ABSTRACT

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development.

This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes.

This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

chapter 1|10 pages

The Freeze-Drying of Pharmaceutical Products

Introduction and Basic Concepts

chapter 4|24 pages

Infrared Imaging and Multivariate Image Analysis (MIA)

A New PAT for Freeze-Drying Monitoring and Control

chapter 5|22 pages

Through-Vial Impedance Spectroscopy (TVIS)

A New Method for Determining the Ice Nucleation Temperature and the Solidification End Point

chapter 8|20 pages

Continuous Manufacturing in Lyophilization of Pharmaceuticals

Drawbacks of Batch Processing, Current Status, and Perspectives