Study of MCC, Mannitol and SiO2 Based Co-processed Excipient for Improving the Direct Compression Properties of Paracetamol using SeDeM/SeDeM-ODT Expert System

Co-processed excipients have enhanced functionality attributes required for developing tablet dosage forms by direct compression technology. In the present study, mannitol, microcrystalline cellulose, and silicon dioxide were developed by dry granulation and proposed as a viable solution for correcting the flowability and compressibility issues commonly encountered in developing paracetamol tablets. SeDeM (12 parameter based) and SeDeM ODT (15 parameter based) expert systems were employed as tools for developing orally disintegrating tablets of paracetamol. SeDeM diagram of paracetamol, mannitol, microcrystalline cellulose and co-processed excipients were prepared and parametric index values of 3.9 and 2.01 indicated poor flowability and compressibility properties of paracetamol. The percentage of corrective excipient required to correct the flowability and compressibility of paracetamol was then calculated followed by preparation of SeDeM ODT expert system diagrams. An increase in concentration of silicon dioxide from 1% to 5% in the co-processed excipient resulted in a decrease in dissolution rate due to increased apparent viscosity/ gel-like structure at higher concentrations of silicon dioxide. The study revealed that co-processed excipient sample with 2.5% of silicon dioxide showed the highest IGCB value of 6.39, implying its suitability for the direct compression of tablets.