Formulation and Selection of Immediate Release Layer for Designing the Paracetamol Sustained Release Tablets Based on In vitro Profile

This study focused on designing paracetamol immediate release (IR) layers using three disintegrants- Banana starch (BS), Sodium starch glycolate (SSG), and Croscarmellose sodium (CCS)- at concentrations of 2%, 4%, 6%, and 8% (w/w).A total of 24 formulations are prepared: 12 via direct compression (IL1-IL12) and 12 via wet granulation (IL13-IL24). Pre-compression properties (bulk density: 0.45-0.48 g/cm3, tapped density: 0.55-0.60 g/cm3, Carr’s index: 11.8%-20%, Hausner’s ratio: 1.22-1.25) and post-compression parameters (weight variation: 0.9%-1.6%, hardness: 5.45-5.6kg/cm2, friability: 0.1%-0.4%, in vitro wetting time: 1.44-4.4 minutes, in vitro disintegration time: 1.4-4.4 minutes were within acceptable limits. Direct compression formulations exhibited superior dissolution rates, with fold enhancements of 1.22 (BS), 1.23 (SSG), and 1.18 (CCS) compared to wet granulation. Formulations IL4, IL8, and IL12 (8% disintegrant, direct compression) demonstrated optimal dissolution and mechanical properties, making them the final IR layers selected for sustained release (SR) tablet design. These findings support their potential application in fever management in conditions such as COVID-19.