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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