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 fro
Pharmaceutical Process Scale-Up
β Scribed by Michael Levin
- Publisher
- CRC Press
- Year
- 2001
- Tongue
- English
- Leaves
- 590
- Series
- Drugs and the Pharmaceutical Sciences
- Category
- Library
No coin nor oath required. For personal study only.
β¦ Synopsis
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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Scale-up is generally defined as the process of increasing batch size. Scale-up of a process can also be viewed as a procedure for applying the same process to different output volumes. There is a subtle difference between these two definitions: batch size enlargement does not always translate into
<p><span>The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seekin
The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to deve
There is a need explain that generic versions of a drug may not be manufactured by the same process as brand-name drugs and that the different processes may have dramatically different environmental impacts. Two global forces are at odds todayβthe push for "greener" processes and the push for lower