FORMULATION DEVELOPMENT AND EVALUATION OF FLOATING TABLET OF RANITIDINE HYDROCHLORIDE FOR THE TREATMENT OF DUODENAL ULCER

Abstract

Ranitidine hydrochloride (RHCl) is a histamine H2-receptor antagonist. It is widely prescribed in Duodenal ulcers, gastric ulcers, Zollinger- Ellison syndrome, gastro esophageal reflux disease, and erosive esophagitis. The H2-antagonists are comparative inhibitors of histamine at the parietal cell H2 receptor. They suppress the normal secretion of acid by parietal cells. The recommended adult oral dosage of ranitidine is 150 mg twice daily or 300 mg once daily. The present study involved the preparation of floating tablet of ranitidine. The tablets were prepared with both direct compression and wet granulation methods. It was found that wet granulation method facilitated greater efficiency in controlling ranitidine release behavior from the matrices. Hence, all further formulations were prepared with wet granulation technique.(R01) was prepared by direct compression but it was failed because it was not compressed so this batch failed. Then we prepared batches (R02-R10) by wet granulation and studied their release kinetic. The formulations were studied for their floating behaviour using simulated gastric fluid; the floating lag time and duration of floating were noted for each formulation. The tablets were also studied for drug release for 12 h using 0.1N HCl as dissolution media. Lubricated blends were characterized for physical properties like loose bulk density, tapped density, angle of repose, Carr’s index, Hausner´s ratio; all blends showed satisfactory properties. All lubricated blends were compressed into tablets using round shaped punches. Tablets were evaluated for uniformity of weight, thickness, hardness, percentage (%) friability and in vitro release studies. The release kinetics of the final batch (R06) and batch (R07) was carried out and it was found batch followed zero order kinetic model and less floating lag time. The optimized formulation has drug release profile up to 12 hours.