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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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This study explains the reduced drug release from amorphous solid dispersions (ASDs) at high drug loads. Thermodynamic analysis reveals simultaneous liquid-liquid and amorphous phase separation drive this behavior.

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Area of Science:

  • Pharmaceutical Sciences
  • Physical Chemistry
  • Materials Science

Background:

  • Amorphous solid dispersions (ASDs) enhance drug solubility and release.
  • High drug loads in ASDs often lead to a significant decrease in drug release.
  • The underlying mechanisms for this release collapse remain incompletely understood.

Purpose of the Study:

  • To provide a thermodynamic explanation for the observed drug release behavior in ASDs.
  • To link liquid-liquid and amorphous phase separation phenomena to a common thermodynamic origin.
  • To analyze the release mechanism of ritonavir (RIT) and poly(vinylpyrrolidone-co-vinyl acetate) (PVPVA) ASDs.

Main Methods:

  • Quantitative thermodynamic phase diagram prediction using PC-SAFT.
  • Analysis of amorphous solid dispersion (ASD) release mechanisms.
  • Investigation of ritonavir (RIT) and poly(vinylpyrrolidone-co-vinyl acetate) (PVPVA) systems.

Main Results:

  • The study links ASD release behavior to a unified thermodynamic model.
  • Both liquid-liquid and amorphous phase separation were identified as originating from the same thermodynamic principles.
  • Non-congruent drug and polymer release was observed when amorphous phase separation occurred prior to dissolution.

Conclusions:

  • The thermodynamic phase diagram accurately predicts ASD release behavior.
  • Liquid-liquid phase separation in the dissolution medium (nanodroplet formation) and amorphous phase separation within the ASD are interconnected.
  • Understanding these thermodynamic phenomena is crucial for designing effective ASD formulations.