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US 10,537,581 B2Granted
Vaginal inserted estradiol pharmaceutical compositions and methods
AssigneeTherapeuticsMD, Inc.
InventorsBrian A. Bernick, Thorsteinn Thorsteinsson, Peter H. R. Persicaner, Janice Louise Cacace, Frederick D. Sancilio, Neda Irani, Julia Amadio
Life of this patent
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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.
Claims11
A pessary consisting of:
- a) a liquid pharmaceutical composition comprising:
- about 1 μg to about 25 μg of estradiol;
- and
- a solubilizing agent comprising a medium chain oil;
- wherein the viscosity of the liquid pharmaceutical composition ranges from about 50 cP to about 1000 cP at 25 ° C., and
- wherein the liquid pharmaceutical composition does not include a hydrophilic gel-forming bioadhesive agent;
- and
- b) a soft gelatin capsule encapsulating the liquid pharmaceutical composition;
- wherein estradiol is the only active hormone in the pessary;
- and
- wherein the pessary is for intravaginal administration.
8 more elements
A pessary consisting of:
- a) a liquid pharmaceutical composition comprising:
- about 1 μg to about 25 μg of estradiol;
- a caprylic/capric triglyceride;
- and
- a non-ionic surfactant comprising PEG-6 stearate and ethylene glycol palmitostearate;
- wherein the viscosity of the liquid pharmaceutical composition ranges from about 50 cP to about 1000 cP at 25° C., and
- wherein the liquid pharmaceutical composition does not include a hydrophilic gel-forming bioadhesive agent;
- and
- b) a soft gelatin capsule encapsulating the liquid pharmaceutical composition, wherein estradiol is the only active hormone in the pessary;
- and wherein the pessary is for intravaginal administration.
7 more elements
A pessary consisting of:
- (a) a liquid pharmaceutical composition comprising:
- about 1 μg to about 25 μg of estradiol and
- a solubilizing agent comprising a medium chain oil,
- wherein the viscosity of the liquid pharmaceutical composition ranges from about 50 cP to about 1000 cP at 25 ° C., and
- wherein the liquid pharmaceutical composition does not include a hydrophilic gel-forming bioadhesive agent;
- and
- (b) a soft gelatin capsule encapsulating the liquid pharmaceutical composition;
- wherein estradiol is the only active hormone in the pessary;
- and
- wherein administration of the pessary to the proximal region of the vagina of a patient provides a therapeutically effective concentration of estradiol over 24 hours in the proximal region of the vagina.
7 more elements
Dependencies are inferred from the claim text.