Abstract:Background: Famotidine, an H₂-receptor antagonist used to treat peptic ulcers and gastroesophageal reflux disease (GERD), exhibits poor bioavailability due to its short gastric residence time and pH-dependent solubility. The present study aims to develop gastroretentive floating tablets of Famotidine using hydrophilic polymers and gas-generating agents to enhance gastric retention and sustained drug release.
Objectives: The primary objective of this study was to formulate and evaluate floating tablets of Famotidine with optimized buoyancy, swelling behavior, and controlled drug release. The study also aimed to investigate the effect of polymer concentration on floating lag time, swelling index, and drug release kinetics.
Methods: The direct compression method was used to formulate floating tablets with HPMC K100M and Carbopol 934P as controlled-release polymers and sodium bicarbonate-citric acid as effervescent agents. The formulations were evaluated for pre-compression and post-compression parameters, buoyancy studies, swelling behavior, and in vitro drug release. Statistical analysis, including correlation studies and t-tests, was performed to determine the significance of formulation variables. Drug release kinetics were evaluated using zero-order, first-order, Higuchi, and Korsmeyer-Peppas models.
Results: The optimized formulation (F5) exhibited a floating lag time of 21 seconds, buoyancy exceeding 13.5 hours, a swelling index of 98.1%, and a sustained drug release of 92.5% over 12 hours. Korsmeyer-Peppas model fitting (R² = 0.992) confirmed a non-Fickian diffusion-controlled release mechanism. Statistical analysis revealed significant correlations between polymer concentration, swelling index, floating behavior, and drug release.
Conclusion: This study confirms that gastroretentive floating systems significantly enhance the gastric retention and bioavailability of Famotidine. The optimized formulation ensures prolonged drug release, improved therapeutic efficacy, and better patient compliance. Further in vivo studies and clinical evaluations are required to validate its pharmacokinetic performance.