THE STUDY OF THE INCORPORATION METHODS OF EXCIPIENTS (LENTINUS TUBER REGIUM) USED IN PARACETAMOL TABLETS FORMULATION

Background: Tablets remain the dominant solid oral dosage form worldwide due to their convenience, stability, precise dosing, and patient acceptability. Superdisintegrants are essential excipients in immediate-release formulations, promoting rapid tablet disintegration and drug release. Synthetic superdisintegrants (croscarmellose sodium, crospovidone, sodium starch glycolate) are effective but expensive, imported, and non-biodegradable, posing economic and sustainability challenges in resource-limited settings like Nigeria. Natural alternatives from locally abundant sources are increasingly explored to address these limitations. Objective: This study investigated the disintegrant performance of Lentinus tuber-regium (LT) powder in paracetamol tablets, comparing intragranular (IG) and extragranular (EG) incorporation methods using native (NLT), boiled (BLT), and palm wine-soaked (SPLT) LT powders against sodium starch glycolate (SSG) as the standard. Methods: Paracetamol tablets were prepared by wet granulation with LT powders (3.0%, 7.0%, 10.0% w/w) incorporated either IG or EG. Granules and tablets were evaluated for density, flow properties, weight uniformity, hardness, friability, disintegration time, and dissolution profile using pharmacopoeial methods. Statistical analysis included one-way ANOVA and t-tests (α = 0.05). Results: Processed LT powders (BLT, SPLT) exhibited superior flowability and compressibility compared to NLT. EG tablets showed faster disintegration (<2 min) than IG tablets (<5 min) and superior dissolution (peak release 64.0% at 3.0% w/w SPLT by 10 min, sustained through 30 min). EG formulations outperformed IG in drug release, with SPLT and SSG achieving comparable peak performance (64.0%). All tablets met USP standards for weight uniformity and friability. Conclusion: Extragranular incorporation of processed Lentinus tuber-regium powder significantly enhances disintegrant performance in paracetamol tablets, offering a sustainable, cost-effective, locally sourced alternative to synthetic superdisintegrants. The findings support further development and scale-up of LT-based excipients for pharmaceutical manufacturing in Nigeria.