| Bioequivalence evaluation of menthol after oral administration of peppermint oil soft capsules in dogs. | |
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MedLine Citation:
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PMID: 20863003 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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 The drug was given in a single dose of two capsules (total, 200 mg), and blood samples were withdrawn during the 12 h after drug administration.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. |
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Authors:
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Jing-Fang Wu; Bing-Ren Xiang; Kui-Xing Li |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Arzneimittel-Forschung Volume: 60 ISSN: 0004-4172 ISO Abbreviation: Arzneimittelforschung Publication Date: 2010 |
Date Detail:
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Created Date: 2010-09-24 Completed Date: 2010-10-21 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372660 Medline TA: Arzneimittelforschung Country: Germany |
Other Details:
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Languages: eng Pagination: 479-82 Citation Subset: IM |
Affiliation:
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Center for Instrumental Analysis, Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, China Pharmaceutical University, Nanjing, P. R. China. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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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
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