Impact of Intra-Granular Method of Disintegrant Incorporation on Formulated Paracetamol Tablets Dissolution

Background: Disintegrants are essential excipients in immediate-release tablets because they facilitate tablet breakup and promote rapid drug dissolution and bioavailability. Although synthetic superdisintegrants such as sodium starch glycolate (SSG) are widely used, there is increasing interest in natural, biodegradable, and locally sourced alternatives. Lentinus tuber regium, an edible mushroom, has shown potential as a pharmaceutical excipient, but its disintegrant performance depends on processing and formulation conditions. Objective: This study evaluated the effect of processing and intra-granular incorporation of Lentinus tuber regium powder on the dissolution performance of formulated paracetamol tablets. Methods: Natural Lentinus tuber regium powder (NLT) was processed by bleaching to obtain bleached LT (BLT) and by solvent purification to obtain solvent-purified LT (SPLT). Each powder was incorporated intra-granularly at concentrations of 3.0%, 7.0%, and 10.0% w/w using the wet granulation method. Sodium starch glycolate served as the reference superdisintegrant. Paracetamol tablets were compressed under uniform conditions and evaluated for dissolution using the USP paddle apparatus in suitable dissolution medium maintained at 37 ± 1 °C. Dissolution profiles were analyzed to determine the influence of processing method and concentration on drug release. Results: Tablets containing NLT exhibited slow and incomplete drug release at all concentrations, indicating limited hydration and disintegration efficiency of the unprocessed powder. In contrast, BLT formulations showed significantly enhanced dissolution, particularly at low concentration, while SPLT exhibited optimal dissolution at moderate concentration. At higher concentrations, both BLT and SPLT showed reduced dissolution, possibly due to excessive swelling and restricted diffusion pathways within the tablet matrix. Generally, processed LT powders performed comparably to, and in some cases better than, SSG. Conclusion: Processing and intra-granular method of incorporation significantly improved the disintegrant performance of Lentinus tuber regium. The results support the potential of processed Lentinus tuber regium as a natural, cost-effective alternative superdisintegrant for immediate-release tablet formulations.