Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients

A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition

The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book's regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2^nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API's) and 2) Drug Product Design, Development and Modeling.

The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition:

- Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety

- Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying

- Presents updated and expanded example calculations

- Includes contributions from noted experts in the field

Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industry focuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.

David J. am Ende, PhD, is President of Nalas Engineering Services, Inc. Previously, he was a Research Fellow at Pfizer Inc. in Chemical Research & Development. He has over 25 years's experience in chemical and pharmaceutical process development.

Mary T. am Ende, PhD, is Vice President of Process Development at Lyndra Therapeutics, Inc. Previously, she was a Research Fellow at Pfizer, Inc. in Drug Product Design. She has over 25 years' experience in drug product formulation, process development and computational modeling.