High speed electrospinning for scaled-up production of amorphous solid dispersion of itraconazole

International Journal of Pharmaceutics

Volumn 480, Issue 1-2, 2015, Pages 137-142

  Nagy, Zsombor K ^a   Balogh, Attila ^a   Démuth, Balázs ^a   Pataki, Hajnalka ^a   Vigh, Tamás ^a   Szabó, Bence ^a   Molnár, Kolos ^a   Schmidt, Bence T ^a   Horák, Péter ^a   Marosi, György ^a   Verreck, Geert ^b   Van Assche, Ivo ^b   Brewster, Marcus E ^b  

^a BUDAPEST UNIVERSITY OF TECHNOLOGY AND ECONOMICS   (Hungary)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Amorphous solid dispersion; Continuous nanoformulation; Dissolution enhancement; Electrospinning; Itraconazole; Scaling up

Indexed keywords

ITRACONAZOLE; MICROSPHERE; ANTIFUNGAL AGENT; NANOFIBER; POLYMER; SOLVENT;

AMORPHOUS SOLID DISPERSION; ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DISPERSION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SOLUBILITY; ELECTROSPINNING; HIGH SPEED ELECTROSPINNING; PRIORITY JOURNAL; SCALE UP; SCANNING ELECTRON MICROSCOPY; SPRAY DRYING; X RAY DIFFRACTION; CHEMISTRY; CRYSTALLIZATION; DRUG INDUSTRY; MEDICINAL CHEMISTRY; PHARMACEUTICS; PROCEDURES; SOLUBILITY;

ANTIFUNGAL AGENTS; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DRUG INDUSTRY; ITRACONAZOLE; MICROSPHERES; NANOFIBERS; POLYMERS; SOLUBILITY; SOLVENTS; TECHNOLOGY, PHARMACEUTICAL; X-RAY DIFFRACTION;

EID: 84921730384     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2015.01.025     Document Type: Article

References (44)

1. Amidon, G.L., Lennernäs, H., Shah, V.P., Crison, J.R., 1995. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12, 413-420.
2. Balogh, A., Drávavölgyi, G., Faragó, K., Farkas, A., Vigh, T., Sóti, P.L., Wagner, I., Madarász, J., Pataki, H., Marosi, G., Nagy, Z.K., 2014. Plasticized drug-loaded melt electrospun polymer mats: characterization, thermal degradation, and release kinetics. J. Pharm. Sci. 103, 1278-1287.
3. Bohr, A., Boetker, J.P., Rades, T., Rantanen, J., Yang, M., 2014. Application of spray-drying and electrospraying/electrospinning for poorly water-soluble drugs: a particle engineering approach. Curr. Pharm. Des. 20, 325-348.
4. Brewster, M.E., Verreck, G., Chun, I., Rosenblatt, J., Mensch, J., Van Dijck, A., Noppe, M., Arien, A., Bruining, M., Peeters, J., 2004. The use of polymer-based electrospun nanofibers containing amorphous drug dispersions for the delivery of poorly water-soluble pharmaceuticals. Pharmazie 59, 387-391.
5. Driscoll, T.P., Nakasone, R.H., Szczesny, S.E., Elliott, D.M., Mauck, R.L., 2013. Biaxial mechanics and inter-lamellar shearing of stem-cell seeded electrospun angle-ply laminates for annulus fibrosus tissue engineering. J. Orthop. Res. 31, 864-870.
6. Hu, X., Liu, S., Zhou, G., Huang, Y., Xie, Z., Jing, X., 2014. Electrospinning of polymeric nanofibers for drug delivery applications. J. Control. Release 185, 12-21.
7. Huang, C., Lucas, B., Vervaet, C., Braeckmans, K., Van Calenbergh, S., Karalic, I., Vandewoestyne, M., Deforce, D., Demeester, J., De Smedt, S.C., 2010. Unbreakable codes in electrospun fibers: digitally encoded polymers to stop medicine counterfeiting. Adv. Mater. 22, 2657-2662.
8. Huang, C., Soenen, S.J., Rejman, J., Trekker, J., Chengxun, L., Lagae, L., Ceelen, W., Wilhelm, C., Demeester, J., De Smedt, S.C., 2012a. Magnetic electrospun fibers for cancer therapy. Advan. Funct. Mater. 22, 2479-2486.
9. Huang, C., Soenen, S.J., Van Gulck, E., Vanham, G., Rejman, J., Van Calenbergh, S., Vervaet, C., Coenye, T., Verstraelen, H., Temmerman, M., 2012b. Electrospun cellulose acetate phthalate fibers for semen induced anti-HIV vaginal drug delivery. Biomaterials 33, 962-969.
10. Huang, C., Soenen, S.J., Gulck, E., Rejman, J., Vanham, G., Lacus, B., Geers, B., Braeckmans, K., Shahin, V., Spanoghe, P., 2014. Electrospun polystyrene fibers for HIV entrapment. Polym. Advan. Technol. 25, 827-834.
11. Ignatious, F., Sun, L., Lee, C.P., Baldoni, J., 2010. Electrospun nanofibers in oral drug delivery. Pharm. Res. 27, 576-588.
12. Keseru{combining double acute accent}, G.M., Makara, G.M., 2009. The influence of lead discovery strategies on the properties of drug candidates. Nat. Rev. Drug Discov. 8, 203-212.
13. Kostakova, E., Meszaros, L., Gregr, J., 2009. Composite nanofibers produced by modified needleless electrospinning. Mater. Lett. 63, 2419-2422.
14. Kostakova, E., Seps, M., Pokorny, P., Lukas, D., 2014. Study of polycaprolactone wet electrospinning process. Express Polym. Lett. 8, 554-564.
15. Li, J., Gao, F., Liu, L., Zhang, Z., 2013a. Needleless electro-spun nanofibers used for filtration of small particles. Express Polym. Lett. 7, 683-689.
16. Li, X., Kanjwal, M.A., Lin, L., Chronakis, I.S., 2013b. Electrospun polyvinyl-alcohol nanofibers as oral fast-dissolving delivery systems of caffeine and riboflavin. Colloids Surf. B 103, 182-188.
17. Lipinski, C.A., 2000. Drug-like properties and the causes of poor solubility and poor permeability. J. Pharmacol. Toxicol. 44, 235-249.
18. Lipinski, C.A., Lombardo, F., Dominy, B.W., Feeney, P.J., 1997. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv. Drug Deliv. Rev. 23, 3-25.
19. Lukas, D., Sarkar, A., Pokorny, P., 2008. Self-organization of jets in electrospinning from free liquid surface: a generalized approach. J. Appl. Phys. 103, 084309.
20. Lukas, D., Sarkar, A., Martinova, L., Vodsedalkova, K., Lubasova, D., Chaloupek, J., Pokorny, P., Mikes, P., Chvojka, J., Komarek, M., 2009. Physical principles of electrospinning (electrospinning as a nano-scale technology of the twenty-first century). Text. Prog. 41, 59-140.
21. Macri, L.K., Sheihet, L., Singer, A.J., Kohn, J., Clark, R.A., 2012. Ultrafast and fast bioerodible electrospun fiber mats for topical delivery of a hydrophilic peptide. J. Control. Release 161, 813-820.
22. Molnár, K., Nagy, Z.K., Mészáros, L., Marosi, G., 2012. Electrostatic spinneret and modified process for high-throughput production of nanofibers. P1200677.
23. Molnár, K., Kostakova, E., Mészáros, L., 2014. The effect of needleless electrospun nanofibrous interleaves on mechanical properties of carbon fabrics/epoxy laminates. Express Polym. Lett. 8, 62-72.
24. Nagy, Z.K., Nyúl, K., Wagner, I., Molnár, K., Marosi, G., 2010. Electrospun water soluble polymer mat for ultrafast release of Donepezil HCl. Express Polym. Lett. 4, 763-772.
25. Nagy, Z.K., Balogh, A., Vajna, B., Farkas, A., Patyi, G., Kramarics, Á., Marosi, G., 2012. Comparison of electrospun and extruded soluplus-based solid dosage forms of improved dissolution. J. Pharm. Sci. 101, 322-332.
26. Nagy, Z.K., Balogh, A., Drávavölgyi, G., Ferguson, J., Pataki, H., Vajna, B., Marosi, G., 2013. Solvent-free melt electrospinning for preparation of fast dissolving drug delivery system and comparison with solvent-based electrospun and melt extruded systems. J. Pharm. Sci. 102, 508-517.
27. Nagy, Z.K., Wagner, I., Suhajda, Á., Tobak, T., Harasztos, A., Vigh, T., Sóti, P., Pataki, H., Molnár, K., Marosi, G., 2014. Nanofibrous solid dosage form of living bacteria prepared by electrospinning. Express Polym. Lett. 8, 352-361.
28. Niu, H., Lin, T., 2012. Fiber generators in needleless electrospinning. J. Nanomater. doi:http://dx.doi.org/10.1155/2012/725950.
29. Pelipenko, J., Kocbek, P., Govedarica, B., Rošic, R., Baumgartner, S., Kristl, J., 2013. The topography of electrospun nanofibers and its impact on the growth and mobility of keratinocytes. Eur. J. Pharm. Biopharm. 84, 401-411.
30. Pouton, C.W., 2006. Formulation of poorly water-soluble drugs for oral administration: physicochemical and physiological issues and the lipid formulation classification system. Eur. J. Pharm. Sci. 29, 278-287.
31. Prentis, R., Lis, Y., Walker, S.,1988. Pharmaceutical innovation by the seven UK-owned pharmaceutical companies (1964-1985). Brit. J. Clin. Pharmacol. 25, 387-396.
32. Rosic, R., Kocbek, P., Pelipenko, J., Kristl, J., Baumgartner, S., 2013. Nanofibers and their biomedical use. Acta Pharm. 63, 295-304.
33. Sebe, I., Szabo, B., Nagy, Z.K., Szabo, D., Zsidai, L., Kocsis, B., Zelko, R., 2013. Polymer structure and antimicrobial activity of polyvinylpyrrolidone-based iodine nanofibers prepared with high-speed rotary spinning technique. Int. J. Pharm. 458, 99-103.
34. Six, K., Verreck, G., Peeters, J., Binnemans, K., Berghmans, H., Augustijns, P., Kinget, R., Van den Mooter, G., 2001. Investigation of thermal properties of glassy itraconazole: identification of a monotropic mesophase. Thermochim. Acta 376, 175-181.
35. Sóti, P.L., Telkes, L., Rapi, Z., Tóth, A., Vigh, T., Nagy, Z.K., Bakó, P., Marosi, G., 2014. Synthesis of an aza chiral crown ether grafted to nanofibrous silica support and application in asymmetric Michael addition. J. Inorg. Organomet. Polym. 24, 713-721.
36. Vardakou, M., Mercuri, A., Barker, S.A., Craig, D.Q., Faulks, R.M., Wickham, M.S., 2011. Achieving antral grinding forces in biorelevant in vitro models: comparing the USP dissolution apparatus II and the dynamic gastric model with human in vivo data. AAPS PharmSciTech 12, 620-626.
37. Verreck, G., Chun, I., Peeters, J., Rosenblatt, J., Brewster, M.E., 2003. Preparation and characterization of nanofibers containing amorphous drug dispersions generated by electrostatic spinning. Pharm. Res. 20, 810-817.
38. Vrbata, P., Berka, P., Stránská, D., Doležal, P., Musilová, M., Cižinská, L., 2013. Electrospun drug loaded membranes for sublingual administration of sumatriptan and naproxen. Int. J. Pharm. 457, 168-176.
39. Wagner, I., Pataki, H., Balogh, A., Nagy, Z.K., Harasztos, A., Suhajda, Á., Marosi, G., 2011. Electrospun nanofibers for topical drug delivery. Eur. J. Pharm. Sci. 44, 148-149.
40. Williams, G.R., Chatterton, N.P., Nazir, T., Yu, D.G., Zhu, L.M., Branford-White, C.J., 2012. Electrospun nanofibers in drug delivery: recent developments and perspectives. Ther. Deliv. 3, 515-533.
41. Yan, J., Wu, Y.H., Yu, D.G., Williams, G.R., Huang, S.M., Tao, W., Sun, J.Y., 2014. Electrospun acid-base pair solid dispersions of quercetin. RSC Adv. 4, 58265-58271.
42. Yu, D.G., Chian, W., Wang, X., Li, X.Y., Li, Y., Liao, Y.Z., 2013a. Linear drug release membrane prepared by a modified coaxial electrospinning process. J. Membrane Sci. 428, 150-156.
43. Yu, D.G., Hu, M.H., Zhou, W., Chen, B.Y., Wang, X., 2013b. Electrospun ketoprofen sustained release nanofibers prepared using coaxial electrospinning. Appl. Mech. Mater. 395, 138-143.
44. Yu, D.G., Liu, F., Cui, L., Liu, Z.P., Wang, X., Annie Bligh, S.W., 2013c. Coaxial electrospinning using a concentric Teflon spinneret to prepare biphasic-release nano fibers of helicid. RSC Adv. 3, 17775-17783.