Preface

Volume 3 ties the fundamental process principles and the formulation and excipient

principles presented in the previous two volumes together and applies these principles,

along with additional information, to the commercial production and quality control of

tablets. In particular, scale-up and troubleshooting are covered. Chapters 1-4 address the

equipment, instrumentation for research and process control, automation in tablet

production, and scale-up. In Chapters 5-7, the focus is on postmanufacture testing and

evaluation of tablets, and the setting of dissolution specifications. Chapter 8 discusses the

regulatory and good manufacturing practices environment in which tablets must be

manufactured, with focus on the new paradigms of process analytical technology and

quality by design. This volume concludes with chapters discussing the role of near-

infrared chemical imaging in testing oral solid dosage forms, surface area and important

related physical characteristics of solids, and intellectual property and the patent process.