Controlled release hydrocodone formulations

A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising hydrocodone or a pharmaceutically acceptable salt thereof, a controlled release material and hydroxypropylcellulose or hydroxypropylmethylcellulose, such that the dosage form provides 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, wherein

• the dosage form is a compressed tablet,
• the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and
• the hydrocodone or pharmaceutically acceptable salt thereof is the only active agent in the dosage form.

A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising hydrocodone or a pharmaceutically acceptable salt thereof, a controlled release material and hydroxypropylcellulose or hydroxypropylmethylcellulose, 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, wherein

• the dosage form is a compressed tablet,
• the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and
• the hydrocodone or pharmaceutically acceptable salt thereof is the only active agent in the dosage form.

A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising hydrocodone or a pharmaceutically acceptable salt thereof, a controlled release material and hydroxypropylcellulose or hydroxypropylmethylcellulose, such that the dosage form provides a Tmax of hydrocodone of from about 4 to about 14 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, wherein

• the dosage form is a compressed tablet,
• the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and
• the hydrocodone or a pharmaceutically acceptable salt thereof is the only active agent in the dosage form.

A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising hydrocodone bitartrate, a controlled release material and hydroxypropylcellulose or hydroxypropylmethylcellulose, such that the dosage form provides 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, wherein

• the dosage form is a compressed tablet,
• the amount of hydrocodone bitartrate in the dosage form is equivalent to from about 0.5 mg to about 1250 mg hydrocodone, and
• the hydrocodone bitartrate is the only active agent in the dosage form.