Pharmaceutical Process Scale-Up

Pharmaceutical Process Scale-Up

Author
Michael Levin
Publisher
Informa Healthcare
Language
English
Edition
1
Year
2001
Page
584
ISBN
0824706250,9780824706258,9780585405902
File Type
pdf
File Size
5.1 MiB

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.

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