Natural combination hormone replacement formulations and therapies
AssigneeTherapeuticsMD, Inc.
InventorsBrian A. Bernick, Janice Louise Cacace, Peter H.R. Persicaner, Neda Irani, Julia M. Amadio
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Abstract
Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.
Claims19
(canceled)
A method of treating a menopause-related symptom in a woman comprising:
- administering to the woman an effective amount of a pharmaceutical composition, the pharmaceutical composition comprising:
- solubilized estradiol;
- suspended progesterone;
- and
- a solubilizing agent;
- wherein each of the estradiol and the suspended progesterone are present in the solubilizing agent and the estradiol and progesterone are uniformly dispersed;
- wherein at least about 90% of the estradiol is solubilized in the solubilizing agent;
- and
- wherein the solubilizing agent comprises predominately at least one of mono-, di-, and triglycerides containing an ester of a C6-C12 fatty acid.
A method of treating a menopause symptom in a woman comprising:
- administering a pharmaceutical composition to the woman, the pharmaceutical composition comprising:
- solubilized estradiol;
- suspended progesterone;
- and
- a solubilizing agent, the solubilizing agent comprising predominately mono-, di-, and triglycerides containing an ester of a C6-C12 fatty acid;
- wherein the estradiol and the suspended progesterone are present in the solubilizing agent, the estradiol and progesterone are uniformly dispersed, and at least about 90% of the estradiol is solubilized in the solubilizing agent;
- and
- wherein the estradiol does not precipitate for at least 14 days.
A method of treating a menopause symptom comprising:
- administering an effective amount of a pharmaceutical composition to a woman, the pharmaceutical composition comprising:
- solubilized estradiol;
- suspended progesterone;
- and
- a solubilizing agent, the estradiol being stable in the solubilizing agent for at least 14 days;
- wherein each of the estradiol and the suspended progesterone are present in the solubilizing agent;
- wherein the estradiol and progesterone are uniformly dispersed;
- wherein at least about 90% of the estradiol is solubilized in the solubilizing agent, and
- wherein the solubilizing agent comprises predominately mono-, di-, and triglycerides containing an ester of a C6-C12 fatty acid.
Dependencies are inferred from the claim text.