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Anja Vetter, Alastair Lockwood, Hala Fadda, Simon Gaisford, Peng T. Khaw, Stephen Brocchini; The Effect Of Gamma Irradiation On The Physicochemical Properties Of A Matrix Metalloproteinase Inhibitor Ilomastat: A Multi-supplier Consistency Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3232.
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Ilomastat is a matrix metalloproteinase inhibitor (MMPi) that has been shown to improve surgical outcome significantly by reducing scar tissue after experimental glaucoma filtration surgery. Further improvements in outcome have been achieved by producing a slow release ilomastat tablet to be placed at the site of surgery. Sterilisation of the tablet is currently best carried out using gamma irradation. This comparative study evaluated the effect of 25 kGy gamma irradiation on ilomastat from different suppliers.
Ilomastat tablets (2 mm, 1.5 mg) from each supplier were produced, placed in a vial and then subjected to gamma irradiation (25 kGy). Unprocessed ilomastat powder was also sterilised in the same way. The tablets were analysed before and after sterilisation by scanning electron microscopy (SEM), X-ray diffraction, mass spectrometry (MS), nuclear magnetic resonance spectroscopy (NMR), high performance liquid chromatography (HPLC) and differential scanning calorimetry (DSC).
SEM images of irradiated and non-irradiated powder and tablet samples showed no significant changes in surface topography. A crystalline structure was confirmed by polarised light microscopy. Likewise, no changes were observed in the proton NMR spectra. HPLC data showed a 2% decrease in the ilomastat concentration in the area under the curve after irradiation. During the study, one supplier provided ilomastat that displayed a decreased melting point by DSC, different NMR spectra and X-ray diffraction patterns.
This study demonstrated that physicochemical properties of ilomastat in powder and tablet forms were not significantly affected by the exposure to gamma irradiation at a standard dose of 25 kGy. Some inter-supplier differences in the physicochemical properties of ilomastat were observed. Since such difference could influence in vivo behavior it is imperative that quality control follows well defined specifications.
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