US2023062295A1PendingUtilityA1
Vaginal inserted estradiol pharmaceutical compositions and methods
Est. expiryDec 21, 2032(~6.4 yrs left)· nominal 20-yr term from priority
Inventors:Brian A. BernickThorsteinn ThorsteinssonPeter H. R. PersicanerJanice Louise CacaceFrederick D. SancilioNeda IraniJulia M. Amadio
A61K 9/4858A61K 9/06A61K 31/57A61K 47/14A61K 9/0036A61K 31/565A61K 9/4866
82
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Claims
Abstract
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.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . A vaginal suppository comprising a liquid composition, the liquid composition comprising:
a) about 4 μg of estradiol; b) about 90 wt %′ of a mixture of caprylic and capric triglycerides; and c) about 10 wt % of a mixture of PEG-6 stearate, ethylene glycol palmitostearate, and PEG-32 stearate.
2 . The vaginal suppository of claim 1 , wherein estradiol is the only active hormone in the vaginal suppository.
3 . The vaginal suppository of claim 1 , wherein the estradiol is solubilized.
4 . The vaginal suppository of claim 1 , wherein the liquid composition has a viscosity between about 50 cps to about 1000 cps at 25° C.
5 . The vaginal suppository of claim 4 , wherein the viscosity of the liquid composition is about 90 cps at 25° C.
6 . The vaginal suppository of claim 1 further comprising a gelatin capsule delivery vehicle encapsulating the liquid composition.
7 . A vaginal suppository comprising a liquid composition, the liquid composition comprising:
a) about 10 μg of estradiol; b) about 90 wt % caprylic and capric triglycerides; and c) about 10 wt % of a mixture of PEG-6 stearate, ethylene glycol palmitostearate, and PEG-32 stearate.
8 . The vaginal suppository of claim 7 , wherein estradiol is the only active hormone in the vaginal suppository.
9 . The vaginal suppository of claim 7 , wherein the estradiol is solubilized.
10 . The vaginal suppository of claim 7 , wherein the liquid composition has a viscosity between about 50 cps to about 10(0) cps at 25° C.
11 . The vaginal suppository of claim 7 , wherein the viscosity of the liquid composition is about 90 eps at 25° C.
12 . The vaginal suppository of claim 7 further comprising a gelatin capsule delivery vehicle encapsulating the liquid composition.
13 . A vaginal suppository comprising a liquid composition, the liquid composition comprising:
a) about 4 μg or 10 μg of estradiol or estradiol hemihydrate; b) about 270 mg of a mixture of caprylic and capric triglycerides; and c) about 30 mg of a mixture of PEG-6 stearate, ethylene glycol palmitostearate, and PEG-32 stearate.
14 . The vaginal suppository of claim 13 , wherein estradiol or estradiol hemihydrate is the only active hormone in the vaginal suppository.
15 . The vaginal suppository of claim 13 , wherein the estradiol or estradiol hemihydrate is solubilized.
16 . The vaginal suppository of claim 13 , wherein the liquid composition has a viscosity between about 50 cps to about 1000 cps at 25° C.
17 . The vaginal suppository of claim 13 , wherein the viscosity of the liquid composition is about 90 cps at 25° C.
18 . The vaginal suppository of claim 13 further comprising a gelatin capsule delivery vehicle encapsulating the liquid composition.Join the waitlist — get patent alerts
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