A One Year Estrogen/Progestin Implant

描述（由申请人提供）：该计划的目标是一年 用于绝经后激素替代的可生物降解雌激素/孕激素植入物 疗法将依普利加左炔诺孕酮纳入创新的 BIOTEK已经开发了植入物设计，用于输送纯 左炔诺孕酮作为维持避孕药。植入物由一个 无药物的、可生物降解的聚合物核被含药物的壳包围， 其提供有效的药物递送。这种植入物如果留在 在一年多的时间里，他们可以在手术前被移除。 如果有必要的话，年底。不需要跟踪每天的药片或每周 补丁，并没有什么理由担心一个不愉快的删除插曲，如 植入物应该提供一种受欢迎的新形式的持续激素替代品 疗法第一阶段证明了提供雌二醇的可行性， 从相同的植入物中以可接受的速率注射左炔诺孕酮。第二阶段将 改性核聚合物以加速降解，改进生产方法， 在体外表征有前途的设计，并在家兔中确认性能。 拟定商业应用： 拟议的工作应导致发展一种新的持久的，高度 有效、可生物降解的药物递送植入物。 一旦完全实施，类似的植入物 设计应该是有用的许多其他种类的药物维持治疗。

DESCRIPTION (provided by applicant): This program targets a one-year biodegradable estrogen/progestin implant for postmenopausal hormone replacement therapy. Estradiol plus levonorgestrel will be incorporated into an innovative implant design already being developed by BIOTEK for delivery of pure levonorgestrel as a maintenance contraceptive. The implant consists of a drug-free, biodegradable polymer core surrounded by a drug-containing shell, which provides efficient drug delivery. Such implants will biodegrade if left in place for more than a year, yet they can be surgically removed before the end of a year if necessary. With no need to keep track of daily pills or weekly patches, and with little reason to fear an unpleasant removal episode, such implants should provide a welcome new form of sustained hormone replacement therapy. Phase I demonstrated the feasibility of delivering estradiol and levonorgestrel at acceptable rates from the same implants. Phase II will now modify the core polymer to accelerate degradation, improve production methods, characterize promising designs in vitro, and confirm performance in rabbits. PROPOSED COMMERCIAL APPLICATION: The proposed work should lead to the development of a new kind of long lasting, highly effective, biodegradable drug delivery implant. Once fully impemented, implants of similar design should be useful for many other kinds of drug maintenance therapy.