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Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients Vital Source e-bog
David J. amEnde og Mary T. amEnde
(2019)
John Wiley & Sons
3.599,00 kr.
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Chemical Engineering in the Pharmaceutical Industry
Active Pharmaceutical Ingredients
David J. am Ende og Mary T. am Ende
(2019)
Sprog: Engelsk
John Wiley & Sons, Incorporated
4.022,00 kr.
Print on demand. Leveringstid vil være ca 2-3 uger.
Detaljer om varen
- 2. Udgave
- Vital Source searchable e-book (Reflowable pages)
- Udgiver: John Wiley & Sons (Marts 2019)
- Forfattere: David J. amEnde og Mary T. amEnde
- ISBN: 9781119285878
A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: • Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety • Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying • Presents updated and expanded example calculations • Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industry focuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.
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Online udgaven er tilgængelig: 365 dage fra købsdato.
Offline udgaven er tilgængelig: ubegrænset dage fra købsdato.
Udgiveren oplyser at følgende begrænsninger er gældende for dette produkt:
Print: -1 sider kan printes ad gangen
Copy: højest -1 sider i alt kan kopieres (copy/paste)
Detaljer om varen
- 2. Udgave
- Hardback: 1168 sider
- Udgiver: John Wiley & Sons, Incorporated (April 2019)
- Forfattere: David J. am Ende og Mary T. am Ende
- ISBN: 9781119285861
A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition
The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book's regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API's) and 2) Drug Product Design, Development and Modeling.
The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition:
- Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety
- Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying
- Presents updated and expanded example calculations
- Includes contributions from noted experts in the field
Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.
List of Contributors xi Preface xv Unit Conversions xvii
Part I Introduction 1 1 Chemical Engineering in the Pharmaceutical Industry: An Introduction 3 David J. am Ende and Mary T. am Ende 2 Current Challenges and Opportunities in the Pharmaceutical Industry 19 Joseph L. Kukura and Michael P. Thien
Part II Mass and Energy Balances 27 3 Process Safety and Reaction Hazard Assessment 29 Wim Dermaut 4 Calorimetric Approaches to Characterizing Undesired Reactions 61 Megan Roth and Tom Vickery 5 Case Study of a Borane-THF Explosion 91 David J. am Ende and Richard M. Davis 6 Analytical Aspects for Determination of Mass Balances 115 Matthew Jorgensen 7 Quantitative Applications of NMR Spectroscopy 133 Brian L. Marquez and R. Thomas Williamson
Part III Reaction Kinetics and Mixing Processes 151 8 Reaction Kinetics and Characterization 153 Utpal K. Singh, Brandon J. Reizman, Shujauddin M. Changi, Justin L. Burt, and Chuck Orella 9 Understanding Fundamental Processes in Catalytic Hydrogenation Reactions 191 Yongkui Sun and Carl LeBlond 10 Characterization and First Principles Prediction of API Unit Operations 203 Joe Hannon 11 Scale-Up of Mass Transfer-Limited Reactions: Fundamentals and a Case Study 227 Ayman Allian and Seth Huggins 12 Scale-Up of Mixing Processes: A Primer 241 Francis X. McConville and Stephen B. Kessler 13 Stirred Vessels: Computational Modeling of Multiphase Flows and Mixing 261 Avinash R. Khopkar and Vivek V. Ranade
Part IV Continuous Processing 319 14 Process Development and Case Studies of Continuous Reactor Systems for Production of API and Pharmaceutical Intermediates 321 Thomas L. LaPorte, Chenchi Wang, and G. Scott Jones 15 Development and Application of Continuous Processes for the Intermediates and Active Pharmaceutical Ingredients 341 Flavien Susanne 16 Design and Selection of Continuous Reactors for Pharmaceutical Manufacturing 367 Martin D. Johnson, Scott A. May, Michael E. Kopach, Jennifer McClary Groh, Timothy Braden, Vaidyaraman Shankarraman, and Jeremy Miles Merritt
Part V Biologics 387 17 Chemical Engineering Principles in Biologics: Unique Challenges and Applications 389 Sourav Kundu, Vivek Bhatnagar, Naveen Pathak, and Cenk Undey
Part VI Thermodynamics 417 18 Applications of Thermodynamics Toward Pharmaceutical Problem Solving 419 Ahmad Y. Sheikh, Alessandra Mattei, Raimundo Ho, Moiz Diwan, Thomas Borchardt, Gerald Danzer, Nadine Ding, and Xinmin (Sam) Xu 19 A General Framework for Solid-Liquid Equilibria in Pharmaceutical Systems 439 Thomas Lafitte, Vasileios Papaioannou, Simon Dufal, and Constantinos C. Pantelides 20 Drug Solubility, Reaction Thermodynamics, and Co-Crystal Screening 467 Karin Wichmann, Christoph Loschen, and Andreas Klamt 21 Thermodynamic Modeling of Aqueous and Mixed Solvent Electrolyte Systems 493 Benjamin Caudle, Toni E. Kirkes, Cheng-Hsiu Yu, and Chau-Chyun Chen 22 Thermodynamics and Relative Solubility Prediction of Polymorphic Systems 505 Yuriy A. Abramov and Klimentina Pencheva 23 Toward a Rational Solvent Selection for Conformational Polymorph Screening 519 Yuriy A. Abramov, Mark Zell, and Joseph F. Krzyzaniak
Part VII Crystallization and Final Form 533 24 Crystallization Design and Scale-Up 535 James Wertman, Robert McKeown, Lotfi Derdour, and Philip Dell''Orco 25 Introduction to Chiral Crystallization in Pharmaceutical Development and Manufacturing 569 Jose E. Tabora, Shawn Brueggemeier, Michael Lovette, and Jason Sweeney 26 Measurement of Solubility and Estimation of Crystal Nucleation and Growth Kinetics 591 Nandkishor K. Nere, Manish S. Kelkar, Ann M. Czyzewski, Kushal Sinha, and Evelina B. Kim 27 Case Studies On Crystallization Scale-Up 617 Nandkishor K. Nere, Moiz Diwan, Ann M. Czyzewski, James C. Marek, Kushal Sinha, and Huayu Li 28 Population Balance-Enabled Model for Batch and Continuous Crystallization Processes 635 Ajinkya Pandit, Rahul Bhambure, and Vivek V. Ranade 29 Solid Form Development for Poorly Soluble Compounds 665 Alessandra Mattei, Shuang Chen, Jie Chen, and Ahmad Y. Sheikh 30 Multiscale Assessment of API Physical Properties in the Context of Materials Science Tetrahedron Concept 689 Raimundo Ho, Yujin Shin, Yinshan Chen, Laura Poloni, Shuang Chen, and Ahmad Y. Sheikh
Part VIII Separations, Filtration, Drying and Milling 713 31 The Design and Economics of Large-Scale Chromatographic Separations 715 Firoz D. Antia 32 Membrane Systems for Pharmaceutical Applications 733 Dimitrios Zarkadas and Kamalesh K. Sirkar 33 Design of Distillation and Extraction Operations 751 Eric M. Cordi 34 Case Studies On the Use of Distillation in the Pharmaceutical Industry 787 Laurie Mlinar, Kushal Sinha, Elie Chaaya, Subramanya Nayak, and Andrew Cosbie 35 Design of Filtration and Drying Operations 799 Praveen K. Sharma, Saravanababu Murugesan, and Jose E. Tabora 36 Filtration Case Studies 833 Seth Huggins, Andrew Cosbie, and John Gaertner 37 Drying Case Studies 847 John Gaertner, Nandkishor K. Nere, James C. Marek, Shailendra Bordawekar, Laurie Mlinar, Moiz Diwan, and Lei Cao 38 Milling Operations in the Pharmaceutical Industry 861 Kevin D. Seibert, Paul C. Collins, Carla V. Luciani, and Elizabeth S. Fisher
Part IX Statistical Models, Pat, and Process Modeling Applications 881 39 Experimental Design for Pharmaceutical Development 883 Gregory S. Steeno 40 Multivariate Analysis in API Development 909 James C. Marek 41 Probabilistic Models for Forecasting Process Robustness 919 Jose E. Tabora, Jacob Albrecht, and Brendan Mack 42 Use of Process Analytical Technology (PAT) in Small Molecule Drug Substance Reaction Development 937 Dimitri Skliar, Jeffrey Nye, and Antonio Ramirez 43 Process Modeling Applications Toward Enabling Development and Scale-Up: Chemical Reactions 957 Anuj A. Verma, Steven Richter, Brian Kotecki, and Moiz Diwan
Part X Manufacturing 971 44 Process Scale-Up and Assessment 973 Alan Braem, Jason Sweeney, and Jean Tom 45 Scale-Up Do''s and Don''ts 1001 Francis X. McConville 46 Kilo Lab and Pilot Plant Manufacturing 1011 Matthew Casey, Jason Hamm, Melanie Miller, Tom Ramsey, Richard Schild, Andrew Stewart, and Jean Tom 47 The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients 1037 Demetri Petrides, Doug Carmichael, Charles Siletti, Dimitris Vardalis, Alexandros Koulouris, and Pericles Lagonikos
Part XI Quality by Design and Regulatory 1067 48 Scientific Opportunities through Quality by Design 1069 Timothy J. Watson and Roger Nosal 49 Applications of Quality Risk Assessment in Quality by Design (QbD) Drug Substance Process Development 1073 Alan Braem and Gillian Turner 50 Development of Design Space for Reaction Steps: Approaches and Case Studies for Impurity Control 1091 Srinivas Tummala, Antonio Ramirez, Sushil Srivastava, and Daniel M. Hallow Index 1123
Part I Introduction 1 1 Chemical Engineering in the Pharmaceutical Industry: An Introduction 3 David J. am Ende and Mary T. am Ende 2 Current Challenges and Opportunities in the Pharmaceutical Industry 19 Joseph L. Kukura and Michael P. Thien
Part II Mass and Energy Balances 27 3 Process Safety and Reaction Hazard Assessment 29 Wim Dermaut 4 Calorimetric Approaches to Characterizing Undesired Reactions 61 Megan Roth and Tom Vickery 5 Case Study of a Borane-THF Explosion 91 David J. am Ende and Richard M. Davis 6 Analytical Aspects for Determination of Mass Balances 115 Matthew Jorgensen 7 Quantitative Applications of NMR Spectroscopy 133 Brian L. Marquez and R. Thomas Williamson
Part III Reaction Kinetics and Mixing Processes 151 8 Reaction Kinetics and Characterization 153 Utpal K. Singh, Brandon J. Reizman, Shujauddin M. Changi, Justin L. Burt, and Chuck Orella 9 Understanding Fundamental Processes in Catalytic Hydrogenation Reactions 191 Yongkui Sun and Carl LeBlond 10 Characterization and First Principles Prediction of API Unit Operations 203 Joe Hannon 11 Scale-Up of Mass Transfer-Limited Reactions: Fundamentals and a Case Study 227 Ayman Allian and Seth Huggins 12 Scale-Up of Mixing Processes: A Primer 241 Francis X. McConville and Stephen B. Kessler 13 Stirred Vessels: Computational Modeling of Multiphase Flows and Mixing 261 Avinash R. Khopkar and Vivek V. Ranade
Part IV Continuous Processing 319 14 Process Development and Case Studies of Continuous Reactor Systems for Production of API and Pharmaceutical Intermediates 321 Thomas L. LaPorte, Chenchi Wang, and G. Scott Jones 15 Development and Application of Continuous Processes for the Intermediates and Active Pharmaceutical Ingredients 341 Flavien Susanne 16 Design and Selection of Continuous Reactors for Pharmaceutical Manufacturing 367 Martin D. Johnson, Scott A. May, Michael E. Kopach, Jennifer McClary Groh, Timothy Braden, Vaidyaraman Shankarraman, and Jeremy Miles Merritt
Part V Biologics 387 17 Chemical Engineering Principles in Biologics: Unique Challenges and Applications 389 Sourav Kundu, Vivek Bhatnagar, Naveen Pathak, and Cenk Undey
Part VI Thermodynamics 417 18 Applications of Thermodynamics Toward Pharmaceutical Problem Solving 419 Ahmad Y. Sheikh, Alessandra Mattei, Raimundo Ho, Moiz Diwan, Thomas Borchardt, Gerald Danzer, Nadine Ding, and Xinmin (Sam) Xu 19 A General Framework for Solid-Liquid Equilibria in Pharmaceutical Systems 439 Thomas Lafitte, Vasileios Papaioannou, Simon Dufal, and Constantinos C. Pantelides 20 Drug Solubility, Reaction Thermodynamics, and Co-Crystal Screening 467 Karin Wichmann, Christoph Loschen, and Andreas Klamt 21 Thermodynamic Modeling of Aqueous and Mixed Solvent Electrolyte Systems 493 Benjamin Caudle, Toni E. Kirkes, Cheng-Hsiu Yu, and Chau-Chyun Chen 22 Thermodynamics and Relative Solubility Prediction of Polymorphic Systems 505 Yuriy A. Abramov and Klimentina Pencheva 23 Toward a Rational Solvent Selection for Conformational Polymorph Screening 519 Yuriy A. Abramov, Mark Zell, and Joseph F. Krzyzaniak
Part VII Crystallization and Final Form 533 24 Crystallization Design and Scale-Up 535 James Wertman, Robert McKeown, Lotfi Derdour, and Philip Dell''Orco 25 Introduction to Chiral Crystallization in Pharmaceutical Development and Manufacturing 569 Jose E. Tabora, Shawn Brueggemeier, Michael Lovette, and Jason Sweeney 26 Measurement of Solubility and Estimation of Crystal Nucleation and Growth Kinetics 591 Nandkishor K. Nere, Manish S. Kelkar, Ann M. Czyzewski, Kushal Sinha, and Evelina B. Kim 27 Case Studies On Crystallization Scale-Up 617 Nandkishor K. Nere, Moiz Diwan, Ann M. Czyzewski, James C. Marek, Kushal Sinha, and Huayu Li 28 Population Balance-Enabled Model for Batch and Continuous Crystallization Processes 635 Ajinkya Pandit, Rahul Bhambure, and Vivek V. Ranade 29 Solid Form Development for Poorly Soluble Compounds 665 Alessandra Mattei, Shuang Chen, Jie Chen, and Ahmad Y. Sheikh 30 Multiscale Assessment of API Physical Properties in the Context of Materials Science Tetrahedron Concept 689 Raimundo Ho, Yujin Shin, Yinshan Chen, Laura Poloni, Shuang Chen, and Ahmad Y. Sheikh
Part VIII Separations, Filtration, Drying and Milling 713 31 The Design and Economics of Large-Scale Chromatographic Separations 715 Firoz D. Antia 32 Membrane Systems for Pharmaceutical Applications 733 Dimitrios Zarkadas and Kamalesh K. Sirkar 33 Design of Distillation and Extraction Operations 751 Eric M. Cordi 34 Case Studies On the Use of Distillation in the Pharmaceutical Industry 787 Laurie Mlinar, Kushal Sinha, Elie Chaaya, Subramanya Nayak, and Andrew Cosbie 35 Design of Filtration and Drying Operations 799 Praveen K. Sharma, Saravanababu Murugesan, and Jose E. Tabora 36 Filtration Case Studies 833 Seth Huggins, Andrew Cosbie, and John Gaertner 37 Drying Case Studies 847 John Gaertner, Nandkishor K. Nere, James C. Marek, Shailendra Bordawekar, Laurie Mlinar, Moiz Diwan, and Lei Cao 38 Milling Operations in the Pharmaceutical Industry 861 Kevin D. Seibert, Paul C. Collins, Carla V. Luciani, and Elizabeth S. Fisher
Part IX Statistical Models, Pat, and Process Modeling Applications 881 39 Experimental Design for Pharmaceutical Development 883 Gregory S. Steeno 40 Multivariate Analysis in API Development 909 James C. Marek 41 Probabilistic Models for Forecasting Process Robustness 919 Jose E. Tabora, Jacob Albrecht, and Brendan Mack 42 Use of Process Analytical Technology (PAT) in Small Molecule Drug Substance Reaction Development 937 Dimitri Skliar, Jeffrey Nye, and Antonio Ramirez 43 Process Modeling Applications Toward Enabling Development and Scale-Up: Chemical Reactions 957 Anuj A. Verma, Steven Richter, Brian Kotecki, and Moiz Diwan
Part X Manufacturing 971 44 Process Scale-Up and Assessment 973 Alan Braem, Jason Sweeney, and Jean Tom 45 Scale-Up Do''s and Don''ts 1001 Francis X. McConville 46 Kilo Lab and Pilot Plant Manufacturing 1011 Matthew Casey, Jason Hamm, Melanie Miller, Tom Ramsey, Richard Schild, Andrew Stewart, and Jean Tom 47 The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients 1037 Demetri Petrides, Doug Carmichael, Charles Siletti, Dimitris Vardalis, Alexandros Koulouris, and Pericles Lagonikos
Part XI Quality by Design and Regulatory 1067 48 Scientific Opportunities through Quality by Design 1069 Timothy J. Watson and Roger Nosal 49 Applications of Quality Risk Assessment in Quality by Design (QbD) Drug Substance Process Development 1073 Alan Braem and Gillian Turner 50 Development of Design Space for Reaction Steps: Approaches and Case Studies for Impurity Control 1091 Srinivas Tummala, Antonio Ramirez, Sushil Srivastava, and Daniel M. Hallow Index 1123
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