Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia

摘要

The present disclosure provides an extended release pharmaceutical composition comprising hydrocodone and acetaminophen that provides a rapid onset of analgesia, and reduced levels of acetaminophen near the end of the dosing interval. Also provided are methods for reducing the risk of acetaminophen-induced hepatic damage in a subject being treated with an acetaminophen containing composition, as well as methods for treating pain in a subject in need thereof.

主权项

1. An extended release pharmaceutical composition, comprising:
an immediate release portion comprising hydrocodone or a pharmaceutically acceptable salt of hydrocodone, acetaminophen, or a combination thereof; and an extended release portion comprising hydrocodone or a pharmaceutically acceptable salt of hydrocodone, acetaminophen, or a combination thereof; wherein the total amount of acetaminophen in the composition is from about 325 mg to about 650 mg and the total amount of hydrocodone or a pharmaceutically acceptable salt thereof in the composition is from about 7.5 mg to about 15 mg; wherein when the composition is orally administered to a subject in need thereof the composition delivers the hydrocodone or the pharmaceutically acceptable salt thereof and the acetaminophen to the subject's upper gastrointestinal tract for at least about 4 hours to about 12 hours; and wherein there is substantially no effect on AUC0-inf for hydrocodone and acetaminophen when the pharmaceutical composition is administered in a fed versus fasted state.