Nonclassical Experimental Design Applied in the Optimization of a Placebo Granulate Formulation in High-Shear Mixer

Abstract

The optimization of wet granulation in a 10-liter high-shear mixer was investigated using a nonclassical experimental mixture design. Hydroxypropylmethylcellulose, lactose, cornstarch, and microcrystalline cellulose were used as excipients of the granulate, while polyvinylpyrrolidone was used as binder. Besides the minimization of the number of experiments, the strategy applied takes into account the cost of each experiment. The introduction of such a modification allowed us to select an experimental matrix giving enough information with a relatively low number of experiments and at a minimum cost.