Abstract

ASSESSMENT OF GRANULAR PROPERTIES OF PARACETAMOL TABLETS PREFORMULATED WITH LENTINUS TUBER REGIUM AS NATURAL DISINTEGRANT

Ucheokoro Adaeze S.*, Ugoeze Kenneth C., Nwachukwu Nkemakolam

ABSTRACT

Background: Tablets remain the most widely prescribed solid oral dosage form due to their convenience, stability, accurate dosing, and high patient compliance. Superdisintegrants are critical for ensuring rapid tablet disintegration and drug release, particularly for BCS Class III drugs like paracetamol. Synthetic superdisintegrants dominate commercial formulations but face limitations in cost, availability, sustainability, and environmental impact, especially in developing countries like Nigeria. Natural alternatives from locally abundant sources are gaining attention, with Lentinus tuber-regium (LT) sclerotia showing potential due to their high polysaccharide content and swelling capacity. Objective: To assess the granular properties of paracetamol granules preformulated with native, boiled, and palm wine-soaked Lentinus tuber-regium powders as a natural disintegrant and compare them with a synthetic superdisintegrant. Methods: LT sclerotia were processed intonative (NLT), boiled (BLT), and palm wine-soaked (SPLT) powders. Physicochemical (density, flow properties, swelling index) and micromeritic properties were evaluated. Compatibility was confirmed using FTIR spectroscopy. Paracetamol granules were prepared using wet granulation with LT powders (10% w/w) and a standard synthetic superdisintegrant. Granular properties (bulk/tapped density, Carr’s index, Hausner’s ratio, angle of repose, particle size, SEM morphology) were determined using pharmacopoeial methods. Statistical analysis included one-way ANOVA and t-tests (α = 0.05). Results: Processed LT powders exhibited superior flowability (Carr’s index 18.6–19.2%, angle of repose 32–34°), lower moisture content (8.2–8.5%), and higher swelling index (45–50%) compared to NLT (p < 0.001). FTIR confirmed no chemical interactions. Granules with BLT and SPLT showed better flow, compressibility, and uniform morphology than NLT-based granules. Conclusion: Processed Lentinus tuber-regium powder, particularly BLT and SPLT, demonstrates promising granular properties for use as a natural superdisintegrant in paracetamol preformulation, offering a sustainable, cost-effective alternative to synthetic excipients.

Keywords: Lentinus tuber-regium, natural superdisintegrant, granular properties, paracetamol preformulation, micromeritics, flowability.