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

AVE-1625（DRINABANT。DRINABANT）的剂型开发、生产和稳定性研究 IV 袋研究

• 批准号: 10953683
• 负责人: ROBERT GIANNINI
• 金额: $ 7.96万
• 依托单位: IRISYS, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-25 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10953683
• 关键词: DOSAGE; FORM; DEVELOPMENT; MANUFACTURE; STABILITY

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.

AVE-1625被评估为急性大麻素过量（ACO）的潜在治疗方法。 NCAT一直在支持AVE-1625注射药物的CMC公式开发。在进行更广泛的研究之后，他们到达以找到三个原型前浓缩公式的候选者，这可能会使最终公式的结论纳入临床研究。但是，以前的稀释研究并未表征溶液的性质，因为它似乎是乳液而不是纯溶液。在使用IV袋进行临床模拟研究之前，需要在玻璃小瓶中评估乳液型溶液的表征。稀释后产品的表征将通过视觉评估，测定，显微镜和粒度测量。由于这不是最初的同意，探索具有表征的更多稀释评估，因此有必要修改电流以执行这项额外的研究。