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Solid-state properties and crystallization behavior of PHA-739521 polymorphs.

Changquan Calvin Sun1

  • 1Pfizer Global Research and Development, 7000 Portage Road, Portage, MI 49001, USA. ccsun@amgen.com

International Journal of Pharmaceutics
|May 25, 2006
PubMed
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PHA-739521 exhibits polymorphism with two stable anhydrous crystal forms. Understanding their properties is key for large-scale manufacturing of the desired polymorph.

Area of Science:

  • Solid-state chemistry
  • Pharmaceutical sciences
  • Materials science

Background:

  • Polymorphism is a critical factor in pharmaceutical development, affecting drug stability and bioavailability.
  • PHA-739521, an experimental compound, is known to exist in multiple crystalline forms.

Purpose of the Study:

  • To characterize the two anhydrous crystal forms (I and II) of PHA-739521.
  • To investigate the physical properties and solid-state behavior of these polymorphs.
  • To inform the development of a scalable crystallization process for PHA-739521.

Main Methods:

  • Powder X-ray diffractometry (PXRD) for crystal structure determination.
  • Thermal analyses (e.g., DSC, TGA) to assess thermal stability and transitions.
  • Moisture sorption gravimetry to evaluate hygroscopicity.

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Main Results:

  • Both Form I and Form II are non-hygroscopic and stable under compaction pressure.
  • Melting points were determined: ~152°C for Form I and ~168°C for Form II.
  • An enantiotropic relationship was identified, with Form I being more stable below ~70°C.

Conclusions:

  • The characterized properties of PHA-739521 polymorphs provide essential data for process design.
  • Knowledge of solid-state behavior facilitates the development of robust crystallization methods for large-scale production.
  • Successful manufacturing of the desired polymorph can be achieved through controlled crystallization processes.