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Title: | Aging behavior of pharmaceutical formulations of itraconazole on SBA-15 ordered mesoporous silica carrier material | Authors: | Mellaerts, Randy Houthoofd, Kristof ELEN, Ken Chen, Hong Van Speybroeck, Michiel Van Humbeeck, Jan Augustijns, Patrick MULLENS, Jules Van den Mooter, Guy Martens, Johan A. |
Issue Date: | 2010 | Publisher: | ELSEVIER SCIENCE BV | Source: | MICROPOROUS AND MESOPOROUS MATERIALS, 130(1-3). p. 154-161 | Abstract: | SBA-15 ordered mesoporous material is an excellent carrier material for the poorly soluble drug molecule itraconazole. Immediate itraconazole release is obtained upon contacting the formulation with simulated biological fluid. The stability of the formulation upon storage was investigated. Samples were stored for 3, 6 and 12 months at 4 and 25 degrees C and relative humidity of 0%, 52% and 97%. The original release behavior was maintained upon storage in dry conditions. Surprisingly, long-term storage at a relative humidity of 52% or 97% had a beneficial effect on the release. The surface chemical modification of the formulation upon storage in humid atmosphere was investigated using nitrogen adsorption, Si-29 MAS NMR, TGA-MS, XPS and DSC. Itraconazole phase analysis using DSC and analysis of the presence of itraconazole concentration gradients using XPS revealed that storage did not cause migration, aggregation nor crystallization of itraconazole. The surface of the pores of SBA-15 was found to undergo hydroxylation at high relative humidity. The enhanced hydrophilicity was responsible for the observed improvement of itraconazole release upon contact with water. These findings contribute to the understanding of drug delivery systems based on mesoporous silica carrier materials. (C) 2009 Elsevier Inc. All rights reserved. | Notes: | [Mellaerts, Randy; Houthoofd, Kristof; Martens, Johan A.] Katholieke Univ Leuven, Ctr Surface Chem & Catalysis, BE-3001 Heverlee, Belgium. [Van Humbeeck, Jan] Katholieke Univ Leuven, Dept Met & Mat Engn, BE-3001 Heverlee, Belgium. [Van Speybroeck, Michiel; Augustijns, Patrick; Van den Mooter, Guy] Katholieke Univ Leuven, Lab Pharmacotechnol & Biopharm, BE-3000 Louvain, Belgium. [Chen, Hong] Ctr Mat Advice & Anal VITO, BE-2400 Mol, Belgium. [Elen, Ken; Mullens, Jules] Hasselt Univ, Inst Mat Res Inorgan & Phys Chem, BE-3590 Diepenbeek, Belgium. johan.martens@biw.kuleuven.be | Keywords: | Ordered mesoporous silica; SBA-15; Drug delivery; Stability; Itraconazole | Document URI: | http://hdl.handle.net/1942/10818 | ISSN: | 1387-1811 | e-ISSN: | 1873-3093 | DOI: | 10.1016/j.micromeso.2009.10.026 | ISI #: | 000275702600021 | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2011 |
Appears in Collections: | Research publications |
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