Statistical Optimization and in Vitro Evaluation of Nizatidine Floating Tablets

Nizatidine is a histamine (H2) receptor antagonist that is indicated in the management of Gastric Esophageal Reflux Disorder, Peptic Ulcer Disease, gastric and duodenal ulcer. The bioavailabilty of Nizatidine is around 70% and the drug suffers from low permeability issues due to its hydrophilic nature. The aim of this work was to formulate and develop non effervescent floating matrix tablets of Nizatidine to increase the bioavailability of the drug by increasing gastric residence time. NEGFMT of Nizatidine were prepared using Glyceryl Laurate (GL), lactose, aerosol and magnesium stearate. 3² full factorial design was employed for the design and optimization of formulations using Design Expert software. Amount of GL (X1) and percentage of lactose (X2) were taken as independent variables while percentage of drug release in 1 hour (Y1) and time to release 100% of the drug (Y2) were selected as dependent variables. Nizatidine granules were prepared using melt granulation technique and evaluated for flow properties and then compressed into NEGFMT. Prepared formulations were evaluated for various post compression parameters, dissolution studies and stability studies. The lower density of GL when compared to gastric fluid and its capability to sustain the release of drug makes it an ideal choice to prepare non effervescent floating matrix tablets. Response surface methodology of the statistical mathematical models showed a good correlation between the predicted and actual values. Optimized formulations were successfully developed based on full factorial design and statistical methods.