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Understanding processing-induced phase transformations in erythromycin-PEG 6000 solid dispersions.

Sabiruddin Mirza1, Jyrki Heinämäki, Inna Miroshnyk

  • 1Division of Pharmaceutical Technology, Faculty of Pharmacy, University of Helsinki, Finland.

Journal of Pharmaceutical Sciences
|June 24, 2006
PubMed
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Investigating pharmaceutical solid dispersions revealed that polyethylene glycol (PEG) 6000 alters erythromycin (EM) dihydrate phase behavior during hot-melt processing, inducing anhydrate formation. This study enhances understanding of processing-induced transformations in drug formulations.

Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Solid-State Chemistry

Background:

  • Pharmaceutical solid formulation quality relies on the drug and excipient solid states.
  • Processing-induced transformations (PITs) can significantly impact drug performance.
  • Understanding these changes is crucial for developing stable and effective drug products.

Purpose of the Study:

  • To investigate physical phenomena during hot-melt formulation of erythromycin (EM) dihydrate solid dispersions with polyethylene glycol (PEG) 6000.
  • To monitor processing-induced transformations (PITs) in situ.
  • To elucidate the role of PEG in altering EM's solid-state behavior.

Main Methods:

  • In situ monitoring using variable temperature X-ray powder diffraction (VT-XRPD).

Related Experiment Videos

  • Differential scanning calorimetry (DSC) and hot-stage microscopy (HSM) for thermal analysis.
  • Fourier transform infrared (FTIR) spectroscopy to study drug-polymer interactions.

    • Main Results:

    • In the absence of PEG, only dehydration of EM dihydrate was observed.
    • Hot-melt processing with PEG 6000 induced multiple phase transformations: EM dihydrate → EM dehydrate → EM anhydrate.
    • PEG 6000 promoted nucleation and crystal growth of EM anhydrate via a solvent-mediated route.

    Conclusions:

    • PEG 6000 significantly alters the phase behavior of erythromycin dihydrate during hot-melt processing.
    • In situ techniques like VT-XRPD and HSM are valuable for early detection of PITs.
    • This research provides a better understanding of solid dispersion formation and process control.