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Characterization of Hydrogel Drug Delivery System Stability Using Column-Switching Multimodal Liquid

Brady W Drennan1, Phat Dinh1, Kevin A Schug1

  • 1Department of Chemistry and Biochemistry, The University of Texas at Arlington, Arlington, Texas 76019, United States.

Analytical Chemistry
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Summary
This summary is machine-generated.

This study developed a novel multimodal liquid chromatography method to analyze complex drug delivery systems (DDSs). The technique efficiently characterizes DDS components and degradation products, ensuring drug stability and efficacy.

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Area of Science:

  • Analytical Chemistry
  • Materials Science
  • Pharmaceutical Sciences

Background:

  • Drug delivery systems (DDSs) require comprehensive characterization due to diverse components.
  • Existing analytical methods for DDSs are often numerous and time-consuming.
  • Hyaluronic acid-based hydrogels are a common DDS requiring stability assessment.

Purpose of the Study:

  • To develop and validate a single, consolidated analytical method for characterizing DDS components and degradation.
  • To evaluate the stability of a hyaluronic acid-based hydrogel DDS under forced degradation conditions.
  • To monitor hydrogel degradation kinetics and therapeutic presence over time.

Main Methods:

  • A column-switching multimodal liquid chromatography (LC) system was configured with restricted access medium (RAM) and size-exclusion chromatography (SEC) coupled to reversed-phase (RP) LC and mass spectrometry.
  • The method enabled simultaneous separation and analysis of small molecules, polymers, and degradation products from a single injection.
  • Forced alkaline and enzymatic degradation studies were performed on a hyaluronic acid-based hydrogel DDS.

Main Results:

  • The multimodal LC method successfully separated diverse DDS analytes, including drugs, impurities, polymers, and degradation products.
  • Distinct degradation profiles were observed under alkaline and enzymatic conditions, with the active therapeutic consistently detected.
  • System suitability was confirmed using acetaminophen, demonstrating robust analyte trapping and elution throughout the study.

Conclusions:

  • The developed multimodal LC configuration provides a powerful and efficient approach for simultaneous analysis of complex DDS.
  • This method facilitates comprehensive characterization and stability assessment of DDS, crucial for drug development.
  • The technique offers a viable solution for maximizing data collection and streamlining analytical workflows for DDS.