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

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.Content: Chapter 1 Chemical Engineering in the Pharmaceutical Industry: An Introduction (pages 1–20): David J. am EndeChapter 2 Current Challenges and Opportunities in the Pharmaceutical Industry (pages 21–27): Joseph L. Kukura and Michael Paul ThienChapter 3 Chemical Engineering Principles in Biologics: Unique Challenges and Applications (pages 29–55): Sourav Kundu, Vivek Bhatnagar, Naveen Pathak and Cenk UndeyChapter 4 Designing a Sustainable Pharmaceutical Industry: The Role of Chemical Engineers (pages 57–65): Concepcion Jimenez?Gonzalez, Celia S. Ponder, Robert E. Hannah and James R. HaganChapter 5 Scientific Opportunities through Quality by Design (pages 67–69): Timothy J. Watson and Roger NosalChapter 6 The Role of Chemical Engineering in Pharmaceutical API Process R&D (pages 71–78): Edward L. PaulChapter 7 Reaction Kinetics and Characterization (pages 79–99): Utpal K. Singh and Charles J. OrellaChapter 8 Understanding Rate Processes in Catalytic Hydrogenation Reactions (pages 101–111): Yongkui Sun and Carl LeblondChapter 9 Characterization and First Principles Prediction of API Reaction Systems (pages 113–136): Joe HannonChapter 10 Modeling, Optimization, and Applications of Kinetic Mechanisms with OpenChem (pages 137–153): John E. Tolsma, Brian Simpson, Taeshin Park and Jason MustakisChapter 11 Process Safety and Reaction Hazard Assessment (pages 155–182): Wim DermautChapter 12 Design of Distillation and Extraction Operations (pages 183–212): Eric M. CordiChapter 13 Crystallization Design and Scale?Up (pages 213–247): Robert Rahn McKeown, James T. Wertman and Philip C. Dell'OrcoChapter 14 Scale?Up of Mixing Processes: A Primer (pages 249–267): Francis X. McConville and Stephen B. KesslerChapter 15 Stirred Vessels: Computational Modeling of Multiphase Flows and Mixing (pages 269–297): Avinash R. Khopkar and Vivek V. RanadeChapter 16 Membrane Systems for Pharmaceutical Applications (pages 299–314): Dimitrios Zarkadas and Kamalesh K. SirkarChapter 17 Design of Filtration and Drying Operations (pages 315–345): Saravanababu Murugesan, Praveen K. Sharma and Jose E. TaboraChapter 18 The Design and Economics of Large?Scale Chromatographic Separations (pages 347–363): Firoz D. AntiaChapter 19 Milling Operations in the Pharmaceutical Industry (pages 365–378): Kevin D. Seibert, Paul C. Collins and Elizabeth FisherChapter 20 Process Scale?Up and Assessment (pages 379–405): Alan D. Braem, Jason T. Sweeney and Jean W. TomChapter 21 Scale?Up Dos and Don'ts (pages 407–416): Francis X. McConvilleChapter 22 Kilo Lab and Pilot Plant Manufacturing (pages 417–436): Jason C. Hamm, Melanie M. Miller, Thomas Ramsey, Richard L. Schild, Andrew Stewart and Jean W. TomChapter 23 Process Development and Case Studies of Continuous Reactor Systems for Production of API and Pharmaceutical Intermediates (pages 437–455): Thomas L. LaPorte, Chenchi Wang and G. Scott JonesChapter 24 Drug Solubility and Reaction Thermodynamics (pages 457–476): Karin Wichmann and Andreas KlamtChapter 25 Thermodynamics and Relative Solubility Prediction of Polymorphic Systems (pages 477–490): Yuriy A. Abramov and Klimentina PenchevaChapter 26 Toward a Rational Solvent Selection for Conformational Polymorph Screening (pages 491–504): Yuriy A. Abramov, Mark Zell and Joseph F. KrzyzaniakChapter 27 Molecular Thermodynamics for Pharmaceutical Process Modeling and Simulation (pages 505–519): Chau?Chyun ChenChapter 28 The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients (pages 521–541): Demetri Petrides, Alexandros Koulouris, Charles Siletti, Jose O. Jimenez and Pericles T. LagonikosChapter 29 Quality by Design for Analytical Methods (pages 543–562): Timothy W. Graul, Kimber L. Barnett, Simon J. Bale, Imogen Gill and Melissa Hanna?BrownChapter 30 Analytical Chemistry for API Process Engineering (pages 563–579): Matthew L. JorgensenChapter 31 Quantitative Applications of NMR Spectroscopy (pages 581–596): Brian L. Marquez and R. Thomas WilliamsonChapter 32 Experimental Design for Pharmaceutical Development (pages 597–620): Gregory S. SteenoChapter 33 Multivariate Analysis for Pharmaceutical Development (pages 621–632): Frederick H. LongChapter 34 Process Modeling Techniques and Applications for Solid Oral Drug Products (pages 633–662): Mary T. am Ende, Rahul Bharadwaj, Salvador Garcia?Munoz, William Ketterhagen, Andrew Prpich and Pankaj DoshiChapter 35 Process Design and Development for Novel Pharmaceutical Dosage Forms (pages 663–672): Leah Appel, Joshua Shockey, Matthew Shaffer and Jennifer ChuChapter 36 Design of Solid Dosage Formulations (pages 673–702): Kevin J. Bittorf, Tapan Sanghvi and Jeffrey P. KatstraChapter 37 Controlled Release Technology and Design of Oral Controlled Release Dosage Forms (pages 703–726): Avinash G. Thombre, Mary T. am Ende and Xiao Yu(Shirley) WuChapter 38 Design and Scale?Up of Dry Granulation Processes (pages 727–755): Omar L. Sprockel and Howard J. StamatoChapter 39 Wet Granulation Processes (pages 757–780): Karen P. Hapgood and James D. LitsterChapter 40 Spray Atomization Modeling for Tablet Film Coating Processes (pages 781–799): Alberto Aliseda, Alfred Berchielli, Pankaj Doshi and Juan C. LasherasChapter 41 The Freeze?Drying Process: The Use of Mathematical Modeling in Process Design, Understanding, and Scale?Up (pages 801–817): Venkat Koganti, Sumit Luthra and Michael J. PikalChapter 42 Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions (pages 819–836): Luke Schenck, Gregory M. Troup, Mike Lowinger, Li Li and Craig McKelveyChapter 43 Continuous Processing in Secondary Production (pages 837–851): Martin WarmanChapter 44 Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization (pages 853–878): Theodora Kourti