Vaginal inserted estradiol pharmaceutical compositions and methods
Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).
1. A method for treating vaginal dryness, the method comprising administering to a female subject in need thereof, a vaginal suppository comprising: (a) a liquid composition comprising: a therapeutically effective amount of estradiol; a caprylic/capric triglyceride; a non-ionic surfactant comprising PEG-6 stearate or ethylene glycol palmitostearate; and (b) a soft gelatin capsule; wherein the vaginal suppository includes from about 1 microgram to about 25 micrograms of estradiol; and wherein estradiol is the only active hormone in the vaginal suppository.
2. The method of claim 1 , wherein the vaginal suppository does not include a hydrophilic gel-forming bioadhesive agent in the liquid composition.
3. The method of claim 1 , wherein the suppository is administered to the subject daily for two weeks, and twice weekly thereafter.
4. The method of claim 1 , wherein the suppository includes about 10 ug of estradiol.
5. The method of claim 1 , wherein the suppository includes about 25 ug of estradiol.
6. A method for treating dyspareunia, the method comprising administering to a female subject in need thereof, a vaginal suppository comprising: (a) a liquid composition comprising: a therapeutically effective amount of estradiol; a caprylic/capric triglyceride; a non-ionic surfactant comprising PEG-6 stearate or ethylene glycol palmitostearate; and (b) a soft gelatin capsule; wherein the vaginal suppository includes from about 1 microgram to about 25 micrograms of estradiol; and wherein estradiol is the only active hormone in the vaginal suppository.
7. The method of claim 6 , wherein the vaginal suppository does not include a hydrophilic gel-forming bioadhesive agent in the liquid composition.
8. The method of claim 6 , wherein the suppository is administered to the subject daily for two weeks, and twice weekly thereafter.
9. The method of claim 6 , wherein the suppository includes about 10 ug of estradiol.
10. The method of claim 6 , wherein the suppository includes about 25 ug of estradiol.