersibility. SeDeM-ODT expert system facilitates the process of excipient selection and calculation of their relative proportion in oral solid dosage form. A data base can be developed for various excipients which will help in the selection of excipients having desired characteristics. It avoids extra experimentation for optimization of various characteristics of powder blend, reducing the cost and time span of formulation development process. This method characterizes the individual components of a formulation and applies a mathematical analysis to determine the exact amount of each ingredient in the final formulation. This innovative tool is consistent with the current requirements of regulatory health authorities such as the FDA and ICH, whereas data generated on the basis of the system can contribute to the concept of Quality by Design. SeDeM-ODT expert system has certain limitations, and misleading results are possible in certain cases. Suitability of material for direct compression is decided on the basis of index of good compressibility value, which is based on "r" values of the individual parameters. Substances having high "r" values will raise IGC value and vice versa. So suitability of a material should not be judged on the basis of IGC value. The incidence factor value should be considered, and outliers in "r" value of the individual factors, if present, should be properly addressed. Overall SeDeM-ODT expert system is an unmatched tool for material characterization at pre-formulation level and has significantly decreased time span and cost of pharmaceutical formulation development process.
