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Related Experiment Videos

Existence of a mannitol hydrate during freeze-drying and practical implications

L Yu1, N Milton, E G Groleau

  • 1Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, Indiana 46285, USA.yu_lian@lilly.com

Journal of Pharmaceutical Sciences
|February 9, 1999
PubMed
Summary

A new mannitol hydrate crystal form emerges during freeze-drying, impacting drying rates and leading to vial-to-vial moisture variations. This metastable hydrate converts to anhydrous forms when heated or exposed to moisture.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Freeze-drying is a critical process for stabilizing pharmaceutical products.
  • Mannitol is a common excipient used in lyophilization.
  • Understanding excipient behavior during freeze-drying is essential for formulation development.

Purpose of the Study:

  • To identify and characterize a novel mannitol hydrate formed during freeze-drying.
  • To investigate the formation conditions and properties of this mannitol hydrate.
  • To assess the implications of mannitol hydrate formation on the freeze-drying process and product stability.

Main Methods:

  • Freeze-drying of mannitol solutions (1-4% w/v) using a specific temperature and time cycle.
  • X-ray powder diffraction (XRPD) for crystallographic analysis.

Related Experiment Videos

  • Differential Scanning Calorimetry (DSC) for thermal analysis and desolvation behavior.
  • Observation of hydrate formation in the presence of sorbitol.

    • Main Results:

    • A previously unknown mannitol hydrate was identified through thermal and crystallographic analysis.
    • The hydrate exhibited a unique XRPD pattern, low melting point, and characteristic desolvation behavior.
    • Formation was observed during freeze-drying of mannitol solutions and in the presence of sorbitol.
    • The mannitol hydrate is metastable, converting to anhydrous forms upon heating or moisture exposure.

    Conclusions:

    • The formation of mannitol hydrate during freeze-drying is a significant phenomenon.
    • This hydrate can influence drying rates and lead to vial-to-vial variations in moisture content.
    • Understanding and controlling mannitol hydrate formation is crucial for optimizing freeze-drying cycles and ensuring product uniformity and stability.