Comparative Evaluation of Gum Ghatti-Based Sustained Release Formulation with A Marketed Diclofenac Sodium Product

Abstract

Sustained-release formulations are designed to prolong therapeutic effects, enhance patient compliance, and minimize side effects. Natural polymers such as Gum Ghatti (GG) offer a promising alternative to synthetic excipients due to their biocompatibility, cost-effectiveness, and gelling properties. This study aims to compare the performance of a Gum Ghatti-based sustained-release formulation of Diclofenac Sodium (GGF) with a marketed formulation (MF) in terms of physical parameters, drug release behavior, compatibility, and stability. A matrix tablet was formulated using 25% w/w Gum Ghatti and evaluated alongside a marketed sustained-release product. Comparative analysis included hardness, friability, weight variation, drug content, swelling behavior, in vitro drug release, and release kinetics. Drug-excipient compatibility was assessed using TLC and DSC, and stability testing was conducted under accelerated conditions (40°C ± 2°C / 75% RH ± 5%) for 60 days. GGF showed comparable drug content (98.25%) and acceptable hardness (5.64 ± 0.12 kg/cm²) with MF. The drug release profile of GGF was similar to MF over 12 hours, with cumulative release values of 64.89% and 63.10%, respectively. Both formulations followed non-Fickian (anomalous) release kinetics. No significant drug-excipient interactions were observed. Stability studies confirmed the physical and chemical integrity of GGF. The Gum Ghatti-based formulation demonstrated pharmaceutical equivalence to the marketed product, indicating its potential as a natural, effective, and stable excipient for sustained-release drug delivery systems.