Perspective on PSE in pharmaceutical process development and innovation

Emmanouil Papadakis, John M. Woodley, Rafiqul Gani

Research output: Chapter in Book/Report/Conference proceedingBook chapterResearchpeer-review

Abstract

Development and possible uses of a systematic methodology for pharmaceutical process development based on enhanced process understanding, a data-rich environment, and exploiting opportunities for continuous operation is presented in this chapter. The methodology is implemented into a computer-aided framework through which systematic model-based methods and tools are retrieved and used for specific pharmaceutical process-related problems. For this purpose, a suite of computer-aided methods and tools needed to generate process knowledge and to evaluate different operational scenarios have been developed. These include a special reactions database, a modeling tool plus a model library, a solvent-swap tool, solid solubility prediction tool, simulation engine, and many more. A case study involving the production of ibuprofen is used to illustrate the need and use of the developed and implemented methods and tools, highlighting the contributions of process systems engineering in pharmaceutical process development.
Original languageEnglish
Title of host publicationProcess Systems Engineering for Pharmaceutical Manufacturing
EditorsRavendra Singh, Zhihong Yuan
Volume41
PublisherElsevier
Publication date2018
Pages597-656
Chapter24
ISBN (Electronic)978-0-444-63963-9
DOIs
Publication statusPublished - 2018
SeriesComputer Aided Chemical Engineering
ISSN1570-7946

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