ONE YEAR ESTROGEN/PROGESTIN IMPLANT

本项目旨在开发一种为期一年的可生物降解的雌激素/黄体酮植入物，用于绝经后激素替代治疗。该项目将使用一种经过验证的激素组合，雌二醇和左炔诺孕酮。研究表明，雌激素治疗的副作用可以通过使用黄体酮和雌激素来降低。这两种激素将被整合到BIOTEK正在开发的一种创新植入设计中，以提供纯左炔诺孕酮作为维持性避孕药。新的植入物是由非常高分子量的聚l -丙交酯热成型的，使用了一种在制造过程中最小化降解的方法。植入物有一个装载激素的外壳，用于有效的药物输送，以及一个纯聚合物核心，用于提高机械强度。如果植入物放置一年以上，它将被生物降解，但在较早的时候，由于医疗原因，它可以通过手术切除。由于不需要跟踪每天的剂量，也没有理由预料到不愉快的移除事件，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，几乎毫不费力地符合稳定的激素水平。拟议的商业应用：拟议的工作包括将药物结合到坚固，易于施用的植入物的外部部分，该植入物在体内停留一年以上即可生物降解。同样的技术也适用于其他长期使用的激素和维持药物的输送。

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.