Potential factors of Helicobacter pylori resistance to clarithromycin

Svetlana Serebrova; Daria Kurguzova; Lyudmila Krasnykh; Galina Vasilenko; Vladimir Drozdov; Natalia Lazareva; Eugenia Shikh; Marina Zhuravleva; Svetlana Rykova; Natalia Eremenko; Elena Kareva; Karin Mirzaev; Dmitriy Sychev; Alexey Prokofiev

doi:10.1515/dmpt-2021-0193

Article

Potential factors of Helicobacter pylori resistance to clarithromycin

Svetlana Serebrova , Daria Kurguzova , Lyudmila Krasnykh , Galina Vasilenko , Vladimir Drozdov , Natalia Lazareva , Eugenia Shikh , Marina Zhuravleva , Svetlana Rykova , Natalia Eremenko , Elena Kareva , Karin Mirzaev , Dmitriy Sychev and Alexey Prokofiev

Published/Copyright: August 29, 2022

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From the journal Drug Metabolism and Personalized Therapy Volume 37 Issue 4

Abstract

Objectives

A comparative dissolution kinetics test (CDKT) and bioequivalence studies of generic proton pump inhibitors (PPIs) do not model pharmacological acid suppression (PAS) and pathological duodenogastric reflux (PDGR). This study aimed to model them in CDKT to assess drugs stability and potential pantoprazole-clarithromycin interactions.

Methods

In CDKT, PDGR (dissolution medium pH 7.00 ± 0.05, preexposure at pH 1.20 ± 0.05) and PAS (pH 4.00 ± 0.05) were modelled for original pantoprazole (OP) and its generics (GP1-4). In CDKT with high-performance liquid chromatography, dissolution gastric medium in adequate (pH 4.00 ± 0.05) and inadequate (pH 1.20 ± 0.05) PAS were modelled for original clarithromycin (OC) and its generics (GC1-4).

Results

After exposure in pH 7.00 ± 0.05, pantoprazole was released from GP1 within 10 min in the amount of 68.8%. In рН 4.00 ± 0.05, 83.0% and 81.5% of pantoprazole were released from GP1 and GP4. When OP, GP2 and GP3 were placed in pH 7.00 ± 0.05, pantoprazole was released in amount: 99.4%, 88.0% and 98.2%. Clarithromycin releasing from OC, GC1, GC2, GC3, GC4 in pH 4.00 ± 0.05 was 93.5%, 91.6%, 92.9%, 79.4% and 83.0%. In pH 1.20 ± 0.05: 9.7%, 6.7%, 8.5%, 33.3%, 28.8%.

Conclusions

Destruction of enteric coats of some local pantoprazole generics in CDKT-models might be a potential factor for inadequate therapy.

Keywords: bioequivalence; clarithromycin; comparative dissolution kinetics test; Helicobacter pylori ; pantoprazole; pathological duodenogastric reflux; pharmacological acid suppression; proton pump inhibitor

Corresponding author: Daria Kurguzova, I.M. Sechenov First Moscow State Medical University (Sechenov University), Trubetskaya str., 8, bld. 2, 119991, Moscow, Russian Federation, E-mail: d.kurguzova@mail.ru

Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Not applicable.
Ethical approval: Not applicable.

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Received: 2021-11-16

Accepted: 2022-03-07

Published Online: 2022-08-29

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Articles in the same Issue

https://doi.org/10.1515/dmpt-2021-0193

Keywords for this article

bioequivalence; clarithromycin; comparative dissolution kinetics test; Helicobacter pylori; pantoprazole; pathological duodenogastric reflux; pharmacological acid suppression; proton pump inhibitor