| Abstract: |
Famotidine, a potent histamine H2-receptor antagonist with oral bioavailability of merely 40–50% and a plasma half-life of approximately 2.6 hours, presents significant pharmacokinetic challenges necessitating a gastroretentive drug delivery approach. The present investigation was designed to develop and evaluate effervescent floating tablets of famotidine using hydroxypropyl methylcellulose (HPMC K4M and HPMC K100M) as hydrophilic matrix-forming polymers and sodium bicarbonate with citric acid as gas-generating agents, employing wet granulation technique. The formulations were assessed for floating lag time (FLT), total floating duration (TFD), swelling index in 0.1N HCl dissolution medium, and extended-release drug kinetics. Accelerated stability testing was performed at 40°C ± 2°C/75% ± 5% RH for three months as per ICH Q1A(R2) guidelines. The optimized formulation (F6) demonstrated an FLT of less than 60 seconds, total floating duration exceeding 12 hours, swelling index of 92.4%, and cumulative drug release of 96.8% at 12 hours, following non-Fickian diffusion mechanism. Stability studies revealed no significant variation in physical or chemical parameters. The gastroretentive system developed herein demonstrates meaningful potential for improving therapeutic outcomes in peptic ulcer and GERD management. |
