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Characterization of MB-102, a New Fluorescent Tracer Agent for Point-of-Care Renal Function Monitoring.

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MB-102 is a fluorescent tracer agent designed for measurement of point-of-care glomerular filtration rate (GFR), and is currently in clinical studies. MB-102 possesses a strong UV absorbance at 266 nm… Click to show full abstract

MB-102 is a fluorescent tracer agent designed for measurement of point-of-care glomerular filtration rate (GFR), and is currently in clinical studies. MB-102 possesses a strong UV absorbance at 266 nm and 435 nm, and broad fluorescent emission at ∼560 nm when excited at ∼440 nm. The MB-102 formulation is stable at 2 - 8 °C for > 3 years. The pKa's of the two acid groups are 2.71 and 3.40. Both x-ray crystallography and HPLC confirmed the D, D chirality of MB-102 in solid, in solution, and in the drug formulation. Initial safety and toxicity was published previously [Bugaj and Dorshow, 2015], which enabled the commencement of clinical studies. In vitro studies showed that 4.1% of MB-102 is bound to human plasma proteins, compared to 6.0% for the accepted standard GFR agent iohexol. The blood/plasma ratio for MB-102 was 0.590, illustrating minimal distribution of MB-102 into red blood cells. The GMP manufacture of MB-102 yields the designed molecular structure at high purity (>95% wt/wt).

Keywords: fluorescent tracer; agent; tracer agent; point care

Journal Title: Journal of pharmaceutical sciences
Year Published: 2019

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