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Absence of concentration congruity in six compounded polidocanol samples obtained for leg sclerotherapy
Robert A Weiss1, Robert Voigts, David J Howell
1New Product Development, Merz Aesthetics, San Mateo, California, USA. erweiss@mdlsv.com
Background:
In the arena of venous sclerotherapy, sodium tetradecyl sulfate (STS), hypertonic saline, and polidocanol (POL) are the most widely used agents in the world for treating endothelial vein wall destruction. Pharmaceutical-grade STS and hypertonic saline are available from manufacturers. Until 2010, POL was only available in the United States through compounding pharmacies.
Objective:
To identify whether a risk exists when using freely available compounded POL samples for venous sclerotherapy.
Materials And Methods:
Six samples of 1% POL solutions obtained from four compounding pharmacies were evaluated using gas chromatography mass spectrometry (GC/MS) assays for POL concentration and identification of material impurities.
Results:
Disparities in POL concentrations between six samples ranged from 1.0% to 3.1%. The GC/MS analysis showed impurities in all six compounded POL samples.
Conclusions:
In this study, compounded POL solutions did not deliver the claimed concentration five out of six times. This inconsistency poses risks to the patient and the treating physician during venous sclerotherapy with pharmacy-compounded POL. Merz Aesthetics provided funding for this study.
