Title Pending 1337

This is an accepted article with a DOI pre-assigned that is not yet published. SeDeM-ODT expert system algorithm assisted design ofnovel α-lactose-based directly compactable orodispersible diluents wasconducted in this study to develop multifunctionalorodispersible coprocessed diluents from regulatory established singlecomponent excipients. The primary excipients were α-lactose monohydrate (SorboLac400®, FlowLac90®, Tablettose100®), cornstarch, and sodium starch glycolate (Explotab®). Thepreformulation parameters of the primary excipients were characterizedaccording to the United States Pharmacopoeia (USP41-NF46) and scientificallyvalidated procedures. The experimentalparameter values were normalized into radius units within the range [0,10].SeDeM and SeDeM-ODT expert diagrams were constructed, respectively as regulardodecagon and tetradecagon using the graphing software OriginPro® (Version2021b, OriginLab Corporation, Northampton, USA). The direct compression (DC)and bucodispersion propensity of the excipients were analysed using theincidence functions, parametric profile index (IPP), Index of Good Compression(IGC), and Bucodispersion (IGBC). The reliabilityfunctions of the novel SeDeM-ODT (n=14) and conventional SeDeM (n=12) expertsystems were 0.97 and 0.96, respectively, implying high quality prediction ofdirect compression properties. The SeDeM derived preformulationparameters were used to identify the critical physicotechnical deficits andrationalize coprocessing operation. The DC and bucodispersion propensities ofthe engineered orodispersible coprocessed diluents lie within the theoreticalacceptable limit of <!--[if gte msEquation 12]><m:oMath><m:r>8.382≤</m:r><m:r>IGCB</m:r><m:r>≥5.0</m:r></m:oMath><![endif]--><!--[if !msEquation]--><v:shapetype id="_x0000_t75" coordsize="21600,21600" o:spt="75" o:preferrelative="t" path="m@4@5l@4@11@9@11@9@5xe" filled="f" stroked="f"> <v:stroke joinstyle="miter"> <v:formulas> <v:f eqn="if lineDrawn pixelLineWidth 0"> <v:f eqn="sum @0 1 0"> <v:f eqn="sum 0 0 @1"> <v:f eqn="prod @2 1 2"> <v:f eqn="prod @3 21600 pixelWidth"> <v:f eqn="prod @3 21600 pixelHeight"> <v:f eqn="sum @0 0 1"> <v:f eqn="prod @6 1 2"> <v:f eqn="prod @7 21600 pixelWidth"> <v:f eqn="sum @8 21600 0"> <v:f eqn="prod @7 21600 pixelHeight"> <v:f eqn="sum @10 21600 0"> </v:f></v:f></v:f></v:f></v:f></v:f></v:f></v:f></v:f></v:f></v:f></v:f></v:formulas> <v:path o:extrusionok="f" gradientshapeok="t" o:connecttype="rect"> <o:lock v:ext="edit" aspectratio="t"></o:lock></v:path></v:stroke></v:shapetype><v:shape id="_x0000_i1025" type="#_x0000_t75" style="width:86.4pt; height:37.2pt"> <v:imagedata src="file:///C:/Users/SALIMI~1/AppData/Local/Temp/msohtmlclip1/01/clip_image001.png" o:title="" chromakey="white"></v:imagedata></v:shape><!--[endif]--> recommendedby the expertsystem.