Pharmaceutical Process Chemistry for Synthesis Rethinking the Routes to Scale-Up

There is a need to inform the public that not all generic drugs are manufactured by the same process and that the different processes may have dramatically different environmental impacts. Two global forces are at odds today - the push for "greener" processes and the push for lower drug prices.This book presents detailed discussions of the published process chemistry of the ten top-selling small molecule drugs in the US in 2007, information which is usually carefully protected by the current and future manufacturers. The author identifies methodology for manufacturing these blockbuster drugs most efficiently and to highlight methodology and strategies which might be used to expedite the manufacturing of the blockbusters of the future.The content of each chapter reflects the range of tasks assigned to process chemists whose role on a process research and development team may be early route selection in one project or late troubleshooting of a difficult crystallization to produce a target which filters well and meets crystal size and purity specifications in another.

Peter J. Harrington is the founder of Better Pharma Processes, LLC, a consulting firm specializing in pharmaceutical process design and development. From 1988–2008, he worked for the Syntex Technology Center, later Roche Colorado, as a research fellow. Dr. Harrington has more than fifty patents and research publications, including reviews and abstracts, as well as the book Transition Metals in Total Synthesis (Wiley).