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Abstract

FORMULATION, IN-VITRO EVALUATION AND OPTIMIZATION OF GI FLOATING TABLET OF RANITIDINE HCl

Nisha Panth*, Keshav Raj Paudel, Kushal Sharma, Rudra Pangeni, Bandana Karki, Monika Pradhan, Dr. Uttam Budhathoki, Gulam Muhammad Khan

ABSTRACT

Objective: The objective of the research was to formulate, evaluate and optimize the GI floating tablet of Ranitidine HCl. Introduction: Ranitidine HCl, the model drug for this study, is a histamine H2-receptor antagonist used for the treatment of duodenal ulcers, gastric ulcers, Zollinger-Ellison syndrome, gastro esophageal reflux disease and erosive oesophagitis. Floating drug delivery systems remain buoyant in the gastric fluid ensuring prolonged gastric residence time and continuously release the drug before it reaches the absorption window, thus ensuring optimal bioavailability. Methods: Thirteen batches of floating matrix tablets of Ranitidine HCl (336) mg were prepared by direct compression technique, using different amount of polymers such as Hydroxy Propyl Methyl Cellulose (HPMC) K4M, HPMC K100M. Sodium bicarbonate and citric acid were incorporated as a gas generating agent. The effect of different polymers on drug release profile and floating properties were investigated. The tablets were evaluated for hardness, percentage friability, weight variation, swelling index, drug content, disintegration time, dissolution study and in-vitro buoyancy study. After evaluation of each batch, Stat Graphica was used to get the contour plot and the surface response curve to get the tentative value of HPMC K4M and HPMC K100M. Using Stat Graphica, the optimized formulation for GI floating tablet of Ranitidine HCl was determined. The optimized formulation was subjected to various physicochemical evaluation parameters. Results: The formulations were evaluated for pharmacopoeial quality control tests and all the physical parameters evaluated for quality control were within the acceptable limits. The results of the in vitro drug release studies showed that the optimized formulation could sustain drug release for 8h and remain buoyant for 24h. Conclusion: In conclusion, effervescent approach is essential for the formulation to have good floating property. The interaction of both HPMC K4M and HPMC K100M had significant impact on the release and floating properties of the delivery system. It was established that floating behavior of the low-density drug delivery systems could successfully prolong the drug release patterns.

Keywords: Ranitidine HCl, Floating drug delivery system, HPMC, Optimization, Buoyancy.


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