DESIGN AND EVALUATION OF CONTROLLED RELEASE MATRIX TABLETS OF NIZATIDINE BY USING POLYMERS - HPMC K4M, CARBOPOL-934 AND GUARGUM

ABSTRACT Nizatidine is used in the treatment of Zollinger-Ellison Syndrome, Gastro Esophageal Reflux Disease, Duodenal and Gastric, Peptic ulcers. It is Histamine (H-2) receptor antagonist. Oral administration of Nizatidine is absorbed incompletely from the GI tract. Oral administration favors controlled release due to low Biological half life (1-2 hrs) and high Bioavailability (70%). Nizatidine controlled release matrix tablets prepared by using a Hydroxy Propyl Methyl Cellulose (HPMC K4M), Carbopol-934 as hydrophillic polymer and Guargum as natural polymer with three different concentrations (Drug: polymers 1:0.5, 1:0.75 and 1:1) by using Wet granulation method. The prepared granules were evaluated for pre-compression properties. The tablets were subjected to evaluate post compression properties. In-vitro drug release studies were evaluated to compare the Nizatidine formulations (N1-N10) with available marketed product. Among all the prepared formulations, high proportion of Guargum (1:1)(N6) was able to control drug delivery for 24 hours (94.2%). In-vitro drug release data fitting to kinetic analysis, mechanism of all the formulations followed to both Diffusion and Erosion10. All formulations were stored at 40 0±2 0C, 75 ± 5%RH, conducted to stability studies upto 6 months. Results showed that all the formulations are stable for physically and chemically. KEYWORDS: Nizatidine, Controlled Release, Peptic Ulcer, Zollinger Ellison Syndrome, Gastro-Esophageal Reflux Disease, Duodenal Ulcer