2nd Edition
by am Ende, Mary T. (Editor), am Ende, David J. (Editor)
A guide to the important chemical engineering concepts for the development of new drugs, revised second edition
The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry
offers a guide to the experimental and computational methods related to
drug product design and development. The second edition has been
greatly expanded and covers a range of topics related to formulation
design and process development of drug products. The authors review
basic analytics for quantitation of drug product quality attributes,
such as potency, purity, content uniformity, and dissolution, that are
addressed with consideration of the applied statistics, process
analytical technology, and process control. The 2nd Edition
is divided into two separate books: 1) Active Pharmaceutical Ingredients
(API’s) and 2) Drug Product Design, Development and Modeling.
The
contributors explore technology transfer and scale-up of batch
processes that are exemplified experimentally and
computationally. Written for engineers working in the field, the book
examines in-silico process modeling tools that streamline experimental
screening approaches. In addition, the authors discuss the emerging
field of continuous drug product manufacturing. This revised second
edition:
- Contains 21 new or revised chapters, including
chapters on quality by design, computational approaches for drug product
modeling, process design with PAT and process control, engineering
challenges and solutions
- Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up
- Offers analytical methods and applied statistics that highlight drug product quality attributes as design features
- Presents updated and new example calculations and associated solutions
- Includes contributions from leading experts in the field
Written
for pharmaceutical engineers, chemical engineers, undergraduate and
graduation students, and professionals in the field of pharmaceutical
sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition
contains information designed to be of use from the engineer's
perspective and spans information from solid to semi-solid to
lyophilized drug products.
