A B S T R A C T
Finerenone, a novel non-steroidal mineralocorticoid receptor antagonist, has emerged as an effective therapeutic agent for managing chronic kidney disease (CKD) linked to type 2 diabetes mellitus. Despite its clinical potential, the drug suffers from poor aqueous solubility and pronounced first-pass metabolism, leading to reduced oral bioavailability. The present investigation was undertaken to design and evaluate a sustained-release (SR) tablet of Finerenone utilizing Tamarind Seed Polysaccharide (TSP), a natural, biodegradable polymer, as a rate controlling excipient. Tablets were formulated by the wet granulation technique with different concentrations of TSP and subjected to comprehensive evaluation for pre-compression and post compression characteristics, drug content uniformity, and in-vitro dissolution performance. Among all the developed batches, the optimized formulation (F5) displayed desirable physicochemical attributes, consistent drug distribution, and sufficient mechanical strength. The in-vitro release profile indicated a prolonged and controlled drug release of approximately 92% over 24 hours, adhering to Higuchi kinetics with a non-Fickian diffusion mechanism. Hence, the developed Finerenone SR tablets employing TSP as a release- modifying polymer can effectively prolong drug release, minimize dosing frequency, and enhance therapeutic efficiency and patient adherence in the long-term management of CKD.
Keywords: Finerenone, Tamarind Seed Polysaccharide, Sustained Release, Controlled Drug Delivery, Chronic Kidney Disease.