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https://doi.org/10.37358/Rev.Chim.1949

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Revista de Chimie (Rev. Chim.), Year 2019, Volume 70, Issue 8, 2805-2810

https://doi.org/10.37358/RC.19.8.7432

Ion Mircioiu, Valentina Anuta, Constantin Mircioiu, Victor Voicu, Roxana Sandulovici

Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies

Abstract:

Paper presents the effect of food on the pharmacokinetics of omeprazole and on the extraction yield of its internal standard, lansoprazole. The experimental data were obtained over three bioequivalence studies performed by the authors. Statistical analysis of plasma level curves of omeprazole indicated that food induces a delay of the time of maximum concentrations, but had a lower effect on maximum concentration and area under curves. Peak areas of lansoprazole were not constant, presenting a similar pattern in all seven periods of the clinical experiment, both in feeding and fasting conditions: an increase after the standard meal at four hours from the administration of drug followed by relatively constant, but higher areas afterwards. Statistical analysis of data (1500 points) in the 3 - 6 h interval, i.e. from immediately before until two hours after food intake revealed a two phase effect: an initial decrease of areas followed by an increase to a higher level than in the preprandial conditions, leading to the appearance of a minimum in curves one hour after food intake. In almost all cases a good parabolic fitting of data was obtained, which is in agreement with authors previous results on extraction of ketoconazole from pasma in methylene chloride in the presence of bile salts. The increase of peak areas of lansoprazole from two hours after meal by 24 h lead to an artificial decrease of calculated omeprazole concentrations. This effect could explain the unexpected lack of food effect on the area under curve of omeprazole, observed in the comparison between areas in fasting and fed conditions.
Keywords:
omeprazole; ketoconazole; methylene chloride

Issue: 2019, Volume 70, Issue 8
Pages: 2805-2810
Publication date: 2019/9/15
https://doi.org/10.37358/RC.19.8.7432
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Creative Commons License
This article is published under the Creative Commons Attribution 4.0 International License
Citation Styles
Cite this article as:
MIRCIOIU, I., ANUTA, V., MIRCIOIU, C., VOICU, V., SANDULOVICI, R., Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies, Rev. Chim., 70(8), 2019, 2805-2810.

Vancouver
Mircioiu I, Anuta V, Mircioiu C, Voicu V, Sandulovici R. Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies. Rev. Chim.[internet]. 2019 Aug;70(8):2805-2810. Available from: https://doi.org/10.37358/RC.19.8.7432


APA 6th edition
Mircioiu, I., Anuta, V., Mircioiu, C., Voicu, V. & Sandulovici, R. (2019). Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies. Revista de Chimie, 70(8), 2805-2810. https://doi.org/10.37358/RC.19.8.7432


Harvard
Mircioiu, I., Anuta, V., Mircioiu, C., Voicu, V., Sandulovici, R. (2019). 'Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies', Revista de Chimie, 70(8), pp. 2805-2810. https://doi.org/10.37358/RC.19.8.7432


IEEE
I. Mircioiu, V. Anuta, C. Mircioiu, V. Voicu, R. Sandulovici, "Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies". Revista de Chimie, vol. 70, no. 8, pp. 2805-2810, 2019. [online]. https://doi.org/10.37358/RC.19.8.7432


Text
Ion Mircioiu, Valentina Anuta, Constantin Mircioiu, Victor Voicu, Roxana Sandulovici,
Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies,
Revista de Chimie,
Volume 70, Issue 8,
2019,
Pages 2805-2810,
ISSN 2668-8212,
https://doi.org/10.37358/RC.19.8.7432.
(https://revistadechimie.ro/Articles.asp?ID=7432)
Keywords: omeprazole; ketoconazole; methylene chloride


RIS
TY - JOUR
T1 - Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies
A1 - Mircioiu, Ion
A2 - Anuta, Valentina
A3 - Mircioiu, Constantin
A4 - Voicu, Victor
A5 - Sandulovici, Roxana
JF - Revista de Chimie
JO - Rev. Chim.
PB - Revista de Chimie SRL
SN - 2668-8212
Y1 - 2019
VL - 70
IS - 8
SP - 2805
EP - 2810
UR - https://doi.org/10.37358/RC.19.8.7432
KW - omeprazole
KW - ketoconazole
KW - methylene chloride
ER -


BibTex
@article{RevCh2019P2805,
author = {Mircioiu Ion and Anuta Valentina and Mircioiu Constantin and Voicu Victor and Sandulovici Roxana},
title = {Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies},
journal = {Revista de Chimie},
volume = {70},
number = {8},
pages = {2805-2810},
year = {2019},
issn = {2668-8212},
doi = {https://doi.org/10.37358/RC.19.8.7432},
url = {https://revistadechimie.ro/Articles.asp?ID=7432}
}
 
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