Immediate release dosage form
AssigneeKenvue Brands LLC
InventorsJitendra Krishan Somani, Murali K. Vuppala
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Abstract
An improved immediate release solid dosage form of naproxen with a certain particle size distribution for the intragranular portion, and a certain particle size distribution for the carbonate portion that allows naproxen to remain in solution and achieves fast dissolution and fast absorption of naproxen. The invention provides a naproxen dosage form that when administered to a human in a fasted state provides an average blood plasma naproxen concentration of at least 15-20 μg/ml in 10 minutes or less. The invention also provides a naproxen dosage form that when administered to a human in a fed state provides an average blood plasma naproxen concentration of at least 15-20 μg/ml in 50 minutes or less.
Claims26
-14. (canceled)
A method for the treatment of pain, which method comprises administering to a fasted subject in need thereof, an immediate release naproxen sodium formulation so that the blood plasma concentration levels of naproxen range from and include at least 15-20 μg/ml in 10 minutes or less.
A method for the treatment of pain, which method comprises administering to a fed subject in need thereof, an immediate release naproxen sodium formulation so that the blood plasma concentration levels of naproxen range from and include at least 15-20 μg/ml in 50 minutes or less.
An immediate release solid dosage form comprising an effective amount of naproxen, salts thereof and combinations thereof, and a soluble carbonate, wherein the particle size of the soluble carbonate is from about 50 microns to 200 microns.
Dependencies are inferred from the claim text.