Natural combination hormone replacement formulations and therapies
First Claim
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1. A pharmaceutical composition comprising:
- a solubilizing agent, the solubilizing agent comprising an effective amount of a C6-C12 oil;
0.5 mg estradiol or 0.52 mg estradiol hemihydrate, the estradiol or estradiol hemihydrate being at least about 90% solubilized in the solubilizing agent; and
100 mg progesterone;
wherein a portion of the progesterone is suspended; and
wherein the estradiol or the estradiol hemihydrate and the suspended progesterone are uniformly dispersed.
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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.
1172 Citations
12 Claims
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1. A pharmaceutical composition comprising:
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a solubilizing agent, the solubilizing agent comprising an effective amount of a C6-C12 oil; 0.5 mg estradiol or 0.52 mg estradiol hemihydrate, the estradiol or estradiol hemihydrate being at least about 90% solubilized in the solubilizing agent; and 100 mg progesterone; wherein a portion of the progesterone is suspended; and wherein the estradiol or the estradiol hemihydrate and the suspended progesterone are uniformly dispersed. - View Dependent Claims (2, 3)
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4. A pharmaceutical composition comprising:
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about 100 mg progesterone; about 0.5 mg estradiol or about 0.52 mg estradiol hemihydrate, the estradiol or estradiol hemihydrate being at least about 90% solubilized; about 196.48 mg of monoglycerides and diglycerides of caprylic acid and capric acid (CAPMUL MCM); and about 3.0 mg of at least one of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides NF, or lauroyl polyoxylglycerides (GELUCIRE 44/14); wherein a portion of the progesterone is suspended; and wherein the estradiol or the estradiol hemihydrate and the suspended progesterone are uniformly dispersed.
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5. A method comprising administering an effective amount of pharmaceutical composition to a subject in need thereof, the pharmaceutical composition comprising:
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about 100 mg progesterone; about 0.5 mg estradiol, the estradiol being at least about 90% solubilized in the solubilizing agent; about 196.48 mg of monoglycerides and diglycerides of caprylic acid and capric acid (CAPMUL MCM); and about 3.0 mg of at least one of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides NF, or lauroyl polyoxylglycerides (GELUCIRE 44/14); wherein a portion of the progesterone is suspended; and wherein the estradiol and the suspended progesterone are uniformly dispersed. - View Dependent Claims (6, 7)
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8. A method comprising administering an effective amount of a pharmaceutical composition comprising:
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0.5 mg estradiol or about 0.52 mg estradiol hemihydrate, the estradiol or estradiol hemihydrate being about 90% solubilized, the estradiol being at least about 90% solubilized in the solubilizing agent; 100 mg progesterone; and
7 a solubilizing agent, the solubilizing agent comprising an effective amount of a C6-C12 oil;wherein a portion of the progesterone is suspended; wherein the estradiol and the suspended progesterone are uniformly dispersed; and wherein the pharmaceutical composition is administered once daily for the treatment of symptoms associated with menopause. - View Dependent Claims (9, 10, 11, 12)
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Specification