INJECTABLE MICROCAPSULE FOR ESTROGEN REPLACEMENT THERAPY

描述：(改编自申请者摘要)：目标 该计划是开发一种90天可注射的微囊形式的 雌激素将用于绝经后的雌激素替代治疗 女人。在第一阶段，Biotek使用了新的喷芯微流态化 床层法制备雌二醇微胶囊及其应用 这种胶囊在兔和大鼠体内的持续释放时间为90天。 在第二阶段，将完成微胶囊的开发；所有 将进行FDA要求的临床前研究；制造 规范、流程和控制将被文件化，IND 将向FDA提交申请；临床用微胶囊 将进行研究，并进行安全性和临床研究 将进行药代动力学研究。

DESCRIPTION: (Adapted from the Applicant's Abstract): The objective of the program is to develop a 90-day injectable microcapsule form of estradiol to be used for estrogen replacement therapy in postmenopausal women. During Phase I, BIOTEK used the new spray-core microfluidized bed process to prepare estradiol loaded microcapsules and demonstrated sustained 90-day delivery from such capsules in rabbits and in rats. During Phase II, microcapsule development will be completed; all preclinical studies required by the FDA will be conducted; manufacturing specifications, processes and controls will be documented, IND application will be filed with the FDA; microcapsules for clinical studies will be manufactured and a clinical study of safety and pharmacokinetics will be conducted.