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Miscibility as a factor for component crystallization in multisolute frozen solutions.

Ken-Ichi Izutsu1, Hiroko Shibata1, Hiroyuki Yoshida1

  • 1National Institute of Health Sciences, Setagaya, Tokyo 158-8501, Japan.

Journal of Pharmaceutical Sciences
|June 7, 2014
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Summary
This summary is machine-generated.

Formulation ingredient miscibility impacts crystallization during lyophilization. Dextran addition prevented myo-inositol crystallization by improving solute mixing and preventing phase separation.

Keywords:
amorphouscalorimetrycrystallizationfreeze-dryingglass transitionprotein formulationthermal analysis

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Lyophilization is a critical process for stabilizing pharmaceuticals.
  • Understanding solute crystallization during freezing is essential for formulation development.
  • Miscibility of formulation excipients influences amorphous solid-state properties.

Purpose of the Study:

  • To investigate the relationship between formulation ingredient miscibility and myo-inositol crystallization during lyophilization.
  • To determine the effect of cosolutes, such as dextran 40,000, on the thermal properties and phase behavior of frozen solutions.
  • To elucidate the mechanisms of crystallization and amorphous-amorphous phase separation in freeze-concentrated systems.

Main Methods:

  • Differential Scanning Calorimetry (DSC) was used to analyze thermal properties of frozen solutions.
  • Heating scans were performed from -70 °C before and after heat treatment at -20 °C to -5 °C.
  • The influence of cosolutes (dextran 40,000, glucose, recombinant human albumin) on myo-inositol crystallization was evaluated.

Main Results:

  • Addition of dextran 40,000 reduced and prevented myo-inositol crystallization.
  • Heat treatment induced phase separation (Tg' splitting) and myo-inositol crystallization in some formulations.
  • Solute miscibility directly correlated with the prevention of myo-inositol crystallization, as observed in systems with glucose and albumin.

Conclusions:

  • Miscibility of formulation ingredients is crucial for preventing unwanted crystallization during lyophilization.
  • Amorphous-amorphous phase separation can precede and facilitate myo-inositol crystallization.
  • Strategic use of cosolutes like dextran can enhance formulation stability by controlling miscibility and preventing crystallization.