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 forkinetic modeling and extends these concepts into Quality by Design strategiesfor 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 INDICE: Preface. Introduction. 1) Chemical Engineering in the Pharmaceutical Industry: An Introduction (David J. am Ende, Pfizer, Inc.). 2) Current Challenges and Opportunities in the Pharmaceutical Industry (Joe Kukura and Mike Thien, Merck (John Tolsma, Brian Simpson, Taeshin Park, RES Group and Jason Mustakis, Pfizer, Inc.). 11) Process Safety and Reaction Hazard Assessment (Wim Dermaut, JANSSEN). 12) Design of Distillation and Extraction Operations (Eric Cordi, Pfizer, Inc.). 13) Crystallization Design and Scale-Up (Robert McKeown, James Wertman, and Philip DellOrco, GlaxoSmithKline). 14) Scale-Up of Mixing Processes - A Primer (Francis X. McConville and Stephen B. Kessler, Impact Technology Consultants). 15) Stirred Vessels: Computational Modeling of MultiphaseFlows and Mixing (Avinash R. Khopkar, Dow Chemicals International and Vivek V. Ranade , Tridiagonal Solutions). 16) Membrane Systems for Pharmaceutical Applications (Dimitrios Zarkadas, Merck ts (Francis X. McConville, Impact Technology Consultants). 22) Kilo Lab and Pilot Plant Manufacturing (Jason Hamm, Melanie Miller, Tom Ramsey, Rich Schild, Andrew Stewart, Jean Tom Bristol-Myers Squibb). 23) Process Development and Case Studies of Continuous Reactor Systems for Production of API and pharmaceutical intermediates (Thomas LaPorte and Chenchi Wang, Bristol-Myers Squibb). 24) Drug Solubility and Reaction Thermodynamics using CosmoRS (Karin Wichmann and Andreas Klamt, CosmoLogic). 25) Thermodynamics and Relative Solubility Prediction of Polymorphic Systems (Yuriy A. Abramov and Klimentina Pencheva , Pfizer, Inc.). 26) Towards a Rational Solvent Selection for Conformational Polymorph Screening (Yuriy A. Abramov, Mark Zell, Joeseph Krzyzaniak, Pfizer, Inc.). 27) Molecular Thermodynamics for Pharmaceutical Process Modeling and Simulation (Chau-Chyun Chen, AspenTech). 28) The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients (Demetri Petrides, Ph.D, INTELLIGEN, INC., Alexandros Koulouris, A.T.E.I. of Thessaloniki, Charles Siletti, INTELLIGEN, INC., Jos O. Jimnez, INTELLIGEN, INC.,ÿ. PericlesÿT. Lagonikos, Merck & Co.). Analytical Methods and Applied Statistics. 29) Quality by Design for Analytical Methods (Timothy W. Graul, Simon J. Bale, Imogen Gill, Melissa Hanna-Brown, Kimber L. Barnett-Rundlett, Pfizer, Inc.). 30) Analytical Chemistry for API Process Engineering (Matthew L. Jorgensen, Pfizer, Inc.). 31) Quantitative Applications of NMR Spectroscopy (Brian Marquez, Pfizer, Inc. and R. Thomas Williamson, Roche Carolina). 32) Experimental Design for Pharmaceutical Development (Greg Steeno, Pfizer, Inc.). 33) Multivariate Analysis for Pharmaceutical Development (Frederick H. Long, Spectroscopic Solutions, LLC). Drug Product. 34) Process Modeling Techniques and Applications for Solid Oral Drug Products (Mary T. am Ende, Rahul Bharadwajh, Salvador García-Muñoz, William Ketterhagen, and Andrew Prpich, Pfizer Inc., Pankaj Doshi (National Chemical Laboratory, Pune, India)). 35) Process Design and Development for Novel Pharmaceutical Dosage Forms(Leah Appel and Josh Shockey, Matthew Shaffer, Green Ridge Consulting, and Jennifer Chu (Neurogen Corp.)). 36) Design of Solid Dosage Formulations (Kevin Bittorf, Tapan Sanghi, Jeff Katstra Vertex Pharmaceuticals). 37) Controlled Release Technology and Design of Oral Controlled Release Dosage Forms (Avinash G.Thombre, Pfizer, Inc., Shirley X.Y. Wu (U. of Toronto), Mary T. am Ende, Pfizer, Inc.). 38) Design and Scale-Up of Dry Granulation Processes (Omar Sprockeland Howard Stamato, Bristol Myers-Squibb). 39) Wet Granulation Processes (Karen Hapgood, Monash University, Clayton, VIC, Australia and Jim Litster, PurdueUniversity, W. Lafayette, IN). 40) Spray Atomization Modeling for Tablet FilmCoating Processes (Alberto Aliseda (U. Washington), Alfred Berchielli (Pfizer, Inc.), Pankaj Doshi (National Chemical Laboratory, Pune, India), and Juan Lasheras (U. Cal. San Diego)). 41) The Freeze Drying Process: The use of mathematical modeling in process design, understanding and scale up (Venkat Koganti, Sumit Luthra, Pfizer, Inc and Michael Pikal, University of Connecticut). 42) Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions (Luke Schenck, Gregory M. Troup, Mike Lowinger, Li Li, Craig McKelvey, Merck & Co.). 43) Continuous Processing in Secondary Production (Martin Warman, Vertex Pharmaceuticals Inc., Cambridge, MA). 44) Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization (Theodora Kourti, PhD., Pharma Launch and Global Supply, GlaxoSmithKline).

• ISBN: 978-0-470-42669-2
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 920
• Fecha Publicación: 22/12/2010
• Nº Volúmenes: 1
• Idioma: Inglés