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Development of Nafamostat Mesylate Immediate-Release Tablet by Drug Repositioning Using Quality-by-Design Approach.

Hyeon-A Kim1, Joo-Eun Kim1

  • 1Department of Pharmaceutical Engineering, Catholic University of Daegu, Hayang-Ro 13-13, Gyeongsan City 38430, Korea.

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Summary

Nafamostat mesylate immediate-release tablets were developed for COVID-19 treatment. Oral administration showed a longer half-life and improved bioavailability compared to injections and solutions.

Keywords:
COVID-19drug repositioningimmediate-release tabletsnafamostat mesylatepharmacokinetic studyquality-by-design approach

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Area of Science:

  • Pharmaceutical Sciences
  • Virology
  • Drug Development

Background:

  • Nafamostat mesylate, a serine protease inhibitor, targets the SARS-CoV-2 virus.
  • It inhibits transmembrane protease, serine 2 (TMPRSS2), crucial for viral entry.
  • Drug repositioning explored nafamostat mesylate injection for COVID-19 treatment.

Purpose of the Study:

  • To develop stable nafamostat mesylate immediate-release tablets for COVID-19.
  • To evaluate oral drug delivery of nafamostat mesylate.
  • To compare pharmacokinetic profiles of different nafamostat mesylate formulations.

Main Methods:

  • Manufacturing via wet granulation and direct tableting processes.
  • Stability studies and formulation optimization using Design of Experiments (DoE) and Quality by Design (QbD).
  • In vitro dissolution testing and in vivo pharmacokinetic studies in non-human primates.

Main Results:

  • A stable nafamostat mesylate immediate-release tablet formulation was successfully developed.
  • The developed tablet exhibited rapid dissolution (>90% in 30 min) in most tested media.
  • Oral administration in monkeys demonstrated a significantly longer half-life and ~25% higher bioavailability than oral solutions.

Conclusions:

  • Immediate-release nafamostat mesylate tablets represent a promising oral drug delivery system for COVID-19.
  • The developed formulation offers improved pharmacokinetic properties for potential therapeutic use.
  • Further clinical studies are warranted to confirm efficacy and safety in COVID-19 patients.