Abstract
One of the most wide-reaching changes in freeze-drying over the past 20 years has been the commercial availability of a range of discriminating analytical methods to identify critical temperatures in formulations to be freeze dried. Here, we briefly describe the development of these techniques from the earlier bespoke methods, setting their rise in a historical context. We then review techniques such as freeze-drying microscopy, differential scanning calorimetry, and less widely applied alternative technologies. Practical examples of the results obtained with these techniques are discussed and upcoming new trends and troubleshooting problems are addressed.
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Acknowledgments
We thank Kiran Malik and Chinwe Duru (NIBSC) for performing many of the thermal analyses included in the figures, Thomas Codd (BPS) for compiling many of the FDM and TASC images, and Jason Hockley (Biostatistician at NIBSC) for statistical analysis of the raw data from the TASC subjectivity study.
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Ward, K.R., Matejtschuk, P. (2019). Characterization of Formulations for Freeze-Drying. In: Ward, K., Matejtschuk, P. (eds) Lyophilization of Pharmaceuticals and Biologicals. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-8928-7_1
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DOI: https://doi.org/10.1007/978-1-4939-8928-7_1
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