An analysis of 72% chromated glycerin used for sclerotherapy: sterility, potency, and cost after extended shelf life

Sclerotherapy is the treatment of reticular veins and telangiectasias of the lower extremities. Sclerosants destroy endothelial tissue and expose subendothelial collagen fibers, which lead to subsequent fibrosis of vessels, thus preventing recanalization. There are several available sclerosants incl...

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Bibliographic Details
Published inDermatologic surgery Vol. 41; no. 1; p. 121
Main Authors Ghaznavi, Amir M, Nakamura, Mio, Tepper, Donna
Format Journal Article
LanguageEnglish
Published United States 01.01.2015
Subjects
Chromates - chemistry
Chromates - economics
Colony Count, Microbial
Costs and Cost Analysis
Drug Storage
Endotoxins - analysis
Glycerol - chemistry
Glycerol - economics
Polyethylene Glycols - economics
Sclerosing Solutions - chemistry
Sclerosing Solutions - economics
Sclerotherapy - economics
Sodium Tetradecyl Sulfate - economics
Sterilization
Time Factors
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Summary:Sclerotherapy is the treatment of reticular veins and telangiectasias of the lower extremities. Sclerosants destroy endothelial tissue and expose subendothelial collagen fibers, which lead to subsequent fibrosis of vessels, thus preventing recanalization. There are several available sclerosants including sodium tetradecyl sulfate (STS), polidocanol (POL), and chromated glycerin (CG) with varying efficacy, potency, side effect profile, and cost. To identify the possible bacterial contamination and potency of CG beyond the current recommended shelf life of 3 months and to prove if CG is as cost effective as other available sclerosants. Samples of 72% CG underwent bacterial endotoxin, sterility, and potency analysis at Days 0, 24, and 183. In addition, cost comparison was performed with other commercially available sclerosants including STS and POL. No samples of CG showed any bacterial contamination. All aliquots of glycerin remained sterile at Day 14. Potency at Day 24 was 99.2%, which was the same at Day 183. Cost comparison with other sclerosants revealed that CG is lower cost per milliliter than STS and POL. Seventy-two percent CG has no contamination and maintains its reported potency up to 6 months while comparable with the cost of other commercially available sclerosants.
ISSN:1524-4725
DOI:10.1097/DSS.0000000000000239