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Direct structure determination of vemurafenib polymorphism from compact spherulites using 3D electron diffraction.

Shuting Li1, Molly Lightowler2, Xiao Ou1

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Communications Chemistry
|January 25, 2023
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Researchers determined the crystal structures of five vemurafenib (VMN) polymorphs directly from compact spherulites using 3D electron diffraction. This breakthrough enables crystal structure determination from melt-crystallized materials, advancing polymorphism research.

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Area of Science:

  • Materials Science
  • Crystallography
  • Pharmaceutical Science

Background:

  • Spherulites are common crystalline morphologies, especially in melt-crystallized products.
  • The polycrystalline nature of spherulites has historically limited crystal structure determination.
  • Vemurafenib (VMN) is a clinical drug with four known polymorphs.

Purpose of the Study:

  • To demonstrate the direct crystal structure determination of vemurafenib (VMN) polymorphs from compact spherulite samples using 3D electron diffraction (3D ED).
  • To overcome limitations in crystal structure determination for materials with spherulitic morphology.
  • To explore and characterize VMN polymorphs, including those not amenable to single-crystal X-ray diffraction.

Main Methods:

  • Utilizing 3D electron diffraction (3D ED) for direct crystal structure determination.
  • Analyzing compact spherulite samples of vemurafenib (VMN).
  • Comparing 3D ED results with single-crystal X-ray diffraction data where applicable.

Main Results:

  • Successfully determined the crystal structures of α-, β-, and γ-VMN from compact spherulites, consistent with X-ray diffraction data.
  • Determined the crystal structure of the δ-VMN polymorph directly from spherulites, a form previously not obtainable as single crystals.
  • Discovered and determined the crystal structure of a new polymorph, ε-VMN, from spherulites, overcoming limitations of thin single crystals.
  • Elucidated the structures of all five VMN polymorphs from compact spherulites.

Conclusions:

  • Direct crystal structure determination from melt-grown compact spherulite samples is feasible using 3D ED.
  • This method significantly improves the efficiency and expands the scope of polymorphism research.
  • The findings have particular implications for the study of melt crystallization and pharmaceutical polymorphism.