Controlled Release Doxycycline

摘要

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.

主权项

1. 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; andless 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.