Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles

Tarja Limnell, Teemu Heikkilä, Hélder A. Santos, Sanna Sistonen, Sanna Hellstén, Timo Laaksonen, Leena Peltonen, Narendra Kumar, Dmitry Yu. Murzin, Marjatta Louhi-Kultanen, Jarno Salonen, Jouni Hirvonen, Vesa-Pekka Lehto

    Research output: Contribution to journalArticleScientificpeer-review

    46 Citations (Scopus)

    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 °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.
    Original languageEnglish
    Pages (from-to)242-251
    Number of pages10
    JournalInternational Journal of Pharmaceutics
    Volume416
    Issue number1
    DOIs
    Publication statusPublished - 2011
    Publication typeA1 Journal article-refereed

    Keywords

    • Mesoporous silica
    • Indomethacin
    • Physical
    • Chemical
    • Stability
    • Drug release
    • STATE NMR CHARACTERIZATION
    • DRUG-DELIVERY SYSTEM
    • POORLY SOLUBLE DRUGS
    • AMORPHOUS STATE
    • PORE-SIZE
    • RELEASE
    • IBUPROFEN
    • CRYSTALLIZATION
    • SPECTROSCOPY
    • MECHANISM

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