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Physical stability of API/polymer-blend amorphous solid dispersions.

Kristin Lehmkemper1, Samuel O Kyeremateng2, Mareike Bartels3

  • 1AbbVie Deutschland GmbH & Co. KG, Global Pharmaceutical R&D, Knollstraße, D-67061 Ludwigshafen am Rhein, Germany; TU Dortmund, Department of Biochemical and Chemical Engineering, Laboratory of Thermodynamics, Emil-Figge-Str. 70, D-44227 Dortmund, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|December 23, 2017
PubMed
Summary

Physical stability of amorphous solid dispersions (ASDs) containing naproxen or acetaminophen in polymer blends was assessed. Stability decreased with higher HPMCAS content and humidity, predictable by thermodynamic modeling.

Keywords:
Amorphous solid dispersionExcipientsKwei equationPC-SAFTPhase behaviorPhysical stabilityPolymer blendsThermodynamic model

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) enhance drug solubility and bioavailability by embedding active pharmaceutical ingredients (APIs) in polymers.
  • Physical stability is crucial for ASD formulation development, impacting drug performance and shelf-life.
  • Polymer blends offer tunable properties for optimizing ASD characteristics.

Purpose of the Study:

  • To investigate the physical stability of API/polymer-blend ASDs using thermodynamic modeling and experimental studies.
  • To evaluate the impact of hydroxypropyl methylcellulose acetate succinate (HPMCAS) content and relative humidity (RH) on ASD stability.
  • To assess the predictive capability of PC-SAFT and Kwei equation for ASD physical stability.

Main Methods:

  • Preparation of amorphous solid dispersions (ASDs) with amorphous naproxen (NAP) and acetaminophen (APAP) in HPMCAS/poly(vinylpyrrolidone) (PVP) or HPMCAS/poly(vinylpyrrolidone-co-vinyl acetate) (PVPVA64) blends.
  • Thermodynamic modeling using Perturbed-Chain Statistical Associating Fluid Theory (PC-SAFT) for API solubility and Kwei equation for glass-transition temperature.
  • Experimental stability studies under various relative humidity conditions (0%, 60%, 75% RH) for six months.

Main Results:

  • Physical stability of ASDs decreased with increasing HPMCAS content in the polymer blend.
  • Higher relative humidity (RH) significantly reduced the physical stability of all investigated ASD systems.
  • Both PC-SAFT and Kwei equation accurately predicted the observed trends in physical stability, correlating well with experimental data.
  • The findings were consistent across different APIs (NAP, APAP) and polymer blend compositions (PVP/HPMCAS, PVPVA64/HPMCAS).

Conclusions:

  • Increasing HPMCAS content and relative humidity negatively impacts the physical stability of API/polymer-blend ASDs.
  • Thermodynamic modeling tools (PC-SAFT, Kwei equation) are effective for predicting the physical stability of these complex formulations.
  • This research provides valuable insights for designing stable ASDs with optimized dissolution properties.