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Abstract

This study aimed to develop and evaluate sustained release (SR) paracetamol 1000 mg tablets for 12-hour drug release, integrating immediate release (IR) and controlled release (CR) layers. IR layers (300 mg paracetamol) were formulated using banana starch (BS), polyvinyl alcohol (PVA), and hydroxypropyl methylcellulose (HPMC) as release rate retardants. Selected IR and CR layers were combined into 15 SR tablet formulations (SR1-SR15) prepared by direct compression. Evaluation of post-compression parameters and in vitro dissolution in pH 6.8 phosphate buffer showed ten formulations achieved over 90% drug release by 12 hours. Notably, SR1 and SR3, incorporating BS in both IR and CR layers, achieved 97.12% and 95.56% release, respectively. BS demonstrated superior functionality as a disintegrating agent and rate release retardant, with direct compression providing optimal SR tablet performance for sustained therapeutic efficacy.