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Polymers are classified as linear or branched on the basis of their chain architecture. The polymer chains in linear polymers have a long chain-like structure with minimal to no branching at all. Even if a polymer features large substituent groups on the monomer, which appear as branches to the skeleton, it is not considered a branched polymer. A branched polymer contains secondary polymer chains that arise from the main polymer chain. The branching occurs when the polymer growth shifts from...
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Synthesis of Cyclic Polymers and Characterization of Their Diffusive Motion in the Melt State at the Single Molecule Level
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A New Method of Constructing a Drug-Polymer Temperature-Composition Phase Diagram Using Hot-Melt Extrusion.

Yiwei Tian1, David S Jones1, Conor Donnelly1

  • 1Pharmaceutical Engineering Group, School of Pharmacy , Queen's University Belfast , 97 Lisburn Road , Belfast BT9 7BL , United Kingdom.

Molecular Pharmaceutics
|December 6, 2017
PubMed
Summary

This study introduces a new method to accurately measure drug solubility in polymers, overcoming limitations of previous techniques. The improved approach provides reliable thermodynamic solubility data for pharmaceutical applications.

Keywords:
high-speed differential scanning calorimetryhighly viscous polymersmodel drug−polymer systemsmall-scale hot-melt extrusion

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Current methods for determining drug solubility in polymers often require extrapolation, leading to inaccuracies.
  • High polymer viscosity can skew experimental results for thermodynamic solubility.
  • Previous work highlighted the impact of experimental conditions on solubility measurements.

Purpose of the Study:

  • To develop a novel method for accurately determining the thermodynamic solubility of active pharmaceutical ingredients (APIs) in polymers.
  • To address and mitigate errors caused by polymer viscosity in solubility measurements.
  • To experimentally determine the upper and lower boundaries of the liquid-solid curve for a drug-polymer system.

Main Methods:

  • Utilized small-scale hot-melt extrusion (HME) to create multiphase drug-polymer systems.
  • Employed an extended annealing method combined with high-speed differential scanning calorimetry (DSC).
  • Investigated the felodipine-Soluplus model drug-polymer system.

Main Results:

  • The new method accurately determined the thermodynamic solubility boundaries, unlike traditional methods that underestimated values.
  • The relationship between inverse temperature and the drug-polymer solubility parameter (χ) was linear at lower drug loadings.
  • Significantly higher solubility and miscibility were observed for the felodipine-Soluplus system using the new approach.

Conclusions:

  • The developed method provides a more accurate determination of thermodynamic solubility by minimizing viscosity-related errors.
  • This technique enables precise measurement of the liquid-solid curve boundaries.
  • The findings suggest enhanced solubility and miscibility in drug-polymer systems when using this improved methodology.