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Polymorphic properties of micronized carbamazepine produced by RESS.

P M Gosselin1, R Thibert, M Preda

  • 1Faculté de Pharmacie, Université de Montréal, C.P. 6128, Succursale Centre-Ville, Que., Montreal, Canada. patrick.gosselin@umontreal.ca

International Journal of Pharmaceutics
|January 29, 2003
PubMed
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The rapid expansion of supercritical carbon dioxide solutions (RESS) method effectively produced carbamazepine microparticles. Operating conditions precisely controlled particle polymorphs and significantly reduced particle size for improved drug formulation.

Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Chemical Engineering

Background:

  • Carbamazepine is a widely used antiepileptic drug.
  • Controlling the polymorphic form and particle size of carbamazepine is crucial for its bioavailability and therapeutic efficacy.
  • Existing methods for carbamazepine production may result in suboptimal particle characteristics.

Purpose of the Study:

  • To investigate the production of carbamazepine microparticles using the rapid expansion of supercritical carbon dioxide solutions (RESS) method.
  • To analyze the influence of operating parameters on the crystalline nature and particle size of carbamazepine.
  • To determine if specific operating conditions can yield the desired carbamazepine polymorph.

Main Methods:

  • Carbamazepine microparticles were synthesized via the RESS technique.

Related Experiment Videos

  • Particle characterization involved X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), and scanning electron microscopy (SEM).
  • Image analysis was employed to assess particle size and distribution.

    • Main Results:

    • The crystalline nature and polymorph of carbamazepine microparticles were dependent on RESS operating pressure and temperature.
    • Specific conditions (temperature < 40°C, pressure < 240 bar) favored the formation of the US Pharmacopeia-compliant polymorph.
    • RESS processing significantly reduced particle size to below 3 micrometers with a narrow size distribution, compared to unprocessed material (~85 micrometers).

    Conclusions:

    • The RESS method offers precise control over carbamazepine microparticle polymorphism and particle size.
    • Varying pressure and temperature during RESS processing allows for targeted production of desired carbamazepine polymorphs.
    • This technique presents a viable approach for producing high-quality carbamazepine microparticles suitable for pharmaceutical applications.