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Study of retinoic acid polymorphism.

Gabriele Caviglioli1, Marcella Pani, Paolo Gatti

  • 1Dipartimento di Chimica e Tecnologie Farmaceutiche ed Alimentari, Università degli Studi di Genova, via Brigata Salerno (Ponte), 16147 Genova, Italy. Caviglioli@dictfa.unige.it

Journal of Pharmaceutical Sciences
|August 3, 2006
PubMed
Summary

This study investigated retinoic acid (RA) polymorphism, finding only two known forms, not a new one. The research refines understanding of these RA polymorphs and their properties.

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Area of Science:

  • Solid-state chemistry
  • Pharmaceutical sciences
  • Materials science

Background:

  • Polymorphism in retinoic acid (RA) has been previously investigated.
  • Recent hypotheses suggested a novel RA phase, necessitating further characterization.

Purpose of the Study:

  • To investigate the hypothesized new retinoic acid (RA) phase.
  • To refine the characterization and understanding of known RA polymorphs.
  • To establish methods for obtaining pure RA polymorphs.

Main Methods:

  • X-Ray Powder Diffraction (XRPD) for phase identification.
  • Differential Scanning Calorimetry (DSC), Infrared (IR), and Raman spectroscopy for characterization.
  • Solubility studies and Intrinsic Dissolution Rate (IDR) measurements.

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Main Results:

  • XRPD confirmed only the known monoclinic (I) and triclinic (II) RA modifications.
  • An enantiotropic relationship between forms I and II was established, with form II being less stable.
  • The intrinsic dissolution rate (IDR) confirmed the energetic relationship, and a validated DSC method can detect 1% of form I in mixtures.

Conclusions:

  • The existence of a new retinoic acid (RA) phase is excluded.
  • The properties of the known RA polymorphs (monoclinic I and triclinic II) have been refined.
  • Efficient methods for producing pure RA polymorphs and a sensitive DSC detection method were developed.