Process Chemistry in the Pharmaceutical Industry, Volume 2: Challenges in an Ever Changing Climate

by Gadamasetti; Kumar

• ISBN13: 9780849390517
• ISBN10: 0849390516
• Edition: 1st
• Format: Hardcover
• Copyright: 2007-12-10
• Publisher: CRC Press

Summary

Defying the misconception of process chemistry as mere scale-up work, this volume explores the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercial drug candidates. It discusses new approaches to synthetic processes, examines the latest safety methods and design experiments, and suggests realistic solutions to problems encountered in manufacturing and process development. Topics include new synthesis methods, instrumentation, automization, quality control, cost considerations, regulatory issues, outsourcing, green practices, and future trends. Case studies demonstrate strategies for aggressive drug development programs.

Table of Contents

Process Chemistry in the Pharmaceutical Industry: Challenges in an Ever Changing Climate-An Overview	p. 1
Emerging Trends in Process Chemistry	p. 13
Varenicline: Discovery Synthesis and Process Chemistry Developments	p. 23
The SUTENT Story	p. 49
An Efficient and Scalable Process for the Preparation of a Potent MC4 Receptor Agonist	p. 65
Process Research and Development of LY414197, a 5HT[subscript 2B] Antagonist	p. 89
To Overcome the Hurdles: Coping with the Synthesis of Robalzotan, a Complex Chroman Antidepressant	p. 111
Chiral Amine Synthesis-Strategies, Examples, and Limitations	p. 137
Unnatural Amino Acids	p. 157
The Chemical Development of a Potential Manufacturing Route to the Endothelin Antagonists UK-350,926 and UK-349,862	p. 181
Cefovecin Sodium: A Single-Dose Long-Acting Antibiotic for Use in Companion Animals	p. 191
The Lithium-Halogen Exchange Reaction in Process Chemistry	p. 205
Oxetan-3-one: Chemistry and Synthesis	p. 217
Well-Defined (NHC)Pd (II) Complexes and Their Use in C-C and C-N Bond-Forming Reactions	p. 231
Toward Truly Efficient Organic Reactions in Water	p. 249
The Chemical Development of the Commercial Route to Sildenafil Citrate	p. 267
Stereoselective Enzymatic Synthesis of Intermediates Used for Antihypertensive, Antiinfective, and Anticancer Compounds	p. 279
Designing Robust Crystallization Processes for Active Pharmaceutical Ingredients-From Art to Science	p. 295
In Situ Mid-Infrared Spectroscopy for Process Development	p. 313
Optimizing an Asymmetric Homologation in a Tandem Asymmetric Homologation-Homoaldol Process	p. 317
Development of Efficient One-Pot Process in the Synthesis of Sitagliptin: Application of Online-Infrared for Kinetic Studies to Probe the Reaction Mechanism	p. 333
Mid-Infrared Monitoring Applications during Development of the Vinyl Ether Formation Step in the Preparation of Aprepitant (Emend)	p. 349
Process Analytical Technology in the Manufacture of Bulk Active Pharmaceuticals-Promise, Practice, and Challenges	p. 361
PEGylation of Biological Macromolecules	p. 383
Microwave Technology in Process Optimization	p. 403
Process Development Considerations for Therapeutic Monoclonal Antibodies in Mammalian Cell Culture	p. 427
Reaction Progress Kinetic Analysis: A Powerful Methodology for Streamlining Pharmaceutical Reaction Steps	p. 455
Trends in Outsourcing	p. 465
Sourcing Pharmaceutical Products in China and India	p. 471
Index	p. 481
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