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US 2014/0213565 A1Published application
Soluble estradiol capsule for vaginal insertion
AssigneeTherapeuticsMD, Inc.
InventorsBrian A. Bernick, Julia M. Amadio, Peter H.R. Persicaner, Thorsteinn Thorsteinsson, Janice Louise Cacace
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Abstract
According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.
Claims20
-50. (canceled)
A vaginal suppository comprising:
- a) a therapeutically effective amount of estradiol;
- and
- b) a solubilizing agent, wherein the solubilizing agent comprises at least one C6-C12 fatty acid or a glycol, monoglyceride, diglyceride, or triglyceride ester thereof.
A vaginal suppository comprising:
- a) a therapeutically effective amount of estradiol;
- b) a caprylic / capric triglyceride;
- c) a non-ionic surfactant comprising PEG-6 palmitostearate and ethylene glycol palmitostearate;
- and
- d) a soft gelatin capsule.
2 more elements
A method of treating an estrogen-deficient state, the method comprising administering to a female in need thereof, a vaginal suppository comprising:
- a) a therapeutically effective amount of solubilized estradiol;
- and
- b) a solubilizing agent, wherein the solubilizing agent comprises at least one C6-C12 fatty acid or a glycol, monoglyceride, diglyceride, or triglyceride ester thereof.
Dependencies are inferred from the claim text.