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Related Experiment Videos

Identifying the stable polymorph early in the drug discovery-development process.

Jonathan M Miller1, Benjamin M Collman, Landon R Greene

  • 1Pharmaceutical Research and Development, World Wide Pharmaceutical Sciences, Pfizer Global Research and Development, Ann Arbor Laboratories, Ann Arbor, Michigan 48105, USA. jonathan.miller@pfizer.com

Pharmaceutical Development and Technology
|June 2, 2005
PubMed
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Discovering the most stable crystalline form early is crucial for pharmaceutical development. A new screen efficiently identifies the stable polymorph and determines solubility using diverse solvents.

Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Chemical Engineering

Background:

  • The thermodynamically most stable polymorph is the preferred crystalline form for pharmaceutical development.
  • Early identification of the stable polymorph is critical for efficient drug development processes.

Purpose of the Study:

  • To develop and describe a screening method for discovering the most stable polymorph of a pharmaceutical compound early in drug development.
  • To simultaneously determine compound solubility during the stable polymorph screen.

Main Methods:

  • A novel screening method involves suspending small amounts of the compound in various solvents for two weeks to crystallize the most stable polymorph.
  • Solubility is determined concurrently using a simple gravimetric method for each solvent tested.

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Main Results:

  • The developed screen successfully identified the most stable polymorph for model compounds, including Ritonavir and Pfizer compound A.
  • The method proved effective for early-stage polymorph discovery in drug development.

Conclusions:

  • The described screening method is a valuable tool for the early identification of the most stable polymorphs in pharmaceutical development.
  • Integrating solubility determination enhances the utility of the stable polymorph screen, aiding in process optimization.