ONE YEAR ESTROGEN/PROGESTIN IMPLANT

该计划旨在开发一种为期一年的可生物降解的雌激素/孕激素植入物，用于绝经后激素替代治疗。该计划将利用一种已得到证实的激素组合--雌二醇和左旋诺孕酮。已有研究表明，雌激素治疗的副作用可以通过服用孕激素和雌激素来降低。这两种激素将被纳入Biotek已经在开发的一种创新的植入物设计中，以提供纯左旋诺孕酮作为维持避孕药。这种新的植入物是由超高相对分子质量的聚L丙交酯热成形的，使用了一种在制造过程中将降解降至最低的方法。这种植入物有一个荷尔蒙含量高的外壳，可以有效地输送药物，还有一个纯聚合物核心，可以提高机械强度。如果放置一年以上，植入物将被生物降解，但在更早的时候，由于医疗原因，它可以通过手术移除。由于不需要记录每天的剂量，也没有什么理由预计会出现令人不快的摘除事件，女性和医生都应该欢迎这种植入物，因为它是一种方便的新形式的雌激素替代疗法，结合了几乎毫不费力的依从性和稳定的激素水平。拟议的商业应用：拟议的工作涉及将一种药物整合到一种坚固、易于管理的植入物的外部，当放置在体内一年以上时，该植入物会生物降解。同样的技术也可以用于其他长期给药的激素和维持性药物的输送。

This program seeks to develop a one year biodegradable estrogen/progestin implant for postmenopausal hormone replacement therapy. The program will utilize a proven hormone combination, estradiol and levonorgestrel. It has been shown that side effects of estrogen therapy can be lowered by administering a progestin with the estrogen. Both hormones will be incorporated into an innovative implant design already under development by BIOTEK to deliver pure levonorgestrel as a maintenance contraceptive. The new implant is thermoformed from very high molecular weight poly-L-lactide, using a method which minimizes degradation during manufacture. The implant has a hormone-loaded outer shell for efficient drug delivery and a pure polymer core for mechanical strength. The implant will biodegrade if left in place for more than one year, but it can be surgically removed for medical reasons at earlier times. With no need to keep track of daily dosing, and little reason to anticipate an unpleasant removal episode, both women and doctors should welcome such implants as a convenient new form of estrogen replacement therapy combining almost effortless compliance with stable hormone levels. PROPOSED COMMERCIAL APPLICATIONS: The proposed work involves incorporating a drug into the outer portion of a strong, easily administered implant which biodegrades when left in the body for more than a year. The same technique could be useful for delivery of other chronically administered hormones and maintenance medications.