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

This study aimed to design a controlled-release (CR) layer for 700 mg paracetamol using banana starch (BS) and compare it with polyvinyl alcohol (PVA) and hydroxypropyl methylcellulose (HPMC). Tablets were prepared by direct compression and wet granulation methods. A total of 24 CR layers were developed using three polymers at 10%, 15%, 20% and 25% w/w concentrations. Pre-compression parameters (bulk density, tapped density, Carr's index, Hausner's ration and angle of repose) and post-compression parameters (weight variation, hardness, friability and assay) confirmed good mechanical properties. Selected CR layers demonstrated robust manufacturing characteristics and optimal release profiles, suitable for controlled drug delivery. The selected best CR layers were CR2(nearly 90%), CR7 (nearly 98%), CR12 (nearly 97%), CR14(nearly 6%) and CR23 (nearly 97%). CR layers by direct compression, especially with BS, showed superior controlled release CR2 (90%, direct compression) and CR14 (96%, wet granulation) exhibited optimal release, with CR2 being the most effective.