Controlled release hydrocodone formulations

摘要

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.

主权项

1. A solid oral controlled-release dosage form, the dosage form comprising a compressed tablet comprising
a plurality of multiparticulates collectively consisting essentially of from about 5 mg to about 60 mg of hydrocodone or a pharmaceutically acceptable salt thereof, hydroxypropylmethyl cellulose and ethylcellulose, each multiparticulate individually coated with a coating consisting of (i) ethylcellulose, (ii) a wax and (iii) optional plasticizer(s), said dosage form, after a first administration to a human patient, provides a C12/Cmax hydrocodone ratio of 0.55 to 0.85 and a therapeutic effect for about 12 hours.