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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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Forced Solid-State Oxidation Studies of Nifedipine-PVP Amorphous Solid Dispersion.

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Molecular Pharmaceutics
|January 21, 2022
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Summary

Polymer chain length significantly impacts nifedipine oxidative degradation in amorphous solid dispersions (ASDs). Shorter poly(vinyl pyrrolidone) (PVP) K30 led to greater drug degradation compared to longer PVP K90, highlighting chain length

Keywords:
PVP chain lengthamorphous solid dispersionautoxidationchemical stability

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Area of Science:

  • Materials Science
  • Pharmaceutical Sciences
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) are crucial for improving drug solubility and bioavailability.
  • Oxidative degradation is a major stability concern for amorphous drugs, impacting shelf-life and efficacy.
  • Poly(vinyl pyrrolidone) (PVP) is a common polymer used in ASD formulations.

Purpose of the Study:

  • To investigate the oxidative degradation behavior of nifedipine (NIF) in ASDs formulated with different chain lengths of PVP (K30 and K90).
  • To elucidate the role of drug-polymer interactions and molecular mobility in the oxidative stability of NIF-PVP ASDs.
  • To evaluate the predictive capability of accelerated oxidative degradation studies for long-term stability.

Main Methods:

  • Preparation of NIF-PVP ASDs using dry ball-milling.
  • Analysis of ASDs using Fourier transform infrared (IR) spectroscopy, X-ray scattering, and differential scanning calorimetry (DSC).
  • Exposure of ASDs to accelerated thermal-oxidative conditions (pressurized oxygen and high temperatures) and solution-state degradation studies.
  • Electron paramagnetic resonance (EPR) spectroscopy for free radical detection.
  • Electronic structure calculations to understand intermolecular interactions.

Main Results:

  • Nifedipine (NIF) exhibited greater oxidative degradation in ASDs with shorter chain poly(vinyl pyrrolidone) (PVP) K30 compared to longer chain PVP K90.
  • Free radicals were detected in ASDs, and their consumption was higher in PVP K30 systems.
  • Lower glass-transition temperature and higher molecular mobility of PVP K30 contributed to increased NIF degradation.
  • Accelerated degradation studies correlated well with long-term storage observations.

Conclusions:

  • Polymer chain length is a critical factor influencing the oxidative stability of nifedipine in amorphous solid dispersions.
  • The enhanced molecular mobility associated with shorter PVP chains (K30) promotes greater oxidative degradation of nifedipine.
  • Accelerated oxidative degradation testing provides a reliable method for predicting the long-term chemical stability of polymeric ASDs.