236
Views
3
CrossRef citations to date
0
Altmetric
Research Articles

A sensitive and high-throughput LC-ESI-MS/MS method to detect budesonide in human plasma: application to an evaluation of pharmacokinetics of budesonide intranasal formulations with and without charcoal-block in healthy volunteers

, , , , , , , , & show all
Pages 329-336 | Received 15 Oct 2020, Accepted 16 Jan 2021, Published online: 01 Feb 2021

References

  • Brożek JL, Bousquet J, Agache I, et al. Allergic rhinitis and its impact on asthma (ARIA) guidelines-2016 revision. J Allergy Clin Immunol. 2017;140:950–958.
  • Dykewicz MS, Wallace DV, Baroody F, et al., Workgroup Chair and Cochair. Treatment of seasonal allergic rhinitis: an evidence-based focused 2017 guideline update. Ann Allergy Asthma Immunol. 2017;119:489–511. e41.
  • Smith CL, Kreutner W. In vitro glucocorticoid receptor binding and transcriptional activation by topically active glucocorticoids. Arzneimittelforschung. 1998; 48:956–960.
  • Marttin E, Schipper NGM, Verhoef JC, et al. Nasal mucociliary clearance as a factor in nasal drug delivery. Adv Drug Deliver Rev. 1998;29:13–38.
  • Wong YC, Zuo Z. Intranasal delivery-modification of drug metabolism and brain disposition. Pharm Res. 2010; 27:1208–1223.
  • Food and Drug Administration. Guidance for industry: bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action. Rockville (MD): US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; 2003. https://www.fda.gov/media/70867/download
  • Liu Q, Absar M, Saluja B, et al. Scientific considerations for the review and approval of first generic mometasone furoate nasal suspension spray in the United States from the bioequivalence perspective. AAPS J. 2019; 21:14
  • Kågedal M, Zingmark PH, Hedlund C, et al. True nasopharyngeal absorption of zolmitriptan after administration via nasal spray in healthy male volunteers. Am J Adv Drug Deliv. 2005; 3:133–140.
  • Szefler SJ. Pharmacokinetics of intranasal corticosteroids. J Allergy Clin Immunol. 2001; 108:S26–S31.
  • Derendorf H, Meltzer EO. Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications. Allergy. 2008; 63:1292–1300.
  • AstraZeneca Pharms. Rhinocort® AquaTM (budesonide) [package insert]. U.S. Food and Drug Administration. [revised 1999 Aug 30]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20746lbl.pdf
  • Dimova H, Wang Y, Pommery S, et al. SPE/RIA vs LC/MS for measurement of low levels of budesonide in plasma. Biomed Chromatogr. 2003; 17:14–20.
  • Hochhaus G, Fröehlich P, Hochhaus R, et al. A selective HPLC/RIA for the determination of budesonide. J Pharmaceut Biomed. 1998; 17:1235–1242.
  • Pujos E, Flament-Waton MM, Paisse O, et al. Comparison of the analysis of corticosteroids using different techniques. Anal Bioanal Chem. 2005; 381:244–254.
  • Ahmed S, Atia NN. Controlled microwave derivatization reaction for reproducible trace analysis of budesonide in human plasma. Anal Chim Acta. 2019; 1048:132–142.
  • Rower JE, Anderson DJ, Sherwin CM, et al. Development and validation of an assay for quantifying budesonide in dried blood spots collected from extremely low gestational age neonates. J Pharm Biomed Anal. 2019; 167:7–14.
  • Draft ICH guideline M10 on bioanalytical method validation. European Medicines Agency Committee for human medicinal products. Available from: https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation
  • Szeitz A, Manji J, Riggs KW, et al. Validated assay for the simultaneous determination of cortisol and budesonide in human plasma using ultra high performance liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal. 2014; 90:198–206.
  • Lu Y, Sun Z, Zhang Y, et al. Simultaneous quantification of 22R and 22S epimers of budesonide in human plasma by ultra-high-performance liquid chromatography–tandem mass spectrometry: application in a stereoselective pharmacokinetic study. J Chromatogr B. 2013;921-922:27–34.
  • do Carmo Borges NC, Astigarraga RB, Sverdloff CE, et al. Budesonide quantification by HPLC coupled to atmospheric pressure photoionization (APPI) tandem mass spectrometry. Application to a comparative systemic bioavailability of two budesonide formulations in healthy volunteers. J Chromatogr B Analyt Technol Biomed Life Sci. 2011; 879:236–242.
  • Wang Y, Tang Y, Moellmann H, et al. Simultaneous quantification of budesonide and its two metabolites, 6β‐hydroxybudesonide and 16α‐hydroxyprednisolone, in human plasma by liquid chromatography negative electrospray ionization tandem mass spectrometry. Biomed Chromatogr. 2003; 17:158–164.
  • Nilsson K, Andersson M, Beck O. Phospholipid removal combined with a semi-automated 96-well SPE application for determination of budesonide in human plasma with LC–MS/MS. J Chromatogr B. 2014; 970:31–35.
  • Kronkvist K, Gustavsson M, Wendel AK, et al. Automated sample preparation for the determination of budesonide in plasma samples by liquid chromatography and tandem mass spectrometry. J Chromatogr A. 1998; 823:401–409.
  • Li YNB, Tattam B, Brown KF, et al. Quantification of epimeric budesonide and fluticasone propionate in human plasma by liquid chromatography–atmospheric pressure chemical ionization tandem mass spectrometry. J Chromatogr B. 2001; 761:177–185.
  • Streel B, Cahay B, Klinkenberg R. Using total error concept for the validation of a liquid chromatography-tandem mass spectrometry method for the determination of budesonide epimers in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2009; 877:2290–2300.
  • Al-Numani D, Colucci P, Ducharme MP. Rethinking bioequivalence and equivalence requirements of orally inhaled drug products. Asian J Pharm Sci. 2015; 10:461–471.
  • Lähelmä S, Kirjavainen M, Kela M, et al. Equivalent lung deposition of budesonide in vivo: a comparison of dry powder inhalers using a pharmacokinetic method. Br J Clin Pharmacol. 2005; 59:167–173.
  • Oliveira P, Fortuna A, Alves G, et al. Drug-metabolizing enzymes and efflux transporters in nasal epithelium: influence on the bioavailability of intranasally administered drugs. Curr Drug Metab. 2016; 17:628–647.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.