Controlled release hydrocodone formulations
DCFirst Claim
1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a plurality of multiparticulates comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone and a controlled release material,the plurality of multiparticulates compressed into a tablet,the dosage form providinga ratio of a plasma concentration of hydrocodone at the end of a dosing interval to a maximum plasma concentration of hydrocodone during the dosing interval of about 0.55 to about 1, and an effective pain relief over a period of time of about 12 hours or longer after administration to a human patient or a population of patients,an in-vitro release of hydrocodone when measured by the USP Basket method at 100 rpm in 700 ml aqueous buffer at a pH of 1.2 at 37°
- C. of from 10% to about 45% by weight hydrocodone released at 1 hour,wherein said hydrocodone bitartrate salt is the only active agent in the dosage form.
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Abstract
A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.
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Citations
30 Claims
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1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a plurality of multiparticulates comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone and a controlled release material,
the plurality of multiparticulates compressed into a tablet, the dosage form providing a ratio of a plasma concentration of hydrocodone at the end of a dosing interval to a maximum plasma concentration of hydrocodone during the dosing interval of about 0.55 to about 1, and an effective pain relief over a period of time of about 12 hours or longer after administration to a human patient or a population of patients, an in-vitro release of hydrocodone when measured by the USP Basket method at 100 rpm in 700 ml aqueous buffer at a pH of 1.2 at 37° - C. of from 10% to about 45% by weight hydrocodone released at 1 hour,
wherein said hydrocodone bitartrate salt is the only active agent in the dosage form. - View Dependent Claims (2, 3, 4, 26, 27)
- C. of from 10% to about 45% by weight hydrocodone released at 1 hour,
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5. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a plurality of multiparticulates comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone and a controlled release material, the multiparticulates individually coated with a controlled-release coating and compressed into a tablet,
the controlled release material included in an effective amount such that the dosage form provides a W50 of hydrocodone of between 4 and 22 hours and a plasma concentration of hydrocodone within a therapeutic range but below toxic concentrations over a period of time of about 12 hours or longer after administration to a human patient or a population of patients, wherein said hydrocodone bitartrate salt is the only active agent in the dosage form.
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11. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a plurality of pharmaceutically acceptable matrices comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone and a controlled release material, the pharmaceutically acceptable matrices individually coated with a controlled-release coating and compressed into a tablet,
the dosage form providing a Tmax of hydrocodone of from about 4 to about 10 hours and a plasma concentration of hydrocodone within a therapeutic range but below toxic concentrations over a period of time of about 12 hours or longer after administration to a human patient or a population of patients, wherein said hydrocodone bitartrate salt is the only active agent in the dosage form.
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17. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a plurality of pharmaceutically acceptable matrices comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone and a controlled release material,
the pharmaceutically acceptable matrices compressed into a tablet, the controlled release material included in an effective amount such that the dosage form provides a Tmax of hydrocodone of from about 4 to about 10 hours and a plasma concentration of hydrocodone within a therapeutic range but below toxic concentrations over a period of time of about 12 hours or longer after administration to a human patient or a population of patients, wherein said hydrocodone bitartrate salt is the only active agent in the dosage form.
Specification