Controlled release hydrocodone formulations
DCFirst Claim
1. An oral dosage form comprising a or a pharmaceutically acceptable salt thereof the dosage form releasing the hydrocodone or pharmaceutically acceptable salt thereof at such a rate that plasma concentrations of hydrocodone are maintained within the therapeutic range but below toxic concentrations for about 12 hours or longer,wherein the hydrocodone or pharmaceutically acceptable salt thereof is the only drug in the dosage form,the dosage form provides a hydrocodone plasma concentration of at least about 8 ng/ml at about 8 hours after oral administration,a hydrocodone plasma concentration of about 5 ng/ml or greater at 12 hours after oral administration, andthe dosage form is a tablet or a capsule.
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Abstract
A solid oral controlled-release oral dosage form of hydrocodone is disclosed. The dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and a sufficient amount of a controlled release material to render the dosage form suitable for twice-a-day administration to a human patient, the dosage form providing a C12/Cmax ratio of 0.55 to 0.85, said dosage form providing a therapeutic effect for at least about 12 hours.
361 Citations
32 Claims
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1. An oral dosage form comprising a or a pharmaceutically acceptable salt thereof the dosage form releasing the hydrocodone or pharmaceutically acceptable salt thereof at such a rate that plasma concentrations of hydrocodone are maintained within the therapeutic range but below toxic concentrations for about 12 hours or longer,
wherein the hydrocodone or pharmaceutically acceptable salt thereof is the only drug in the dosage form, the dosage form provides a hydrocodone plasma concentration of at least about 8 ng/ml at about 8 hours after oral administration, a hydrocodone plasma concentration of about 5 ng/ml or greater at 12 hours after oral administration, and the dosage form is a tablet or a capsule.
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24. An oral dosage form comprising from or a pharmaceutically acceptable salt thereof and an excipient, the excipient comprising from 1% to 80% of the dosage form by weight, wherein
hydrocodone or a pharmaceutically acceptable salt thereof is the only drug in the dosage form, and the dosage form provides a controlled release of hydrocodone or a pharmaceutically acceptable salt thereof over about 8 to about 24 hours, a hydrocodone plasma concentration of at least about 8 ng/ml from at about 8 hours after oral administration, and a hydrocodone plasma concentration of about 5 ng/ml or greater at 12 hours after oral administration.
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31. An oral dosage form comprising a or a pharmaceutically acceptable salt thereof the dosage form releasing the hydrocodone or a pharmaceutically acceptable salt thereof at such a rate that plasma concentrations of hydrocodone are maintained within the therapeutic range but below toxic concentrations for about 12 hours or longer,
wherein the hydrocodone or a pharmaceutically acceptable salt thereof is the only drug in the dosage form, the dosage form provides a hydrocodone plasma concentration of at least about 8 ng/ml at about 8 hours after oral administration, a hydrocodone plasma concentration of 3.93 ng/ml or greater at 12 hours after oral administration, and the dosage form is a tablet or a capsule.
Specification