Formulation and evaluation of matrix tablets of Famotidine using hydrophilic polymer

By A. M. Umarunnisha, S. Palanichamy, M. Rajesh, S. Jeganath and   A. Thangathirupathi

Abstract

Famotidine is a potent H2 receptor antagonist used in the management of benign gastric and duodenal ulceration, zollinger-Ellison syndrome and gastro esophageal reflux disease.Famotidine is incompletely absorbed from the GI tract following oral administration. The low bioavailability (40-45%) and short biological half-life (2.5 - 4 hrs) of famotidine following oral administration favors development of a controlled release formulation. Controlled release matrix tablets of famotidine were prepared using a hydrophilic polymer Hydroxypropyl methylcellulose K100M (HPMC K100M) with three concentrations (Drug: polymers 1:0.5, 1:0.75 and 1:1) by wet granulation method. The granules were evaluated for angle of repose, bulk density, tapped density, bulkiness, compressibility index and Hausners ratio. The tablets were subjected to weight variation, hardness, friability and drug content test. Invitro release studies revealed that famotidine formulation with high proportion of HPMC K100M (1:1) was able to sustain the drug release for 10 hours (84.1% ±1.85). Fitting the invitro drug release data to kinetic analysis, all the formulations followed the mechanism of both diffusion and erosion. All the formulations were stored at 450±20C, 75 ± 5%RH and subjected to stability studies upto 45 days. It showed that all the formulations are physically and chemically stable.

Keywords: Bioavailability, Controlled release, Famotidine, Hydrophilic polymer, Wet granulation.

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