Extended Release Compositions Comprising Hydrocodone And Acetaminophen For Rapid Onset And Prolonged Analgesia That May Be Administered Without Regard To Food

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. A solid oral dosage form comprising:
(a) at least one immediate release portion comprising acetaminophen and hydrocodone or a pharmaceutically acceptable salt thereof; and (b) at least one extended release portion comprising acetaminophen, hydrocodone or a pharmaceutically acceptable salt thereof, and an extended release component; wherein the total amount of acetaminophen in the dosage form is about 325 mg to about 650 mg, and the total amount of hydrocodone or its pharmaceutically acceptable salt in the dosage form is about 5 mg to about 15 mg; and wherein upon oral administration of the dosage form to a subject, the dosage form provides a higher AUC for hydrocodone when the dosage form is administered to the subject in an intact state versus when the dosage form is administered to the subject in a crushed or ground state.