Natural combination hormone replacement formulations and therapies
DCFirst Claim
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1. A method of treating a subject having vasomotor symptoms associated with estrogen deficiency, the method comprising administering to the subject an effective amount of a pharmaceutical composition comprising:
- about 0.25 mg estradiol, wherein at least 80% of the estradiol in the composition is solubilized estradiol;
progesterone, wherein the progesterone comprises suspended progesterone; and
a medium-chain oil comprising medium chain fatty acid esters of glycerol, polyethylene glycol, or propylene glycol, or mixtures thereof, wherein the medium chain fatty acid esters are predominantly esters of C6 to C12 fatty acids, and wherein the entire amount of the estradiol and the progesterone in the composition is present in the oil;
wherein administration of the composition to the subject produces, in a plasma sample from the subject, one or more 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.
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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.
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Citations
20 Claims
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1. A method of treating a subject having vasomotor symptoms associated with estrogen deficiency, the method comprising administering to the subject an effective amount of a pharmaceutical composition comprising:
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about 0.25 mg estradiol, wherein at least 80% of the estradiol in the composition is solubilized estradiol; progesterone, wherein the progesterone comprises suspended progesterone; and a medium-chain oil comprising medium chain fatty acid esters of glycerol, polyethylene glycol, or propylene glycol, or mixtures thereof, wherein the medium chain fatty acid esters are predominantly esters of C6 to C12 fatty acids, and wherein the entire amount of the estradiol and the progesterone in the composition is present in the oil; wherein administration of the composition to the subject produces, in a plasma sample from the subject, one or more 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 17)
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8. A method of treating a subject having vasomotor symptoms associated with estrogen deficiency, the method comprising administering to the subject an effective amount of a pharmaceutical composition comprising:
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about 0.5 mg estradiol, wherein at least 80% of the estradiol in the composition is solubilized estradiol; progesterone, wherein the progesterone comprises suspended progesterone; and a medium-chain oil comprising medium chain fatty acid esters of glycerol, polyethylene glycol, or propylene glycol, or mixtures thereof, wherein the medium chain fatty acid esters are predominantly esters of C6 to C12 fatty acids, and wherein the entire amount of the estradiol and the progesterone in the composition is present in the oil; wherein administration of the composition to the subject produces, in a plasma sample from the subject, one or more 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. - View Dependent Claims (9, 10, 11, 15, 18, 19)
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12. A method of treating a subject having vasomotor symptoms associated with estrogen deficiency, the method comprising administering to the subject an effective amount of a pharmaceutical composition comprising:
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about 1 mg estradiol, wherein at least 80% of the estradiol in the composition is solubilized estradiol; progesterone, wherein the progesterone comprises suspended progesterone; and a medium-chain (C6-C12) oil comprising medium chain fatty acid esters of glycerol, polyethylene glycol, or propylene glycol, or mixtures thereof, wherein the medium chain fatty acid esters are predominantly esters of C6 to C12 fatty acids, and wherein the entire amount of the estradiol and the progesterone in the composition is present in the oil; wherein administration of the composition to the subject produces, in a plasma sample from the subject, one or more 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. - View Dependent Claims (13, 14, 16, 20)
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Specification