Claims for Patent: 10,052,386

Summary for Patent: 10,052,386

Title:	Progesterone formulations
Abstract:	Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.
Inventor(s):	Bernick; Brian A. (Boca Raton, FL), Amadio; Julia M. (Boca Raton, FL), Persicaner; Peter H. R. (Boca Raton, FL), Cacace; Janice Louise (Miami, FL), Thorsteinsson; Thorsteinn (West Palm Beach, FL), Sancilio; Frederick D. (Palm Beach Gardens, FL)
Assignee:	TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:	14/125,547
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,052,386
Patent Claims:	1. A pharmaceutical composition comprising: progesterone; a medium chain oil; and a non-ionic surfactant; wherein the progesterone is present from about 20 to about 50 weight percent of the composition. 2. The pharmaceutical composition of claim 1, wherein the progesterone is ultra-micronized and has an X50 less than or equal to 15 microns. 3. The pharmaceutical composition of claim 2, wherein the ultra-micronized progesterone has an X90 of less than about 25 microns. 4. The pharmaceutical composition of claim 1, wherein a portion of the progesterone is solubilized and a portion of the progesterone is suspended. 5. 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. 6. The pharmaceutical composition of claim 1, wherein the composition is provided in a gelatin capsule. 7. The pharmaceutical composition of claim 1, wherein the composition provides increased bioavailability compared to a micronized progesterone suspended in peanut oil. 8. The pharmaceutical composition of claim 1, wherein progesterone is the sole active ingredient. 9. The pharmaceutical composition of claim 1, wherein the medium chain oil comprises at least one C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol or mono- or di-ester of a glycol. 10. The pharmaceutical composition of claim 9, wherein the at least one C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol is a C.sub.8 fatty acid mono-, di-, or tri-ester of glycerol. 11. The pharmaceutical composition of claim 10, further comprising a second C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol. 12. The pharmaceutical composition of claim 11, wherein the second C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol is a C.sub.10 fatty acid mono-, di-, or tri-ester of glycerol. 13. The pharmaceutical composition of claim 12, wherein the medium chain oil is MIGLYOL 812. 14. A pharmaceutical composition comprising: 75 mg of progesterone; a medium chain oil; and a non-ionic surfactant; wherein the progesterone is present at from about 20 to about 50 weight percent of the composition. 15. The pharmaceutical composition of claim 14, wherein the progesterone is ultra-micronized and has an X50 less than or equal to 15 microns. 16. The pharmaceutical composition of claim 15, wherein the ultra-micronized progesterone has an X90 of less than about 25 microns. 17. The pharmaceutical composition of claim 14, wherein a portion of the progesterone is solubilized and a portion of the progesterone is suspended. 18. The pharmaceutical composition of claim 14, 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. 19. The pharmaceutical composition of claim 14, wherein the composition is provided in a gelatin capsule. 20. The pharmaceutical composition of claim 14, wherein the composition provides increased bioavailability compared to a micronized progesterone suspended in peanut oil. 21. The pharmaceutical composition of claim 14, wherein progesterone is the sole active ingredient. 22. The pharmaceutical composition of claim 14, wherein the medium chain oil comprises at least one C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol or mono- or di-ester of a glycol. 23. The pharmaceutical composition of claim 22, wherein the at least one C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol is a C.sub.8 fatty acid mono-, di-, or tri-ester of glycerol. 24. The pharmaceutical composition of claim 23, further comprising a second C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol. 25. The pharmaceutical composition of claim 24, wherein the second C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol is a C.sub.10 fatty acid mono-, di-, or tri-ester of glycerol. 26. The pharmaceutical composition of claim 25, wherein the medium chain oil is MIGLYOL 812. 27. A pharmaceutical composition comprising: 150 mg progesterone; a medium chain oil; and a non-ionic surfactant; wherein the progesterone is present at from about 20 to about 50 weight percent of the composition. 28. The pharmaceutical composition of claim 27, wherein the progesterone is ultra-micronized and has an X50 less than or equal to 15 microns. 29. The pharmaceutical composition of claim 28, wherein the ultra-micronized progesterone has an X90 of less than about 25 microns. 30. The pharmaceutical composition of claim 27, wherein a portion of the progesterone is solubilized and a portion of the progesterone is suspended. 31. The pharmaceutical composition of claim 27, 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. 32. The pharmaceutical composition of claim 27, wherein the composition is provided in a gelatin capsule. 33. The pharmaceutical composition of claim 27, wherein the composition provides increased bioavailability compared to a micronized progesterone suspended in peanut oil. 34. The pharmaceutical composition of claim 27, wherein progesterone is the sole active ingredient. 35. The pharmaceutical composition of claim 27, wherein the medium chain oil comprises at least one C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol or mono- or di-ester of a glycol. 36. The pharmaceutical composition of claim 35, wherein the at least one C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol is a C.sub.8 fatty acid mono-, di-, or tri-ester of glycerol. 37. The pharmaceutical composition of claim 36, further comprising a second C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol. 38. The pharmaceutical composition of claim 37, wherein the second C.sub.6-C.sub.14 fatty acid mono-, di-, or tri-ester of glycerol is a C.sub.10 fatty acid mono-, di-, or tri-ester of glycerol. 39. The pharmaceutical composition of claim 38, wherein the medium chain oil is MIGLYOL 812. 40. The pharmaceutical composition of claim 27, wherein the medium chain oil is MIGLYOL 812, the non-ionic surfactant is lauroyl polyoxyl-32-glycerides, and wherein the pharmaceutical formulation provides increased progesterone bioavailability compared to a formulation comprising an equivalent amount of micronized progesterone suspended in peanut oil.