Development and Characterization of Gastroretentive Microspheres of Clarithromycin for H. Pylori infection

Gastroretentive systems have the unique quality to remain in the gastric region for several hours. Due to this they prolong the gastric residence time of the drug significantly. Floating microspheres possess the advantage of better flowing properties attributed to the use of low density polymers. Clarithromycin is a broad-spectrum antibiotic and extensively absorbed orally. It is used in the eradication of H. Pylori infection combined with an acid suppressing agent. Clarithromycin floating microspheres were prepared using polymer Ethyl Cellulose in different concentrations by solvent evaporation method. The FTIR studies showed no interaction between drug and polymers. The floating microspheres were evaluated for angle of repose, percentage yield, particle size, SEM, buoyancy percentage, drug content, percentage drug entrapment, in-vitro dissolution studies, kinetics of drug release and stability studies. Formulation F3 was found to be the best formulation showing the highest degree of sustained release that is 73.86% at the end of 12 hours. Formulations were seen to follow zero order release profile and Korsemeyer-Peppas model was the best fitting model. Marginal changes were observed in the drug content, buoyancy time and In-vitro dissolution studies which are insignificant. Storage conditions were carried out at 40±20C/75±5%RH for 6 months.