Process Chemistry in the Pharmaceutical Industry, Volume 2: Challenges in an Ever Changing Climate, 1st Edition (Hardback) book cover

Process Chemistry in the Pharmaceutical Industry, Volume 2

Challenges in an Ever Changing Climate, 1st Edition

Edited by Kumar Gadamasetti, Tamim Braish

CRC Press

520 pages | 381 B/W Illus.

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Hardback: 9780849390517
pub: 2007-12-10
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Description

As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates.

The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends.

Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

Reviews

"The second installment in this progressive series, this volume reviews the latest breakthroughs to advance process chemistry . . . Jointly edited by the founder/ president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions by reputed scientists, technologists, engineers, and professors from leading academic institutions and from principal pharmaceutical companies influencing today’s market."

– In Anticancer Research, July/ August 2008, Vol. 28, No. 4A

"This is an excellent book . . . Overall this book is definitely recommended and the editors are to be congratulated on a job well done."

– In Scientific Update, 2008

"This is an excellent book . . . this book is definitely recommended, and the editors are to be congratulated on a job well done."

– W. J. Watson, Scientific Update, in Organic Process Research & Development, October 2008, Vol. 30, No. 20

Table of Contents

Process Chemistry in the Pharmaceutical Industry: Challenges in an Ever-Changing Climate—An Overview; K. Gadamasetti

Emerging Trends in Process Chemistry; T.F. Braish, F. De Knaep, and K. Gadamasetti

Varenicline: Discovery Synthesis and Process Chemistry Developments; J.W. Coe, H.A. Watson Jr., and R.A. Singer

The SUTENT® Story; R. Vaidyanathan

An Efficient and Scalable Process for the Preparation of a Potent MC4 Receptor Agonist; C. Savarin, J. Chung, J.A. Murry, R.J. Cvetovich, C. McWilliams, D. Hughes, J. Amato, G. Boice, K. Conrad, E. Corley, R. Reamer, and L. DiMichele

Process Research and Development of LY414197, a 5HT2B Antagonist; A. Borghese and A. Merschaert

To Overcome the Hurdles: Coping with the Synthesis of Robalzotan, a Complex Chroman Antidepressant; H. J.Federsel and A. Sveno

Chiral Amine Synthesis—Strategies, Examples, and Limitations; T.C. Nugent

Unnatural Amino Acids; D.J. Ager

The Chemical Development of a Potential Manufacturing Route to the Endothelin Antagonists UK-350,926 and UK-349,862; C.P. Ashcroft, S. Challenger, A.M. Derrick, Y. Hajikarimian, and N.M. Thomson

Cefovecin Sodium: A Single-Dose Long-Acting Antibiotic for Use in Companion Animals; T. Norris

The Lithium–Halogen Exchange Reaction in Process Chemistry; W.F. Bailey and T.L. Rathman

Oxetan-3-one: Chemistry and Synthesis; G. Wuitschik, E.M. Carreira, M. Rogers-Evans, and K. Müller

Well-Defined (NHC)Pd (II) Complexes and Their Use in C–C and C–N Bond-Forming Reactions; O. Navarro and S.P. Nolan

Toward Truly Efficient Organic Reactions in Water; C. Ogawa and S. Kobayashi

The Chemical Development of the Commercial Route to Sildenafil Citrate; P.J. Dunn

Stereoselective Enzymatic Synthesis of Intermediates Used for Antihypertensive, Antiinfective, and Anticancer Compounds; R.L. Hanson

Designing Robust Crystallization Processes for Active Pharmaceutical Ingredients—From Art to Science; D. Wieckhusen

In Situ Mid-Infrared Spectroscopy for Process Development; D.A. Conlon, W. Izzo, J. Christopher McWilliams, R.A. Reamer, F. Xu, and P. Collins

Optimizing an Asymmetric Homologation in a Tandem Asymmetric Homologation–Homoaldol Reaction; J.C. McWilliams and R.A. Reamer

Development of Efficient One-Pot Process in the Synthesis of Sitagliptin: Application of Online-Infrared for Kinetic Studies to Probe the Reaction Mechanism; F. Xu

Mid-Infrared Monitoring Applications during Development of the Vinyl Ether Formation Step in the Preparation of Aprepitant (Emend®); D.A. Conlon, W. Izzo, and P. Collins

Process Analytical Technology in the Manufacture of Bulk Active Pharmaceuticals—Promise, Practice, and Challenges; C.A. Mojica and L. St. Pierre-Berry

PEGylation of Biological Macromolecules; J.J. Buckley, R.F. Finn, J. Mo, L.A. Bass, and S.V. Ho

Microwave Technology in Process Optimization; F. Mavandadi

Process Development Considerations for Therapeutic Monoclonal Antibodies in Mammalian Cell Culture;

S. Casnocha, R. Fedechko, P. Mensah, J. Mott, and S. Nema

Reaction Progress Kinetic Analysis: A Powerful Methodology for Streamlining Pharmaceutical Reaction Steps; N. Zotova, S.P. Mathew, H. Iwamura, and D.G. Blackmond

Trends in Outsourcing; J. Lu and I. Shinkai

Sourcing Pharmaceutical Products in China and India; D. Robins and S. Hannon Index

Subject Categories

BISAC Subject Codes/Headings:
MED072000
MEDICAL / Pharmacy
SCI013000
SCIENCE / Chemistry / General
SCI013060
SCIENCE / Chemistry / Industrial & Technical