CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège CESAM - Complex and Entangled Systems from Atoms to Materials - ULiège Center for Education and Research on Macromolecules (CERM)
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Thiry, Justine ; Université de Liège > Département de pharmacie > Pharmacie galénique
Krier, Fabrice
Ratwatte, Shenelka
Thomassin, Jean-Michel ; University of Liège - ULiège > Complex and Entangled Systems from Atoms to Materials (CESAM), Center for Education and Research on Macromolecules (CERM)
Jérôme, Christine ; University of Liège - ULiège > Complex and Entangled Systems from Atoms to Materials (CESAM), Center for Education and Research on Macromolecules (CERM)
Evrard, Brigitte ; Université de Liège > Département de pharmacie > Pharmacie galénique
Language :
English
Title :
Hot-Melt Extrusion as a Continuous Manufacturing Process to Form Ternary Cyclodextrin Inclusion Complexes
Amidon, G.L., Lennernas, H., Shah, V.P., Crison, J.R., A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12 (1995), 413–420.
Barillaro, V., Bertholet, P., Henry de Hassonville, S., Ziemon, E., Evrard, B., Delattre, L., Piel, G., Effect of acidic ternary compounds on the formation of miconazole/cyclodextrin inclusion complexes by means of supercritical carbon dioxide. J. Pharm. Sci. 7 (2004), 378–388.
Bruce, L.D., Shah, N.H., Waseem Malick, A., Infeld, M.H., McGinity, J.W., Properties of hot-melt extruded tablet formulations for the colonic delivery of 5-aminosalicylic acid. Eur. J. Pharm. Biopharm. 59 (2005), 85–97.
Das, S.K., Roy, S., Kalimuthu, Y., Khanam, J., Nanda, A., Solid dispersions: an approach to enhance the bioavailability of poorly water-soluble drugs. International Journal of Pharmacology and Pharmaceutical Technology 1 (2012), 37–46.
Del Valle, E.M.M., Cyclodextrins and their uses: a review. Process Biochem. 39 (2004), 1033–1046.
Fukuda, M., Miller, D.A., Peppas, N.A., McGinity, J.W., Influence of sulfobutyl ether β-cyclodextrin (Captisol®) on the dissolution properties of a poorly soluble drug from extrudates prepared by hot-melt extrusion. Int. J. Pharm. 350 (2008), 188–196.
Hardung, H., Djuric, D., Ali, S., Combining HME & solubilization: Soluplus® - the solid solution. Drug Delivery Technology 10 (2010), 20–27.
Hassan, H.A., Al-Marzouqi, A.H., Jobe, B., Hamza, A.A., Ramadan, G.A., Enhancement of dissolution amount and in vivo bioavailability of itraconazole by complexation with beta-cyclodextrin using supercritical carbon dioxide. J. Pharm. Biomed. Anal. 45 (2007), 243–250.
Hens, B., Brouwers, J., Corsetti, M., Augustijns, P., Supersaturation and precipitation of posaconazole upon entry in the upper small intestine in humans. J. Pharm. Sci. 105 (2016), 2677–2684.
Leuner, C., Dressman, J., Improving drug solubility for oral delivery using solid dispersions. Eur. J. Pharm. Biopharm. 50 (2000), 47–60.
Linn, M., Collnot, E.M., Djuric, D., Hempel, K., Fabian, E., Kolter, K., Lehr, C.M., Soluplus® as an effective absorption enhancer of poorly soluble drugs in vitro and in vivo. Eur. J. Pharm. Sci. 45 (2012), 336–343.
Loftsson, T., Cyclodextrin Complexation. 1995.
Loftsson, T., Brewster, M.E., Pharmaceutical applications of cyclodextrins: basic science and product development. J. Pharm. Pharmacol. 62 (2010), 1607–1621.
Loftsson, T., Brewster, M.E., Cyclodextrins as functional excipients: methods to enhance complexation efficiency. J. Pharm. Sci. 101 (2012), 3019–3032.
Medarevic, D., Kachrimanis, K., Djuric, Z., Ibric, S., Influence of hydrophilic polymers on the complexation of carbamazepine with hydroxypropyl-beta-cyclodextrin. Eur. J. Pharm. Sci. 78 (2015), 273–285.
Miletic, T., Kyriakos, K., Graovac, A., Ibric, S., Spray-dried voriconazole-cyclodextrin complexes: solubility, dissolution rate and chemical stability. Carbohydr. Polym. 98 (2013), 122–131.
Mura, P., Analytical techniques for characterization of cyclodextrin complexes in the solid state: a review. J. Pharm. Biomed. Anal. 113 (2015), 226–238.
Olesen, N.E., Westh, P., Holm, R., Displacement of drugs from cyclodextrin complexes by bile salts: a suggestion of an intestinal drug-solubilizing capacity from an in vitro model. J. Pharm. Sci. 105 (2016), 2640–2647.
Rambali, B., Verreck, G., Baert, L., Massart, D.L., Itraconazole formulation studies of the melt-extrusion process with mixture design. Drug Dev. Ind. Pharm. 29 (2003), 641–652.
Stappaerts, J., Augustijns, P., Displacement of itraconazole from cyclodextrin complexes in biorelevant media: in vitro evaluation of supersaturation and precipitation behavior. Int. J. Pharm., 2016 (In press).
Taupitz, T., Dressman, J.B., Buchanan, C.M., Klein, S., Cyclodextrin-water soluble polymer ternary complexes enhance the solubility and dissolution behaviour of poorly soluble drugs. Case example: Itraconazole. Eur. J. Pharm. Biopharm. 83 (2013), 378–387.
Taupitz, T., Dressman, J.B., Klein, S., New formulation approaches to improve solubility and drug release from fixed dose combinations: case examples pioglitazone/glimepiride and ezetimibe/simvastatin. Eur. J. Pharm. Biopharm. 84 (2013), 208–218.
Thiry, J., Krier, F., Evrard, B., A review of pharmaceutical extrusion: critical process parameters and scaling-up. Int. J. Pharm. 479 (2015), 227–240.
Thiry, J., Broze, G., Pestieau, A., Tatton, A.S., Baumans, F., Damblon, C., Krier, F., Evrard, B., Investigation of a suitable in vitro dissolution test for itraconazole-based solid dispersions. Eur. J. Pharm. Sci. 85 (2016), 94–105.
Thiry, J., Lebrun, P., Vinassa, C., Adam, M., Netchacovitch, L., Ziemon, E., Hubert, P., Krier, F., Evrard, B., Continuous production of itraconazole-based solid dispersions by hot melt extrusion: preformulation, optimization and design space determination. International Journal of Pharmaceutics in Reviewing, 2016.
Tiwari, G., Tiwari, R., Rai, A.K., Cyclodextrins in delivery systems: applications. J. Pharm. Bioallied Sci. 2 (2010), 72–79.
US Department of Health and Human Services, F., Center for Drug Evaluation and Research, Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. 1997.
Yano, H., Kleinebudde, P., Improvement of dissolution behavior for poorly water-soluble drug by application of cyclodextrin in extrusion process: comparison between melt extrusion and wet extrusion. AAPS PharmSciTech 11 (2010), 885–893.
