KREPPNER WAYNE,크레프너, 웨인,FOGARTY SIOBHAN,포가티, 시오반,OBEREGGER WERNER,오브레거, 워너,MAES PAUL JOSE PIERRE MARIE,메스, 파울, 조제, 피에르, 마리
申请号：
KR1020137033180
公开号：
KR1020140033408A
申请日:
2012.05.15
申请国别(地区):
KR
年份:
2014
代理人:
摘要：
The present invention relates to intranasal testosterone gels for the controlled release of testosterone into the systemic circulation of males and females for providing constant effective testosterone blood levels, without inducing undesired testosterone spike in blood levels, following pernasal administration. The intranasal testosterone gels of the present invention are safe, convenient to use, well tolerated, stable and easily and reproducibly manufactured on scale up. Moreover, because supra- normal and sub-normal testosterone blood levels are believed to be essentially kept to a minimum or avoided and the testosterone serum levels are believed to remain essentially constant during dose life, i.e., the intranasal testosterone gels of the present invention mimic or restore testosterone blood levels to normal physiologic daily rhythmic testosterone levels, the novel intranasal testosterone gels of the present invention are uniquely suited for testosterone replacement or supplemental therapy and effective for treating males diagnosed with, for example, male testosterone deficiency, such as, low sexual libido, low sexual drive, low sexual activity, low fertility, low spermatogenesis, aspermatogenesis, depression and/or hypogonadism, and females who are diagnosed with, for example, female sexual dysfunction, such as, low sexual libido, low sexual drive, low sexual activity, low amygdala reactivity, low sexual stimulation, hypoactive sexual desire disease ("HSDD"), female sexual arousal disorder and/or anorgasmia. The present invention also relates to methods and pre- filled multi-dose airless applicator systems for pernasal administration of the nasal testosterone gels of the present invention.본 발명은 경비성 투여 후, 혈중 농도에 있어서 원치않는 테스토스테론 스파이크를 유도하지 않으면서, 일정한 유효 테스토스테론 혈중 농도를 제공하기 위해, 남성 및 여성의 체순환에 테스토스테론을 조절방출하기 위한 비내용 테스토스테론 겔에 관한 것으로서, 본 발명의 비내용 테스토스테론 겔은 안전하고, 사용하기에 편리하며, 잘 관용되며, 안정하고, 규모를 증대하여 쉽고 재생가능하게 제조되며, 게다가, 정상-이상 및 정상-이하의 테스토스테론 혈중 농도가 반드시 최소로 유지되거나 피해지는 것으로 믿어
