Absence of Concentration Congruity in Six Compounded Polidocanol Samples Obtained for Leg Sclerotherapy

BACKGROUNDIn 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. Unti...

Full description

Saved in:
Bibliographic Details
Published inDermatologic surgery Vol. 37; no. 6; pp. 812 - 815
Main Authors WEISS, ROBERT A, VOIGTS, ROBERT, HOWELL, DAVID J
Format Journal Article
LanguageEnglish
Published Malden, MA by the American Society for Dermatologic Surgery, Inc 01.06.2011
Wiley
Subjects
Biological and medical sciences
Dermatology
Drug Compounding - standards
Medical sciences
Polyethylene Glycols - chemistry
Polyethylene Glycols - standards
Quality Control
Sclerosing Solutions - chemistry
Sclerosing Solutions - standards
Sclerotherapy
Skin plastic surgery
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Local anesthetic
Polidocanol
Treatment
Dermatology
Surgery
Contraceptive
Sclerosing agent
Concentration
Sclerotherapy
Spermicide
Leg
Online AccessGet full text

Cover

More Information
Summary:BACKGROUNDIn 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. OBJECTIVETo identify whether a risk exists when using freely available compounded POL samples for venous sclerotherapy. MATERIALS AND METHODSSix 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. RESULTSDisparities 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. CONCLUSIONSIn 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. Dr. Weiss is a consultant to Merz. Mr. Voigts is employed by Merz Aesthetics (San Mateo, CA). Dr. Howell is a freelance medical writer.
ISSN:1076-0512
1524-4725
DOI:10.1111/j.1524-4725.2011.01906.x