Potential factors of Helicobacter pylori resistance to clarithromycin.

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.

• Authors: 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
• Journal: Drug metabolism and personalized therapy (Drug Metab Pers Ther) Vol. 37 Issue 4 Pg. 383-391 (12 01 2022) ISSN: 2363-8915 [Electronic] Germany
• PMID: 36027921 (Publication Type: Journal Article)
• Copyright: © 2022 Walter de Gruyter GmbH, Berlin/Boston.

Chemical References

• Clarithromycin

Topics

• Humans
• Clarithromycin (pharmacology)
• Helicobacter pylori