A1 Refereed original research article in a scientific journal
Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles
Authors: Limnell T, Heikkila T, Santos HA, Sistonen S, Hellsten S, Laaksonen T, Peltonen L, Kumar N, Murzin DY, Louhi-Kultanen M, Salonen J, Hirvonen J, Lehto VP
Publisher: ELSEVIER SCIENCE BV
Publication year: 2011
Journal: International Journal of Pharmaceutics
Journal name in source: INTERNATIONAL JOURNAL OF PHARMACEUTICS
Journal acronym: INT J PHARMACEUT
Number in series: 1
Volume: 416
Issue: 1
First page : 242
Last page: 251
Number of pages: 10
ISSN: 0378-5173
DOI: https://doi.org/10.1016/j.ijpharm.2011.06.050
Abstract
Stability of high indomethacin (IMC) content formulations based on ordered mesoporous silica MCM-41 and SBA-15 materials was studied before and after a 3 month storage in stressed conditions (30 degrees C/56% RH). Overall, the physical stability of the samples was found satisfactory after the storage. However, some issues with the chemical stability were noted, especially with the MCM-41 based samples. The stability issues were evident from the decreased HPLC loading degrees of the drug after stressing as well as from the observed extra peaks in the HPLC chromatograms of the drug in the stressed samples. Drug release from the mesoporous formulations before stressing was rapid at pH 1.2 in comparison to bulk crystalline IMC. The release profiles also remained similar after stressing. Even faster and close to complete IMC release was achieved when the pH was raised from 1.2 to 6.8. To our knowledge, this is the first report of chemical stability issues of drugs in mesoporous silica drug formulations. The present results encourage further study of the factors affecting the chemical stability of drugs in mesoporous silica MCM-41 and SBA-15 formulations in order to realize their potential in oral drug delivery. (C) 2011 Elsevier B.V. All rights reserved.
Stability of high indomethacin (IMC) content formulations based on ordered mesoporous silica MCM-41 and SBA-15 materials was studied before and after a 3 month storage in stressed conditions (30 degrees C/56% RH). Overall, the physical stability of the samples was found satisfactory after the storage. However, some issues with the chemical stability were noted, especially with the MCM-41 based samples. The stability issues were evident from the decreased HPLC loading degrees of the drug after stressing as well as from the observed extra peaks in the HPLC chromatograms of the drug in the stressed samples. Drug release from the mesoporous formulations before stressing was rapid at pH 1.2 in comparison to bulk crystalline IMC. The release profiles also remained similar after stressing. Even faster and close to complete IMC release was achieved when the pH was raised from 1.2 to 6.8. To our knowledge, this is the first report of chemical stability issues of drugs in mesoporous silica drug formulations. The present results encourage further study of the factors affecting the chemical stability of drugs in mesoporous silica MCM-41 and SBA-15 formulations in order to realize their potential in oral drug delivery. (C) 2011 Elsevier B.V. All rights reserved.
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