A One Year Estrogen/Progestin Implant

描述(由申请者提供)：该项目的目标是一年制 可生物降解雌激素/孕激素植入物用于绝经后激素替代 心理治疗。雌二醇加左旋诺孕酮将被纳入一种创新的 Biotek已经在开发植入物设计，用于输送纯 左旋诺孕酮作为维持性避孕药。植入物由一个 无药物，可生物降解的聚合物核心，由含药物外壳包围， 它提供了高效的药物输送。这样的植入物如果留下来会生物降解 已经放了一年多了，但在手术之前可以通过手术移除 如有必要，可在一年内结束。不需要记录每天或每周的药片 补丁，几乎没有理由害怕不愉快的搬家事件，比如 植入物应该提供一种受欢迎的新形式的持续激素替代 心理治疗。第一阶段论证了雌二醇类药物和 左旋诺孕酮在相同的植入物中以可接受的速度进行。第二阶段现在 对岩心聚合物进行改性以加速降解，改进生产方法， 在体外鉴定有前景的设计，并确认在兔子身上的表现。 建议的商业应用： 拟议的工作应导致开发一种新型的持久、高度 有效的、可生物降解的药物输送植入物。一旦完全植入，类似的植入物 设计应该对许多其他类型的药物维持疗法有用。

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.