Progesterone formulations having a desirable pk profile
AssigneeTherapeuticsMD, Inc.
InventorsJulia Amadio, Brian Bernick, Peter H.R. Persicaner
Life of this patent
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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.
Claims9
A pharmaceutical composition for administering progesterone to subject in need thereof, the composition comprising an amount of progesterone and one or more solubilizing agents, wherein upon administration to the subject in need thereof, the composition produces at least one the following pharmacokinetic parameters in said subject:
- a. an AUC0−t in (ng/ml)*hr of from about 5 to about 500;
- b. an AUC0−∞ in (ng/ml)*hr of from about 5 to about 500;
- or
- c. a Cmax in ng/ml of from about 3 to about 350;
- wherein the amount of progesterone is less than 200 mg.
Dependencies are inferred from the claim text.