Document Detail


Bioequivalence evaluation of menthol after oral administration of peppermint oil soft capsules in dogs.
MedLine Citation:
PMID:  20863003     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A randomized, two-way, crossover, bioequivalence study in 6 beagle dogs was conducted to compare the bioavailability of two peppermint oil formulations, soft capsule and hard capsule. The drug was given in a single dose of two capsules (total, 200 mg), and blood samples were withdrawn during the 12 h after drug administration. Menthol (CAS 2216-51-5) as the main component of peppermint oil was determined by a gas chromatography-tandem mass spectrometry (GC-MS/I MS) method after cleavage with beta-glucuronidase. The following pharmacokinetic variables were computed for the two formulations: maximum concentration (Cmax), time to maximum concentration (Tmax), half-life of elimination (t1/2), mean residence time (MRT), and areas under the plasma concentration-time curve (AUC(0-t) and AUC(0-infinity)). For calculation of the 90% confidence interval (CI), an analysis of variance (ANOVA) was carried out. The results indicated that treatment and subject had statistically significant effect on AUC(0-t), AUC(0-infinity), and Cmax, and the 90% CIs for AUC(0-t), AUC(0-infinity), and Cmax were outside the acceptable bioequivalence range. The relative bioavailability was 121.4 +/- 10.6% for AUC(0-infinity). Therefore, it can be concluded that the two formulations are not bioequivalent and the bioavailability of soft capsules is significantly higher than that of hard capsules.
Authors:
Jing-Fang Wu; Bing-Ren Xiang; Kui-Xing Li
Related Documents :
18477493 - Bioavailability of mifepristone in capsule versus tablet form in healthy nonpregnant wo...
6861873 - Comparative multiple dose kinetics of two formulations of indomethacin.
7141573 - Inhibition by an antioxidant of the carcinogenic effect of nitrosomorpholine formed in ...
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Arzneimittel-Forschung     Volume:  60     ISSN:  0004-4172     ISO Abbreviation:  Arzneimittelforschung     Publication Date:  2010  
Date Detail:
Created Date:  2010-09-24     Completed Date:  2010-10-21     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372660     Medline TA:  Arzneimittelforschung     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  479-82     Citation Subset:  IM    
Affiliation:
Center for Instrumental Analysis, Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, China Pharmaceutical University, Nanjing, P. R. China.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Animals
Area Under Curve
Biological Availability
Capsules
Chromatography, High Pressure Liquid
Dogs
Female
Gas Chromatography-Mass Spectrometry
Glucuronidase / metabolism
Half-Life
Male
Mass Spectrometry
Menthol / administration & dosage,  adverse effects,  pharmacokinetics*
Plant Oils / administration & dosage,  adverse effects,  pharmacokinetics*
Reproducibility of Results
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Capsules; 0/Plant Oils; 1490-04-6/Menthol; 8006-90-4/peppermint oil; EC 3.2.1.31/Glucuronidase

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Effect of valproic acid and environmental enrichment on behavioral functions in rats.
Next Document:  Effects of multiple-dose esomeprazole and pantoprazole on diazepam pharmacokinetic profile and pharm...