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Consider a ternary system, which is composed of three components: water (W), ethanoic acid (E), and trichloromethane (T). Here, Ethanoic acid (E) is fully miscible with both water (W) and trichloromethane (T), meaning it can mix entirely with either of them. However, water and trichloromethane have partial miscibility, meaning they can only mix to a certain extent, beyond which two separate phases will form.The phase diagram of a ternary system is represented as an equilateral triangle, where...
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Construction and Validation of Binary Phase Diagram for Amorphous Solid Dispersion Using Flory-Huggins Theory.

Krishna Bansal1, Uttam Singh Baghel2, Seema Thakral3,4

  • 1GVM College of Pharmacy, Sonipat, Haryana, 131001, India.

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|June 21, 2015
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Summary

Estimating drug-polymer miscibility using Flory-Huggins theory aids amorphous solid dispersion formulation. This study validates theoretical predictions with experimental data for aceclofenac and Soluplus.

Keywords:
Flory–Huggins interaction parameteramorphous solid dispersionmiscibilityphase diagramphysical stability

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Drug-polymer miscibility is crucial for amorphous solid dispersion (ASD) formulations.
  • Predicting miscibility theoretically can streamline formulation development.

Purpose of the Study:

  • To theoretically estimate drug-polymer miscibility and solubility using Flory-Huggins (F-H) theory.
  • To experimentally validate the phase diagram of a model drug-polymer system.

Main Methods:

  • Estimated F-H interaction parameter (χ d-p) via melting point depression and solubility parameter calculations.
  • Established a temperature-dependent relationship for the F-H interaction parameter.
  • Generated free energy of mixing (ΔG mix) and spinodal curves.
  • Validated predictions using X-ray diffraction, differential scanning calorimetry, and dissolution studies.

Main Results:

  • The F-H interaction parameter was successfully estimated for aceclofenac-Soluplus.
  • Theoretical predictions of miscibility and phase behavior were experimentally validated.
  • The study demonstrated the utility of the interaction parameter in predicting miscibility.

Conclusions:

  • Flory-Huggins theory provides a reliable framework for predicting drug-polymer miscibility.
  • The interaction parameter can serve as a preliminary tool for ASD formulation design.
  • Experimental validation confirms the theoretical approach for phase diagram generation.