Controlled release hydrocodone formulations

摘要

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.

主权项

1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a matrix comprising a bitartrate salt of hydrocodone and microcrystalline cellulose, the dosage form, after administration to a human subject, providing a C24/Cmax hydrocodone ratio of from about 0.55 to about 1.0, wherein
the dosage form is a tablet, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and the bitartrate salt of hydrocodone is the only active agent in the dosage form.