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Polymorphs and Amorphous State of Glipizide: Preparation and Solid-State Transformations.

Kailin Xu1, Jie Bai2, Qing-Lan Li1

  • 1School of Biomedical and Pharmaceutical Sciences, Guangdong University of Technology, Guangzhou 510006, China.

Journal of Pharmaceutical Sciences
|November 8, 2020
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Summary

Understanding glipizide solid forms is key for drug production and storage. This study details how different conditions trigger transformations between glipizide

Keywords:
Amorphous stateGlipizidePolymorphsSolid-state transformations

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry

Background:

  • The solid-state properties of active pharmaceutical ingredients (APIs) are critical for drug formulation, stability, and bioavailability.
  • Investigating different polymorphic forms and their interconversion is essential for robust manufacturing processes.

Purpose of the Study:

  • To characterize three distinct solid forms of glipizide.
  • To extensively investigate the solid-state transformations between these glipizide forms under various conditions.

Main Methods:

  • Synthesis of glipizide forms via crystallization and milling.
  • Solvent-mediated slurry conversion experiments (SSCE) to study transformations.
  • Analysis of solid-state transformations under neat and liquid-assisted milling conditions.

Main Results:

  • Glipizide Form I can be prepared by multiple crystallization and SSCE methods.
  • Form I transforms to Form II during neat milling, but solvent inhibits this.
  • Forms II and III are stable under neat milling; Form III is also stable under liquid-assisted milling.
  • Amorphous glipizide conversion in SSCE is highly dependent on solvent type and temperature.
  • Form II converts to Form I or III in water above 50°C, and to Form I at 25°C.

Conclusions:

  • Solid-state transformations of glipizide are sensitive to processing methods, including milling and SSCE.
  • Solvent choice, temperature, and physical state (neat vs. solvent-assisted) significantly influence glipizide polymorphic transitions.
  • Understanding these transformations is crucial for controlling glipizide solid forms during pharmaceutical manufacturing and storage.