INJECTABLE MICROCAPSULE FOR ESTROGEN REPLACEMENT THERAPY

描述：（改编自申请人的摘要）： 该计划是开发一种90天可注射微胶囊形式， 雌二醇用于绝经后雌激素替代治疗 妇女在第一阶段，BIOTEK使用了新的喷雾核心微流化 床工艺制备载雌二醇的微囊，并证明 在兔子和大鼠中持续90天从这样的胶囊递送。 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;生产 将记录质量标准、过程和控制，IND 申请将提交给FDA;用于临床的微胶囊 将进行研究，并进行安全性和 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.