AI Article Synopsis
- The study examined the stability of high indomethacin (IMC) content formulations using ordered mesoporous silica materials MCM-41 and SBA-15 after three months of storage in stressed conditions (30°C/56% RH).
- Overall, while the physical stability was deemed satisfactory, MCM-41 samples exhibited notable chemical stability issues, indicated by reduced drug loading and unexpected peaks in HPLC chromatograms.
- Drug release was initially rapid at pH 1.2 for the mesoporous formulations, maintaining similar profiles post-stress, with even quicker release observed at a higher pH of 6.8, highlighting the need for further investigation into chemical stability factors in these formulations for effective oral drug delivery.
Article 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.
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| http://dx.doi.org/10.1016/j.ijpharm.2011.06.050 | DOI Listing |
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