Statistical optimization of gastric floating system for oral controlled delivery of clarithromycin

The development of an optimized gastric floating drug delivery system is described. Statistical experimental design and data analysis using response surface methodology is also illustrated. A 3 super(2)factorial design for the controlled release of clarithromycin was used with two formulation variables: X1 (HPMC K4M) and X2 (citric acid). Nine formulations were prepared and dissolution studies and floating characteristics were performed on these formulations. The dissolution data obtained were then fitted to the PCP disso version 2.08 software. Linear regression analysis and model fitting depicted that the formulations followed Hixon Crowell model. The two formulation variables were found to be significant for the release properties (P < 0.05), while citric acid loading was found to be significant for floating lag time. The quadratic mathematical model developed could be used to further predict formulations with desirable release and floating properties.