Otwarty dostęp

Biopharmaceutical classification of desloratadine – not all drugs are classified the easy way


Zacytuj

1. R. S. Geha and E. O. Meltzer, Desloratadine: a new, nonsedating, oral antihistamine, J. Allergy Clin. Immunol.107 (2001) 751–762; https://doi.org/10.1067/mai.2001.11423910.1067/mai.2001.114239Search in Google Scholar

2. M. Molimard, B. Diquet and M.S. Benedetti, Comparison of pharmacokinetics and metabolism of desloratadine, fexofenadine, levocetirizine and mizolastine in humans, Fundam. Clin. Pharmacol.18 (2004) 399–411; https://doi.org/10.1111/j.1472-8206.2004.00254.x10.1111/j.1472-8206.2004.00254.xSearch in Google Scholar

3. J. Bartra, A. L. Valero, A. del Cuvillo, I. Dávila, I. Jáuregui, J. Montoro, J. Mullol and J. Sastre, Interactions of the H1 antihistamines, J. Investig. Allergol. Clin. Immunol. 16 (2006) 29–36.Search in Google Scholar

4. R. Bustami, S. Khasawneh, W. Absi, H. Feddah, M. Menassa, E. Daccache, M. S. Taha and S. Kyriacos, Bioequivalence of a fixed dose combination of desloratadine/betamethasone tablets (Oradus Beta) in healthy human volunteers, J. Bioequiv. Availab.8 (2016) 233–241; doi:10.4172/jbb.100030110.4172/jbb.1000301Search in Google Scholar

5. Prescriber Digital Reference (PDR), desloratadine – Drug Summary;http://www.pdr.net/drug-summary/Clarinex-desloratadine-334.789; access date March 19, 2018.Search in Google Scholar

6. A. Crowe and C. Wright, The impact of P-glycoprotein mediated efflux on absorption of 11 sedating and less-sedating antihistamines using Caco-2 monolayers, Xenobiotica42 (2012) 538–549; https://doi.org/10.3109/00498254.2011.64325610.3109/00498254.2011.643256Search in Google Scholar

7. B. R. Falcão, L. de Melo Teixeira, F. Z. Philippsen and T. R. Sausen, Development and validation of a dissolution method for desloratadine coated tablets, UK. J. Pharm. Biosci. 5 (2017) 12–17; http://dx.doi.org/10.20510/ukjpb/5/i1/14702010.20510/ukjpb/5/i1/147020Search in Google Scholar

8. Erratum, Br. J. Clin. Pharmacol.74 (2012) 224–225; https://doi.org/10.1111/j.1365-2125.2012.04349.x10.1111/j.1365-2125.2012.04349.xSearch in Google Scholar

9. CDER/FDA, Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Guidance for industry. 2017; https://www.fda.gov/downloads/Drugs/Guidances/ucm070246.pdf; access date March 19, 2018.Search in Google Scholar

10. B. M. Davit, I. Kanfer, Y. C. Tsang and J. M. Cardot, BCS biowaivers: similarities and differences among EMA, FDA, and WHO requirements, AAPS J. 18 (2016) 612–618; https://doi.org/10.1208/s12248-016-9877-210.1208/s12248-016-9877-2Search in Google Scholar

11. Bayer Inc., Product monograph Aerius®Desloratadine Tablet 5 mg Aerius Kids®Desloratadine syrup 0.5 mg/mL Histamine H1-Receptor Antagonist, November 2017; http://omr.bayer.ca/omr/online/aeriusaeriuskids-pm-en.pdf; access date March 19, 2018.Search in Google Scholar

12. B. B. Hodgson and R. J. Kizior, Desloratadine, in Saunders nursing drug handbook, Elsevier/Saunders, St. Louis 2012, pp. 326–328.Search in Google Scholar

13. R. Ramanathan, L. Reyderman, A. D. Su, N. Alvarez, S. K. Chowdhury, K. B. Alton, M. A. Wirth, R. P. Clement, P. Statkevich and J. E. Patrick, Disposition of desloratadine in healthy volunteers, Xenobiotica37 (2007) 770–787; https://doi.org/10.1080/0049825070146332510.1080/00498250701463325Search in Google Scholar

14. G. Popović, M. Čakar and D. Agbaba, Acid–base equilibria and solubility of loratadine and desloratadine in water and micellar media, J. Pharm. Biomed. Anal.49 (2009) 42–47; https://doi.org/10.1016/j.jpba.2008.09.04310.1016/j.jpba.2008.09.043Search in Google Scholar

15. T. C. McIlvaine, A buffer solution for colorimetric comparison, J. Biol. Chem.49 (1921) 183–186.10.1016/S0021-9258(18)86000-8Search in Google Scholar

16. S. Žakelj, K. Šturm and A. Kristl, Ciprofloxacin permeability and its active secretion through rat small intestine in vitro, Int. J. Pharm.313 (2006) 175–180; https://doi.org/10.1016/j.ijpharm.2006.02.00410.1016/j.ijpharm.2006.02.00416529884Search in Google Scholar

17. L. Peternel, K. Kristan, M. Petruševska, T. L. Rižner and I. Legen, Suitability of isolated rat jejunum model for demonstration of complete absorption in humans for BCS-based biowaiver request, J. Pharm. Sci.101 (2012) 1436–1449; https://doi.org/10.1002/jps.2302710.1002/jps.2302722234826Search in Google Scholar

18. T. Wang, K. Zhang, T. Li, L. He, H. Xie, X. Jiang and L. Wang, Prevalence of desloratadine slow-metabolizer phenotype and food-dependent pharmacokinetics of desloratadine in healthy Chinese volunteers, Clin. Drug. Investig.35 (2015) 807–813; https://doi.org/10.1007/s40261-015-0343-110.1007/s40261-015-0343-126446005Search in Google Scholar

19. M. Zur, M. Gasparini, O. Wolk, G. L. Amidon and A. Dahan, The low/high BCS permeability class boundary: physicochemical comparison of metoprolol and labetalol, Mol. Pharm. 11 (2014) 1707–1714; https://doi.org/10.1021/mp500152y10.1021/mp500152y24735251Search in Google Scholar

20. D. A. Volpe, Application of method suitability for drug permeability classification, The AAPS J.12 (2010) 670–678; https://doi.org/10.1208/s12248-010-9227-810.1208/s12248-010-9227-8297698420811966Search in Google Scholar

21. T. Jarc, M. Novak, N. Hevir, T. Lanišnik Rižner, M. Erdani Kreft and K. Kristan, Demonstrating suitability of the Caco-2 cell model for BCS-based biowaiver according to the recent FDA and ICH harmonised guidelines, J. Pharm. Pharmacol. (2019), article in press.10.1111/jphp.1311131155721Search in Google Scholar

22. C. A. Larregieu and L. Z. Benet, Distinguishing between the permeability relationships with absorption and metabolism to improve BCS and BDDCS predictions in early drug discovery, Mol. Pharm.11 (2014) 1335–1344; https://doi.org/10.1021/mp400785810.1021/mp4007858398336924628254Search in Google Scholar

23. S. Ferruzza, C. Rossi, M. L. Scarino and Y. Sambuy, A protocol for differentiation of human intestinal Caco-2 cells in asymmetric serum-containing medium, Toxicol. In Vitro26 (2012) 1252–1255; https://doi.org/10.1016/j.tiv.2012.01.00810.1016/j.tiv.2012.01.00822265977Search in Google Scholar

eISSN:
1846-9558
Język:
Angielski
Częstotliwość wydawania:
4 razy w roku
Dziedziny czasopisma:
Pharmacy, other