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US 10,869,877 B2Granted
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 reduced side effects such as nausea and irritation.
Claims25
A dosage form, comprising a plurality of modified release doxycycline salt pellets, wherein the doxycycline salt pellets comprise a doxycycline salt core and a controlled release polymer composition disposed over the core,
- wherein said controlled release polymer composition comprises a blend of hydroxypropyl methylcellulose phthalate and hydroxypropyl methyl cellulose;
- wherein said dosage form comprises doxycycline salt in an amount equivalent to 60, 90, or 120 mg of doxycycline base;
- wherein said dosage form comprising doxycycline salt maintains doxycycline base release levels measured under USP <711> conditions at pH 5 that provide a clinically effective plasma level of doxycycline base;
- wherein said dosage form releases less than 15% of the doxycycline at pH 1.2 and less than 40% of the doxycycline at pH 4.5 after 60 minutes;
- and
- wherein after administration of a single dose under fasting conditions to a patient in need thereof, the average AUC0-∞ is 80% to 125% of 200-300 ng·hr/ml per mg of doxycycline base administered.
3 more elements
Dependencies are inferred from the claim text.