Methods of providing analgesia
DCFirst Claim
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1. A method of providing analgesia in a human comprising:
- orally administering to the human a dosage form comprising a therapeutically effective amount of hydrocodone or a pharmaceutically acceptable salt thereofwherein the dosage form releases 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,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 administration,a hydrocodone plasma concentration of about 5 ng/ml or greater at 12 hours after 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.
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Citations
32 Claims
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1. A method of providing analgesia in a human comprising:
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orally administering to the human a dosage form comprising a therapeutically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof wherein the dosage form releases 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, 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 administration, a hydrocodone plasma concentration of about 5 ng/ml or greater at 12 hours after administration, and the dosage form is a tablet or a capsule. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method of providing analgesia in a human comprising:
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orally administering to the human a dosage form comprising from about 5 mg to about 1250 mg of hydrocodone or a pharmaceutically acceptable salt thereof and an excipient, wherein the excipient comprises from 1% to 80% of the dosage form by weight, 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 administration, and a hydrocodone plasma concentration of about 5 ng/ml or greater at 12 hours after administration. - View Dependent Claims (25, 26, 27, 28, 29, 30)
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31. A method of providing analgesia in a human comprising:
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orally administering to the human a dosage form comprising a therapeutically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, wherein the dosage form releases 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, 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 administration, a hydrocodone plasma concentration of about 3.93 ng/ml or greater at 12 hours after administration, and the dosage form is a tablet or a capsule. - View Dependent Claims (32)
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Specification