DOSAGE FORM DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES OF AVE-1625 (DRINABANT. DRINABANT) IV BAG STUDY

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AVE-1625 is being evaluated as a potential treatment for acute cannabinoid overdose (ACO). The NCATS has been supporting the CMC formulation development of AVE-1625 injectable drug product. After the broader studies have been done, they reached to find three candidates of prototype pre-concentrate formulation which may give the conclusion of the final formulation into the clinical study. However, Previous dilution studies didn’t have characterized the nature of the solution as it appears to be an emulsion rather than pure solution. The characterization of the emulsion-type solution needs to be evaluated in the glass vial with higher clarity before pursuing clinical simulation study by using IV bags. Characterization of product post dilution will be done with visual assessment, assay, microscopy and particle size measurement. As this is not in the initial agreement to explore more dilution evaluation with characterization, it is necessary to modify the current to perform this additional study.