TRANSDERMAL LEVONORGESTREL FOR EMERGENCY CONTRACEPTION
TRANSDERMAL LEVONORGESTREL FOR EMERGENCY CONTRACEPTION
批准号:
6015346
负责人:
LARRY D NICHOLS
金额:
$10.0万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-09-28 至 2001-03-27
中文摘要
该计划将试图开发一种透皮系统,能够在24小时内提供足够的左炔诺孕酮,以提供紧急性交后避孕,与目前批准的口服方法一样有效,但更方便,副作用更少。 I期可行性研究将寻求确认和改善BIOTEK在过去避孕和抗骨质疏松贴剂研究中观察到的左炔诺孕酮通量。 这样的通量将允许贴剂递送更多的左炔诺孕酮。建议的商业应用口服药物,现在可用于紧急预防意外怀孕引起非常不愉快的副作用,其中透皮给药是不太可能引起的。 这种产品的开发涉及证明和实现左炔诺孕酮(一种高度不溶性类固醇)的非常高的透皮通量。 这将为激素替代疗法、避孕、预防骨质疏松和治疗内分泌失调等领域的其他新产品打开大门。
英文摘要
This program will attempt to develop a transdermal system capable of delivering enough levonorgestrel in 24 hours to provide emergency postcoital contraception as effective as currently approved oral methods, but with greater convenience and fewer side effects. The Phase I feasibility study will seek to confirm and improve on levonorgestrel fluxes of observed by BIOTEK during past work on contraceptive and anti- osteoporosis patches. Such fluxes would allow a patch to deliver more levonorgestrel. PROPOSED COMMERCIAL APPLICATION Oral medications now available for the emergency prevention of unwanted pregnancies cause very unpleasant side effects, which transdermal delivery is less likely to provoke. The development of such a product involves demonstrating and implementing a very high transdermal flux for levonorgestrel, a highly insoluble steroid. This should open the door to other new products in such areas as hormone replacement therapy, contraception, prevention of osteoporosis, and treatment of endocrine disorders.
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