Am Ende M.T., am Ende D.J. (eds) Chemical Engineering in the Pharmaceutical Industry: Drug Product Design, Development, and Modeling

2nd Edition. — Wiley, 2019. — 688 p. — ISBN10: 1119285496.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.Chemical engineering in the pharmaceutical industry: an introduction.
Drug product design, development, and modeling.
Design of solid dosage formulations.
Powder process challenges and solutions.
Design and scaleвђђup of dry granulation processes.
Modelвђђbased development of roller compaction processes.
Wet granulation processes.
Toward a generic model for twinвђђscrew wet granulation.
Modeling a dosator capsule filling process for hardвђђshell capsules.
Powder compaction: process design and understanding.
Punch sticking: factors and solutions.
Spray atomization modeling for tablet film coating processes.
Spray drying and amorphous dispersions.
The freeze drying process: the use of mathematical modeling in process design, understanding, and scaleвђђup.
Sterilization processes in the pharmaceutical industry.
Controlled release technology and design of oral controlled release dosage forms.
Process design and development for novel pharmaceutical dosage forms.
Multiscale modeling of a pharmaceutical fluid bed coating process using cfd/dem and population balance models to predict coating uniformity.
Process design of topical semisolids: application of fundamental concepts in pharmaceutical engineering to peg ointment development.
Achieving a hot melt extrusion design space for the production of solid solutions.
Drug product process modeling.
Continuous manufacturing.
Continuous manufacturing in secondary production.
Continuous direct compression using portable continuous miniature modular & manufacturing (pcm&m).
Process control levels for continuous pharmaceutical tablet manufacturing.
Applied statistics and regulatory environment.
Multivariate analysis for pharmaceutical and medical device development.
Pharmaceutical manufacturing: the role of multivariate analysis in design space, control strategy, process understanding, troubleshooting, and optimization.
Quality by design: pilot to realityвђђthe honeymoon phase to the stormy years.