References
- 1. C. A. Dendrou, L. Fugger and M. A. Friese, Immunopathology of multiple sclerosis, Nat. Rev. Immunol. 15 (2015) 545–558; https://doi.org/10.1038/nri387110.1038/nri3871
- 2. A. Lugaresi, Pharmacology and clinical efficacy of dalfampridine for treating multiple sclerosis, Expert Opin. Drug Metab. Toxicol.11 (2014) 295–306; https://doi.org/10.1517/17425255.2015.99331510.1517/17425255.2015.993315
- 3. S. Weir, R. Torkin and H. R. Henney, Pharmacokinetic profile of dalfampridine extended release: clinical relevance in patients with multiple sclerosis, Curr. Med. Res. Opin. 29 (2012) 1627–1636; https://doi.org/10.1185/03007995.2012.74922110.1185/03007995.2012.749221
- 4. W. A. Coetzee, Y. Amarillo, J. Chiu, A. Chow, D. Lau, T. McCormack, H. Moreno, M. S. Nadal, A. Ozaita, D. Pountney, M. Saganich, E. V. S. de Miera and B. Rudy, Molecular diversity of K+ channels, Ann. N. Y. Acad. Sci. 868 (1999) 233–255.10.1111/j.1749-6632.1999.tb11293.x
- 5. A. D. Goodman, T. R. Brown, L. B. Krupp, R. T. Schapiro, S. R. Schwid, R. Cohen, L. M. Marinucci and A. R. Blight, Sustained-release oral fampridine in multiple sclerosis: a randomised, doubleblind, controlled trial, Lancet373 (2009) 732–738; https://doi.org/10.1016/S0140-6736(09)60442-610.1016/S0140-6736(09)60442-6
- 6. A. D. Goodman, T. R. Brown, K. R. Edwards, L. B. Krupp, R. T. Schapiro, R. Cohen, L. N. Marinucci and A. R. Blight, A phase 3 trial of extended release oral dalfampridine in multiple sclerosis, Ann. Neurol.68 (2010) 494–502; https://doi.org/10.1002/ana.2224010.1002/ana.2224020976768
- 7. US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Application Number 22-250s000, Approval Letter, FDA, Silver Spring (MD) 2010; https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022250s000_Approv.pdf; last access date June 15, 2019
- 8. European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), Summary of Opinion (Initial Authorisation) for Fampyra (Fampridine), May 2011; https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-fampyra_en.pdf; last access date June 18, 2019
- 9. V. K. Redasani, G. L. Shaikh and S. S. Surana, Development and validation of spectroscopic methods for the estimation of dalfampridine in bulk and in tablet formulation, Anal. Chem. Indian J. 14 (2014) 37–41.
- 10. S. Thomas, S. Shandilya, A. Bharti and A. Agarwal, A stability indicating simultaneous dual wavelength UV-HPLC method for the determination of potential impurities in fampridine active pharmaceutical ingredient, J. Pharm. Biomed. Anal.58 (2012) 136–140; https://doi.org/10.1016/j.jpba.2011.09.00910.1016/j.jpba.2011.09.00922000073
- 11. C. Babu, K. N. Rao, N. Devanna and K. S Reddy, Development and validation of stability indicating reversed phase high performance liquid chromatographic method for the determination of related substances in fampridine drug substance and tablet dosage forms, Asian J. Pharm. Clin. Res. 10 (2017) 334–338.10.22159/ajpcr.2017.v10i10.19796
- 12. N. R. Dharani, K. Padmini and S. Sumakala, Stability indicating RP-HPLC method development and validation for estimation of dalfampridine in its bulk and formulation, Int. J. Adv. Res.4 (2016) 184–191; https://doi.org/10.21474/IJAR01/147110.21474/IJAR01/1471
- 13. M. Jain, V. Srivastava, R. Kumar, V. Dangi, S. G. Hiriyanna, A. Kumar and P. Kumar, Determination of five potential genotoxic impurities in dalfampridine using liquid chromatography, J. Pharm. Biomed. Anal.133 (2017) 27–31; https://doi.org/10.1016/j.jpba.2016.10.013.10.1016/j.jpba.2016.10.01327969064
- 14. W. Smith, S. Swan, T. Marbury and H. Henney, Single-dose pharmacokinetics of sustained-release fampridine (fampridine-SR) in healthy volunteers and adults with renal impairment, J. Clin. Pharmacol. 50 (2010) 151–159; https://doi.org/10.1177/009127000934485710.1177/009127000934485719966074
- 15. A. Suneetha and R. K. Raja, High-throughput liquid chromatography tandem mass spectrometry method for simultaneous determination of fampridine, paroxetine, and quinidine in rat plasma: Application to in vivo perfusion study, J. Food. Drug Anal. 24 (2016) 866–875; https://doi.org/10.1016/j.jfda.2016.03.00410.1016/j.jfda.2016.03.00428911626
- 16. A. Suneetha and R. K. Raja, Comparison of LC-UV and LC–MS methods for simultaneous determination of teriflunomide, dimethyl fumarate and fampridine in human plasma: application to rat pharmacokinetic study, Biomed. Chromatogr.30 (2016) 1371–1377; https://doi.org/10.1002/bmc.369410.1002/bmc.369426849839
- 17. United States Pharmacopeia/National Formulary (USP 42-NF 37), United States Pharmacopeial Convention, Rockville (MD) 2017; last access date November 1, 2019
- 18. A. Dean, D. Voss and D. Draguljic, Design and Analysis of Experiments, 2nd ed., Springer International Publishing, Cham 2017.10.1007/978-3-319-52250-0
- 19. L. Eriksson, E. Johansson, N. Kettaneh-Wold, C. Wilkström and S. Wold, Design of Experiments – Principles and Applications, 3rd ed., MKS Umetrics AB, Umeå 2008.
- 20. A. L. Vonica-Gligor, I. Tomuţă I and S.E. Leucuţa, Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system, Acta Pharm. 66 (2016) 173–189; https://doi.org/10.1515/acph-2016-002510.1515/acph-2016-002527279062
- 21. A. Ćurić, R. Reul, J. Möschwitzer and G. Fricker, Formulation optimization of itraconazole loaded PEGylated liposomes for parenteral administration by using design of experiments, Int. J. Pharm. 448 (2013) 189–197; https://doi.org/10.1016/j.ijpharm.2013.03.02910.1016/j.ijpharm.2013.03.02923524086
- 22. C. Saroja and P. K. Lakshmi, Formulation and optimization of fenofibrate lipospheres using Taguchi’s experimental design, Acta Pharm. 63 (2013) 71–83; https://doi.org/10.2478/acpb-2013-000810.2478/acpb-2013-000823482314
- 23. B. Sylvester, A. Porfire, D. M. Muntean, L. Vlase and I. Tomuţă, Formulation optimization of pravastatin loaded long-circulating liposomes using a design of experiments, Farmacia64 (2016) 449–458.
- 24. Z. I. Szabó, B. Székely-Szentmiklósi, B. Deák, I. Székely-Szentmiklósi, B. Kovács, K. Zöldi and E. Sipos, Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design, Acta Pharm. 66 (2016) 191–206; https://doi.org/10.1515/acph-2016-001910.1515/acph-2016-001927279063
- 25. L. R. Tefas, B. Sylvester, I. Tomuță, A. Sesarman, E. Licarete, M Banciu and A. Porfire, Development of antiproliferative long-circulating liposomes co-encapsulating doxorubicin and curcumin, through the use of a quality-by-design approach, Drug Des. Devel. Ther. 11 (2017) 1605–1621; https://doi.org/10.2147/DDDT.S12900810.2147/DDDT.S129008544869728579758
- 26. B. Kovács, L. K. Kántor, M. D. Croitoru, É. K. Kelemen, M. Obreja, E. E. Nagy, B. Székely-Szentmiklósi and Á. Gyéresi, Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design, Acta Pharm.68 (2018) 171–183; https://doi.org/10.2478/acph-2018-001910.2478/acph-2018-001929702478
- 27. P. Shah, T. Pandya, M. Gohel and V. Thakkar, Development and validation of HPLC method for simultaneous estimation of rifampicin and ofloxacin using experimental design, J. Taibah Univ. Sci.13 (2018) 146–154; https://doi.org/10.1080/16583655.2018.154874810.1080/16583655.2018.1548748
- 28. User guide to MODDE Version 12, Sartorius Stedim Data Analytics, Umeå, Sweden, 2017; https://blog.umetrics.com/hubfs/Download%20Files/MODDE%2012.0.1%20User%20Guide.pdf; last access date November 12, 2019
- 29. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Dissolution Methods, FDA, Silver Spring (MD), USA, 2012; https://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_SearchResults.cfm, last access date November 14, 2019