Design and Optimization of Famotidine Multiparticulate System through Mixture Experimental Design - a Novel Approach

The objective of this study was to develop a multiparticulate dosage form and optimise its release profile through a novel approach employing simplex mixture design. Microparticles of Famotidine were prepared with Eudragitâ RS100, RL100 and Ethyl cellulose separately using 1:4 drug polymer ratios by emulsification solvent evaporation technique. The three master formulations were characterised for different physicochemical properties and their release profile was studied. Statistical modelling and numerical optimisation was done to predict blends of component microparticles of three polymers, which gave the desired release profile. Experimental validation of the response parameters showed only around 5% error in prediction. Thus, an accurate, economical and time saving methodology could be devised for easy and reproducible development and optimisation of multiparticulate sustained release product.