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Related Concept Videos

Raman Spectroscopy: Overview01:20

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The underlying principle of Raman spectroscopy is based on the interaction between light and matter, specifically molecules' inelastic scattering of photons. When a monochromatic beam of light, typically from a laser source, interacts with a sample, most scattered light has the same frequency as the incident light. This is known as Rayleigh scattering.
However, a small fraction of the scattered light exhibits a frequency shift due to the exchange of energy between the incident photons and...
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A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
The monochromatic laser source, typically using visible or near-infrared radiation, generates a highly focused beam of light. This light interacts with the molecules of the sample, scattering some of the light. Liquid and gaseous samples are usually tested in ordinary glass capillaries, while solids can be analyzed as powders packed in capillaries or as potassium...
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Kinetics of Water-Induced Amorphous Phase Separation in Amorphous Solid Dispersions via Raman Mapping.

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Summary

This study quantifies the kinetics of water-induced amorphous phase separation in amorphous solid dispersions (ASDs) of ritonavir (RIT) and poly(vinylpyrrolidone-co-vinyl acetate) (PVPVA). The findings align with thermodynamic predictions, offering insights into ASD stability and drug bioavailability.

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Raman imagingamorphous phase separationconfocal Raman spectroscopycopovidonekineticsmiscibility gapphase behavior

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) enhance drug bioavailability but are susceptible to API crystallization or phase separation.
  • Water-induced amorphous phase separation can compromise drug release and efficacy.
  • Previous work identified thermodynamic drivers for ritonavir (RIT) release collapse in RIT/poly(vinylpyrrolidone-co-vinyl acetate) (PVPVA) ASDs.

Purpose of the Study:

  • To quantify the kinetics of water-induced amorphous phase separation in RIT/PVPVA ASDs.
  • To determine the compositions of the evolving amorphous phases during phase separation.
  • To validate thermodynamic predictions of ASD behavior under humid conditions.

Main Methods:

  • Confocal Raman spectroscopy was employed for in situ monitoring of amorphous phase separation.
  • Indirect Hard Modeling was utilized for spectral data evaluation.
  • Experiments were conducted on RIT/PVPVA ASDs with 20 wt% and 25 wt% drug loading at 25 °C and 94% relative humidity.

Main Results:

  • The kinetics of amorphous phase separation were successfully quantified for RIT/PVPVA ASDs.
  • In situ measured compositions of the separating amorphous phases closely matched predictions from the ternary phase diagram.
  • The study provides the first kinetic data for water-induced amorphous phase separation in this ASD system.

Conclusions:

  • The kinetics and compositions of water-induced amorphous phase separation in RIT/PVPVA ASDs can be accurately quantified.
  • Experimental results validate the predictive power of PC-SAFT modeling for ASD stability.
  • Understanding these kinetics is crucial for designing stable ASD formulations with predictable drug bioavailability.