Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia
AssigneeMallinckrodt Inc.
InventorsKrishna Devarakonda, Michael J. Giuliani, Vishal K. Gupta, Ralph A. Heasley, Susan Shelby
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Abstract
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.
Claims27
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.
An extended release pharmaceutical composition comprising:
- at least one immediate release portion comprising hydrocodone or a pharmaceutically acceptable salt thereof and acetaminophen and at least one extended release portion comprising an extended release component, hydrocodone or a pharmaceutically acceptable salt thereof, and acetaminophen;
- wherein the at least one immediate release portion comprises from about 20% to about 30% (w/w) of the total amount of the hydrocodone or a pharmaceutically acceptable salt thereof, and about 40% to about 60% (w/w) of the total amount of the acetaminophen in the composition;
- wherein the sum of the amounts of the acetaminophen in the immediate release and the extended release portions is about 325 mg;
- wherein the sum of the amounts of the hydrocodone or pharmaceutically acceptable salt thereof in the immediate release and extended release portions is about 7.5 mg;
- and
- wherein the composition can be administered to a subject in need thereof without regard to food.
A pharmaceutical composition comprising an immediate release portion and an extended release portion, wherein:
- the immediate release portion comprises acetaminophen and hydrocodone or a pharmaceutically acceptable salt thereof,
- the extended release comprises acetaminophen, hydrocodone or a pharmaceutically acceptable salt thereof, and an extended release component, and
- the total amount of acetaminophen in the pharmaceutical composition is from about 325 mg to about 650 mg and the total amount of hydrocodone or a pharmaceutically acceptable salt thereof in the pharmaceutical composition is from about 7.5 mg to about 15 mg,
- wherein the pharmaceutical composition provides an AUC(0-3hr) for hydrocodone after a single dose from about 1.0 ng·hr/mL/mg to about 5.0 ng·hr/mL/mg.
Dependencies are inferred from the claim text.