Performance study of cross-linked carboxymethyl rice starch, co-processed with sodium silicate as a direct compression excipient using SeDeM expert system

This work presents the performance study of cross-linked carboxymethyl rice starch, co-processed with sodium silicate (CXO) as a multifunctional excipient for direct compression (DC). The compression behavior of the powder was investigated, while SeDeM expert system was applied to determine its suitability for the DC process. The results showed that CXO particles highly rearranged during the initial stage of compression. The distortion occurred mainly through plastic deformation with little elastic recovery; thus, promoting excellent compressibility. The small particle size (%Pf) and silicification rendered low lubricant sensitivity. The SeDeM analysis revealed that most incidence factors surpassed the acceptance limit, confirming that CXO was suitable for the DC process. The formulation study suggested that CXO could be diluted with paracetamol up to 54% w/w in the DC formulation. At this ratio, CXO tablets exhibited narrow weight variation (2.3%), low friability (0.42%), and acceptable drug content (101.3%). The moderate disintegration time (5 min) did not limit the tablet dissolution, of which the cumulative drug release was found to surpass 85% within 15 min in all tested media. On the other hand, the formulations containing commercial DC excipients failed to produce DC tablets due to low cumulative drug release and high friability, respectively. These findings indicate the application of CXO as a multifunctional excipient for DC.