Formulation, Optimization and Evaluation of Raft Forming Formulations Containing Nizatidine.

The main objective of this research is to formulate, optimize and evaluate raft forming chewable tablets of Nizatidine. Various raft-forming agents were used in preliminary screening. Sodium alginate showed maximum raft strength, so tablets were prepared using sodium alginate as the raft forming agent, along with calcium carbonate (CaCO3 ) as antacid and raft strengthening agent, and sodium bicarbonate (NaHCO3 ) as a gas generating agent.

RESEARCH DESIGN AND METHODS: Raft forming chewable tablets containing Nizatidine were prepared by direct compression and wet granulation methods, and evaluated for drug content, acid neutralization capacity, raft strength, and in- vitro drug release in 0.1 N HCl. Box- Behnken design was used for optimization.

RESULTS: two optimized formulations were predicted from the design space. The first optimized recommended concentrations of the independent variables were predicted to be X1 = 275.92 mg, X2 = 28.60 mg and X3 = 202.14 mg for direct compression technique and the second optimized recommended concentrations were predicted to be X1 = 253.62 mg, X2 = 24.60 mg and X3 = 201.77 mg for wet granulation technique. Optimized formulations were stable at accelerated environmental testing for six months at 35 °C and 45 °C with 75% relative humidity. X- Ray showed that the raft floated immediately after ingestion and remained intact for approximately 3 hours.

CONCLUSION: raft was successfully formed and optimized. Upon chewing tablets, a raft is formed on stomach content. That results in rapid relief of acid burning symptoms and delivering drug into systemic circulation with enhanced bioavailability.