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.