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

ویرایش:  
 
سری:  
ISBN (شابک) : 9780470426692, 9780470882221 
ناشر:  
سال نشر: 2010 
تعداد صفحات: 876 
زبان: English 
فرمت فایل : PDF (درصورت درخواست کاربر به PDF، EPUB یا AZW3 تبدیل می شود) 
حجم فایل: 74 مگابایت 

قیمت کتاب (تومان) : 42,000

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 Ende
Chapter 2 Current Challenges and Opportunities in the Pharmaceutical Industry (pages 21–27): Joseph L. Kukura and Michael Paul Thien
Chapter 3 Chemical Engineering Principles in Biologics: Unique Challenges and Applications (pages 29–55): Sourav Kundu, Vivek Bhatnagar, Naveen Pathak and Cenk Undey
Chapter 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. Hagan
Chapter 5 Scientific Opportunities through Quality by Design (pages 67–69): Timothy J. Watson and Roger Nosal
Chapter 6 The Role of Chemical Engineering in Pharmaceutical API Process R&D (pages 71–78): Edward L. Paul
Chapter 7 Reaction Kinetics and Characterization (pages 79–99): Utpal K. Singh and Charles J. Orella
Chapter 8 Understanding Rate Processes in Catalytic Hydrogenation Reactions (pages 101–111): Yongkui Sun and Carl Leblond
Chapter 9 Characterization and First Principles Prediction of API Reaction Systems (pages 113–136): Joe Hannon
Chapter 10 Modeling, Optimization, and Applications of Kinetic Mechanisms with OpenChem (pages 137–153): John E. Tolsma, Brian Simpson, Taeshin Park and Jason Mustakis
Chapter 11 Process Safety and Reaction Hazard Assessment (pages 155–182): Wim Dermaut
Chapter 12 Design of Distillation and Extraction Operations (pages 183–212): Eric M. Cordi
Chapter 13 Crystallization Design and Scale?Up (pages 213–247): Robert Rahn McKeown, James T. Wertman and Philip C. Dell'Orco
Chapter 14 Scale?Up of Mixing Processes: A Primer (pages 249–267): Francis X. McConville and Stephen B. Kessler
Chapter 15 Stirred Vessels: Computational Modeling of Multiphase Flows and Mixing (pages 269–297): Avinash R. Khopkar and Vivek V. Ranade
Chapter 16 Membrane Systems for Pharmaceutical Applications (pages 299–314): Dimitrios Zarkadas and Kamalesh K. Sirkar
Chapter 17 Design of Filtration and Drying Operations (pages 315–345): Saravanababu Murugesan, Praveen K. Sharma and Jose E. Tabora
Chapter 18 The Design and Economics of Large?Scale Chromatographic Separations (pages 347–363): Firoz D. Antia
Chapter 19 Milling Operations in the Pharmaceutical Industry (pages 365–378): Kevin D. Seibert, Paul C. Collins and Elizabeth Fisher
Chapter 20 Process Scale?Up and Assessment (pages 379–405): Alan D. Braem, Jason T. Sweeney and Jean W. Tom
Chapter 21 Scale?Up Dos and Don'ts (pages 407–416): Francis X. McConville
Chapter 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. Tom
Chapter 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 Jones
Chapter 24 Drug Solubility and Reaction Thermodynamics (pages 457–476): Karin Wichmann and Andreas Klamt
Chapter 25 Thermodynamics and Relative Solubility Prediction of Polymorphic Systems (pages 477–490): Yuriy A. Abramov and Klimentina Pencheva
Chapter 26 Toward a Rational Solvent Selection for Conformational Polymorph Screening (pages 491–504): Yuriy A. Abramov, Mark Zell and Joseph F. Krzyzaniak
Chapter 27 Molecular Thermodynamics for Pharmaceutical Process Modeling and Simulation (pages 505–519): Chau?Chyun Chen
Chapter 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. Lagonikos
Chapter 29 Quality by Design for Analytical Methods (pages 543–562): Timothy W. Graul, Kimber L. Barnett, Simon J. Bale, Imogen Gill and Melissa Hanna?Brown
Chapter 30 Analytical Chemistry for API Process Engineering (pages 563–579): Matthew L. Jorgensen
Chapter 31 Quantitative Applications of NMR Spectroscopy (pages 581–596): Brian L. Marquez and R. Thomas Williamson
Chapter 32 Experimental Design for Pharmaceutical Development (pages 597–620): Gregory S. Steeno
Chapter 33 Multivariate Analysis for Pharmaceutical Development (pages 621–632): Frederick H. Long
Chapter 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 Doshi
Chapter 35 Process Design and Development for Novel Pharmaceutical Dosage Forms (pages 663–672): Leah Appel, Joshua Shockey, Matthew Shaffer and Jennifer Chu
Chapter 36 Design of Solid Dosage Formulations (pages 673–702): Kevin J. Bittorf, Tapan Sanghvi and Jeffrey P. Katstra
Chapter 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) Wu
Chapter 38 Design and Scale?Up of Dry Granulation Processes (pages 727–755): Omar L. Sprockel and Howard J. Stamato
Chapter 39 Wet Granulation Processes (pages 757–780): Karen P. Hapgood and James D. Litster
Chapter 40 Spray Atomization Modeling for Tablet Film Coating Processes (pages 781–799): Alberto Aliseda, Alfred Berchielli, Pankaj Doshi and Juan C. Lasheras
Chapter 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. Pikal
Chapter 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 McKelvey
Chapter 43 Continuous Processing in Secondary Production (pages 837–851): Martin Warman
Chapter 44 Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization (pages 853–878): Theodora Kourti