Part 1

Fundamentals

Chapter 1 Introduction to Formulations Development

Chapter 2 Basics of Experimentation and Response Surface Methodology

Part 1 discusses examples of formulation and how to graphically display formulations. We also present some case studies that illustrate the problems addressed in formulation studies and show how the resulting problems are resolved. A strategic approach for formulations development that links screening experiments and optimization experiments is introduced. Our strategy includes the collection of data using an experimental design from which a model is developed to understand the formulation system and identify formulations that meet the objectives of the study. We address the fundamentals of good experimentation that enable the collection of quality data. We also introduce a roadmap for sequential experimentation and modeling of formulation systems.