Controlled Release Pharmaceutical Dosage Forms
AssigneeMedicis Pharmaceutical Corporation
InventorsSajeev CHANDRAN, Shirishkumar KULKARNI, Pravin Meghrajji BHUTADA, Ashish Ashokrao DESHMUKH, Douglas BAKAN, Mitchell WORTZMAN
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Abstract
The present disclosure provides novel controlled release pharmaceutical dosage form, methods of making the same, and methods of using the same to treat dermatological conditions.
Claims16
A method for treating acne, rosacea, or a combination thereof comprising administering to a patient in need thereof a controlled release pharmaceutical dosage form comprising doxycycline, wherein said controlled release pharmaceutical dosage form has a mean Cmax that is at least about 70% that of an immediate release dosage form of equivalent strength and has an AUC that is at least about 85% of an immediate release dosage form of equivalent strength.
A method for treating acne, rosacea, or a combination thereof comprising administering to a patient in need thereof a controlled release dosage form comprising doxycycline, wherein said dosage form has a tmax that is at least about 1.15 times greater than the tmax of an immediate release dosage form of equivalent strength.
A method of treating acne, rosacea, or a combination thereof comprising administering to a patient in need thereof, a controlled release pharmaceutical dosage form comprising doxycycline, wherein the dosage form has an in vitro dissolution profile, such that at least about 10% to 25% of the total doxycycline present in the dosage form is released in 1 hour, or at least about 25% to 50% of the total doxycycline is released in 4 hours, or at least about more than 90% of the total doxycycline is released in 10 hours, wherein the release profile is measured in a USP Basket apparatus using 0.1N HCl at 100 rpm.
Dependencies are inferred from the claim text.