Table of Contents

PREFACE.
CONTRIBUTORS.


CONVERSION TABLE.


PART I INTRODUCTION.


1 Chemical Engineering in the Pharmaceutical Industry: An
Introduction (David J. am Ende).


2 Current Challenges and Opportunities in the Pharmaceutical
Industry (Joseph L. Kukura and Michael Paul Thien).


3 Chemical Engineering Principles in Biologics: Unique
Challenges and Applications (Sourav Kundu, Vivek Bhatnagar,
Naveen Pathak, and Cenk Undey).


4 Designing a Sustainable Pharmaceutical Industry: The Role of
Chemical Engineers (Concepcion Jimenez-Gonzalez, Celia S.
Ponder, Robert E. Hannah, and James R. Hagan).


5 Scientific Opportunities Through Quality by Design (Timothy
J. Watson and Roger Nosal).


PART II ACTIVE PHARMACEUTICAL INGREDIENT (API).


6 The Role of Chemical Engineering in Pharmaceutical API Process
R&D (Edward L. Paul).


7 Reaction Kinetics and Characterization (Utpal K. Singh and
Charles J. Orella).


8 Understanding Rate Processes in Catalytic Hydrogenation
Reactions (Yongkui Sun and Carl LeBlond).


9 Characterization and First Principles Prediction of API
Reaction Systems (Joe Hannon).


10 Modeling, Optimization, and Applications of Kinetic
Mechanisms with OpenChem (John E. Tolsma, Brian Simpson, Taeshin
Park, and Jason Mustakis).


11 Process Safety and Reaction Hazard Assessment (Wim
Dermaut).


12 Design of Distillation and Extraction Operations (Eric M.
Cordi).


13 Crystallization Design and Scale-Up (Robert Rahn McKeown,
James T. Wertman, and Philip C. Dell'Orco).


14 Scale-Up of Mixing Processes: A Primer (Francis X.
McConville and Stephen B. Kessler).


15 Stirred Vessels: Computational Modeling of Multiphase Flows
and Mixing (Avinash R. Khopkar and Vivek V. Ranade).


16 Membrane Systems for Pharmaceutical Applications
(Dimitrios Zarkadas and Kamalesh K. Sirkar).


17 Design of Filtration and Drying Operations (Saravanababu
Murugesan, Praveen K. Sharma, and Jose E. Tabora).


18 The Design and Economics of Large-Scale Chromatographic
Separations (Firoz D. Antia).


19 Milling Operations in the Pharmaceutical Industry (Kevin
D. Seibert, Paul C. Collins, and Elizabeth Fisher).


20 Process Scale-Up and Assessment (Alan D. Braem, Jason T.
Sweeney, and Jean W. Tom).


21 Scale-Up Dos and Don.ts (Francis X. McConville).


22 Kilo Lab and Pilot Plant Manufacturing (Jason C. Hamm,
Melanie M. Miller, Thomas Ramsey, Richard L. Schild, Andrew
Stewart, and Jean W. Tom).


23 Process Development and Case Studies of Continuous Reactor
Systems for Production of API and Pharmaceutical Intermediates
(Thomas L. LaPorte, Chenchi Wang, and G. Scott Jones).


24 Drug Solubility and Reaction Thermodynamics (Karin
Wichmann and Andreas Klamt).


25 Thermodynamics and Relative Solubility Prediction of
Polymorphic Systems (Yuriy A. Abramov and Klimentina
Pencheva).


26 Toward a Rational Solvent Selection for Conformational
Polymorph Screening (Yuriy A. Abramov, Mark Zell, and Joseph F.
Krzyzaniak).


27 Molecular Thermodynamics for Pharmaceutical Process Modeling
and Simulation (Chau-Chyun Chen).


28 The Role of Simulation and Scheduling Tools in the
Development and Manufacturing of Active Pharmaceutical Ingredients
(Demetri Petrides, Alexandros Koulouris, Charles Siletti, Jose
O. Jimenez, and Pericles T. Lagonikos).


PART III ANALYTICAL METHODS AND APPLIED STATISTICS.


29 Quality by Design for Analytical Methods (Timothy W.
Graul, Kimber L. Barnett, Simon J. Bale, Imogen Gill, and Melissa
Hanna-Brown).


30 Analytical Chemistry for API Process Engineering (Matthew
L. Jorgensen).


31 Quantitative Applications of NMR Spectroscopy (Brian L.
Marquez and R. Thomas Williamson).


32 Experimental Design for Pharmaceutical Development
(Gregory S. Steeno).


33 Multivariate Analysis for Pharmaceutical Development
(Frederick H. Long).


PART IV DRUG PRODUCTS.


34 Process Modeling Techniques and Applications for Solid Oral
Drug Products (Mary T. am Ende, Rahul Bharadwaj, Salvador
Garc?´a-Mun?oz, William Ketterhagen, Andrew Prpich,
and Pankaj Doshi).


35 Process Design and Development for Novel Pharmaceutical
Dosage Forms (Leah Appel, Joshua Shockey, Matthew Shaffer, and
Jennifer Chu).


36 Design of Solid Dosage Formulations (Kevin J. Bittorf,
Tapan Sanghvi, and Jeffrey P. Katstra).


37 Controlled Release Technology and Design of Oral Controlled
Release Dosage Forms (Avinash G. Thombre, Mary T. am Ende, and
Xiao Yu (Shirley) Wu).


38 Design and Scale-Up of Dry Granulation Processes (Omar L.
Sprockel and Howard J. Stamato).


39 Wet Granulation Processes (Karen P. Hapgood and James D.
Litster).


40 Spray Atomization Modeling for Tablet Film Coating Processes
(Alberto Aliseda, Alfred Berchielli, Pankaj Doshi, and Juan C.
Lasheras).


41 The Freeze-Drying Process: The Use of Mathematical Modeling
in Process Design, Understanding, and Scale-Up (Venkat Koganti,
Sumit Luthra, and Michael J. Pikal).


42 Achieving a Hot Melt Extrusion Design Space for the
Production of Solid Solutions (Luke Schenck, Gregory M. Troup,
Mike Lowinger, Li Li, and Craig McKelvey).


43 Continuous Processing in Secondary Production (Martin
Warman).


44 Pharmaceutical Manufacturing: The Role of Multivariate
Analysis in Design Space, Control Strategy, Process Understanding,
Troubleshooting, and Optimization (Theodora Kourti).


INDEX.

About the Author

DAVID J. AM ENDE is a Research Fellow with over fifteen years experience in chemical research and development with Pfizer, Inc. in Groton, Connecticut.

Reviews

"Coverage is practical and up-to-date concerning industry practicesincluding, for example, software used in the design and modeling ofexperiments for pharmaceutical development and for support of thecomplexities of moving drugs from the laboratory to themanufacturing plant." (Booknews, 1 April 2011) "The book will be split into four distinct yet related parts.These parts will address the fundamentals of analytical techniquesfor engineers,thermodynamic modeling, and finally provides anappendix with common engineering tools and examples of theirapplications. " (Gadgets, 8 March 2011)