Source:http://linkedlifedata.com/resource/pubmed/id/14999733
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
4
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pubmed:dateCreated |
2004-3-4
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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.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Adrenergic alpha-Agonists,
http://linkedlifedata.com/resource/pubmed/chemical/Aluminum,
http://linkedlifedata.com/resource/pubmed/chemical/Epinephrine,
http://linkedlifedata.com/resource/pubmed/chemical/Indicators and Reagents,
http://linkedlifedata.com/resource/pubmed/chemical/Pharmaceutical Solutions,
http://linkedlifedata.com/resource/pubmed/chemical/Sulfonic Acids
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pubmed:status |
MEDLINE
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pubmed:month |
Apr
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pubmed:issn |
0022-3549
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pubmed:author | |
pubmed:copyrightInfo |
Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association.
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pubmed:issnType |
Print
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pubmed:volume |
93
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
969-80
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pubmed:dateRevised |
2006-11-15
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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
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pubmed:year |
2004
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pubmed:articleTitle |
Long-term stability study of L-adrenaline injections: Kinetics of sulfonation and racemization pathways of drug degradation.
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pubmed:affiliation |
Research & Quality Control Laboratory, The Medical Corps, Mil. P.O. Box 02149, Israel Defense Forces, Israel Defense Forces, Israel.
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pubmed:publicationType |
Journal Article
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