Natural combination hormone replacement formulations and therapies
AssigneeTherapeuticsMD, Inc.
InventorsBrian A. Bernick, Peter H.R. Persicaner, Julia M. Amadio
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Abstract
Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.
Claims20
-36. (canceled)
A pharmaceutical composition for administering estradiol and progesterone to a human female subject having a vasomotor symptom associated with estrogen deficiency, the composition comprising:
- about 0.25 mg estradiol,
- progesterone, and
- a solubilizing agent, the solubilizing agent comprising a C6-C12 oil,
- wherein the estradiol and the progesterone are present in the solubilizing agent, and at least 80% of the estradiol is solubilized;
- and
- wherein administration of the composition to the subject produces, in a plasma sample from the subject, one or both parameters selected from:
- (i) an area under the curve (AUC)(0-t) for estradiol that is from 140.3733 pg·hr/ml to 219.3333 pg·hr/ml;
- and
- (ii) a Cmax for estradiol that is from 6.4790 pg/ml to 10.1235 pg/ml.
A pharmaceutical composition for administering estradiol and progesterone to a human female subject having a vasomotor symptom associated with estrogen deficiency, the composition comprising:
- about 0.5 mg estradiol,
- progesterone, and
- a solubilizing agent, the solubilizing agent comprising a C6-C12 oil,
- wherein the estradiol and the progesterone are present in the solubilizing agent, and at least 80% of the estradiol is solubilized;
- and
- wherein administration of the composition to the subject produces, in a plasma sample from the subject, one or both parameters selected from:
- (i) an area under the curve (AUC)(0-t) for estradiol that is from 280.7467 pg·hr/ml to 438.6667 pg·hr/ml;
- and
- (ii) a Cmax for estradiol that is from 12.9580 pg/ml to 20.2469 pg/ml.
A pharmaceutical composition for administering estradiol and progesterone to a human female subject having a vasomotor symptom associated with estrogen deficiency comprising:
- about 1.0 mg estradiol,
- progesterone, and
- a solubilizing agent, the solubilizing agent comprising a C6-C12 oil,
- wherein the estradiol and the progesterone are present in the solubilizing agent, and at least 80% of the estradiol is solubilized;
- and
- wherein administration of the composition to the subject produces, in a plasma sample from the subject, one or both parameters selected from:
- (i) an area under the curve (AUC)(0-t) for estradiol that is from 561.4933 pg·hr/ml to 877.3333 pg·hr/ml;
- and
- (ii) a Cmax for estradiol that is from 25.9161 pg/ml to 40.4939 pg/ml.
Dependencies are inferred from the claim text.