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Arzneimittelforschung 2010; 60(8): 479-482
DOI: 10.1055/s-0031-1296315
Antiemetics · Gastrointestinal Drugs · Urologic Drugs
Editio Cantor Verlag Aulendorf (Germany)

Bioequivalence evaluation of menthol after oral administration of peppermint oil soft capsules in dogs

Jing-Fang Wu
Center for Instrumental Analysis, Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, China Pharmaceutical University, Nanjing, P. R. China
,
Bing-Ren Xiang
Center for Instrumental Analysis, Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, China Pharmaceutical University, Nanjing, P. R. China
,
Kui-Xing Li
Center for Instrumental Analysis, Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, China Pharmaceutical University, Nanjing, P. R. China
› Author Affiliations
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Publication History

Publication Date:
03 December 2011 (online)

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Abstract

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 The drug was given in a single dose of two capsules (total, 200 mg), and blood samples were withdrawn during the 12 h after drug administration.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/MS) method after cleavage with p-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 (AUC0–t and AUC0–∞). 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 AUC0–t, AUC0–∞ and Cmax, and the 90% CIs for AUC0–t, AUC0–∞ and Cmax were outside the acceptable bioequivalence range. The relative bioavailability was 121.4 ± 10.6% for AUC0–∞. 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.

Key words

Beagle dogs - CAS 2216-51-5 - Menthol - Peppermint oil, bioequivalence, pharmacokinetics, soft or hard capsule
 

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