Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2007-4-23
pubmed:abstractText
Rabeprazole is among the most potent proton pump inhibitors (PPI) identified to date and it has been demonstrated that it is effective in such diseases as gastroesophageal reflux disease (GERD), duodenal ulcer and gastric ulcer. There is currently interest in developing a new formulation: rabeprazole sterile powder for injection (RSPI). This investigation was conducted to evaluate the preclinical pharmacokinetics of RSPI in rats and at the same time a comparative study was carried out in dogs between RSPI and Pariet tablets using liquid chromatographic-mass spectrometry analysis. The liquid chromatographic-mass spectrometry method was first conducted and validated as being specific, and having accuracy, precision, sensitivity and a satisfactory recovery. After intravenous administration of RSPI (i.v.: 2, 6 and 18 mg/kg) to rats, no significant dose-dependency was found in the CL (4.20-5.72 l/h/kg), V(area) (d) (0.94-1.32 l/kg), dose-normalized AUC (197.20-245.82 microg/l*h based on 1 mg/kg) and t(1/2) (p>0.05). In the dog, a randomized, open-label, crossover experiment was carried out to show that the mean area under the plasma concentration-time curve (AUC(0-infinity)) after i.v. administration of RSPI was at least four times larger than that following oral administration of Pariet tablet at an equivalent dose but the elimination half-life of these two formulation was similar (p>0.05). The results showed that the pharmacokinetics of RSPI was linear (r(2) = 0.98) in the dose range 2-18 mg/kg and the RSPI had a much higher AUC(0-infinity) and similar t(1/2) values compared with the enteric-coated tablet.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
0142-2782
pubmed:author
pubmed:copyrightInfo
Copyright (c) 2007 John Wiley & Sons, Ltd.
pubmed:issnType
Print
pubmed:volume
28
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
177-86
pubmed:dateRevised
2009-11-3
pubmed:meshHeading
pubmed-meshheading:17377959-2-Pyridinylmethylsulfinylbenzimidazoles, pubmed-meshheading:17377959-Animals, pubmed-meshheading:17377959-Anti-Ulcer Agents, pubmed-meshheading:17377959-Chemistry, Pharmaceutical, pubmed-meshheading:17377959-Chromatography, Liquid, pubmed-meshheading:17377959-Dogs, pubmed-meshheading:17377959-Female, pubmed-meshheading:17377959-Half-Life, pubmed-meshheading:17377959-Injections, Intravenous, pubmed-meshheading:17377959-Male, pubmed-meshheading:17377959-Mass Spectrometry, pubmed-meshheading:17377959-Metabolic Clearance Rate, pubmed-meshheading:17377959-Powders, pubmed-meshheading:17377959-Proton Pumps, pubmed-meshheading:17377959-Rats, pubmed-meshheading:17377959-Rats, Sprague-Dawley, pubmed-meshheading:17377959-Species Specificity, pubmed-meshheading:17377959-Tissue Distribution
pubmed:year
2007
pubmed:articleTitle
Liquid chromatographic-mass spectrometry analysis and pharmacokinetic studies of a novel rabeprazole formulation, sterile powder for injection, in dogs and rats.
pubmed:affiliation
Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing, 210009, Jiangsu Province, China.
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't