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Stability of Tranexamic Acid Mouth Rinse.

Ronald F Donnelly1

  • 1The Ottawa Hospital (Civic Campus), Ottawa, Ontario, Canada. rdonnelly@toh.ca.

International Journal of Pharmaceutical Compounding
|November 2, 2018
PubMed
Summary

Tranexamic acid mouth rinse is stable for 31 days when stored properly. Flavoring masked bitterness, but some tablet formulations changed color at room temperature.

Area of Science:

  • Pharmacology
  • Pharmaceutical Science

Background:

  • Tranexamic acid is an antifibrinolytic agent crucial for managing fibrinolytic hemorrhages.
  • Compounding tranexamic acid mouth rinse involves masking its bitter taste using flavorings and sweeteners.

Purpose of the Study:

  • To evaluate the stability of compounded tranexamic acid mouth rinse solutions.
  • To assess the impact of storage conditions and formulation type on mouth rinse stability.

Main Methods:

  • Tranexamic acid mouth rinse was prepared from API powder and commercial tablets.
  • Solutions were flavored with cherry-vanilla or peppermint/mint and aspartame.
  • Stability was assessed over 31 days at 23°C and 5°C using HPLC, monitoring color, clarity, pH, and physical properties.

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Main Results:

  • All formulations maintained over 97.2% of initial tranexamic acid concentration after 31 days.
  • Powder-based solutions remained clear with no color change.
  • Tablet formulations stored at 23°C showed discoloration (yellow to dark brown) after 21 days.
  • Insoluble material in tablet formulations settled but was easily resuspended.

Conclusions:

  • Tranexamic acid mouth rinse is chemically stable for 31 days when protected from light and stored at 5°C or 23°C.
  • Powder-based formulations exhibit better physical stability and color integrity compared to tablet-based ones at room temperature.