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Last Updated: October 18, 2019

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Claims for Patent: 8,993,549

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Summary for Patent: 8,993,549
Title:Natural combination hormone replacement formulations and therapies
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.
Inventor(s): Bernick; Brian A. (Boca Raton, FL), Cacace; Janice Louise (Miami, FL), Persicaner; Peter H. R. (Boca Raton, FL), Irani; Neda (Palm Beach Garden, FL), Amadio; Julia M. (Boca Raton, FL)
Assignee: TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:14/475,864
Patent Claims: 1. A 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 an effective amount of a monoglyceride, a diglyceride or a combination thereof containing an ester of a C6-C12 fatty acid.

2. The pharmaceutical composition of claim 1, further comprising partially solubilized progesterone, wherein the partially solubilized progesterone is solubilized in the solubilizing agent.

3. The pharmaceutical composition of claim 1, wherein the formulation is formulated as a gelatin capsule.

4. The pharmaceutical composition of claim 1, wherein said estradiol has a dosage strength of at least about 0.125 mg and wherein said progesterone has a dosage strength of at least about 25 mg.

5. The pharmaceutical composition of claim 1, wherein the ratio of progesterone to estradiol is about 24:1, about 25:1, about 96:1, about 100:1, about 192:1, or about 200:1.

6. The pharmaceutical composition of claim 1, wherein the estradiol does not precipitate for at least 14 days.

7. A 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 an effective amount of a monoglyceride thereof containing an ester of a C6-C12 fatty acid.

8. The pharmaceutical composition of claim 7, further comprising partially solubilized progesterone, wherein the partially solubilized progesterone is solubilized in the solubilizing agent.

9. The pharmaceutical composition of claim 7, wherein the composition is formulated as a gelatin capsule.

10. The pharmaceutical composition of claim 7, wherein the estradiol has a dosage strength of at least about 0.125 mg and wherein the progesterone has a dosage strength of at least about 25 mg.

11. The pharmaceutical composition of claim 7, wherein the ratio of progesterone to estradiol is about 24:1, about 25:1, about 96:1, about 100:1, about 192:1, or about 200:1.

12. The pharmaceutical composition of claim 7, wherein the estradiol does not precipitate for at least 14 days.

13. A 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 comprising an effective amount of a diglyceride containing an ester of a C6-C12 fatty acid.

14. The pharmaceutical composition of claim 13, further comprising partially solubilized progesterone, wherein the partially solubilized progesterone is solubilized in the solubilizing agent.

15. The pharmaceutical composition of claim 13, wherein the composition is formulated in a gelatin capsule.

16. The pharmaceutical composition of claim 13, wherein the estradiol has a dosage strength of at least about 0.125 mg and wherein the progesterone has a dosage strength of at least about 25 mg.

17. The pharmaceutical composition of claim 13, wherein the ratio of progesterone to estradiol is about 24:1, about 25:1, about 96:1, about 100:1, about 192:1, or about 200:1.

18. The pharmaceutical composition of claim 13, wherein the estradiol does not precipitate for at least 14 days.

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