Abstract
It is quite critical prior to design of the lyophilization process to completely characterize the formulation and understand the thermal events and physical state changes that occurs as a function of cooling and warming. Definitions of various freeze drying properties are described and illustrated with examples/figures. Various techniques such as MDSC and FDM that can be used to characterize under various conditions and determine the freeze drying properties/values of the formulation along with the science behind the design of the experiments, analyze and interpret the data is described and Illustrated with case studies. Finally, how some freeze drying properties can be predicted theoretically using Gordon & Taylor equations is discussed with example.
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Jameel, F. (2023). Characterization and Determination of Freeze-Drying Properties of Frozen Formulations: Case Studies. In: Jameel, F. (eds) Principles and Practices of Lyophilization in Product Development and Manufacturing . AAPS Advances in the Pharmaceutical Sciences Series, vol 59. Springer, Cham. https://doi.org/10.1007/978-3-031-12634-5_2
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DOI: https://doi.org/10.1007/978-3-031-12634-5_2
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