Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2004-3-4
pubmed:abstractText
Injectable formulations of L-adrenaline are commonly used in emergency medicine. Despite numerous studies, the comparative contribution and kinetics of the L-adrenaline inactivation pathways during storage have not been conclusively evaluated. We examined the kinetics of L-adrenaline degradation in a prospective study and determined the extent of drug inactivation by different pathways during and beyond the stipulated product shelf-life in 42 batches of adrenaline ampules stored under controlled conditions. The content of L-adrenaline and degradation products was determined with a chiral high-performance liquid chromatography (HPLC) assay, and the degradation products were identified by mass spectrometric detection as D-adrenaline and L- and D-adrenaline sulfonate. The kinetics of the content change with storage was analyzed simultaneously for L-adrenaline and the degradation products using kinetic modeling. The lower acceptable level of adrenaline content in the formulation stated by US Pharmacopoeia (90% as a sum of L- and D-isomers) was attained after 2.0 years of storage, at which time the content of the therapeutically active L-isomer amounted to as low as 85%. The modeling revealed significant differences in the degradation kinetics in the formulations produced before and after 1997, whose cause remained unidentified in this study.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Apr
pubmed:issn
0022-3549
pubmed:author
pubmed:copyrightInfo
Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association.
pubmed:issnType
Print
pubmed:volume
93
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
969-80
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:14999733-Adrenergic alpha-Agonists, pubmed-meshheading:14999733-Algorithms, pubmed-meshheading:14999733-Aluminum, pubmed-meshheading:14999733-Chromatography, High Pressure Liquid, pubmed-meshheading:14999733-Drug Stability, pubmed-meshheading:14999733-Epinephrine, pubmed-meshheading:14999733-Hydrogen-Ion Concentration, pubmed-meshheading:14999733-Indicators and Reagents, pubmed-meshheading:14999733-Injections, pubmed-meshheading:14999733-Kinetics, pubmed-meshheading:14999733-Mass Spectrometry, pubmed-meshheading:14999733-Models, Chemical, pubmed-meshheading:14999733-Pharmaceutical Solutions, pubmed-meshheading:14999733-Reproducibility of Results, pubmed-meshheading:14999733-Spectrophotometry, Ultraviolet, pubmed-meshheading:14999733-Stereoisomerism, pubmed-meshheading:14999733-Sulfonic Acids
pubmed:year
2004
pubmed:articleTitle
Long-term stability study of L-adrenaline injections: Kinetics of sulfonation and racemization pathways of drug degradation.
pubmed:affiliation
Research & Quality Control Laboratory, The Medical Corps, Mil. P.O. Box 02149, Israel Defense Forces, Israel Defense Forces, Israel.
pubmed:publicationType
Journal Article