Vaginal inserted estradiol pharmaceutical compositions and methods

摘要

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

主权项

1. A pessary comprising about 25 μg of 17β-estradiol in a solubilizing agent comprising a medium chain oil, wherein after a single administration of the pessary to a patient provides, in a plasma sample from the patient:
1) a corrected geometric mean peak plasma concentration (Cmax) of 17β-estradiol of about 19 pg*hr/ml to about 29 pg*hr/ml; and 2) a corrected geometric mean area under the curve (AUC)0-24 of 17β-estradiol of about 75 pg*hr/ml to about 112 pg*hr/ml, wherein 17β-estradiol is the only active hormone in the pessary.