Progesterone formulations
Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.
1. A pharmaceutical composition comprising:
progesterone and an effective amount of estradiol not exceeding 2 mg, wherein the estradiol and progesterone are present in a weight ratio of 1:100;
a medium chain oil; and
a non-ionic surfactant;
further wherein the progesterone is present from about 20 to about 50 weight percent of the composition.
2. The pharmaceutical composition of claim 1 , wherein a portion of the progesterone is solubilized and a portion of the progesterone is suspended.
3. The pharmaceutical composition of claim 1 , wherein the non-ionic surfactant is selected from the group consisting of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides, and caprylocaproyl macrogol-8 glycerides EP.
4. The pharmaceutical composition of claim 1 , wherein the composition is provided in a gelatin capsule.
5. The pharmaceutical composition of claim 1 , wherein the composition provides increased progesterone bioavailability compared to a micronized progesterone suspended in peanut oil.
6. The pharmaceutical composition of claim 1 , wherein the medium chain oil comprises at least one C6-C14 fatty acid mono-, di-, or tri-ester of glycerol or mono- or di-ester of a glycol.
7. The pharmaceutical composition of claim 6 , wherein the at least one C6-C14 fatty acid mono-, di-, or tri-ester of glycerol is a C8 fatty acid mono-, di-, or tri-ester of glycerol.
8. The pharmaceutical composition of claim 6 , further comprising a second C6-C14 fatty acid mono-, di-, or tri-ester of glycerol.
9. The pharmaceutical composition of claim 8 , wherein the second C6-C14 fatty acid mono-, di-, or tri-ester of glycerol is a C10 fatty acid mono-, di-, or tri-ester of glycerol.
10. The pharmaceutical composition of claim 9 , wherein the medium chain oil is CAPMUL MCM.
11. The pharmaceutical composition of claim 1 , comprising 50 mg of progesterone.
12. The pharmaceutical composition of claim 1 , comprising 100 mg of progesterone.
13. The pharmaceutical composition of claim 12 , wherein the progesterone is ultra-micronized and has an X50 less than or equal to 15 microns.
14. The pharmaceutical composition of claim 13 , wherein the ultra-micronized progesterone has an X90 of less than about 25 microns.
15. The pharmaceutical composition of claim 12 , wherein a portion of the progesterone is solubilized and a portion of the progesterone is suspended.
16. The pharmaceutical composition of claim 15 , wherein the non-ionic surfactant is selected from the group consisting of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides, and caprylocaproyl macrogol-8 glycerides EP.
17. The pharmaceutical composition of claim 16 , wherein the composition is provided in a gelatin capsule.
18. The pharmaceutical composition of claim 16 , wherein the composition provides increased progesterone bioavailability compared to a micronized progesterone suspended in peanut oil.
19. The pharmaceutical composition of claim 18 , wherein the medium chain oil comprises at least one C6-C14 fatty acid mono-, di-, or tri-ester of glycerol or mono- or di-ester of a glycol.
20. The pharmaceutical composition of claim 19 , wherein the at least one C6-C14 fatty acid mono-, di-, or tri-ester of glycerol is a C8 fatty acid mono-, di-, or tri-ester of glycerol.
21. The pharmaceutical composition of claim 20 , further comprising a second C6-C14 fatty acid mono-, di-, or tri-ester of glycerol.
22. The pharmaceutical composition of claim 21 , wherein the second C6-C14 fatty acid mono-, di-, or tri-ester of glycerol is a C10 fatty acid mono-, di-, or tri-ester of glycerol.
23. The pharmaceutical composition of claim 22 , wherein the medium chain oil is CAPMUL MCM.