Controlled Release Doxycycline
AssigneeMayne Pharma International Pty Ltd.
InventorsStefan Lukas, Angelo Lepore, Stuart Mudge
Life of this patent
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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.
Claims30
A dosage form, comprising doxycycline combined with a controlled release composition,
- wherein said dosage form comprises 60, 90, or 120 mg of doxycycline, and at pH 5.0 the normalized average release of doxycycline measured under USP <711> conditions is at least one of:
- less than about 48% at 15 minutes;
- less than about 64% at 20 minutes;
- and
- less than about 72% at 25 minutes;
- 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 1100-2400 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.
A dosage form, comprising doxycycline combined with a controlled release composition,
- wherein said dosage form comprises 60, 90, or 120 mg of doxycycline, and at pH 5.0 the normalized average release of doxycycline measured under USP <711> conditions is at least one of:
- less than about 48% at 15 minutes;
- less than about 64% at 20 minutes;
- and
- less than about 72% at 25 minutes;
- wherein when the amount of doxycycline of said dosage form is 60 mg, after administration of a single dose to a patient in need thereof, the average AUC0-∞ is about 80% to about 125% of about 10000-24000 ng·hr/ml;
- or
- wherein when the amount of doxycycline of said dosage form is 90 mg, after administration of a single dose to a patient need thereof, the average AUC0-∞ is about 80% to about 125% of about 15000-36500 ng·hr/ml;
- or
- wherein when the amount of doxycycline of said dosage form is 120 mg, after administration of a single dose to a patient need thereof, the average AUC0-∞ is about 80% to about 125% of about 20000-48500 ng·hr/ml.
A dosage form, comprising doxycycline combined with a controlled release composition,
- wherein at pH 5.0 the normalized average release of doxycycline measured under USP <711> conditions is at least one of:
- less than about 48% at 15 minutes;
- less than about 64% at 20 minutes;
- and
- less than about 72% at 25 minutes;
- wherein 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 10-27 ng/ml per mg of doxycycline administered.
A dosage form, comprising doxycycline combined with a controlled release composition,
- wherein at pH 5.0 the normalized average release of doxycycline measured under USP <711> conditions is at least one of:
- less than about 48% at 15 minutes;
- less than about 64% at 20 minutes;
- and
- less than about 72% at 25 minutes;
- wherein after administration of a single dose to a patient in need thereof,
- the average AUC0-∞ is about 80% to about 125% of about 167-404 ng·hr/ml per mg of doxycycline administered.
Dependencies are inferred from the claim text.