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Discrimination of prohibited oral use from authorized inhaled treatment of budesonide in sports.
MedLine Citation:
PMID:  23318282     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
BACKGROUND: : Budesonide (22(R,S)-16α,17α-butylidenedioxy-11β,21-dihydroxypregna-1,4-diene-3,20-dione) (BUD) is a glucocorticoid widely used for the treatment of asthma and rhinitis. Its use in sport competitions is prohibited when administered by oral, intravenous, intramuscular, or rectal routes, but its use by other routes (eg, inhalation) is allowed. The objective of this study was to evaluate the urinary profiles of different metabolites of BUD after oral and inhaled administrations in order to define a criterion to discriminate between forbidden and authorized administrations of the drug.
METHODS: : A liquid chromatography-tandem mass spectrometry method was validated to quantify BUD, 16α-hydroxy-prednisolone, 6β-hydroxy-budesonide, and 6α-hydroxy-budesonide and to qualitatively determine 13 additional BUD metabolites. The method was applied to urine samples collected in clinical studies where BUD was administered to healthy volunteers by the oral route (n = 2) and by inhalation for 3 consecutive days followed by a single oral dose (n = 8).
RESULTS: : Reporting levels of the different metabolites were evaluated in terms of specificity (no false-positive results after inhalation) and sensitivity (no false-negative results after oral intake).
CONCLUSION: : Taking into consideration the administered doses, the best compromise to discriminate between authorized inhaled administration and forbidden oral intake of BUD was found using a reporting level of 20 ng/mL of metabolite 6β-hydroxy-budesonide.
Authors:
Xavier Matabosch; Oscar J Pozo; Clara Pérez-Mañá; Magi Farré; Josep Marcos; Jordi Segura; Rosa Ventura
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Therapeutic drug monitoring     Volume:  35     ISSN:  1536-3694     ISO Abbreviation:  Ther Drug Monit     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7909660     Medline TA:  Ther Drug Monit     Country:  United States    
Other Details:
Languages:  eng     Pagination:  118-28     Citation Subset:  IM    
Affiliation:
*Bioanalysis Research Group, (Institut Hospital del Mar d'Investigacions Mèdiques) IMIM †Human Pharmacology and Neurosciences Research Group, IMIM and UCICEC-IMIM-CAIBER ‡Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona §Department of Experimental and Health Sciences, Universitat Pompeu Fabra, Barcelona, Spain.
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