chapter  16
34 Pages


The optimization of pharmaceutical formulations with regard to one or more attributes has always been a subject of importance and attention for those engaged in formulation research. Product formulation is often considered an art, the formulator’s experience and creativity providing the ‘‘raw material’’ for the creation of a new product. Given the same active ingredient and a description of the final marketed product, two different scientists will very likely concoct different formulations. Certainly, human input is an essential ingredient of the creative process. In addition to the art of formulation, techniques are available that can aid the scientist’s choice of formulation components which will optimize one or more product attributes. These techniques have been traditionally applied in the chemical and food industries, for example, and in recent years have been applied successfully to pharmaceutical formulations. In this chapter we describe the application of factorial designs (and modified factorials) and simplex lattice designs to formulation optimization. When the effects of factors on a pharmaceutical process or response are unknown, the use of screening designs to estimate factor effects may be indicated.