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Combining drug salt formation with amorphous solid dispersions - a double edged sword.

Tze Ning Hiew1, Lynne S Taylor1

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Summary

Salt formation impacts amorphous solid dispersion (ASD) drug release and stability. Lowering the glass transition temperature (Tg) of drug salts in ASDs can improve drug release but may decrease physical stability.

Keywords:
Amorphous solid dispersionCopovidoneGlass transition temperatureLumefantrineSalt formation

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Glass transition temperature (Tg) is critical for amorphous compound stability.
  • Salt formation can increase Tg and reduce drug re-crystallization.
  • The impact of salt formation on amorphous solid dispersion (ASD) drug release and stability is not fully understood.

Purpose of the Study:

  • To investigate the influence of salt formation and Tg elevation on the release performance of lumefantrine in ASDs.
  • To determine the optimal Tg for lumefantrine salts in PVPVA-based ASDs for both stability and drug release.

Main Methods:

  • Lumefantrine salts were prepared using various acids.
  • Lumefantrine salt-PVPVA ASDs were formulated at different drug loadings (5-30%).
  • Tg, drug release, and physical stability (re-crystallization) were evaluated under stress conditions.

Main Results:

  • Salt formation elevated lumefantrine's Tg, with lumefantrine sulfate showing the highest increase.
  • Lower Tg salts enabled higher drug loadings with sustained drug release.
  • High Tg salts resulted in premature cessation of drug release at low drug loadings.
  • ASDs with low Tg salts (benzoate, PEG 250 diacid) exhibited poor physical stability against re-crystallization.

Conclusions:

  • Salt Tg has opposing effects on physical stability and drug release in PVPVA-based ASDs.
  • Careful selection of drug salts is necessary to balance Tg, physical stability, and drug release performance in ASD formulations.