Solid state development and processing of pharmaceutical molecules : salts, cocrystals, and polymorphism

목차 (Table of Contents)

• CONTENTS
• Series Editors Preface = xxi
• Preface = xxiii
• 1 Aspects for Developing and Processing Solid Forms 1 Michael Gruss = 1
• 1.1 Aspects for Developing and Processing Solid Forms = 1
• List of Abbreviations = 37
• References = 38
• 2 Determination of Current Knowledge / Andriy Kuzmov ; Ronak Savla = 45
• 2.1 Why is it Important to Search for Relevant Information Before Starting a Solid-State Project? = 45
• 2.2 Where to Begin a Literature Search for a Solid-State Project? = 47
• 2.3 Patent Search = 51
• 2.4 Other Useful Resources for Solid-State Projects = 61
• List of Abbreviations = 62
• References = 63
• 3 Systematic Screening and Investigation of Solid-State Landscapes / Ulrike Werthmann = 67
• 3.1 Introduction = 67
• 3.2 General Aspects of Solid-State Investigations in Early Drug Discovery Phase = 68
• 3.3 Transition Phase from Late Stage Research to Early Stage Development = 69
• 3.4 Solid-State Characteristics in Preclinical Formulations = 70
• 3.5 API-crystallization Strategy in Candidate Profiling Phase = 73
• 3.6 Selection Criteria of a Suitable Solid Form = 77
• 3.7 Knowledge Management = 79
• 3.8 Control of Solid Form Properties in Development = 79
• 3.9 Exploratory Crystallization Experiments = 80
• List of Abbreviations = 87
• References = 88
• 4.1 Solid-State Characterization Techniques : Microscopy / Luis Almeida e Sousa ; Constanca Cacela = 91
• List of Abbreviations = 103
• References = 104
• 4.2 Standards and Trends in Analytical Characterization - X-ray Diffraction (XRD) / Clemens Kuhn = 107
• List of Abbreviations = 125
• References = 125
• Further Reading = 127
• 4.3 Standards and Trends in Solid-State Characterization Techniques - Thermal Analysis / Juergen Thun ; Nikolaus Martin = 129
• Acknowledgments = 146
• List of Abbreviations = 146
• Notes = 146
• References = 146
• 4.4 Standards and Trends in Solid-State Characterization Techniques: Infrared (IR) Spectroscopy / Dagmar Lischke = 151
• List of Abbreviations = 162
• References = 163
• 4.5 Transmission Raman Spectroscopy - Implementation in Pharmaceutical Quality Control / Meike Roemer = 165
• List of Abbreviations = 181
• References = 182
• 4.6 Solid-state Characterization Techniques : Particle Size / Maria Paisana ; Constanca Cacela = 185
• List of Abbreviations = 199
• References = 200
• 4.7 Micro Computational Tomography / Susana Campos ; Constanca Cacela = 203
• List of Abbreviations = 211
• Notes 211 References = 211
• 4.8 In Situ Methods for Monitoring Solid-State Processes in Molecular Materials / Adam A. L. Michalchuk ; Anke Kabelitz ; Franziska Emmerling = 215
• List of Abbreviations = 242
• References = 243
• 4.9 Application of Process Monitoring and Modeling / Jochen Schoell ; Roberto Irizarry = 249
• List of Abbreviations = 265
• References = 266
• 4.10 Photon Density Wave (PDW) Spectroscopy for Nano- and Microparticle Sizing / Lena Bressel ; Roland Hass = 271
• List of Abbreviations = 286
• References = 287
• 5 Impact of Solid Forms on API Scale-Up / Sophie Janbon ; Clare Mayes ; Amy L. Robertson = 289
• 5.1 Introduction = 289
• 5.2 Background = 290
• 5.3 Small-Scale Crystallization Development = 291
• 5.4 Crystallization Scale-Up = 302
• 5.5 People and Skill Requirements = 315
• 5.6 Regulatory Requirements = 315
• 5.7 Closing Remarks = 317
• List of Abbreviations = 318
• References = 318
• 6 Impact on Drug Development and Drug Product Processing / Susanne Page ; Aniko Szepes = 325
• 6.1 Introduction = 325
• 6.2 Pharmaceutical Profiling = 327
• 6.3 Formulation Development = 330
• 6.4 Process Development and Transfer to Commercial Manufacturing = 344
• 6.5 Control Strategy = 348
• 6.6 Regulatory Submissions = 349
• List of Abbreviations = 352
• References = 353
• 7 Workflow Management / Christian Grosse = 365
• 7.1 Motivation = 365
• 7.2 Workflow Management = 365
• 7.3 Organization of Solid-State Development by Project Management = 366
• 7.4 Workflows in the Environment of the Crystallization Laboratory = 369
• 7.5 Processes in the Solid-State Lab = 382
• 7.6 Development of Crystallization Processes = 387
• 7.7 Support Processes = 388
• 7.8 Conclusion = 392
• List of Abbreviations = 393
• References = 393
• 8 Digitalization in Laboratories of the Pharmaceutical Industry / Tanja S. Picker = 397
• 8.1 Introduction = 397
• 8.2 Motivation of Digitalization in the Laboratory = 398
• 8.3 Categories of Laboratory IT Systems = 403
• 8.4 System Interfaces for Data Exchange = 406
• 8.5 Implementation of IT Solutions = 411
• 8.6 Conclusion = 416
• List of Abbreviations = 416
• References = 417
• 9.1 Polymorphs and Patents - the US Perspective / Kristi McIntyre = 421
• Notes = 429
• References = 430
• 9.2 Polymorphs and Patents - The EU Perspective / Oliver Brosch = 431
• Success 445
• List of Abbreviations = 447
• References = 447
• 10 Regulatory Frameworks Affecting Solid-State Development / Christoph Saal = 449
• 10.1 Introduction - The Need for Regulation in Pharmaceutical Industry = 449
• 10.2 Solid-State Forms to Be Used for Drugs = 451
• 10.3 General Regulatory Considerations for Pharmaceutical Solid-State Forms = 453
• 10.4 Regulatory Framework for Pharmaceutical Salts = 454
• 10.5 Regulatory Framework for Co-crystals = 471
• 10.6 Summary = 476
• List of Abbreviations = 476
• References 477
• 11 Opportunities and Challenges for Generic Development from a Solid-state Perspective / Judith Aronhime ; Mike Teiler = 481
• 11.1 The Birth of a New Drug and the Generic Siblings that Will Follow - Two Different Mindsets = 481
• 11.2 Portfolio Management - How is a Portfolio Constructed and Maintained? = 484
• 11.3 Challenges in Developing a Generic Product from the Solid-state Perspective = 495
• 11.4 Generic Solid-state Development = 498
• 11.5 Success Factors = 520
• List of Abbreviations = 523
• References = 524
• Index = 531