Автор: Michael Levin Название: Pharmaceutical Process Scale-Up Издательство: CRC Press Год: 2001 ISBN: 978-0824706258 Серия: Drugs and the Pharmaceutical Sciences (Book 118) Язык: English Формат: pdf Размер: 14,5 mb Страниц: 584
Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale.
It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling, granulation and drying, fluid bed applications, compaction and tableting, and film coating and regulatory requirements for scale-up and postapproval changes.
Drawing on the experience of twenty contributing researchers, the book employs dimensional analysis as a unified scientific approach to quantify similar processes on different scales.