Controlled Release of Paracetamol from HPMC-Based Hydrophilic Matrix Tablets: A Dry Granulation Approach and Kinetic Modeling

The goal of this study was to create and evaluate an oral sustained-release drug delivery system for the commonly prescribed pain reliever paracetamol. We produced hydrophilic matrix-based tablets with different concentrations of hydroxypropyl methylcellulose using the dry granulation method. The tablets had a dosage of 400 mg and were designed for once-a-day use. We assessed the formulations for the release of paracetamol over 24 hours, using USP type I dissolution testing equipment. The physical characteristics of the tablets were also evaluated. The in-vitro drug release tests showed that the tablets containing 12% HPMC of the total tablet mass achieved good results and controlled the release for 20 hours. The in-vitro release data of the prepared formulations closely followed Korsmeyer-Peppas and Higuchi kinetics. We compared the selected formulation to a commercial product based on the drug release profile and found a similarity factor (f2) greater than 50. We also analyzed the chosen formulation in relation to a paracetamol extended-release tablet made using the wet granulation technique. In conclusion, the dissolution characteristics and the fit of the mathematical models indicate that we can effectively manage the release of paracetamol using hydrophilic matrix systems.