This book deals with the elements of chemical engineering science unique to drug product development and commercialization specifically related to the successful formulation design and process development of the Active Pharmaceutical Ingredient (API) into the desired dosage form. It emphasizes the need for scientific integration of Chemical Engineering and Pharmaceutical Sciences during R&D, as well as with Manufacturing Engineers, Analytical Chemists and other scientific disciplines necessary to deliver pharmaceuticals to the marketplace. This book covers the basic chemical engineering theories with its emphasis toward providing experimental methods, analysis, and contemporary process modeling methods in chemical engineering. This book attempts to provide guidance on analytical methods for Engineers in R&D as well as predictive computational methods, and manufacturing principles. In addition, emphasis is given on experimental techniques and considerations necessary to address scale-up issues and approach general process design related challenges to pharmaceutical process R&D. As a professional reference it is intended to be part “text” book and part “How To” book, and includes many worked examples related to problem solving via experimental and computational predictive methods.The new edition of the Drug Products volume includes two new parts (Emerging Modalities and Pre-Competitive Consortia with eight new chapters in those parts. Additionally, most of the original chapters will be updated or expanded with additional example calculations of interest to Chemical Engineers.
