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• W2002114527 abstract "Chromoendoscopy is a safe and effective method to improve detection of colonic polyps. Oral tablets containing methylene blue (MB) with MMX technology, which allows dye release at colonic level, have been developed to provide an easy and cheap method to dye the colonic surface before colonoscopic examination. Study design: open label, randomised study to evaluate in healthy volunteers the safety, tolerability and bioavailability of 200 mg MB MMX tablets, administered as single ascending oral dose in comparison to MB 1% vials administered as single iv dose of 100mg. Healthy subjects received either one of the 2 regimens in a randomized cross-over design in 2 consecutive study periods with a wash-out period of at least 7 days. Subjects receiving MMX tablets also received a full dose regimen of PEG solution. Blood and urine samples were analysed and bioavailability was calculated. In case of absolute bioavailability between >45% and < 60% an increasing oral dose of 400mg, 600 mg and 800 mg of oral tablets was administered. Primary variables were: AEs, vital sign (BP, HR), ECG, lab parameters including methaemoglobin. Secondary variables were: Tmax, Cmax, AUC0-30, t1/2, MRT, Fabs, Xu0-t and %Xu0-t. Ten healthy volunteers were enrolled and completed the study. No adverse events and no changes of all primary variables were recorded. The concentration vs. time curve obtained after the iv administration showed a biphasic shape, with a fast and short distribution phase and a slower and prolonged elimination phase. A mean C0 value of 2.66±1.35 μg/mL was back-extrapolated as the theoretical maximum concentration a t0. The curve obtained after MMX administration showed a monophasic shape with a substantial lag between the time of administration and the start of absorption. First concentration values higher than the Lower Quantification Limit (20 ng/mL) were achieved at 3-12 hours post-dose and peaked (Cmax) between 9-20 hours after the administration (median tmax= 16 h). The mean test formulation Cmax was 1.66±0.50 μg/mL. Measurement of a long tlag and the high values of tmax showed a prevalent colonic absorption model. A calculated mean value of Fabs of 1.39±0.52 was an indication that MB had both an high absorbability and a non-linear elimination pharmacokinetic. The mean total amount of excretion was 79.34±38.38 mg for the test formulation and 40.15±7.63 mg for the reference formulation. Both formulations excreted 40% of the dose.Oral MMX MB administration is safe and tolerated. Data on bioavailability and excretion show that colonic absorption of oral MB takes 5-20 hours thus confirming that persistent active staining of the colonic mucosa is obtained within the interval between starting the bowel prep and beginning of colonoscopic examination." @default.
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• W2002114527 date "2011-04-01" @default.
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• W2002114527 title "Mo1360 A New Tool for Pre-Colonoscopy Dying of the Colonic Mucosa With Oral Multi Matrix Release Technology (MMX®)-Released Methylene Blue: A Preliminary Study of Absorption, Bioavailability and Toxicity" @default.
• W2002114527 doi "https://doi.org/10.1016/j.gie.2011.03.658" @default.
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