Pharmacokinetic study of prolonged release capsules of mebeverine
Abstract
Pharmacokinetic study of prolonged release capsules of mebeverine was carried out on 24 volunteers. It is known that the drug substance is completely metabolized due to first-pass effect. Therefore, pharmacokinetic parameters of the main metabolites -mebeverine acid and desmethyl mebeverine acid were measured. Bioanalytical method was developed to measurement of concentrations of these metabolites in blood plasma by using HPLC-MS/MS.
About the Authors
A. L. Khokhlov
The Yaroslavl State Medical University; Quinta-Analytica Yaroslavl LLC
Russian Federation
Russian Federation
Yu. A. Dzhurko
Quinta-Analytica Yaroslavl LLC
Russian Federation
Russian Federation
L. N. Shitov
The Yaroslavl State Medical University; Quinta-Analytica Yaroslavl LLC
Russian Federation
Russian Federation
I. I. Yaichkov
The Yaroslavl State Medical University; Quinta-Analytica Yaroslavl LLC
Russian Federation
Russian Federation
A. M. Shitova
Quinta-Analytica Yaroslavl LLC
Russian Federation
Russian Federation
L. A. Khozova
Quinta-Analytica Yaroslavl LLC
Russian Federation
Russian Federation
A. E. Miroshnikov
The Yaroslavl State Medical University
Russian Federation
Russian Federation
References
1. Brittain H.G. Analytical Profiles of Drug Substances and Excipients, Vol. 25.California:Academic press, 1998.
2. StockisA., Guelen P.J.M., de Vos D. Identification of Mebeverine Acid as the Main Circulating Metabolite of Mebeverine in Man. J Pharm Biomed Anal. 2002; 29: 335-340.
3. Winsemius A., Meuwsen I.M., Boon C., van der Laan A., Brekle A., de Vries M. A pharmacokinetic comparison of the modified release capsule and a plain tablet formulation of mebeverine. Int J Clin Pract. 2002; 9 (56): 659-662.
4. Elliott S., Burgess V. Investigative implications of the Instability and Metabolism of Mebeverine. J Anal Tox. 2006; 30: 91-97.
5. Bergeron M., Bergeron A., Amsterdam P., Furtado M., Garofolo F. Use of polarity switching for the simultaneous bioanalysis of analytes with three orders of magnitude difference in concentration by HPLC-MS/MS. Bioanal. 2013; 5 (15): 1911-1918.
6. Khatri C.A., Phanikumar Ch.V., Jayaveera K., Reddy K.Y. Development and Validation of Bioanalytical Method for Simultaneous Quantification of Veratric Acid, Mebeverine Acid and Desmethyl Mebeverine Acid in Human Edta Plasma by Using LC-MS/MS. J Pharm Chem. 2012; 4 (6): 11 - 18.
7. Guideline on validation of bioanalytical methods (draft), European Medicines Agency, Committee for medicinal products for human use; 2010.
8. Guidance for Industry: Bioanalytical method validation. U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evolution and Research (CDER), U. S. Government Printing Office, Washington, DC; 2013.
9. Миронов А.Н., ред. Руководство по экспертизе лекарственных средств. Т. 1. М.: Гриф и К; 2013.
10. Food and Drugs Administration Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on Biopharmaceutics Classification SystemRockville, MD: U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; 2015.
11. Guidance on the investigation of bioequivalence,European Medicines Agency, Committee for medicinal products for human use; 2010.
12. Declaration of Helsinki of the AMM-Ethical Principles for Medical Research in humans, World Medical Assembly, 64th General Assembly; 2013.
13. Хохлов А.Л., Лилеева Е.Г., Синицина О.А., Спешилова С.А., Демарша С.М., Шитов Л.Н. Проблемы проведения биоаналитической части исследований биоэквивалентности лекарственных препаратов в России. Фармакокинетика Фармакодинамика. 2014; 1: 37-43.
Review
For citations:
Khokhlov A.L., Dzhurko Yu.A., Shitov L.N., Yaichkov I.I., Shitova A.M., Khozova L.A., Miroshnikov A.E. Pharmacokinetic study of prolonged release capsules of mebeverine. Pharmacokinetics and Pharmacodynamics. 2017;(1):57-62. (In Russ.)
Views:
993
Email this article 