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Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing

ISBN: 978-1-118-08810-4
904 pages
March 2011
Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing (1118088107) cover image
This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity.

The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.

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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 Garcı´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.

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DAVID J. AM ENDE is a Research Fellow with over fifteen years experience in chemical research and development with Pfizer, Inc. in Groton, Connecticut.
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"Coverage is practical and up-to-date concerning industry practices including, for example, software used in the design and modeling of experiments for pharmaceutical development and for support of the complexities of moving drugs from the laboratory to the manufacturing plant." (Booknews, 1 April 2011)

"The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers,thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications. " (Gadgets, 8 March 2011)

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