GELS NASAUX DE TESTOSTERONE A LIBERATION PROLONGEE, METHODES ASSOCIEES ET SYSTEMES APPLICATEURS MULTI-DOSES PRE-REMPLIS DESTINES A UNE ADMINISTRATION PERNASALE
KREPPNER, WAYNE,FOGARTY, SIOBHAN,OBEREGGER, WERNER,MAES, PAUL JOSE PIERRE MARIE
申请号：
CA3034552
公开号：
CA3034552A1
申请日:
2012.05.15
申请国别(地区):
CA
年份:
2012
代理人:
摘要：
The present invention relates to intranasal testosterone gels for thecontrolled release of testosteroneinto the systemic circulation of males and females for providing constanteffective testosterone bloodlevels, without inducing undesired testosterone spike in blood levels,following pernasal administration.The intranasal testosterone gels of the present invention are safe, convenientto use, well tolerated, stableand easily and reproducibly manufactured on scale up. Moreover, because supra-normal and sub-normaltestosterone blood levels are believed to be essentially kept to a minimum oravoided and thetestosterone serum levels are believed to remain essentially constant duringdose life, i.e., the intranasaltestosterone gels of the present invention mimic or restore testosterone bloodlevels to normalphysiologic daily rhythmic testosterone levels, the novel intranasaltestosterone gels of the presentinvention are uniquely suited for testosterone replacement or supplementaltherapy and effective fortreating males diagnosed with, for example, male testosterone deficiency, suchas, low sexual libido, lowsexual drive, low sexual activity, low fertility, low spermatogenesis,aspermatogenesis, depression and/orhypogonadism, and females who are diagnosed with, for example, female sexualdysfunction, such as,low sexual libido, low sexual drive, low sexual activity, low amygdalareactivity, low sexual stimulation,hypoactive sexual desire disease ("HSDD"), female sexual arousal disorderand/or anorgasmia. Thepresent invention also relates to methods and pre- filled multi-dose airlessapplicator systems for pernasaladministration of the nasal testosterone gels of the present invention.
