Chapter 5 - Route Design and Selection

Process chemists in the pharmaceutical industry are responsible for designing an efficient synthetic route for the manufacture of an active pharmaceutical ingredient (API). The design of synthetic routes typically follows a plan–do–review cycle. The degree of success in working through this cycle de...

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Bibliographic Details
Published inPharmaceutical Process Development: Current Chemical and Engineering Challenges pp. 90 - 116
Main Author Mike Butters
Format Book Chapter
LanguageEnglish
Published The Royal Society of Chemistry 2011
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Summary:Process chemists in the pharmaceutical industry are responsible for designing an efficient synthetic route for the manufacture of an active pharmaceutical ingredient (API). The design of synthetic routes typically follows a plan–do–review cycle. The degree of success in working through this cycle depends upon four key capabilities: (1) responding to the needs of the drug development programme, (2) criteria for route evaluation and selection, (3) generation and prioritisation of ideas for route design and (4) maximising the value of experimental work. Criteria for route evaluation and selection involve factors associated with safety, environmental, legal, economics, control and throughput (SELECT). These factors are illustrated using examples from drug development programmes from different pharmaceutical companies. The final aim of a route design project is to identify and select a suitable synthetic route for API manufacture.
Bibliography:istex:BBD2FB51F838DD405CAAE7404382E4286095B491
ArticleID:BK9781849731461-00090
ark:/67375/P0J-FQBC7M09-6
ISBN:1849731462
9781849731461
ISSN:2041-3203
2041-3211
DOI:10.1039/9781849733076-00090