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Food-effect study on the pharmacokinetics of indapamide prolonged-release tablets Cover

Food-effect study on the pharmacokinetics of indapamide prolonged-release tablets

Open Access
|Dec 2024

References

  1. Ma G, Zhou C, Han Z, Mu T, Ma X. Social support and physical literacy in young and middle-aged patients with hypertension: the mediating effects of sense of coherence and self-efficacy. BMC Psychiatry. 2024;24:494.
  2. World Health Organization. Hypertension. 2023. Available from: https://www.who.int/news-room/fact-sheets/detail/hypertension
  3. Abbas B, Sabri NA, El-Khouly AA. Association between Food/UGT2B7 polymorphisms and pharmacokinetics/pharmacodynamics properties of indapamide in healthy humans. Biomedicines. 2023;11:1501.
  4. Robinson DM, Wellington K. Indapamide sustained release: A review of its use in the treatment of hypertension. Drugs. 2006;66 (2):257–71.
  5. Algabbani FM, Algabbani AM. Treatment adherence among patients with hypertension: findings from a cross- sectional study. Clin Hypertens. 2020;26:18.
  6. World Health Organization. Guideline for the pharmacological treatment of hypertension in adults. 2021. Available from: https://iris.who.int/bitstream/handle/10665/344424/9789240033986-eng.pdf
  7. Medicines and Healthcare products Regulatory Agency (MHRA). Product Information– Indapamide 2.5mg tablets, Zentiva Pharma UK Limited, Approved 2006, Revised 2024. Available from: https://www.medicines.org.uk/emc/files/pil.4188.pdf
  8. Medicines and Healthcare products Regulatory Agency (MHRA). Product Information– Cardide 1.5 mg tablets, Teva UK Limited, Approved 2013, Revised 2023. Available from: https://products.tevauk.com/mediafile/id/53068.pdf
  9. Health Products Regulatory Authority (HPRA). Product Information– Natrilix SR 1.5 mg, prolonged-release film-coated tablets, Les Laboratoires Servier, Approved 1996, Revised 2021. Available from: https://www.hpra.ie/img/uploaded/swedocuments/565bedf9-6886-40a5-8f71-8a6305ec730c.pdf
  10. Thomas JR. A review of 10 years of experience with indapamide as an antihypertensive agent. Hypertension. 1985;7(2):152–156.
  11. Antovska P, Ugarkovic S, Petruševski G, Stefanova B, Manchevska B, Petkovska R, et al. Development and experimental design of a novel controlled-release matrix tablet formulation for indapamide hemihydrate. Pharm Dev Technol. 2017;22:851–859.
  12. Caruso FS, Szabadi RR, Vukovich RA. Pharmacokinetics and clinical pharmacology of indapamide. Am Heart. 1983;106:212.
  13. Livingstone K, McKay G, Fisher M. Indapamide. Pract Diab Int. 2008;25(7):290–291.
  14. Medicines and Healthcare products Regulatory Agency (MHRA). Product Information– Natrilix 2.5 mg coated tablets, Servier Laboratoires Ltd, Approved 1977, Revised 2021. Available from: https://www.medicines.org.uk/emc/files/pil.1151.pdf
  15. Fleisher D, Li C, Zhou Y, Pao LH, Karim A. Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implications. Clin Pharmacokinet. 1999;36(3):233–254.
  16. Leonetti G. Clinical positioning of indapamide sustained release 1.5 mg in management protocols for hypertension. Drugs. 2000;59(2):27–38.
  17. Codreanu M, Iacob D, Vlase A-M, Muntean DM, Vlase L. Assessment of relative bioavailability of two indapamide tablet formulations after administration of single doses to fasted Caucasian subjects in 2-way crossover study. Farmacia. 2024;72(3):499-505.
  18. European Medicines Agency (EMA). Guideline Good Clinical Practice E6(R2). Adopted 1997. Available from: https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline
  19. U.S. Food and Drug Administration (FDA). Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations. 2022. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-effects-food-drugs-indsand-ndas-clinical-pharmacology-considerations
  20. Health Canada. Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies. Vol. 01, 2023. Available from: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/conduct-analysis-comparative.pdf
  21. Certara. Phoenix WinNonlin reference user manual. Available from: https://onlinehelp.certara.com/phoenix/8.2/index.html#t=topics%2Fintrownl.htm
  22. Tanaka E. Gender-related differences in pharmacokinetics and their clinical significance. J Clin Pharm Ther. 1999;24:339–346.
  23. Farkouh A, Riedl T, Gottardi R, Czejka M, Kautzky-Willer A. Sex-related differences in pharmacokinetics and pharmacodynamics of frequently prescribed drugs: A review of the literature. Adv Ther. 2019;37:644–655.
  24. Mauvais-Jarvis F, Berthold HK, Campesi I, Carrero JJ, Dakal S, Franconi F, et al. Sex-and gender-based pharmacological response to drugss. Pharmacol Rev. 2021;73:730–762.
  25. Soldin OP, Mattison DR. Sex differences in pharmacokinetics and pharmacodynamics. Clin Pharmacokinet. 2009;48(3):143–157.
  26. Prieto-Garcia JM, Graham L, Alkhabbaz O, Mazzari ALDA. Potential pharmacokinetic interactions of common cardiovascular drugs and selected European and Latin American herbal medicines: A scoping review. Plants. 2023;12:623.
  27. Yan F, Hu Y, Di B, He PL, Sun G. Effects of some antihypertensive drugs on the metabolism and pharmacokinetics of indapamide in rats. J Pharm Pharm Sci. 2012;15(2):208–220.
  28. Sun H, Moore C, Dansette PM, Kumar S, Halpert JR, et all. Dehydrogenation of the indoline-containing drug 4-chloroN-(2-methyl-1-indolinyl)-3-sulfamoylbenzamide (indapamide) by CYP3A4: Correlation with in silico predictions. Drug Metab Dispos. 2009;37(3):672–684.
  29. Wang TH, Hsiong CH, Ho HT, Shih TY, Yen SJ, Wang HH, et al. Genetic polymorphisms of metabolic enzymes and the pharmacokinetics of indapamide in Taiwanese subjects. AAPS J. 2014;16 (2):206–213.
  30. Federal Institute for Drugs and Medical Devices (BfArM). Public Assessment Report of Indapamide J & P Pharma 1.5 mg Retardtabletten (Procedure Number: DE/H/1034/001/DC), J & P Pharma UK Ltd.; 2022. Available from: https://mri.cts-mrp.eu/portal
  31. Li G, Zhang X, Tian Y, Zhang Z, Rui J, Chu X. Pharmacokinetics and bioequivalence study of two indapamide formulations after single-dose administration in healthy Chinese male volunteers. Drug Res. 2013;63:13-18.
  32. Deng J, Zhu X, Chen Z, Fan CH, Kwan HS, Wong CH, et al. A review of food–drug interactions on oral drug absorption. Drugs. 2017;77:1833–1855.
  33. Li M, Zhao P, Pan Y, Wagner C. Predictive performance of physiologically based pharmacokinetic models for the effect of food on oral drug absorption: Current status. CPT Pharmacometrics Syst Pharmacol. 2018;7:82–89.
  34. Pop DI, Gheldiu A-M, Oroian M, Marcovici A, Bhardwaj S, Khuroo A, et al. Effect of food on the pharmacokinetics of gliclazide 60 mg modified release tablet in healthy Caucasian volunteers. Acta Med Marisiensis. 2018;64(4):161–168.
  35. Kondža M, Brizić I, Jokić S. Flavonoids as CYP3A4 inhibitors in vitro. Biomedicines. 2024;12:644.
  36. Eagles SK, Gross AS, McLachlan AJ. The effects of cruciferous vegetable-enriched diets on drug metabolism: A systematic review and meta-analysis of dietary intervention trials in humans. Clin Pharmacol Ther. 2020;108(2):212–227.
  37. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Guideline ‘Biopharmaceutics Classification System-Based Biowaivers’ M9. 2019. Available from: https://database.ich.org/sites/default/files/M9_Guideline_Step4_2019_1116.pdf
  38. Omachi F, Kaneko M, Iijima R, Watanabe M, Itagaki F. Relationship between the effects of food on the pharmacokinetics of oral antineoplastic drugs and their physicochemical properties. J Pharm Health Care Sci. 2019;5:26.
  39. Zou P, Vaidyanathan J, Tran D, Raines K, Chatterjee P, Madabushi R, et al. Predicting food effects on oral extended-release drug products: A retrospective evaluation. AAPS J. 2023;25:33.
  40. Li Z, He X, Tian S, Feng G, Huang C, Xun M, et al. Simultaneous evaluation of dissolution and permeation of oral drug solid formulations for predicting absorption rate–limiting factors and in vitro–in vivo correlations: case study using a poorly soluble weakly basic drug. AAPS PharmSciTech. 2019;20:321.
  41. Davanço MG, Campos DR, de Oliveira Carvalho P. In vitro – In vivo correlation in the development of oral drug formulation: A screenshot of the last two decades. Int J Pharm. 2020;580:119210.
  42. Kelemen ÉK, Kelemen L, Gyéresi Á, Imre S, Obreja M. Development of a dissolution method for modified release tablets containing an insoluble active substance. Acta Med Marisiensis. 2012;58(5):300-303.
  43. Saleh A, Elkordy AA, Chaw CS, Mcgarry K, Childs S. Feasibility of self-emulsifying drug delivery system for dissolution enhancement of indapamide. Glob Drugs Therap. 2020;5:1–4.
  44. Oroian M, Pop DI, Gheldiu A-M, Bhardwaj S, Marcovici A, Khuroo A, et al. The relative bioavailability of two formulations containing 10 mg dapagliflozin assessed under fasting conditions in a randomized crossover study in healthy Caucasian subjects. Acta Med Marisiensis. 2020;66(1):30-34.
  45. Oroian M, Pop DI, Gheldiu A-M, Bhardwaj S, Marcovici A, Khuroo A, et al. Relative bioavailability of two formulations containing dapagliflozin 10 mg under fed condition in a randomized crossover study in healthy Caucasian subjects. Farmacia. 2020;68(1):76-81.
  46. Oroian M, Vlase A-M, Marcovici A, Vlase L. Kinetics of Dapagliflozin 10mg immediate release tablet in healthy Caucasian volunteers: does food intake affect its disposition in the body? Studia UBB Chemia. 2023;LXVIII(1):37-48.
  47. Schiavi P, Jochemsen R, Guez D. Pharmacokinetics of sustained and immediate release formulations of indapamide after single and repeated oral administration in healthy volunteers. Fundam Clin Pharmacol. 2000;14:139–146.
DOI: https://doi.org/10.2478/amma-2024-0032 | Journal eISSN: 2668-7763 | Journal ISSN: 2668-7755
Language: English
Page range: 238 - 245
Submitted on: Aug 29, 2024
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Accepted on: Oct 8, 2024
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Published on: Dec 24, 2024
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2024 Maria Codreanu, Diana Iacob, Maria Ioana Onofrei, Ana-Maria Vlase, Dana Maria Muntean, Laurian Vlase, published by University of Medicine, Pharmacy, Science and Technology of Targu Mures
This work is licensed under the Creative Commons Attribution 4.0 License.