DEVELOPMENT OF A NALTREXONE MICROCAPSULE INJECTION

描述：(改编自申请人的摘要)。Biotek，Inc. 建议开发一种临床有用的缓释纳曲酮 用于减少最近戒除的人的再成瘾的微胶囊 施虐者。纳曲酮是一种阿片类拮抗剂，从生理上讲 阻挡了麻醉剂强化机制。微胶囊是 目标是包含50%以上的药物，并提供大约 每日5毫克，连服1个月。申请人之前已经制定了一项 产生阿片类拮抗作用的注射用纳曲酮微囊 猴子30天或更长时间。PI计划复制(并改进和 必要时优化)原型配方，进行必要的 需要提交IND的研究。

DESCRIPTION: (Adapted from the Applicant's Abstract). BIOTEK, INC proposes to develop a clinically useful sustained release naltrexone microcapsules for reducing re-addiction among recently withdrawn abusers. Naltrexone is an opiate antagonist which physiologically blocks the narcotic reinforcement mechanism. The microcapsules are targeted to contain more than 50 percent drug and deliver approximately 5 mg/day for 1 month. The applicant has previously developed an injectable naltrexone microcapsules which produced opioid antagonism for 30 days or more in monkeys. The PI plans to reproduce (and improve and optimize, if necessary) the prototype formulation, conduct the necessary studies needed to submit an IND.