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Mannitol Crystallization at Sub-Zero Temperatures: Time/Temperature-Resolved Synchrotron X-ray Diffraction Study and

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Mannitol crystallization in water is sensitive to cooling rates, influencing its solid form. This study reveals mannitol follows the Ostwald rule, not equilibrium, impacting pharmaceutical manufacturing.

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Area of Science:

  • Physical Chemistry
  • Materials Science
  • Pharmaceutical Sciences

Background:

  • Mannitol is a widely used pharmaceutical excipient with complex polymorphic behavior.
  • Understanding mannitol's phase transitions is crucial for stable drug formulation and manufacturing.
  • Binary mannitol/water mixtures display intricate crystallization patterns.

Purpose of the Study:

  • To investigate the crystallization kinetics and phase behavior of mannitol in aqueous mixtures.
  • To construct a temperature-composition phase diagram for mannitol/water systems.
  • To elucidate the crystallization pathway of mannitol under varying cooling rates.

Main Methods:

  • Time/temperature-resolved synchrotron X-ray diffraction during freezing and thawing cycles.
  • Controlled cooling and heating experiments of mannitol/water mixtures.
  • Construction of a temperature-composition phase diagram.

Main Results:

  • Mannitol crystallization is highly dependent on the cooling rate, with a critical rate observed.
  • Below the critical rate, crystallization occurs during cooling; above it, amorphous mannitol forms and crystallizes upon heating.
  • The constructed phase diagram includes eutectic and peritectic points, and equilibria with ice and mannitol hemihydrate.
  • Experimental data suggest mannitol crystallization follows the Ostwald crystallization rule, deviating from equilibrium predictions.

Conclusions:

  • Mannitol's crystallization pathway in water is kinetically controlled, not equilibrium-driven.
  • The Ostwald rule governs mannitol's phase transitions in aqueous systems.
  • These findings offer critical insights for optimizing pharmaceutical and biopharmaceutical manufacturing processes and formulations.