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[Crystalline modifications and polymorphism changes during drug manufacture].

E Doelker1

  • 1Laboratoire de pharmacie galénique, Section de pharmacie, Université de Genève, Quai Ernest-Ansermet 30, CH-1211 Genève 4, Switzerland.

Annales Pharmaceutiques Francaises
|June 7, 2002
PubMed
Summary

Most pharmaceuticals exhibit polymorphism, affecting their solid-state properties and bioavailability. Understanding and controlling these crystalline forms is crucial for drug development and stability.

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Area of Science:

  • Solid-state chemistry
  • Materials science
  • Pharmaceutical sciences

Context:

  • Over 50% of pharmaceutical compounds display polymorphism or pseudopolymorphism.
  • Crystalline and amorphous forms exhibit varying physicochemical properties.
  • These variations impact drug product performance and stability.

Purpose:

  • To review the fundamental aspects of pharmaceutical polymorphism.
  • To highlight the influence of solid-state properties on drug performance.
  • To present literature examples of polymorphic transformations.

Summary:

  • Pharmaceutical compounds can exist as multiple crystalline structures (polymorphs, hydrates, solvates) or amorphous forms.
  • Polymorphism affects critical properties like solubility, dissolution rate, and bioavailability.

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  • Transformations can occur during manufacturing processes (milling, tabletting) or storage.

    • Impact:

    • Ensures consistent drug product quality and therapeutic efficacy.
    • Informs strategies for controlling solid-state forms during drug development.
    • Mitigates risks associated with unintended polymorphic changes.
    • Improves understanding of drug stability and bioavailability.
    • Guides formulation development for optimal drug delivery.