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US 2016/0101052 A1Published application
Controlled release doxycycline
AssigneeMayne Pharma International Pty Ltd.
InventorsStefan Lukas, Angelo Lepore, Stuart Mudge
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Abstract
The disclosure provides controlled release compositions comprising tetracyclines and in some embodiments, doxycycline. The controlled release doxycycline compositions of the invention exhibit a superior dissolution profile and provide reduce side effects such as nausea and irritation.
Claims26
A dosage form, comprising a plurality of modified release doxycycline pellets, wherein each doxycycline pellet comprises:
- doxycycline;
- and
- a controlled release polymer composition disposed over the doxycycline, wherein said dosage form comprises 60, 90, or 120 mg of doxycycline and releases less than about 15% of the doxycycline at pH 1.2, and less than 40% of the doxycycline at pH 4.5 after 60 minutes, measured under USP <711> conditions;
- and
- wherein when the amount of doxycycline of said dosage form is 60 mg, after administration of a single dose under fasting conditions to a patient in need thereof, the average Cmax is about 80% to about 125% of about 625-1600 ng/ml;
- or
- wherein when the amount of doxycycline of said dosage form is 90 mg, after administration of a single dose under fasting conditions to a patient in need thereof, the average Cmax is about 80% to about 125% of about 940-2400 ng/ml;
- or
- wherein when the amount of doxycycline of said dosage form is 120 mg, after administration of a single dose under fasting conditions to a patient in need thereof, the average Cmax is about 80% to about 125% of about 1250-3200 ng/ml.
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Dependencies are inferred from the claim text.