Progesterone formulations having a desirable PK profile
AssigneeTherapeuticsMD, Inc.
InventorsJanice Cacace, Peter H. R. Persicaner, Thorsteinn Thorsteinsson, Frederick Sancilio, Julia Amadio, Brian Bernick
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Abstract
This disclosure provides progesterone formulations, methods of using these formulations, and their related pharmacokinetic parameters. In particular embodiments, the formulations disclosed herein allow for a reduction in the amount of progesterone administered to a patient in need thereof, while still providing the benefits of a larger dosage amount.
Claims32
A pharmaceutical composition for orally administering progesterone to a subject in need thereof, the composition comprising:
- progesterone;
- a solubilizing agent;
- and
- a nonionic surfactant;
- wherein the solubilizing agent comprises predominantly C6-C12 fatty acid tri-esters of glycerol;
- wherein the progesterone is present from about 20 to about 50 weight percent of the composition;
- and
- wherein the composition provides increased progesterone bioavailability compared to micronized progesterone suspended in peanut oil.
A pharmaceutical composition for orally administering progesterone to a subject in need thereof, the composition comprising:
- progesterone;
- a solubilizing agent;
- and
- a nonionic surfactant;
- wherein the solubilizing agent comprises predominantly C6-C12 fatty acid tri-esters of glycerol;
- wherein the progesterone is present from about 20 to about 50 weight percent of the composition and wherein less than 6 percent of the progesterone is soluble in the solubilizing agent;
- and
- wherein the composition provides increased progesterone bioavailability compared to micronized progesterone suspended in peanut oil.
Dependencies are inferred from the claim text.