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

Artikel

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 und Alexey Prokofiev

Veröffentlicht/Copyright: 29. August 2022

Veröffentlicht von

Veröffentlichen auch Sie bei De Gruyter Brill

Manuskript einreichen Informationen für Autor*innen

Aus der Zeitschrift Drug Metabolism and Personalized Therapy Band 37 Heft 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.

References

1. Savoldi, A, Carrara, E, Graham, DY, Conti, M, Tacconelli, E. Prevalence of antibiotic resistance in Helicobacter pylori: a systematic review and meta-analysis in World health organization regions. Gastroenterology 2018;155:1372–82. https://doi.org/10.1053/j.gastro.2018.07.007.Suche in Google Scholar PubMed PubMed Central

2. Mégraud, F. H pylori antibiotic resistance: prevalence, importance, and advances in testing. Gut 2004;53:1374–84.10.1136/gut.2003.022111Suche in Google Scholar PubMed PubMed Central

3. Vianna, JS, Ramis, IB, Ramos, DF, VON Groll, A, Silva, PE. Drug resistance in Helicobacter pylori. Arq Gastroenterol 2016;53:215–23. https://doi.org/10.1590/s0004-28032016000400002.Suche in Google Scholar PubMed

4. Manani, RO, Abuga, KO, Chepkwony, HK. Pharmaceutical equivalence of clarithromycin oral dosage forms marketed in Nairobi county, Kenya. Sci Pharm 2017;85:20. https://doi.org/10.3390/scipharm85020020.Suche in Google Scholar PubMed PubMed Central

5. Geus, WP, Mathôt, RA, Mulder, PG, Lamers, CB. Pharmacodynamics and kinetics of omeprazole MUPS 20 mg and pantoprazole 40 mg during repeated oral administration in Helicobacter pylori-negative subjects. Aliment Pharmacol Ther 2000;14:1057–64. https://doi.org/10.1046/j.1365-2036.2000.00806.x.Suche in Google Scholar PubMed

6. Kirchheiner, J, Glatt, S, Fuhr, U, Klotz, U, Meineke, I, Seufferlein, T, et al.. Relative potency of proton-pump inhibitors-comparison of effects on intragastric pH. Eur J Clin Pharmacol 2009;65:19–31. https://doi.org/10.1007/s00228-008-0576-5.Suche in Google Scholar PubMed

7. Sjöstedt, S, Sagar, M, Lindberg, G, Wikström, B, Nord, CE, Seensalu, R. Prolonged and profound acid inhibition is crucial in Helicobacter pylori treatment with a proton pump inhibitor combined with amoxicillin. Scand J Gastroenterol 1998;33:39–43.10.1080/00365529850166185Suche in Google Scholar

8. Sugimoto, M, Furuta, T. Efficacy of tailored Helicobacter pylori eradication therapy based on antibiotic susceptibility and CYP2C19 genotype. World J Gastroenterol 2014;20:6400–11. https://doi.org/10.3748/wjg.v20.i21.6400.Suche in Google Scholar PubMed PubMed Central

9. Gupta, HP, Saini, K, Dhingra, P, Pandey, R. Study of acid catalyzed reactions of proton pump inhibitors at D. M.E. Portugaliae Electrochimica Acta 2007;26:433–48. https://doi.org/10.4152/pea.200805433.Suche in Google Scholar

10. Seshadri, RK, Raghavaraju, TV, Chakravarthy, IE. A single gradient stability-indicating reversed-phase LC method for the estimation of impurities in omeprazole and domperidone capsules. Sci Pharm 2013;81:437–8. https://doi.org/10.3797/scipharm.1209-12.Suche in Google Scholar PubMed PubMed Central

11. United States Pharmacopeia and National Formulary (USP 41-NF 36). United States Pharmacopeial Convention, 2016 [Online]. Available from: https://online.uspnf.com/uspnf/document/GUID-AC788D41-90A2-4F36-A6E7-769954A9ED09_1_en-US [Accessed 18 Jan 2019].Suche in Google Scholar

12. FDA/CDER resources page. [Online]. Available from: https://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_SearchResults.cfm [Accessed 26 Apr 2017].Suche in Google Scholar

13. Fuchs, KH, DeMeester, TR, Hinder, RA, Stein, HJ, Barlow, AP, Gupta, NC. Computerized identification of pathologic duodenogastric reflux using 24-hour gastric pH monitoring. Ann Surg 1991;213:13–20. https://doi.org/10.1097/00000658-199101000-00003.Suche in Google Scholar PubMed PubMed Central

14. The British Pharmacopoeia resources page. [Online]. Available from: https://www.pharmacopoeia.com/bp-2020/momographs/rabeprazole-sodium [Accessed 25 Dec 2019].Suche in Google Scholar

15. Celli, JP, Turner, BS, Afdhal, NH, Ewoldt, RH, McKinley, GH, Bansil, R, et al.. Rheology of gastric mucin exhibits a pH-dependent sol-gel transition. Biomacromolecules 2007;8:1580–6. https://doi.org/10.1021/bm0609691.Suche in Google Scholar PubMed

16. Cao, X, Bansil, R, Bhaskar, KR, Turner, BS, LaMont, JT, Niu, N, et al.. pH-dependent conformational change of gastric mucin leads to sol-gel transition. Biophys J 1999;76:1250–8. https://doi.org/10.1016/s0006-3495(99)77288-7.Suche in Google Scholar PubMed PubMed Central

17. Roche, VF. The chemically elegant proton pump inhibitors. Am J Pharm Educ 2006;70:101. https://doi.org/10.5688/aj7005101.Suche in Google Scholar PubMed PubMed Central

18. Scott, DR, Sachs, G, Marcus, EA. The role of acid inhibition in Helicobacter pylori eradication. F1000 Faculty Rev-1747 2016;5. https://doi.org/10.12688/f1000research.8598.1.Suche in Google Scholar PubMed PubMed Central

19. McGowan, CC, Cover, TL, Blaser, MJ. Helicobacter pylori and gastric acid: biological and therapeutic implications. Gastroenterology 1996;110:926–38. https://doi.org/10.1053/gast.1996.v110.pm8608904.Suche in Google Scholar PubMed

20. Schreiber, S, Bücker, R, Groll, C, Azevedo-Vethacke, M, Garten, D, Scheid, P, et al.. Rapid loss of motility of Helicobacter pylori in the gastric lumen in vivo. Infect Immun 2005;73:1584–9. https://doi.org/10.1128/iai.73.3.1584-1589.2005.Suche in Google Scholar

21. The USP resource pages on Clarithromycin (100 mg) [Online]. Available from: https://store.usp.org/OA_HTML/ibeCCtpItmDspRte.jsp?item=18621 [Accessed 14 Jan 2020].Suche in Google Scholar

22. Bell, NJ, Burget, D, Howden, CW, Wilkinson, J, Hunt, RH. Appropriate acid suppression for the management of gastro-oesophageal reflux disease. Digestion 1992;51(1 Suppl):S59–67. https://doi.org/10.1159/000200917.Suche in Google Scholar PubMed

23. FDA. Guidance for industry: dissolution testing of immediate release solid oral dosage forms. Rockville MD, USA: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 1997:11 p.Suche in Google Scholar

24. FDA. Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. Rockville MD, USA: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 1997:24 p.Suche in Google Scholar

25. Koziolek, M, Grimm, M, Becker, D, Iordanov, V, Zou, H, Shimizu, J, et al.. Investigation of pH and temperature profiles in the GI tract of fasted human subjects using the Intellicap(®) system. J Pharm Sci 2015;104:2855–63. https://doi.org/10.1002/jps.24274.Suche in Google Scholar PubMed

26. Brown, CK, Friedel, HD, Barker, AR, Buhse, LF, Keitel, S, Cecil, TL, et al.. FIP/AAPS joint workshop report: dissolution/in vitro release testing of novel/special dosage forms. AAPS PharmSciTech 2011;12:782–94. https://doi.org/10.1208/s12249-011-9634-x.Suche in Google Scholar PubMed PubMed Central

27. Hellmig, S, Von Schöning, F, Gadow, C, Katsoulis, S, Hedderich, J, Fölsch, UR, et al.. Gastric emptying time of fluids and solids in healthy subjects determined by 13C breath tests: influence of age, sex and body mass index. J Gastroenterol Hepatol 2006;21:1832–8. https://doi.org/10.1111/j.1440-1746.2006.04449.x.Suche in Google Scholar PubMed

28. Vasavid, P, Chaiwatanarat, T, Pusuwan, P, Sritara, C, Roysri, K, Namwongprom, S, et al.. Normal solid gastric emptying values measured by scintigraphy using asian-style meal:A multicenter study in healthy volunteers. J Neurogastroenterol Motil 2014;20:371–8. https://doi.org/10.5056/jnm13114.Suche in Google Scholar PubMed PubMed Central

29. Horn, JR, Howden, CW. Review article: similarities and differences among delayed-release proton-pump inhibitor formulations. Aliment Pharmacol Ther 2005;22(3 Suppl):S20–4. https://doi.org/10.1111/j.1365-2036.2005.02714.x.Suche in Google Scholar PubMed

30. Murakami, T. Absorption sites of orally administered drugs in the small intestine. Expert Opin Drug Discov 2017;12:1219–32. https://doi.org/10.1080/17460441.2017.1378176.Suche in Google Scholar PubMed

31. Blume, H, Donath, F, Warnke, A, Schug, BS. Pharmacokinetic drug interaction profiles of proton pump inhibitors. Drug Saf 2006;29:769–84. https://doi.org/10.2165/00002018-200629090-00002.Suche in Google Scholar PubMed

32. Vlase, L, Neag, M, Popa, A, Muntean, D, Leucuta, SE. Pharmacokinetic interaction between fluoxetine and omeprazole in healthy male volunteers: a prospective pilot study. Curr Ther Res Clin Exp 2010;71:360–8. https://doi.org/10.1016/s0011-393x(10)80002-5.Suche in Google Scholar PubMed PubMed Central

33. Balderas-Acata, JI, Ríos-Rogríguez Bueno, EP, del Castillo-García, S, Espinosa-Martínez, C, Burke-Fraga, V, de la Parra, MG. Bioavailability of two coated-tablet formulations of a single dose of pantoprazole 40 mg: an open-label, randomized, two-period crossover, comparison in healthy Mexican adult volunteers. J Bioequiv Availab 2011;3:77–81. https://doi.org/10.4172/jbb.1000063.Suche in Google Scholar

34. Figura, N, Crabtree, JE, Dattilo, M. In-vitro activity of lansoprazole against Helicobacter pylori. J Antimicrob Chemother 1997;39:585–90. https://doi.org/10.1093/jac/39.5.585.Suche in Google Scholar PubMed

35. Territorial compulsory medical insurance fund resources page. Federal compulsory medical insurance fund [Online]. Available from: http://www.ffoms.ru/system-oms/territorial-funds/ [Accessed 23 Oct 2019].Suche in Google Scholar

36. The Ministry of Health of the Russian Federation resources on healthcare standards in patients with gastrointestinal pathology, IX class (in Russian) [Online]. Available from: https://minzdrav.gov.ru/ministry/61/22/stranitsa-979/stranitsa-983/2-standarty-spetsializirovannoy-meditsinskoy-pomoschi/klass-xi-bolezni-organov-pischevareniya-k00-k93 [Accessed 20 Jan 2020].Suche in Google Scholar

Received: 2021-11-16

Accepted: 2022-03-07

Published Online: 2022-08-29

Sie haben derzeit keinen Zugang zu diesem Inhalt.

Artikel in diesem Heft

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

Schlagwörter für diesen Artikel

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